Outcomes research primer

June 8, 2017 | Autor: Jay Piccirillo | Categoria: Otolaryngology, Clinical Sciences, Outcomes Research, Otolaryngology - Head and Neck Surgery
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CLINICAL EPIDEMIOLOGYIOUTCOMES RESEARCH JAY F. PICCIRILLO, MD Clinical Epidemiology/Outcomes Research Associate Editor

Outcomes research primer JAY F. PICCIRILLO, MD, MICHAEL G. STEWART,MD, MPH, RICHARD E. GLIKLICH, MD, and BEVAN YUEH, MD, MPH, St. Louis, Missouri, Houston, Texas, Boston, Massachusetts, and New Haven, Connecticut

O u t c o m e s research is the scientific study of the outcomes o f diverse therapies used for a particular disease, condition, or illness. 1,2 The goals of this type of research are to document treatment effectiveness, to create treatment guidelines, and to study the impact of insurance status or reimbursement polices on outcomes of care. 3,4 Increasingly, otolaryngology providers are being asked by third-party payers, managed care organizations, and other organizations to document treatment outcomes. The American A c a d e m y of O t o l a r y n g o l o g y - H e a d and Neck Surgery ( A A O - H N S ) Foundation has recently begun a research grant program specially targeted to support outcomes research projects in otolaryngology, Each y e a r m o r e instruction courses on outcomes research axe offered at the annual A A O - H N S meeting. Clearly, the A A O - H N S membership are more interested in outcomes research than ever before. For that reason, we decided to prepare this Primer on outcomes research. It is our hope that this primer will provide the interested reader with a "starting" point to explore the published literature on outcomes research. We do not claim that this primer is exhaustive and admit that many excellent articles may have been omitted. Furthermore, we recognize that the field of outcomes research continues to grow, and we plan periodic updates to include new articles describing these new developments.

From the Departments of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine (Dr. Piccirillo), Baylor College of Medicine (Dr. Stewart), Massachusetts Eye and Eat" Infirmary (Dr. Gliklich); and the Section of Otolaryngology, Department of Surgery and the Robert Wood Johnson Clinical Scholars Program, Department of Medicine Yale University School of Medicine (Dr. Yueh). Dr. Yueh is a Robert Wood Johnson Clinical Scholars Fellow. Reprint requests: Jay F. Piccirillo, MD, Box 8115, 517 S. Euclid Ave., Washington University School of Medicine, St. Louis, MO 63110. Otolaryngol Head Neck Surg 1997;117:380-7. Copyright © 1997 by the American Academy of OtolaryngologyHead and Neck Surgery Foundation, Inc. 0194-5998/97/$5.00 + 0 23/1/82130 380

The primer is divided into three main parts: Key Articles, General Articles, and Otolaryngology-specific Articles. As the name implies, the Key Articles section includes those articles we believe are fundamental to the field of outcomes research. These articles are, or will be, classics in the field. Because of their importance, we have provided a short annotated bibliography to help the reader decide whether the article is of particular importance to him or her. The General Articles section contains articles of a general medical nature, and the Otolaryngology-specific section contains articles pertaining to otolaryngology. REFERENCES 1. Piccirillo JF. Outcomes research and otolaryngology. Otolaryngol Head Neck Surg 1994;111:764-9. 2. Roper WL, Winkenwerder W, Hackbarth GM, Krakauer H. Effectiveness in health care. An initiative to evaluate and improve medical practice. N Engl J Med 1988;319:1197-202. 3. Epstein AM. The outcomes movement--will it get us where we want to go? N Engl J Med 1990;323:266-9. 4. Relman AS. Assessment and accountability.The third revolution in medical care. N Engl J Med 1988;319:1220-2. KEY ARTICLES I. Bergner M. Quality of life, health status, and clinical research. Med Care 1988;27:S148-56. The traditional end points of clinical research are morbidity and mortality, and not quality of fife. Clinical information on the relative usefulness and sensitivity of quality-of-life instruments is often lacking. The author discusses these issues and makes suggestions about techniques and investigations to assist with these problems. 2. Cella DF, Bonomi AE. Measuring quality of life: 1995 update. Oncology 1995;9:47-60. This is an excellent review article that discusses the definition of quality of life and statistical and methodologic issues with quality-of-life assessment. The authors provide a summary of a large number of quality-of-life instruments. 3. Charlson ME, Pompei R Ales HL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987;40:373-83. The authors describe the validation of a weighted comorbidity scaling system and its usefulness in predicting 1-

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year morality in patients with breast cancer. Basically, comorbid conditions (diseases other than the disease of interest) are weighted according to severity, and an index score is calculated that assists in prospectwe prognostic stratification. 4. Chassin MR, Kosecoff J, Park RE, et al. Does inappropriate use explain geographic variations in the use of health care services? JAMA 1987;258:2533-7. The authors study the degree of appropriateness of coronary angiography, upper gastrointestinal endoscopy, and carotid endarterectomy using established protocols in three different geographic areas. Across all three geographic regions, the authors note relatively high levels of inappropriate utilization. In addition, they find no relationship between levels of appropriateness and different levels of utilization. Therefore inappropriate use does not explain geographic variations in health care utilization. 5. D'Agostino RB, Kwan H. Measuring effectiveness: what to expect without a randomized control groap. Med Care 1995;33:AS95-105. Randomized controlled trials are considered the ideal way to evaluate treatment efficacy. However, such trials are not always possible, and even when possible, they a r e often performed with such restrictions that they do not provide the true measures of the effectiveness of the treatment in the "real world" or under climcal conditions of usual practice. This article reviews the use of nonrandomized studies to measure effectiveness when a randomized controlled trial is not possible. 6. Donabedima A. The quality of care: How can it be assessed? JAMA t988;260:1743-8. This is an overview of issues in determining quality of health care. Two components of quality (technical performance and interpersonal skills) are discussed with respect to cost, techniques in sampling and measurement, and sources of data. Distinctions between structure, process, and outcomes data are drawn. 7. Eddy DM. Clinical decision making: from theory to practice. Cost-effectiveness analysis. A conversation with my father. JAMA 1992;267:1669-75. The first of a series of articles that introduces principles of cost-effectiveness, including its rationale, methods, and applications, through a series of imaginary conversations. Questions are asked and answered with examples from clinical practice. Avoids use of technical economic language. 8. Eisenberg JM. Economics. JAMA 1995;273:16'70-1. This article highlights major findings about the managed care industry from 1994 to 1995. Studies suggest that favorable patient selection and decreases in inpatient utilization were partly responsible for health maintenance organization savings. The differences in health outcomes between fee-for-service or managed care plans are small; satisfaction outcomes are mixed. 9. Ellwood PM. Shattuck lecture---outcomes management. A technology of patient experience. N Engl J Med 1988;318:1549-56. This special report discusses the problems faced by the American medical system and suggests that a new technology of patient experience will help patients, payers,


and providers make rational medical choices. Outcomes management consists of a common patient-understood language of health outcomes. The author describes several different aspects of outcomes management. 10. Epstein AM. The outcomes movement--Will it get us where we want to go? N Engi J Med 1990;323:266-9. The author considers the forces that have brought about the outcomes movement and the direction it has taken. The goals of the movement and likely impediments to its progress are discussed. 11. Feinstein AR. Clinical biostatistics. XLI. Hard science, soft data, and the challenges of choosing clinical variables in research. Clin Pharmacol Ther 1977;22:485-98. The choice of variables for clinical research should be selected based on their importance to the condition under study. The essence of science is not the use of "hard" variables over "soft" variables but, rather, the selection of variables that are reliable and accurate. Soft variables that describe many of the important aspects of clinical care can be made more scientific through techniques of clinimetrics and then included in clinical studies. 12. Foundation for Health Services Research. Health outcomes research: a primer. Washington (DC): The Foundation; 1993: This primer provides an overview of health services and outcomes research. 13. Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA 1994;272:619-26. The authors review the published literature on quality of life and identify the lack of a well-accepted and generalty used definition of quality of life. Authors state that because quality of life is a uniquely personal perspective, patient-specific measures should be used. 14. Greenfield S. The state of outcomes research: are we on target? [editorial]. N Engl J Med 1989;320:1142-3. The author argues that large national databases should be constructed to collect information on the outcomes for patients with different conditions. 15. Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. Canadian Medical Association Journal 1986;134:889-95. The authors discuss the development, validation, and usefulness of disease-specific quality of life measures in clinical research. A detailed description is provided for techniques of item selection, item reduction, item format, and validation. 16. Iezzoni LI. Severity of illness measures. Comments and caveats. Med Care 1990;28:757-61. This editorial presents information on analyzing severity of illness measures and understanding problems and pitfalls of their use. 17. Kassirer JR The quality of care and the quality of measuring it. N Engl J Med 1993;329:1263-5. This essay about the motivations and intentions behind the movements to establish practice guidelines discusses implications of the rigid applications of these standards. 18. Katz JN, Larson MG, Phillips CB, Fossel AH, Liang MH. Comparative measurement sensitivity of short and longer health status instruments. Med Care 1992;30:917-25. In the study patients are given five different health status measures to assess whether short measures of health stares are as sensitive as longer measures. Overall, short

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health status measures are more responsive then longer, more established measures. 19. Leape LL, Park RE, Solomon DH, Chassin MR, Kosec0ff J, Brook RH. Does inappropriate use explain small-area variations in the use of health care services? JAMA 1990;263:669-72. Using information from Medicare beneficiaries in several adjacent counties in the same state, the investigators assess whether inappropriate utilization accounts for the large differences in utilization in adjacent counties. Although inappropriate utilization is noted, there are no large differences between counties. Therefore inappropriate use does not explain variation in health care utilization between different counties in the same state. 20. Lohr KN. Outcome measurement: concepts and questions. Inquiry 1988;25:37-50. The need for the accurate measurement of patient outcomes is self-evident. The author describes outcomes research and its use in the measurement of quality of care. The author suggests four areas of improvement to link outcomes to the measurement of process of care. 21. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989;27:$217-32. This article discusses the differences between generic and disease-specific outcomes instruments. Generic measures may be more generalizable and therefore useful for policy studies. Disease-specific instruments may be more sensitive to clinical changes. The authors review considerations selecting an appropriate instrument. 22. Phelps CE. The methodologic foundations of studies of the appropriateness of medical care. N Engl J Med 1993;329:12415. Exploration of potential flaws in studies reporting on appropriateness of care. The article considers how such studies may incorrectly "diagnose" appropriate practice patterns as inappropriate (and vice versa) and draws a mathematical analogy to the imperfect sensitivities and specificities of all diagnostic tests. 23. Piccirillo JR Outcomes research and otolaryngology. Otolaryngol Head Neck Surg 1994; 111:764-9. This overview of the historic development of the outcomes research movement explores the ways outcomes research is different from traditional clinical research. The article also provides four methodologic requirements for outcomes research. Examples of otolaryngology conditions that seem particularly suited to study with outcomes methodology are presented. 24. Piccirillo JF, Feinstein AR. Black-box mathematics and medical practice. Arch Otolaryngol Head Neck Surg 1993; 119:147-55. Two articles presented in the otolaryngology literature using outcomes methodology are presented. These articles present results that are at odds with usual clinical practice. The reasons for this discrepancy are discussed, and an argument is made for improvements in the quality of clinical research provided. 25. Pliskin N, Taylor AK. General principles: cost benefit and decision analysis. In: Bunker J, Barnes B, Mosteller F, editors. Costs, risks and benefits of surgery. New York: Oxford University Press; 1977. p. 5-27. Examples of cost benefit and decision analysis are p r o -

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vided in this textbook chapter. Concepts such as the time value of money and the use of utility functions to assess nontraditional outcomes are introduced. Several concepts are illustrated with clinical scenarios. 26. Relman AS. Assessment and accountability. The third revolution in medical care. N Engl J Med 1988;319:1220-2. The author describes the historic changes in medicine since 1940 and argues that we have entered a third revolution as a result of uncontrolled expansion in health services and unsustainable growth in expenses. This third era of medicine is based on the consensus for the need for assessment accountability in health care. 27. Roper WL, Winkenwerder W, Hackbarth GM, Krakauer H. Effectiveness in health care. An initiative to evaluate and improve medical practice. N Engl J Med 1988;319:1197-202. A detailed discussion of the effectiveness initiative. Several examples from different clinical conditions are provided to illustrate how outcomes research methodology can improve patient care. 28. Rubin HR, Gandek B, Rogers WH, Kosinsji M, McHorney CA, Ware JE Jr. Patients' ratings of outpatient visits in different practice settings. Results from the Medical Outcomes Study. JAMA 1993 ;270: 835-40. A standard and valid questionnaire of patient satisfaction with their outpatient visit is used to assess satisfaction across general medical practices, such as fee for service, group practice, and prepaid HMO. Implications of patient satisfaction information are provided. 29. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-2. This essay argues that evidence-based medicine is the conscientious application of the best available evidence to making decisions about patient care. It includes a description of what evidence-based medicine is, discusses its merits, and counters its most common criticisms. 30. Tarlov AR, Ware JE Jr, Greenfield S, Nelson EC, Perrin E, Zubkoff M. The Medical Outcomes Study: an application of methods for monitoring the results of medical care. JAMA 1989;262:925-30. This important paper describes the methods and results of the Medical Outcomes Study. This was a 2-year observational study designed to help explain how specific components of the health care system affect outcomes. 31. Wennberg J, Gittelsohn A. Variations in medical care among small areas. Sci Am 1982;246:120-34. The authors discuss the differences in utilization rates of many surgical procedures in adjacent counties in Vermont. They conclude that differences are largely the result of the different mix of specialists and the procedures they prefer, rather than the health status of patients. 32. Wennberg JE. Outcomes research, cost containment, and the fear of health care rationing. N Engl J Med 1990;323:1202-4. The authors discuss implications of different rates of health care utilization on health care costs and the potential effects of rationing of health care. The use of outcomes research to identify health outcomes of procedures and medical treatments is less important than society addressing important issues of supply, demand and availability of health care, given fixed budgets and limited resources.

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GENERAL ARTICLES 1. Assessing medical technologies. Washington (DC): National Academy Press; 1985. 2. Committee on Methods for Setting Priorities for Guidelines Development, Institute of Medicine. In: Field M J, editor. Setting priorities for clinical practice guidelines. Washington (DC): National Academy Press; 1995. 3. Aaronson NK. Quality of life assessment in clinical trials. Control Clin Trials 1989;10:195S-208S. 4. Aaronson NK. Quality of life research in clinical trials. A need for common rules and language. Oncology 1990;4:59-66. 5. Anderson JR Kaplan RM, Berry CC, Bush JW Rumbaut RG. Interday reliability of function assessment for a health status measure: the Quality of Well-Being Scale, Med Care 1989;27:1076-84. 6. Apgar V. A proposal for a new method of evaluation of the newborn infant. Anesth Analg 1953;32:260-7. 7. Baldwin LM, Inui TS, Stenkamp S. The effect ~f coordinated, multidisciplinary ambulatory care on service use. charges, quality of care and patient satisfaction in the elderly. J Community Health 1993;18:95-108. 8. Bergner M. Measurement of health statu~. Med Care 1985;23:696-704. 9. Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health stares measure. Med Care 1981;19:787-805. 10. Berwick DM. Continuous improvement as an ~deal in health care. N Engl J M e t 1989;320:53-6. 11. Berwick DM, Godfrey AB, Roessner J. Curing health care. San Francisco (CA): Jossey-Bass; 1990. 12. Bjelle A. Functional status assessment. Curt Opin Rheumatol 1991 ;3:280.-5. 13. Borchardt WW. Patient perception of quality in the clinic setting and relevant strategies for improvement. Cc,llege Review I994;Spring:72-97. 14. Brazier JE, Harper R, Jones NMB, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992;305:160-4. 15. Brook RH, Lohr KN. Monitoring quality of care in the Medicare program. Two proposed systems. JAMA 1987;258: 3138-41. 16. Brook RH, McGlynn EA. Maintaining qualit~ of care. In: Ginzberg E, editor. Health services research. Key to health policy. Cambridge (MA): Harvard University Press; 1991. p. 284314. 17. Brook RH, 'Ware JE, Davies-Avery A, et al. Overview of adult health status measures fielded in Rand's Health Insurance Study. Med Care 1979;17:1-131. 18. Brook RH, Ware JE, Rogers WH, et al. Does free care improve adults' health? Results from a randomized trial. N Engl J Med 1983;309:1426-34. 19. Busschbach JJV, Horikx PE, van den Bosch JMM, De la Riviere AB, de Charro FT. Measuring the quality of life before and after bilateral lung transplantation in patients with c:/stic fibrosis. Chest 1994; 105:911-7. 20. Caine N, Harrison SC, Sharpies LD, Wallwork 3. Prospective study of quality of life before and after coronary bypass grafting. BMJ 1991;302:511-6. 21. Carey RG, Lloyd RC. Measuring quality improvement in health care. A guide to statistical process control applications. New York: Quality Resources; 1995. 22. Cella DE Cherin EA. Quality of life during and after cancer treatment. Compr Ther 1988;14:69-75. 23. Cella DE Tulsky DS. Measuring quality of life today: methodologic aspects. Oncology 1990;4:29-38. 24. Cella DE Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570-9. 25. Chassin MR, Kosecoff J, Park RE, et al. Indications for selected


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OTO LARYNGOLOGY-SPECIFIC ARTICLES 1. Consensus Development Panel. NIH Consensus Development Conference Consensus Statement on Acoustic Neuroma. Bethesda (MD): N1H; 1991 Dec 11-13. 2. Early identification of hearing impairment in infants and young children. NIH Consensus Statement, Mar 1-3. 1993;11(1):1-24. 3. Baker CA. Factors associated with rehabilitation in head and neck cancer. Cancer Nurs 1992;15:395-400. 4. Benninger MS, King F, Nichols RD. Management guidelines for improvement of otolaryngology referrals from primary care physicians. Otolaryngol Head Neck Surg 1995; 113:446-52. 5. Bjordal K, Kaasa S, Mastekaasa A. Quality of life in patients treated for head and neck cancer: a follow-up study 7-11 years after radiotherapy. Int J Radiat Oncol Biol Phys 1994;28:847-56. 6. Browman GP, Levine MN, Hodson DI, et al. The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instru-


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Head Neck Surg 1991;I17:984-9. 42. Rubin HR. Can patients evaluate the quality of hospital care? Med Care Rev 1990;47:267-326. 43. Rubin HR, Wu AW. Patient satisfaction: its importance and how to measure it. In: Gitnick G, editor. The business of medicine: a physician's guide. New York: Elsevier Science Publishing; 1991. p. 397-409. 44. Sher AE, Schechtman KB, Piccirillo JR The efficacy of surgical treatments for obstructive sleep apnea. Sleep 1996; 19:156-77. 45. Snyderman CH, D'Amico E Outcome of carotid artery-resection for neoplastic disease: a meta-analysis. Am J Otolaryngol 1992;13:373-80. 46. The Otitis Media Guideline Panel. Clinical practice guideline, otitis media with effusion in young children. 1994 July. Publication No.: 94-0622. Rockville (MD): Agency for Health Care Policy and Research; 1994. p. iv. 47. Turner RG, Nielsen DV~qApplication of clinical decision analysis to audiological tests. Ear Hear 1984;5:125-33. 48. US Department of Health and Human Services. Managing otitis media with effusion in young children. Arch Otolaryngol Head Neck Surg 1994;120:793-6. 49. Weiss MH, Harrison LB, Isaacs RS. Use of decision analysis in planning a management strategy for the stage NO neck [review]. Arch Otolaryngol Head Neck Surg 1994; 120:699-702.

W e t h a n k Drs. E d w i n M. M o n s e l l , C o o r d i n a t o r o f Research, and Maureen Hannley, Associate Vice President for Research and Development, of the American Academy of Otolaryngology-Head and Neck S u r g e r y F o u n d a t i o n , Inc., f o r t h e i r s u p p o r t o f this work.

Craniofacial and Skull Base Surgery The 2nd Congress on Craniofacial and Skull Base Surgery will he held Jan. 20-25, 1998, in Cancun Mexico. CME credit is available. For further information contact Peggy M. Podboy, CMP, FOCUS Meetings and Events, 625 S George St.,, Mount Prospect, IL 60056-3915; phone (847)398-5821; fax (847)398-5822

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