Protocol for a systematic review and individual patient data meta-analysis of prognostic factors of foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

Background Diabetes–related lower limb amputations are associated with considerable morbidity and mortality and are usually preceded by foot ulceration. The available systematic reviews of aggregate data are compromised because the primary studies report both adjusted and unadjusted estimates. As adjusted meta-analyses of aggregate data can be challenging, the best way to standardise the analytical approach is to conduct a meta-analysis based on individual patient data (IPD). There are however many challenges and fundamental methodological omissions are common; protocols are rare and the assessment of the risk of bias arising from the conduct of individual studies is frequently not performed, largely because of the absence of widely agreed criteria for assessing the risk of bias in this type of review. In this protocol we propose key methodological approaches to underpin our IPD systematic review of prognostic factors of foot ulceration in diabetes. Review questions; 1. What are the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes? 2. Can the data from each study be adjusted for a consistent set of adjustment factors? 3. Does the model accuracy change when patient populations are stratified according to demographic and/or clinical characteristics? Methods MEDLINE and EMBASE databases from their inception until early 2012 were searched and the corresponding authors of all eligible primary studies invited to contribute their raw data. We developed relevant quality assurance items likely to identify occasions when study validity may have been compromised from several sources. A confidentiality agreement, arrangements for communication and reporting as well as ethical and governance considerations are explained. We have agreement from the corresponding authors of all studies which meet the eligibility criteria and they collectively possess data from more than 17000 patients. We propose, as a provisional analysis plan, to use a multi-level mixed model, using “study” as one of the levels. Such a model can also allow for the within-patient clustering that occurs if a patient contributes data from both feet, although to aid interpretation, we prefer to use patients rather than feet as the unit of analysis. We intend to only attempt this analysis if the results of the investigation of heterogeneity do not rule it out and the model diagnostics are acceptable. Discussion This review is central to the development of a global evidence-based strategy for the risk assessment of the foot in patients with diabetes, ensuring future recommendations are valid and can reliably inform international clinical guidelines

Treatment Features Associated with Youth Cognitive Behavioral Therapy Follow-Up Effects for Internalizing Disorders: A Meta-Analysis

Our aim was to investigate whether four treatment features (i.e., the inclusion of parental involvement, goal-setting strategies, maintenance/relapse prevention sessions, the addition of booster sessions) were associated with posttreatment and follow-up effect size of youth cognitive behavioral therapies (yCBTs) for anxiety, depression, posttraumatic stress disorder, and obsessive-compulsive disorder in age groups spanning young children to adolescents. We conducted a random-effects meta-analysis of 106 yCBTs tested in 76 randomized clinical trials from the PracticeWise Database to examine average effects of yCBTs posttreatment and at a later follow-up assessment. We coded the use of parental involvement, goal setting, booster sessions, and maintenance/relapse prevention in each yCBT and conducted random-effects meta-regression analyses to investigate whether these treatment features were associated with yCBT effects at posttreatment as well as at follow-up. Overall, yCBTs produced large pre- to posttreatment effects (d = 1.05), 95% confidence interval [0.94, 1.15], and larger pre- to follow-up effects (d = 1.29), 95% confidence interval [1.18, 1.40]. Metaregression results indicated that parental involvement was significantly associated with larger pre- to posttreatment effect sizes as well as pre- to follow-up effect sizes. Booster sessions, goal setting, and maintenance/relapse prevention were not significantly related to effect sizes at posttreatment or follow-up. Parental involvement may be helpful for maximizing long-term effectiveness of yCBT. Future studies should investigate for whom and under what conditions inclusion of yCBT treatment features is related to the durability of treatment gains

Strategies for incorporating culture into psychosocial interventions for youth of color

This review summarized the literature on psychosocial interventions for youth of color. Ninety-three journal articles of randomized clinical trials, with samples comprised of youth of color, published between 1974 and 2018 were coded for sample characteristics, intervention characteristics, and strategies for incorporating culture into psychotherapy. Results found 69 psychosocial interventions to be efficacious for youth of color; 32% of these psychosocial interventions included a strategy for incorporating culture into psychotherapy. The evidence base was largest for Black and Hispanic/Latinx populations and for psychosocial interventions targeting disruptive behavior problems. The most common strategies for incorporating culture into treatment among effective psychosocial interventions were employing procedures for addressing cultural context and including providers with awareness and knowledge of the client’s culture. The inclusion of strategies for incorporating culture was not associated with treatment efficacy. Findings from this review highlight the laudable efforts that have been made to identify efficacious psychosocial interventions for youth of color and illuminate remaining gaps in the evidence base (e.g., efficacious psychosocial interventions for Asian, Native American and Alaska Native, and Native Hawaiian and Pacific Islander youth). Findings also emphasize the nuance of providing effective mental health services that are compatible with client’s cultural worldviews, values, and practices and allude to the promise of decision support tools to help providers determine whether, when, and how to culturally tailor their psychotherapy with youth of color