Patient-centered recruitment and retention for a randomized controlled study.

BACKGROUND: Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. METHODS: This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. RESULTS: We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. CONCLUSIONS: We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies. TRIAL REGISTRATION: Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.

Trends in substance use admissions among older adults.

BACKGROUND: Substance abuse is a growing, but mostly silent, epidemic among older adults. We sought to analyze the trends in admissions for substance abuse treatment among older adults (aged 55 and older). METHODS: Treatment Episode Data Set - Admissions (TEDS-A) for period between 2000 and 2012 was used. The trends in admission for primary substances, demographic attributes, characteristics of substance abused and type of admission were analyzed. RESULTS: While total number of substance abuse treatment admissions between 2000 and 2012 changed slightly, proportion attributable to older adults increased from 3.4% to 7.0%. Substantial changes in the demographic, substance use pattern, and treatment characteristics for the older adult admissions were noted. Majority of the admissions were for alcohol as the primary substance. However there was a decreasing trend in this proportion (77% to 64%). The proportion of admissions for following primary substances showed increase: cocaine/crack, marijuana/hashish, heroin, non-prescription methadone, and other opiates and synthetics. Also, admissions for older adults increased between 2000 and 2012 for African Americans (21% to 28%), females (20% to 24%), high school graduates (63% to 75%), homeless (15% to 19%), unemployed (77% to 84%), and those with psychiatric problems (17% to 32%).The proportion of admissions with prior history of substance abuse treatment increased from 39% to 46% and there was an increase in the admissions where more than one problem substance was reported. Ambulatory setting continued to be the most frequent treatment setting, and individual (including self-referral) was the most common referral source. The use of medication assisted therapy remained low over the years (7% - 9%). CONCLUSIONS: The changing demographic and substance use pattern of older adults implies that a wide array of psychological, social, and physiological needs will arise. Integrated, multidisciplinary and tailored policies for prevention and treatment are necessary to address the growing epidemic of substance abuse in older adults.

Minimal important difference to infer changes in health-related quality of life-a systematic review.

OBJECTIVES: The objective of the study was to assess the usability of minimal important difference (MID) and minimal clinically important difference (MCID) for measuring meaningful changes in disease-specific and generic health-related quality-of-life (HRQoL) outcomes in patient-centered care. STUDY DESIGN AND SETTING: We adopted a two-step literature review process. First, we used PubMed and Google scholar to identify a broad range of search terms. Next, we searched OVID Medline, JSTOR, and PubMed for terms "MID," and "MCID." We excluded non-English language studies, articles older than 1995, those not related to generic- and disease-specific HRQoL measures, and protocols of future studies. Studies were grouped according to generic- and disease-specific measures. We assessed MID or MCID calculation methods, effect sizes, estimated values, and significance. RESULTS: Eighty articles satisfied the inclusion criteria. Our synthesis provides a comprehensive assessment of MID or MCID for 10 generic-specific and 80 disease-specific instruments. We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures. Only 43 (54%) studies used both anchor and distribution methods to elicit MID or MCID. Thirty-four articles estimated MID values only, whereas 47 articles estimated MCID. CONCLUSION: The anchor-based method yields conservative estimates of MID or MCID, compared to the distribution-based method. The distribution method does not take into account patient perspectives and should be accompanied by anchor method while computing MID. The MID should be interpreted with caution, and available estimates for a particular instrument must be used. This will help in integrating the MID estimates into the overall research or clinical plan for a specific context.

Comparative effectiveness of prostate cancer treatments for patient-centered outcomes: A systematic review and meta-analysis (PRISMA Compliant).

BACKGROUND: In the context of prostate cancer (PCa) characterized by the multiple alternative treatment strategies, comparative effectiveness analysis is essential for informed decision-making. We analyzed the comparative effectiveness of PCa treatments through systematic review and meta-analysis with a focus on outcomes that matter most to newly diagnosed localized PCa patients. METHODS: We performed a systematic review of literature published in English from 1995 to October 2016. A search strategy was employed using terms "prostate cancer," "localized," "outcomes," "mortality," "health related quality of life," and "complications" to identify relevant randomized controlled trials (RCTs), prospective, and retrospective studies. For observational studies, only those adjusting for selection bias using propensity-score or instrumental-variables approaches were included. Multivariable adjusted hazard ratio was used to assess all-cause and disease-specific mortality. Funnel plots were used to assess the level of bias. RESULTS: Our search strategy yielded 58 articles, of which 29 were RCTs, 6 were prospective studies, and 23 were retrospective studies. The studies provided moderate data for the patient-centered outcome of mortality. Radical prostatectomy demonstrated mortality benefit compared to watchful waiting (all-cause HR = 0.63 CI = 0.45, 0.87; disease-specific HR = 0.48 CI = 0.40, 0.58), and radiation therapy (all-cause HR = 0.65 CI = 0.57, 0.74; disease-specific HR = 0.51 CI = 0.40, 0.65). However, we had minimal comparative information about tradeoffs between and within treatment for other patient-centered outcomes in the short and long-term. CONCLUSION: Lack of patient-centered outcomes in comparative effectiveness research in localized PCa is a major hurdle to informed and shared decision-making. More rigorous studies that can integrate patient-centered and intermediate outcomes in addition to mortality are needed.