- Email: [email protected]
Using quality-of-life measurements in clinical practice
Surgical research review Using quality-of-life measurements in clinical practice Vic Velanovich, MD, Detroit, Mich From the Division of General Surgery, Henry Ford Hospital, Detroit, Mich
“To cure sometimes, to relieve often, to comfort always— this is our work.” William Osler, MD
Traditionally, to assess the value of an intervention, physicians have used objective, “physiciancentered,” outcomes measures. These kinds of measures would include such endpoints as survival of cancer patients, recurrences after hernia repair, increased blood flow after vascular bypass, incidence of stroke after carotid artery surgery, and the like. Although such measures are valuable, they do not tell the whole story of the patient’s experience. In some respects, they are surrogates for the true endpoint: Is the patient feeling better and can he or she function and enjoy life? It is this aspect of measuring patient-perceived functional improvements that the field of quality of life research developed.1-3 The addition of “quality of life” to other objective measures of outcomes leads to an “algebra” of sorts to determine the “net benefit” of an intervention for the patient.1 Many patients understand intuitively and value this algebra—“I don’t want to exchange my quality of life for quantity of life.” It is the purpose of this review to highlight how quality of life measurements can be incorporated into the clinical surgeon’s practice. Patient-reported outcomes is defined as “any endpoint derived from patient reports, whether collected in the clinic, in a diary, or by other means, including single-item outcome measures, event
Accepted for publication October 17, 2006. Reprint requests: Vic Velanovich, MD, Division of General Surgery, K-8, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202-2689. E-mail: [email protected]. Surgery 2007;141:127-33. 0039-6060/$ - see front matter © 2007 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2006.10.002
logs, symptom reports, formal instruments to measure health-related quality of life, health status, adherence, and satisfaction with treatment.”4 This concept has lead to an explosion of research in quality of life. In fact, a Medline literature search from 1996 to 2005 using “quality of life” as the keyword identified more than 34,000 articles. Clearly, the ability to assimilate and use this information is becoming increasingly important to the practicing surgeon. The question then becomes: How is one to use quality of life measurement in the clinical practice of surgery? Donaldson5 enumerates the potential benefits of quality of life measurement in clinical practice, which include the following: 1. Assessment: Description of the patient’s status upon entering treatment, and the detection of treatable problems that may have been overlooked. An example of documenting a patient’s status would be assessing the level of symptom severity of a patient with gastroesophageal reflux disease prior to treatment using a disease-specific questionnaire. An example of detecting an overlooked problem would be identifying depression in a pancreatic cancer patient by reviewing the mental health component of a generic questionnaire. 2. Monitoring: Evaluation of disease progression and treatment response. An example of this would be to assess pain severity periodically in a patient being treated for chronic pancreatitis. 3. Diagnosis: Detection, measurement, and identification of the causes of decreased functioning. Examples include differentiation of physical, emotional, and other problems; detection of treatment side effects or toxicity; prediction of the course of the disease. 4. Treatment: Application of the results of clinical studies to treatment choices. This concept is probably the most important use of quality of life research. Particularly for those interventions designed primarily to improve symptoms or function, having standardized, SURGERY 127
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measurable changes can help the clinician decide on the relative values of competing treatments. 5. Facilitate communication: Foster shared decision-making between physicians and patients to improve treatment planning and to guide changes in therapeutic plans that are consistent with patient preferences. Provide feedback to patients about their progress, and explore their goals and expectations. Encourage patient adherence to medical advice. Improve patient’s satisfaction with care. Ask patients to participate in quality-of-life measurements, and then talk about their scores. Many patients feel that these actions validate their subjective feelings. In addition, the physician may become aware of other health issues that were not communicated during the routine clinical encounter.
It is clear that many, if not all, of these goals are desirable in a surgical practice. Nevertheless, the practical aspects of using quality-of-life measurements to turn these goals into reality are not obvious. The purpose of this review is to address these issues. ASSIMILATING QUALITY-OF-LIFE INFORMATION INTO CLINICAL PRACTICE Information from quality of life research can be applied at the macro, meso, or micro levels. The macro level of decision-making affects large communities of people, such as a governmental jurisdiction. The meso level affects a targeted group of patients. The micro level deals with the individual patient with the purpose of effecting a health benefit for that patient.6 It is at this level, that of the individual patient, on which this review will focus its attention. Most surgeons will receive quality-of-life information from the literature, and so it behooves them to understand how to assess these studies. This is not a trivial matter, because there may be flaws in the literature that make interpretation of the data problematic.7 Let us review how health-related quality of life is determined. Quality of life is measured by questionnaires completed by the patient.8-10 These questionnaires are called instruments. The questions in each instrument are called items. If an instrument measures more that one aspect of quality of life, such as physical functioning, pain, or social activities, each of these aspects is called a domain. The instrument is scored, and these scores quantitate quality of life. This approach can beg the question, “Why is having a quality-of-life score valuable? Why can’t we just ask patients how they are feeling?” Wright11
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perhaps gives the most cogent answer: Patients come to doctors with unique, individual concerns, and this communication is the fundamental interchange between the physician and patient. Patient-centered measures are a particular type of measurement that allows patients to state their individual concerns and weight their relative importance; therefore, these questionnaires provide the physician a standardized method of assessing patient status. There are 3 basic types of instruments: generic, disease-specific, and symptom severity. Generic instruments are designed to be broadly applicable across a wide range of types and severity of diseases, across different medical treatments or health interventions, and across demographic and cultural subgroups.12 Disease-specific instruments are designed to assess specific diagnostic groups or patient populations, especially with the goal of measuring “clinically important changes.”12 Symptom severity instruments focus only on the symptoms produced by a given disease process without addressing other quality-of-life issues, such as social interactions or psychologic stresses. When reading an article in the literature that uses quality of life endpoints, the practicing surgeon needs to assess certain aspects of the instrument used in the study.7,13-15 The following list of instrument characteristics are of particular importance when making this assessment: 1. Validity. Does the instrument measure what it intended to measure? There are various types of validity and not all are necessary to make an instrument useful in assessing quality of life.10,15 The article should state or make reference to how the validity of the instrument was established, and how this validation is appropriate for the study. 2. Reliability. The instrument must produce the same results on repeated administrations when the patient has the same level of quality of life.10,15 Again, simple reference to the study that tested the reliability of the instrument is adequate from the standpoint of the reader. 3. Responsiveness (sensitivity to change). The instrument must be able to detect and measure change over time or after an intervention. From the standpoint of the clinical surgeon, this is one of the most important characteristics. If clinically important changes in quality of life or functional status occur as a result of an operation, but the instrument does not measure this change, it is not an appropriate instrument for use by the clinical surgeon.
There are other characteristics important to qualityof-life instruments, but these have more interest to
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Table I. Definitions of the lowest and highest scores on the SF-36* Domain
Lowest score (0, floor)
Highest score (100, ceiling)
Physical Functioning
Limited a lot in performing all physical activities including bathing or dressing due to health
Role-Physical
Problems with work or other daily activities as a result of physical health
Bodily Pain General Health
Very severe and extremely limiting pain Evaluates personal health as poor and believes it is likely to get worse Feels tired and worn out all of the time
Performs all types of physical activities including the most vigorous without limitations due to health No problems with work or other daily activities as a result of physical health No pain or limitations due to pain Evaluates personal health as excellent
Vitality Social Functioning
Role-Emotional
Mental Health
Extreme and frequent interference with normal social activities due to physical or emotional problems Problems with work or other daily activities as a result of emotional problems Feelings of nervousness and depression all of the time
Feels full of pep and energy all of the time Performs normal social activities without interference due to physical or emotional problems No problems with work or other daily activities as a result of emotional problems Feels peaceful, happy, and calm all of the time
*Adopted from Table 8.2.16
the researcher rather than clinical surgeons trying to determine if the study results would be useful for their patients. As with any other published research study, the reader needs to assess the quality of the data and if clinically meaningful changes have occurred. Let us take the example of the SF-36, one of the most widely used of the generic quality-of-life instruments.16-18 This instrument is just one of many available instruments (a catalog of quality-of-life instruments can be found at MAPI Research Trust website, proqolid.org). The SF-36 measures 8 domains of quality of life: physical functioning (limitations to physical activities due to health, such as self-care, walking, and climbing stairs); role-physical (interference with work or daily activities due to physical health); role-emotional (limitations to work or daily activities due to emotional health); bodily pain (pain intensity and how this pain affects work in and out of the home); vitality (how full of energy the patient feels); mental health (overall emotional and psychologic status); social functioning (how much health interferes with social interactions); and general health (overall evaluation of health). The scores are standardized so that the worst possible score is 0 (the floor), and the best possible score is 100 (the ceiling). Table I defines 0 and 100 to help with interpretation of the scores. Note that 0 is not equivalent to death, and 100 is not equivalent to perfect health. In addition, the domains
can be compressed into a physical and a mental component summary score. These scores can then be standardized to national norms (which exist for many countries). Absolute changes in scores that signify clinically meaningful change is still an area of active investigation19; comparisons of an individual patient’s score to population norms is valuable to gauge “where a patient is at.”16,17 USING QUALITY-OF-LIFE DATA IN CLINICAL DECISION-MAKING When surgeons would initially use quality-of-life information is in making a treatment choice for a particular patient. Essentially this is taking mesolevel data and applying it to the micro level. As with any application of clinical research to the individual patient, the first question to ask is, “Is my patient in the same group of patients in which the intervention worked?” For example, a quality of life study of the effects of doxorubicin-based chemotherapy after operations for breast cancer will not apply to a patient whose cardiac function is so poor that it is a contraindication to this drug. Therefore, surgeons have to assess if the patients they are evaluating has the same disease process as the study patients (which may be more involved than simply matching the disease name), if the comorbidities and their severities are similar (or, at least, not important), if the treatment studied is one the surgeon is contemplating, and if any cultural differences exist that make how the quality of life was
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assessed in the study not applicable to the surgeon’s patient. Treatment choices. Quality of life data may influence treatment choices when the treatments are intended to improve symptoms, or if the treatments provide similar survival but one treatment offers a superior quality of life. Let us take the example of inguinal hernia repair. Traditionally, the effectiveness of a hernia repair was measured by the recurrence rate. Very little else mattered. It is clear, however, that other outcomes matter to patients. For example, the Cooperative Hernia Study found that more than 50% of patients who had inguinal hernia repairs had groin pain more than 2 years after their operation.20 Clearly, although the surgeon can be satisfied that there was “no recurrence,” the patient’s functioning or sense of wellbeing was compromised. With this introduction, let us evaluate a randomized trail of open to laparoscopic inguinal hernia repair.21 The decision to perform laparoscopic or open inguinal hernia repair balances the incidence of hernia recurrence (a traditional “physician-centered” outcome) with such quality-of-life issues as pain, return to normal activities, and physical functioning (ie, patient-centered outcomes). Neumayer et al21 conducted a randomized trial of laparoscopic versus open mesh inguinal hernia repair with the primary outcome of hernia recurrence at 2 years; secondary outcome measures were complications, death, and patient-centered outcomes. Patient-centered outcomes were pain using the Visual Analogue Scale (VAS) and functional status using the SF-36. The laparoscopic repair had a 2-year recurrence rate of 10.1%, whereas the open repair had a 4.9% recurrence rate. Using the VAS, laparoscopic patients reported less pain than open mesh repair patients did on the day of operation and at 2 weeks, but similar levels of pain at 3 months and beyond. Both groups had improved functioning relative to preoperative levels, according to the physical-component scores and mentalcomponent scores of the SF-36. There were no differences between the groups in these scores at 3 months or at 2 years. How is the practicing surgeon to use this information? Beyond the usual assessment of a randomized trial,22 the reader needs to assess the patient-centered outcomes. First, is the use of a VAS appropriate to measure postoperative pain? In fact, the VAS is valid, reliable, and sensitive to change (responsive) for the measurement of postoperative pain; importantly, the authors cite the source for this information (ref #23 in their article). Next, is the SF-36 appropriate to measure functional status after her-
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nia repair? Although the SF-36 has not been validated specifically for inguinal hernia repair, it is a generic instrument that can be applied to a wide variety of disease processes16 and has been used in assessing laparoscopic and open hernia repair.23 The real criticism of the SF-36 in the assessment of functional outcome of hernia repair is sensitivity to change.24 That is, is the fact that there were no differences between the repair types truly reflects that the operative outcomes are the same, or is it due to the SF-36 not being sensitive enough to detect a difference? Evidence to support the former is that there are improvements in scores in both groups postoperatively compared to preoperatively; therefore, the SF-36 can detect change in functional status as a result of a hernia operation. In addition, because the SF-36 was administered at 3 months and 2 years postoperatively, there was also no difference in pain at those time points as measured by the VAS. For hernia repair, it would be incongruent for there to be differences in the SF-36 but not in the VAS. Therefore, the choices of instruments in this study seem appropriate. How is the surgeon to use this information in treatment choice of hernia repair? This study demonstrates the potential tradeoff in what was considered the most important clinical endpoint of repair (recurrence), for less pain in the early postoperative period. Therefore, if less pain early is important to the patient, and the patient is willing to exchange a higher risk of recurrence, the laparoscopic repair would be appropriate. On the other hand, if the patient wishes to reduce maximally his risk of recurrence and is willing to exchange a higher level of pain in the early postoperative course, then the open repair would be most appropriate. Prediction and prognosis. Patient-reported quality-of-life measurements can be used as a predictive tool. There are examples of pretreatment quality of life measurements predicting mortality in cardiovascular surgery25 as well as oncology.26,27 The International Breast Cancer Study Group conducted 2 trials of adjuvant cytotoxic chemotherapy. Patients enrolled in these trials had quality of life assessments using 4 linear analog self-assessment indicators. After relapse, these scores were predictive of subsequent overall survival.26 Specifically using the Cox regression analysis, 1 month after relapse, better mood in premenopausal patients and better appetite in postmenopausal patients were associated with longer survival. Six months after relapse, better physical well-being and appetite in premenopausal patients, and better physical wellbeing, mood, appetite, and coping in postmeno-
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Table II. The GERD-HRQL ●
Scale: No symptoms⫽0; Symptoms noticeable, but not bothersome⫽1; Symptoms noticeable and bothersome, but not every day⫽2; Symptoms bothersome every day⫽3; Symptoms affect daily activities⫽4; Symptoms are incapacitating, unable to do daily activities⫽5
●
Questions
1. How bad is your heartburn? 2. Heartburn when lying down? 3. Heartburn when standing up? 4. Heartburn after meals? 5. Does heartburn change your diet? 6. Does heartburn wake you from sleep? 7. Do you have difficulty swallowing? 8. Do you have pain with swallowing? 9. Do you have bloating or gassy feelings? 10. If you take medication, does this affect your daily life? How satisfied are you with your present condition?
pausal patients predicted longer survival. Outside the realm of mortality, quality-of-life scores predict the progression of disability from multiple sclerosis.28 A good example is how a preoperative quality of life score can predict postoperative patient satisfaction after antireflux surgery.29 From the patient’s perspective, one of the goals is symptomatic relief, without the exchange of reflux symptoms for other operation-induced symptoms. Nevertheless, satisfaction after an operation is multifactorial and may not relate to how well the operation corrects the index problem. Prior to operation, patients with gastroesophageal reflux disease completed the SF-36. All patients were considered good candidates for antireflux surgery by symptoms and physiologic studies. Postoperatively, 12% of patients were dissatisfied with the operation. Compared with patients who were satisfied ultimately with antireflux surgery, the dissatisfied patients had lower median preoperative scores in 6 of the 8 domains of the SF-36. Therefore, in multiple areas, quality-oflife measurements can be used for prognosis, predicting future disability and treatment failure, and patient satisfaction. Such predictive knowledge of which patients will feel that they did not benefit from surgical intervention may help the surgeon choose alternative therapy. Patient monitoring. Quality-of-life assessment can be used in patient monitoring after a medical or surgical intervention.5,30,31 For the individual patient and surgeon, this may mean documentation of both short- and long-term response to the operation.32 Such monitoring can help the surgeon identify other clinical, hidden issues with the patient, monitoring for disease recurrence, and assessing side effects.
0 0 0 0 0 0 0 0 0 0 Satisfied ____
Neutral ____
1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Dissatisfied ____
USING QUALITY-OF-LIFE MEASUREMENTS IN COUNSELING AND COMMUNICATION Patient counseling. Information from quality of life outcomes is valuable in patient counseling. Patients will ask frequently questions such as, “How much better is this operation going to make me?” and “How will this operation affect my life?” Knowledge of quality-of-life data will aid the surgeon in answering these questions. Take the example of gastroesophageal reflux disease. There are many studies published using a variety of instruments.33 A surgeon who wishes to use such information in counseling would have the patient complete one of these instruments prior to the clinical encounter. The score from this instrument can be discussed with the patient as their present level of symptom severity. The surgeon can then refer to studies using this instrument (or to his or her own results, if available) to inform the patient about the typical score after an antireflux procedure, as well as the range of scores, and the number of patients who showed improvement. As the patient completed the questionnaire prior to this counseling, these differences in quality-of-life scores have meaning to the patient, who will develop realistic expectations from the operation, and they give the surgeon the opportunity to clarify what may be improved and what will not. To develop this concept more fully, I will show how I use the GERD-HRQL questionnaire33 in my practice. The GERD-HRQL is a symptom severity instrument that measures the “typical” symptoms of gastroesophageal reflux disease (Table II). It is a 10-item questionnaire with each question having a 0 to 5 answer. Each answer is anchored to a symp-
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tom level. The patients complete the instrument, which is scored by adding the responses. The best possible score is 0 (“asymptomatic” in all questions), and the worst possible score is 50 (“incapacitated” in all questions). The patient completes the instrument while in the waiting room, and I score it prior to my evaluation of the patient. If, after my evaluation, I have determined that the patient would be a good candidate for antireflux surgery, I review with the patient his/her present level of symptoms as determined by the GERD-HRQL. When I tell the patient that his/her present symptom level is, say, 28, the patient “self-calibrates” his/her symptoms to that number. I then discuss the operation in detail, as well as the potential complications, and tell the patient that after the operation, one-half (ie, the median score) of patients will report a score of 4 or less, with the range of scores being from 0 to 22, with 12% of patients ultimately dissatisfied with the operation. If the patient has “risk factors” for dissatisfaction, such as low preoperative SF-36 scores or associated psychoemotional or chronic pain syndromes,34 I will discuss with the patient that he/she is more likely to be dissatisfied with the operation because of other symptoms, even though their reflux symptoms would have improved. This approach leads to further discussion and an ultimately better-informed patient. Physician-to-patient communication. The routine use of quality of life measurements in clinical practice facilitates physician-patient communication.27,31 An example of this comes from the routine use of a cancer-specific instrument in the clinical practices of oncologists.35 In a randomized, crossover trial, 10 physicians were randomized to either a control group or an intervention group. Physicians in the intervention group administered quality of life instruments routinely to their oncology patients. In the intervention group, quality of life issues were discussed more frequently than in the control group, and a greater number of these patients had moderate to severe health problems identified because of these questionnaires. Essentially, all of the physicians and 87% of patients felt that use of the quality-of-life instrument facilitated communication between physician and patient, and all expressed interest in its continued use in subsequent clinic visits. Also, other issues that the surgeon did not consider or did not realize were important were brought to light and could be addressed. Such communication stimulated by quality of life measurement improves patient satisfaction and increases compliance with care.5
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Physician-to-physician communication. The use of quality of life measurements in physician-to-physician communication has not received a great deal of attention. As these measurements are a routine part of my practice, the following information regarding referring physician communication is based on personal experience. It appears that referring physicians value objective quality-of-life information pertaining to their patients. Documentation of improved quality of life, functional status, and symptom severity helps the referring physician understand the changes resulting from operative intervention. Many referring physicians will have knowledge of quality-of-life measurement from other medical specialties; therefore, they may be able to compare the magnitude of change in quality of life for their patient. In addition, routine quality of life feedback will provide objective evidence of the surgeon’s results compared to published results in the medical literature. Over time, the referring physician develops a better understanding of what to expect postoperatively in their patients. Ultimately, the referring physician can use this information in counseling their patients on why they believe surgical referral is necessary. CAVEATS AND DIFFICULTIES There are several caveats and difficulties in the use of quality-of-life measures in clinical practice5,36 which can be divided generally into instrumentrelated, clinician-related, health care delivery system–related, and patient-related. With respect to instruments, the problem centers on which instruments to use and when. There is no universal instrument that is valid, reliable, appropriate for the disease or its treatment, and assesses all of the aspects of quality of life important to the patient. Therefore, it seems that the number and choice of instruments depends on what the physician or patient feel is important to measure. Clinician-related issues include ease of use, interpretation of qualityof-life scores, effects on clinical workflow, resources needed for data collection, and management and reimbursement. Issues with health care delivery systems pertain to the costs of data collection and management, timely review of data, and ensuring patient privacy and confidentially. Lastly, patientrelated issues include acceptability of the instrument, psychologic and physical burden of completing the instrument, and the potential effect on the patient-physician relationship. There are no easy answers to these potential problems. Creative solutions by individual practitioners and institutions will be needed to overcome these barriers.
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CONCLUSIONS Although applying quality-of-life measures to everyday clinical practice poses challenges, there are clear advantages to the physician and to the patient. The most important of these is in treatment choice, when treatments are primarily for symptom relief or if treatments may have noticeable side effects. Clinical decision-making can be enhanced using such measures as predictive or prognostic tools and in monitoring patient response to treatment or disease recurrence. Communication with patients, especially in the area of preoperative patient counseling, can be enhanced, as well as communication with referring physicians. Therefore, although there is effort to overcome the administrative burden of routine use of quality of life instruments in clinical practice, the surgeon will be rewarded.34 REFERENCES 1. Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N Engl J Med 1996;334:835-40. 2. Wood-Dauphinee S. Assessing quality of life in clinical research: from where have we come and where are we going? J Clin Epidemiol 1999;52:355-63. 3. Prutkin JM, Feinstein AL. Quality of life measurements: origin and pathogenesis. Yale J Biol Med 2002;75:79-93. 4. Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Controlled Clin Trials 2004;25:535-52. 5. Donaldson MS. Taking stock of health-related quality-of-life measurement in oncology practice in the United States. J Natl Cancer Inst Monogr 2004;33:155-67. 6. Osoba D. A taxonomy of the uses of health-related qualityof-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 2002;40(Suppl III):III31-8. 7. Velanovich V. The quality of quality of life studies in general surgical journals. J Am Coll Surg 2001;193:288-96. 8. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118;622-9. 9. Lee CW, Chi KN. The standard of reporting of healthrelated quality of life in clinical cancer trials. J Clin Epidemiol 2000;53:451-8. 10. Fayers PM, Machin D. Quality of life: assessment, analysis and interpretation. Chichester (UK): John Wiley & Sons, Ltd; 2000. 11. Wright JG. Evaluating the outcome of treatment: shouldn’t we be asking patients if they are better? J Clin Epidemiol 2000;53:549-53. 12. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989;27:S217-32. 13. Guyatt GH, Naylor CD, Juniper E, et al. Users’ guides to the medical literature. XII. How to use articles about healthrelated quality of life. JAMA 1997;277:1232-7. 14. Velanovich V. Using quality-of-life instruments to assess surgical outcomes. Surgery 1999;126:1-4. 15. Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002;11:193-205. 16. Ware JE Jr, Snow KK, Kosinkis M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Center; 1993.
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17. Ware JE Jr, Kosinski M, Keller SD. Physical and mental component summary scales: a user’s manual. Boston (MA): The Health Institute, New England Medical Center; 1994. 18. www.SF-36.org. Last accessed: January 2, 2007. 19. Hays RD, Brodsky M, Johnston MF, et al. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Evaluation and the Health Professions 2005;28:160-71. 20. Cunningham J, Temple WJ, Mitchell P, et al. Cooperative hernia study: pain in the postrepair patient. Ann Surg 1996;224:598-602. 21. Neumayer L, Giobbie-Hurder A, Jonasson O, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 2004;350:1819-27. 22. Thoma A, Farrokhyor F, Bhandari M, et al. User’s guide to the surgical literature: how to assess a randomized controlled trial in surgery. Can J Surg 2004;47:200-8. 23. Velanovich V. Laparoscopic vs. open surgery: a preliminary comparison of quality-of-life outcomes. Surg Endosc 2000; 14:16-21. 24. Fitzpatrick R, Ziebland S, Jenkinson C, et al. Importance of sensitivity of change as a criterion for selecting health status measures. Qual Health Care 1992;1:89-93. 25. Rumsfeld JS, MaWhinney S, McCarthy M, et al. Health-related quality of life as a predictor of mortality following coronary artery bypass graft surgery. JAMA 1999;281:1298-1303. 26. Coates AS, Hurny C, Peterson HF, et al. Quality-of-life scores predict outcome in metastatic but not early breast cancer. International Breast Cancer Study Group. J Clin Oncol 2000;18:3768-74. 27. Gotay CC. Assessing cancer-related quality of life across a spectrum of applications. J Natl Cancer Inst Monogr 2004;33:126-33. 28. Nortvedt MW, Riise T, Myhr KM, Nyland HI. Quality of life as a predictor for change in disability in MS. Neurology 2000;55:51-4. 29. Velanovich V. Using quality-of-life measurements to predict patient satisfaction outcomes for antireflux surgery. Arch Surg 2004;139:621-6. 30. Erickson P. A health outcomes framework for assessing health status and quality of life: enhanced data for decision making. J Natl Cancer Inst Monogr 2004;33:168-77. 31. Bjordal K. Impact of quality of life measurement in daily clinical practice. Ann Oncol 2004;15(Suppl 4):iv279-82. 32. Velanovich V. Experience with a generic quality of life instrument in a general surgical practice. Int J Surg Invest 2000;1:447-52. 33. Wood-Dauphine S, Korolija D. Symptoms, health-related quality of life and patient satisfaction: using these patientreported outcomes in people with gastroesophageal reflux disease. In: Granderath FA, Kamolz T, Pointner R, editors. Gastroesophageal reflux disease: principles of disease, diagnosis, and treatment. Vienna: Springer; 2006. p. 269-86. 34. Velanovich V. The effect of chronic pain syndromes and psychoemotional disorders on symptomatic and quality of life outcomes of antireflux surgery. J Gastrointest Surg 2003;7:53-8. 35. Detmar SB, Muller MJ, Schornagel JH, Wever LDV, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002;288:3027-34. 36. Greenhalgh J, Long AF, Flynn R. The use of patient reported outcomes measures in routine clinical practice: lack of impact or lack of theory? Soc Sci Med 2005;60:833-43.
“To cure sometimes, to relieve often, to comfort always— this is our work.” William Osler, MD
Traditionally, to assess the value of an intervention, physicians have used objective, “physiciancentered,” outcomes measures. These kinds of measures would include such endpoints as survival of cancer patients, recurrences after hernia repair, increased blood flow after vascular bypass, incidence of stroke after carotid artery surgery, and the like. Although such measures are valuable, they do not tell the whole story of the patient’s experience. In some respects, they are surrogates for the true endpoint: Is the patient feeling better and can he or she function and enjoy life? It is this aspect of measuring patient-perceived functional improvements that the field of quality of life research developed.1-3 The addition of “quality of life” to other objective measures of outcomes leads to an “algebra” of sorts to determine the “net benefit” of an intervention for the patient.1 Many patients understand intuitively and value this algebra—“I don’t want to exchange my quality of life for quantity of life.” It is the purpose of this review to highlight how quality of life measurements can be incorporated into the clinical surgeon’s practice. Patient-reported outcomes is defined as “any endpoint derived from patient reports, whether collected in the clinic, in a diary, or by other means, including single-item outcome measures, event
Accepted for publication October 17, 2006. Reprint requests: Vic Velanovich, MD, Division of General Surgery, K-8, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202-2689. E-mail: [email protected]. Surgery 2007;141:127-33. 0039-6060/$ - see front matter © 2007 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2006.10.002
logs, symptom reports, formal instruments to measure health-related quality of life, health status, adherence, and satisfaction with treatment.”4 This concept has lead to an explosion of research in quality of life. In fact, a Medline literature search from 1996 to 2005 using “quality of life” as the keyword identified more than 34,000 articles. Clearly, the ability to assimilate and use this information is becoming increasingly important to the practicing surgeon. The question then becomes: How is one to use quality of life measurement in the clinical practice of surgery? Donaldson5 enumerates the potential benefits of quality of life measurement in clinical practice, which include the following: 1. Assessment: Description of the patient’s status upon entering treatment, and the detection of treatable problems that may have been overlooked. An example of documenting a patient’s status would be assessing the level of symptom severity of a patient with gastroesophageal reflux disease prior to treatment using a disease-specific questionnaire. An example of detecting an overlooked problem would be identifying depression in a pancreatic cancer patient by reviewing the mental health component of a generic questionnaire. 2. Monitoring: Evaluation of disease progression and treatment response. An example of this would be to assess pain severity periodically in a patient being treated for chronic pancreatitis. 3. Diagnosis: Detection, measurement, and identification of the causes of decreased functioning. Examples include differentiation of physical, emotional, and other problems; detection of treatment side effects or toxicity; prediction of the course of the disease. 4. Treatment: Application of the results of clinical studies to treatment choices. This concept is probably the most important use of quality of life research. Particularly for those interventions designed primarily to improve symptoms or function, having standardized, SURGERY 127
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measurable changes can help the clinician decide on the relative values of competing treatments. 5. Facilitate communication: Foster shared decision-making between physicians and patients to improve treatment planning and to guide changes in therapeutic plans that are consistent with patient preferences. Provide feedback to patients about their progress, and explore their goals and expectations. Encourage patient adherence to medical advice. Improve patient’s satisfaction with care. Ask patients to participate in quality-of-life measurements, and then talk about their scores. Many patients feel that these actions validate their subjective feelings. In addition, the physician may become aware of other health issues that were not communicated during the routine clinical encounter.
It is clear that many, if not all, of these goals are desirable in a surgical practice. Nevertheless, the practical aspects of using quality-of-life measurements to turn these goals into reality are not obvious. The purpose of this review is to address these issues. ASSIMILATING QUALITY-OF-LIFE INFORMATION INTO CLINICAL PRACTICE Information from quality of life research can be applied at the macro, meso, or micro levels. The macro level of decision-making affects large communities of people, such as a governmental jurisdiction. The meso level affects a targeted group of patients. The micro level deals with the individual patient with the purpose of effecting a health benefit for that patient.6 It is at this level, that of the individual patient, on which this review will focus its attention. Most surgeons will receive quality-of-life information from the literature, and so it behooves them to understand how to assess these studies. This is not a trivial matter, because there may be flaws in the literature that make interpretation of the data problematic.7 Let us review how health-related quality of life is determined. Quality of life is measured by questionnaires completed by the patient.8-10 These questionnaires are called instruments. The questions in each instrument are called items. If an instrument measures more that one aspect of quality of life, such as physical functioning, pain, or social activities, each of these aspects is called a domain. The instrument is scored, and these scores quantitate quality of life. This approach can beg the question, “Why is having a quality-of-life score valuable? Why can’t we just ask patients how they are feeling?” Wright11
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perhaps gives the most cogent answer: Patients come to doctors with unique, individual concerns, and this communication is the fundamental interchange between the physician and patient. Patient-centered measures are a particular type of measurement that allows patients to state their individual concerns and weight their relative importance; therefore, these questionnaires provide the physician a standardized method of assessing patient status. There are 3 basic types of instruments: generic, disease-specific, and symptom severity. Generic instruments are designed to be broadly applicable across a wide range of types and severity of diseases, across different medical treatments or health interventions, and across demographic and cultural subgroups.12 Disease-specific instruments are designed to assess specific diagnostic groups or patient populations, especially with the goal of measuring “clinically important changes.”12 Symptom severity instruments focus only on the symptoms produced by a given disease process without addressing other quality-of-life issues, such as social interactions or psychologic stresses. When reading an article in the literature that uses quality of life endpoints, the practicing surgeon needs to assess certain aspects of the instrument used in the study.7,13-15 The following list of instrument characteristics are of particular importance when making this assessment: 1. Validity. Does the instrument measure what it intended to measure? There are various types of validity and not all are necessary to make an instrument useful in assessing quality of life.10,15 The article should state or make reference to how the validity of the instrument was established, and how this validation is appropriate for the study. 2. Reliability. The instrument must produce the same results on repeated administrations when the patient has the same level of quality of life.10,15 Again, simple reference to the study that tested the reliability of the instrument is adequate from the standpoint of the reader. 3. Responsiveness (sensitivity to change). The instrument must be able to detect and measure change over time or after an intervention. From the standpoint of the clinical surgeon, this is one of the most important characteristics. If clinically important changes in quality of life or functional status occur as a result of an operation, but the instrument does not measure this change, it is not an appropriate instrument for use by the clinical surgeon.
There are other characteristics important to qualityof-life instruments, but these have more interest to
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Table I. Definitions of the lowest and highest scores on the SF-36* Domain
Lowest score (0, floor)
Highest score (100, ceiling)
Physical Functioning
Limited a lot in performing all physical activities including bathing or dressing due to health
Role-Physical
Problems with work or other daily activities as a result of physical health
Bodily Pain General Health
Very severe and extremely limiting pain Evaluates personal health as poor and believes it is likely to get worse Feels tired and worn out all of the time
Performs all types of physical activities including the most vigorous without limitations due to health No problems with work or other daily activities as a result of physical health No pain or limitations due to pain Evaluates personal health as excellent
Vitality Social Functioning
Role-Emotional
Mental Health
Extreme and frequent interference with normal social activities due to physical or emotional problems Problems with work or other daily activities as a result of emotional problems Feelings of nervousness and depression all of the time
Feels full of pep and energy all of the time Performs normal social activities without interference due to physical or emotional problems No problems with work or other daily activities as a result of emotional problems Feels peaceful, happy, and calm all of the time
*Adopted from Table 8.2.16
the researcher rather than clinical surgeons trying to determine if the study results would be useful for their patients. As with any other published research study, the reader needs to assess the quality of the data and if clinically meaningful changes have occurred. Let us take the example of the SF-36, one of the most widely used of the generic quality-of-life instruments.16-18 This instrument is just one of many available instruments (a catalog of quality-of-life instruments can be found at MAPI Research Trust website, proqolid.org). The SF-36 measures 8 domains of quality of life: physical functioning (limitations to physical activities due to health, such as self-care, walking, and climbing stairs); role-physical (interference with work or daily activities due to physical health); role-emotional (limitations to work or daily activities due to emotional health); bodily pain (pain intensity and how this pain affects work in and out of the home); vitality (how full of energy the patient feels); mental health (overall emotional and psychologic status); social functioning (how much health interferes with social interactions); and general health (overall evaluation of health). The scores are standardized so that the worst possible score is 0 (the floor), and the best possible score is 100 (the ceiling). Table I defines 0 and 100 to help with interpretation of the scores. Note that 0 is not equivalent to death, and 100 is not equivalent to perfect health. In addition, the domains
can be compressed into a physical and a mental component summary score. These scores can then be standardized to national norms (which exist for many countries). Absolute changes in scores that signify clinically meaningful change is still an area of active investigation19; comparisons of an individual patient’s score to population norms is valuable to gauge “where a patient is at.”16,17 USING QUALITY-OF-LIFE DATA IN CLINICAL DECISION-MAKING When surgeons would initially use quality-of-life information is in making a treatment choice for a particular patient. Essentially this is taking mesolevel data and applying it to the micro level. As with any application of clinical research to the individual patient, the first question to ask is, “Is my patient in the same group of patients in which the intervention worked?” For example, a quality of life study of the effects of doxorubicin-based chemotherapy after operations for breast cancer will not apply to a patient whose cardiac function is so poor that it is a contraindication to this drug. Therefore, surgeons have to assess if the patients they are evaluating has the same disease process as the study patients (which may be more involved than simply matching the disease name), if the comorbidities and their severities are similar (or, at least, not important), if the treatment studied is one the surgeon is contemplating, and if any cultural differences exist that make how the quality of life was
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assessed in the study not applicable to the surgeon’s patient. Treatment choices. Quality of life data may influence treatment choices when the treatments are intended to improve symptoms, or if the treatments provide similar survival but one treatment offers a superior quality of life. Let us take the example of inguinal hernia repair. Traditionally, the effectiveness of a hernia repair was measured by the recurrence rate. Very little else mattered. It is clear, however, that other outcomes matter to patients. For example, the Cooperative Hernia Study found that more than 50% of patients who had inguinal hernia repairs had groin pain more than 2 years after their operation.20 Clearly, although the surgeon can be satisfied that there was “no recurrence,” the patient’s functioning or sense of wellbeing was compromised. With this introduction, let us evaluate a randomized trail of open to laparoscopic inguinal hernia repair.21 The decision to perform laparoscopic or open inguinal hernia repair balances the incidence of hernia recurrence (a traditional “physician-centered” outcome) with such quality-of-life issues as pain, return to normal activities, and physical functioning (ie, patient-centered outcomes). Neumayer et al21 conducted a randomized trial of laparoscopic versus open mesh inguinal hernia repair with the primary outcome of hernia recurrence at 2 years; secondary outcome measures were complications, death, and patient-centered outcomes. Patient-centered outcomes were pain using the Visual Analogue Scale (VAS) and functional status using the SF-36. The laparoscopic repair had a 2-year recurrence rate of 10.1%, whereas the open repair had a 4.9% recurrence rate. Using the VAS, laparoscopic patients reported less pain than open mesh repair patients did on the day of operation and at 2 weeks, but similar levels of pain at 3 months and beyond. Both groups had improved functioning relative to preoperative levels, according to the physical-component scores and mentalcomponent scores of the SF-36. There were no differences between the groups in these scores at 3 months or at 2 years. How is the practicing surgeon to use this information? Beyond the usual assessment of a randomized trial,22 the reader needs to assess the patient-centered outcomes. First, is the use of a VAS appropriate to measure postoperative pain? In fact, the VAS is valid, reliable, and sensitive to change (responsive) for the measurement of postoperative pain; importantly, the authors cite the source for this information (ref #23 in their article). Next, is the SF-36 appropriate to measure functional status after her-
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nia repair? Although the SF-36 has not been validated specifically for inguinal hernia repair, it is a generic instrument that can be applied to a wide variety of disease processes16 and has been used in assessing laparoscopic and open hernia repair.23 The real criticism of the SF-36 in the assessment of functional outcome of hernia repair is sensitivity to change.24 That is, is the fact that there were no differences between the repair types truly reflects that the operative outcomes are the same, or is it due to the SF-36 not being sensitive enough to detect a difference? Evidence to support the former is that there are improvements in scores in both groups postoperatively compared to preoperatively; therefore, the SF-36 can detect change in functional status as a result of a hernia operation. In addition, because the SF-36 was administered at 3 months and 2 years postoperatively, there was also no difference in pain at those time points as measured by the VAS. For hernia repair, it would be incongruent for there to be differences in the SF-36 but not in the VAS. Therefore, the choices of instruments in this study seem appropriate. How is the surgeon to use this information in treatment choice of hernia repair? This study demonstrates the potential tradeoff in what was considered the most important clinical endpoint of repair (recurrence), for less pain in the early postoperative period. Therefore, if less pain early is important to the patient, and the patient is willing to exchange a higher risk of recurrence, the laparoscopic repair would be appropriate. On the other hand, if the patient wishes to reduce maximally his risk of recurrence and is willing to exchange a higher level of pain in the early postoperative course, then the open repair would be most appropriate. Prediction and prognosis. Patient-reported quality-of-life measurements can be used as a predictive tool. There are examples of pretreatment quality of life measurements predicting mortality in cardiovascular surgery25 as well as oncology.26,27 The International Breast Cancer Study Group conducted 2 trials of adjuvant cytotoxic chemotherapy. Patients enrolled in these trials had quality of life assessments using 4 linear analog self-assessment indicators. After relapse, these scores were predictive of subsequent overall survival.26 Specifically using the Cox regression analysis, 1 month after relapse, better mood in premenopausal patients and better appetite in postmenopausal patients were associated with longer survival. Six months after relapse, better physical well-being and appetite in premenopausal patients, and better physical wellbeing, mood, appetite, and coping in postmeno-
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Table II. The GERD-HRQL ●
Scale: No symptoms⫽0; Symptoms noticeable, but not bothersome⫽1; Symptoms noticeable and bothersome, but not every day⫽2; Symptoms bothersome every day⫽3; Symptoms affect daily activities⫽4; Symptoms are incapacitating, unable to do daily activities⫽5
●
Questions
1. How bad is your heartburn? 2. Heartburn when lying down? 3. Heartburn when standing up? 4. Heartburn after meals? 5. Does heartburn change your diet? 6. Does heartburn wake you from sleep? 7. Do you have difficulty swallowing? 8. Do you have pain with swallowing? 9. Do you have bloating or gassy feelings? 10. If you take medication, does this affect your daily life? How satisfied are you with your present condition?
pausal patients predicted longer survival. Outside the realm of mortality, quality-of-life scores predict the progression of disability from multiple sclerosis.28 A good example is how a preoperative quality of life score can predict postoperative patient satisfaction after antireflux surgery.29 From the patient’s perspective, one of the goals is symptomatic relief, without the exchange of reflux symptoms for other operation-induced symptoms. Nevertheless, satisfaction after an operation is multifactorial and may not relate to how well the operation corrects the index problem. Prior to operation, patients with gastroesophageal reflux disease completed the SF-36. All patients were considered good candidates for antireflux surgery by symptoms and physiologic studies. Postoperatively, 12% of patients were dissatisfied with the operation. Compared with patients who were satisfied ultimately with antireflux surgery, the dissatisfied patients had lower median preoperative scores in 6 of the 8 domains of the SF-36. Therefore, in multiple areas, quality-oflife measurements can be used for prognosis, predicting future disability and treatment failure, and patient satisfaction. Such predictive knowledge of which patients will feel that they did not benefit from surgical intervention may help the surgeon choose alternative therapy. Patient monitoring. Quality-of-life assessment can be used in patient monitoring after a medical or surgical intervention.5,30,31 For the individual patient and surgeon, this may mean documentation of both short- and long-term response to the operation.32 Such monitoring can help the surgeon identify other clinical, hidden issues with the patient, monitoring for disease recurrence, and assessing side effects.
0 0 0 0 0 0 0 0 0 0 Satisfied ____
Neutral ____
1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Dissatisfied ____
USING QUALITY-OF-LIFE MEASUREMENTS IN COUNSELING AND COMMUNICATION Patient counseling. Information from quality of life outcomes is valuable in patient counseling. Patients will ask frequently questions such as, “How much better is this operation going to make me?” and “How will this operation affect my life?” Knowledge of quality-of-life data will aid the surgeon in answering these questions. Take the example of gastroesophageal reflux disease. There are many studies published using a variety of instruments.33 A surgeon who wishes to use such information in counseling would have the patient complete one of these instruments prior to the clinical encounter. The score from this instrument can be discussed with the patient as their present level of symptom severity. The surgeon can then refer to studies using this instrument (or to his or her own results, if available) to inform the patient about the typical score after an antireflux procedure, as well as the range of scores, and the number of patients who showed improvement. As the patient completed the questionnaire prior to this counseling, these differences in quality-of-life scores have meaning to the patient, who will develop realistic expectations from the operation, and they give the surgeon the opportunity to clarify what may be improved and what will not. To develop this concept more fully, I will show how I use the GERD-HRQL questionnaire33 in my practice. The GERD-HRQL is a symptom severity instrument that measures the “typical” symptoms of gastroesophageal reflux disease (Table II). It is a 10-item questionnaire with each question having a 0 to 5 answer. Each answer is anchored to a symp-
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tom level. The patients complete the instrument, which is scored by adding the responses. The best possible score is 0 (“asymptomatic” in all questions), and the worst possible score is 50 (“incapacitated” in all questions). The patient completes the instrument while in the waiting room, and I score it prior to my evaluation of the patient. If, after my evaluation, I have determined that the patient would be a good candidate for antireflux surgery, I review with the patient his/her present level of symptoms as determined by the GERD-HRQL. When I tell the patient that his/her present symptom level is, say, 28, the patient “self-calibrates” his/her symptoms to that number. I then discuss the operation in detail, as well as the potential complications, and tell the patient that after the operation, one-half (ie, the median score) of patients will report a score of 4 or less, with the range of scores being from 0 to 22, with 12% of patients ultimately dissatisfied with the operation. If the patient has “risk factors” for dissatisfaction, such as low preoperative SF-36 scores or associated psychoemotional or chronic pain syndromes,34 I will discuss with the patient that he/she is more likely to be dissatisfied with the operation because of other symptoms, even though their reflux symptoms would have improved. This approach leads to further discussion and an ultimately better-informed patient. Physician-to-patient communication. The routine use of quality of life measurements in clinical practice facilitates physician-patient communication.27,31 An example of this comes from the routine use of a cancer-specific instrument in the clinical practices of oncologists.35 In a randomized, crossover trial, 10 physicians were randomized to either a control group or an intervention group. Physicians in the intervention group administered quality of life instruments routinely to their oncology patients. In the intervention group, quality of life issues were discussed more frequently than in the control group, and a greater number of these patients had moderate to severe health problems identified because of these questionnaires. Essentially, all of the physicians and 87% of patients felt that use of the quality-of-life instrument facilitated communication between physician and patient, and all expressed interest in its continued use in subsequent clinic visits. Also, other issues that the surgeon did not consider or did not realize were important were brought to light and could be addressed. Such communication stimulated by quality of life measurement improves patient satisfaction and increases compliance with care.5
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Physician-to-physician communication. The use of quality of life measurements in physician-to-physician communication has not received a great deal of attention. As these measurements are a routine part of my practice, the following information regarding referring physician communication is based on personal experience. It appears that referring physicians value objective quality-of-life information pertaining to their patients. Documentation of improved quality of life, functional status, and symptom severity helps the referring physician understand the changes resulting from operative intervention. Many referring physicians will have knowledge of quality-of-life measurement from other medical specialties; therefore, they may be able to compare the magnitude of change in quality of life for their patient. In addition, routine quality of life feedback will provide objective evidence of the surgeon’s results compared to published results in the medical literature. Over time, the referring physician develops a better understanding of what to expect postoperatively in their patients. Ultimately, the referring physician can use this information in counseling their patients on why they believe surgical referral is necessary. CAVEATS AND DIFFICULTIES There are several caveats and difficulties in the use of quality-of-life measures in clinical practice5,36 which can be divided generally into instrumentrelated, clinician-related, health care delivery system–related, and patient-related. With respect to instruments, the problem centers on which instruments to use and when. There is no universal instrument that is valid, reliable, appropriate for the disease or its treatment, and assesses all of the aspects of quality of life important to the patient. Therefore, it seems that the number and choice of instruments depends on what the physician or patient feel is important to measure. Clinician-related issues include ease of use, interpretation of qualityof-life scores, effects on clinical workflow, resources needed for data collection, and management and reimbursement. Issues with health care delivery systems pertain to the costs of data collection and management, timely review of data, and ensuring patient privacy and confidentially. Lastly, patientrelated issues include acceptability of the instrument, psychologic and physical burden of completing the instrument, and the potential effect on the patient-physician relationship. There are no easy answers to these potential problems. Creative solutions by individual practitioners and institutions will be needed to overcome these barriers.
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CONCLUSIONS Although applying quality-of-life measures to everyday clinical practice poses challenges, there are clear advantages to the physician and to the patient. The most important of these is in treatment choice, when treatments are primarily for symptom relief or if treatments may have noticeable side effects. Clinical decision-making can be enhanced using such measures as predictive or prognostic tools and in monitoring patient response to treatment or disease recurrence. Communication with patients, especially in the area of preoperative patient counseling, can be enhanced, as well as communication with referring physicians. Therefore, although there is effort to overcome the administrative burden of routine use of quality of life instruments in clinical practice, the surgeon will be rewarded.34 REFERENCES 1. Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N Engl J Med 1996;334:835-40. 2. Wood-Dauphinee S. Assessing quality of life in clinical research: from where have we come and where are we going? J Clin Epidemiol 1999;52:355-63. 3. Prutkin JM, Feinstein AL. Quality of life measurements: origin and pathogenesis. Yale J Biol Med 2002;75:79-93. 4. Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Controlled Clin Trials 2004;25:535-52. 5. Donaldson MS. Taking stock of health-related quality-of-life measurement in oncology practice in the United States. J Natl Cancer Inst Monogr 2004;33:155-67. 6. Osoba D. A taxonomy of the uses of health-related qualityof-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 2002;40(Suppl III):III31-8. 7. Velanovich V. The quality of quality of life studies in general surgical journals. J Am Coll Surg 2001;193:288-96. 8. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118;622-9. 9. Lee CW, Chi KN. The standard of reporting of healthrelated quality of life in clinical cancer trials. J Clin Epidemiol 2000;53:451-8. 10. Fayers PM, Machin D. Quality of life: assessment, analysis and interpretation. Chichester (UK): John Wiley & Sons, Ltd; 2000. 11. Wright JG. Evaluating the outcome of treatment: shouldn’t we be asking patients if they are better? J Clin Epidemiol 2000;53:549-53. 12. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989;27:S217-32. 13. Guyatt GH, Naylor CD, Juniper E, et al. Users’ guides to the medical literature. XII. How to use articles about healthrelated quality of life. JAMA 1997;277:1232-7. 14. Velanovich V. Using quality-of-life instruments to assess surgical outcomes. Surgery 1999;126:1-4. 15. Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002;11:193-205. 16. Ware JE Jr, Snow KK, Kosinkis M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Center; 1993.
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17. Ware JE Jr, Kosinski M, Keller SD. Physical and mental component summary scales: a user’s manual. Boston (MA): The Health Institute, New England Medical Center; 1994. 18. www.SF-36.org. Last accessed: January 2, 2007. 19. Hays RD, Brodsky M, Johnston MF, et al. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Evaluation and the Health Professions 2005;28:160-71. 20. Cunningham J, Temple WJ, Mitchell P, et al. Cooperative hernia study: pain in the postrepair patient. Ann Surg 1996;224:598-602. 21. Neumayer L, Giobbie-Hurder A, Jonasson O, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 2004;350:1819-27. 22. Thoma A, Farrokhyor F, Bhandari M, et al. User’s guide to the surgical literature: how to assess a randomized controlled trial in surgery. Can J Surg 2004;47:200-8. 23. Velanovich V. Laparoscopic vs. open surgery: a preliminary comparison of quality-of-life outcomes. Surg Endosc 2000; 14:16-21. 24. Fitzpatrick R, Ziebland S, Jenkinson C, et al. Importance of sensitivity of change as a criterion for selecting health status measures. Qual Health Care 1992;1:89-93. 25. Rumsfeld JS, MaWhinney S, McCarthy M, et al. Health-related quality of life as a predictor of mortality following coronary artery bypass graft surgery. JAMA 1999;281:1298-1303. 26. Coates AS, Hurny C, Peterson HF, et al. Quality-of-life scores predict outcome in metastatic but not early breast cancer. International Breast Cancer Study Group. J Clin Oncol 2000;18:3768-74. 27. Gotay CC. Assessing cancer-related quality of life across a spectrum of applications. J Natl Cancer Inst Monogr 2004;33:126-33. 28. Nortvedt MW, Riise T, Myhr KM, Nyland HI. Quality of life as a predictor for change in disability in MS. Neurology 2000;55:51-4. 29. Velanovich V. Using quality-of-life measurements to predict patient satisfaction outcomes for antireflux surgery. Arch Surg 2004;139:621-6. 30. Erickson P. A health outcomes framework for assessing health status and quality of life: enhanced data for decision making. J Natl Cancer Inst Monogr 2004;33:168-77. 31. Bjordal K. Impact of quality of life measurement in daily clinical practice. Ann Oncol 2004;15(Suppl 4):iv279-82. 32. Velanovich V. Experience with a generic quality of life instrument in a general surgical practice. Int J Surg Invest 2000;1:447-52. 33. Wood-Dauphine S, Korolija D. Symptoms, health-related quality of life and patient satisfaction: using these patientreported outcomes in people with gastroesophageal reflux disease. In: Granderath FA, Kamolz T, Pointner R, editors. Gastroesophageal reflux disease: principles of disease, diagnosis, and treatment. Vienna: Springer; 2006. p. 269-86. 34. Velanovich V. The effect of chronic pain syndromes and psychoemotional disorders on symptomatic and quality of life outcomes of antireflux surgery. J Gastrointest Surg 2003;7:53-8. 35. Detmar SB, Muller MJ, Schornagel JH, Wever LDV, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002;288:3027-34. 36. Greenhalgh J, Long AF, Flynn R. The use of patient reported outcomes measures in routine clinical practice: lack of impact or lack of theory? Soc Sci Med 2005;60:833-43.