Palliative Care and Advance Care Planning Intervention Fidelity Monitoring: Methods and Lessons Learned From PCORI-Funded Large-Scale, Pragmatic Clinical Trials.

Over the past decade, the Patient-Centered Outcomes Research Institute (PCORI) funded multiple large-scale, comparative effectiveness clinical trials evaluating palliative care and advance care planning interventions. These are complex multicomponent interventions that need robust but flexible fidelity monitoring. Fidelity is necessary to maintain both internal and external validity within palliative care intervention research and to ultimately evaluate the real-world impact of high-quality interventions. Different trials not only took varying approaches to fidelity monitoring but also uncovered both unique and common challenges and facilitators. This article summarizes 8 of these trials and highlights approaches, adaptations, barriers, and facilitators for intervention fidelity monitoring. Identifying and delivering core elements while simultaneously allowing adaptations of noncore elements is a vital part of fidelity monitoring. Dissemination of such experiences can inform both future palliative care research as well as ongoing implementation of palliative care and advance care planning interventions across diverse clinical practices. Adoption of rigorous intervention fidelity methods is critical to advancing the science and reproducibility of palliative care interventions.

Association between physician age and patterns of end-of-life care among older Americans.

BACKGROUND: End-of-life (EOL) care patterns may differ by physician age given differences in how physicians are trained or changes associated with aging. We sought to compare patterns of EOL care delivered to older Americans according to physician age. METHODS: We conducted a cross-sectional study of a 20% sample of Medicare fee-for-service beneficiaries aged ≥66 years who died in 2016-2019 (n = 487,293). We attributed beneficiaries to the physician who had >50% of primary care visits during the last 6 months of life. We compared beneficiary-level outcomes by physician age (<40, 40-49, 50-59, or ≥60) in two areas: (1) advance care planning (ACP) and palliative care; and (2) high-intensity care at the EOL. RESULTS: Beneficiaries attributed to younger physicians had slightly higher proportions of billed ACP (adjusted proportions, 17.1%, 16.1%, 15.5%, and 14.0% for physicians aged <40, 40-49, 50-59, and ≥60, respectively; p-for-trend adjusted for multiple comparisons <0.001) and palliative care counseling or hospice use in the last 180 days of life (64.5%, 63.6%, 61.9%, and 60.8%; p-for-trend <0.001). Similarly, physicians' younger age was associated with slightly lower proportions of emergency department visits (57.4%, 57.0%, 57.4%, and 58.1%; p-for-trend <0.001), hospital admissions (51.2%, 51.1%, 51.4%, and 52.1%; p-for-trend <0.001), intensive care unit admissions (27.8%, 27.9%, 28.2%, and 28.3%; p-for-trend = 0.03), or mechanical ventilation or cardiopulmonary resuscitation (14.2, 14.9%, 15.2%, and 15.3%; p-for-trend <0.001) in the last 30 days of life, and in-hospital death (20.2%, 20.6%, 21.3%, and 21.5%; p-for-trend <0.001). CONCLUSIONS: We found that differences in patterns of EOL care between beneficiaries cared for by younger and older physicians were small, and thus, not clinically meaningful. Future research is warranted to understand the factors that can influence patterns of EOL care provided by physicians, including initial and continuing medical education.

The Impact of COVID-19 on Routine Medical Care and Cancer Screening.

BACKGROUND: COVID-19 restrictions and fear dramatically changed the use of medical care. Understanding the magnitude of cancelled and postponed appointments and associated factors can help identify approaches to mitigate unmet need. OBJECTIVE: To determine the proportion of medical visits cancelled or postponed and for whom. We hypothesized that adults with serious medical conditions and those with higher anxiety, depressive symptoms, and avoidance-oriented coping would have more cancellations/postponements. DESIGN: Four nationally representative cross-sectional surveys conducted online in May, July, October, and December 2020. PARTICIPANTS: 59,747 US adults who completed 15-min online surveys. 69% cooperation rate. MEASURES: Physical and mental health visits and cancer screening cancelled or postponed over prior 2 months. Plan to cancel or postpone visits over the next 2 months. Relationship with demographics, medical conditions, local COVID-19 death rate, anxiety, depressive symptoms, coping, intolerance of uncertainty, and perceived COVID-19 risk. KEY RESULTS: Of the 58% (N = 34,868) with a medical appointment during the 2 months before the survey, 64% had an appointment cancelled or postponed in May, decreasing to 37% in December. Of the 41% of respondents with scheduled cancer screening, 20% cancelled/postponed, which was stable May to December. People with more medical conditions were more likely to cancel or postpone medical visits (OR 1.19 per condition, 95% CI 1.16, 1.22) and cancer screening (OR 1.20, 95% CI 1.15, 1.24). Race, ethnicity, and income had weak associations with cancelled/postponed visits, local death rate was unrelated, but anxiety and depressive symptoms were strongly related to cancellations, and this grew between May and December. CONCLUSIONS: Cancelled medical care and cancer screening were more common among persons with medical conditions, anxiety and depression, even after accounting for COVID-19 deaths. Outreach and support to ensure that patients are not avoiding needed care due to anxiety, depression and inaccurate perceptions of risk will be important.

Impact of a Palliative Care Nurse Practitioner in an Oncology Clinic: A Quality Improvement Effort.

PURPOSE: Guidelines support early integration of palliative care (PC) into standard oncology practice; however, little is known as to whether outcomes can be improved by modifying health care delivery in a real-world setting. METHODS: We report our 6-year experience of embedding a nurse practitioner in an oncology clinic (March 2014-March 2020) to integrate early, concurrent advance care planning and PC. RESULTS: Compared with patients with advanced cancer not enrolled in the palliative care nurse practitioner program, in March 2020, patients who are enrolled are more likely to have higher quality of PC (eg, goals of care note documentation [82% v 15%; P < .01], referral to the psychosocial oncology program [67% v 37%; P < .01], and referral to hospice [61% v 34%; P < .01]) and less inpatient utilization in the last 6 months of life (eg, hospital days [12 v 18; P < .01] and intensive care unit days [1.2 v 2.3; P < .01]). The program expanded over time with the support of faculty skills training for advance care planning and PC, supporting a shared mental model of PC delivery within the oncology clinic. CONCLUSION: Embedding a trained palliative care nurse practitioner in oncology clinics to deliver early integrated PC can lead to improved quality of care for patients with advanced cancer.

The Impact of Provider Sex and Experience on the Quality of Care Provided for Women with Urinary Incontinence.

BACKGROUND: Although specialists are skilled in the management of urinary incontinence, primary care clinicians are integral in early diagnosis and initiation of management in order to decrease overuse of specialty care and improve the quality of specialist visits. We measured the quality of incontinence care provided by primary care clinicians prior to referral to a specialist and evaluated the impact of provider variables on quality of care. METHODS: We performed a retrospective review of 200 women referred for urinary incontinence to a Female Pelvic Medicine and Reconstructive Surgery specialist between March 2017 and July 2018. We measured primary care adherence to 12 quality indicators in the 12 months prior to specialist consultation. We stratified adherence to quality indicators by clinician sex and years of experience. RESULTS: Half of women with incontinence underwent a pelvic examination or had a urinalysis ordered. Few patients with urge urinary incontinence were recommended behavioral therapy (14%) or prescribed medication (8%). When total aggregate scores were compared, female clinicians performed the recommended care 47% ± 25% of the time, compared with 35% ± 23% for male clinicians (P = .003). Increasing years of experience was associated with worse overall urinary incontinence care (r -0.157, P = .02). CONCLUSIONS: We found low rates of adherence to a set of quality indicators for women with urinary incontinence, with male clinicians performing significantly worse than female clinicians. Improvement of incontinence care in primary care could significantly reduce costs of care and preserve outcomes.

Improving Serious Illness Care for Surgical Patients: Quality Indicators for Surgical Palliative Care.

OBJECTIVE: Develop quality indicators that measure access to and the quality of primary PC delivered to seriously ill surgical patients. SUMMARY OF BACKGROUND DATA: PC for seriously ill surgical patients, including aligning treatments with patients' goals and managing symptoms, is associated with improved patient-oriented outcomes and decreased healthcare utilization. However, efforts to integrate PC alongside restorative surgical care are limited by a lack of surgical quality indicators to evaluate primary PC delivery. METHODS: We developed a set of 27 preliminary indicators that measured palliative processes of care across the surgical episode, including goals of care, decision-making, symptom assessment, and issues related to palliative surgery. Then using the RAND-UCLA Appropriateness method, a 12-member expert advisory panel rated the validity (primary outcome) and feasibility of each indicator twice: (1) remotely and (2) after an in-person moderated discussion. RESULTS: After 2 rounds of rating, 24 indicators were rated as valid, covering the preoperative evaluation (9 indicators), immediate preoperative readiness (2 indicators), intraoperative (1 indicator), postoperative (8 indicators), and end of life (4 indicators) phases of surgical care. CONCLUSIONS: This set of quality indicators provides a comprehensive set of process measures that possess the potential to measure high quality PC for seriously ill surgical patients throughout the surgical episode.

Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study.

BACKGROUND: Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. OBJECTIVE: This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. METHODS: The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. RESULTS: The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that "I trust researchers to use leftover biological specimens to promote the public's health" and "Sharing a biological sample for research is safe because of the privacy protections in place" discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. CONCLUSIONS: Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives.

Measure Scan and Synthesis of Palliative and End-of-Life Process Quality Measures for Advanced Cancer.

PURPOSE: Monitoring and improving the quality of palliative and end-of-life cancer care remain pressing needs in the United States. Among existing measures that assess the quality of palliative and end-of-life care, many operationalize similar concepts. We identified existing palliative care process measures and synthesized these measures to aid stakeholder prioritization that will facilitate health system implementation in patients with advanced cancer. METHODS: We reviewed MEDLINE/PubMed-indexed articles for process quality measures related to palliative and end-of-life care for patients with advanced cancer, supplemented by expert input. Measures were inductively grouped into "measure concepts" and higher-level groups. RESULTS: Literature review identified 226 unique measures from 23 measure sources, which we grouped into 64 measure concepts within 12 groups. Groups were advance care planning (11 measure concepts), pain (7), dyspnea (9), palliative care-specific issues (6), other specific symptoms (17), comprehensive assessment (2), symptom assessment (1), hospice/palliative care referral (1), spiritual care (2), mental health (5), information provision (2), and culturally appropriate care (1). CONCLUSION: Measure concepts covered the spectrum of care from acute symptom management to advance care planning and psychosocial needs, with variability in the number of measure concepts per group. This taxonomy of process quality measure concepts can be used by health systems seeking stakeholder input to prioritize targets for improving palliative and end-of-life care quality in patients with advanced cancer.

2020 American College of Rheumatology Guideline for the Management of Gout.

OBJECTIVE: To provide guidance for the management of gout, including indications for and optimal use of urate-lowering therapy (ULT), treatment of gout flares, and lifestyle and other medication recommendations. METHODS: Fifty-seven population, intervention, comparator, and outcomes questions were developed, followed by a systematic literature review, including network meta-analyses with ratings of the available evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and patient input. A group consensus process was used to compose the final recommendations and grade their strength as strong or conditional. RESULTS: Forty-two recommendations (including 16 strong recommendations) were generated. Strong recommendations included initiation of ULT for all patients with tophaceous gout, radiographic damage due to gout, or frequent gout flares; allopurinol as the preferred first-line ULT, including for those with moderate-to-severe chronic kidney disease (CKD; stage >3); using a low starting dose of allopurinol (≤100 mg/day, and lower in CKD) or febuxostat (<40 mg/day); and a treat-to-target management strategy with ULT dose titration guided by serial serum urate (SU) measurements, with an SU target of <6 mg/dl. When initiating ULT, concomitant antiinflammatory prophylaxis therapy for a duration of at least 3-6 months was strongly recommended. For management of gout flares, colchicine, nonsteroidal antiinflammatory drugs, or glucocorticoids (oral, intraarticular, or intramuscular) were strongly recommended. CONCLUSION: Using GRADE methodology and informed by a consensus process based on evidence from the current literature and patient preferences, this guideline provides direction for clinicians and patients making decisions on the management of gout.

The Community Perspective on Potentially Inappropriate Treatment.

Rationale: Medical interventions that prolong life without achieving an effect that the patient can appreciate as a benefit are often considered futile or inappropriate by healthcare providers. In recent years, a multicenter guideline has been released with recommendations on how to resolve conflicts between families and clinicians in these situations and to increase public engagement. Although laypeople are acknowledged as important stakeholders, their perceptions and understanding of the terms "potentially inappropriate" or "futile" treatment have received little formal evaluation.Objectives: To evaluate the community perspective about the meaning of futile treatment.Methods: Six focus groups (two groups each of ages <65, 65-75, and >75 yr) were convened to explore what constitutes futile treatment and who should decide in situations of conflict between doctors and families. Focus group discussions were analyzed using grounded theory.Results: There were 39 participants aged 18 or older with at least one previous hospitalization (personal or by immediate relative). When asked to describe futile or inappropriate treatment, community members found the concept difficult to understand and the terminology inadequate, though when presented with a case describing inappropriate treatment, most participants recognized it as the provision of inappropriate treatment. Several themes emerged regarding participant difficulty with the concept, including inadequate physician-patient communication, lack of public emphasis on end-of-life issues, skepticism that medical treatment can be completely inappropriate, and doubts and fears that medical futility could undermine patient and/or family autonomy. Participants also firmly believed that in situations of conflict families should be the ultimate decision-makers.Conclusions: Public engagement in policy development and discourse around medical futility will first require intense education to familiarize the lay public about use of inappropriate treatment at the end of life.

Cost health literacy as a physician skill-set: the relationship between oncologist reported knowledge and engagement with patients on financial toxicity.

INTRODUCTION: Oncologists are increasingly encouraged to communicate with patients about cost; however, they may lack the cost health literacy required to effectively perform this task. METHODS: We conducted a pilot survey of oncologists in an academic medical center to assess potential factors that may influence provider attitudes and practices related to financial toxicity. We assessed perceived provider knowledge of treatment costs, insurance coverage and co-pays, and financially focused resources. We then evaluated the relationship between perceived knowledge and reported engagement with issues of financial toxicity. RESULTS: Of 45 respondents (85% response rate), 58% had changed treatment within the past year as a result of patient financial burden. On self-report, 36% discussed out-of-pocket costs with patients, 42% assessed patient financial distress, but only 20% felt they could intervene upon financial toxicity. Self-perceived awareness of cost health literacy concepts were low; only 16% reporting high out-of-pocket cost knowledge, 31-33% high insurance knowledge, and 8% high awareness of financial resources. Report of cost discussion was associated with greater perceived awareness of both out-of-pocket costs and insurance design. However, reported financial distress assessment was only associated with perceived insurance awareness, not perceived cost knowledge. Cost health literacy was not associated with an increased sense of being able to impact on financial toxicity. CONCLUSION: Oncologists acknowledge deficits in knowledge and skills that may play a role in the discussion and management of financial toxicity. Some cost health literacy competencies appear to correlate with physician involvement with financial toxicity, suggesting that education on this topic may facilitate physician engagement.

Establishing a Denominator for Palliative Care Quality Metrics for Patients with Advanced Cancer.

Background: Measurement and monitoring of palliative care quality metrics for patients with advanced cancer promote early integration of palliative care within the oncology clinic. Accurately identifying the subset of advanced cancer patients within a population of cancer patients who would most benefit from palliative care is critical to the development of palliative care-relevant quality improvement activities. Methods: We evaluated two automated approaches to identifying patients with solid tumors sufficiently advanced to warrant discussions of palliative care and advanced care planning. These approaches included (1) pattern matching of words indicating an advanced cancer in oncology notes, radiology imaging, and active problem lists and (2) International Classification of Diseases (ICD-10) codes. We randomly selected 586 charts of patients with active cancer who are patients in our health system to establish a gold standard for advanced cancer through expert chart review. We evaluated the sensitivity and specificity of these automated approaches to identify advanced cancer patients compared with the gold standard. Results: We found that the highest performing pattern matching method had a specificity of 76% and a sensitivity of 81%. Using our final ICD-10 algorithm, we achieved a specificity of 92% and a sensitivity of 68%. We improved our sensitivity to 76% while maintaining our specificity at 91% when we excluded patients assigned to oncologists who predominantly see hematological malignancies. Conclusions: We achieved high specificity and reasonable sensitivity for an advanced cancer quality metric denominator using an ICD-10 algorithm within an academic oncology practice. This concrete definition will help inform quality improvement efforts locally and beyond.

Risk estimation, anxiety, and breast cancer worry in women at risk for breast cancer: A single-arm trial of personalized risk communication.

OBJECTIVE: Elevated anxiety and breast cancer worry can impede mammographic screening and early breast cancer detection. Genetic advances and risk models make personalized breast cancer risk assessment and communication feasible, but it is unknown whether such communication of risk affects anxiety and disease-specific worry. We studied the effect of a personalized breast cancer screening intervention on risk perception, anxiety, and breast cancer worry. METHODS: Women with a normal mammogram but elevated risk for breast cancer (N = 122) enrolled in the Athena Breast Health risk communication program were surveyed before and after receiving a letter conveying their breast cancer risk and a breast health genetic counselor consultation. We compared breast cancer risk estimation, anxiety, and breast cancer worry before and after risk communication and evaluated the relationship of anxiety and breast cancer worry to risk estimation accuracy. RESULTS: Women substantially overestimated their lifetime breast cancer risk, and risk communication somewhat mitigated this overestimation (49% pre-intervention, 42% post-intervention, 13% Gail model risk estimate, P < .001). Both general anxiety and breast cancer worry declined significantly after risk communication in women with high baseline anxiety. Baseline anxiety and breast cancer worry were essentially unrelated to risk estimation accuracy, but risk communication increased alignment of worry with accuracy of risk assessment. CONCLUSIONS: Personalized communication about breast cancer risk was associated with modestly improved risk estimation accuracy in women with relatively low anxiety and less anxiety and breast cancer worry in women with higher anxiety. We detected no negative consequences of informing women about elevated breast cancer risk.

Resource utilisation and description of patients perceived as receiving inappropriate critical care.

OBJECTIVE: Medical interventions that do not offer the patient meaningful benefit due to inconsistency with prognoses are often considered "inappropriate" by clinicians. We described the clinical details and resource utilisation of patients who were assessed as receiving inappropriate treatment. DESIGN: Chart abstraction was performed on 123 patients who were assessed by their critical care physician as having received inappropriate treatment to document clinical characteristics, diagnostic testing, life-sustaining treatments and nursing assessments of daily pain and level of consciousness. RESULTS: The mean age was 67 and on admission, 41% had cancer and 25% had advanced pulmonary disease. At least one of the following three conditions was noted in 57% of the patients: severe neurological injury, overwhelming sepsis or irreversible respiratory failure. Patients were less likely to be alert (OR 0.39, CI 0.16-0.91, p = 0.03) on days they were assessed as receiving inappropriate critical care. After they were assessed as receiving inappropriate critical care, they received 172 imaging studies, 151 procedures, 522 days of mechanical ventilation (excludes one patient who received 1020 days of mechanical ventilation), 254 days of vasopressors, 226 days of hemodialysis and 10 attempts at cardiopulmonary resuscitation. CONCLUSIONS: Patients assessed as receiving inappropriate critical care receive resource-intensive medical care, largely while non-alert.

Implementing a Population-Based Breast Cancer Risk Assessment Program.

BACKGROUND: Personalized breast cancer risk assessment is important in identifying and managing women at increased risk for breast cancer. However, there has been little evaluation of the practical aspects of implementing a population-based program that identifies and refers high-risk patients for further evaluation. PATIENTS AND METHODS: We implemented a semiautomated approach to collect personal and family history to identify women at high risk of breast cancer. On the basis of the survey, women identified as elevated risk received letters inviting them to telephone consultations with licensed breast health genetic counselors (BHGCs). High-risk women's history was verified and counseling and referrals provided, as appropriate. RESULTS: Among 20,558 women screened, 2000 (9.7%) women were identified as high risk on the basis of patient initial report. However, most (1,580) were excluded from receiving risk communication after BHGC review of risk information with the woman or because of previous attention to breast cancer risk or an abnormal mammogram. Among 420 subjects who received risk letters, 225 received a BHGC consultation. Of these 225 women, 63 were reclassified as average risk, 158 were referred to high-risk clinics, and 5 consultations were incomplete after determining that further information was needed. Of the 158 women referred to high-risk breast clinics, 51 attended an appointment. CONCLUSION: This study highlights the complex nature of a population-based breast cancer screening program in a clinical setting and shows the substantial effort needed to identify newly discovered women at high risk for breast cancer and refer them to appropriate services.

Role of Clinical and Imaging Risk Factors in Predicting Breast Cancer Diagnosis Among BI-RADS 4 Cases.

PURPOSE: To analyze women with suspicious findings (assessed as Breast Imaging Reporting and Data System [BI-RADS] 4), examining the value of clinical and imaging predictors in predicting cancer diagnosis. PATIENTS AND METHODS: A set of 2138 examinations (1978 women) given a BI-RADS 4 with matching pathology results were analyzed. Predictors such as patient demographics, clinical risk factors, and imaging-derived features such as BI-RADS assessment and qualitative breast density were considered. Independent predictors of breast cancer were determined by univariate analysis and multivariate logistic regression. RESULTS: In univariate analysis, age, race, body mass index, age at first live birth, BI-RADS assessment, qualitative breast density, and risk triggers were found to be independent predictors. In multivariate analysis, age, BI-RADS score, breast density, race, presence of a lump, and number of risk triggers were the most predictive. An integrative logistic regression model achieved a performance of 0.84 cross-validated area under the curve. No variable was a constant independent predictor when stratifying the population on the basis of the BI-RADS score. CONCLUSION: While BI-RADS assessment remains the strongest predictor of breast cancer, the inclusion of clinical risk factors such as age, breast density, presence of a lump, and number of risk triggers derived from guidelines improves the specificity of identifying individuals with imaging descriptors associated with BI-RADS 4A and 4B that are more likely to be diagnosed with breast cancer.

Association Between Estimated Mortality Risk and Measured Quality of Care in Older Adults.

Quality measures based on processes of care (e.g., breast cancer screening) are frequently used to compare performance of providers and healthcare organizations in a value-based reimbursement system, but using these measures to make performance comparisons could penalize clinicians caring for older adults with multiple comorbidities. These clinicians may more frequently withhold recommended care based on limited prognosis, patient preference, or potential adverse effects and, as a result, may incur financial penalties because of poor measured performance. Alternatively, they may need to perform additional administrative work to exclude patients from quality measurement. To examine the potential performance handicap associated with caring for complex populations, we cross-sectionally examined the association between broad outpatient processes of care and 5-year mortality risk in a nationally representative older adult sample (≥ 65) from the 2002 to 2015 Medical Expenditure Panel Survey (n=26,006). In adjusted analyses, performance score based on process-of-care measures was significantly worse in the high-risk group (5-year mortality risk ≥50; adjusted performance score 67.4%; adjusted absolute difference 6.7%, 95% confidence interval (CI)=5.3-8.1%, p<.001) and in the intermediate-risk group (5-year mortality risk 25-49%; adjusted performance score 71.7%; adjusted absolute difference 2.4%, 95% CI=1.7-3.1%, p<.001) than in the low-risk group (5-year mortality risk <25%); adjusted performance score 74.1% following <25%. The trend was overall constant across types of care processes and was more prominent in the younger age brackets of our sample. These results suggest that use of process-of-care measures can lead to disproportionate burden for clinicians and organizations primarily taking care of complex populations.

Quality Indicators for Global Benchmarking of Localized Prostate Cancer Management.

PURPOSE: We sought to develop a core set of clinical indicators to enable international benchmarking of localized prostate cancer management using data available in the TrueNTH Global Registry. MATERIALS AND METHODS: An international expert panel completed an online survey and participated in a face-to-face meeting. Participants included 3 urologists, 3 radiation oncologists, 2 psychologists, 1 medical oncologist, 1 nurse and 1 epidemiologist with prostate cancer expertise from a total of 7 countries. Current guidelines on prostate cancer treatment and potential quality indicators were identified from a literature review. These potential indicators were refined and developed through a modified Delphi process during which each panelist independently and repeatedly rated each indicator based on importance (satisfying the indicator demonstrated a provision of high quality care) and feasibility (the likelihood that data used to construct the indicator could be collected at a population level). The main outcome measure was items with panel agreement indicated by a disagreement index less 1, median importance 8.5 or greater and median feasibility 9 or greater. RESULTS: The expert panel endorsed 33 indicators. Seven of these 33 prostate cancer quality indicators assessed care relating to diagnosis, 7 assessed primary treatment, 1 assessed salvage treatment and 18 assessed health outcomes. CONCLUSIONS: We developed a set of quality indicators to measure prostate cancer care using numerous international evidence-based clinical guidelines. These indicators will be pilot tested in the TrueNTH Global Registry. Reports comparing indicator performance will subsequently be distributed to groups at participating sites with the purpose of improving the consistency and quality of prostate cancer management on a global basis.