The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).¹ This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.² Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.³ These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.^4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),^6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).⁸ If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).¹ This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.² Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.³ These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.^4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),^6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).⁸ If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).¹ This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.² Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.³ These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.^4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),^6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).⁸ If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.¹ With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.^2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.⁷ Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,⁸ highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,⁹ hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas^6,9-13 with increased patient satisfaction,^10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES²³ Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.¹¹ Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.²⁴ McCarty and colleagues⁸ demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood¹⁶ were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.¹⁹ All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.¹⁹ Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.¹⁵ Among TSA patients, McCarty and colleagues⁸ reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.²⁶ In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).²⁷ In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.¹⁴

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues¹⁸ reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.²⁰ This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.¹ With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.^2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.⁷ Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,⁸ highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,⁹ hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas^6,9-13 with increased patient satisfaction,^10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES²³ Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.¹¹ Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.²⁴ McCarty and colleagues⁸ demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood¹⁶ were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.¹⁹ All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.¹⁹ Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.¹⁵ Among TSA patients, McCarty and colleagues⁸ reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.²⁶ In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).²⁷ In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.¹⁴

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues¹⁸ reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.²⁰ This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.¹ With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.^2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.⁷ Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,⁸ highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,⁹ hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas^6,9-13 with increased patient satisfaction,^10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES²³ Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.¹¹ Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.²⁴ McCarty and colleagues⁸ demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood¹⁶ were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.¹⁹ All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.¹⁹ Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.¹⁵ Among TSA patients, McCarty and colleagues⁸ reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.²⁶ In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).²⁷ In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.¹⁴

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues¹⁸ reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.²⁰ This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.

“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.

Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.

Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.

Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.

“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”

Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.

“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.

“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.

Study details

The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).

Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.

Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.

In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).

The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).

Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.

SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.

Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.

“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.

Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.

Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.

Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.

“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”

Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.

“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.

“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.

Study details

The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).

Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.

Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.

In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).

The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).

Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.

SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.

Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.

“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.

Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.

Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.

Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.

“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”

Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.

“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.

“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.

Study details

The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).

Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.

Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.

In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).

The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).

Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.

SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.

Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.

Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).

Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.

However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.

The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.

SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.

Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.

Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).

Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.

However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.

The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.

SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.

Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.

Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).

Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.

However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.

The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.

SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.

Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.

Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.

“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.

“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.

The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.

Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.

Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.

The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.

“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H₂ blockers,” the authors reported.

“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.

The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.

Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.

SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.

Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.

Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.

“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.

“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.

The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.

Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.

Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.

The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.

“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H₂ blockers,” the authors reported.

“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.

The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.

Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.

SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.

Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.

Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.

“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.

“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.

The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.

Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.

Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.

The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.

“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H₂ blockers,” the authors reported.

“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.

The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.

Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.

SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

[email protected]

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

[email protected]

The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.

The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.

The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.

Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).

[email protected]

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

[email protected]

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

[email protected]

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

[email protected]

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

A randomized, multi-center, double-blinded trial is underway to study gastrointestinal recovery after open ventral hernia repair in patients who are treated with alvimopan or placebo.

One group will be given a 12-mg dose of alvimopan 30-90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on postoperative Day 1 after nasogastric tube (NGT) removal until hospital discharge or for a maximum of 7 days (up to 15 doses). The other group will be given a similarly colored 12-mg placebo capsule 30-90 minutes on the same schedule.

Primary outcomes will include the length of time (hrs/days) for recovery of the GI tract, measured by time to first flatus and time to first bowel movement, both measured twice daily. In addition, toleration of diet and oral pain medication will be measured. Variables such as NGT insertion, diet restriction or reductions, episodes of emesis, bloating, and pain will be recorded twice daily.

[email protected]

SOURCE: Clinicaltrials.gov, NCT02379858.

A randomized, multi-center, double-blinded trial is underway to study gastrointestinal recovery after open ventral hernia repair in patients who are treated with alvimopan or placebo.

One group will be given a 12-mg dose of alvimopan 30-90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on postoperative Day 1 after nasogastric tube (NGT) removal until hospital discharge or for a maximum of 7 days (up to 15 doses). The other group will be given a similarly colored 12-mg placebo capsule 30-90 minutes on the same schedule.

Primary outcomes will include the length of time (hrs/days) for recovery of the GI tract, measured by time to first flatus and time to first bowel movement, both measured twice daily. In addition, toleration of diet and oral pain medication will be measured. Variables such as NGT insertion, diet restriction or reductions, episodes of emesis, bloating, and pain will be recorded twice daily.

[email protected]

SOURCE: Clinicaltrials.gov, NCT02379858.

A randomized, multi-center, double-blinded trial is underway to study gastrointestinal recovery after open ventral hernia repair in patients who are treated with alvimopan or placebo.

One group will be given a 12-mg dose of alvimopan 30-90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on postoperative Day 1 after nasogastric tube (NGT) removal until hospital discharge or for a maximum of 7 days (up to 15 doses). The other group will be given a similarly colored 12-mg placebo capsule 30-90 minutes on the same schedule.

Primary outcomes will include the length of time (hrs/days) for recovery of the GI tract, measured by time to first flatus and time to first bowel movement, both measured twice daily. In addition, toleration of diet and oral pain medication will be measured. Variables such as NGT insertion, diet restriction or reductions, episodes of emesis, bloating, and pain will be recorded twice daily.

[email protected]

SOURCE: Clinicaltrials.gov, NCT02379858.