The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.

BACKGROUND: Decision aids help patients consider the benefits and drawbacks of care options but rarely include cost information. We assessed the impact of a conversation-based decision aid containing information about low-risk prostate cancer management options and their relative costs. METHODS: We conducted a stepped-wedge cluster randomised trial in outpatient urology practices within a US-based academic medical center. We randomised five clinicians to four intervention sequences and enroled patients newly diagnosed with low-risk prostate cancer. Primary patient-reported outcomes collected postvisit included the frequency of cost conversations and referrals to address costs. Other patient-reported outcomes included: decisional conflict postvisit and at 3 months, decision regret at 3 months, shared decision-making postvisit, financial toxicity postvisit and at 3 months. Clinicians reported their attitudes about shared decision-making pre- and poststudy, and the intervention's feasibility and acceptability. We used hierarchical regression analysis to assess patient outcomes. The clinician was included as a random effect; fixed effects included education, employment, telehealth versus in-person visit, visit date, and enrolment period. RESULTS: Between April 2020 and March 2022, we screened 513 patients, contacted 217 eligible patients, and enroled 117/217 (54%) (51 in usual care, 66 in the intervention group). In adjusted analyses, the intervention was not associated with cost conversations (ß = .82, p = .27), referrals to cost-related resources (ß = -0.36, p = .81), shared decision-making (ß = -0.79, p = .32), decisional conflict postvisit (ß = -0.34, p= .70), or at follow-up (ß = -2.19, p = .16), decision regret at follow-up (ß = -9.76, p = .11), or financial toxicity postvisit (ß = -1.32, p = .63) or at follow-up (ß = -2.41, p = .23). Most clinicians and patients had positive attitudes about the intervention and shared decision-making. In exploratory unadjusted analyses, patients in the intervention group experienced more transient indecision (p < .02) suggesting increased deliberation between visit and follow-up. DISCUSSION: Despite enthusiasm from clinicians, the intervention was not significantly associated with hypothesised outcomes, though we were unable to robustly test outcomes due to recruitment challenges. Recruitment at the start of the COVID-19 pandemic impacted eligibility, sample size/power, study procedures, and increased telehealth visits and financial worry, independent of the intervention. Future work should explore ways to support shared decision-making, cost conversations, and choice deliberation with a larger sample. Such work could involve additional members of the care team, and consider the detail, quality, and timing of addressing these issues. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians were engaged as stakeholder advisors meeting monthly throughout the duration of the project to advise on the study design, measures selected, data interpretation, and dissemination of study findings.

Erectile dysfunction management after failed phosphodiesterase-5-inhibitor trial: a cost-effectiveness analysis.

BACKGROUND: To evaluate the cost-effectiveness of alternate erectile dysfunction (ED) management options after failed first line phosphodiesterase-5-inhibitors (PDE5-I). METHODS: An empiric, repetitive decision tree analysis model was constructed using literature review and expert clinical judgement. This assessed the expected costs and quality adjusted life years (QALYs) of decision alternatives over a 10-year period. The model incorporated interventions including alternate PDE5-Is, intracorporal injections (ICI) with alprostadil or trimix (alprostadil, phentolamine, and papaverine), and inflatable penile prosthesis placement (IPP) and included respective risks of failure, subsequent interventions, and other complications (including priapism risk). Average model QALY estimates obtained from the literature were as follows: ED =0.56, successful alternate PDE5-I =0.70, successful ICI =0.70, and successful IPP =0.78. Cost data were calculated from a high-volume academic center and published manufacturer data. RESULTS: Over the 10-year period, IPP placement was the most cost-effective management option per preserved QALY (QALY =7.82, cost =$22,009/10 years) as compared to ICI alprostadil (QALY =8.51, cost =$62,890/10 years), ICI trimix (QALY =8.47, cost =$48,617/10 years) and alternate PDE5-I (QALY =7.73, $52,883/10 years). CONCLUSIONS: Using expert opinion and published utility, cost, and complication data in a decision analysis, we demonstrated that IPP placement is the most cost-effective ED intervention following failed initial PDE5-I over a 10-year period as compared to alternate treatment options. Such cost-effectiveness outcomes may be used in ED management counseling.

Validation of Using Claims Data to Measure Safety of Lumbar Fusion Surgery.

STUDY DESIGN: Retrospective analysis of patients undergoing elective lumbar fusion operations, comparing rates of repeat spine surgery based on method of ascertainment. OBJECTIVE: We report the accuracy of a claims-based approach for reporting repeat surgery compared with medical records abstraction as the "gold standard." SUMMARY OF BACKGROUND DATA: Previous studies have reported the validity of a claims-based algorithm for grouping patients by surgical indication and classifying operative features, but their accuracy in measuring surgical quality indicators has not been widely examined. METHODS: We identified a subset of patients undergoing elective lumbar fusion operations at a single institution from 1996 to 2011, excluding those with spinal fracture, spinal cord injury, or cancer. From the medical record we abstracted the incidence of repeat spine operation or rehospitalization at 1 year. We cross-classified each event record with its corresponding value derived from claims. The sensitivity and specificity of the claims-based approach were calculated for reoperation within 30, 90, and 365 days, and all-cause hospital readmission within 30 days. RESULTS: Medical records linked to claims data were obtained for 520 patients undergoing elective lumbar fusion. Reoperation rates based on chart review were 1.0%, 1.3%, 3.6%, compared with 0.8%, 1.7%, and 3.8% based on the final claims methods at 30, 90, and 365 days, respectively. The claims-based algorithm had sensitivities of 80.0%, 100%, and 94.1% and specificities of 100%, 99.6%, 99.2% for repeat surgery within 30, 90, and 365 days, respectively. The sensitivity for all-cause readmission was 50%. CONCLUSION: Health care quality improvement efforts often rely on administrative data to report surgical safety. We found that claims-based ascertainment of safety at a single institution was very accurate. However, accuracy depended on careful attention to the timing of outcomes, as well as the definitions and coding of repeat surgery, including how orthopedic device removal codes are classified. LEVEL OF EVIDENCE: 3.

Failing to follow up: predicting patients that will "no-show" for medically advised imaging following endourologic stone surgery.

INTRODUCTION: The purpose of this study is to evaluate predictors of poor compliance after treatment of urinary stone disease. MATERIALS AND METHODS: This study was a retrospective analysis of patients who underwent stent removal following percutaneous nephrolithotomy (PCNL) or ureteroscopy (URS) between 2008-2012. All patients were scheduled for follow up evaluation and renal ultrasound at 4-6 weeks following stent removal. Patients were stratified based on appointment compliance and demographic variables including gender, age, insurance type (Government Assisted Insurance [GAI] or Private Insurance [PI]), initial procedure, season, distance between home and clinic, average monthly gas price at follow up, and median education attainment. Logistic regression was performed to determine independent predictors of missed follow up. RESULTS: A total of 301 patients were included, 153 women (51% female) with a mean age of 54 ± 14.2 years. Of the cohort, 22.6% (n = 68) did not return for follow up. GAI was the only variable associated with a greater risk of non-compliance on univariate analysis (OR 2.13 [95% CI 1.12-3.86] p = 0.011) and multivariate analysis (OR 3.14.10 [95% CI 1.48-6.7], p < 0.01). Gender, age, procedure, season, distance, gas prices, and education were not significant predictors. CONCLUSION: In our study, evaluating characteristics associated with missed follow up after stent removal for PCNL and URS, possession of GAI was the only factor associated with non-compliance. Urologists should be aware that persons with GAI may be at increased risk of missed follow up and should use this information to target interventions to improve compliance.