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Quality-of-Care Indicators for Early-Stage Prostate Cancer

Benjamin A. Spencer, Michael Steinberg, Jennifer Malin, John Adams, Mark S. Litwin

From the RAND Health Science Program, Santa Monica, CA; the Veteran’s Administration/Robert Wood Johnson Clinical Scholars Program, Los Angeles, CA; and the Departments of Medicine, Urology, and Health Services, University of California, Los Angeles, CA.

Address reprint requests to Mark S. Litwin, MD, MPH, University of California, Los Angeles, Department of Urology, Box 951738, Los Angeles, CA 90095-1738; email: mlitwin{at}mednet.ucla.edu.

	ABSTRACT

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Purpose: Decisions regarding treatment for early-stage prostate cancer are frustrated not only by inadequate evidence favoring one treatment modality but also by the absence of data comparing quality among providers. In fact, the choice of provider may be as important as the choice of treatment. We undertook this study to develop an infrastructure to evaluate variations in quality of care for men with early-stage prostate cancer.

Methods: We enlisted several sources to develop a list of proposed quality-of-care indicators and covariates. After an extensive structured literature review and a series of focus groups with patients and their spouses, we conducted structured interviews with national academic leaders in prostate cancer treatment. We then convened an expert panel using the RAND consensus method to discuss and rate the validity and feasibility of the proposed quality indicators and covariates.

Results: The panel endorsed 49 quality-of-care indicators and 14 covariates, which make up our final list of candidate measures. Several domains of quality are represented in the selected indicators, including patient volume, pretreatment referrals, preoperative testing, interpretation of pathology specimens, and 10-year disease-free survival. Covariates include measures of case-mix, such as patient age and comorbidity.

Conclusion: This study establishes a foundation on which to build quality-of-care assessment tools to evaluate the treatment of early-stage prostate cancer. The next step is to field-test the indicators for feasibility, reliability, validity, and clinical utility in a population-based sample. This work will begin to inform medical decision-making for patients and their physicians.

	INTRODUCTION

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ADENOCARCINOMA OF the prostate is the most common malignancy in American men, and its diagnosis and treatment are estimated to cost almost $2 billion per year.¹ With the advent of widespread screening, more than half of new cases are detected at a potentially curable stage. The most common treatment options for men with early-stage prostate cancer are radical prostatectomy and radiation therapy. Although much of the literature on prostate cancer has focused on the choice among modalities, no studies have assessed how men select a particular provider or institution. Indeed, little is known about variation in care among providers or even about which variables should be examined. However, such information is crucial to patients when they are deciding where to be treated for early prostate cancer.

Quality-of-care research evaluates "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."² Several initiatives are under way to collect and disseminate performance information about medical care. For example, the National Committee on Quality Assurance provides information to health care purchasers about the comparative performance of health plans in the United States. The Joint Commission on the Accreditation of Healthcare Organizations applies outcomes-based quality measures to accredit hospitals.³ The Foundation for Accountability, a consumer organization, "creates tools that help people understand and use quality information, develops consumer-focused quality measures, supports efforts to gather and provide quality information, and encourages health policy to empower and inform consumers."⁴ Among the more than 200 performance indicators collected in the National Library of Healthcare Indicators, none addresses prostate cancer treatment. RAND’s Global Quality Assessment Tool includes the only published quality measures for prostate cancer; however, they primarily address the management of metastatic disease.⁵

Against a backdrop of frustrated patients searching for guidance in making treatment decisions, we undertook this study to elucidate the components of high-quality care among providers of radical prostatectomy and external beam radiotherapy for men with early-stage prostate cancer. We used the conceptual framework established by Donabedian.⁶ In this model, quality-of-care measures are categorized into three domains—structure, process, and outcome. Structure of care includes the equipment, resources, and provider experience necessary to provide care. Examples include volume of cases or board certification of providers. Process of care refers to technical and interpersonal elements of care that transpire between doctor and patient, such as the extent of the history and physical examination, documentation of the work-up, and ordering of diagnostic and laboratory tests. Process measures are often considered to be the best measure of quality.⁷ Outcomes include survival rates, complications, and patient-centered outcomes, such as health-related quality of life.

To measure compliance rates with quality indicators across providers, patients must be comparable. Hence, we also developed a list of covariate measures to risk-adjust for differences in case-mix.

	METHODS

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Literature Review
To identify proposed quality-of-care indicators, we performed an extensive literature search. We looked for previous studies that assessed elements of structure, process, or outcomes of care for the two primary treatment modalities, radiation and surgery. Using MEDLINE, we obtained indexed scientific articles published between 1980 and 1997 that included reports of single- or multi-institutional series of localized prostate cancer treatment. The radiation therapy search was limited to articles from 1985 to 1997 to reflect more recent practices. The searches included all articles in English indexed by the Medical Subject Heading subjects "prostatic neoplasms" and "therapy"/"surgery" or "treatment"/"surgery" or "prostatectomy" or "radiotherapy." In addition, the selected articles included one of the following subject headings: "treatment outcome," "outcome assessment," "treatment failure," "recurrence," "outcome and process assessment (health care)," "process assessment (health care)," "mortality," "quality of health care," or "quality of life." Articles primarily addressing transurethral prostatectomy or prostate cancer screening were omitted. The articles were supplemented with additional studies as they became available. We reviewed and abstracted data on the study population, processes of care, treatment, outcomes, and other relevant variables and entered the data into a spreadsheet. The level of evidence was determined for each study according to the Canadian Task Force rating system as follows: level I, randomized, controlled clinical trial; level II, nonrandomized, controlled clinical trial, cohort or case-control study, or multiple time series; and level III, expert opinion.⁸ Each indicator was given a rating based on the best study supporting its validity.

Focus Groups
To understand better what information was available and what additional information would have been helpful to patients and their families when they made treatment decisions, we held three focus groups, which comprised patients who had recently undergone radical prostatectomy, patients who had recently undergone radiation therapy, and spouses of surgery or radiation patients. Twelve practices in the Los Angeles metropolitan area were contacted and asked to invite patients and spouses to participate in the study. We sought to recruit participants who were diverse in ethnicity, age, socioeconomic status, education, employment and insurance status, and participation in prostate cancer support groups. Patient eligibility criteria included treatment for localized prostate cancer with surgery or radiation completed 6 to 12 months before the focus groups, English fluency, and availability on selected dates. Thirty participants (10 in each focus group) were enrolled from nine different practices. Written, informed consent permitting the focus groups to be audio- and videotaped was obtained from participants. A nonclinical, sex-concordant moderator was selected to facilitate the sessions.

Expert Interviews
Using the list of variables extracted from the literature review, we developed a detailed structured interview to probe prostate cancer experts on their beliefs about the importance of these variables to patients’ quality of care and outcomes. To select the experts, we contacted the major professional organizations in urology (American Urological Association) and radiation oncology (American College of Radiology and American Society of Therapeutic Radiation Oncology) to enlist their support and request nominations. Each society submitted a list of nationally recognized clinicians with expertise in treating patients with localized prostate cancer. From the nominated experts, we identified candidates for the expert interviews on the basis of geographic diversity, training, and clinical approaches. Two members of the research team conducted 14 expert interviews in person over 6 months. Each interview was audiotaped, transcribed, and analyzed for content. This information was used to supplement the pool of proposed quality-of-care indicators and covariates that were obtained from the literature.

Expert Panel
On the basis of the literature review, patient focus groups, and expert interviews, a list of proposed quality indicators and covariates was developed. From the remaining pool of identified prostate cancer experts, we then convened an expert panel of 11 clinicians and researchers from the fields of urology (three members), radiation oncology (three members), medical oncology (three members), and health services research (two members). The two nonclinical members of the panel were selected for their expertise in measurement of prostate cancer outcomes. A modified Delphi method, previously developed at RAND to assess appropriate care, was used by a panel of 11 experts to evaluate the validity and feasibility of the proposed quality-of-care indicators.^9–11 This approach asked panel members to, first, review summaries of the prostate cancer literature review, focus groups, and expert interviews; second, review proposed quality indicators and covariates; third, provide initial ratings on the validity and feasibility of the measures as indicators of high-quality care for the treatment of localized prostate cancer; fourth, meet to discuss these indicators and covariates; and fifth, provide revised ratings after these discussions. Steps 1, 2, and 3 occurred before the panel meeting, and panel members provided the initial rankings independently. Steps 4 and 5 took place during the panel meeting held at RAND.

Panel members spent 10 to 45 minutes discussing each indicator. At least one panelist from each discipline (urology, radiation oncology, medical oncology, and health services) discussed the merits of each indicator. Each indicator was discussed and rated in isolation; there was no limit on the number of potential indicators, and participants did not have to choose one indicator over another. Panelists were encouraged to cite evidence from the literature and clinical experience to support their discussion. After all of the proposed indicators in each section (structure, process, outcome, and covariates) were discussed, panelists rated their validity and feasibility. Although the list of proposed indicators and covariates was finite, the panelists were encouraged to present modifications and even suggest entirely new ones. Panel members were asked not to provide assessments of the comparative efficacy of any treatment modality.

Expert Panel Ratings of Validity and Feasibility for Proposed Indicators and Covariates
During the initial round, panel members were asked to rate 59 proposed measures, including 10 structure, 27 process, and 13 outcome measures of quality and nine covariates. They used a nine-point scale to assess the clinical validity of the quality measures and the feasibility of obtaining data from the medical record. A proposed quality indicator or covariate was considered valid if adequate scientific evidence or professional consensus supported the indicator and if, on the basis of the panelists’ professional experience, physicians with significantly better performance as measured by the indicator would be considered higher-quality providers. Ratings of 1 to 3 meant that the indicator/covariate would not be a valid measure for evaluating quality, ratings of 4 to 6 meant that the indicator/covariate would be an uncertain or equivocal measure, and ratings of 7 to 9 meant that the indicator/covariate would be a clearly valid measure.

A proposed quality indicator/covariate was considered feasible if, first, the information necessary to assess the measure could be found in a medical record, a cancer registry, a patient-administered validated instrument, or other systematically recorded data; second, recorded information about the measure was likely to be reported reliably; and third, failure to document relevant information about the measure would be, itself, a marker of poor quality. Ratings of 1 to 3 meant that it would not be feasible to use the indicator/covariate to evaluate quality, ratings of 4 to 6 meant that there would be considerable variability in the feasibility of using the measure, and ratings of 7 to 9 meant that it would be clearly feasible to use the measure. Table 1 shows an example of a rating form.

To determine whether agreement existed, we tested the hypothesis that 80% of the hypothetical population of repeated ratings were within the same region (1 to 3, 4 to 6, or 7 to 9) as the observed median rating. If we were unable to reject that hypothesis on a binomial test at the 0.33 level, the indication was rated "with agreement." For indicators with 11 ratings, this definition of agreement required that no more than three of the ratings be outside the three-point region containing the median. For items with fewer than 11 ratings (eg, if one of the raters chose not to rate an item), agreement required that no more than two of the ratings be outside the three-point region containing the median.

To determine whether disagreement existed, we tested the hypothesis that 90% of the hypothetical population of repeated ratings were within one of two wider regions (1 to 6 or 4 to 9). If we rejected that hypothesis on a binomial test at the 0.10 level, the indication was rated "with disagreement." For items with eight to 11 raters, this definition of disagreement was satisfied when three or more ratings were in the 1 to 3 region and three or more were in the 7 to 9 region. These definitions are equivalent to those from previous studies that used similar expert panel methods.^10,11 A more detailed description of the study methodology and results can be found at the RAND Web site (http://www.rand.org/publications/MR/MR1227/).¹³

	RESULTS

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Final List of Candidate Quality Indicators
Table 3 presents the list of candidate quality-of-care indicators and covariates that the experts retained, along with the ratings for validity and feasibility, the level of literature evidence for each indicator/covariate, and whether the indicator/covariate was treatment-modality specific. An appendix, available online at www.jco.org, lists the quality-of-care indicators and covariates that were rejected by the panel, along with ratings, level of evidence, and treatment-modality specificity.

Process Indicators
The panel endorsed 23 of 40 process indicators, including pretreatment work-up assessments such as clinical stage, total prostate-specific antigen (PSA), and Gleason grade, as well as evidence of documentation of baseline voiding patterns, potency, bowel function, the presence or absence of a family history of prostate cancer, and an assessment of the presence of serious comorbidity. Indicators related to patient counseling were also endorsed. These included discussion of alternative treatment modalities, treatment outcomes based on the provider’s own practice experience, opportunity to consult with other specialists, communication with the patient’s primary care provider, and at least two follow-up visits with the treating physician in the first year after treatment.

Adherence to the College of American Pathologists (CAP) guidelines for managing pathology specimens and use of the tumor-node-metastasis staging system were endorsed as process indicators of quality. Use of computed tomography (CT) scans in both standard and conformal external beam radiation treatment planning was endorsed as a candidate process quality indicator, whereas magnetic resonance imaging (MRI) was not. Assessment of target motion was also not endorsed for either type of radiation. Other radiation therapy process indicators included dose recommendations specific to standard or conformal treatment, use of a high-energy accelerator, and patient immobilization for both forms of radiation. Operative blood loss was endorsed as the only surgery-specific process indicator. Other measures, such as surgical approach, use of a nerve-sparing method, and operative time, were not recommended as quality indicators.

Outcome Indicators
Panel members endorsed 16 of 23 clinical and patient-reported outcomes as potential indicators of quality. These included biochemical failure documented by PSA (with different protocols for assessing failure in postsurgical and postradiation patients) and posttreatment local recurrence as documented by biopsy. Urinary, sexual, and bowel functioning after treatment—reported by patients, not physicians, using a validated survey instrument—were endorsed by the panel. Other outcome measures recommended as clinically valid and feasible were acute surgical complication rates; additional medical treatment for radiation and surgical complications; 5-, 10-, and 15-year disease-free survival and 10- and 15-year overall survival; patient-reported satisfaction with treatment choice, continence, and potency; and, for surgery, length of hospital stay. The panel excluded indicators such as clinical local control, 5-year overall survival, positive surgical margins, perineural invasion, and patient satisfaction with the doctor.

Covariates for Case-Mix Adjustment
The panel endorsed 14 of 15 proposed covariates as important measures to control for when comparing outcomes across providers. The single exclusion was race (black); panel members did not believe that the literature provided clear evidence that differences in outcomes by race were not attributable to other clinical factors, such as stage at diagnosis.

	DISCUSSION

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The experts universally mentioned patient volume and knowledge of treating institution outcomes for both surgery and radiation as the two most important potential quality indicators. This is supported by evidence from other procedures; patient volume has long been associated with outcomes after carotid endarterectomy, coronary artery bypass grafting, resection of abdominal aortic aneurysm, partial gastrectomy, and colectomy.^14–16 Most recently, Birkmeyer et al¹⁷ confirmed the volume-outcome relationship for 14 surgeries, including cystectomy and nephrectomy.

The relationship between patient volume and treatment outcomes in prostate cancer is supported by three recent studies. Yao and Lu-Yao¹⁸ showed that high-volume hospitals ( 75th percentile in 1991 to 1994) had more favorable surgical outcomes after radical prostatectomy (reduced mortality, complication, and readmission rates) and shorter lengths of stay (one of our outcome measures) than low-volume facilities (< 25th percentile in 1991 to 1994). In a similar analysis, Ellison et al¹⁹ showed that, after adjusting for age and case-mix, in-hospital mortality and length of stay were inversely related to surgical volume. Begg et al²⁰ demonstrated that both hospital and surgeon volume were inversely proportional to postoperative mortality and urinary complications.

The panel endorsed the availability of three-dimensional conformal radiation therapy as another potential indicator of high quality. This technology may provide equivalent or better cancer cure with significantly lower morbidity than standard external-beam radiation therapy.^21,22 However, a recent critical review noted that the initial enthusiasm for conformal radiation therapy may be premature and that longer follow-up is needed to affirm these findings.^23–25

The panel recognized that some indicators did not have extensive literature to support their validity; nevertheless, it selected them on the basis of clinical experience. Structure indicators included the availability of psychologic counseling, board certification of providers, and tracking of institutional outcomes. Patients’ experiences could be significantly affected by the opportunity to speak with a mental health professional to verbalize concerns and adjust expectations regarding the treatment. Although board certification has not been shown to correlate explicitly with good quality, requirements such as training in United States residency programs and passing written and oral examinations may provide a minimum quality standard.

An institution that tracks its outcomes does not necessarily practice better-quality medicine. Rather, the assumption is that awareness of one’s successes and failures leads to a process of continuous quality improvement.

The panel selected several process variables as quality indicators. Among these were the documentation of pretreatment evaluation (digital rectal examination, serum PSA, clinical stage, pathologic grade, and family history); assessment of pretreatment sexual, urinary, and bowel function; and documentation of a broad informed consent, including potential complications and the opportunity to discuss alternative treatments with other specialists. Numerous studies have demonstrated age, PSA, clinical stage, and Gleason grade to be the strongest predictors of outcome. Digital rectal examination, however, may lead to understaging.^26–30 Great progress has been made by synthesizing and operationalizing these data into treatment nomograms, which enable clinicians to input patient-specific data to predict the probability of organ-confined disease, extraprostatic extension, and seminal vesicle and pelvic lymph node status, all of which affect treatment decisions.^31–33

Two studies^34,35 have demonstrated an inverse relationship between comorbidity and radical prostatectomy. Using several comorbidity indices, Froehner et al³⁴ found a trend toward more cardiovascular complications with worsening comorbidity among patients younger than 70 years of age. Although only 16% of patients in a study by Dillioglugil et al³⁵ were assigned to American Society of Anesthesiologists class III, they accounted for all deaths, a threefold increase in major complications (one of our outcomes measures), a longer length of stay (another of our outcomes measures), and more frequent intensive care unit admissions and blood transfusions. Operative blood loss (one of our process measures) was also statistically significantly associated with major complications. In addition, Albertsen et al³⁶ have demonstrated the importance of adjusting survival data for comorbid disease. They retrospectively applied three generic comorbidity indices to patients with localized prostate cancer and found the comorbidity scores to be significant predictors of survival. Because case-mix varies significantly among institutions, the provider must adjust outcomes for patient comorbidity for accurate predictions of outcomes.

Kupelian et al³⁷ found that a family history of prostate cancer predicts treatment failure after radiation therapy or radical prostatectomy, even after controlling for patient age, pretreatment PSA, Gleason grade, clinical stage, and treatment modality. Again, this variable should be considered when risk is assessed.

An important development in the management of prostate cancer was the recognition of the importance of quality of life when counseling patients on treatment options; this has become the standard of care. During our interviews, we found that pretreatment urinary, bowel, and sexual function are most commonly assessed by patients’ verbal reports and rarely with validated instruments. Because patients tend to underreport their symptoms and physicians minimize the severity of symptoms, both Litwin et al³⁸ and Talcott et al³⁹ have advocated the routine use of validated instruments. However, Wei and Montie⁴⁰ demonstrated that the correlation between patient and physician assessment of urinary incontinence might improve by having patients report urinary bother and incontinence pad use. Although there are several validated instruments to measure urinary, bowel, and sexual function, none has achieved widespread acceptance as a standard in clinical practice.^41–44

A corollary to the discussion of quality of life is the process of informed consent for treatment. Although no evidence specifically indicates that better treatment outcomes result, a full discussion of the treatment options and risks is an ethical and legal responsibility. Patients increasingly want to know what side effects and complications to expect after treatment.

Continuity of care has been demonstrated to improve clinical outcomes in general medical practice but has never been evaluated in the treatment of prostate cancer.^45–47 Nevertheless, the panel endorsed follow-up visits with the treating physician and continuing care or communication with the primary care provider as indicators of high quality. In some health plans, a physician other than the operating urologist assumes the long-term management. Failure of communication between providers can lead to poorer quality of care. If the number of urologists declines in the next several decades,⁴⁸ primary care physicians may assume a larger role in the management of prostate cancer patients; hence, physician communication may become even more important.⁴⁸

The panel selected many technical parameters related to radiation, but not to surgery. This indicates that great variation exists in radiation practice patterns or that technology is progressing more quickly than its adoption. The indicators will be able to identify such trends. Process indicators relating to the delivery of radiation therapy included the following: for both conventional and conformal radiation therapy, use of CT during treatment planning, patient immobilization during treatment, and use of a high-energy linear accelerator ( 10 MV); for conventional radiation therapy, delivering recommended doses (68 to 72 Gy isocenter [International Commission on Radiological Units]); and for conformal radiation therapy, delivering escalated doses (70 to 80 Gy [International Commission on Radiological Units]) and appropriately protecting the rectal mucosa. Hanks et al⁴⁹ found that conformal radiation therapy resulted in fewer Radiation Therapy Oncology Group grade 2 toxicities than did conventional radiation therapy. However, high-dose conformal treatment may result in an increased risk of severe rectal bleeding; appropriate shielding of the rectal mucosa is recommended to reduce this risk.^50,51 Because the prostate may have considerable movement within the body, patient immobilization and assessment of target motion have been recommended for radiation treatment.^52–54 The panel chose CT over MRI for conformal treatment planning, despite a single study indicating that MRI is more accurate than CT for prostate localization.⁵⁵

The panel endorsed an indicator for the management of pathology specimens, as recommended by the CAP Cancer Committee.⁵⁶ It also endorsed the use of the tumor-node-metastasis staging system, which was recommended by CAP and the World Health Organization.⁵⁷ Although adherence to the CAP guidelines varies significantly, it was shown to be best for margin status (96%) and Gleason grade (97%) and worst for periprostatic fat status (15%).⁵⁸ If a Gleason score were missing from a pathology report, a high-quality physician would likely ask the pathologist; however, the absence of periprostatic fat status in the report might not elicit the same response. Lacking this information could impair further treatment decisions. Whether such adherence improves patient outcomes is unknown.

Outcome measures typically represent the bottom line to patients. Because of the prolonged natural history of prostate cancer, the success of its treatment must be judged at several end points over the course of decades. Results during the treatment include intraoperative blood loss and radiation proctitis. Short-term end points include biochemical failure, complications such as pulmonary embolus, health-related quality of life, and patient satisfaction. Long-term end points include complications such as urethral stricture, biochemical and disease-free survival, and health-related quality of life. The panel selected all of these as relevant outcomes that can be abstracted from patient records.

Although the panel noted continued controversies over the threshold, sensitivity, timing, and number of increasing values for PSA to corroborate treatment failure, all agreed that PSA was an objective and valuable predictor of clinical disease recurrence, even if it serves only as a marker for early failure.⁵⁹ The American Society for Therapeutic Radiology and Oncology’s consensus guidelines for PSA in postradiation therapy surveillance⁶⁰ recommend that biochemical failure be defined as three consecutive increases in PSA after the nadir.⁶⁰ However, this indicator is not intended to be a surrogate for clinical progression or survival, nor is it meant by itself to indicate the need for additional treatment. For surgical outcomes, a detectable PSA may correlate with the risk of recurrence; however, a similar guideline for uniform outcomes reporting has not been developed. Posttreatment PSA protocols will become increasingly uniform, yet even in their present state, they represent the standard of care. Approximately one fourth of Medicare patients undergoing radical prostatectomy receive further cancer treatment after the surgery, further supporting the importance of routine posttreatment follow-up for radical prostatectomy patients.⁶¹

The American Urological Association has endorsed the assessment of patients’ quality of life.⁶² Because clinicians’ assessments of patient functioning may differ sharply from the patients’ own assessments, patient-reported functional status and quality of life may provide additional information about the results of treatment.^38,43,63

Although they are not indicators of quality of care, covariates represent potential confounding or effect-modifier (stratifying) variables that should be used to control for differences among patients, providers, or locations when outcomes are compared. Among the endorsed covariates were clinical stage, Gleason grade, pretreatment PSA, and general indicators such as the presence of comorbidities, family history, and patient age.

With a population-based sample of patient records, a study to field-test the candidate indicators for feasibility, reliability, and validity is the next step. First, the indicators would need to be operationalized and organized into a chart abstraction tool to collect the data relevant for determining indicator compliance. The feasibility of these indicators would be evaluated by determining whether data could be obtained from available sources, such as medical records, patient self-report, claims, and other administrative data. The reliability of the data would be evaluated in terms of test-retest reliability and validity of data sources. Finally, a field test would determine whether adherence to structure and process indicators was associated with improved outcomes. The utility of our proposed covariates would also be assessed when they were used to adjust for case-mix.

With this study, we hope to increase awareness of the value of quality indicators in health care and hope that such awareness will encourage more uniform practice and improve provider documentation of medical care. It may also motivate those not keeping up with the literature and emerging trends in prostate cancer treatment to do so.

In conclusion, this study provides an infrastructure to begin rigorously evaluating indicators of quality of care in the management of localized prostate cancer. The indicators provide a wide-ranging list of measures that warrant further study. It is important to determine whether the proposed quality indicators are associated with clinical outcomes; such an association would establish the indicators as predictors of high-quality care. The proposed indicators represent the synthesis of several data sources that were carefully analyzed by a panel of leaders in the field of prostate cancer. The indicators represent waypoints or landmarks that the high-quality practitioner might pass along the route to successful patient outcomes.

This work has practical applications. For instance, radical prostatectomy is one of the index cases required for board certification in urology. The indicators could be used to evaluate a candidate for board certification by abstracting records to provide a more objective and comprehensive evaluation than the current system of implicit case review. Quality indicators can also be used to create a report card to compare care among individual providers or hospitals. The data can be made available publicly to help patient consumers make better-informed health care decisions.

Our study has several limitations. First, the lack of level I and II evidence for the treatment of localized prostate cancer undermines the development of evidence-based recommendations. Our research team examined extensive level III evidence and selected what we believed to be the best articles. This subjective process had the a priori effect of limiting the pool of measures subsequently proposed for discussion with the experts. A different research team or expert panel might have developed a different list of candidate indicators. It is important to remember that one of the purposes of convening this panel was to identify highlights from the existing literature. If more randomized, controlled trials were available, an expert panel might not have been necessary because the available evidence alone would have provided a framework for measuring quality of care. However, relying solely on existing literature also has the effect of limiting the potential pool of indicators by excluding areas that have not undergone randomized, clinical trials. Notwithstanding these limitations, the RAND expert panel methodology is a validated and accepted avenue for developing recommendations. Second, when we began the study, brachytherapy was performed at only a few centers, and there was sparse literature supporting its efficacy. Although it is an increasingly available and popular option, most patients who select radiation still undergo external beam therapy. As we develop more indicators, brachytherapy will certainly be included. Finally, this work represents an initial exploratory study. The product of the expert panel was generic quality-of-care indicators. To be used and implemented in future studies, the indicators must be further refined and organized into a chart abstraction tool.

	NOTES

 
The views expressed are those of the authors and do not necessarily reflect those of the Robert Wood Johnson Foundation.

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Submitted May 23, 2002; accepted February 3, 2003.

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