Patient and caregiver engagement in research: factors that influence co-enrollment in research.

BACKGROUND: Recruitment of pediatric participants in studies is difficult due to the vulnerability of this population and the scarcity of certain conditions. Co-enrolling in multiple studies is a strategy that may help overcome this problem. Although anecdotal evidence suggests that co-enrollment may increase patient and caregiver burden, few studies have been conducted from the patient perspective. The objective of this quality improvement project was to elicit patient and caregiver opinions on co-enrolling in multiple research studies. METHODS: Patients and caregivers attending the rheumatology clinic at The Hospital for Sick Children were invited to participate in a semi-structured interview or focus group session. Participants were asked to respond to ten prompts, organized into five categories: experience in clinical research, multiple studies, study selection, study timing and other comments. Sessions were recorded, transcribed and analyzed using NVivo 10 to identify common themes. RESULTS: Overall, eighteen caregivers and two patients were included in the study. Participants felt that the level of study involvement, rather than the number of studies, was the biggest factor affecting their decision to participate. Another factor commonly identified was the competing demands of participants' work and family life. Participants indicated that they generally preferred to be informed about all study opportunities and liked to receive this information prior to their appointments. Once informed, they preferred to be approached by the research team while they were waiting for their appointment. CONCLUSION: Patients and caregivers are open to the concept of co-enrolling in multiple research studies. There are multiple factors which influence decisions to co-enroll in studies including the demands of the study and personal limitations. These findings will help guide the design and practices of future research.

Behavioral activation group therapy for reducing depressive symptoms and improving quality of life: a feasibility study.

BACKGROUND: Depression is associated with a loss of productivity and noticeable personal, social, and economic decline; it affects more than 350 million people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has drawn increasingly more interest as a means of treatment for major depressive disorder due to its relative cost-effectiveness and efficacy. In this study, we disseminate findings from a feasibility study evaluating barriers to implementing a group BA program for major depressive disorder. The purpose of this feasibility study is to assess both patient and clinician perceptions on components of a group-based behavioral activation (BA) program. In particular, this feasibility study provides in-depth evaluation of the acceptability of BA prior to the design and implementation of a randomized trial to investigate BA effectiveness. Findings from this study directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. METHODS: This qualitative study was completed through the Mood Disorders Program at St. Joseph's Healthcare Hamilton. The authors of this study used data from two focus group sessions, one consisting of an interdisciplinary group of clinicians working in the Mood Disorders Program, and the other of registered outpatients of the Mood Disorders Program with a confirmed clinical diagnosis of depression. The benefits of offering this program in a group format, mainly social skill development opportunities and the use of technology such as activity tracking device, smart phones, and tablets during the therapy sessions, are a major focus of both the clinician and patient groups. Both groups emphasized the importance of offering sustainable activation. RESULTS: Differences in opinions existed between staff and patient groups regarding the use of technology in the program, though ultimately it was agreed upon that technology could be useful as a therapeutic aid. All participants agreed that behavioral activation was essential to the development of positive habits and routines necessary for recovery from depression. Patients agreed the program looked sustainable and stressed the potential benefit for improving depressive symptoms. CONCLUSIONS: Discussions from clinician and patient-centered focus groups directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. These findings provide insight for clinicians providing behavioral activation programming, and will serve as a framework for the development of the Out of the Blues program, a group-based BA program to be piloted in the Mood Disorders Program at St. Joseph's Healthcare Hamilton. TRIAL REGISTRATION: Clinical Trials registration number NCT02045771.

Testosterone suppression in opioid users: a systematic review and meta-analysis.

BACKGROUND: Whether used for pain management or recreation, opioids have a number of adverse effects including hormonal imbalances. These imbalances have been reported to primarily involve testosterone and affect both males and females to the point of interfering with successful treatment and recovery. We conducted a systematic review and meta-analysis to determine the extent that opioids affect testosterone levels in both men and women, which may be relevant to improved treatment outcomes for opioid dependence and for pain management. METHODS: We searched PubMed, EMBASE, PsycINFO, and CINAHL for relevant articles and included studies that examined testosterone levels in men and women while on opioids. Data collection was completed in duplicate. RESULTS: Seventeen studies with 2769 participants (800 opioid users and 1969 controls) fulfilled the review inclusion criteria; 10 studies were cross-sectional and seven were cohort studies. Results showed a significant difference in mean testosterone level in men with opioid use compared to controls (MD=-164.78; 95% CI: -245.47, -84.08; p<0.0001). Methadone did not affect testosterone differently than other opioids. Testosterone levels in women were not affected by opioids. Generalizability of results was limited due to high heterogeneity among studies and overall low quality of evidence. CONCLUSIONS: Our findings demonstrated that testosterone level is suppressed in men with regular opioid use regardless of opioid type. We found that opioids affect testosterone levels differently in men than women. This suggests that opioids, including methadone, may have different endocrine disruption mechanisms in men and women, which should be considered when treating opioid dependence.