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Research Protocol for Meta-Analyses
Published in Ding-Geng (Din) Chen, Karl E. Peace, Applied Meta-Analysis with R and Stata, 2021
Ding-Geng (Din) Chen, Karl E. Peace
Study characteristics are important in searching for studies that may be synthesized to address the objective of the meta-analysis. These include the (1) type of experimental design, such as whether it is crossover (each patient serves as his/ her own control) or parallel; (2) whether patients are randomly assigned to the treatment and control groups in balanced (equal numbers of patients to each group) or imbalanced (such as twice as many patients randomly assigned to the treatment group as to the control group) fashion or whether randomization is in blocks to ensure balance across time of entry; (3) whether patients are stratified on prognostic factors prior to randomization; and (4) measures taken to eliminate or minimize bias (such as double-blinded: both investigational site personnel and patients are blinded as to identification of the intervention groups) or preserving blinding and preservation of the Type I error if group sequential analyses are performed in the study.
Causal Inference for Observational Studies/Real-World Data
Published in Harry Yang, Binbing Yu, Real-World Evidence in Drug Development and Evaluation, 2021
Observational studies attempt to estimate the treatment effects by comparing outcomes for subjects who are not randomly assigned to treatment and control groups. In the modern era of big data, the sources for observational data are abundant, including administrative records, registries, electronic health records, claim databases, surveys, and so forth. Without a random assignment mechanism, some subjects are more likely than others to receive the treatment due to differences in individual characteristics (e.g., age, gender, disease severity), in observational studies. Therefore, careful statistical adjustments are needed to justify the causal interpretation based on the analysis of observational data. It is clear that the assignment mechanism is broken in observational studies due to the lack of randomization, so it is natural to devise tools to fix this broken link. The propensity score, defined as the conditional probability of exposure to a treatment given observed covariates, is a technical tool that addresses the treatment assignment problem. It can balance the observed covariate distributions between treatment and non-treatment groups and thus approximate a randomization-like scenario in terms of treatment assignment. Thus, propensity score methods can reduce the covariates-induced bias in treatment effect estimation (Rosenbaum and Rubin 1983a).
Prophylactic and Preventive Use of Antiepileptic Drugs
Published in Stanley R. Resor, Henn Kutt, The Medical Treatment of Epilepsy, 2020
Penry et al. (14) administered PHT and PB to head-injured patients in a double-blind fashion, with placebo control. Although the report was limited by the use of the abstract format, the investigators observed a seizure probability in the treated group of 21% and a probability of 13% in controls. The authors concluded that no significant difference was detected between the treatment and control groups. This study suggested that AED administration had no effect on the development of PTE in the treated patients.
Perceived stress among Hispanic young adults: Impact of the coping with work and family stress program
Published in Journal of American College Health, 2023
Marivic B. Torregosa, Marcus Antonius Ynalvez, Maria del Rosario Benavides, Nandita Chaudhuri, Christopher Craddock
This study was conducted from September 2015 through September 2018 after obtaining Institutional Review Board (IRB) approval. The study was a three-year project designed to prevent substance abuse, HIV infection, and hepatitis C infection among young adult Hispanics through an evidence-based stress intervention. IRB approval was obtained from the implementing institution. Hispanic college students aged 18–24 were recruited from a Hispanic-serving institution located in a U.S. southern border city. A permuted block design with repeated measures was used in this study. Participants were randomly assigned to treatment and control groups. The treatment group received the CWFS evidence-based curriculum aimed at reducing perceived stress while the control group did not receive any programming. The CWFS consisting of 12 modules was delivered to the treatment group. One module per week lasting 90 min per session was delivered to small groups of 15–20 participants by trained interventionists or facilitators. The frequency of the intervention delivery was later changed into two modules per week in order to contain the intervention delivery within the regular academic semester. Such change impacted cohorts 2–9.
Cognitive -behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis
Published in Topics in Stroke Rehabilitation, 2023
Jessica Ahrens, Richard Shao, Daymon Blackport, Steven Macaluso, Ricardo Viana, Robert Teasell, Swati Mehta
All studies included both male and female participants with the percentage of male participants ranging from 20%29 to 73.9%38 (Table 1) and an average of 53.15%. Data regarding age was extracted from all studies except for32due to age data not being reported. The mean age of participants ranged from 46.229 to 67.1 years old31 (Table 1), with an average mean age of 60.6 years. Two studies did not specify the time since diagnosis for their participants.29,33 Of the studies that did include information on time since diagnosis, the range was 3-months to being within 5 years, with the median time since diagnosis being between 3 and 6 months (Table 1). All studies provided baseline characteristics for all participants involved, including the treatment and control groups. All studies evaluated either depression29–32,35 or both depression and anxiety.33,34,36–38 Most of the studies used the Hospital Anxiety and Depression Scale (HADS)31,33,34,37,38 or the Beck Depression Inventory (BDI)29,31,32,35,36 as the primary outcome measurement. Other data collection scales included the Beck Anxiety Inventory (BAI),36 Wakefield Depression Inventory (WDI),31,35 and the Center for Epidemiologic Studies Depression Scale.30
Effect of Occupational Therapy Program to Promote Well-Being in People with Experiences of Mental Illness – Quasi-Experimental Study
Published in Occupational Therapy in Mental Health, 2021
Takuya Noguchi, Makoto Kyougoku, Takayuki Kawakami, Yukari Nishimoto, Kenzo Kashihara
The study employed a quasi-experimental design and allowed participants to choose whether to participate in the intervention or control group. The reason for this was that the same intervention could not be administered to both groups in this study due to time constraints. Quasi-experimental methods that involve the creation of a comparison group are most often used when it is not possible to randomize individuals or groups to treatment and control groups (White & Sabarwal, 2014). The intervention group consisted of a standard occupational therapy program conducted in a day hospital/hospital with the addition of an occupational therapy program to promote well-being. The control group participated only in the standard program offered at the day hospital/hospital. This intervention program was conducted by occupational therapists who were instructed in intervention methods. Also, the outcome measures were the same for both groups. The study period in both groups was 12 weeks of intervention and 4 weeks of follow-up.