Acceptance and commitment therapy (ACT) for obsessive-compulsive disorder (OCD) has been found efficacious in randomized clinical trials (RCTs), but the two widely known RCTs were conducted within the United States with predominantly White samples. Research that evaluates treatments like ACT for OCD outside the typical Western cultures is needed. The current scoping review summarizes the key characteristics and findings from 18 RCTs that evaluated ACT for OCD in Iran. These RCTs are largely unknown in the broader scientific literature despite representing the vast majority of ACT for OCD trials, in part because the majority are published in Persian. The preponderance of RCTs treated participants in groups, and most protocols did not include exposure exercises. Of 18 trials, 5 were single sex. Use of selective serotonin reuptake inhibitors (SSRIs) was common with all participants on stable doses at pretreatment in many of the trials. Methodological quality was low to medium. ACT was inconsistent against nontraditional comparison conditions, slightly favorable to empirically validated treatments, and favorable compared with the waitlist and SSRIs. The process of change data indicated that ACT increased the psychological flexibility more than cognitive behavior therapy or SSRIs. These results highlight that findings on ACT for OCD from Western populations replicate and generalize to individuals in Iran. These findings also offer insights gained from studying ACT in Iran and significantly expand the literature based on ACT for OCD that can be integrated into scholarship by all researchers.

OBJECTIVE: Randomized controlled trials (RCTs) are the gold standard for evaluating the comparative efficacy and safety of new cancer therapies. However, enrolling patients in control arms of clinical trials can be challenging for rare cancers, particularly in the context of precision oncology and targeted therapies. External Control Arms (ECAs) are a potential solution to address these challenges in clinical research design. We conducted a scoping review to explore the use of ECAs in oncology.
METHODS: We systematically searched four databases, namely MEDLINE, EMBASE, Web of Science, and Scopus. We screened titles, abstracts, and full texts for eligible articles focusing on patients undergoing therapy for cancer, employing ECAs, and reporting clinical outcomes.
RESULTS: Of the 629 articles screened, 23 were included in this review. The earliest included studies were published in 1996, while most studies were published in the past 5 years. 44% (10/23) of ECAs were employed in blood-related cancer studies. Geographically, 30% (7/23) of studies were conducted in the United States, 22% (5/23) in Japan, and 9% (2/23) in South Korea. The primary data sources used to construct the ECAs involved pooled data from previous trials (35%, 8/23), administrative health databases (17%, 4/23) and electronic medical records (17%, 4/23). While 52% (12/23) of the studies employed methods to align treatment and ECAs characteristics, 48% (11/23) lacked explicit strategies.
CONCLUSIONS: ECAs offer a valuable approach in oncology research, particularly when alternative designs are not feasible. However, careful methodological planning and detailed reporting are essential for meaningful and reliable results.

OBJECTIVE: This study was aimed to review and analyze the evidence of the psychosocial interventions for survivors of childhood cancer.
METHODS: Electronic databases (PubMed, Embase, Medline, Web of Science, Science Direct, and Scopus) and manuel search were performed for psychosocial randomised controlled trials (RCTs) conducted with survivors who were diagnosed under the age of 18 and have completed treatment. Meta-analyses were performed to evaluate the effects of interventions on psychosocial health outcomes. The trials were published in English between 1 January 2000 to 30 June 2022 were included. Extracted data were analyzed using Review Manager 5.4.
RESULTS: Ten trials conducted with 955 childhood cancer survivors were included in the systematic review. Meta-analysis of six RCTs showed no difference in the general quality of life (SMD, 0.07; 95% CI: [-0.09 to 0.23], I2 0%, (p > 0.05)) and three RCTs showed no difference in the physical activity self-efficacy (SMD, 0.12; 95% CI: [-0.35 to 0.58], I2 75%, (p > 0.05)) between intervention and control group. Interventions longer than 24 weeks (including follow-up) were effective in the quality of life and physical activity self-efficacy of the survivors. The overall quality of the evidence was low due to overall low risk of bias for only half of the studies (50%).
CONCLUSIONS: Psychosocial interventions were not effective on quality of life and physical activity self-efficacy of childhood cancer survivors, however, long-term interventions provided improvement in these outcomes.
BACKGROUND: The protocol for the meta-analysis was registered at PROSPERO (CRD42022375053/22 Nov 2022).

Potent P2Y12 receptor antagonists have been used widely for patients undergoing percutaneous coronary intervention with different results. Benefits from different regimens various between trials. Randomized controlled trials (RCTs) have restrictive inclusion and exclusion criteria; thus, they may limit the generalizability of the findings to a broader population. This study was aimed to comprehensively investigate the outcomes of potent P2Y12 inhibitors in patients undergoing PCI, including RCTs and real-world evidence (RWE) studies. Multiple electronic databases were systemically reviewed and searched on compared potent P2Y12 inhibitors with clopidogrel. The primary efficacy end point was composite ischemic cardiovascular event and primary safety endpoint was major bleeding. Overall estimates of proportions and incidence rates with 95 % confidence intervals (CI) were calculated using fixed-effects models. Total 24 studies (140,986 patients) underwent coronary intervention were included in this meta-analysis, including 18 RCTs and 6 large cohort studies with propensity score matching. The potent P2Y12 inhibitors including cangrelor, prasugrel, and ticagrelor, significantly decreased the risk of composite adverse cardiovascular ischemic events (95 % CI 0.89-0.96, p < 0.001), but increased major bleeding (95 % CI 1.15-1.33, p < 0.001) or any bleeding (95 % CI 1.21-1.33, p < 0.001) compared with Clopidogrel. This meta-analysis merges RCTs and RWE studies and comprehensively evidences newer potent P2Y12 inhibitors are significantly more effective than clopidogrel in reduction of composite adverse thrombotic events, but the incidence of major or any bleeding was higher compared with clopidogrel.

OBJECTIVE: This study aims to assess the effectiveness of a peer support intervention on the quality of life (QOL), self-management, self-efficacy, glycated hemoglobin (HbA1c), and depression in patients with type 2 diabetes mellitus (T2DM).
METHODS: A systematic review was conducted by searching 10 databases, namely PubMed, The Cochrane Library, Embase, Medline, CINHAL, Web of Science, Sinomed, CNKI, WanFang Data, and VIP for articles published from January 1974 to April 2023.
RESULTS: A total of 12 studies were included. A narrative synthesis of the results showed that peer support significantly improved QOL, self-management, self-efficacy, and HbA1c control in patients with T2DM, but had no significant effect on depression.
CONCLUSIONS: Peer support is an effective intervention for individuals with T2DM. Future research should focus on more rigorously designed and larger-sample studies.
CONCLUSIONS: Peer support proves to be effective for managing patients with T2DM. Current peer support interventions can provide valuable ideas that can guide the direction of future research.

OBJECTIVE: It is unclear if clinical trials of treatments for lower-limb tendinopathies include clinically homogeneous participant populations (an assumption for pooling in meta-analyses). We assessed the recruitment setting and participant characteristics used in randomized controlled trials (RCTs) that were investigating any treatment for lower-limb tendinopathies. DESIGN: Scoping review. METHODS: We conducted a systematic literature search in the PubMed, Embase, Cochrane CENTRAL, and Web of Science databases. All RCTs that were investigating treatments for lower-limb tendinopathies in an adult population (≥18 years) were eligible for inclusion. At least 2 authors conducted independent screening and selection of full-text papers, and extracted data from included studies. RESULTS: Of 18 341 records, 342 RCTs (21 897 participants) were eligible for inclusion and data extraction. The most common diagnoses were plantar fasciopathy (n = 195, 57%), Achilles tendinopathy (n = 82, 24%), and patellar tendinopathy (n = 41, 12%). Secondary care (n = 144, 42%) was the most reported recruitment setting, followed by an open setting (n = 44, 13%). In 93 (27%) RCTs, the recruitment setting was not described. We found high heterogeneity in participant characteristics (eg, symptom duration, age, body mass index, and the Victorian Institute of Sport Assessment [VISA] questionnaire score) within and between recruitment settings. CONCLUSION: Our results question whether clinical homogeneity can be adequately assumed in clinical trials of lower-limb tendinopathies due to the lack of clear reporting of the recruitment setting and the variability within and between recruitment settings of key participant characteristics. These findings threaten assumptions for meta-analyses in lower-limb tendinopathies. J Orthop Sports Phys Ther 2024;54(1):1-10. Epub 5 December 2023. doi:10.2519/jospt.2023.11722.

Although long-term opioid therapy (LTOT) has its own risks, opioid discontinuation could pose harm for high-risk Veterans Health Administration (VHA) patients receiving LTOT. There is limited information on the impact of a mandate requiring providers to perform case reviews on high-risk patients with an active opioid prescription (ie, mandated case review policy) on opioid discontinuation and mortality.
Our study is a secondary data analysis of a 23-month stepped-wedge cluster randomized controlled trial between April 2018 and March 2020. The study included 10 685 LTOT patients with a predicted risk of a serious adverse event between the top 1% to 5% nationally who entered the risk range between 4/18/2018 and 11/9/2019. We examined whether the mandated case review policy had an impact on opioid discontinuation and mortality for the patients.
Among 10 685 LTOT patients (88.2% male; mean [SD] age, 61.1 [11.7] years), 29.1% experienced discontinuation and the mortality rate was 9.5%. Patients under mandated case review had a decreased risk of opioid discontinuation (average marginal effect [AME], -11.16 [95% CI, -15.30 to -7.01] percentage points) and all-cause mortality (AME, -3.31 [95% CI, -5.63 to -1.00] percentage points), relative to patients who were not under the mandate.
The VHA mandated case review policy was associated with lower probability of discontinuation and all-cause mortality for high-risk patients receiving LTOT. Interventions that maintain care engagement while optimizing pain management for high-risk patients may be beneficial for minimizing mortality and other risks associated with discontinuation.

Reverse shoulder arthroplasty (RSA) is used in the treatment of traumatic and arthritic pathologies, with expanding clinical indications and as a result there has been an increase in clinical research on the topic. The purpose of this study was to examine the statistical fragility of randomized control trials (RCTs) reporting outcomes from RSA. A systematic search was undertaken to find RCTs investigating RSA. The Fragility Index (FI) was calculated using Fisher\'s exact test, by sequentially altering the number of events until there was a reversal of significance. The Fragility Quotient (FQ) was calculated by dividing the FI by the trial population. Each trial was assigned an overall FI and FQ calculated as the median result of its reported findings. Overall, 19 RCTs warranted inclusion in the review, representing 1146 patients, of which 41.2% were male, with a mean age of 74.2 ± 4.3 years and mean follow-up of 22.1 ± 9.9 months. The median RCT population was 59, with a median of 9 patients lost to follow-up. The median FI was 4.5, and median FQ was 0.083, indicating more patients did not complete the trial than the number of outcomes which would have to change to reverse the finding of significance. This review found that the RCT evidence for RSA management may be vulnerable to statistical fragility, with a handful of events required to reverse a finding of significance.

The emerging research in the literature continues to forecast a drastic and alarming increase in negative mental health and sleep health outcomes among populations, especially after the COVID-19 pandemic, which significantly influenced people\'s way of life. With mental health pharmaceutical interventions continuing to be stigmatized and inaccessible among populations, natural supplements provide an opportunity for intervention.
This study sought to conduct a systematic review of the literature on the most recent comprehensive evidence for which nutritional supplements have the greatest therapeutic impact on symptoms of anxiety, depression, and insomnia.
A systematic search of the literature, utilizing several databases, including PubMed and Web of Science, was conducted on 29 April 2022. We used developed keywords and MeSH terms for the search. The study eligibility criteria included (1) a randomized control trial; (2) investigating a plant-based therapeutic or natural supplement as the intervention; (3) measuring at least one health outcome of the following: anxiety symptoms, depressive symptoms, or sleep health outcomes; (4) utilizing validated measurement tools to measure the outcome of interest; (5) written in the English language; (6) peer reviewed; and (7) focused on adults and elderly populations.
Following the PRISMA guidelines, 76 studies were included in this review. We used the revised Risk of Bias tool (RoB2) to assess the quality of all included randomized control trials. A qualitative data synthesis was conducted. Overall, we found several valuable insights from the evidence in the literature, including evidence that demonstrates the benefits of probiotics and vitamin B complexes on anxiety symptoms, depressive symptoms, and sleep quality. Implication of Key Findings: This review provides the most updated findings in the literature on the topic, including an abundance of research that was published in the past 5 years. Given the expected rise in negative mental and sleep health outcomes following the pandemic, the supplements and therapeutics identified in this study should be the target of intervention measures to increase their accessibility and affordability and allow them to be incorporated into clinical guidelines of treatment. PROSPERO registration number: CRD42022361130.

To date, dozens of systematic reviews (SRs) and meta-analyses (MAs) summarize the effectiveness of preventive interventions for perinatal depression. However, the results are inconclusive, making an urgent need to step up to higher levels of evidence synthesis.
To summarize and compare the evidence from the SR&MA examining the effectiveness of all types of interventions for preventing perinatal depression.
PubMed, PsycINFO, Cochrane Database of Systematic Reviews and OpenGrey were searched from inception to December 2022. We selected SR&MA of randomized controlled trials (RCTs) that compared all types of preventive interventions for perinatal depression with control groups whose outcome was the reduction of depressive symptoms and/or incidence of new cases of perinatal depression (PROSPERO: CRD42020173125).
A total of 19 SRs and MAs evaluated 152 unique RCTs that included 83,408 women from 26 countries and five continents. The median effect size for any intervention was SMD = 0.29 (95% CI: 0.20 to 0.38). Exercise/physical activity-based, psychological, and any type of intervention showed median effect sizes of 0.43, 0.28 and 0.36, respectively. The degree of overlap among RCTs was slight. According to AMSTAR-2, 79% of them were rated as low or critically low-quality. The strength of evidence, according to GRADE, was poorly reported and, in most cases, was low.
Exercise/physical activity-based and psychological interventions have a small-to-medium effect on reducing perinatal depressive symptoms. There is insufficient evidence to conclude that dietary supplements and pharmacological interventions are effective in preventing perinatal depression. There is a need for high-quality SR&MA of RCTs, mainly focusing on universal preventive interventions.