Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

For ObGyns, 2 intensely stressful career milestones are the day you start your practice and the day you decide to put it up for sale.

One of us, Dr. Baum, started a practice in 1976. At that time, many clinicians seemed to work right up until the day they died—in mid-examination or with scalpel in hand! Today, clinicians seriously contemplate leaving an active practice at age 55, 60, or, more traditionally, 65.

ObGyns in group practice, even those with only 1 or 2 partners, presumably have in place a well-thought-out and properly drafted contract with buyout and phase-down provisions. For members of a group practice, it is imperative to critically review and discuss contractual arrangements periodically and decide if they make sense as much now as they did at the start. ObGyns who continually revisit their contracts probably have an exit strategy that is fairly self-executing and effective and that will provide the seller with a seamless transition to retirement.

A solo ObGyn who is selling a practice has 3 basic options: find a successor physician, sell to a hospital or to a larger group, or close the practice.

Related article:
ObGyns’ choice of practice environment is a big deal

Preparing your practice for sale

Regardless of who will take over your practice, you need to prepare for its transition.

The most important aspect of selling your practice is knowing its finances and ensuring that they are in order. Any serious buyer will ask to examine your books, see how you are running the business, and assess its vitality and potential growth. Simply, a buyer will want to know where your revenue comes from and where it goes.

Your practice will be attractive to a buyer if it shows a stable or growing revenue base, an attractive payer mix, reasonable overhead, and personal income that is steady if not increasing. If your earning capacity is low or declining, you will need to explain why.

Timing is key

We strongly recommend beginning the process 3 to 5 years before your intended exit.

By starting early, up to 5 years in advance, you can maximize the likelihood that your practice will retain all or most of its value. Moreover, you can use the long lead time to thoroughly explore all available options and find a committed buyer.

Selling a practice can be a complicated affair, and many ObGyns do not have the requisite skills. So much of the success in selling depends on the specifics of the practice, the physician, and the market (the hospital and physician environment).

Identifying potential buyers

Other ObGyns. Recruiting an ObGyn to take over your practice seems to be the best option but can prove very difficult in today’s environment. Many younger clinicians are either joining large groups or becoming hospital employees.

Other physician groups. While working your way down your list of potential buyers, you should also be quietly, subtly, and tactfully assessing other practices, even your competitors, to see if any are candidates for merging with and/or acquiring yours and all your charts, records, and referring physicians.

Hospitals. In today’s health care environment, in which more than half of clinicians are becoming hospital employees, selling to your associated hospital may be a viable option.

Your practice is probably contributing millions of dollars in income to that hospital each year, and of course the hospital would like to maintain this revenue stream. You should consider talking to the hospital’s CEO or medical director.

Hospitals also know that, if you leave and the market cannot absorb the resulting increase in demand for care, patients may go elsewhere, to a competing hospital or outside the community. Rather than lose your market share, a hospital may consider the obvious solution: recruit a replacement ObGyn for your practice.

Your goal here is to negotiate an agreement in which your hospital will recruit a replacement ObGyn, provide financial support, and transition your practice to that ObGyn over a specified period.

The hospital could acquire your practice and either employ you during the transition or provide recruiting support and an income guarantee to help your practice pay the new physician’s salary. Whether to sell or remain independent is often driven by the needs and desires of the recruit. As the vast majority of clinicians coming out of training are seeking employment, in most cases the agreement will require a sale.

Selling to a hospital a few years before your retirement can be a plus. You might find employment a welcome respite from the daunting responsibility of managing your own practice. Life can become much less stressful as you introduce and transition your patients to the new ObGyn. You will be working less, taking fewer calls, and maintaining or even increasing your income, all without the burden of managing the practice.

Read about determining your practice’s value

Putting a monetary value on your practice

After deciding to sell your practice, you need to determine its value. Buying a practice may be the largest financial transaction a young ObGyn will ever make. For a retiring physician, valuation of a practice may reflect a career’s worth of “sweat equity.”

What is your practice worth?

All ObGyns believe their practice is worth far more than any young ObGyn or hospital is willing to pay for it. After all, you have spent a medical lifetime creating, building, and nurturing your practice. You have cared for several thousand patients, who have been loyal and may want to stay with the practice under its new ObGyn. So, how does a retiring physician put a value on his or her practice and then “cast the net” to the marketplace? How do you find a buyer who will pay the asking price and then help the practice make the transition from seller to buyer and continue to serve their patients?

The buyer’s perspective on value. In a pure sense, the value of any asset is what a potential buyer is willing to pay. From a value standpoint, the price that potential buyers are willing to pay varies by the specifics of the situation, regardless of what a valuation or practice appraisal might indicate.

For example, once your plan to retire becomes known, why would a young ObGyn agree to pay X dollars for all your medical records? After all, the potential buyer knows that your existing patients and your referral base will need to seek care from another ObGyn after you leave, and they will likely stay with the practice if they feel they will be treated well by the new clinician.

A hospital may take a similar tack but more often will be willing to pay fair market value for your practice. Hospitals, however, cannot legally pay more than fair market value as determined by an independent appraiser.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Valuation methods

The valuation of any business generally is approached in terms of market, assets, and income.

The market approach usually is taken only with regard to office real estate. Given the lack of reliable and comparable sales information, this approach is seldom used in the valuation of medical practices. If you own your office real estate, a real estate appraiser will establish its fair market value.

In the assets approach, the individual assets of a medical practice are valued on the basis of their current market values. These assets are either tangible or intangible.

Tangible assets can be seen and touched. Furniture, equipment, and office real estate are examples.

The fair market value of used furniture and equipment is most often determined by replacement cost. The value of these items is limited. Usually it starts at 50% of the cost of buying new furniture or equipment of the same utility. From there, the value is lowered on the basis of the age and condition of the items.

Often, the market value of major ObGyn office equipment, such as a DXA (dual-energy x-ray absorptiometry) scanner, is based on similar items for sale or recently sold in the used secondary equipment market.

Tangible assets may include accounts receivable (A/R). A/R represents uncollected payment for work performed. Most buyers want to avoid paying for A/R and assuming the risk of collections. Generally, you should expect to retain your A/R and pay a small or nominal fee to have the buyer handle the collections after you have retired.

Intangible assets are not physical. Examples include the physician’s name, phone number, reputation, referral base, trained staff, and medical records—in other words, what gets patients to keep coming back. Most physicians value these goodwill or “blue-sky” assets highly. Today, unfortunately, most sellers are unable to reap any financial benefit from their intangible assets.

The income approach is based on the premise that the value of any business is in the income it generates for its owner. In simple terms, value in the income approach is a multiple of the cash the business generates after expenses.

Read important keys to transitioning the practice

Transitioning the practice: Role of the seller and the buyer

First and very important is the contract agreement regarding the overlap period, when both the exiting ObGyn and the new ObGyn are at the practice. We suggest making the overlap a minimum of 6 months and a maximum of 1 year. During this period, the exiting physician can introduce the incoming physician to the patients. A face-to-face introduction can amount to an endorsement, which can ease a patient’s mind and help her decide to take on the new ObGyn and philosophy rather than search elsewhere for obstetric and gynecologic care. The new ObGyn also can use the overlap period to become familiar and comfortable with the staff and learn the process for physician and staff management of case flow, from scheduling and examination to insurance and patient follow-up.

We suggest that the exiting ObGyn send a farewell/welcome letter to patients and referring physicians. The letter should state the exiting ObGyn’s intention to leave (or retire from) the practice and should introduce the ObGyn who will be taking over.

The exiting ObGyn should also take the new ObGyn to meet the physicians who have been providing referrals over the years. We suggest visiting each referring physician’s office to make the introduction. Another good way to introduce a new ObGyn to referring physicians and other professionals—endocrinologists, cardiologists, nurses, pharmaceutical representatives—is to host an open house at your practice. Invite the staff members of the referring physicians as well, since they can be invaluable in making referrals.

We recommend that the exiting ObGyn spend the money to update all the practice’s stationery, brochures, and print materials and ensure they look professional. Note that it is not acceptable to place the new ObGyn’s name under the exiting ObGyn’s name. If the practice has a website, introduce the new physician there and make any necessary updates regarding office hours and accepted insurance plans.

If the exiting ObGyn’s practice lacks a robust Internet and social media presence, the new ObGyn should establish one. We recommend setting up an interactive website that patients can use to make appointments and pay bills. The website should have an email component that can be used to ask questions, raise concerns, and get answers. We also recommend opening Facebook, YouTube, and Twitter accounts for the practice and being active on these social media.

In our experience, smoothly transitioning practices can achieve patient retention rates as high as 90% to 95%. For practices without a plan, however, these rates may be as low as 50%, or worse. Therefore, work out a plan in advance, and include the steps described here, so that on arrival the new ObGyn can hit the ground running.

Acquiring a successful medical practice is doable and offers many advantages, such as autonomy and the ability to make business decisions affecting the practice. Despite all the changes happening in health care, we still think this is the best way to go.

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Bottom line

Selling an ObGyn practice can be a daunting process. However, deciding to sell your practice, performing the valuation, and ensuring a smooth transition are part and parcel of making the transfer a success, equitable for both the buyer and the seller.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For ObGyns, 2 intensely stressful career milestones are the day you start your practice and the day you decide to put it up for sale.

One of us, Dr. Baum, started a practice in 1976. At that time, many clinicians seemed to work right up until the day they died—in mid-examination or with scalpel in hand! Today, clinicians seriously contemplate leaving an active practice at age 55, 60, or, more traditionally, 65.

ObGyns in group practice, even those with only 1 or 2 partners, presumably have in place a well-thought-out and properly drafted contract with buyout and phase-down provisions. For members of a group practice, it is imperative to critically review and discuss contractual arrangements periodically and decide if they make sense as much now as they did at the start. ObGyns who continually revisit their contracts probably have an exit strategy that is fairly self-executing and effective and that will provide the seller with a seamless transition to retirement.

A solo ObGyn who is selling a practice has 3 basic options: find a successor physician, sell to a hospital or to a larger group, or close the practice.

Related article:
ObGyns’ choice of practice environment is a big deal

Preparing your practice for sale

Regardless of who will take over your practice, you need to prepare for its transition.

The most important aspect of selling your practice is knowing its finances and ensuring that they are in order. Any serious buyer will ask to examine your books, see how you are running the business, and assess its vitality and potential growth. Simply, a buyer will want to know where your revenue comes from and where it goes.

Your practice will be attractive to a buyer if it shows a stable or growing revenue base, an attractive payer mix, reasonable overhead, and personal income that is steady if not increasing. If your earning capacity is low or declining, you will need to explain why.

Timing is key

We strongly recommend beginning the process 3 to 5 years before your intended exit.

By starting early, up to 5 years in advance, you can maximize the likelihood that your practice will retain all or most of its value. Moreover, you can use the long lead time to thoroughly explore all available options and find a committed buyer.

Selling a practice can be a complicated affair, and many ObGyns do not have the requisite skills. So much of the success in selling depends on the specifics of the practice, the physician, and the market (the hospital and physician environment).

Identifying potential buyers

Other ObGyns. Recruiting an ObGyn to take over your practice seems to be the best option but can prove very difficult in today’s environment. Many younger clinicians are either joining large groups or becoming hospital employees.

Other physician groups. While working your way down your list of potential buyers, you should also be quietly, subtly, and tactfully assessing other practices, even your competitors, to see if any are candidates for merging with and/or acquiring yours and all your charts, records, and referring physicians.

Hospitals. In today’s health care environment, in which more than half of clinicians are becoming hospital employees, selling to your associated hospital may be a viable option.

Your practice is probably contributing millions of dollars in income to that hospital each year, and of course the hospital would like to maintain this revenue stream. You should consider talking to the hospital’s CEO or medical director.

Hospitals also know that, if you leave and the market cannot absorb the resulting increase in demand for care, patients may go elsewhere, to a competing hospital or outside the community. Rather than lose your market share, a hospital may consider the obvious solution: recruit a replacement ObGyn for your practice.

Your goal here is to negotiate an agreement in which your hospital will recruit a replacement ObGyn, provide financial support, and transition your practice to that ObGyn over a specified period.

The hospital could acquire your practice and either employ you during the transition or provide recruiting support and an income guarantee to help your practice pay the new physician’s salary. Whether to sell or remain independent is often driven by the needs and desires of the recruit. As the vast majority of clinicians coming out of training are seeking employment, in most cases the agreement will require a sale.

Selling to a hospital a few years before your retirement can be a plus. You might find employment a welcome respite from the daunting responsibility of managing your own practice. Life can become much less stressful as you introduce and transition your patients to the new ObGyn. You will be working less, taking fewer calls, and maintaining or even increasing your income, all without the burden of managing the practice.

Read about determining your practice’s value

Putting a monetary value on your practice

After deciding to sell your practice, you need to determine its value. Buying a practice may be the largest financial transaction a young ObGyn will ever make. For a retiring physician, valuation of a practice may reflect a career’s worth of “sweat equity.”

What is your practice worth?

All ObGyns believe their practice is worth far more than any young ObGyn or hospital is willing to pay for it. After all, you have spent a medical lifetime creating, building, and nurturing your practice. You have cared for several thousand patients, who have been loyal and may want to stay with the practice under its new ObGyn. So, how does a retiring physician put a value on his or her practice and then “cast the net” to the marketplace? How do you find a buyer who will pay the asking price and then help the practice make the transition from seller to buyer and continue to serve their patients?

The buyer’s perspective on value. In a pure sense, the value of any asset is what a potential buyer is willing to pay. From a value standpoint, the price that potential buyers are willing to pay varies by the specifics of the situation, regardless of what a valuation or practice appraisal might indicate.

For example, once your plan to retire becomes known, why would a young ObGyn agree to pay X dollars for all your medical records? After all, the potential buyer knows that your existing patients and your referral base will need to seek care from another ObGyn after you leave, and they will likely stay with the practice if they feel they will be treated well by the new clinician.

A hospital may take a similar tack but more often will be willing to pay fair market value for your practice. Hospitals, however, cannot legally pay more than fair market value as determined by an independent appraiser.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Valuation methods

The valuation of any business generally is approached in terms of market, assets, and income.

The market approach usually is taken only with regard to office real estate. Given the lack of reliable and comparable sales information, this approach is seldom used in the valuation of medical practices. If you own your office real estate, a real estate appraiser will establish its fair market value.

In the assets approach, the individual assets of a medical practice are valued on the basis of their current market values. These assets are either tangible or intangible.

Tangible assets can be seen and touched. Furniture, equipment, and office real estate are examples.

The fair market value of used furniture and equipment is most often determined by replacement cost. The value of these items is limited. Usually it starts at 50% of the cost of buying new furniture or equipment of the same utility. From there, the value is lowered on the basis of the age and condition of the items.

Often, the market value of major ObGyn office equipment, such as a DXA (dual-energy x-ray absorptiometry) scanner, is based on similar items for sale or recently sold in the used secondary equipment market.

Tangible assets may include accounts receivable (A/R). A/R represents uncollected payment for work performed. Most buyers want to avoid paying for A/R and assuming the risk of collections. Generally, you should expect to retain your A/R and pay a small or nominal fee to have the buyer handle the collections after you have retired.

Intangible assets are not physical. Examples include the physician’s name, phone number, reputation, referral base, trained staff, and medical records—in other words, what gets patients to keep coming back. Most physicians value these goodwill or “blue-sky” assets highly. Today, unfortunately, most sellers are unable to reap any financial benefit from their intangible assets.

The income approach is based on the premise that the value of any business is in the income it generates for its owner. In simple terms, value in the income approach is a multiple of the cash the business generates after expenses.

Read important keys to transitioning the practice

Transitioning the practice: Role of the seller and the buyer

First and very important is the contract agreement regarding the overlap period, when both the exiting ObGyn and the new ObGyn are at the practice. We suggest making the overlap a minimum of 6 months and a maximum of 1 year. During this period, the exiting physician can introduce the incoming physician to the patients. A face-to-face introduction can amount to an endorsement, which can ease a patient’s mind and help her decide to take on the new ObGyn and philosophy rather than search elsewhere for obstetric and gynecologic care. The new ObGyn also can use the overlap period to become familiar and comfortable with the staff and learn the process for physician and staff management of case flow, from scheduling and examination to insurance and patient follow-up.

We suggest that the exiting ObGyn send a farewell/welcome letter to patients and referring physicians. The letter should state the exiting ObGyn’s intention to leave (or retire from) the practice and should introduce the ObGyn who will be taking over.

The exiting ObGyn should also take the new ObGyn to meet the physicians who have been providing referrals over the years. We suggest visiting each referring physician’s office to make the introduction. Another good way to introduce a new ObGyn to referring physicians and other professionals—endocrinologists, cardiologists, nurses, pharmaceutical representatives—is to host an open house at your practice. Invite the staff members of the referring physicians as well, since they can be invaluable in making referrals.

We recommend that the exiting ObGyn spend the money to update all the practice’s stationery, brochures, and print materials and ensure they look professional. Note that it is not acceptable to place the new ObGyn’s name under the exiting ObGyn’s name. If the practice has a website, introduce the new physician there and make any necessary updates regarding office hours and accepted insurance plans.

If the exiting ObGyn’s practice lacks a robust Internet and social media presence, the new ObGyn should establish one. We recommend setting up an interactive website that patients can use to make appointments and pay bills. The website should have an email component that can be used to ask questions, raise concerns, and get answers. We also recommend opening Facebook, YouTube, and Twitter accounts for the practice and being active on these social media.

In our experience, smoothly transitioning practices can achieve patient retention rates as high as 90% to 95%. For practices without a plan, however, these rates may be as low as 50%, or worse. Therefore, work out a plan in advance, and include the steps described here, so that on arrival the new ObGyn can hit the ground running.

Acquiring a successful medical practice is doable and offers many advantages, such as autonomy and the ability to make business decisions affecting the practice. Despite all the changes happening in health care, we still think this is the best way to go.

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Bottom line

Selling an ObGyn practice can be a daunting process. However, deciding to sell your practice, performing the valuation, and ensuring a smooth transition are part and parcel of making the transfer a success, equitable for both the buyer and the seller.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For ObGyns, 2 intensely stressful career milestones are the day you start your practice and the day you decide to put it up for sale.

One of us, Dr. Baum, started a practice in 1976. At that time, many clinicians seemed to work right up until the day they died—in mid-examination or with scalpel in hand! Today, clinicians seriously contemplate leaving an active practice at age 55, 60, or, more traditionally, 65.

ObGyns in group practice, even those with only 1 or 2 partners, presumably have in place a well-thought-out and properly drafted contract with buyout and phase-down provisions. For members of a group practice, it is imperative to critically review and discuss contractual arrangements periodically and decide if they make sense as much now as they did at the start. ObGyns who continually revisit their contracts probably have an exit strategy that is fairly self-executing and effective and that will provide the seller with a seamless transition to retirement.

A solo ObGyn who is selling a practice has 3 basic options: find a successor physician, sell to a hospital or to a larger group, or close the practice.

Related article:
ObGyns’ choice of practice environment is a big deal

Preparing your practice for sale

Regardless of who will take over your practice, you need to prepare for its transition.

The most important aspect of selling your practice is knowing its finances and ensuring that they are in order. Any serious buyer will ask to examine your books, see how you are running the business, and assess its vitality and potential growth. Simply, a buyer will want to know where your revenue comes from and where it goes.

Your practice will be attractive to a buyer if it shows a stable or growing revenue base, an attractive payer mix, reasonable overhead, and personal income that is steady if not increasing. If your earning capacity is low or declining, you will need to explain why.

Timing is key

We strongly recommend beginning the process 3 to 5 years before your intended exit.

By starting early, up to 5 years in advance, you can maximize the likelihood that your practice will retain all or most of its value. Moreover, you can use the long lead time to thoroughly explore all available options and find a committed buyer.

Selling a practice can be a complicated affair, and many ObGyns do not have the requisite skills. So much of the success in selling depends on the specifics of the practice, the physician, and the market (the hospital and physician environment).

Identifying potential buyers

Other ObGyns. Recruiting an ObGyn to take over your practice seems to be the best option but can prove very difficult in today’s environment. Many younger clinicians are either joining large groups or becoming hospital employees.

Other physician groups. While working your way down your list of potential buyers, you should also be quietly, subtly, and tactfully assessing other practices, even your competitors, to see if any are candidates for merging with and/or acquiring yours and all your charts, records, and referring physicians.

Hospitals. In today’s health care environment, in which more than half of clinicians are becoming hospital employees, selling to your associated hospital may be a viable option.

Your practice is probably contributing millions of dollars in income to that hospital each year, and of course the hospital would like to maintain this revenue stream. You should consider talking to the hospital’s CEO or medical director.

Hospitals also know that, if you leave and the market cannot absorb the resulting increase in demand for care, patients may go elsewhere, to a competing hospital or outside the community. Rather than lose your market share, a hospital may consider the obvious solution: recruit a replacement ObGyn for your practice.

Your goal here is to negotiate an agreement in which your hospital will recruit a replacement ObGyn, provide financial support, and transition your practice to that ObGyn over a specified period.

The hospital could acquire your practice and either employ you during the transition or provide recruiting support and an income guarantee to help your practice pay the new physician’s salary. Whether to sell or remain independent is often driven by the needs and desires of the recruit. As the vast majority of clinicians coming out of training are seeking employment, in most cases the agreement will require a sale.

Selling to a hospital a few years before your retirement can be a plus. You might find employment a welcome respite from the daunting responsibility of managing your own practice. Life can become much less stressful as you introduce and transition your patients to the new ObGyn. You will be working less, taking fewer calls, and maintaining or even increasing your income, all without the burden of managing the practice.

Read about determining your practice’s value

Putting a monetary value on your practice

After deciding to sell your practice, you need to determine its value. Buying a practice may be the largest financial transaction a young ObGyn will ever make. For a retiring physician, valuation of a practice may reflect a career’s worth of “sweat equity.”

What is your practice worth?

All ObGyns believe their practice is worth far more than any young ObGyn or hospital is willing to pay for it. After all, you have spent a medical lifetime creating, building, and nurturing your practice. You have cared for several thousand patients, who have been loyal and may want to stay with the practice under its new ObGyn. So, how does a retiring physician put a value on his or her practice and then “cast the net” to the marketplace? How do you find a buyer who will pay the asking price and then help the practice make the transition from seller to buyer and continue to serve their patients?

The buyer’s perspective on value. In a pure sense, the value of any asset is what a potential buyer is willing to pay. From a value standpoint, the price that potential buyers are willing to pay varies by the specifics of the situation, regardless of what a valuation or practice appraisal might indicate.

For example, once your plan to retire becomes known, why would a young ObGyn agree to pay X dollars for all your medical records? After all, the potential buyer knows that your existing patients and your referral base will need to seek care from another ObGyn after you leave, and they will likely stay with the practice if they feel they will be treated well by the new clinician.

A hospital may take a similar tack but more often will be willing to pay fair market value for your practice. Hospitals, however, cannot legally pay more than fair market value as determined by an independent appraiser.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Valuation methods

The valuation of any business generally is approached in terms of market, assets, and income.

The market approach usually is taken only with regard to office real estate. Given the lack of reliable and comparable sales information, this approach is seldom used in the valuation of medical practices. If you own your office real estate, a real estate appraiser will establish its fair market value.

In the assets approach, the individual assets of a medical practice are valued on the basis of their current market values. These assets are either tangible or intangible.

Tangible assets can be seen and touched. Furniture, equipment, and office real estate are examples.

The fair market value of used furniture and equipment is most often determined by replacement cost. The value of these items is limited. Usually it starts at 50% of the cost of buying new furniture or equipment of the same utility. From there, the value is lowered on the basis of the age and condition of the items.

Often, the market value of major ObGyn office equipment, such as a DXA (dual-energy x-ray absorptiometry) scanner, is based on similar items for sale or recently sold in the used secondary equipment market.

Tangible assets may include accounts receivable (A/R). A/R represents uncollected payment for work performed. Most buyers want to avoid paying for A/R and assuming the risk of collections. Generally, you should expect to retain your A/R and pay a small or nominal fee to have the buyer handle the collections after you have retired.

Intangible assets are not physical. Examples include the physician’s name, phone number, reputation, referral base, trained staff, and medical records—in other words, what gets patients to keep coming back. Most physicians value these goodwill or “blue-sky” assets highly. Today, unfortunately, most sellers are unable to reap any financial benefit from their intangible assets.

The income approach is based on the premise that the value of any business is in the income it generates for its owner. In simple terms, value in the income approach is a multiple of the cash the business generates after expenses.

Read important keys to transitioning the practice

Transitioning the practice: Role of the seller and the buyer

First and very important is the contract agreement regarding the overlap period, when both the exiting ObGyn and the new ObGyn are at the practice. We suggest making the overlap a minimum of 6 months and a maximum of 1 year. During this period, the exiting physician can introduce the incoming physician to the patients. A face-to-face introduction can amount to an endorsement, which can ease a patient’s mind and help her decide to take on the new ObGyn and philosophy rather than search elsewhere for obstetric and gynecologic care. The new ObGyn also can use the overlap period to become familiar and comfortable with the staff and learn the process for physician and staff management of case flow, from scheduling and examination to insurance and patient follow-up.

We suggest that the exiting ObGyn send a farewell/welcome letter to patients and referring physicians. The letter should state the exiting ObGyn’s intention to leave (or retire from) the practice and should introduce the ObGyn who will be taking over.

The exiting ObGyn should also take the new ObGyn to meet the physicians who have been providing referrals over the years. We suggest visiting each referring physician’s office to make the introduction. Another good way to introduce a new ObGyn to referring physicians and other professionals—endocrinologists, cardiologists, nurses, pharmaceutical representatives—is to host an open house at your practice. Invite the staff members of the referring physicians as well, since they can be invaluable in making referrals.

We recommend that the exiting ObGyn spend the money to update all the practice’s stationery, brochures, and print materials and ensure they look professional. Note that it is not acceptable to place the new ObGyn’s name under the exiting ObGyn’s name. If the practice has a website, introduce the new physician there and make any necessary updates regarding office hours and accepted insurance plans.

If the exiting ObGyn’s practice lacks a robust Internet and social media presence, the new ObGyn should establish one. We recommend setting up an interactive website that patients can use to make appointments and pay bills. The website should have an email component that can be used to ask questions, raise concerns, and get answers. We also recommend opening Facebook, YouTube, and Twitter accounts for the practice and being active on these social media.

In our experience, smoothly transitioning practices can achieve patient retention rates as high as 90% to 95%. For practices without a plan, however, these rates may be as low as 50%, or worse. Therefore, work out a plan in advance, and include the steps described here, so that on arrival the new ObGyn can hit the ground running.

Acquiring a successful medical practice is doable and offers many advantages, such as autonomy and the ability to make business decisions affecting the practice. Despite all the changes happening in health care, we still think this is the best way to go.

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Bottom line

Selling an ObGyn practice can be a daunting process. However, deciding to sell your practice, performing the valuation, and ensuring a smooth transition are part and parcel of making the transfer a success, equitable for both the buyer and the seller.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

BOSTON—Between 30% and 40% of patients diagnosed with intractable epilepsy do not have epilepsy, according to an overview presented at the 69th Annual Meeting of the American Academy of Neurology. A combination of overreading and overemphasizing EEGs can contribute to misdiagnosis, said Selim R. Benbadis, MD, Professor of Neurology and Director of the Comprehensive Epilepsy Program at the University of South Florida in Tampa.

Neurologists overread EEGs “because of the perception that there is less risk in overdiagnosing epilepsy, as opposed to underdiagnosing [the disease], and that is not correct,” said Dr. Benbadis.

The consequences of an epilepsy misdiagnosis can be serious. Patients can lose driving privileges, which may limit their employment opportunities. Epilepsy also is associated with a stigma that can be difficult to dispel, said Dr. Benbadis. In addition, patients misdiagnosed with epilepsy can have side effects from seizure medications.

Why Are EEGs Overread?

Two of the major reasons for misinterpration of EEGs are lack of training and inexperience, said Dr. Benbadis. Currently, it is not mandatory to learn how to read an EEG during neurology residency. Many neurology programs do require EEG training, but many do not. “If you are not experienced in looking at [an EEG], you will overread and think that everything is abnormal,” said Dr. Benbadis. Many normal variants and artifacts can look like epileptiform discharges to neurologists who are inexperienced in reading EEG.

Commonly overread EEG patterns include normal variants such as wicket rhythms, nonspecific temporal fluctuations, and rhythmic midtemporal theta of drowsiness. In addition, one study found that most patients were misdiagnosed with epilepsy because of overread EEGs; nonspecific fluctuations in the temporal region were misread as sharp waves.

The idea that “phase reversals” represent EEG abnormalities is a misconception, said Dr. Benbadis. A phase reversal, which identifies the location of maximum voltage, does not indicate abnormalities. Every normal waveform can have phase reversals, he said. A “history bias” can also lead to a misdiagnosis of epilepsy. For example, if a patient has a history of seizures or suspected seizures, a neurologist might be biased toward a diagnosis of epilepsy, and “look too hard” when reading the EEG, said Dr. Benbadis.

Steps to Improve EEG Interpretation

When deciding whether a discharge is epileptiform, neurologists should look for waves with an asymmetric contour that clearly stand out from the ongoing background of an EEG. About 98% of the time, with clear epileptiform discharges, neurologists can be sure that they indicate epilepsy without knowing the patient’s history, said Dr. Benbadis. Experts should develop consensus guidelines for EEG interpretation, and all neurology residents should be required to train in the EEG laboratory, said Dr. Benbadis. In addition, when there is doubt about whether an EEG was abnormal, “we must obtain the very EEG previously read as abnormal and redo the tracing or consult a colleague,” he added. Patients who have been diagnosed with epilepsy due to an abnormal EEG are encouraged to get a second opinion from an epilepsy or EEG specialist.

—Erica Tricarico

Suggested Reading

Benbadis SR. “Just like EKGs!” Should EEGs undergo a confirmatory interpretation by a clinical neurophysiologist? Neurology. 2013; 80(1 Suppl 1):S47-S51.

BOSTON—Between 30% and 40% of patients diagnosed with intractable epilepsy do not have epilepsy, according to an overview presented at the 69th Annual Meeting of the American Academy of Neurology. A combination of overreading and overemphasizing EEGs can contribute to misdiagnosis, said Selim R. Benbadis, MD, Professor of Neurology and Director of the Comprehensive Epilepsy Program at the University of South Florida in Tampa.

Neurologists overread EEGs “because of the perception that there is less risk in overdiagnosing epilepsy, as opposed to underdiagnosing [the disease], and that is not correct,” said Dr. Benbadis.

The consequences of an epilepsy misdiagnosis can be serious. Patients can lose driving privileges, which may limit their employment opportunities. Epilepsy also is associated with a stigma that can be difficult to dispel, said Dr. Benbadis. In addition, patients misdiagnosed with epilepsy can have side effects from seizure medications.

Why Are EEGs Overread?

Two of the major reasons for misinterpration of EEGs are lack of training and inexperience, said Dr. Benbadis. Currently, it is not mandatory to learn how to read an EEG during neurology residency. Many neurology programs do require EEG training, but many do not. “If you are not experienced in looking at [an EEG], you will overread and think that everything is abnormal,” said Dr. Benbadis. Many normal variants and artifacts can look like epileptiform discharges to neurologists who are inexperienced in reading EEG.

Commonly overread EEG patterns include normal variants such as wicket rhythms, nonspecific temporal fluctuations, and rhythmic midtemporal theta of drowsiness. In addition, one study found that most patients were misdiagnosed with epilepsy because of overread EEGs; nonspecific fluctuations in the temporal region were misread as sharp waves.

The idea that “phase reversals” represent EEG abnormalities is a misconception, said Dr. Benbadis. A phase reversal, which identifies the location of maximum voltage, does not indicate abnormalities. Every normal waveform can have phase reversals, he said. A “history bias” can also lead to a misdiagnosis of epilepsy. For example, if a patient has a history of seizures or suspected seizures, a neurologist might be biased toward a diagnosis of epilepsy, and “look too hard” when reading the EEG, said Dr. Benbadis.

Steps to Improve EEG Interpretation

When deciding whether a discharge is epileptiform, neurologists should look for waves with an asymmetric contour that clearly stand out from the ongoing background of an EEG. About 98% of the time, with clear epileptiform discharges, neurologists can be sure that they indicate epilepsy without knowing the patient’s history, said Dr. Benbadis. Experts should develop consensus guidelines for EEG interpretation, and all neurology residents should be required to train in the EEG laboratory, said Dr. Benbadis. In addition, when there is doubt about whether an EEG was abnormal, “we must obtain the very EEG previously read as abnormal and redo the tracing or consult a colleague,” he added. Patients who have been diagnosed with epilepsy due to an abnormal EEG are encouraged to get a second opinion from an epilepsy or EEG specialist.

—Erica Tricarico

Suggested Reading

Benbadis SR. “Just like EKGs!” Should EEGs undergo a confirmatory interpretation by a clinical neurophysiologist? Neurology. 2013; 80(1 Suppl 1):S47-S51.

BOSTON—Between 30% and 40% of patients diagnosed with intractable epilepsy do not have epilepsy, according to an overview presented at the 69th Annual Meeting of the American Academy of Neurology. A combination of overreading and overemphasizing EEGs can contribute to misdiagnosis, said Selim R. Benbadis, MD, Professor of Neurology and Director of the Comprehensive Epilepsy Program at the University of South Florida in Tampa.

Neurologists overread EEGs “because of the perception that there is less risk in overdiagnosing epilepsy, as opposed to underdiagnosing [the disease], and that is not correct,” said Dr. Benbadis.

The consequences of an epilepsy misdiagnosis can be serious. Patients can lose driving privileges, which may limit their employment opportunities. Epilepsy also is associated with a stigma that can be difficult to dispel, said Dr. Benbadis. In addition, patients misdiagnosed with epilepsy can have side effects from seizure medications.

Why Are EEGs Overread?

Two of the major reasons for misinterpration of EEGs are lack of training and inexperience, said Dr. Benbadis. Currently, it is not mandatory to learn how to read an EEG during neurology residency. Many neurology programs do require EEG training, but many do not. “If you are not experienced in looking at [an EEG], you will overread and think that everything is abnormal,” said Dr. Benbadis. Many normal variants and artifacts can look like epileptiform discharges to neurologists who are inexperienced in reading EEG.

Commonly overread EEG patterns include normal variants such as wicket rhythms, nonspecific temporal fluctuations, and rhythmic midtemporal theta of drowsiness. In addition, one study found that most patients were misdiagnosed with epilepsy because of overread EEGs; nonspecific fluctuations in the temporal region were misread as sharp waves.

The idea that “phase reversals” represent EEG abnormalities is a misconception, said Dr. Benbadis. A phase reversal, which identifies the location of maximum voltage, does not indicate abnormalities. Every normal waveform can have phase reversals, he said. A “history bias” can also lead to a misdiagnosis of epilepsy. For example, if a patient has a history of seizures or suspected seizures, a neurologist might be biased toward a diagnosis of epilepsy, and “look too hard” when reading the EEG, said Dr. Benbadis.

Steps to Improve EEG Interpretation

When deciding whether a discharge is epileptiform, neurologists should look for waves with an asymmetric contour that clearly stand out from the ongoing background of an EEG. About 98% of the time, with clear epileptiform discharges, neurologists can be sure that they indicate epilepsy without knowing the patient’s history, said Dr. Benbadis. Experts should develop consensus guidelines for EEG interpretation, and all neurology residents should be required to train in the EEG laboratory, said Dr. Benbadis. In addition, when there is doubt about whether an EEG was abnormal, “we must obtain the very EEG previously read as abnormal and redo the tracing or consult a colleague,” he added. Patients who have been diagnosed with epilepsy due to an abnormal EEG are encouraged to get a second opinion from an epilepsy or EEG specialist.

—Erica Tricarico

Suggested Reading

Benbadis SR. “Just like EKGs!” Should EEGs undergo a confirmatory interpretation by a clinical neurophysiologist? Neurology. 2013; 80(1 Suppl 1):S47-S51.

During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

During the past 45 years, the cesarean delivery (CD) rate in the United States has increased from 5.5% in 1970 to 33% from 2009 to 2013, followed by a small decrease to 32% in 2014 and 2015.¹ Many clinical problems cause clinicians and patients to decide that CD is an optimal birth route, including: abnormal labor progress, abnormal or indeterminate fetal heart rate pattern, breech presentation, multiple gestation, macrosomia, placental and cord abnormalities, preeclampsia, prior uterine surgery, and prior CD.² Recent secular trends that contribute to the current rate of CD include an adversarial liability environment,^3,4 increasing rates of maternal obesity,⁵ and widespread use of continuous fetal-heart monitoring during labor.⁶

Wide variation in CD rate has been reported among countries, states, and hospitals. The variation is due, in part, to different perspectives about balancing the harms and benefits of vaginal delivery versus CD. In Europe, in 2010 the CD rates in Sweden and Italy were 17.1% and 38%, respectively.⁷ In 2010, among the states, Alaska had the lowest rate of CD at 22% and Kentucky had the highest rate at 40%.⁸ In 2015, the highest rate was 38%, in Mississippi (FIGURE).⁹ In 2014, among Massachusetts hospitals with more than 2,500 births, the CD rate ranged from a low of 22% to a high of 37%.¹⁰

Clinicians, patients, policy experts, and the media are perplexed and troubled by the “high” US CD rate and the major variation in rate among countries, states, and hospitals. Labor management practices likely influence the rate of CD and diverse approaches to labor management likely account for the wide variation in CD rates.

A nationwide effort to standardize and continuously improve labor management might result in a decrease in the CD rate. Building on this opportunity, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) have jointly recommended new labor management guidelines that may reduce the primary CD rate.⁸

The ACOG/SMFM guidelines encourage obstetricians to extend the time for labor progress in both the 1st and 2nd stages prior to recommending a CD.⁸ These new guidelines emphasize that for a modern obstetrician, patience is a virtue. There are 2 important caveats to this statement: to safely extend the length of time of labor requires both (1) a reassuring fetal heart rate tracing and (2) stable maternal health. If the fetus demonstrates a persistent worrisome Category II or a Category IIIheart-rate tracing, decisive intervention is necessary and permitting an extended labor would not be optimal. Similarly, if the mother has rapidly worsening preeclampsia it may not be wise to extend an induction of labor (IOL) over many days.

There are risks with extending the length of labor. An extended duration of the 1st stage of labor is associated with an increased rate of maternal chorioamnionitis and shoulder dystocia at birth.¹¹ An extended duration of the 2nd stage of labor is associated with an increase in the rate of maternal chorioamnionitis, anal sphincter injury, uterine atony, and neonatal admission to an intensive care unit.¹² Clinicians who adopt practices that permit an extended length of labor must weigh the benefits of avoiding a CD against these maternal and fetal complications.

Active phase redefined

Central to the ACOG/SMFM guidelines is a new definition of the active phase of labor. The research of Dr. Emmanuel Friedman indicated that at approximately 4 cm of cervical dilation many women in labor transition from the latent phase, a time of slow change in cervical dilation, to the active phase, a time of more rapid change in cervical dilation.^13,14 However, more recent research indicates that the transition between the latent and active phase is difficult to precisely define, but more often occurs at about 6 cm of cervical dilation and not 4 cm of dilation.¹⁵ Adopting these new norms means that laboring women will spend much more time in the latent phase, a phase of labor in which patience is a virtue.

The ACOG/SMFM guidelines

Main takeaways from the ACOG/SMFM guidelines are summarized below. Interventions that address common obstetric issues and labor abnormalities are outlined below.

Do not perform CD for a prolonged latent phase of labor, defined as regular contractions of >20 hours duration in nulliparous women and >14 hours duration in multiparous women. Patience with a prolonged latent phase will be rewarded by the majority of women entering the active phase of labor. Alternatively, if appropriate, cervical ripening followed by oxytocin IOL and amniotomy will help the patient with a prolonged latent phase to enter the active phase of labor.¹⁶

For women with an unfavorable cervix as assessed by the Bishop score, cervical ripening should be performed prior to IOL. Use of cervical ripening prior to IOL increases the chance of achieving vaginal delivery within 24 hours and may result in a modest decrease in the rate of CD.^17,18

Related article:
Should oxytocin and a Foley catheter be used concurrently for cervical ripening in induction of labor?
 

Failed IOL in the latent phase should only be diagnosed following 12 to 18 hours of both ruptured membranes and adequate contractions stimulated with oxytocin. The key ingredients for the successful management of the latent phase of labor are patience, oxytocin, and amniotomy.¹⁶

CD for the indication of active phase arrest requires cervical dilation ≥6 cm with ruptured membranes and no change in cervical dilation for ≥4 hours of adequate uterine activity. In the past, most obstetricians defined active phase arrest, a potential indication for CD, as the absence of cervical change for 2 or more hours in the presence of adequate uterine contractions and cervical dilation of at least 4 cm. Given the new definition of active phase arrest, slow but progressive progress in the 1st stage of labor is not an indication for CD.^11,19

“A specific absolute maximum length of time spent in the 2nd stage beyond which all women should be offered an operative delivery has not been identified.”⁸ Diagnosis of arrest of labor in the 2nd stage may be considered after at least 2 hours of pushing in multiparous women and 3 hours of pushing in nulliparous women, especially if no fetal descent is occurring. The guidelines also state “longer durations may be appropriate on an individualized basis (eg, with use of epidural analgesia or with fetal malposition)” as long as fetal descent is observed.

Patience is a virtue, especially in the management of the 2nd stage of labor. Extending the 2nd stage up to 4 hours appears to be reasonably safe if the fetal status is reassuring and the mother is physiologically stable. In a study from San Francisco of 42,268 births with normal newborn outcomes, the 95th percentile for the length of the 2nd stage of labor for nulliparous women was 3.3 hours without an epidural and 5.6 hours with an epidural.²⁰

In a study of 53,285 births, longer duration of pushing was associated with a small increase in the rate of neonatal adverse outcomes. In nulliparous women the rate of adverse neonatal outcomes increased from 1.3% with less than 60 minutes of pushing to 2.4% with greater than 240 minutes of pushing. Remarkably, even after 4 hours of pushing, 78% of nulliparous women who continued to push had a vaginal delivery.²¹ In this study, among nulliparous women the rate of anal sphincter injury increased from 5% with less than 60 minutes of pushing to 16% with greater than 240 minutes of pushing, and the rate of postpartum hemorrhage increased from 1% with less than 60 minutes of pushing to 3.3% with greater than 240 minutes of pushing.

I am not enthusiastic about patiently watching a labor extend into the 5th hour of the 2nd stage, especially if the fetus is at +2 station or lower. In a nulliparous woman, after 4 hours of managing the 2nd stage of labor, my patience is exhausted and I am inclined to identify a clear plan for delivery, either by enhanced labor coaching, operative vaginal delivery, or CD.

Operative vaginal delivery in the 2nd stage of labor is an acceptable alternative to CD. The rate of operative vaginal delivery in the United States has declined over the past 2 decades (TABLE). In Sweden in 2010 the operative vaginal delivery rate was 7.6% with a CD rate of 17.1%.⁷ In the United States in 2010 the operative delivery rate was 3.6%, and the CD rate was 33%.¹ A renewed focus on operative vaginal delivery with ongoing training and team simulation for the procedure would increase our use of operative delivery and decrease the overall rate of CD.

Related article:
STOP using instruments to assist with delivery of the head at cesarean
 

Encourage the detection of persistent fetal occiput posterior position by physical examination and/or ultrasound and consider manual rotation of the fetal occiput from the posterior to anterior position in the 2nd stage. Persistent occiput posterior is the most common fetal malposition.²² This malposition is associated with an increased rate of CD.²³ There are few randomized trials of manual rotation of the fetal occiput from posterior to anterior position in the 2nd stage of labor, and the evidence is insufficient to determine the efficacy of manual rotation.²⁴ Small nonrandomized studies report that manual rotation of the occiput from posterior to anterior position may reduce the CD rate.^25–27

For persistent 2nd stage fetal occiput posterior position in a woman with an adequate pelvis, where manual rotation was not successful and the fetus is at +2 station or below, operative vaginal delivery is an option. “Vacuum or forceps?” and “If forceps, to rotate or not to rotate?” those are the clinical questions. Forceps delivery is more likely to be successfulthan vacuum delivery.²⁸ Direct forceps delivery of the occiput posterior fetus is associated with more anal sphincter injuries than forceps delivery after successful rotation, but few clinicians regularly perform rotational forceps.²⁹ In a study of 2,351 women in the 2nd stage of labor with the fetus at +2 station or below, compared with either forceps or vacuum delivery, CD was associated with more maternal infections and fewer perineal lacerations. Neonatal composite morbidity was not significantly different among the 3 routes of operative delivery.³⁰

Amnioinfusion for repetitive variable decelerations of the fetal heart rate may reduce the risk of CD for an indeterminate fetal heart-rate pattern.³¹

IOL in a well-dated pregnancy at 41 weeks will reduce the risk of CD. In a large clinical trial, 3,407 women at 41 weeks of gestation were randomly assigned to IOL or expectant management. The rate of CD was significantly lower in the women assigned to IOL compared with expectant management (21% vs 25%, respectively; P = .03).³² The rate of neonatal morbidity was similar in the 2 groups.

Women with twin gestations and the first twin in a cephalic presentation may elect vaginal delivery. In a large clinical trial, 1,398 women with a twin gestation and the first twin in a cephalic presentation were randomly assigned to planned vaginal delivery (with cesarean only if necessary) or planned CD.³³ The rate of CD was 44% and 91% for the women in the planned-vaginal and planned-cesarean groups, respectively. There was no significant difference in composite fetal or neonatal death or serious morbidity. The authors concluded that, for twin pregnancy with the presenting twin in the cephalic presentation, there were no demonstrated benefits of planned CD.

Develop maternity care systems that encourage the use of trial of labor after cesarean (TOLAC). The ACOG/SMFM guidelines focus on interventions to reduce the rate of primary CD and do not address the role of TOLAC in reducing CD rates. There are little data from clinical trials to assess the benefits and harms from TOLAC versus scheduled repeat CD.³⁴ However, our experience with TOLAC in the 1990s strongly suggests that encouraging TOLAC will decrease the rate of CD. In 1996 the US rate of vaginal birth after cesarean (VBAC) peaked at 28%, and the rate of CD achieved a recent historic nadir of 21%. Growing concerns that TOLAC occasionally results in fetal harm was followed by a decrease in the VBAC rate to 12% in 2015.¹ A recent study of obstetric practices in countries with high and low VBAC rates concluded that patient and clinician commitment and comfort with prioritizing TOLAC over scheduled repeat CD greatly influenced the VBAC rate.³⁵

Related article:
Should lower uterine segment thickness measurement be included in the TOLAC decision-making process?

Labor management is an art

During labor obstetricians must balance the unique needs of mother and fetus, which requires great clinical skill and patience. Evolving concepts of normal labor progress necessitate that we change our expectations concerning the acceptable rate of progress in the 1st and 2nd stage of labor. Consistent application of these new labor guidelines may help to reduce the rate of CD.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

Free water in the posterior substantia nigra brain region increased as clinical Parkinson’s disease progressed in a 4-year longitudinal study of participants in the Parkinson’s Progression Markers Initiative.

Free water in this brain region is measurable via diffusion MRI, and this study – the first to look at free water in Parkinson’s patients across this time frame – suggests it to be a viable biomarker of disease progression that could be used in clinical trials evaluating Parkinson’s therapies.

Image courtesy of David Vaillancourt, PhD, University of Florida

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

BOSTON – Many selected patients with low- or intermediate-risk differentiated thyroid cancer who have had excellent or good responses to their treatment may be able to safely transition to follow-up monitoring at longer intervals, Bryan R. Haugen, MD, suggested in a keynote lecture during the World Congress on Thyroid Cancer.

Traditionally, thyroid cancer specialists have monitored these patients for persistent or recurrent disease as often as every 6 or 12 months. “But what we’ve realized with recent assessments of response to treatment is that some patients do well without a recurrence over many years; so, the concept of doing less monitoring and less imaging, especially in patients with an excellent response [to their initial treatment], is being studied,” Dr. Haugen said in a video interview following his talk.

He estimated that perhaps two-thirds or as many as three-quarters of patients with differentiated thyroid cancer fall into the category of having low- or intermediate-risk disease with an excellent or good response to treatment, and hence they are potential candidates for eventually transitioning to less frequent follow-up.

During his talk, Dr. Haugen suggested that after several years with no sign of disease recurrence, lower-risk patients with an excellent treatment response may be able to stop undergoing regular monitoring, and those with a good treatment response may be able to safely have their monitoring intervals extended.

According to the most recent (2015) guidelines for differentiated thyroid cancer management from the American Thyroid Association, lower-risk patients with an excellent treatment response should have their serum thyroglobulin measured every 12-24 months and undergo an ultrasound examination every 3-5 years, while patients with a good response are targeted for serum thyroglobulin measurement annually with an ultrasound every 1-3 years (Thyroid. 2016 Jan;26[1]:1-133). Dr. Haugen chaired the expert panel that wrote these guidelines.

In another provocative suggestion, Dr. Haugen proposed that once well-responsive, lower-risk patients have remained disease free for several years, their less frequent follow-up monitoring could be continued by a primary care physician or another less specialized clinician.

At some time in the future, “a patient’s primary care physician could follow a simple tumor marker, thyroglobulin, maybe once every 5 years,” said Dr. Haugen, professor of medicine and head of the division of endocrinology, metabolism, and diabetes at the University of Colorado in Aurora. “At the University of Colorado, we use advanced-practice providers to do long-term follow-up” for lower-risk, treatment-responsive patients, he said.

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee approved licensure for Heplisav-B, a new two-dose recombinant hepatitis B vaccination, after voting that presented data proved the vaccine to be safe for adults 18 and over.

At an advisory meeting, after hearing testimony from government researchers and representatives of Dynavax Technologies Corporation, the manufacturer of Heplisav-B, 11 members voted to approve the drug, 1 member voted no, and 3 abstained.

There are more than 20,000 new infections each year, with a reported increase of 21% between 2014 and 2015, according to research presented by William Schaffner, MD, professor of preventative medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

There are two approved immunizations for hepatitis B: Engerix-B, manufactured by GlaxoSmithKline, and Recombivax HB, by Merck. Both are three-dose, recombinant vaccines produced from yeast cells.

Like the current vaccines, Heplisav-B is a recombinant hepatitis B surface antigen that is derived from yeast; however, this vaccine would be administered in two doses over 1 month, as opposed to three doses over 6 months as is the schedule for currently approved vaccines. Both manufacturing representatives and approving members of the committee stressed this as an important factor due to vaccination dropout rates.

“We have a problem with hepatitis B infections in this country as well as problems with the current vaccines,“ said John Ward, MD, director of the division of viral hepatitis at the Centers for Disease Control and Prevention, “and they happen in these populations where, in terms of data, both of those audiences have problems about going for the second and third dose.”

Patients that drop out before the third dose are at high risk of infection, as only 20%-50% of adults have the appropriate seroprotection after two doses. However, only 54% of patients in a vaccine safety Datalink study reported completing the vaccination series, with 81% reporting having received two doses, according to Dr. Schaffner.

While the committee did approve the safety research as sufficient to approve use of Heplisav-B in adults 18 years and older, members of the committee had an issue with the drug’s correlation with myocardial infarction.

In one of the studies presented, Heplisav-B’s acute myocardial infarction (AMI) events (14 patients) greatly outnumbered those of Engerix-B (1 patient), presenting an AMI relative risk of 6.97.

Dynavax representatives, in response to this concern, presented intention to conduct a postmarketing analysis of the risk of MI in patients who have been administered Heplisav-B, which committee members considered to be a crucial contingency for approval.

“I would like to say I am for the approval of this vaccine, I just think as a statistician that the safety was inconclusive,” said Mei-Ling Ting Lee, PhD, director of the Biostatistics and Risk Assessment Center at the University of Maryland. “But I think for the pharmacological vigilance plan, I think that it will be good to have specific analysis for the myocardial infarction and other risks.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

On Twitter @eaztweets

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.

Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

There is growing recognition that patients and family members have critical insights into healthcare experiences. As consumers of healthcare, patient experience is the definitive gauge of whether healthcare is patient centered. In addition, patients may know things about their healthcare that the care team does not. Several studies have demonstrated that patients have knowledge of adverse events and medical errors that are not detected by other methods.^1-5 For these reasons, systems designed to elicit patient perspectives of care and detect patient-perceived breakdowns in care could be used to improve healthcare safety and quality, including the patient experience.

Historically, hospitals have relied on patient-initiated reporting via complaints or legal action as the main source of information regarding patient-perceived breakdowns in care. However, many patients are hesitant to speak up about problems or uncertain about how to report concerns.^6-8 As a result, healthcare systems often only learn of the most severe breakdowns in care from a subset of activated patients, thus underestimating how widespread patient-perceived breakdowns are.

To overcome these limitations of patient-initiated reporting, hospitals could conduct outreach to patients to actively identify and learn about patient-perceived breakdowns in care. Potential benefits of outreach to patients include more reliable detection of patient-perceived breakdowns in care, identification of a broader range of types of breakdowns commonly experienced by patients, and recognition of problems in real-time when there is more opportunity for redress. Indeed, some hospitals have adopted active outreach programs such as structured nurse manager rounding or postdischarge phone calls.⁹

It is possible that outreach will not overcome patients’ reluctance to speak up, or patients may not share serious or actionable breakdowns. The manner in which outreach is conducted is likely to influence the information patients are willing to share. Prior studies examining patient perspectives of healthcare have primarily taken a structured approach with close-ended questions or a focus on specific aspects of care.^1,10,11 Limited data collected using an open-ended approach suggest patient-perceived breakdowns in care may be very common.^2,12,13 However, the impact of such breakdowns on patients has not been well characterized.

In order to design systems that can optimally detect patient-perceived breakdowns in care, additional information is needed to understand whether patients will report breakdowns in response to outreach programs, what types of problems they will report, and how these problems impact them. Understanding such issues will allow healthcare systems to respond to calls by federal health agencies to develop mechanisms for patients to report concerns about breakdowns in care, thereby providing truly patient-centered care.¹⁴ Therefore, we undertook this study with the overall goal of describing what may be learned from an open-ended outreach approach that directly asks patients about problems they have encountered during hospitalization. Specifically, we aim to (1) describe the types of problems reported by patients in response to this outreach approach and (2) characterize patients’ perceptions of the impact of these events.

Setting

We conducted this study in 2 hospitals between June 2014 and February 2015. One participating hospital is a large, urban, tertiary care medical center serving a predominantly white (78%) patient population in Baltimore, Maryland. The second hospital is a large, inner city, tertiary care medical center serving a predominantly African-American (71%) patient population in Washington, DC.

Three medical-surgical units (MSUs) at each hospital participated. We selected MSUs because MSU patients interact with a variety of clinicians, often have long stays, and are at risk for adverse events. Hospitalists were part of the clinical care team in each of the participating units, serving either as the attending of record or by comanaging patients.

Patient Eligibility

Patients were potentially eligible if they were at least 18 years old, able to speak English or Spanish, and admitted to the hospital for more than 24 hours. Ineligibility criteria included the following: imminent discharge, observation (noninpatient) status, on hospice, on infection precautions (for inpatient interviews only), psychiatric or violence concerns, prisoner status, significant confusion, or inability to provide informed consent.

Eligible patients in each unit were randomized. Interviewers consecutively approached patients according to their random assignment. If a patient was not available, the interviewer proceeded to the next room. Interviewers returned to rooms of missed patients when possible. Recruitment in the unit ended when the recruitment target for that unit was achieved.

Interviewers

Five interviewers conducted interviews. One author (KS) provided interviewer training that included didactic instruction, observation, feedback, and modeling. Interviewers participated in weekly debriefing sessions. One interviewer speaks Spanish fluently and was able to conduct interviews in Spanish. Translator services were available for the other interviewers.

Interview Process

Interviews were conducted in person while the patients were hospitalized or via telephone 7 - 30 days postdischarge. A patient who had completed an interview while hospitalized was not eligible for a postdischarge telephone interview. Family members or friends present at the time of the interviews could also participate in addition to or in lieu of the patients with the patients’ assent. Interviewers obtained verbal, informed consent at the start of each interview.

The interview domains and sample questions were developed specifically for the current study and are listed in Table 1. The goal of the interview was to elicit the patient’s (or family member’s) perception of their care experiences and their perceptions of the consequences of any problems with their care. The interviewer sought to obtain sufficient detail to understand the patient’s concerns and to determine what, if any, action might be needed to remediate problems reported by patients. Interviewers captured patient responses by taking detailed notes on a case report form or by directly entering patient responses using a computer or iPad at the time of interview at the discretion of the interviewer.

We defined a patient-perceived breakdown as something that went wrong during the hospitalization according to the patient. If a patient-perceived breakdown in care was identified, the interviewer attempted to resolve the concern. Some breakdowns had occurred in the past, making further resolution impossible (eg, a long wait in the emergency department). Other breakdowns were active and addressable, such as the patient having clinical questions that had not been answered. In such cases, the interviewer attempted to address the patient’s concerns, typically by working with unit nursing staff. For patients interviewed postdischarge, the interviewer worked to resolve ongoing patient concerns with the assistance of the patient safety, quality, and compliance teams as needed. The interviewer provided a brief narrative summary of all interviews to unit nursing leadership within 24 hours. Positive comments were sent to leadership but not captured systematically for research purposes. Further details of the process of responding to patients’ concerns will be reported elsewhere. All data were entered into REDCap to facilitate data management and reporting.¹⁵

The MedStar Health Research Institute Institutional Review Board reviewed and approved this study.

Categorizing Patients’ Responses: The Patient Experience Coding Tool

Using directed content analysis,¹⁶ we deductively created the Patient Experience Coding Tool (PECT) in order to summarize the narrative information captured during the interviews and categorize patient-perceived breakdowns in care. First, we referred to our prior interviews of patients’ views on breakdowns in cancer care⁶ and surrogate decision-makers’ views on breakdowns in intensive care units¹³ to create the initial categories. We then applied the resultant framework to the interviews in the present study and refined the categories. This involved applying the categorization to an initial set of interviews to check the sufficiency of the coding categories. We clarified the scope of each category (ie, what types of events fit under each category) and created additional categories (eg, medication-related problems) to capture patient experiences that were not included in the initial framework.

We then coded each interview using the PECT. A minimum of 2 readers reviewed the narrative notes for each interview. The first reader provided an initial categorization; the second reader reviewed the narrative and confirmed or questioned the initial categorization to improve coding accuracy. If a reader was uncertain about the correct categorization, it was discussed by three readers until an agreement was achieved. Because facilities-related problems (eg, food or parking) fall outside the realm of provider-based hospital care, such comments were not the focus of the outreach efforts and were not consistently recorded. Therefore, they were not included in the PECT and are not reported here.

Analyses

We computed simple, descriptive statistics including the number and percentage of patients identifying at least one breakdown, as well as the number and percent reporting each type of breakdown. We also computed the number and percentage of patients reporting any harm and each type of harm. We computed the percentage of patients reporting at least 1 breakdown by hospital, type of interview (postdischarge vs inpatient), selected patient demographic characteristics (eg, gender, age, education, race), and interviewee (patient vs someone other than the patient interviewed or present during the interview) using the chi-square statistic to test the statistical significance of the resulting differences. All statistical analyses were performed using SPSS version 22.

A total of 979 outreach interviews were conducted. Of these, 349 were conducted via telephone postdischarge, and 630 were conducted in person during hospitalization. The average interview duration was 8.5 minutes for telephone interviews and 12.2 minutes for in-person interviews. Of the patients approached to participate, 67% completed an interview (61% in person, 83% via telephone). Patient characteristics are summarized in Table 2.

Overall, 386 of 979 interviewees (39.4%) believed they had experienced at least one breakdown in care. The types of patient-perceived breakdowns reported were categorized using the PECT and are summarized in Table 3 and the Figure. The most common concern involved information exchange. Approximately 1 in 10 patients (n = 105, 10.7%) felt that they had not received the information they needed when they needed it. Medication-related concerns were reported by 12.3% (n = 120) of interviewees and predominantly included concerns about what medications were being administered (5.7%) and inadequately treated pain (5.6%). Many of the patients expressing concerns about what medications were administered questioned why they were not receiving their outpatient medications or did not understand why a different medication was being administered, suggesting that many of these instances were related to breakdowns in communication as well. Other relatively common concerns were delays in the admissions process (reported by 9.2% of interviewees), poor team communication (reported by 6.6% of interviewees), healthcare providers with a rude or uncaring manner (reported by 6.3% of interviewees), and problems related to discharge (reported by 5.7% of interviewees).

Through interviews with nearly 1000 patients, we have found that approximately 4 in 10 hospitalized patients believed they experienced a breakdown in care. Not only are patient-perceived breakdowns in care distressingly common, more than one-third of these events resulted in harm according to the patient. Patients reported a diverse range of breakdowns, including problems related to patient experience, as well as breakdowns in technical aspects of medical care. Collectively, these findings illustrate a striking need to identify and address these frequent and potentially harmful breakdowns.

Our findings are consistent with prior studies in which 20% to 50% of patients identified a problem during hospitalization. For example, Weingart et al^. interviewed patients in a single general medical unit and found that 20% experienced an adverse event, near miss, or medical error, while nearly 40% experienced what was defined as a service quality incident.^2,12 Of note, both our study and the study by Weingart et al. systematically elicited patients’ perspectives of breakdowns in care with explicit questions about problems or breakdowns in care.^2,12 Because patients are often reluctant to speak up about problems in care,without such efforts to actively identify problems, providers and leaders are likely to be unaware of the majority of these concerns.^6-8 These findings suggest that hospital-based providers should at least consider routinely asking patients about breakdowns in care to identify and respond to patients’ concerns.

Not only are patient-perceived breakdowns common, more than one-third of patients who experienced a breakdown considered it to be harmful. This suggests that our outreach approach identified predominantly nontrivial concerns. We adopted a broad definition of harm that includes emotional distress, damage to the relationship with providers, and life disruption. This differs from other studies examining patient reports of breakdowns in care, in which harm was restricted to physical injury.^1,2 We consider this inclusive definition of harm to be a strength of the present study as it provides the most complete picture of the impact of such events on patients. This approach is supported by other studies demonstrating that patients place great emphasis on the psychological consequences of adverse events.^17-19 Thus, it is clear from our work and other studies that nonphysical harm is important and warrants concerted efforts to address.

Patients in our study reported a variety of breakdowns, including breakdowns related to patient experience (eg, communication, relationship with providers) and technical aspects of healthcare delivery (eg, diagnosis, treatment). This is consistent with other studies examining patient perspectives of breakdowns in care. Weingart et al.found that hospitalized patients reported a broad range of problems, including adverse events, medical errors, communication breakdowns, and problems with food.^2,12 This variety of events suggests a need for integration between the various hospital groups that handle patient-perceived breakdowns, including bedside providers, risk management, patient relations, patient advocates, and quality and safety groups, in order to provide a coordinated and effective response to the full spectrum of patient-perceived breakdowns in care.

Patients in our study were more likely to report breakdowns related to communication and relationships with providers than those related to technical aspects of care. Similarly, Kuzel et al.found that the most common problems cited by patients in the primary care setting were breakdowns in the clinician-patient relationship and access-related problems.¹⁷This is not surprising, as patients are likely to have more direct knowledge about communication and interpersonal relationships than about technical aspects of care.

We identified several factors associated with the likelihood of reporting a breakdown in care. Most strikingly, involving a friend or family member in the interview was strongly associated with reporting a breakdown. Other work has also suggested that patients’ friends and family members are an important source of information about safety concerns.^20,21 In addition, several patient characteristics were associated with an increased likelihood of reporting a breakdown, including being younger and better educated. These findings highlight the importance of engaging patients’ friends and families in efforts to elicit patient concerns about healthcare, and they confirm recommendations for patients to bring a friend or family member to healthcare encounters.²² In addition, they illustrate the need to better understand how patient characteristics affect perceptions of breakdowns in care and their willingness to speak up, as this could inform efforts to target outreach to especially vulnerable patients.

A strength of this study is the number of interviews completed (almost 1000), which provides a diverse range of patient views and experiences, as evidenced by the demographic characteristics of participants. Interviews were conducted at two hospitals that differ substantially with regard to populations served, further enhancing the generalizability of our findings. Despite the large number of interviews and diverse patient characteristics, patients were drawn from only 3 units at 2 hospitals, which may limit generalizability.

We did not conduct medical record reviews to validate patients’ reports of problems, which may be viewed as a limitation. While such a comparison would be informative, the intent of the current study was to elicit patients’ perceptions of care, including aspects of care that are not typically captured in the medical record, such as communication. Other studies have demonstrated that patients’ reports of medical errors and adverse events tend to differ from providers’ reports of the same subjects.^19,23 Therefore, we considered the patients’ perceptions of care to be a useful endpoint in and of itself. We did not determine the extent to which providers were already aware of patients’ concerns or whether they considered patients’ concerns valid. A related limitation is our inability to determine whether the differences we identified in the rates of breakdown reporting based on patient characteristics reflect differences in willingness to report or differences in experiences. Because we included patients in an MSU, it is possible that breakdowns were related to medical care, surgical care, or both. We did not follow patients longitudinally and therefore only captured harm perceived by a patient at the time of the interview. It is possible that patients may have experienced harm later in their hospitalization or following discharge that was not measured. Lastly, we did not measure interrater reliability of the interview coding and therefore do not present the PECT as a validated instrument. These important questions should be targeted for future study.

When directly asked about their experiences, almost 4 out of 10 hospitalized patients reported a breakdown in their care, many of which were perceived to be harmful. Not all hospitals will have the resources to implement the intensive approach used in this study to elicit patient-perceived breakdowns. Therefore, further work is needed to develop sustainable methods to overcome patients’ reluctance to report breakdowns in care. Engaging patients’ families and friends may be a particularly fruitful strategy. We offer the PECT as a tool that hospitals could use to summarize a variety of sources of patient feedback such as complaints, responses to surveys, and consumer reviews. Hospitals that effectively encourage patients and their family members to speak up about perceived breakdowns will identify many opportunities to address patient concerns, potentially leading to improved patient safety and experience.

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]

The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.

This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.

In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.

A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.

[email protected]