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CLINICAL UPDATE: Women's Health and Nutrition: Demographic Challenges
A supplement to Ob.Gyn. News.
This supplement is supported by Xanodyne Pharmaceuticals, Inc.
•Topic Highlights
•Faculty/Faculty Disclosures
To view the supplement, click the image above.
Topic Highlights
• Nutritional Gaps for Women in the United States
• Role of Obstetricians and Gynecologists in Women's Health Care
Faculty/Faculty Disclosures
Linda D. Bradley MD
Vice Chair, Obstetrics
Gynecology & Women's Health Institute
Cleveland Clinic
Cleveland, OH
Dr. Bradley is a consultant for Xanodyne Pharmaceuticals, Inc.
Beth Reardon, MS, RD, LDN
Integrative Nutritionist
Duke Integrative Nutrition
Durham, NC
Dr. Reardon has nothing to disclose.
John M. Thorp, Jr., MD
McAllister Distinguished Professor
Department of Obstetrics and Gynecology
University of North Carolina at Chapel Hill
Chapel Hill, NC
Dr. Thorp has nothing to disclose.
Barbara A. Underwood, PhD
Adjunct Professor of Nutrition
Columbia University
Institute of Human Nutrition
New York, NY
Dr. Underwood has nothing to disclose.
Fernando E. Viteri, MD, ScD
Professor (Emeritus)
Department of Nutritional Sciences and Toxicology
University of California
Berkeley, CA
and
Scientist
Children's Hospital
Oakland Research Institute
Oakland, CA
Dr. Viteri has received clinical grant funding from the University of California Institute for Mexico and the United States.
Copyright © 2009 by Elsevier Inc.
A supplement to Ob.Gyn. News.
This supplement is supported by Xanodyne Pharmaceuticals, Inc.
•Topic Highlights
•Faculty/Faculty Disclosures
To view the supplement, click the image above.
Topic Highlights
• Nutritional Gaps for Women in the United States
• Role of Obstetricians and Gynecologists in Women's Health Care
Faculty/Faculty Disclosures
Linda D. Bradley MD
Vice Chair, Obstetrics
Gynecology & Women's Health Institute
Cleveland Clinic
Cleveland, OH
Dr. Bradley is a consultant for Xanodyne Pharmaceuticals, Inc.
Beth Reardon, MS, RD, LDN
Integrative Nutritionist
Duke Integrative Nutrition
Durham, NC
Dr. Reardon has nothing to disclose.
John M. Thorp, Jr., MD
McAllister Distinguished Professor
Department of Obstetrics and Gynecology
University of North Carolina at Chapel Hill
Chapel Hill, NC
Dr. Thorp has nothing to disclose.
Barbara A. Underwood, PhD
Adjunct Professor of Nutrition
Columbia University
Institute of Human Nutrition
New York, NY
Dr. Underwood has nothing to disclose.
Fernando E. Viteri, MD, ScD
Professor (Emeritus)
Department of Nutritional Sciences and Toxicology
University of California
Berkeley, CA
and
Scientist
Children's Hospital
Oakland Research Institute
Oakland, CA
Dr. Viteri has received clinical grant funding from the University of California Institute for Mexico and the United States.
Copyright © 2009 by Elsevier Inc.
A supplement to Ob.Gyn. News.
This supplement is supported by Xanodyne Pharmaceuticals, Inc.
•Topic Highlights
•Faculty/Faculty Disclosures
To view the supplement, click the image above.
Topic Highlights
• Nutritional Gaps for Women in the United States
• Role of Obstetricians and Gynecologists in Women's Health Care
Faculty/Faculty Disclosures
Linda D. Bradley MD
Vice Chair, Obstetrics
Gynecology & Women's Health Institute
Cleveland Clinic
Cleveland, OH
Dr. Bradley is a consultant for Xanodyne Pharmaceuticals, Inc.
Beth Reardon, MS, RD, LDN
Integrative Nutritionist
Duke Integrative Nutrition
Durham, NC
Dr. Reardon has nothing to disclose.
John M. Thorp, Jr., MD
McAllister Distinguished Professor
Department of Obstetrics and Gynecology
University of North Carolina at Chapel Hill
Chapel Hill, NC
Dr. Thorp has nothing to disclose.
Barbara A. Underwood, PhD
Adjunct Professor of Nutrition
Columbia University
Institute of Human Nutrition
New York, NY
Dr. Underwood has nothing to disclose.
Fernando E. Viteri, MD, ScD
Professor (Emeritus)
Department of Nutritional Sciences and Toxicology
University of California
Berkeley, CA
and
Scientist
Children's Hospital
Oakland Research Institute
Oakland, CA
Dr. Viteri has received clinical grant funding from the University of California Institute for Mexico and the United States.
Copyright © 2009 by Elsevier Inc.
The Changing Landscape of Cervical Cancer Screening and Implications for the Clinician
A supplement to Ob.Gyn. News.
This educational supplement was supported by an educational grant from CYTYC Corporation.
The articles are based on clinical dialogues with the faculty.
To view the supplement, click the image above.
Topic Highlights/Faculty
Implications of Computer-Assisted Cervical Screening for the Ob.Gyn. Clinician
Co-Chairs:
Randall K. Gibb, MD
Assistant Professor, Division of Gynecologic Oncology
Washington University School of Medicine
St. Louis, Mo.
Thomas J. Herzog, MD
Director, Division of Gynecologic Oncology
Columbia University College of Physicians and Surgeons
New York, N.Y.
Comparison of Manual and Image-Directed Screening of Liquid-Based Cervical Cytology in a Large Metropolitan Cytology Practice
James R. Lingle, MD
Lingle, Gore, and Harding, P.C.
Englewood, Colo.
Fern S. Miller, MSN, CT(ASCP)
Cytology Manager, Cytology Department
Metropolitan Pathologists
Denver, Colo.
Performance of a Computer-Assisted Imaging System in Detecting High-Grade Squamous Intraepithelial Lesions
Bruce R. Dziura, MD
Chief of Pathology
New England Pathology Associates
Mercy Medical Center
Springfield, Mass
Timothy Kelly Fitzpatrick, MD
Attending Physician
Mercy Medical Center
Springfield, Mass.
Evaluation of a Computer-Assisted Imaging System in Diagnosing Uncommon Malignancies
Andrea E. Dawson, MD
Staff Pathologist
Cleveland Clinic Foundation
Cleveland, Ohio
Holly L. Thacker, MD
Director, Women's Health Center
Cleveland Clinic Foundation
Cleveland, Ohio
The faculty report they have nothing to disclose.
Copyright © 2005 by International Medical News Group
A supplement to Ob.Gyn. News.
This educational supplement was supported by an educational grant from CYTYC Corporation.
The articles are based on clinical dialogues with the faculty.
To view the supplement, click the image above.
Topic Highlights/Faculty
Implications of Computer-Assisted Cervical Screening for the Ob.Gyn. Clinician
Co-Chairs:
Randall K. Gibb, MD
Assistant Professor, Division of Gynecologic Oncology
Washington University School of Medicine
St. Louis, Mo.
Thomas J. Herzog, MD
Director, Division of Gynecologic Oncology
Columbia University College of Physicians and Surgeons
New York, N.Y.
Comparison of Manual and Image-Directed Screening of Liquid-Based Cervical Cytology in a Large Metropolitan Cytology Practice
James R. Lingle, MD
Lingle, Gore, and Harding, P.C.
Englewood, Colo.
Fern S. Miller, MSN, CT(ASCP)
Cytology Manager, Cytology Department
Metropolitan Pathologists
Denver, Colo.
Performance of a Computer-Assisted Imaging System in Detecting High-Grade Squamous Intraepithelial Lesions
Bruce R. Dziura, MD
Chief of Pathology
New England Pathology Associates
Mercy Medical Center
Springfield, Mass
Timothy Kelly Fitzpatrick, MD
Attending Physician
Mercy Medical Center
Springfield, Mass.
Evaluation of a Computer-Assisted Imaging System in Diagnosing Uncommon Malignancies
Andrea E. Dawson, MD
Staff Pathologist
Cleveland Clinic Foundation
Cleveland, Ohio
Holly L. Thacker, MD
Director, Women's Health Center
Cleveland Clinic Foundation
Cleveland, Ohio
The faculty report they have nothing to disclose.
Copyright © 2005 by International Medical News Group
A supplement to Ob.Gyn. News.
This educational supplement was supported by an educational grant from CYTYC Corporation.
The articles are based on clinical dialogues with the faculty.
To view the supplement, click the image above.
Topic Highlights/Faculty
Implications of Computer-Assisted Cervical Screening for the Ob.Gyn. Clinician
Co-Chairs:
Randall K. Gibb, MD
Assistant Professor, Division of Gynecologic Oncology
Washington University School of Medicine
St. Louis, Mo.
Thomas J. Herzog, MD
Director, Division of Gynecologic Oncology
Columbia University College of Physicians and Surgeons
New York, N.Y.
Comparison of Manual and Image-Directed Screening of Liquid-Based Cervical Cytology in a Large Metropolitan Cytology Practice
James R. Lingle, MD
Lingle, Gore, and Harding, P.C.
Englewood, Colo.
Fern S. Miller, MSN, CT(ASCP)
Cytology Manager, Cytology Department
Metropolitan Pathologists
Denver, Colo.
Performance of a Computer-Assisted Imaging System in Detecting High-Grade Squamous Intraepithelial Lesions
Bruce R. Dziura, MD
Chief of Pathology
New England Pathology Associates
Mercy Medical Center
Springfield, Mass
Timothy Kelly Fitzpatrick, MD
Attending Physician
Mercy Medical Center
Springfield, Mass.
Evaluation of a Computer-Assisted Imaging System in Diagnosing Uncommon Malignancies
Andrea E. Dawson, MD
Staff Pathologist
Cleveland Clinic Foundation
Cleveland, Ohio
Holly L. Thacker, MD
Director, Women's Health Center
Cleveland Clinic Foundation
Cleveland, Ohio
The faculty report they have nothing to disclose.
Copyright © 2005 by International Medical News Group
Chronic Dysfunctional Uterine Bleeding: Identifying Patients and Helping Them Understand Their Treatment Options
A supplement to Ob.Gyn. News.
Supported by an educational grant from Gynecare Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company.
The articles in this supplement are based on clinical dialogues with the faculty.
•Contents
•Faculty/Faculty Disclosure Statement
To view the supplement, click the image above.
Contents
Introduction
Consequences of Heavy Menstrual Bleeding
Types, Patterns, and Causes of Abnormal Uterine Bleeding
• Evaluating the Endometrial Cavity
Treatment Options: Entering the Dialogue
• Medical Therapy
• Surgical Interventions
• Endometrial Ablation Procedures
Considering Cases:
• An Overweight Patient
• A Patient Who Prefers to Avoid Hysterectomy
• A Patient With Postsurgical HMB
Helping Patients Choose
Conclusion
Faculty/Faculty Disclosure Statement
Mary Jane Minkin, MD, FACOG, Chair
Clinical Professor
Department of Obstetrics and Gynecology
Yale University School of Medicine
New Haven, Conn.
Developed a Web site for Gynecare; Speaker's Bureau: Berlex, Inc.
Charles E. Miller, MD, FACOG
Clinical Associate Professor
Department of Obstetrics and Gynecology
University of Illinois at Chicago
Clinical Associate
Department of Obstetrics and Gynecology
University of Chicago
Consultant: Gynecare Worldwide.
Malcolm G. Munro, MD, FRCS(c), FACOG
Professor
Department of Obstetrics and Gynecology
The David Geffen School of Medicine at UCLA
Los Angeles
Attending Staff
Department of Obstetrics and Gynecology
Kaiser Permanente Los Angeles Medical Center
Received Funding for Clinical Grants: Kaiser Research Foundation and Karl Storz Endoscopy-America, Inc.M
Consultant: Boston Scientific Corporation, Gynecare, and Karl Storz Endoscopy.
Robert K. Zurawin, MD, FACOG
Associate Professor
Department of Obstetrics and Gynecology
Baylor College of Medicine
Houston
Consultant/Speaker: Gynecare Worldwide.
Copyright © 2004 by International Medical News Group
A supplement to Ob.Gyn. News.
Supported by an educational grant from Gynecare Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company.
The articles in this supplement are based on clinical dialogues with the faculty.
•Contents
•Faculty/Faculty Disclosure Statement
To view the supplement, click the image above.
Contents
Introduction
Consequences of Heavy Menstrual Bleeding
Types, Patterns, and Causes of Abnormal Uterine Bleeding
• Evaluating the Endometrial Cavity
Treatment Options: Entering the Dialogue
• Medical Therapy
• Surgical Interventions
• Endometrial Ablation Procedures
Considering Cases:
• An Overweight Patient
• A Patient Who Prefers to Avoid Hysterectomy
• A Patient With Postsurgical HMB
Helping Patients Choose
Conclusion
Faculty/Faculty Disclosure Statement
Mary Jane Minkin, MD, FACOG, Chair
Clinical Professor
Department of Obstetrics and Gynecology
Yale University School of Medicine
New Haven, Conn.
Developed a Web site for Gynecare; Speaker's Bureau: Berlex, Inc.
Charles E. Miller, MD, FACOG
Clinical Associate Professor
Department of Obstetrics and Gynecology
University of Illinois at Chicago
Clinical Associate
Department of Obstetrics and Gynecology
University of Chicago
Consultant: Gynecare Worldwide.
Malcolm G. Munro, MD, FRCS(c), FACOG
Professor
Department of Obstetrics and Gynecology
The David Geffen School of Medicine at UCLA
Los Angeles
Attending Staff
Department of Obstetrics and Gynecology
Kaiser Permanente Los Angeles Medical Center
Received Funding for Clinical Grants: Kaiser Research Foundation and Karl Storz Endoscopy-America, Inc.M
Consultant: Boston Scientific Corporation, Gynecare, and Karl Storz Endoscopy.
Robert K. Zurawin, MD, FACOG
Associate Professor
Department of Obstetrics and Gynecology
Baylor College of Medicine
Houston
Consultant/Speaker: Gynecare Worldwide.
Copyright © 2004 by International Medical News Group
A supplement to Ob.Gyn. News.
Supported by an educational grant from Gynecare Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company.
The articles in this supplement are based on clinical dialogues with the faculty.
•Contents
•Faculty/Faculty Disclosure Statement
To view the supplement, click the image above.
Contents
Introduction
Consequences of Heavy Menstrual Bleeding
Types, Patterns, and Causes of Abnormal Uterine Bleeding
• Evaluating the Endometrial Cavity
Treatment Options: Entering the Dialogue
• Medical Therapy
• Surgical Interventions
• Endometrial Ablation Procedures
Considering Cases:
• An Overweight Patient
• A Patient Who Prefers to Avoid Hysterectomy
• A Patient With Postsurgical HMB
Helping Patients Choose
Conclusion
Faculty/Faculty Disclosure Statement
Mary Jane Minkin, MD, FACOG, Chair
Clinical Professor
Department of Obstetrics and Gynecology
Yale University School of Medicine
New Haven, Conn.
Developed a Web site for Gynecare; Speaker's Bureau: Berlex, Inc.
Charles E. Miller, MD, FACOG
Clinical Associate Professor
Department of Obstetrics and Gynecology
University of Illinois at Chicago
Clinical Associate
Department of Obstetrics and Gynecology
University of Chicago
Consultant: Gynecare Worldwide.
Malcolm G. Munro, MD, FRCS(c), FACOG
Professor
Department of Obstetrics and Gynecology
The David Geffen School of Medicine at UCLA
Los Angeles
Attending Staff
Department of Obstetrics and Gynecology
Kaiser Permanente Los Angeles Medical Center
Received Funding for Clinical Grants: Kaiser Research Foundation and Karl Storz Endoscopy-America, Inc.M
Consultant: Boston Scientific Corporation, Gynecare, and Karl Storz Endoscopy.
Robert K. Zurawin, MD, FACOG
Associate Professor
Department of Obstetrics and Gynecology
Baylor College of Medicine
Houston
Consultant/Speaker: Gynecare Worldwide.
Copyright © 2004 by International Medical News Group
Verbal Communication at Discharge
Hospital discharge can be hazardous because discontinuity and fragmentation of care increase risks to the patient. Inadequate communication has been identified as a major etiology for errors and adverse events occurring shortly after discharge.1, 2 Another potential result of a failed hospital discharge is patient dissatisfaction. Increased patient involvement in care improves health outcomes, and may improve patient satisfaction.3 To engage patients in their care, healthcare providers must collaborate with patients to coordinate care across settings.
In this study, we sought to determine what patients and their caregivers view as essential elements of a safe and high‐quality discharge process. We developed a survey with a broad range of questions related to the hospital discharge process (see Supporting Information, Appendix A, in the online version of this article). The survey included several questions derived from Project BOOST (Better Outcomes for Older adults through Safe Transitions) discharge care plans.4
METHODS
Study Design
We surveyed patients on the second day of admission to the internal medicine wards at the University of Washington Medical Center (a 450‐bed tertiary care teaching hospital) and Harborview Medical Center (a 412‐bed county teaching hospital) from June 1, 2010 to August 1, 2010. All patients 18 years old who were admitted during weekdays were considered for participation. Any potential participant unable to manually fill out the survey was offered the opportunity to use a proxy to help complete the survey. A proxy was any adult support person who was present in the room at the time the patient was approached with the opportunity to participate. Patients were excluded only if they (or their proxies) could not read English. The second day of hospitalization was chosen for several reasons: 1) to attempt to assess patients at a similar point in their hospital stay; 2) to avoid the day of discharge, as this may have introduced confounders such as patients who were actively engaged in the discharge process; and 3) to avoid the day of admission to increase the likelihood that patients would be medically stable at the time of the survey.
The Survey
The study protocol was reviewed and approved by the University of Washington Committee for the Protection of Human Subjects. All subjects gave verbal informed consent. The survey consisted of 3 sections: demographics, questions gauging the importance of various key points in the discharge process to patients, and open‐ended questions. Responses to questions used a Likert scale. Responses to open‐ended questions were handwritten on the paper survey.
Statistical Analysis
The quantitative data were classified categorically and analyzed using Fisher's exact test. Three investigators (M.S., S.E.M., M.B.J.) individually reviewed and coded all written patient or proxy comments using grounded theory methodology.5 Discrepant coding was identified and reconciled. The reconciled coded comments were aggregated into themes.
RESULTS
Demographics
We screened 240 patients or proxies and 200 completed the survey; 10.4% were ineligible due to language barrier, and 6.3% refused. Ninety‐two percent of patients completed the surveys. A majority were male (62.5%), 1859 years old (80%); spoke English as their first language (66%); were community‐dwelling prior to hospitalization (59%); were followed by a primary care provider (PCP) (53%), and many had at least a 4‐year‐college education (45%). One hundred eighty‐five surveys (92.5%) were completed by patients, and 15 (7.5%) were completed by proxies. Ninety surveys were completed at the county teaching hospital, and 110 surveys were completed at the tertiary teaching hospital. See Table 1 for detailed demographic information.
Patient age, n (%) | |
1859 yr | 160 (80) |
6069 yr | 30 (15) |
7079 yr | 5 (2.5) |
80 and older | 5 (2.5) |
Patient gender, n (%) | |
Male | 125 (62.5) |
Female | 75 (37.5) |
Patient schooling, n (%) | |
Less than high school | 20 (10) |
High school | 50 (25) |
Two‐year college | 40 (20) |
Four‐year college | 70 (35) |
Graduate education | 20 (10) |
English is patient's first language, n (%) | |
Yes | 132 (66) |
No | 68 (34) |
Patient has a primary care doctor, n (%) | |
Yes | 106 (53) |
No | 94 (47) |
Patient's residence before hospitalization, n (%) | |
Home without home health | 64 (32) |
Home with home health | 54 (27) |
Skilled nursing facility | 52 (26) |
Shelter | 30 (15) |
Survey Results
One hundred percent of patients rated the following items as essential (highest category on Likert Scale): when you need to follow‐up with primary care doctor, warning signs to call primary care doctor, and medicines to continue post‐hospitalization (Figure 1). Patients rated the following items as less important (these items were not unanimously rated as extremely important or essential): treatment you received, medicines you took pre‐hospitalization, importance of bringing all your medicines to follow‐up appointments, and given the side effect of each medication. One hundred percent of patients wanted a lot of explanation (highest category on Likert Scale) about my condition and my test results. Only 39% of patients wanted a lot of explanation about discharge medications. Sixty‐one percent wanted somewhat of an explanation about discharge medications. When asked to choose the most important piece of information, 67.5% of patients chose lifestyle changes. See Figure 1 for the relative importance of the items.

The majority of patients surveyed, 173 (86.5%), wanted verbal discharge instructions with or without written discharge instructions, with only 10.5% requesting only written discharge instructions (P < 0.0001). The majority of patients, 168 (84%), wanted resources to read about their medical condition, with 97 (57%) requesting brochures and 62 (36.9%) requesting Web sites. One hundred percent of patients thought that personal communication between the inpatient provider and the primary care doctor was extremely important or essential.
We identified 4 major themes in our qualitative review of the patients' and proxies' comments: verbal communication, frustration, opacity of system, and too many physicians. Participant quotes related to the 4 major themes are presented in Table 2. Many participants expressed a desire for verbal, rather than written, communication at the time of discharge with their healthcare team; patients particularly requested time for verbal communication with their physician. In the frustration theme, many patients and caregivers expressed frustration that the healthcare team was not carefully listening to them. In the theme of too many physicians, many patients expressed feeling overwhelmed by the number of different doctors involved in their care; particularly at discharge, patients did not know to whom to direct questions. Finally, as part of the opacity of system theme, patient comments included concerns regarding how information will be passed to outside doctors, and that the system of communication is not clear.
Verbal communication |
Can we just stop and talk? Everybody is rushing in and out. |
I just want my doctor to stop by before I go home and tell me what the plan is. |
Sometimes I feel like no one is talking to me. All they do is give me paperwork. |
I want my doctors to sit down with me before I leave the hospital and tell me exactly what I need to do so that I don't come back. |
I don't want papers, I want people. I want to talk to someone and not read my problems from a sheet of paper. |
Frustration |
I wonder sometimes if anyone is listening to me I seem to be part of a very elaborate organization that has its own rules and regulations and will not alter its ways. |
Why do I have to keep retelling my story? It gets tiring. I wish my story could just be told once. |
Too many physicians |
I saw lots of doctors during my time here, but I didn't see them again when I was leaving. |
I see so many doctors I have no idea who is in charge and who I should direct my questions to. |
I feel overwhelmed by the number of doctors I see every time I come into the hospital. |
I want my main doctor to talk to me. I get so confused when I hear from more than one doctor. |
I miss the days when my primary doctor came in to check on me. He knew exactly what I needed. Now, I meet new people every time I go into the hospital. |
Opacity of system |
I wonder if all my doctors talk to each other. Sometimes, it seems like they don't. |
Who keeps track of all this information? Is there someone who will pass on what happened to me here to the outside world? |
DISCUSSION
Discharge is a period of transition from hospital to home that involves a transfer in responsibility from the inpatient care team to the patient and/or caregivers and primary care physician. Ineffective communication, planning, and coordination of care can undermine patient satisfaction, increase adverse events, and contribute to more frequent hospital readmissions.
The patients we surveyed uniformly placed high value on verbal (more than written) communication about discharge care plans. Protected time during the discharge process for hospital staff to provide verbal recommendations to patients, especially about when they should return for follow‐up, warning signs to contact PCP sooner, and medications to continue after discharge, may improve patient satisfaction.
In open‐ended comments, several subjects suggested that physicians should sit down in the patient's room and provide verbal discharge instructions. Although it is well recognized that verbal communication alone has limitations and that providing patients with written instructions remains crucial, verbal reinforcement may highlight the most important instructions.
Interestingly, subjects valued information about lifestyle changes over detailed information about their medications. This may suggest that hospitalized patients are particularly receptive to information about lifestyle changes such as smoking cessation or importance of compliance with medical appointments.
Lastly, patients we surveyed value personal communication between inpatient and outpatient providers. It is plausible that this would improve transitions of care, and previous studies have suggested that direct communication between inpatient and outpatient providers occurs infrequently, with only 20% of primary care providers in 1 study reporting that they are always notified when their patient is being discharged from a hospitalist service.6
The themes that emerged from our open‐ended questions also highlight the importance of direct verbal communication with patients and careful coordination of care with outside physicians. Because patients may be unlikely to fully remember verbal instructions at discharge, providers may consider providing patients and family members with patient‐centered written materials to take home in order to reinforce important self‐care instructions. The patient comments further suggest that patients may be more satisfied, and that discharges may be smoother, if 1 or 2 physicians were always identified to the patients and their caregivers as the leaders of the care team throughout the hospital course and discharge process.
Our study had several limitations. We only surveyed patients on general medicine services, so our findings might not apply to other populations. We did not enroll participants on weekends and holidays; it is possible that this led to some bias in the enrollment of subjects. We also only surveyed patients and/or proxies who could speak and read English, and this was a fairly highly educated population, with almost half having completed 4 years of college. Finally, we relied on participant self‐report for demographic information because we did not have access to the electronic medical record. This study was conducted at 2 large academic medical centers that include resident physicians in the daily care of patients; thus, these results may not be generalizable to other settings.
Effective verbal communication between physicians, outpatient providers, patients, and their caregivers about discharge care plans might improve patients' understanding of their hospitalizations, increase their satisfaction with care, and reduce readmissions. In addition, physicians should recognize that patients value advice about lifestyle interventions that might improve their health, as part of the discharge care plan. Intervention studies are necessary to test these hypotheses in large, diverse populations.
Acknowledgements
Disclosure: Nothing to report.
- Medical errors related to discontinuity of care from an inpatient to an outpatient setting.J Gen Intern Med.2003;18(8):646–651. , , , .
- Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care.JAMA.2007;297(8):831–841. , , , , , .
- Expanding patient involvement in care. Effects on patient outcomes.Ann Intern Med.1985;102(4):520–528. , , .
- Society of Hospital Medicine. Project BOOST, Better Outcomes for Older adults through Safe Transitions. Available at: http://www.hospitalmedicine.org/AM/Template.cfm?Section=Home1998.
- Primary care physician attitudes regarding communication with hospitalists.Am J Med.2001;111(9B):15S–20S. , , , .
Hospital discharge can be hazardous because discontinuity and fragmentation of care increase risks to the patient. Inadequate communication has been identified as a major etiology for errors and adverse events occurring shortly after discharge.1, 2 Another potential result of a failed hospital discharge is patient dissatisfaction. Increased patient involvement in care improves health outcomes, and may improve patient satisfaction.3 To engage patients in their care, healthcare providers must collaborate with patients to coordinate care across settings.
In this study, we sought to determine what patients and their caregivers view as essential elements of a safe and high‐quality discharge process. We developed a survey with a broad range of questions related to the hospital discharge process (see Supporting Information, Appendix A, in the online version of this article). The survey included several questions derived from Project BOOST (Better Outcomes for Older adults through Safe Transitions) discharge care plans.4
METHODS
Study Design
We surveyed patients on the second day of admission to the internal medicine wards at the University of Washington Medical Center (a 450‐bed tertiary care teaching hospital) and Harborview Medical Center (a 412‐bed county teaching hospital) from June 1, 2010 to August 1, 2010. All patients 18 years old who were admitted during weekdays were considered for participation. Any potential participant unable to manually fill out the survey was offered the opportunity to use a proxy to help complete the survey. A proxy was any adult support person who was present in the room at the time the patient was approached with the opportunity to participate. Patients were excluded only if they (or their proxies) could not read English. The second day of hospitalization was chosen for several reasons: 1) to attempt to assess patients at a similar point in their hospital stay; 2) to avoid the day of discharge, as this may have introduced confounders such as patients who were actively engaged in the discharge process; and 3) to avoid the day of admission to increase the likelihood that patients would be medically stable at the time of the survey.
The Survey
The study protocol was reviewed and approved by the University of Washington Committee for the Protection of Human Subjects. All subjects gave verbal informed consent. The survey consisted of 3 sections: demographics, questions gauging the importance of various key points in the discharge process to patients, and open‐ended questions. Responses to questions used a Likert scale. Responses to open‐ended questions were handwritten on the paper survey.
Statistical Analysis
The quantitative data were classified categorically and analyzed using Fisher's exact test. Three investigators (M.S., S.E.M., M.B.J.) individually reviewed and coded all written patient or proxy comments using grounded theory methodology.5 Discrepant coding was identified and reconciled. The reconciled coded comments were aggregated into themes.
RESULTS
Demographics
We screened 240 patients or proxies and 200 completed the survey; 10.4% were ineligible due to language barrier, and 6.3% refused. Ninety‐two percent of patients completed the surveys. A majority were male (62.5%), 1859 years old (80%); spoke English as their first language (66%); were community‐dwelling prior to hospitalization (59%); were followed by a primary care provider (PCP) (53%), and many had at least a 4‐year‐college education (45%). One hundred eighty‐five surveys (92.5%) were completed by patients, and 15 (7.5%) were completed by proxies. Ninety surveys were completed at the county teaching hospital, and 110 surveys were completed at the tertiary teaching hospital. See Table 1 for detailed demographic information.
Patient age, n (%) | |
1859 yr | 160 (80) |
6069 yr | 30 (15) |
7079 yr | 5 (2.5) |
80 and older | 5 (2.5) |
Patient gender, n (%) | |
Male | 125 (62.5) |
Female | 75 (37.5) |
Patient schooling, n (%) | |
Less than high school | 20 (10) |
High school | 50 (25) |
Two‐year college | 40 (20) |
Four‐year college | 70 (35) |
Graduate education | 20 (10) |
English is patient's first language, n (%) | |
Yes | 132 (66) |
No | 68 (34) |
Patient has a primary care doctor, n (%) | |
Yes | 106 (53) |
No | 94 (47) |
Patient's residence before hospitalization, n (%) | |
Home without home health | 64 (32) |
Home with home health | 54 (27) |
Skilled nursing facility | 52 (26) |
Shelter | 30 (15) |
Survey Results
One hundred percent of patients rated the following items as essential (highest category on Likert Scale): when you need to follow‐up with primary care doctor, warning signs to call primary care doctor, and medicines to continue post‐hospitalization (Figure 1). Patients rated the following items as less important (these items were not unanimously rated as extremely important or essential): treatment you received, medicines you took pre‐hospitalization, importance of bringing all your medicines to follow‐up appointments, and given the side effect of each medication. One hundred percent of patients wanted a lot of explanation (highest category on Likert Scale) about my condition and my test results. Only 39% of patients wanted a lot of explanation about discharge medications. Sixty‐one percent wanted somewhat of an explanation about discharge medications. When asked to choose the most important piece of information, 67.5% of patients chose lifestyle changes. See Figure 1 for the relative importance of the items.

The majority of patients surveyed, 173 (86.5%), wanted verbal discharge instructions with or without written discharge instructions, with only 10.5% requesting only written discharge instructions (P < 0.0001). The majority of patients, 168 (84%), wanted resources to read about their medical condition, with 97 (57%) requesting brochures and 62 (36.9%) requesting Web sites. One hundred percent of patients thought that personal communication between the inpatient provider and the primary care doctor was extremely important or essential.
We identified 4 major themes in our qualitative review of the patients' and proxies' comments: verbal communication, frustration, opacity of system, and too many physicians. Participant quotes related to the 4 major themes are presented in Table 2. Many participants expressed a desire for verbal, rather than written, communication at the time of discharge with their healthcare team; patients particularly requested time for verbal communication with their physician. In the frustration theme, many patients and caregivers expressed frustration that the healthcare team was not carefully listening to them. In the theme of too many physicians, many patients expressed feeling overwhelmed by the number of different doctors involved in their care; particularly at discharge, patients did not know to whom to direct questions. Finally, as part of the opacity of system theme, patient comments included concerns regarding how information will be passed to outside doctors, and that the system of communication is not clear.
Verbal communication |
Can we just stop and talk? Everybody is rushing in and out. |
I just want my doctor to stop by before I go home and tell me what the plan is. |
Sometimes I feel like no one is talking to me. All they do is give me paperwork. |
I want my doctors to sit down with me before I leave the hospital and tell me exactly what I need to do so that I don't come back. |
I don't want papers, I want people. I want to talk to someone and not read my problems from a sheet of paper. |
Frustration |
I wonder sometimes if anyone is listening to me I seem to be part of a very elaborate organization that has its own rules and regulations and will not alter its ways. |
Why do I have to keep retelling my story? It gets tiring. I wish my story could just be told once. |
Too many physicians |
I saw lots of doctors during my time here, but I didn't see them again when I was leaving. |
I see so many doctors I have no idea who is in charge and who I should direct my questions to. |
I feel overwhelmed by the number of doctors I see every time I come into the hospital. |
I want my main doctor to talk to me. I get so confused when I hear from more than one doctor. |
I miss the days when my primary doctor came in to check on me. He knew exactly what I needed. Now, I meet new people every time I go into the hospital. |
Opacity of system |
I wonder if all my doctors talk to each other. Sometimes, it seems like they don't. |
Who keeps track of all this information? Is there someone who will pass on what happened to me here to the outside world? |
DISCUSSION
Discharge is a period of transition from hospital to home that involves a transfer in responsibility from the inpatient care team to the patient and/or caregivers and primary care physician. Ineffective communication, planning, and coordination of care can undermine patient satisfaction, increase adverse events, and contribute to more frequent hospital readmissions.
The patients we surveyed uniformly placed high value on verbal (more than written) communication about discharge care plans. Protected time during the discharge process for hospital staff to provide verbal recommendations to patients, especially about when they should return for follow‐up, warning signs to contact PCP sooner, and medications to continue after discharge, may improve patient satisfaction.
In open‐ended comments, several subjects suggested that physicians should sit down in the patient's room and provide verbal discharge instructions. Although it is well recognized that verbal communication alone has limitations and that providing patients with written instructions remains crucial, verbal reinforcement may highlight the most important instructions.
Interestingly, subjects valued information about lifestyle changes over detailed information about their medications. This may suggest that hospitalized patients are particularly receptive to information about lifestyle changes such as smoking cessation or importance of compliance with medical appointments.
Lastly, patients we surveyed value personal communication between inpatient and outpatient providers. It is plausible that this would improve transitions of care, and previous studies have suggested that direct communication between inpatient and outpatient providers occurs infrequently, with only 20% of primary care providers in 1 study reporting that they are always notified when their patient is being discharged from a hospitalist service.6
The themes that emerged from our open‐ended questions also highlight the importance of direct verbal communication with patients and careful coordination of care with outside physicians. Because patients may be unlikely to fully remember verbal instructions at discharge, providers may consider providing patients and family members with patient‐centered written materials to take home in order to reinforce important self‐care instructions. The patient comments further suggest that patients may be more satisfied, and that discharges may be smoother, if 1 or 2 physicians were always identified to the patients and their caregivers as the leaders of the care team throughout the hospital course and discharge process.
Our study had several limitations. We only surveyed patients on general medicine services, so our findings might not apply to other populations. We did not enroll participants on weekends and holidays; it is possible that this led to some bias in the enrollment of subjects. We also only surveyed patients and/or proxies who could speak and read English, and this was a fairly highly educated population, with almost half having completed 4 years of college. Finally, we relied on participant self‐report for demographic information because we did not have access to the electronic medical record. This study was conducted at 2 large academic medical centers that include resident physicians in the daily care of patients; thus, these results may not be generalizable to other settings.
Effective verbal communication between physicians, outpatient providers, patients, and their caregivers about discharge care plans might improve patients' understanding of their hospitalizations, increase their satisfaction with care, and reduce readmissions. In addition, physicians should recognize that patients value advice about lifestyle interventions that might improve their health, as part of the discharge care plan. Intervention studies are necessary to test these hypotheses in large, diverse populations.
Acknowledgements
Disclosure: Nothing to report.
Hospital discharge can be hazardous because discontinuity and fragmentation of care increase risks to the patient. Inadequate communication has been identified as a major etiology for errors and adverse events occurring shortly after discharge.1, 2 Another potential result of a failed hospital discharge is patient dissatisfaction. Increased patient involvement in care improves health outcomes, and may improve patient satisfaction.3 To engage patients in their care, healthcare providers must collaborate with patients to coordinate care across settings.
In this study, we sought to determine what patients and their caregivers view as essential elements of a safe and high‐quality discharge process. We developed a survey with a broad range of questions related to the hospital discharge process (see Supporting Information, Appendix A, in the online version of this article). The survey included several questions derived from Project BOOST (Better Outcomes for Older adults through Safe Transitions) discharge care plans.4
METHODS
Study Design
We surveyed patients on the second day of admission to the internal medicine wards at the University of Washington Medical Center (a 450‐bed tertiary care teaching hospital) and Harborview Medical Center (a 412‐bed county teaching hospital) from June 1, 2010 to August 1, 2010. All patients 18 years old who were admitted during weekdays were considered for participation. Any potential participant unable to manually fill out the survey was offered the opportunity to use a proxy to help complete the survey. A proxy was any adult support person who was present in the room at the time the patient was approached with the opportunity to participate. Patients were excluded only if they (or their proxies) could not read English. The second day of hospitalization was chosen for several reasons: 1) to attempt to assess patients at a similar point in their hospital stay; 2) to avoid the day of discharge, as this may have introduced confounders such as patients who were actively engaged in the discharge process; and 3) to avoid the day of admission to increase the likelihood that patients would be medically stable at the time of the survey.
The Survey
The study protocol was reviewed and approved by the University of Washington Committee for the Protection of Human Subjects. All subjects gave verbal informed consent. The survey consisted of 3 sections: demographics, questions gauging the importance of various key points in the discharge process to patients, and open‐ended questions. Responses to questions used a Likert scale. Responses to open‐ended questions were handwritten on the paper survey.
Statistical Analysis
The quantitative data were classified categorically and analyzed using Fisher's exact test. Three investigators (M.S., S.E.M., M.B.J.) individually reviewed and coded all written patient or proxy comments using grounded theory methodology.5 Discrepant coding was identified and reconciled. The reconciled coded comments were aggregated into themes.
RESULTS
Demographics
We screened 240 patients or proxies and 200 completed the survey; 10.4% were ineligible due to language barrier, and 6.3% refused. Ninety‐two percent of patients completed the surveys. A majority were male (62.5%), 1859 years old (80%); spoke English as their first language (66%); were community‐dwelling prior to hospitalization (59%); were followed by a primary care provider (PCP) (53%), and many had at least a 4‐year‐college education (45%). One hundred eighty‐five surveys (92.5%) were completed by patients, and 15 (7.5%) were completed by proxies. Ninety surveys were completed at the county teaching hospital, and 110 surveys were completed at the tertiary teaching hospital. See Table 1 for detailed demographic information.
Patient age, n (%) | |
1859 yr | 160 (80) |
6069 yr | 30 (15) |
7079 yr | 5 (2.5) |
80 and older | 5 (2.5) |
Patient gender, n (%) | |
Male | 125 (62.5) |
Female | 75 (37.5) |
Patient schooling, n (%) | |
Less than high school | 20 (10) |
High school | 50 (25) |
Two‐year college | 40 (20) |
Four‐year college | 70 (35) |
Graduate education | 20 (10) |
English is patient's first language, n (%) | |
Yes | 132 (66) |
No | 68 (34) |
Patient has a primary care doctor, n (%) | |
Yes | 106 (53) |
No | 94 (47) |
Patient's residence before hospitalization, n (%) | |
Home without home health | 64 (32) |
Home with home health | 54 (27) |
Skilled nursing facility | 52 (26) |
Shelter | 30 (15) |
Survey Results
One hundred percent of patients rated the following items as essential (highest category on Likert Scale): when you need to follow‐up with primary care doctor, warning signs to call primary care doctor, and medicines to continue post‐hospitalization (Figure 1). Patients rated the following items as less important (these items were not unanimously rated as extremely important or essential): treatment you received, medicines you took pre‐hospitalization, importance of bringing all your medicines to follow‐up appointments, and given the side effect of each medication. One hundred percent of patients wanted a lot of explanation (highest category on Likert Scale) about my condition and my test results. Only 39% of patients wanted a lot of explanation about discharge medications. Sixty‐one percent wanted somewhat of an explanation about discharge medications. When asked to choose the most important piece of information, 67.5% of patients chose lifestyle changes. See Figure 1 for the relative importance of the items.

The majority of patients surveyed, 173 (86.5%), wanted verbal discharge instructions with or without written discharge instructions, with only 10.5% requesting only written discharge instructions (P < 0.0001). The majority of patients, 168 (84%), wanted resources to read about their medical condition, with 97 (57%) requesting brochures and 62 (36.9%) requesting Web sites. One hundred percent of patients thought that personal communication between the inpatient provider and the primary care doctor was extremely important or essential.
We identified 4 major themes in our qualitative review of the patients' and proxies' comments: verbal communication, frustration, opacity of system, and too many physicians. Participant quotes related to the 4 major themes are presented in Table 2. Many participants expressed a desire for verbal, rather than written, communication at the time of discharge with their healthcare team; patients particularly requested time for verbal communication with their physician. In the frustration theme, many patients and caregivers expressed frustration that the healthcare team was not carefully listening to them. In the theme of too many physicians, many patients expressed feeling overwhelmed by the number of different doctors involved in their care; particularly at discharge, patients did not know to whom to direct questions. Finally, as part of the opacity of system theme, patient comments included concerns regarding how information will be passed to outside doctors, and that the system of communication is not clear.
Verbal communication |
Can we just stop and talk? Everybody is rushing in and out. |
I just want my doctor to stop by before I go home and tell me what the plan is. |
Sometimes I feel like no one is talking to me. All they do is give me paperwork. |
I want my doctors to sit down with me before I leave the hospital and tell me exactly what I need to do so that I don't come back. |
I don't want papers, I want people. I want to talk to someone and not read my problems from a sheet of paper. |
Frustration |
I wonder sometimes if anyone is listening to me I seem to be part of a very elaborate organization that has its own rules and regulations and will not alter its ways. |
Why do I have to keep retelling my story? It gets tiring. I wish my story could just be told once. |
Too many physicians |
I saw lots of doctors during my time here, but I didn't see them again when I was leaving. |
I see so many doctors I have no idea who is in charge and who I should direct my questions to. |
I feel overwhelmed by the number of doctors I see every time I come into the hospital. |
I want my main doctor to talk to me. I get so confused when I hear from more than one doctor. |
I miss the days when my primary doctor came in to check on me. He knew exactly what I needed. Now, I meet new people every time I go into the hospital. |
Opacity of system |
I wonder if all my doctors talk to each other. Sometimes, it seems like they don't. |
Who keeps track of all this information? Is there someone who will pass on what happened to me here to the outside world? |
DISCUSSION
Discharge is a period of transition from hospital to home that involves a transfer in responsibility from the inpatient care team to the patient and/or caregivers and primary care physician. Ineffective communication, planning, and coordination of care can undermine patient satisfaction, increase adverse events, and contribute to more frequent hospital readmissions.
The patients we surveyed uniformly placed high value on verbal (more than written) communication about discharge care plans. Protected time during the discharge process for hospital staff to provide verbal recommendations to patients, especially about when they should return for follow‐up, warning signs to contact PCP sooner, and medications to continue after discharge, may improve patient satisfaction.
In open‐ended comments, several subjects suggested that physicians should sit down in the patient's room and provide verbal discharge instructions. Although it is well recognized that verbal communication alone has limitations and that providing patients with written instructions remains crucial, verbal reinforcement may highlight the most important instructions.
Interestingly, subjects valued information about lifestyle changes over detailed information about their medications. This may suggest that hospitalized patients are particularly receptive to information about lifestyle changes such as smoking cessation or importance of compliance with medical appointments.
Lastly, patients we surveyed value personal communication between inpatient and outpatient providers. It is plausible that this would improve transitions of care, and previous studies have suggested that direct communication between inpatient and outpatient providers occurs infrequently, with only 20% of primary care providers in 1 study reporting that they are always notified when their patient is being discharged from a hospitalist service.6
The themes that emerged from our open‐ended questions also highlight the importance of direct verbal communication with patients and careful coordination of care with outside physicians. Because patients may be unlikely to fully remember verbal instructions at discharge, providers may consider providing patients and family members with patient‐centered written materials to take home in order to reinforce important self‐care instructions. The patient comments further suggest that patients may be more satisfied, and that discharges may be smoother, if 1 or 2 physicians were always identified to the patients and their caregivers as the leaders of the care team throughout the hospital course and discharge process.
Our study had several limitations. We only surveyed patients on general medicine services, so our findings might not apply to other populations. We did not enroll participants on weekends and holidays; it is possible that this led to some bias in the enrollment of subjects. We also only surveyed patients and/or proxies who could speak and read English, and this was a fairly highly educated population, with almost half having completed 4 years of college. Finally, we relied on participant self‐report for demographic information because we did not have access to the electronic medical record. This study was conducted at 2 large academic medical centers that include resident physicians in the daily care of patients; thus, these results may not be generalizable to other settings.
Effective verbal communication between physicians, outpatient providers, patients, and their caregivers about discharge care plans might improve patients' understanding of their hospitalizations, increase their satisfaction with care, and reduce readmissions. In addition, physicians should recognize that patients value advice about lifestyle interventions that might improve their health, as part of the discharge care plan. Intervention studies are necessary to test these hypotheses in large, diverse populations.
Acknowledgements
Disclosure: Nothing to report.
- Medical errors related to discontinuity of care from an inpatient to an outpatient setting.J Gen Intern Med.2003;18(8):646–651. , , , .
- Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care.JAMA.2007;297(8):831–841. , , , , , .
- Expanding patient involvement in care. Effects on patient outcomes.Ann Intern Med.1985;102(4):520–528. , , .
- Society of Hospital Medicine. Project BOOST, Better Outcomes for Older adults through Safe Transitions. Available at: http://www.hospitalmedicine.org/AM/Template.cfm?Section=Home1998.
- Primary care physician attitudes regarding communication with hospitalists.Am J Med.2001;111(9B):15S–20S. , , , .
- Medical errors related to discontinuity of care from an inpatient to an outpatient setting.J Gen Intern Med.2003;18(8):646–651. , , , .
- Deficits in communication and information transfer between hospital‐based and primary care physicians: implications for patient safety and continuity of care.JAMA.2007;297(8):831–841. , , , , , .
- Expanding patient involvement in care. Effects on patient outcomes.Ann Intern Med.1985;102(4):520–528. , , .
- Society of Hospital Medicine. Project BOOST, Better Outcomes for Older adults through Safe Transitions. Available at: http://www.hospitalmedicine.org/AM/Template.cfm?Section=Home1998.
- Primary care physician attitudes regarding communication with hospitalists.Am J Med.2001;111(9B):15S–20S. , , , .
Neoplastic Meningitis
Neoplastic Meningitis
- Received 26 May 2011. Accepted 2 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.002
Abstract
Neoplastic meningitis occurs in approximately 5%–10% of all patients with cancer, and aggressive supportive measures are a critical component of comprehensive care. A literature review of the current diagnostic methods, randomized controlled trials, and available treatments was undertaken; and a comprehensive discussion of best-practice supportive care measures is provided. Although the prognosis for those diagnosed with neoplastic meningitis is poor, treatment and supportive care may allow stabilization of neurologic symptoms and afford protection from further neurologic deterioration, allowing patients to maximize their function and independence and adjust their expectations of treatment from cure to palliation.
*For a PDF of the full article and accompanying viewpoints by Alexis Demopoulos and Matthias Holdhoff along with Stuart Grossman, click in the links to the left of this introduction.
Neoplastic Meningitis
- Received 26 May 2011. Accepted 2 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.002
Abstract
Neoplastic meningitis occurs in approximately 5%–10% of all patients with cancer, and aggressive supportive measures are a critical component of comprehensive care. A literature review of the current diagnostic methods, randomized controlled trials, and available treatments was undertaken; and a comprehensive discussion of best-practice supportive care measures is provided. Although the prognosis for those diagnosed with neoplastic meningitis is poor, treatment and supportive care may allow stabilization of neurologic symptoms and afford protection from further neurologic deterioration, allowing patients to maximize their function and independence and adjust their expectations of treatment from cure to palliation.
*For a PDF of the full article and accompanying viewpoints by Alexis Demopoulos and Matthias Holdhoff along with Stuart Grossman, click in the links to the left of this introduction.
Neoplastic Meningitis
- Received 26 May 2011. Accepted 2 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.002
Abstract
Neoplastic meningitis occurs in approximately 5%–10% of all patients with cancer, and aggressive supportive measures are a critical component of comprehensive care. A literature review of the current diagnostic methods, randomized controlled trials, and available treatments was undertaken; and a comprehensive discussion of best-practice supportive care measures is provided. Although the prognosis for those diagnosed with neoplastic meningitis is poor, treatment and supportive care may allow stabilization of neurologic symptoms and afford protection from further neurologic deterioration, allowing patients to maximize their function and independence and adjust their expectations of treatment from cure to palliation.
*For a PDF of the full article and accompanying viewpoints by Alexis Demopoulos and Matthias Holdhoff along with Stuart Grossman, click in the links to the left of this introduction.
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
- Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
- Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.007
Abstract
Background
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
- Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
- Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.007
Abstract
Background
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
- Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
- Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.06.007
Abstract
Background
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
- a Behavioral Health Research Program, Mayo Clinic, Rochester, NY
- b Cancer Center, May Clinic, Rochester, NY
- c Department of Biostatistics, Mayo Clinic, Rochester, NY
- d Department of Chaplain Services, Mayo Clinic, Rochester, NY
- e Department of Nursing Services, Mayo Clinic, Rochester, NY
- f Division of Nursing Services, Mayo Clinic, Scottsdale, AZ
- Received 15 March 2011. Accepted 1 September 2011. Available online 14 December 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.09.001,
Abstract
Background
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
- a Behavioral Health Research Program, Mayo Clinic, Rochester, NY
- b Cancer Center, May Clinic, Rochester, NY
- c Department of Biostatistics, Mayo Clinic, Rochester, NY
- d Department of Chaplain Services, Mayo Clinic, Rochester, NY
- e Department of Nursing Services, Mayo Clinic, Rochester, NY
- f Division of Nursing Services, Mayo Clinic, Scottsdale, AZ
- Received 15 March 2011. Accepted 1 September 2011. Available online 14 December 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.09.001,
Abstract
Background
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
- a Behavioral Health Research Program, Mayo Clinic, Rochester, NY
- b Cancer Center, May Clinic, Rochester, NY
- c Department of Biostatistics, Mayo Clinic, Rochester, NY
- d Department of Chaplain Services, Mayo Clinic, Rochester, NY
- e Department of Nursing Services, Mayo Clinic, Rochester, NY
- f Division of Nursing Services, Mayo Clinic, Scottsdale, AZ
- Received 15 March 2011. Accepted 1 September 2011. Available online 14 December 2011.
- http://dx.doi.org/10.1016/j.suponc.2011.09.001,
Abstract
Background
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
The Role of Spirituality and Religious Coping in the Quality of Life of Patients With Advanced Cancer Receiving Palliative Radiation Therapy
The Role of Spirituality and Religious Coping in the Quality of Life of Patients With Advanced Cancer Receiving Palliative Radiation Therapy
Abstract
Objectives
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
The Role of Spirituality and Religious Coping in the Quality of Life of Patients With Advanced Cancer Receiving Palliative Radiation Therapy
Abstract
Objectives
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
The Role of Spirituality and Religious Coping in the Quality of Life of Patients With Advanced Cancer Receiving Palliative Radiation Therapy
Abstract
Objectives
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
A Practical Update on Sexually Transmitted Infections: Advances in Diagnosis and Treatment
A supplement to Ob. Gyn. News.
Supported by a restricted educational grant from 3M Pharmaceuticals.
Highlights of presentations that took place at a continuing medical education conference held April 5-6, 2003, Washington, DC.
To view the supplement, click the image above.
Contents/Faculty Disclosure
Introduction
Jack D. Sobel, MD
Professor, Chief
Division of Infectious Disease
Wayne State University School of Medicine
Harper Hospital
Detroit, MI
Clinical Grants: 3M Pharmaceuticals, Pfizer, and Ortho-McNeil. Discusses the investigational use of fluconazole and 17.4% topical flucytosine cream for treating Candida glabrata, and 10% hydrocortisone for treating erosive lichen planus.
Phillip G. Stubblefield, MD
Professor and Chairman, Obstetrics and Gynecology
Boston University School of Medicine
Director, Obstetrics and Gynecology
Boston Medical Center
Boston, MA
Nothing to disclose.
Jonathan M. Zenilman, MD
Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: Osmetech PLC; Consultant: Merck and Company; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
Normal Vaginal Flora
Jeanne M. Marrazzo, MD, MPH
Assistant Professor, Department of Medicine
Division of Allergy and Infectious Diseases
University of Washington, Harborview Medical Center
Seattle, WA
Discusses the use of intravaginal Lactobacillus crispatus capsules for the treatment of bacterial vaginosis.
Diagnosis and Treatment of Routine and Resistant Trichomoniasis
Anne M. Rompalo, MD, ScM
Associate Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: GlaxoSmithKline; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
New Findings in Routine and Recurrent Vulvovaginal Candidiasis Treatment
Jack D. Sobel, MD
Overview of Bacterial Vaginosis and Its Role in Upper Genital Tract Infection
David A. Eschenbach, MD
Professor and Director, Women's Health
Chair, Department of Obstetrics and Gynecology
University of Washington
Seattle, WA
Consultant: 3M Pharmaceuticals.
Noninfectious Vulvovaginal Symptoms as Manifestations of Systemic Diseases
Jack D. Sobel, MD
Copyright © 2003 by International Medical News Group
A supplement to Ob. Gyn. News.
Supported by a restricted educational grant from 3M Pharmaceuticals.
Highlights of presentations that took place at a continuing medical education conference held April 5-6, 2003, Washington, DC.
To view the supplement, click the image above.
Contents/Faculty Disclosure
Introduction
Jack D. Sobel, MD
Professor, Chief
Division of Infectious Disease
Wayne State University School of Medicine
Harper Hospital
Detroit, MI
Clinical Grants: 3M Pharmaceuticals, Pfizer, and Ortho-McNeil. Discusses the investigational use of fluconazole and 17.4% topical flucytosine cream for treating Candida glabrata, and 10% hydrocortisone for treating erosive lichen planus.
Phillip G. Stubblefield, MD
Professor and Chairman, Obstetrics and Gynecology
Boston University School of Medicine
Director, Obstetrics and Gynecology
Boston Medical Center
Boston, MA
Nothing to disclose.
Jonathan M. Zenilman, MD
Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: Osmetech PLC; Consultant: Merck and Company; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
Normal Vaginal Flora
Jeanne M. Marrazzo, MD, MPH
Assistant Professor, Department of Medicine
Division of Allergy and Infectious Diseases
University of Washington, Harborview Medical Center
Seattle, WA
Discusses the use of intravaginal Lactobacillus crispatus capsules for the treatment of bacterial vaginosis.
Diagnosis and Treatment of Routine and Resistant Trichomoniasis
Anne M. Rompalo, MD, ScM
Associate Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: GlaxoSmithKline; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
New Findings in Routine and Recurrent Vulvovaginal Candidiasis Treatment
Jack D. Sobel, MD
Overview of Bacterial Vaginosis and Its Role in Upper Genital Tract Infection
David A. Eschenbach, MD
Professor and Director, Women's Health
Chair, Department of Obstetrics and Gynecology
University of Washington
Seattle, WA
Consultant: 3M Pharmaceuticals.
Noninfectious Vulvovaginal Symptoms as Manifestations of Systemic Diseases
Jack D. Sobel, MD
Copyright © 2003 by International Medical News Group
A supplement to Ob. Gyn. News.
Supported by a restricted educational grant from 3M Pharmaceuticals.
Highlights of presentations that took place at a continuing medical education conference held April 5-6, 2003, Washington, DC.
To view the supplement, click the image above.
Contents/Faculty Disclosure
Introduction
Jack D. Sobel, MD
Professor, Chief
Division of Infectious Disease
Wayne State University School of Medicine
Harper Hospital
Detroit, MI
Clinical Grants: 3M Pharmaceuticals, Pfizer, and Ortho-McNeil. Discusses the investigational use of fluconazole and 17.4% topical flucytosine cream for treating Candida glabrata, and 10% hydrocortisone for treating erosive lichen planus.
Phillip G. Stubblefield, MD
Professor and Chairman, Obstetrics and Gynecology
Boston University School of Medicine
Director, Obstetrics and Gynecology
Boston Medical Center
Boston, MA
Nothing to disclose.
Jonathan M. Zenilman, MD
Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: Osmetech PLC; Consultant: Merck and Company; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
Normal Vaginal Flora
Jeanne M. Marrazzo, MD, MPH
Assistant Professor, Department of Medicine
Division of Allergy and Infectious Diseases
University of Washington, Harborview Medical Center
Seattle, WA
Discusses the use of intravaginal Lactobacillus crispatus capsules for the treatment of bacterial vaginosis.
Diagnosis and Treatment of Routine and Resistant Trichomoniasis
Anne M. Rompalo, MD, ScM
Associate Professor, Infectious Diseases Division
Johns Hopkins School of Medicine
Baltimore, MD
Clinical Grants/Research: GlaxoSmithKline; Speaker's Bureau: GlaxoSmithKline, Pfizer, Inc.
New Findings in Routine and Recurrent Vulvovaginal Candidiasis Treatment
Jack D. Sobel, MD
Overview of Bacterial Vaginosis and Its Role in Upper Genital Tract Infection
David A. Eschenbach, MD
Professor and Director, Women's Health
Chair, Department of Obstetrics and Gynecology
University of Washington
Seattle, WA
Consultant: 3M Pharmaceuticals.
Noninfectious Vulvovaginal Symptoms as Manifestations of Systemic Diseases
Jack D. Sobel, MD
Copyright © 2003 by International Medical News Group
Detection of Physiologic Deterioration
Patients in general medicalsurgical wards who experience unplanned transfer to the intensive care unit (ICU) have increased mortality and morbidity.13 Using an externally validated methodology permitting assessment of illness severity and mortality risk among all hospitalized patients,4, 5 we recently documented observed‐to‐expected mortality ratios >3.0 and excess length of stay of 10 days among patients who experienced such transfers.6
It is possible to predict adverse outcomes among monitored patients (eg, patients in the ICU or undergoing continuous electronic monitoring).7, 8 However, prediction of unplanned transfers among medicalsurgical ward patients presents challenges. Data collection (vital signs and laboratory tests) is relatively infrequent. The event rate (3% of hospital admissions) is low, and the rate in narrow time periods (eg, 12 hours) is extremely low: a hospital with 4000 admissions per year might experience 1 unplanned transfer to the ICU every 3 days. Not surprisingly, performance of models suitable for predicting ward patients' need for intensive care within narrow time frames have been disappointing.9 The Modified Early Warning Score (MEWS), has a c‐statistic, or area under the receiver operator characteristic of 0.67,1012 and our own model incorporating 14 laboratory tests, but no vital signs, has excellent performance with respect to predicting inpatient mortality, but poor performance with respect to unplanned transfer.6
In this report, we describe the development and validation of a complex predictive model suitable for use with ward patients. Our objective for this work was to develop a predictive model based on clinical and physiologic data available in real time from a comprehensive electronic medical record (EMR), not a clinically intuitive, manually assigned tool. The outcome of interest was unplanned transfer from the ward to the ICU, or death on the ward in a patient who was full code. This model has been developed as part of a regional effort to decrease preventable mortality in the Northern California Kaiser Permanente Medical Care Program (KPMCP), an integrated healthcare delivery system with 22 hospitals.
MATERIALS AND METHODS
For additional details, see the Supporting Information, Appendices 112, in the online version of this article.
This project was approved by the KPMCP Institutional Board for the Protection of Human Subjects.
The Northern California KPMCP serves a total population of approximately 3.3 million members. All Northern California KPMCP hospitals and clinics employ the same information systems with a common medical record number and can track care covered by the plan but delivered elsewhere. Databases maintained by the KPMCP capture admission and discharge times, admission and discharge diagnoses and procedures (assigned by professional coders), bed histories permitting quantification of intra‐hospital transfers, inter‐hospital transfers, as well as the results of all inpatient and outpatient laboratory tests. In July 2006, the KPMCP began deployment of the EMR developed by Epic Systems Corporation (
Our setting consisted of 14 hospitals in which the KPHC inpatient EMR had been running for at least 3 months (the KPMCP Antioch, Fremont, Hayward, Manteca, Modesto, Roseville, Sacramento, Santa Clara, San Francisco, Santa Rosa, South Sacramento, South San Francisco, Santa Teresa, and Walnut Creek hospitals). We have described the general characteristics of KPMCP hospitals elsewhere.4, 6 Our initial study population consisted of all patients admitted to these hospitals who met the following criteria: hospitalization began from November 1, 2006 through December 31, 2009; initial hospitalization occurred at a Northern California KPMCP hospital (ie, for inter‐hospital transfers, the first hospital stay occurred within the KPMCP); age 18 years; hospitalization was not for childbirth; and KPHC had been operational at the hospital for at least 3 months.
Analytic Approach
The primary outcome for this study was transfer to the ICU after admission to the hospital among patients residing either in a general medicalsurgical ward (ward) or transitional care unit (TCU), or death in the ward or TCU in a patient who was full code at the time of death (ie, had the patient survived, s/he would have been transferred to the ICU). The unit of analysis for this study was a 12‐hour patient shift, which could begin with a 7 AM T0 (henceforth, day shift) or a 7 PM T0 (night shift); in other words, we aimed to predict the occurrence of an event within 12 hours of T0 using only data available prior to T0. A shift in which a patient experienced the primary study outcome is an event shift, while one in which a patient did not experience the primary outcome is a comparison shift. Using this approach, an individual patient record could consist of both event and comparison shifts, since some patients might have multiple unplanned transfers and some patients might have none. Our basic analytic approach consisted of creating a cohort of event and comparison shifts (10 comparison shifts were randomly selected for each event shift), splitting the cohort into a derivation dataset (50%) and validation dataset (50%), developing a model using the derivation dataset, then applying the coefficients of the derivation dataset to the validation dataset. Because some event shifts were excluded due to the minimum 4‐hour length‐of‐stay requirement, we also applied model coefficients to these excluded shifts and a set of randomly selected comparison shifts.
Since the purpose of these analyses was to develop models with maximal signal extraction from sparsely collected predictors, we did not block a time period after the T0 to allow for a reaction time to the alarm. Thus, since some events could occur immediately after the T0 (as can be seen in the Supporting Information, Appendices, in the online version of this article), our models would need to be run at intervals that are more frequent than 2 times a day.
Independent Variables
In addition to patients' age and sex, we tested the following candidate independent variables. Some of these variables are part of the KPMCP risk adjustment model4, 5 and were available electronically for all patients in the cohort. We grouped admission diagnoses into 44 broad diagnostic categories (primary conditions), and admission types into 4 groups (emergency medical, emergency surgical, elective medical, and elective surgical). We quantified patients' degree of physiologic derangement in the 72 hours preceding hospitalization with a Laboratory‐based Acute Physiology Score (LAPS) using 14 laboratory test results prior to hospitalization; we also tested individual laboratory test results obtained after admission to the hospital. We quantified patients' comorbid illness burden using a COmorbidity Point Score (COPS) based on patients' preexisting diagnoses over the 12‐month period preceding hospitalization.4 We extracted temperature, heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation, and neurological status from the EMR. We also tested the following variables based on specific information extracted from the EMR: shock index (heart rate divided by systolic blood pressure)13; care directive status (patients were placed into 4 groups: full code, partial code, do not resuscitate [DNR], and no care directive in place); and a proxy for measured lactate (PML; anion gap/serum bicarbonate 100).1416 For comparison purposes, we also created a retrospective electronically assigned MEWS, which we refer to as the MEWS(re), and we assigned this score to patient records electronically using data from KP HealthConnect.
Statistical Methods
Analyses were performed in SAS 9.1, Stata 10, and R 2.12. Final validation was performed using SAS (SAS Institute Inc., Carey, North Carolina). Since we did not limit ourselves to traditional severity‐scoring approaches (eg, selecting the worst heart rate in a given time interval), but also included trend terms (eg, change in heart rate over the 24 hours preceding T0), the number of potential variables to test was very large. Detailed description of the statistical strategies employed for variable selection is provided in the Supporting Information, Appendices, in the online version of this article. Once variables were selected, our basic approach was to test a series of diagnosis‐specific logistic regression submodels using a variety of predictors that included vital signs, vital signs trends (eg, most recent heart rate minus earliest heart rate, heart rate over preceding 24 hours), and other above‐mentioned variables.
We assessed the ability of a submodel to correctly distinguish patients who died, from survivors, using the c‐statistic, as well as other metrics recommended by Cook.17 At the end of the modeling process, we pooled the results across all submodels. For vital signs, where the rate of missing data was <3%, we tested submodels in which we dropped shifts with missing data, as well as submodels in which we imputed missing vital signs to a normal value. For laboratory data, where the rate of missing data for a given shift was much greater, we employed a probabilistic imputation method that included consideration of when a laboratory test result became available.
RESULTS
During the study period, a total of 102,488 patients experienced 145,335 hospitalizations at the study hospitals. We removed 66 patients with 138 hospitalizations for data quality reasons, leaving us with our initial study sample of 102,422 patients whose characteristics are summarized in Table 1. Table 1, in which the unit of analysis is an individual patient, shows that patients who experienced the primary outcome were similar to those patients described in our previous report, in terms of their characteristics on admission as well as in experiencing excess morbidity and mortality.6
Never Admitted to ICU | Direct Admit to ICU From ED | Unplanned Transfer to ICU* | Other ICU Admission | |
---|---|---|---|---|
| ||||
N | 89,269 | 5963 | 2880 | 4310 |
Age (mean SD) | 61.26 18.62 | 62.25 18.13 | 66.12 16.20 | 64.45 15.91 |
Male (n, %) | 37,228 (41.70%) | 3091 (51.84%) | 1416 (49.17%) | 2378 (55.17%) |
LAPS (mean SD) | 13.02 15.79 | 32.72 24.85 | 24.83 21.53 | 11.79 18.16 |
COPS(mean SD) | 67.25 51.42 | 73.88 57.42 | 86.33 59.33 | 78.44 52.49 |
% Predicted mortality risk (mean SD) | 1.93% 3.98% | 7.69% 12.59% | 5.23% 7.70% | 3.66% 6.81% |
Survived first hospitalization to discharge∥ | 88,479 (99.12%) | 5336 (89.49%) | 2316 (80.42%) | 4063 (94.27%) |
Care order on admission | ||||
Full code | 78,877 (88.36%) | 5198 (87.17%) | 2598 (90.21%) | 4097 (95.06%) |
Partial code | 664 (0.74%) | 156 (2.62%) | 50 (1.74%) | 27 (0.63%) |
Comfort care | 21 (0.02%) | 2 (0.03%) | 0 (0%) | 0 (0%) |
DNR | 8227 (9.22%) | 539 (9.04%) | 219 (7.60%) | 161 (3.74%) |
Comfort care and DNR | 229 (0.26%) | 9 (0.15%) | 2 (0.07%) | 2 (0.05%) |
No order | 1251 (1.40%) | 59 (0.99%) | 11 (0.38%) | 23 (0.53%) |
Admission diagnosis (n, %) | ||||
Pneumonia | 2385 (2.67%) | 258 (4.33%) | 242 (8.40%) | 68 (1.58%) |
Sepsis | 5822 (6.52%) | 503 (8.44%) | 279 (9.69%) | 169 (3.92%) |
GI bleeding | 9938 (11.13%) | 616 (10.33%) | 333 (11.56%) | 290 (6.73%) |
Cancer | 2845 (3.19%) | 14 (0.23%) | 95 (3.30%) | 492 (11.42%) |
Total hospital length of stay (days SD) | 3.08 3.29 | 5.37 7.50 | 12.16 13.12 | 8.06 9.53 |
Figure 1shows how we developed the analysis cohort, by removing patients with a comfort‐care‐only order placed within 4 hours after admission (369 patients/744 hospitalizations) and patients who were never admitted to the ward or TCU (7,220/10,574). This left a cohort consisting of 94,833 patients who experienced 133,879 hospitalizations spanning a total of 1,079,062 shifts. We then removed shifts where: 1) a patient was not on the ward at the start of a shift, or was on the ward for <4 hours of a shift; 2) the patient had a comfort‐care order in place at the start of the shift; and 3) the patient died and was ineligible to be a case (the patient had a DNR order in place or died in the ICU). The final cohort eligible for sampling consisted of 846,907 shifts, which involved a total of 92,797 patients and 130,627 hospitalizations. There were a total of 4,036 event shifts, which included 3,224 where a patient was transferred from the ward to the ICU, 717 from the TCU to the ICU, and 95 where a patient died on the ward or TCU without a DNR order in place. We then randomly selected 39,782 comparison shifts. Thus, our final cohort for analysis included 4,036 event shifts (1,979 derivation/2,057 validation and 39,782 comparison shifts (19,509/20,273). As a secondary validation, we also applied model coefficients to the 429 event shifts excluded due to the <4‐hour length‐of‐stay requirement.

Table 2 compares event shifts with comparison shifts. In the 24 hours preceding ICU transfer, patients who were subsequently transferred had statistically significant, but not necessarily clinically significant, differences in terms of these variables. However, missing laboratory data were more common, ranging from 18% to 31% of all shifts (we did not incorporate laboratory tests where 35% of the shifts had missing data for that test).
Predictor | Event Shifts | Comparison Shifts | P |
---|---|---|---|
| |||
Number | 4036 | 39,782 | |
Age (mean SD) | 67.19 15.25 | 65.41 17.40 | <0.001 |
Male (n, %) | 2007 (49.73%) | 17,709 (44.52%) | <0.001 |
Day shift | 1364 (33.80%) | 17,714 (44.53%) | <0.001 |
LAPS* | 27.89 22.10 | 20.49 20.16 | <0.001 |
COPS | 116.33 72.31 | 100.81 68.44 | <0.001 |
Full code (n, %) | 3496 (86.2%) | 32,156 (80.8%) | <0.001 |
ICU shift during hospitalization | 3964 (98.22%) | 7197 (18.09%) | <0.001 |
Unplanned transfer to ICU during hospitalization∥ | 353 (8.8%) | 1466 (3.7%) | <0.001 |
Temperature (mean SD) | 98.15 (1.13) | 98.10 (0.85) | 0.009 |
Heart rate (mean SD) | 90.30 (20.48) | 79.86 (5.27) | <0.001 |
Respiratory rate (mean SD) | 20.36 (3.70) | 18.87 (1.79) | <0.001 |
Systolic blood pressure (mean SD) | 123.65 (23.26) | 126.21 (19.88) | <0.001 |
Diastolic blood pressure (mean SD) | 68.38 (14.49) | 69.46 (11.95) | <0.001 |
Oxygen saturation (mean SD) | 95.72% (3.00) | 96.47 % (2.26) | <0.001 |
MEWS(re) (mean SD) | 3.64 (2.02) | 2.34 (1.61) | <0.001 |
% <5 | 74.86% | 92.79% | |
% 5 | 25.14% | 7.21% | <0.001 |
Proxy for measured lactate# (mean SD) | 36.85 (28.24) | 28.73 (16.74) | <0.001 |
% Missing in 24 hr before start of shift** | 17.91% | 28.78% | <0.001 |
Blood urea nitrogen (mean SD) | 32.03 (25.39) | 22.72 (18.9) | <0.001 |
% Missing in 24 hr before start of shift | 19.67% | 20.90% | <0.001 |
White blood cell count 1000 (mean SD) | 12.33 (11.42) | 9.83 (6.58) | <0.001 |
% Missing in 24 hr before start of shift | 21.43% | 30.98% | <0.001 |
Hematocrit (mean SD) | 33.08 (6.28) | 33.07 (5.25) | 0.978 |
% Missing in 24 hr before start of shift | 19.87% | 29.55% | <0.001 |
After conducting multiple analyses using the derivation dataset, we developed 24 submodels, a compromise between our finding that primary‐condition‐specific models showed better performance and the fact that we had very few events among patients with certain primary conditions (eg, pericarditis/valvular heart disease), which forced us to create composite categories (eg, a category pooling patients with pericarditis, atherosclerosis, and peripheral vascular disease). Table 3 lists variables included in our final submodels.
Variable | Description |
---|---|
| |
Directive status | Full code or not full code |
LAPS* | Admission physiologic severity of illness score (continuous variable ranging from 0 to 256). Standardized and included as LAPS and LAPS squared |
COPS | Comorbidity burden score (continuous variable ranging from 0 to 701). Standardized and included as COPS and COPS squared. |
COPS status | Indicator for absent comorbidity data |
LOS at T0 | Length of stay in the hospital (total time in hours) at the T0; standardized. |
T0 time of day | 7 AM or 7 PM |
Temperature | Worst (highest) temperature in 24 hr preceding T0; variability in temperature in 24 hr preceding T0. |
Heart rate | Most recent heart rate in 24 hr preceding T0; variability in heart rate in 24 hr preceding T0. |
Respiratory rate | Most recent respiratory rate in 24 hr preceding T0; worst (highest) respiratory rate in 24 hr preceding T0; variability in respiratory rate in 24 hr preceding T0. |
Diastolic blood pressure | Most recent diastolic blood pressure in 24 hr preceding T0 transformed by subtracting 70 from the actual value and squaring the result. Any value above 2000 is subsequently then set to 2000, yielding a continuous variable ranging from 0 to 2000. |
Systolic pressure | Variability in systolic blood pressure in 24 hr preceding T0. |
Pulse oximetry | Worst (lowest) oxygen saturation in 24 hr preceding T0; variability in oxygen saturation in 24 hr preceding T0. |
Neurological status | Most recent neurological status check in 24 hr preceding T0. |
Laboratory tests | Blood urea nitrogen |
Proxy for measured lactate = (anion gap serum bicarbonate) 100 | |
Hematocrit | |
Total white blood cell count |
Table 4 summarizes key results in the validation dataset. Across all diagnoses, the MEWS(re) had c‐statistic of 0.709 (95% confidence interval, 0.6970.721) in the derivation dataset and 0.698 (0.6860.710) in the validation dataset. In the validation dataset, the MEWS(re) performed best among patients with a set of gastrointestinal diagnoses (c = 0.792; 0.7260.857) and worst among patients with congestive heart failure (0.541; 0.5000.620). In contrast, across all primary conditions, the EMR‐based models had a c‐statistic of 0.845 (0.8260.863) in the derivation dataset and 0.775 (0.7530.797) in the validation dataset. In the validation dataset, the EMR‐based models also performed best among patients with a set of gastrointestinal diagnoses (0.841; 0.7830.897) and worst among patients with congestive heart failure (0.683; 0.6100.755). A negative correlation (R = 0.63) was evident between the number of event shifts in a submodel and the drop in the c‐statistic seen in the validation dataset.
No. of Shifts in Validation Dataset | c‐Statistic | |||
---|---|---|---|---|
Diagnoses Group* | Event | Comparison | MEWS(re) | EMR Model |
| ||||
Acute myocardial infarction | 36 | 169 | 0.541 | 0.572 |
Diseases of pulmonary circulation and cardiac dysrhythmias | 40 | 329 | 0.565 | 0.645 |
Seizure disorders | 45 | 497 | 0.594 | 0.647 |
Rule out myocardial infarction | 77 | 727 | 0.602 | 0.648 |
Pneumonia | 163 | 847 | 0.741 | 0.801 |
GI diagnoses, set A | 58 | 942 | 0.755 | 0.803 |
GI diagnoses, set B∥ | 256 | 2,610 | 0.772 | 0.806 |
GI diagnoses, set C | 46 | 520 | 0.792 | 0.841 |
All diagnosis | 2,032 | 20,106 | 0.698 | 0.775 |
We also compared model performance when our datasets were restricted to 1 randomly selected observation per patient; in these analyses, the total number of event shifts was 3,647 and the number of comparison shifts was 29,052. The c‐statistic for the MEWS(re) in the derivation dataset was 0.709 (0.6940.725); in the validation dataset, it was 0.698 (0.6920.714). The corresponding values for the EMR‐based models were 0.856 (0.8350.877) and 0.780 (0.7560.804). We also tested models in which, instead of dropping shifts with missing vital signs, we imputed missing vital signs to their normal value. The c‐statistic for the EMR‐based model with imputed vital sign values was 0.842 (0.8230.861) in the derivation dataset and 0.773 (0.7520.794) in the validation dataset. Lastly, we applied model coefficients to a dataset consisting of 4,290 randomly selected comparison shifts plus the 429 shifts excluded because of the 4‐hour length‐of‐stay criterion. The c‐statistic for this analysis was 0.756 (0.7030.809).
As a general rule, the EMR‐based models were more than twice as efficient as the MEWS(re). For example, a MEWS(re) threshold of 6 as the trigger for an alarm would identify 15% of all transfers to the ICU, with 34.4 false alarms for each transfer; in contrast, using the EMR‐based approach to identify 15% of all transfers, there were 14.5 false alarms for each transfer. Applied to the entire KPMCP Northern California Region, using the MEWS(re), a total of 52 patients per day would need to be evaluated, but only 22 per day using the EMR‐based approach. If one employed a MEWS(re) threshold of 4, this would lead to identification of 44% of all transfers, with a ratio of 69 false alarms for each transfer; using the EMR, the ratio would be 34 to 1. Across the entire KPMCP, a total of 276 patients per day (or about 19.5 a day per hospital) would need to be evaluated using the MEWS(re), but only 136 (or about 9.5 per hospital per day) using the EMR.
DISCUSSION
Using data from a large hospital cohort, we have developed a predictive model suitable for use in non‐ICU populations cared for in integrated healthcare settings with fully automated EMRs. The overall performance of our model, which incorporates acute physiology, diagnosis, and longitudinal data, is superior to the predictive ability of a model that can be assigned manually. This is not surprising, given that scoring systems such as the MEWS make an explicit tradeoff losing information found in multiple variables in exchange for ease of manual assignment. Currently, the model described in this report is being implemented in a simulated environment, a final safety test prior to piloting real‐time provision of probability estimates to clinicians and nurses. Though not yet ready for real‐time use, it is reasonable for our model to be tested using the KPHC shadow server, since evaluation in a simulated environment constitutes a critical evaluation step prior to deployment for clinical use. We also anticipate further refinement and revalidation to occur as more inpatient data become available in the KPMCP and elsewhere.
A number of limitations to our approach must be emphasized. In developing our models, we determined that, while modeling by clinical condition was important, the study outcome was rare for some primary conditions. In these diagnostic groups, which accounted for 12.5% of the event shifts and 10.6% of the comparison shifts, the c‐statistic in the validation dataset was <0.70. Since all 22 KPMCP hospitals are now online and will generate an additional 150,000 adult hospitalizations per year, we expect to be able to correct this problem prior to deployment of these models for clinical use. Having additional data will permit us to improve model discrimination and thus decrease the evaluation‐to‐detection ratio. In future iterations of these models, more experimentation with grouping of International Classification of Diseases (ICD) codes may be required. The problem of grouping ICD codes is not an easy one to resolve, in that diagnoses in the grouping must share common pathophysiology while having a grouping with a sufficient number of adverse events for stable statistical models.
Ideally, it would have been desirable to employ a more objective measure of deterioration, since the decision to transfer a patient to the ICU is discretionary. However, we have found that key data points needed to define such a measure (eg, vital signs) are not consistently charted when a patient deterioratesthis is not surprising outside the research setting, given that nurses and physicians involved in a transfer may be focusing on caring for the patient rather than immediately charting. Given the complexities of end‐of‐life‐care decision‐making, we could not employ death as the outcome of interest. A related issue is that our model does not differentiate between reasons for needing transfer to the ICU, an issue recently discussed by Bapoje et al.18
Our model does not address an important issue raised by Bapoje et al18 and Litvak, Pronovost, and others,19, 20 namely, whether a patient should have been admitted to a non‐ICU setting in the first place. Our team is currently developing a model for doing exactly this (providing decision support for triage in the emergency department), but discussion of this methodology is outside the scope of this article.
Because of resource and data limitations, our model also does not include newborns, children, women admitted for childbirth, or patients transferred from non‐KPMCP hospitals. However, the approach described here could serve as a starting point for developing models for these other populations.
The generalizability of our model must also be considered. The Northern California KPMCP is unusual in having large electronic databases that include physiologic as well as longitudinal patient data. Many hospitals cannot take advantage of all the methods described here. However, the methods we employed could be modified for use by hospital systems in countries such as Great Britain and Canada, and entities such as the Veterans Administration Hospital System in the United States. The KPMCP population, an insured population with few barriers to access, is healthier than the general population, and some population subsets are underrepresented in our cohort. Practice patterns may also vary. Nonetheless, the model described here could serve as a good starting point for future collaborative studies, and it would be possible to develop models suitable for use by stand‐alone hospitals (eg, recalibrating so that one used a Charlson comorbidity21 score based on present on‐admission codes rather than the COPS).
The need for early detection of patient deterioration has played a major role in the development of rapid response teams, as well as scores such as the MEWS. In particular, entities such as the Institute for Healthcare Improvement have advocated the use of early warning systems.22 However, having a statistically robust model to support an early warning system is only part of the solution, and a number of new challenges must then be addressed. The first is actual electronic deployment. Existing inpatient EMRs were not designed with complex calculations in mind, and we anticipate that some degradation in performance will occur when we test our models using real‐time data capture. As Bapoje et al point out, simply having an alert may be insufficient, since not all transfers are preventable.18 Early warning systems also raise ethical issues (for example, what should be done if an alert leads a clinician to confront the fact that an end‐of‐life‐care discussion needs to occur?). From a research perspective, if one were to formally test the benefits of such models, it would be critical to define outcome measures other than death (which is strongly affected by end‐of‐life‐care decisions) or ICU transfer (which is often desirable).
In conclusion, we have developed an approach for predicting impending physiologic deterioration of hospitalized adults outside the ICU. Our approach illustrates how organizations can take maximal advantage of EMRs in a manner that exceeds meaningful use specifications.23, 24 Our study highlights the possibility of using fully automated EMR data for building and applying sophisticated statistical models in settings other than the highly monitored ICU without the need for additional equipment. It also expands the universe of severity scoring to one in which probability estimates are provided in real time and throughout an entire hospitalization. Model performance will undoubtedly improve over time, as more patient data become available. Although our approach has important limitations, it is suitable for testing using real‐time data in a simulated environment. Such testing would permit identification of unanticipated problems and quantification of the degradation of model performance due to real life factors, such as delays in vital signs charting or EMR system brownouts. It could also serve as the springboard for future collaborative studies, with a broader population base, in which the EMR becomes a tool for care, not just documentation.
Acknowledgements
We thank Ms Marla Gardner and Mr John Greene for their work in the development phase of this project. We are grateful to Brian Hoberman, Andrew Hwang, and Marc Flagg from the RIMS group; to Colin Stobbs, Sriram Thiruvenkatachari, and Sundeep Sood from KP IT, Inc; and to Dennis Andaya, Linda Gliner, and Cyndi Vasallo for their assistance with data‐quality audits. We are also grateful to Dr Philip Madvig, Dr Paul Feigenbaum, Dr Alan Whippy, Mr Gregory Adams, Ms Barbara Crawford, and Dr Marybeth Sharpe for their administrative support and encouragement; and to Dr Alan S. Go, Acting Director of the Kaiser Permanente Division of Research, for reviewing the manuscript.
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- Risk adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases.Med Care.2008;46(3):232–239. , , , , , .
- The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.J Clin Epidemiol.2010;63(7):798–803. , , , .
- Intra‐hospital transfers to a higher level of care: contribution to total hospital and intensive care unit (ICU) mortality and length of stay (LOS).J Hosp Med.2011;6(2):74–80. , , , , , .
- Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis.Intensive Care Med.1999;25(12):1360–1366. , , , , , .
- Integration of early physiological responses predicts later illness severity in preterm infants.Sci Transl Med.2010;2(48):48ra65. , , , , .
- Reproducibility of physiological track‐and‐trigger warning systems for identifying at‐risk patients on the ward.Intensive Care Med.2007;33(4):619–624. , , .
- Validation of a Modified Early Warning Score in medical admissions.Q J Med.2001;94:521–526. , , , .
- Effect of introducing the Modified Early Warning score on clinical outcomes, cardio‐pulmonary arrests and intensive care utilisation in acute medical admissions.Anaesthesia.2003;58(8):797–802. , , , , .
- MERIT Study Investigators.Introduction of the medical emergency team (MET) system: a cluster‐randomized controlled trial.Lancet.2005;365(9477):2091–2097.
- Unplanned transfers to the intensive care unit: the role of the shock index.J Hosp Med.2010;5(8):460–465. , , , , , .
- The delta (delta) gap: an approach to mixed acid‐base disorders.Ann Emerg Med.1990;19(11):1310–1313. .
- Acid‐base disorders: classification and management strategies.Am Fam Physician.1995;52(2):584–590. .
- Unmeasured anions in critically ill patients: can they predict mortality?Crit Care Med.2003;31(8):2131–2136. , , , .
- Use and misuse of the receiver operating characteristic curve in risk prediction.Circulation.2007;115(7):928–935. .
- Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care.J Hosp Med.2011;6(2):68–72. , , , .
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Patients in general medicalsurgical wards who experience unplanned transfer to the intensive care unit (ICU) have increased mortality and morbidity.13 Using an externally validated methodology permitting assessment of illness severity and mortality risk among all hospitalized patients,4, 5 we recently documented observed‐to‐expected mortality ratios >3.0 and excess length of stay of 10 days among patients who experienced such transfers.6
It is possible to predict adverse outcomes among monitored patients (eg, patients in the ICU or undergoing continuous electronic monitoring).7, 8 However, prediction of unplanned transfers among medicalsurgical ward patients presents challenges. Data collection (vital signs and laboratory tests) is relatively infrequent. The event rate (3% of hospital admissions) is low, and the rate in narrow time periods (eg, 12 hours) is extremely low: a hospital with 4000 admissions per year might experience 1 unplanned transfer to the ICU every 3 days. Not surprisingly, performance of models suitable for predicting ward patients' need for intensive care within narrow time frames have been disappointing.9 The Modified Early Warning Score (MEWS), has a c‐statistic, or area under the receiver operator characteristic of 0.67,1012 and our own model incorporating 14 laboratory tests, but no vital signs, has excellent performance with respect to predicting inpatient mortality, but poor performance with respect to unplanned transfer.6
In this report, we describe the development and validation of a complex predictive model suitable for use with ward patients. Our objective for this work was to develop a predictive model based on clinical and physiologic data available in real time from a comprehensive electronic medical record (EMR), not a clinically intuitive, manually assigned tool. The outcome of interest was unplanned transfer from the ward to the ICU, or death on the ward in a patient who was full code. This model has been developed as part of a regional effort to decrease preventable mortality in the Northern California Kaiser Permanente Medical Care Program (KPMCP), an integrated healthcare delivery system with 22 hospitals.
MATERIALS AND METHODS
For additional details, see the Supporting Information, Appendices 112, in the online version of this article.
This project was approved by the KPMCP Institutional Board for the Protection of Human Subjects.
The Northern California KPMCP serves a total population of approximately 3.3 million members. All Northern California KPMCP hospitals and clinics employ the same information systems with a common medical record number and can track care covered by the plan but delivered elsewhere. Databases maintained by the KPMCP capture admission and discharge times, admission and discharge diagnoses and procedures (assigned by professional coders), bed histories permitting quantification of intra‐hospital transfers, inter‐hospital transfers, as well as the results of all inpatient and outpatient laboratory tests. In July 2006, the KPMCP began deployment of the EMR developed by Epic Systems Corporation (
Our setting consisted of 14 hospitals in which the KPHC inpatient EMR had been running for at least 3 months (the KPMCP Antioch, Fremont, Hayward, Manteca, Modesto, Roseville, Sacramento, Santa Clara, San Francisco, Santa Rosa, South Sacramento, South San Francisco, Santa Teresa, and Walnut Creek hospitals). We have described the general characteristics of KPMCP hospitals elsewhere.4, 6 Our initial study population consisted of all patients admitted to these hospitals who met the following criteria: hospitalization began from November 1, 2006 through December 31, 2009; initial hospitalization occurred at a Northern California KPMCP hospital (ie, for inter‐hospital transfers, the first hospital stay occurred within the KPMCP); age 18 years; hospitalization was not for childbirth; and KPHC had been operational at the hospital for at least 3 months.
Analytic Approach
The primary outcome for this study was transfer to the ICU after admission to the hospital among patients residing either in a general medicalsurgical ward (ward) or transitional care unit (TCU), or death in the ward or TCU in a patient who was full code at the time of death (ie, had the patient survived, s/he would have been transferred to the ICU). The unit of analysis for this study was a 12‐hour patient shift, which could begin with a 7 AM T0 (henceforth, day shift) or a 7 PM T0 (night shift); in other words, we aimed to predict the occurrence of an event within 12 hours of T0 using only data available prior to T0. A shift in which a patient experienced the primary study outcome is an event shift, while one in which a patient did not experience the primary outcome is a comparison shift. Using this approach, an individual patient record could consist of both event and comparison shifts, since some patients might have multiple unplanned transfers and some patients might have none. Our basic analytic approach consisted of creating a cohort of event and comparison shifts (10 comparison shifts were randomly selected for each event shift), splitting the cohort into a derivation dataset (50%) and validation dataset (50%), developing a model using the derivation dataset, then applying the coefficients of the derivation dataset to the validation dataset. Because some event shifts were excluded due to the minimum 4‐hour length‐of‐stay requirement, we also applied model coefficients to these excluded shifts and a set of randomly selected comparison shifts.
Since the purpose of these analyses was to develop models with maximal signal extraction from sparsely collected predictors, we did not block a time period after the T0 to allow for a reaction time to the alarm. Thus, since some events could occur immediately after the T0 (as can be seen in the Supporting Information, Appendices, in the online version of this article), our models would need to be run at intervals that are more frequent than 2 times a day.
Independent Variables
In addition to patients' age and sex, we tested the following candidate independent variables. Some of these variables are part of the KPMCP risk adjustment model4, 5 and were available electronically for all patients in the cohort. We grouped admission diagnoses into 44 broad diagnostic categories (primary conditions), and admission types into 4 groups (emergency medical, emergency surgical, elective medical, and elective surgical). We quantified patients' degree of physiologic derangement in the 72 hours preceding hospitalization with a Laboratory‐based Acute Physiology Score (LAPS) using 14 laboratory test results prior to hospitalization; we also tested individual laboratory test results obtained after admission to the hospital. We quantified patients' comorbid illness burden using a COmorbidity Point Score (COPS) based on patients' preexisting diagnoses over the 12‐month period preceding hospitalization.4 We extracted temperature, heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation, and neurological status from the EMR. We also tested the following variables based on specific information extracted from the EMR: shock index (heart rate divided by systolic blood pressure)13; care directive status (patients were placed into 4 groups: full code, partial code, do not resuscitate [DNR], and no care directive in place); and a proxy for measured lactate (PML; anion gap/serum bicarbonate 100).1416 For comparison purposes, we also created a retrospective electronically assigned MEWS, which we refer to as the MEWS(re), and we assigned this score to patient records electronically using data from KP HealthConnect.
Statistical Methods
Analyses were performed in SAS 9.1, Stata 10, and R 2.12. Final validation was performed using SAS (SAS Institute Inc., Carey, North Carolina). Since we did not limit ourselves to traditional severity‐scoring approaches (eg, selecting the worst heart rate in a given time interval), but also included trend terms (eg, change in heart rate over the 24 hours preceding T0), the number of potential variables to test was very large. Detailed description of the statistical strategies employed for variable selection is provided in the Supporting Information, Appendices, in the online version of this article. Once variables were selected, our basic approach was to test a series of diagnosis‐specific logistic regression submodels using a variety of predictors that included vital signs, vital signs trends (eg, most recent heart rate minus earliest heart rate, heart rate over preceding 24 hours), and other above‐mentioned variables.
We assessed the ability of a submodel to correctly distinguish patients who died, from survivors, using the c‐statistic, as well as other metrics recommended by Cook.17 At the end of the modeling process, we pooled the results across all submodels. For vital signs, where the rate of missing data was <3%, we tested submodels in which we dropped shifts with missing data, as well as submodels in which we imputed missing vital signs to a normal value. For laboratory data, where the rate of missing data for a given shift was much greater, we employed a probabilistic imputation method that included consideration of when a laboratory test result became available.
RESULTS
During the study period, a total of 102,488 patients experienced 145,335 hospitalizations at the study hospitals. We removed 66 patients with 138 hospitalizations for data quality reasons, leaving us with our initial study sample of 102,422 patients whose characteristics are summarized in Table 1. Table 1, in which the unit of analysis is an individual patient, shows that patients who experienced the primary outcome were similar to those patients described in our previous report, in terms of their characteristics on admission as well as in experiencing excess morbidity and mortality.6
Never Admitted to ICU | Direct Admit to ICU From ED | Unplanned Transfer to ICU* | Other ICU Admission | |
---|---|---|---|---|
| ||||
N | 89,269 | 5963 | 2880 | 4310 |
Age (mean SD) | 61.26 18.62 | 62.25 18.13 | 66.12 16.20 | 64.45 15.91 |
Male (n, %) | 37,228 (41.70%) | 3091 (51.84%) | 1416 (49.17%) | 2378 (55.17%) |
LAPS (mean SD) | 13.02 15.79 | 32.72 24.85 | 24.83 21.53 | 11.79 18.16 |
COPS(mean SD) | 67.25 51.42 | 73.88 57.42 | 86.33 59.33 | 78.44 52.49 |
% Predicted mortality risk (mean SD) | 1.93% 3.98% | 7.69% 12.59% | 5.23% 7.70% | 3.66% 6.81% |
Survived first hospitalization to discharge∥ | 88,479 (99.12%) | 5336 (89.49%) | 2316 (80.42%) | 4063 (94.27%) |
Care order on admission | ||||
Full code | 78,877 (88.36%) | 5198 (87.17%) | 2598 (90.21%) | 4097 (95.06%) |
Partial code | 664 (0.74%) | 156 (2.62%) | 50 (1.74%) | 27 (0.63%) |
Comfort care | 21 (0.02%) | 2 (0.03%) | 0 (0%) | 0 (0%) |
DNR | 8227 (9.22%) | 539 (9.04%) | 219 (7.60%) | 161 (3.74%) |
Comfort care and DNR | 229 (0.26%) | 9 (0.15%) | 2 (0.07%) | 2 (0.05%) |
No order | 1251 (1.40%) | 59 (0.99%) | 11 (0.38%) | 23 (0.53%) |
Admission diagnosis (n, %) | ||||
Pneumonia | 2385 (2.67%) | 258 (4.33%) | 242 (8.40%) | 68 (1.58%) |
Sepsis | 5822 (6.52%) | 503 (8.44%) | 279 (9.69%) | 169 (3.92%) |
GI bleeding | 9938 (11.13%) | 616 (10.33%) | 333 (11.56%) | 290 (6.73%) |
Cancer | 2845 (3.19%) | 14 (0.23%) | 95 (3.30%) | 492 (11.42%) |
Total hospital length of stay (days SD) | 3.08 3.29 | 5.37 7.50 | 12.16 13.12 | 8.06 9.53 |
Figure 1shows how we developed the analysis cohort, by removing patients with a comfort‐care‐only order placed within 4 hours after admission (369 patients/744 hospitalizations) and patients who were never admitted to the ward or TCU (7,220/10,574). This left a cohort consisting of 94,833 patients who experienced 133,879 hospitalizations spanning a total of 1,079,062 shifts. We then removed shifts where: 1) a patient was not on the ward at the start of a shift, or was on the ward for <4 hours of a shift; 2) the patient had a comfort‐care order in place at the start of the shift; and 3) the patient died and was ineligible to be a case (the patient had a DNR order in place or died in the ICU). The final cohort eligible for sampling consisted of 846,907 shifts, which involved a total of 92,797 patients and 130,627 hospitalizations. There were a total of 4,036 event shifts, which included 3,224 where a patient was transferred from the ward to the ICU, 717 from the TCU to the ICU, and 95 where a patient died on the ward or TCU without a DNR order in place. We then randomly selected 39,782 comparison shifts. Thus, our final cohort for analysis included 4,036 event shifts (1,979 derivation/2,057 validation and 39,782 comparison shifts (19,509/20,273). As a secondary validation, we also applied model coefficients to the 429 event shifts excluded due to the <4‐hour length‐of‐stay requirement.

Table 2 compares event shifts with comparison shifts. In the 24 hours preceding ICU transfer, patients who were subsequently transferred had statistically significant, but not necessarily clinically significant, differences in terms of these variables. However, missing laboratory data were more common, ranging from 18% to 31% of all shifts (we did not incorporate laboratory tests where 35% of the shifts had missing data for that test).
Predictor | Event Shifts | Comparison Shifts | P |
---|---|---|---|
| |||
Number | 4036 | 39,782 | |
Age (mean SD) | 67.19 15.25 | 65.41 17.40 | <0.001 |
Male (n, %) | 2007 (49.73%) | 17,709 (44.52%) | <0.001 |
Day shift | 1364 (33.80%) | 17,714 (44.53%) | <0.001 |
LAPS* | 27.89 22.10 | 20.49 20.16 | <0.001 |
COPS | 116.33 72.31 | 100.81 68.44 | <0.001 |
Full code (n, %) | 3496 (86.2%) | 32,156 (80.8%) | <0.001 |
ICU shift during hospitalization | 3964 (98.22%) | 7197 (18.09%) | <0.001 |
Unplanned transfer to ICU during hospitalization∥ | 353 (8.8%) | 1466 (3.7%) | <0.001 |
Temperature (mean SD) | 98.15 (1.13) | 98.10 (0.85) | 0.009 |
Heart rate (mean SD) | 90.30 (20.48) | 79.86 (5.27) | <0.001 |
Respiratory rate (mean SD) | 20.36 (3.70) | 18.87 (1.79) | <0.001 |
Systolic blood pressure (mean SD) | 123.65 (23.26) | 126.21 (19.88) | <0.001 |
Diastolic blood pressure (mean SD) | 68.38 (14.49) | 69.46 (11.95) | <0.001 |
Oxygen saturation (mean SD) | 95.72% (3.00) | 96.47 % (2.26) | <0.001 |
MEWS(re) (mean SD) | 3.64 (2.02) | 2.34 (1.61) | <0.001 |
% <5 | 74.86% | 92.79% | |
% 5 | 25.14% | 7.21% | <0.001 |
Proxy for measured lactate# (mean SD) | 36.85 (28.24) | 28.73 (16.74) | <0.001 |
% Missing in 24 hr before start of shift** | 17.91% | 28.78% | <0.001 |
Blood urea nitrogen (mean SD) | 32.03 (25.39) | 22.72 (18.9) | <0.001 |
% Missing in 24 hr before start of shift | 19.67% | 20.90% | <0.001 |
White blood cell count 1000 (mean SD) | 12.33 (11.42) | 9.83 (6.58) | <0.001 |
% Missing in 24 hr before start of shift | 21.43% | 30.98% | <0.001 |
Hematocrit (mean SD) | 33.08 (6.28) | 33.07 (5.25) | 0.978 |
% Missing in 24 hr before start of shift | 19.87% | 29.55% | <0.001 |
After conducting multiple analyses using the derivation dataset, we developed 24 submodels, a compromise between our finding that primary‐condition‐specific models showed better performance and the fact that we had very few events among patients with certain primary conditions (eg, pericarditis/valvular heart disease), which forced us to create composite categories (eg, a category pooling patients with pericarditis, atherosclerosis, and peripheral vascular disease). Table 3 lists variables included in our final submodels.
Variable | Description |
---|---|
| |
Directive status | Full code or not full code |
LAPS* | Admission physiologic severity of illness score (continuous variable ranging from 0 to 256). Standardized and included as LAPS and LAPS squared |
COPS | Comorbidity burden score (continuous variable ranging from 0 to 701). Standardized and included as COPS and COPS squared. |
COPS status | Indicator for absent comorbidity data |
LOS at T0 | Length of stay in the hospital (total time in hours) at the T0; standardized. |
T0 time of day | 7 AM or 7 PM |
Temperature | Worst (highest) temperature in 24 hr preceding T0; variability in temperature in 24 hr preceding T0. |
Heart rate | Most recent heart rate in 24 hr preceding T0; variability in heart rate in 24 hr preceding T0. |
Respiratory rate | Most recent respiratory rate in 24 hr preceding T0; worst (highest) respiratory rate in 24 hr preceding T0; variability in respiratory rate in 24 hr preceding T0. |
Diastolic blood pressure | Most recent diastolic blood pressure in 24 hr preceding T0 transformed by subtracting 70 from the actual value and squaring the result. Any value above 2000 is subsequently then set to 2000, yielding a continuous variable ranging from 0 to 2000. |
Systolic pressure | Variability in systolic blood pressure in 24 hr preceding T0. |
Pulse oximetry | Worst (lowest) oxygen saturation in 24 hr preceding T0; variability in oxygen saturation in 24 hr preceding T0. |
Neurological status | Most recent neurological status check in 24 hr preceding T0. |
Laboratory tests | Blood urea nitrogen |
Proxy for measured lactate = (anion gap serum bicarbonate) 100 | |
Hematocrit | |
Total white blood cell count |
Table 4 summarizes key results in the validation dataset. Across all diagnoses, the MEWS(re) had c‐statistic of 0.709 (95% confidence interval, 0.6970.721) in the derivation dataset and 0.698 (0.6860.710) in the validation dataset. In the validation dataset, the MEWS(re) performed best among patients with a set of gastrointestinal diagnoses (c = 0.792; 0.7260.857) and worst among patients with congestive heart failure (0.541; 0.5000.620). In contrast, across all primary conditions, the EMR‐based models had a c‐statistic of 0.845 (0.8260.863) in the derivation dataset and 0.775 (0.7530.797) in the validation dataset. In the validation dataset, the EMR‐based models also performed best among patients with a set of gastrointestinal diagnoses (0.841; 0.7830.897) and worst among patients with congestive heart failure (0.683; 0.6100.755). A negative correlation (R = 0.63) was evident between the number of event shifts in a submodel and the drop in the c‐statistic seen in the validation dataset.
No. of Shifts in Validation Dataset | c‐Statistic | |||
---|---|---|---|---|
Diagnoses Group* | Event | Comparison | MEWS(re) | EMR Model |
| ||||
Acute myocardial infarction | 36 | 169 | 0.541 | 0.572 |
Diseases of pulmonary circulation and cardiac dysrhythmias | 40 | 329 | 0.565 | 0.645 |
Seizure disorders | 45 | 497 | 0.594 | 0.647 |
Rule out myocardial infarction | 77 | 727 | 0.602 | 0.648 |
Pneumonia | 163 | 847 | 0.741 | 0.801 |
GI diagnoses, set A | 58 | 942 | 0.755 | 0.803 |
GI diagnoses, set B∥ | 256 | 2,610 | 0.772 | 0.806 |
GI diagnoses, set C | 46 | 520 | 0.792 | 0.841 |
All diagnosis | 2,032 | 20,106 | 0.698 | 0.775 |
We also compared model performance when our datasets were restricted to 1 randomly selected observation per patient; in these analyses, the total number of event shifts was 3,647 and the number of comparison shifts was 29,052. The c‐statistic for the MEWS(re) in the derivation dataset was 0.709 (0.6940.725); in the validation dataset, it was 0.698 (0.6920.714). The corresponding values for the EMR‐based models were 0.856 (0.8350.877) and 0.780 (0.7560.804). We also tested models in which, instead of dropping shifts with missing vital signs, we imputed missing vital signs to their normal value. The c‐statistic for the EMR‐based model with imputed vital sign values was 0.842 (0.8230.861) in the derivation dataset and 0.773 (0.7520.794) in the validation dataset. Lastly, we applied model coefficients to a dataset consisting of 4,290 randomly selected comparison shifts plus the 429 shifts excluded because of the 4‐hour length‐of‐stay criterion. The c‐statistic for this analysis was 0.756 (0.7030.809).
As a general rule, the EMR‐based models were more than twice as efficient as the MEWS(re). For example, a MEWS(re) threshold of 6 as the trigger for an alarm would identify 15% of all transfers to the ICU, with 34.4 false alarms for each transfer; in contrast, using the EMR‐based approach to identify 15% of all transfers, there were 14.5 false alarms for each transfer. Applied to the entire KPMCP Northern California Region, using the MEWS(re), a total of 52 patients per day would need to be evaluated, but only 22 per day using the EMR‐based approach. If one employed a MEWS(re) threshold of 4, this would lead to identification of 44% of all transfers, with a ratio of 69 false alarms for each transfer; using the EMR, the ratio would be 34 to 1. Across the entire KPMCP, a total of 276 patients per day (or about 19.5 a day per hospital) would need to be evaluated using the MEWS(re), but only 136 (or about 9.5 per hospital per day) using the EMR.
DISCUSSION
Using data from a large hospital cohort, we have developed a predictive model suitable for use in non‐ICU populations cared for in integrated healthcare settings with fully automated EMRs. The overall performance of our model, which incorporates acute physiology, diagnosis, and longitudinal data, is superior to the predictive ability of a model that can be assigned manually. This is not surprising, given that scoring systems such as the MEWS make an explicit tradeoff losing information found in multiple variables in exchange for ease of manual assignment. Currently, the model described in this report is being implemented in a simulated environment, a final safety test prior to piloting real‐time provision of probability estimates to clinicians and nurses. Though not yet ready for real‐time use, it is reasonable for our model to be tested using the KPHC shadow server, since evaluation in a simulated environment constitutes a critical evaluation step prior to deployment for clinical use. We also anticipate further refinement and revalidation to occur as more inpatient data become available in the KPMCP and elsewhere.
A number of limitations to our approach must be emphasized. In developing our models, we determined that, while modeling by clinical condition was important, the study outcome was rare for some primary conditions. In these diagnostic groups, which accounted for 12.5% of the event shifts and 10.6% of the comparison shifts, the c‐statistic in the validation dataset was <0.70. Since all 22 KPMCP hospitals are now online and will generate an additional 150,000 adult hospitalizations per year, we expect to be able to correct this problem prior to deployment of these models for clinical use. Having additional data will permit us to improve model discrimination and thus decrease the evaluation‐to‐detection ratio. In future iterations of these models, more experimentation with grouping of International Classification of Diseases (ICD) codes may be required. The problem of grouping ICD codes is not an easy one to resolve, in that diagnoses in the grouping must share common pathophysiology while having a grouping with a sufficient number of adverse events for stable statistical models.
Ideally, it would have been desirable to employ a more objective measure of deterioration, since the decision to transfer a patient to the ICU is discretionary. However, we have found that key data points needed to define such a measure (eg, vital signs) are not consistently charted when a patient deterioratesthis is not surprising outside the research setting, given that nurses and physicians involved in a transfer may be focusing on caring for the patient rather than immediately charting. Given the complexities of end‐of‐life‐care decision‐making, we could not employ death as the outcome of interest. A related issue is that our model does not differentiate between reasons for needing transfer to the ICU, an issue recently discussed by Bapoje et al.18
Our model does not address an important issue raised by Bapoje et al18 and Litvak, Pronovost, and others,19, 20 namely, whether a patient should have been admitted to a non‐ICU setting in the first place. Our team is currently developing a model for doing exactly this (providing decision support for triage in the emergency department), but discussion of this methodology is outside the scope of this article.
Because of resource and data limitations, our model also does not include newborns, children, women admitted for childbirth, or patients transferred from non‐KPMCP hospitals. However, the approach described here could serve as a starting point for developing models for these other populations.
The generalizability of our model must also be considered. The Northern California KPMCP is unusual in having large electronic databases that include physiologic as well as longitudinal patient data. Many hospitals cannot take advantage of all the methods described here. However, the methods we employed could be modified for use by hospital systems in countries such as Great Britain and Canada, and entities such as the Veterans Administration Hospital System in the United States. The KPMCP population, an insured population with few barriers to access, is healthier than the general population, and some population subsets are underrepresented in our cohort. Practice patterns may also vary. Nonetheless, the model described here could serve as a good starting point for future collaborative studies, and it would be possible to develop models suitable for use by stand‐alone hospitals (eg, recalibrating so that one used a Charlson comorbidity21 score based on present on‐admission codes rather than the COPS).
The need for early detection of patient deterioration has played a major role in the development of rapid response teams, as well as scores such as the MEWS. In particular, entities such as the Institute for Healthcare Improvement have advocated the use of early warning systems.22 However, having a statistically robust model to support an early warning system is only part of the solution, and a number of new challenges must then be addressed. The first is actual electronic deployment. Existing inpatient EMRs were not designed with complex calculations in mind, and we anticipate that some degradation in performance will occur when we test our models using real‐time data capture. As Bapoje et al point out, simply having an alert may be insufficient, since not all transfers are preventable.18 Early warning systems also raise ethical issues (for example, what should be done if an alert leads a clinician to confront the fact that an end‐of‐life‐care discussion needs to occur?). From a research perspective, if one were to formally test the benefits of such models, it would be critical to define outcome measures other than death (which is strongly affected by end‐of‐life‐care decisions) or ICU transfer (which is often desirable).
In conclusion, we have developed an approach for predicting impending physiologic deterioration of hospitalized adults outside the ICU. Our approach illustrates how organizations can take maximal advantage of EMRs in a manner that exceeds meaningful use specifications.23, 24 Our study highlights the possibility of using fully automated EMR data for building and applying sophisticated statistical models in settings other than the highly monitored ICU without the need for additional equipment. It also expands the universe of severity scoring to one in which probability estimates are provided in real time and throughout an entire hospitalization. Model performance will undoubtedly improve over time, as more patient data become available. Although our approach has important limitations, it is suitable for testing using real‐time data in a simulated environment. Such testing would permit identification of unanticipated problems and quantification of the degradation of model performance due to real life factors, such as delays in vital signs charting or EMR system brownouts. It could also serve as the springboard for future collaborative studies, with a broader population base, in which the EMR becomes a tool for care, not just documentation.
Acknowledgements
We thank Ms Marla Gardner and Mr John Greene for their work in the development phase of this project. We are grateful to Brian Hoberman, Andrew Hwang, and Marc Flagg from the RIMS group; to Colin Stobbs, Sriram Thiruvenkatachari, and Sundeep Sood from KP IT, Inc; and to Dennis Andaya, Linda Gliner, and Cyndi Vasallo for their assistance with data‐quality audits. We are also grateful to Dr Philip Madvig, Dr Paul Feigenbaum, Dr Alan Whippy, Mr Gregory Adams, Ms Barbara Crawford, and Dr Marybeth Sharpe for their administrative support and encouragement; and to Dr Alan S. Go, Acting Director of the Kaiser Permanente Division of Research, for reviewing the manuscript.
Patients in general medicalsurgical wards who experience unplanned transfer to the intensive care unit (ICU) have increased mortality and morbidity.13 Using an externally validated methodology permitting assessment of illness severity and mortality risk among all hospitalized patients,4, 5 we recently documented observed‐to‐expected mortality ratios >3.0 and excess length of stay of 10 days among patients who experienced such transfers.6
It is possible to predict adverse outcomes among monitored patients (eg, patients in the ICU or undergoing continuous electronic monitoring).7, 8 However, prediction of unplanned transfers among medicalsurgical ward patients presents challenges. Data collection (vital signs and laboratory tests) is relatively infrequent. The event rate (3% of hospital admissions) is low, and the rate in narrow time periods (eg, 12 hours) is extremely low: a hospital with 4000 admissions per year might experience 1 unplanned transfer to the ICU every 3 days. Not surprisingly, performance of models suitable for predicting ward patients' need for intensive care within narrow time frames have been disappointing.9 The Modified Early Warning Score (MEWS), has a c‐statistic, or area under the receiver operator characteristic of 0.67,1012 and our own model incorporating 14 laboratory tests, but no vital signs, has excellent performance with respect to predicting inpatient mortality, but poor performance with respect to unplanned transfer.6
In this report, we describe the development and validation of a complex predictive model suitable for use with ward patients. Our objective for this work was to develop a predictive model based on clinical and physiologic data available in real time from a comprehensive electronic medical record (EMR), not a clinically intuitive, manually assigned tool. The outcome of interest was unplanned transfer from the ward to the ICU, or death on the ward in a patient who was full code. This model has been developed as part of a regional effort to decrease preventable mortality in the Northern California Kaiser Permanente Medical Care Program (KPMCP), an integrated healthcare delivery system with 22 hospitals.
MATERIALS AND METHODS
For additional details, see the Supporting Information, Appendices 112, in the online version of this article.
This project was approved by the KPMCP Institutional Board for the Protection of Human Subjects.
The Northern California KPMCP serves a total population of approximately 3.3 million members. All Northern California KPMCP hospitals and clinics employ the same information systems with a common medical record number and can track care covered by the plan but delivered elsewhere. Databases maintained by the KPMCP capture admission and discharge times, admission and discharge diagnoses and procedures (assigned by professional coders), bed histories permitting quantification of intra‐hospital transfers, inter‐hospital transfers, as well as the results of all inpatient and outpatient laboratory tests. In July 2006, the KPMCP began deployment of the EMR developed by Epic Systems Corporation (
Our setting consisted of 14 hospitals in which the KPHC inpatient EMR had been running for at least 3 months (the KPMCP Antioch, Fremont, Hayward, Manteca, Modesto, Roseville, Sacramento, Santa Clara, San Francisco, Santa Rosa, South Sacramento, South San Francisco, Santa Teresa, and Walnut Creek hospitals). We have described the general characteristics of KPMCP hospitals elsewhere.4, 6 Our initial study population consisted of all patients admitted to these hospitals who met the following criteria: hospitalization began from November 1, 2006 through December 31, 2009; initial hospitalization occurred at a Northern California KPMCP hospital (ie, for inter‐hospital transfers, the first hospital stay occurred within the KPMCP); age 18 years; hospitalization was not for childbirth; and KPHC had been operational at the hospital for at least 3 months.
Analytic Approach
The primary outcome for this study was transfer to the ICU after admission to the hospital among patients residing either in a general medicalsurgical ward (ward) or transitional care unit (TCU), or death in the ward or TCU in a patient who was full code at the time of death (ie, had the patient survived, s/he would have been transferred to the ICU). The unit of analysis for this study was a 12‐hour patient shift, which could begin with a 7 AM T0 (henceforth, day shift) or a 7 PM T0 (night shift); in other words, we aimed to predict the occurrence of an event within 12 hours of T0 using only data available prior to T0. A shift in which a patient experienced the primary study outcome is an event shift, while one in which a patient did not experience the primary outcome is a comparison shift. Using this approach, an individual patient record could consist of both event and comparison shifts, since some patients might have multiple unplanned transfers and some patients might have none. Our basic analytic approach consisted of creating a cohort of event and comparison shifts (10 comparison shifts were randomly selected for each event shift), splitting the cohort into a derivation dataset (50%) and validation dataset (50%), developing a model using the derivation dataset, then applying the coefficients of the derivation dataset to the validation dataset. Because some event shifts were excluded due to the minimum 4‐hour length‐of‐stay requirement, we also applied model coefficients to these excluded shifts and a set of randomly selected comparison shifts.
Since the purpose of these analyses was to develop models with maximal signal extraction from sparsely collected predictors, we did not block a time period after the T0 to allow for a reaction time to the alarm. Thus, since some events could occur immediately after the T0 (as can be seen in the Supporting Information, Appendices, in the online version of this article), our models would need to be run at intervals that are more frequent than 2 times a day.
Independent Variables
In addition to patients' age and sex, we tested the following candidate independent variables. Some of these variables are part of the KPMCP risk adjustment model4, 5 and were available electronically for all patients in the cohort. We grouped admission diagnoses into 44 broad diagnostic categories (primary conditions), and admission types into 4 groups (emergency medical, emergency surgical, elective medical, and elective surgical). We quantified patients' degree of physiologic derangement in the 72 hours preceding hospitalization with a Laboratory‐based Acute Physiology Score (LAPS) using 14 laboratory test results prior to hospitalization; we also tested individual laboratory test results obtained after admission to the hospital. We quantified patients' comorbid illness burden using a COmorbidity Point Score (COPS) based on patients' preexisting diagnoses over the 12‐month period preceding hospitalization.4 We extracted temperature, heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation, and neurological status from the EMR. We also tested the following variables based on specific information extracted from the EMR: shock index (heart rate divided by systolic blood pressure)13; care directive status (patients were placed into 4 groups: full code, partial code, do not resuscitate [DNR], and no care directive in place); and a proxy for measured lactate (PML; anion gap/serum bicarbonate 100).1416 For comparison purposes, we also created a retrospective electronically assigned MEWS, which we refer to as the MEWS(re), and we assigned this score to patient records electronically using data from KP HealthConnect.
Statistical Methods
Analyses were performed in SAS 9.1, Stata 10, and R 2.12. Final validation was performed using SAS (SAS Institute Inc., Carey, North Carolina). Since we did not limit ourselves to traditional severity‐scoring approaches (eg, selecting the worst heart rate in a given time interval), but also included trend terms (eg, change in heart rate over the 24 hours preceding T0), the number of potential variables to test was very large. Detailed description of the statistical strategies employed for variable selection is provided in the Supporting Information, Appendices, in the online version of this article. Once variables were selected, our basic approach was to test a series of diagnosis‐specific logistic regression submodels using a variety of predictors that included vital signs, vital signs trends (eg, most recent heart rate minus earliest heart rate, heart rate over preceding 24 hours), and other above‐mentioned variables.
We assessed the ability of a submodel to correctly distinguish patients who died, from survivors, using the c‐statistic, as well as other metrics recommended by Cook.17 At the end of the modeling process, we pooled the results across all submodels. For vital signs, where the rate of missing data was <3%, we tested submodels in which we dropped shifts with missing data, as well as submodels in which we imputed missing vital signs to a normal value. For laboratory data, where the rate of missing data for a given shift was much greater, we employed a probabilistic imputation method that included consideration of when a laboratory test result became available.
RESULTS
During the study period, a total of 102,488 patients experienced 145,335 hospitalizations at the study hospitals. We removed 66 patients with 138 hospitalizations for data quality reasons, leaving us with our initial study sample of 102,422 patients whose characteristics are summarized in Table 1. Table 1, in which the unit of analysis is an individual patient, shows that patients who experienced the primary outcome were similar to those patients described in our previous report, in terms of their characteristics on admission as well as in experiencing excess morbidity and mortality.6
Never Admitted to ICU | Direct Admit to ICU From ED | Unplanned Transfer to ICU* | Other ICU Admission | |
---|---|---|---|---|
| ||||
N | 89,269 | 5963 | 2880 | 4310 |
Age (mean SD) | 61.26 18.62 | 62.25 18.13 | 66.12 16.20 | 64.45 15.91 |
Male (n, %) | 37,228 (41.70%) | 3091 (51.84%) | 1416 (49.17%) | 2378 (55.17%) |
LAPS (mean SD) | 13.02 15.79 | 32.72 24.85 | 24.83 21.53 | 11.79 18.16 |
COPS(mean SD) | 67.25 51.42 | 73.88 57.42 | 86.33 59.33 | 78.44 52.49 |
% Predicted mortality risk (mean SD) | 1.93% 3.98% | 7.69% 12.59% | 5.23% 7.70% | 3.66% 6.81% |
Survived first hospitalization to discharge∥ | 88,479 (99.12%) | 5336 (89.49%) | 2316 (80.42%) | 4063 (94.27%) |
Care order on admission | ||||
Full code | 78,877 (88.36%) | 5198 (87.17%) | 2598 (90.21%) | 4097 (95.06%) |
Partial code | 664 (0.74%) | 156 (2.62%) | 50 (1.74%) | 27 (0.63%) |
Comfort care | 21 (0.02%) | 2 (0.03%) | 0 (0%) | 0 (0%) |
DNR | 8227 (9.22%) | 539 (9.04%) | 219 (7.60%) | 161 (3.74%) |
Comfort care and DNR | 229 (0.26%) | 9 (0.15%) | 2 (0.07%) | 2 (0.05%) |
No order | 1251 (1.40%) | 59 (0.99%) | 11 (0.38%) | 23 (0.53%) |
Admission diagnosis (n, %) | ||||
Pneumonia | 2385 (2.67%) | 258 (4.33%) | 242 (8.40%) | 68 (1.58%) |
Sepsis | 5822 (6.52%) | 503 (8.44%) | 279 (9.69%) | 169 (3.92%) |
GI bleeding | 9938 (11.13%) | 616 (10.33%) | 333 (11.56%) | 290 (6.73%) |
Cancer | 2845 (3.19%) | 14 (0.23%) | 95 (3.30%) | 492 (11.42%) |
Total hospital length of stay (days SD) | 3.08 3.29 | 5.37 7.50 | 12.16 13.12 | 8.06 9.53 |
Figure 1shows how we developed the analysis cohort, by removing patients with a comfort‐care‐only order placed within 4 hours after admission (369 patients/744 hospitalizations) and patients who were never admitted to the ward or TCU (7,220/10,574). This left a cohort consisting of 94,833 patients who experienced 133,879 hospitalizations spanning a total of 1,079,062 shifts. We then removed shifts where: 1) a patient was not on the ward at the start of a shift, or was on the ward for <4 hours of a shift; 2) the patient had a comfort‐care order in place at the start of the shift; and 3) the patient died and was ineligible to be a case (the patient had a DNR order in place or died in the ICU). The final cohort eligible for sampling consisted of 846,907 shifts, which involved a total of 92,797 patients and 130,627 hospitalizations. There were a total of 4,036 event shifts, which included 3,224 where a patient was transferred from the ward to the ICU, 717 from the TCU to the ICU, and 95 where a patient died on the ward or TCU without a DNR order in place. We then randomly selected 39,782 comparison shifts. Thus, our final cohort for analysis included 4,036 event shifts (1,979 derivation/2,057 validation and 39,782 comparison shifts (19,509/20,273). As a secondary validation, we also applied model coefficients to the 429 event shifts excluded due to the <4‐hour length‐of‐stay requirement.

Table 2 compares event shifts with comparison shifts. In the 24 hours preceding ICU transfer, patients who were subsequently transferred had statistically significant, but not necessarily clinically significant, differences in terms of these variables. However, missing laboratory data were more common, ranging from 18% to 31% of all shifts (we did not incorporate laboratory tests where 35% of the shifts had missing data for that test).
Predictor | Event Shifts | Comparison Shifts | P |
---|---|---|---|
| |||
Number | 4036 | 39,782 | |
Age (mean SD) | 67.19 15.25 | 65.41 17.40 | <0.001 |
Male (n, %) | 2007 (49.73%) | 17,709 (44.52%) | <0.001 |
Day shift | 1364 (33.80%) | 17,714 (44.53%) | <0.001 |
LAPS* | 27.89 22.10 | 20.49 20.16 | <0.001 |
COPS | 116.33 72.31 | 100.81 68.44 | <0.001 |
Full code (n, %) | 3496 (86.2%) | 32,156 (80.8%) | <0.001 |
ICU shift during hospitalization | 3964 (98.22%) | 7197 (18.09%) | <0.001 |
Unplanned transfer to ICU during hospitalization∥ | 353 (8.8%) | 1466 (3.7%) | <0.001 |
Temperature (mean SD) | 98.15 (1.13) | 98.10 (0.85) | 0.009 |
Heart rate (mean SD) | 90.30 (20.48) | 79.86 (5.27) | <0.001 |
Respiratory rate (mean SD) | 20.36 (3.70) | 18.87 (1.79) | <0.001 |
Systolic blood pressure (mean SD) | 123.65 (23.26) | 126.21 (19.88) | <0.001 |
Diastolic blood pressure (mean SD) | 68.38 (14.49) | 69.46 (11.95) | <0.001 |
Oxygen saturation (mean SD) | 95.72% (3.00) | 96.47 % (2.26) | <0.001 |
MEWS(re) (mean SD) | 3.64 (2.02) | 2.34 (1.61) | <0.001 |
% <5 | 74.86% | 92.79% | |
% 5 | 25.14% | 7.21% | <0.001 |
Proxy for measured lactate# (mean SD) | 36.85 (28.24) | 28.73 (16.74) | <0.001 |
% Missing in 24 hr before start of shift** | 17.91% | 28.78% | <0.001 |
Blood urea nitrogen (mean SD) | 32.03 (25.39) | 22.72 (18.9) | <0.001 |
% Missing in 24 hr before start of shift | 19.67% | 20.90% | <0.001 |
White blood cell count 1000 (mean SD) | 12.33 (11.42) | 9.83 (6.58) | <0.001 |
% Missing in 24 hr before start of shift | 21.43% | 30.98% | <0.001 |
Hematocrit (mean SD) | 33.08 (6.28) | 33.07 (5.25) | 0.978 |
% Missing in 24 hr before start of shift | 19.87% | 29.55% | <0.001 |
After conducting multiple analyses using the derivation dataset, we developed 24 submodels, a compromise between our finding that primary‐condition‐specific models showed better performance and the fact that we had very few events among patients with certain primary conditions (eg, pericarditis/valvular heart disease), which forced us to create composite categories (eg, a category pooling patients with pericarditis, atherosclerosis, and peripheral vascular disease). Table 3 lists variables included in our final submodels.
Variable | Description |
---|---|
| |
Directive status | Full code or not full code |
LAPS* | Admission physiologic severity of illness score (continuous variable ranging from 0 to 256). Standardized and included as LAPS and LAPS squared |
COPS | Comorbidity burden score (continuous variable ranging from 0 to 701). Standardized and included as COPS and COPS squared. |
COPS status | Indicator for absent comorbidity data |
LOS at T0 | Length of stay in the hospital (total time in hours) at the T0; standardized. |
T0 time of day | 7 AM or 7 PM |
Temperature | Worst (highest) temperature in 24 hr preceding T0; variability in temperature in 24 hr preceding T0. |
Heart rate | Most recent heart rate in 24 hr preceding T0; variability in heart rate in 24 hr preceding T0. |
Respiratory rate | Most recent respiratory rate in 24 hr preceding T0; worst (highest) respiratory rate in 24 hr preceding T0; variability in respiratory rate in 24 hr preceding T0. |
Diastolic blood pressure | Most recent diastolic blood pressure in 24 hr preceding T0 transformed by subtracting 70 from the actual value and squaring the result. Any value above 2000 is subsequently then set to 2000, yielding a continuous variable ranging from 0 to 2000. |
Systolic pressure | Variability in systolic blood pressure in 24 hr preceding T0. |
Pulse oximetry | Worst (lowest) oxygen saturation in 24 hr preceding T0; variability in oxygen saturation in 24 hr preceding T0. |
Neurological status | Most recent neurological status check in 24 hr preceding T0. |
Laboratory tests | Blood urea nitrogen |
Proxy for measured lactate = (anion gap serum bicarbonate) 100 | |
Hematocrit | |
Total white blood cell count |
Table 4 summarizes key results in the validation dataset. Across all diagnoses, the MEWS(re) had c‐statistic of 0.709 (95% confidence interval, 0.6970.721) in the derivation dataset and 0.698 (0.6860.710) in the validation dataset. In the validation dataset, the MEWS(re) performed best among patients with a set of gastrointestinal diagnoses (c = 0.792; 0.7260.857) and worst among patients with congestive heart failure (0.541; 0.5000.620). In contrast, across all primary conditions, the EMR‐based models had a c‐statistic of 0.845 (0.8260.863) in the derivation dataset and 0.775 (0.7530.797) in the validation dataset. In the validation dataset, the EMR‐based models also performed best among patients with a set of gastrointestinal diagnoses (0.841; 0.7830.897) and worst among patients with congestive heart failure (0.683; 0.6100.755). A negative correlation (R = 0.63) was evident between the number of event shifts in a submodel and the drop in the c‐statistic seen in the validation dataset.
No. of Shifts in Validation Dataset | c‐Statistic | |||
---|---|---|---|---|
Diagnoses Group* | Event | Comparison | MEWS(re) | EMR Model |
| ||||
Acute myocardial infarction | 36 | 169 | 0.541 | 0.572 |
Diseases of pulmonary circulation and cardiac dysrhythmias | 40 | 329 | 0.565 | 0.645 |
Seizure disorders | 45 | 497 | 0.594 | 0.647 |
Rule out myocardial infarction | 77 | 727 | 0.602 | 0.648 |
Pneumonia | 163 | 847 | 0.741 | 0.801 |
GI diagnoses, set A | 58 | 942 | 0.755 | 0.803 |
GI diagnoses, set B∥ | 256 | 2,610 | 0.772 | 0.806 |
GI diagnoses, set C | 46 | 520 | 0.792 | 0.841 |
All diagnosis | 2,032 | 20,106 | 0.698 | 0.775 |
We also compared model performance when our datasets were restricted to 1 randomly selected observation per patient; in these analyses, the total number of event shifts was 3,647 and the number of comparison shifts was 29,052. The c‐statistic for the MEWS(re) in the derivation dataset was 0.709 (0.6940.725); in the validation dataset, it was 0.698 (0.6920.714). The corresponding values for the EMR‐based models were 0.856 (0.8350.877) and 0.780 (0.7560.804). We also tested models in which, instead of dropping shifts with missing vital signs, we imputed missing vital signs to their normal value. The c‐statistic for the EMR‐based model with imputed vital sign values was 0.842 (0.8230.861) in the derivation dataset and 0.773 (0.7520.794) in the validation dataset. Lastly, we applied model coefficients to a dataset consisting of 4,290 randomly selected comparison shifts plus the 429 shifts excluded because of the 4‐hour length‐of‐stay criterion. The c‐statistic for this analysis was 0.756 (0.7030.809).
As a general rule, the EMR‐based models were more than twice as efficient as the MEWS(re). For example, a MEWS(re) threshold of 6 as the trigger for an alarm would identify 15% of all transfers to the ICU, with 34.4 false alarms for each transfer; in contrast, using the EMR‐based approach to identify 15% of all transfers, there were 14.5 false alarms for each transfer. Applied to the entire KPMCP Northern California Region, using the MEWS(re), a total of 52 patients per day would need to be evaluated, but only 22 per day using the EMR‐based approach. If one employed a MEWS(re) threshold of 4, this would lead to identification of 44% of all transfers, with a ratio of 69 false alarms for each transfer; using the EMR, the ratio would be 34 to 1. Across the entire KPMCP, a total of 276 patients per day (or about 19.5 a day per hospital) would need to be evaluated using the MEWS(re), but only 136 (or about 9.5 per hospital per day) using the EMR.
DISCUSSION
Using data from a large hospital cohort, we have developed a predictive model suitable for use in non‐ICU populations cared for in integrated healthcare settings with fully automated EMRs. The overall performance of our model, which incorporates acute physiology, diagnosis, and longitudinal data, is superior to the predictive ability of a model that can be assigned manually. This is not surprising, given that scoring systems such as the MEWS make an explicit tradeoff losing information found in multiple variables in exchange for ease of manual assignment. Currently, the model described in this report is being implemented in a simulated environment, a final safety test prior to piloting real‐time provision of probability estimates to clinicians and nurses. Though not yet ready for real‐time use, it is reasonable for our model to be tested using the KPHC shadow server, since evaluation in a simulated environment constitutes a critical evaluation step prior to deployment for clinical use. We also anticipate further refinement and revalidation to occur as more inpatient data become available in the KPMCP and elsewhere.
A number of limitations to our approach must be emphasized. In developing our models, we determined that, while modeling by clinical condition was important, the study outcome was rare for some primary conditions. In these diagnostic groups, which accounted for 12.5% of the event shifts and 10.6% of the comparison shifts, the c‐statistic in the validation dataset was <0.70. Since all 22 KPMCP hospitals are now online and will generate an additional 150,000 adult hospitalizations per year, we expect to be able to correct this problem prior to deployment of these models for clinical use. Having additional data will permit us to improve model discrimination and thus decrease the evaluation‐to‐detection ratio. In future iterations of these models, more experimentation with grouping of International Classification of Diseases (ICD) codes may be required. The problem of grouping ICD codes is not an easy one to resolve, in that diagnoses in the grouping must share common pathophysiology while having a grouping with a sufficient number of adverse events for stable statistical models.
Ideally, it would have been desirable to employ a more objective measure of deterioration, since the decision to transfer a patient to the ICU is discretionary. However, we have found that key data points needed to define such a measure (eg, vital signs) are not consistently charted when a patient deterioratesthis is not surprising outside the research setting, given that nurses and physicians involved in a transfer may be focusing on caring for the patient rather than immediately charting. Given the complexities of end‐of‐life‐care decision‐making, we could not employ death as the outcome of interest. A related issue is that our model does not differentiate between reasons for needing transfer to the ICU, an issue recently discussed by Bapoje et al.18
Our model does not address an important issue raised by Bapoje et al18 and Litvak, Pronovost, and others,19, 20 namely, whether a patient should have been admitted to a non‐ICU setting in the first place. Our team is currently developing a model for doing exactly this (providing decision support for triage in the emergency department), but discussion of this methodology is outside the scope of this article.
Because of resource and data limitations, our model also does not include newborns, children, women admitted for childbirth, or patients transferred from non‐KPMCP hospitals. However, the approach described here could serve as a starting point for developing models for these other populations.
The generalizability of our model must also be considered. The Northern California KPMCP is unusual in having large electronic databases that include physiologic as well as longitudinal patient data. Many hospitals cannot take advantage of all the methods described here. However, the methods we employed could be modified for use by hospital systems in countries such as Great Britain and Canada, and entities such as the Veterans Administration Hospital System in the United States. The KPMCP population, an insured population with few barriers to access, is healthier than the general population, and some population subsets are underrepresented in our cohort. Practice patterns may also vary. Nonetheless, the model described here could serve as a good starting point for future collaborative studies, and it would be possible to develop models suitable for use by stand‐alone hospitals (eg, recalibrating so that one used a Charlson comorbidity21 score based on present on‐admission codes rather than the COPS).
The need for early detection of patient deterioration has played a major role in the development of rapid response teams, as well as scores such as the MEWS. In particular, entities such as the Institute for Healthcare Improvement have advocated the use of early warning systems.22 However, having a statistically robust model to support an early warning system is only part of the solution, and a number of new challenges must then be addressed. The first is actual electronic deployment. Existing inpatient EMRs were not designed with complex calculations in mind, and we anticipate that some degradation in performance will occur when we test our models using real‐time data capture. As Bapoje et al point out, simply having an alert may be insufficient, since not all transfers are preventable.18 Early warning systems also raise ethical issues (for example, what should be done if an alert leads a clinician to confront the fact that an end‐of‐life‐care discussion needs to occur?). From a research perspective, if one were to formally test the benefits of such models, it would be critical to define outcome measures other than death (which is strongly affected by end‐of‐life‐care decisions) or ICU transfer (which is often desirable).
In conclusion, we have developed an approach for predicting impending physiologic deterioration of hospitalized adults outside the ICU. Our approach illustrates how organizations can take maximal advantage of EMRs in a manner that exceeds meaningful use specifications.23, 24 Our study highlights the possibility of using fully automated EMR data for building and applying sophisticated statistical models in settings other than the highly monitored ICU without the need for additional equipment. It also expands the universe of severity scoring to one in which probability estimates are provided in real time and throughout an entire hospitalization. Model performance will undoubtedly improve over time, as more patient data become available. Although our approach has important limitations, it is suitable for testing using real‐time data in a simulated environment. Such testing would permit identification of unanticipated problems and quantification of the degradation of model performance due to real life factors, such as delays in vital signs charting or EMR system brownouts. It could also serve as the springboard for future collaborative studies, with a broader population base, in which the EMR becomes a tool for care, not just documentation.
Acknowledgements
We thank Ms Marla Gardner and Mr John Greene for their work in the development phase of this project. We are grateful to Brian Hoberman, Andrew Hwang, and Marc Flagg from the RIMS group; to Colin Stobbs, Sriram Thiruvenkatachari, and Sundeep Sood from KP IT, Inc; and to Dennis Andaya, Linda Gliner, and Cyndi Vasallo for their assistance with data‐quality audits. We are also grateful to Dr Philip Madvig, Dr Paul Feigenbaum, Dr Alan Whippy, Mr Gregory Adams, Ms Barbara Crawford, and Dr Marybeth Sharpe for their administrative support and encouragement; and to Dr Alan S. Go, Acting Director of the Kaiser Permanente Division of Research, for reviewing the manuscript.
- Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation.Med Care.2002;40(6):530–539. , , , .
- The hospital mortality of patients admitted to the ICU on weekends.Chest.2004;126(4):1292–1298. , , , et al.
- Mortality among patients admitted to intensive care units during weekday day shifts compared with “off” hours.Crit Care Med.2007;35(1):3–11. , , , et al.
- Risk adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases.Med Care.2008;46(3):232–239. , , , , , .
- The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.J Clin Epidemiol.2010;63(7):798–803. , , , .
- Intra‐hospital transfers to a higher level of care: contribution to total hospital and intensive care unit (ICU) mortality and length of stay (LOS).J Hosp Med.2011;6(2):74–80. , , , , , .
- Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis.Intensive Care Med.1999;25(12):1360–1366. , , , , , .
- Integration of early physiological responses predicts later illness severity in preterm infants.Sci Transl Med.2010;2(48):48ra65. , , , , .
- Reproducibility of physiological track‐and‐trigger warning systems for identifying at‐risk patients on the ward.Intensive Care Med.2007;33(4):619–624. , , .
- Validation of a Modified Early Warning Score in medical admissions.Q J Med.2001;94:521–526. , , , .
- Effect of introducing the Modified Early Warning score on clinical outcomes, cardio‐pulmonary arrests and intensive care utilisation in acute medical admissions.Anaesthesia.2003;58(8):797–802. , , , , .
- MERIT Study Investigators.Introduction of the medical emergency team (MET) system: a cluster‐randomized controlled trial.Lancet.2005;365(9477):2091–2097.
- Unplanned transfers to the intensive care unit: the role of the shock index.J Hosp Med.2010;5(8):460–465. , , , , , .
- The delta (delta) gap: an approach to mixed acid‐base disorders.Ann Emerg Med.1990;19(11):1310–1313. .
- Acid‐base disorders: classification and management strategies.Am Fam Physician.1995;52(2):584–590. .
- Unmeasured anions in critically ill patients: can they predict mortality?Crit Care Med.2003;31(8):2131–2136. , , , .
- Use and misuse of the receiver operating characteristic curve in risk prediction.Circulation.2007;115(7):928–935. .
- Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care.J Hosp Med.2011;6(2):68–72. , , , .
- Rethinking rapid response teams.JAMA.2010;304(12):1375–1376. , .
- Rapid response teams—walk, don't run.JAMA.2006;296(13):1645–1647. , , .
- A new method of classifying prognostic comorbidity in longitudinal populations: development and validation.J Chronic Dis.1987;40:373–383. , , , .
- Institute for Healthcare Improvement.Early Warning Systems:The Next Level of Rapid Response.2011. http://www.ihi.org/IHI/Programs/AudioAndWebPrograms/ExpeditionEarlyWarningSystemsTheNextLevelofRapidResponse.htm?player=wmp. Accessed 4/6/11.
- Assessing readiness for meeting meaningful use: identifying electronic health record functionality and measuring levels of adoption.AMIA Annu Symp Proc.2010;2010:66–70. .
- Medicare and Medicaid Programs;Electronic Health Record Incentive Program. Final Rule.Fed Reg.2010;75(144):44313–44588.
- Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation.Med Care.2002;40(6):530–539. , , , .
- The hospital mortality of patients admitted to the ICU on weekends.Chest.2004;126(4):1292–1298. , , , et al.
- Mortality among patients admitted to intensive care units during weekday day shifts compared with “off” hours.Crit Care Med.2007;35(1):3–11. , , , et al.
- Risk adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases.Med Care.2008;46(3):232–239. , , , , , .
- The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.J Clin Epidemiol.2010;63(7):798–803. , , , .
- Intra‐hospital transfers to a higher level of care: contribution to total hospital and intensive care unit (ICU) mortality and length of stay (LOS).J Hosp Med.2011;6(2):74–80. , , , , , .
- Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis.Intensive Care Med.1999;25(12):1360–1366. , , , , , .
- Integration of early physiological responses predicts later illness severity in preterm infants.Sci Transl Med.2010;2(48):48ra65. , , , , .
- Reproducibility of physiological track‐and‐trigger warning systems for identifying at‐risk patients on the ward.Intensive Care Med.2007;33(4):619–624. , , .
- Validation of a Modified Early Warning Score in medical admissions.Q J Med.2001;94:521–526. , , , .
- Effect of introducing the Modified Early Warning score on clinical outcomes, cardio‐pulmonary arrests and intensive care utilisation in acute medical admissions.Anaesthesia.2003;58(8):797–802. , , , , .
- MERIT Study Investigators.Introduction of the medical emergency team (MET) system: a cluster‐randomized controlled trial.Lancet.2005;365(9477):2091–2097.
- Unplanned transfers to the intensive care unit: the role of the shock index.J Hosp Med.2010;5(8):460–465. , , , , , .
- The delta (delta) gap: an approach to mixed acid‐base disorders.Ann Emerg Med.1990;19(11):1310–1313. .
- Acid‐base disorders: classification and management strategies.Am Fam Physician.1995;52(2):584–590. .
- Unmeasured anions in critically ill patients: can they predict mortality?Crit Care Med.2003;31(8):2131–2136. , , , .
- Use and misuse of the receiver operating characteristic curve in risk prediction.Circulation.2007;115(7):928–935. .
- Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care.J Hosp Med.2011;6(2):68–72. , , , .
- Rethinking rapid response teams.JAMA.2010;304(12):1375–1376. , .
- Rapid response teams—walk, don't run.JAMA.2006;296(13):1645–1647. , , .
- A new method of classifying prognostic comorbidity in longitudinal populations: development and validation.J Chronic Dis.1987;40:373–383. , , , .
- Institute for Healthcare Improvement.Early Warning Systems:The Next Level of Rapid Response.2011. http://www.ihi.org/IHI/Programs/AudioAndWebPrograms/ExpeditionEarlyWarningSystemsTheNextLevelofRapidResponse.htm?player=wmp. Accessed 4/6/11.
- Assessing readiness for meeting meaningful use: identifying electronic health record functionality and measuring levels of adoption.AMIA Annu Symp Proc.2010;2010:66–70. .
- Medicare and Medicaid Programs;Electronic Health Record Incentive Program. Final Rule.Fed Reg.2010;75(144):44313–44588.
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