© 2004 by Oxford University Press
2004 © Oxford University Press
Article |
Health-Related Quality of Life, Satisfaction, and Economic Outcome Measures in Studies of Prostate Cancer Screening and Treatment, 1990-2000
M. McNaughton-Collins, E. Walker-Corkery, and M.J. Barry, Medical Practices Evaluation Center, Massachusetts General Hospital, Boston, MA.
Correspondence to: Mary McNaughton-Collins, MD, MPH, Medical Practices Evaluation Center, Massachusetts General Hospital, 50 Staniford St., 9th Floor, Boston, MA 02114 (e-mail: mmcnaughtoncollins{at}partners.org).
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ABSTRACT |
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 TopNotes Abstract IntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest—health-related quality of life (QOL), satisfaction with care, and economic cost impact—hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.
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INTRODUCTION |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints such as tumor shrinkage or patient compliance, to final endpoints such as survival or disease-free survival. Our article focuses on three types of final endpoints that are of growing interest to patients, providers, payers, and regulators—health-related quality of life (QOL), satisfaction with care, and economic cost effect. Such nontraditional endpoints hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment, although there remain methodologic challenges to overcome in measuring these nontraditional endpoints.
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BACKGROUND ON PROSTATE CANCER |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Prostate cancer is a major public health concern for men, with 198 100 new prostate cancer cases and 31 500 prostate cancer deaths expected in the United States in 2001 (1). As a result of widespread prostate-specific antigen (PSA) screening, the lifetime risk of a prostate cancer diagnosis is now 16%, whereas the lifetime risk of a prostate cancer death is 3.4% (2), indicating that most men diagnosed with prostate cancer are not destined to die of their disease. In the "PSA era," the difficulty in distinguishing indolent prostate cancers from those destined to cause morbidity or death has resulted in many men who are not destined to die of their prostate cancer being diagnosed and treated aggressively.
Early detection of prostate cancer is controversial because of the absence of randomized trials showing that screening and subsequent aggressive treatment with surgery or radiation reduces mortality, as well as because of the uncertain natural history of prostate cancer. Large, randomized trials of prostate cancer screening are underway in the United States (the Prostate, Lung, Colon, and Ovary Screening Trial) and Europe (the European Randomized Study of Screening for Prostate Cancer), and randomized trials of prostate cancer treatment are also underway in the United States (the Prostate Cancer Intervention versus Observation Trial). A recently published trial of radical prostatectomy versus expectant management from Scandinavia reported a small absolute reduction in prostate-cancer specific mortality with surgery after approximately 6 years of follow-up, but few of the study subjects were diagnosed through screening (3). Meanwhile, advocates of prostate cancer screening cite the recent declines in population-based prostate cancer mortality in the United States (4) as evidence of the effectiveness of prostate cancer screening. However, great caution must be exercised in drawing such conclusions from observational data because alternative explanations exist, as detailed in a three-part series in this journal (5-7).
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POTENTIAL ROLE AND IMPORTANCE OF OUTCOMES RESEARCH FOR THIS CANCER |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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The effect of widespread prostate cancer screening on the psychological health of participants has received only limited attention (8,9), and the net value of mass screening has been questioned (10). Because screening affects a large number of men relative to those who benefit, even a small adverse effect of screening on QOL could carry an effect on public health, outweighing any gain to be achieved by the screening. Outcomes research is needed to evaluate topics such as the potential benefits and harms of prostate cancer screening from the patient's perspective, the barriers to follow-up of suspicious screening tests, and the economic burden of screening.
Men diagnosed with either early or advanced prostate cancer face difficult treatment decisions, because there are various treatment options at each phase of disease, but the optimal treatment for any given stage of disease is unknown. For practical purposes, the phases of care for prostate cancer are broadly grouped as nonmetastatic and metastatic. With nonmetastatic disease there is a gradient of probabilities of extracapsular spread or nodal metastases (11), rather than a sharp distinction, in part because one would need surgical staging to be certain. For metastatic disease, this phase of care can be subclassified as hormone-sensitive or hormone-refractory prostate cancer.
For men with clinically localized prostate cancer, the choices range from aggressive, potentially curative therapy, such as radical prostatectomy, external beam radiation, and brachytherapy, which are all associated with clinically important side effects (12-18), to watchful waiting. Because of the good prognosis of the majority of clinically localized prostate cancers regardless of treatment choice, treatment outcomes, such as the likelihood of experiencing side effects from the various treatments, may be a critical factor for some men faced with a prostate cancer treatment decision (19). Most men treated have a >10-year life expectancy; thus, they have the potential to live many years with the outcomes (i.e., side effects) of therapy. For men with a rising PSA after presumably curative surgery or radiation therapy, the treatment of choice is often androgen deprivation; however, hormonal therapy has yet to be proven effective in this situation, and it is associated with clinically important side effects, as well. Meanwhile, data on the natural history of progression after PSA elevation following radical prostatectomy show that the median time to metastasis is 8 years, and the median time to death once metastases were documented is another 5 years—a relatively long interval between biochemical recurrence and clinical metastatic disease and death (20). Therefore, men weighing their choices of prostate cancer treatment should focus on the quality as well as the quantity of their lives (21).
In this report we review the last decade's published literature regarding the outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The purpose of the review was to enumerate the types of outcome measurement used in the studies, rather than to determine the results of each study. Prostate cancer outcome measures can be applied in a variety of arenas (as noted in this Monograph's "Overview," p. 1-7); however, this article examines their use in descriptive and analytical studies. Thus, the focus of our article is on randomized clinical trials, observational studies, and economic and decision analytic investigations. It does not address the use of outcome measures in prostate cancer population surveillance studies or in clinical practice to improve patient-provider decision-making. The latter two arenas of application are discussed elsewhere in this Monograph.
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METHODS |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Literature Search Strategy
The search strategy used to identify potentially relevant articles is provided below. The search strategy was designed to maximize the specificity of the search. The original search was run on September 1, 1999, and an update search was run on February 14, 2001. Search strategy (MH = MESH heading; MT = major topic):
Quality of life (MH), or
Survival analysis (MT), or
Health status indicators (MH), or
Activities of daily living (MH), or
Decision support techniques (MT), or
Decision making (MT), or
Choice behavior (MT), or
Medical futility (MT), or
Economics (MT), or
Costs and cost analysis (MT), or
Economic value of life (MT), or
Economics, hospital (MT), or
Economics, nursing (MT), or
Economics, pharmaceutical (MT), or
Health services research (MH), or
Delivery of health care (MT), or
Attitude to death (MT), or
Attitude to health (MT), or
Health services needs and demand (MT), or
Needs assessment (MT), or
Professional-patient relations (MT), or
Quality of health care (MT), or
Medical audit (MT), or
Nursing audit (MT), or
Outcome and process assessment (health care) (MT), or
Peer review, health care (MT), or
Professional review organizations (MT), or
Program evaluation (MT), or
Quality assurance, health care (MT), or
Guidelines (MT), or
Total quality management (MT), or
Quality indicators, health care (MT), or
Utilization review (MT),
And Prostatic Neoplasms,
And English language,
And Journal article,
And 1990-1999 (August); update was done for 8/99-2/01
And Abstract present
Each retrieved article was reviewed by one of the authors. Articles were included in the overview if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened or treated for prostate cancer (review papers were excluded unless they were quantitative syntheses of the results of other primary studies). Reasons for exclusions were enumerated. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts.
Summary Descriptions of Articles Identified, Retrieved, and Reviewed
The search strategy identified 397 potentially eligible papers (297 from the original search and 100 from the update search). All 397 papers were retrieved. After review of the retrieved papers, 198 were included in the overview and 199 were excluded. A table reporting summary information for each of the included papers is provided as Appendix 1. Reasons for exclusion for the remainder of the papers are provided in Table 1. Each paper was also identified as pertaining to prostate cancer screening or prostate cancer treatment. Overall, 54 of 397 papers were categorized as screening papers, and seven met the criteria for inclusion in this review. The most common reason for exclusion of a screening paper was because it reported solely on baseline knowledge or attitudes regarding prostate cancer screening, but not on QOL outcomes (n = 21). The second most common exclusion was for lack of an appropriate patient-centered outcome (i.e., only laboratory values or test results may have been presented; n = 16).
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Data Abstraction Technique
A data abstraction form was developed, pretested, revised, and finalized for this study. For papers excluded after review, only the reason or reasons for the exclusion were recorded. Each included paper was assigned one primary, mutually exclusive study design: randomized trial, nonrandomized trial, cohort study, case-control study, cross-sectional study, meta-analysis, decision modeling, cost-identification study, cost-effectiveness study, or cost-benefit study. We then abstracted different information for the first six design categories (generally presenting primary data on actual patient outcomes, the "primary data" studies) and the last four categories (the "economic and decision analytic" papers, usually presenting outcomes data on hypothetical patients).
For the primary data papers, available information was abstracted on the care setting, dates of the study, racial distribution of the study population, mean or median age, and total sample size. Distributions of tumor differentiation (well, moderate, or poor) and cancer stage were also abstracted when presented, and whether survival was reported was noted. For those papers included from the update search, whether statistical power and clinical importance of observed differences were discussed, and whether confidence intervals were provided around point estimates of measured outcomes, was also noted. Finally, all patient-centered outcome measures were enumerated. The measures included single and multi-item patient questionnaires, addressing different aspects of the effect of prostate cancer screening and treatment on the lives of men. Reviewers were provided a menu of standard published health-related QOL (HRQOL) questionnaires used in prostate cancer outcome studies and could record an unlimited number of additional outcome measures for each study. Reviewers also indicated whether, using their best judgment, these questionnaires were primarily addressing overall HRQOL, cancer-specific HRQOL, prostate cancer-specific HRQOL, patient satisfaction, risk-based utilities for different health states, or other domains.
For the economic and decision analytic papers, available information was abstracted on stage of disease (localized or metastatic), age range, outcomes (survival and quality-adjusted survival), costs, and whether utilities were measured. For utilities, whether patients or proxies completed utility assessments was reported.
Statistical Analysis
Completed abstraction forms were entered into an Access database and imported into SAS (SAS Institute, Cary, NC) for analysis. Trends in the proportion of papers using standard HRQOL measures and presenting age and race data were assessed with the chi-square test for trend (22).
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RESULTS |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Distribution of Study Designs for Included Papers
Of the 198 included papers, there were 161 (81%) "primary data papers" categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The 37 "economic and decision analytic papers" consisted of 17 decision modeling studies, 13 cost-identification studies, and 7 cost-effectiveness studies (Table 2).
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Characteristics of Study Populations
Information on the study populations in the primary data papers was often incomplete. Dates of data collection were missing 40% of the time.
Age and Race
Of the 161 primary data studies, 28 (17%) did not report the age of their subjects. The median value of the mean/median ages of the studies reporting this variable was 68 (interquartile range = 67-71). Only 53 (33%) of the 161 studies described the racial distribution of the study populations, although a number of the studies that did not provide a racial distribution were from countries with fairly homogenous populations. Fifty papers provided a proportion of whites in the study population (median proportion = 88%), 38 papers provided information on blacks (median proportion = 11%), 16 papers provided information on Hispanics (median proportion 3.4%), and 6 papers provided a proportion of "other" races (median = 1.3%). Although prostate cancer has a higher incidence and mortality among African Americans, only eight studies (23-30) had a preponderance of black subjects, and the sample sizes of these studies were limited (range of number of African American subjects, 42-132). The study with the largest sample size of African American men was a screening study with 51% white men and 44% African American men (n = 415). (31)
Tumor Stage and Grade
Almost one-quarter (24%) of primary data studies did not include stage of disease, and another 4% reported incomplete data. More than three-quarters (77%) of these papers did not report tumor grades. Of those papers that reported information on grade distribution, the median proportion of poorly differentiated tumors was 22%, moderately differentiated tumors was 53%, and well-differentiated tumors was 19.5%. Not all papers reported on all categories.
Sample Size and Power Calculations
The median sample size for the 161 primary data studies was 125.5 (interquartile range = 58-281). The smallest study (32) was a study of six men with metastatic prostate cancer who were treated with strontium chloride Sr 89 for their painful bone metastases, and whose clinical response was determined by a series of clinical notes and patient observations which might generally reflect QOL, although no details of the assessment were given. The largest study (33) was a comparison of prostate cancer treatment practices and 10-year survival outcomes in health maintenance organization and fee-for service populations. Of the 43 primary data studies reviewed after the updated search, nine (21%) discussed statistical power (33-41), six (14%) discussed the clinical importance of observed differences (34,37,38,42-44), and eight (19%) reported confidence intervals (33-35,37,38,41,45,46). These three variables were not included in the abstraction form for the original search.
Care Setting
The care settings for the 161 primary data papers were categorized as follows: single institution (n = 82), multi-institution (n = 65), community-based (n = 7), health maintenance organization or managed care (n = 1), large U.S. population-based database (Medicare; Surveillance, Epidemiology, and End Results; n = 3), and miscellaneous (n = 3; patients from a prostate cancer support group [n = 1], meta-analysis of Medline papers [n = 1], and not reported [n = 1]).
Type of Outcome Measured
Of the 161 primary data papers, survival was reported in 55 (34%) of reviewed papers; 12 papers reported survival data alone (33,45-55). Of note, there are likely to be survival papers that were not included in our review, because of the specifications of our search strategy. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard). Three papers included seven outcome measures (27,56,57), and one included nine (58). Table 3 shows the types of outcomes measured and the number of papers using the various types of outcome measures.
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Specific Instruments Used by Type of Outcome Measured
Table 4 shows the specific instruments used within each outcome type and the number of uses of the various instruments among the 149 primary data papers measuring outcomes other than survival. The SF-36 was the most commonly used QOL-generic instrument, the EORTC QLQ-C30 was the most commonly used QOL-cancer specific instrument, and the UCLA-PCI was the most commonly used QOL-prostate cancer specific instrument.
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There were no standard measures of satisfaction used, although 12 papers mentioned that satisfaction was measured in some way. One paper (27) used an "Attitudes towards care questionnaire" adopted from the 43 item patient satisfaction questionnaire used in the Medical Outcomes Study. Of the remaining 11 papers that measured satisfaction, six used a general question about overall satisfaction with treatment (56,57,59-62), and six asked a question about whether the patient would choose the treatment again (56,57,59,60,62,63). Two studies asked a single question about whether the patient would recommend a treatment to someone else (64,65), and two studies asked about patients' confidence in their doctors (59,62). One paper stated that patients were asked about their satisfaction with the information their physicians presented and about their satisfaction with the treatment options they received (26).
Among the 37 economic and decision analytic papers, 13 measured some or all costs directly (66-78), and 14 used estimated costs either in combination with actual measured costs or alone (66,67,70,72,74,78-86). One primary data paper included a measurement of costs, using actual economic costs as well as charges and estimates (87).
There were five primary data papers that measured utilities (23,24,27,40,88). The utility assessment methodologies included were time trade-off (n = 5) (23,24,27,40,88), standard gamble (n = 1) (27), Health Utility Index (n = 1) (40), and analog (40) or rating (27) scales (each used once).
Among the 37 economic and decision analytic papers, 16 papers measured patient utilities. These studies included two that measured utilities directly from patients (67,89), 11 that used proxies to measure utilities (72,78,80,90-97), and one that used both methods (98). Two papers did not supply enough information to allow determination of whether the utilities were obtained from patients or proxies (79,99). Of the three that included utilities measured directly from patients, two used time trade-off assessments (89,98) and one a QOL scale transformation using a previously published technique (67). Of the 12 papers that used proxy utility measurements, eight used time trade-off (72,80,90-93,96,98), one used a trade-off measurement of survival versus potency (95), two calculated their utility measurements (78,97), and one used an instrument called the Kaplan-Anderson Well-Being Scale (94).
Phase of Care
Table 5 shows the number of papers that examined patients in various phases of prostate cancer screening and treatment by study design. There were seven screening papers, two prospective cohort studies (31,100), and five economic and decision analytic studies (72,81,90,94,96). Forty-five papers (23%) did not provide data or provided incomplete data on cancer stage, making an assignment of phase of care impossible (31 [49%] cross-sectional studies, 10 [18%] cohort studies, two [7%] randomized trials, one [50%] meta-analysis, and one [8%] cost-identification study). Among treatment papers, studies of patients with nonmetastatic disease (65 papers) were more common than studies of patients with metastatic disease (49 papers) or both (32 papers).
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Time Trends Across the Decade for Use of Standard HRQOL Instruments, Age, and Race
To assess time trends from 1990 to 2000 (11 years), the primary data papers were grouped by publication date into three time periods: 1990 to 1993, 1994 to 1997, and 1998 to 2000, representing the early, middle, and late years of the decade. Table 6 shows a non-statistically significant trend toward more frequent use of standardized HRQOL instruments over the 11-year time frame, no trend toward more frequent reporting of age, and a statistically significant trend toward increased reporting of at least some information on race (P = .003).
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DISCUSSION |
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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Strengths and Limitations of Prostate Cancer Outcomes Research to Date
Strengths of the literature. There are a number of published, validated prostate cancer-specific HRQOL indices, and as can be seen in Table 4, these measures were used in many of the studies included in our review. Also, over time, standard HRQOL instruments tended to be used more frequently, although this trend was not statistically significant. Finally, there was a statistically significant trend over the decade toward improved reporting of basic demographic information, such as race.
Limitations of the literature. The recent literature describing the outcomes of prostate cancer screening and treatment is flawed in many respects. First, many studies relied on unvalidated instruments, despite the availability of published, validated measures. Second, when validated instruments were used, studies did not use the same ones. Thus, the heterogeneity in outcomes measures made it almost impossible to compare results across studies. Third, very few studies examined patient-centered screening outcomes. Fourth, relatively few randomized trials addressed treatment options for men with advanced disease. Fifth, non-experimental studies tended to be cross-sectional in nature, lacking data on subjects' baseline demographics and condition before diagnosis and treatment, and not allowing assessment of how prostate cancer patients' qualities of life evolve over time. This problem is particularly important, because many prostate cancer patients, even those men with advanced disease, survive for years.
Limitations of this Systematic Review
The search strategy was developed favoring specificity, perhaps at the expense of some sensitivity. A broader search strategy might well have identified additional papers with patient-centered outcomes data from patients screened or treated for prostate cancer. However, it is likely that the papers we identified, which were specifically categorized as having relevant outcomes data in Medline, are representative of the body of literature we did not identify.
Recommendations for Outcomes Measurement in Prostate Cancer
In general, the message to the research community interested in prostate cancer screening and treatment outcomes is clear. First, there needs to be consensus on which validated instruments, both generic and disease-specific, should be regarded as the gold standard for measuring prostate cancer screening and treatment outcomes, and then this core set of questions should be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how men screened and treated for prostate cancer are doing over time.
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NOTES |
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See "Note" following "References."
This work was supported by contracts from the National Cancer Institute, National Institutes of Health. Dr. McNaughton-Collins is a recipient of a Doris Duke Clinical Scientist Award.
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TopNotesAbstractIntroductionBackground on Prostate CancerPotential Role and Importance...MethodsResultsDiscussionReferences |
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