OBJECTIVE: To assess the efficacy and safety of extracorporeal shockwave therapy (ESWT) combined with sodium hyaluronate (HA) for the treatment of knee osteoarthritis (KOA). METHODS: PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang database, China Science and Technology Journal Database, and SinoMed were searched from inception to July 2020. The quality of the randomized controlled trials was evaluated independently by two reviewers according to the criteria in the Cochrane Collaboration for Systematic Reviews. The identified articles were then screened individually using EndnoteX9 for eligibility in this Meta-analysis. The heterogeneity among the articles was evaluated using I2. RESULTS: A total of 17 studies, comprising 2000 individuals, were included in this Meta-analysis. The results showed that a significant improvement was observed in knee pain and function based on the clinical efficacy of ESWT combined with HA. Statistical analysis of clinical efficacy showed that [relative risk (RR) = 1.21, 95% confidence interval (CI) (1.12, 1.30), P < 0.01]. Statistical analysis of visual analog scale showed that [standardized mean difference (SMD) = -2.84, 95%CI ( - 4.01, - 1.66), P < 0.01]. Western Ontario and McMaster University osteoarthritis index statistical analysis showed that [SMD = -1.57, 95% CI ( -2.52, -0.61), P < 0.01]. Lysholm score statistical analysis showed that [SMD = 1.71, 95% CI (0.98, 2.44), P < 0.01]. In addition, only minor side effects, such as redness and swelling of the skin, were observed. CONCLUSIONS: Medium to low quality evidence showed that ESWT combined with HA offers an inexpensive, welltolerated, safe, and effective method to improve pain and functionality in patients with KOA. However, tightly controlled, randomized, large multicenter trials are warranted to validate the current findings.

Aim: This meta-analysis aimed to compare the efficacy of in-person and digital mental health interventions in addressing Postpartum Depression. Methods: Following PRISMA guidelines, the protocol for this meta-analysis was registered at the Open Science Framework (Retrieved from osf.io/wy3s4). This meta analysis included Randomized Controlled Trials (RCTs) conducted between 2013 and 2023. A comprehensive literature search identified 35 eligible RCTs from various electronic databases. Inclusion criteria focused on pregnant women over 18 years old, encompassing antenatal depression and up to two years postpartum. Diagnostic interviews or Edinburgh Postnatal Depression Scale (EPDS) were used to establish PPD. Digital interventions included telephonic, app-based, or internet-based approaches, while in-person interventions involved face-to-face sessions. Results: The meta-analysis revealed a moderate overall effect size of -0.69, indicating that psychological interventions are effective for PPD. Digital interventions (g = -0.86) exhibited a higher mean effect size than in-person interventions (g = -0.55). Both types of interventions displayed substantial heterogeneity (digital: I2 = 99%, in-person: I2 = 92%), suggesting variability in intervention content, delivery methods, and participant characteristics. Conclusion: Digital mental health interventions show promise in addressing PPD symptoms, with a potentially greater effect size compared to in-person interventions. However, the high heterogeneity observed in both modalities underscores the need for further research to identify key drivers of success and tailor interventions to diverse populations. Additionally, the choice between digital and in-person interventions should consider individual needs and preferences. Ongoing research should further investigate and optimise intervention modalities to better serve pregnant women at risk of PPD.

Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve health, for example, healthy eating, psychological wellbeing. Harms are often recorded poorly or inconsistently within randomized controlled trials of BCIs. This scoping review aimed to collate and describe literature on categories, definitions, and mechanisms of harms from BCIs; methods of identifying plausible harms; and recommendations for recording harms. Study design and setting: A scoping review was conducted. Three databases (MEDLINE, PsycINFO, and CINAHL) were searched. Reference list checking and citation searching were performed. Articles were included if they discussed (1) interventions that aimed to modify behavior, (2) categories or mechanisms of harms, and (3) methods or recommendations for recording harms. All research designs were included. One reviewer reviewed titles, abstracts, and full texts; queries were checked with another reviewer. Data were extracted and synthesized descriptively by one reviewer and checked by another reviewer. A thematic map was constructed to summarize the review findings. Harms described from specific BCIs were identified, and examples were selected and summarized. Results: The review included 37 articles. Nineteen of 37 articles contributed to a thematic review. Three articles described categories of harms; categories of harm included physical, psychological, group and social interactions, cultural, equity, opportunity cost, environmental, and economic. Seven articles included mechanisms or underlying factors for harms including feelings of failure leading to shame or stigma, and group interventions enabling knowledge exchange on unhealthy behaviors. Twelve articles provided recommendations for recording harms, including taking a proportionate approach by focusing on the most plausible and important harms, collecting different perspectives on whether harms had occurred (eg, caregivers and family members), and using qualitative research methods to identify harms. One article described a three-step method to identify plausible harms from an intervention, and six articles supported aspects of the method. Eighteen of 37 articles contributed to a review which collated harms arising from specific interventions, for example, a peer support intervention in inflammatory bowel disease caused distressing conversations which might lead to anxiety and confrontation with a possible negative future. Conclusion: BCIs can cause harm. This review identified categories and proposed mechanisms of harms, as well as methods and recommendations for identifying and recording harms in BCIs for inclusion in forthcoming recommendations.

Background: Gestational weight gain (GWG) below or above the Institute of Medicine (IOM) recommendations has been associated with adverse perinatal outcomes. Few studies have examined the effect of prenatal nutrient supplementations on GWG in low- and middle-income countries (LMICs). Objectives: We aimed to investigate the effects of multiple micronutrient supplements (MMSs) and small-quantity lipid-based nutrient supplements (LNSs) on GWG in LMICs. Methods: A 2-stage meta-analysis of individual participant data was conducted to examine the effects of MMSs (45,507 women from 14 trials) and small-quantity LNSs (6237 women from 4 trials) on GWG compared with iron and folic acid supplements only. Percentage adequacy of GWG and total weight gain at delivery were calculated according to the IOM 2009 guidelines. Binary outcomes included severely inadequate (percentage adequacy 125%) GWG. Results from individual trials were pooled using fixed-effects inverse-variance models. Heterogeneity was examined using I2, stratified analysis, and meta-regression. Results: MMSs resulted in a greater percentage adequacy of GWG [weighted mean difference (WMD): 0.86%; 95% CI: 0.28%, 1.44%; P < 0.01] and higher GWG at delivery (WMD: 209 g; 95% CI: 139, 280 g; P < 0.01) than among those in the control arm. Women who received MMSs had a 2.9% reduced risk of severely inadequate GWG (RR: 0.971; 95% CI: 0.956, 0.987; P < 0.01). No association was found between small-quantity LNSs and GWG percentage adequacy (WMD: 1.51%; 95% CI: -0.38%, 3.40%; P = 0.21). Neither MMSs nor small-quantity LNSs were associated with excessive GWG. Conclusions: Maternal MMSs were associated with greater GWG percentage adequacy and total GWG at delivery than was iron and folic acid only. This finding is consistent with previous results on birth outcomes and will inform policy development and local recommendations of switching routine prenatal iron and folic acid supplements to MMSs.

Objectives: To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias.Study Design and Setting: We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two re-viewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above.Results: Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items. Conclusion: Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.(c) 2022 Elsevier Inc. All rights reserved.

Purpose Accumulating evidence showed that probiotics therapy might be effective in treating diarrhea-predominant irritable bowel syndrome (IBS-D). This study aimed to evaluate the effectiveness and safety of probiotics therapy for the treatment of IBS-D. Methods We performed a comprehensive literature search in eight electronic databases, and gray literature from inception to August 4, 2021. Randomized controlled trials (RCTs) of probiotics therapy for the treatment of IBS-D were included and the quality was assessed using the risk of bias tool recommended by the Cochrane Handbook version 5.1.0. RevMan 5.4 software was used to perform the meta-analysis on the outcomes of IBS-D symptoms, abdominal pain, quality of life, and abdominal distension. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence. Results Ten RCTs evaluating 943 patients were identified. Only one study had unclear risk of bias, while nine studies had a high risk of bias. The meta-analysis results showed that, compared to the placebo, probiotics therapy significantly decreased the score of IBS-D symptoms (SMD = - 0.55, 95% CI: [- 0.83, - 0.27], P < 0.05), abdominal pain (SMD = - 0.43, 95% CI: [- 0.57, - 0.29], P < 0.05), and abdominal distension (SMD = - 0.45, 95%CI: [- 0.81, - 0.09], P < 0.05). There was no statistical difference in the quality of life. However, all the certainty of evidence was very low. Conclusion Very low certainty evidence showed that probiotics might be an effective treatment for improving the IBS-D symptoms, abdominal pain, and abdominal distension, in adult IBS-D patients. However, these conclusions should be supported by high-quality evidence.

Aim To assess the effect of lubricants on reducing perineal trauma during vaginal delivery. Methods PubMed, Embase, the Cochrane Library, CINAHL, China National Knowledge Infrastructure, China Biology Medicine disc, WanFang databases, and , were searched for literature up to 25 June 2021. Randomized controlled trials published in English or Chinese that compared the vaginal application of lubricant with standard care for women were included. Two reviewers independently performed study screening, data extraction, risk of bias assessment, and certainty of evidence assessment. Pooled effect sizes and corresponding 95% confidence intervals (CI) were calculated using meta-analysis. Results Nineteen trials enrolling 5445 pregnant women were included. Compared with standard care, women using lubricants had a lower incidence of perineal trauma (risk ratio [RR] 0.84, 95% CI 0.76-0.93; low certainty evidence), second-degree perineal laceration (RR 0.72, 95% CI 0.64-0.82; moderate certainty evidence) and episiotomy (RR 0.77, 95% CI 0.62-0.96; very low certainty evidence), and had a shorter duration of the second-stage labor (MD -13.72 min, 95% CI -22.68 to -4.77; very low certainty evidence). Conclusion Lubricants might reduce the incidence of perineal trauma, especially second-degree perineal laceration, and shorten the duration of the second-stage labor. More well-designed studies will continue developing high-quality evidence in this field.

AIMS: To synthesize the effectiveness of web-based psychosocial interventions on self-efficacy, anxiety, depression, quality of life (QoL), non-specific psychological and cancer-specific distress among patients with colorectal cancer (CRC). DESIGN: A systematic review and meta-analysis. DATA SOURCES: Six databases (PubMed, PsycINFO, Embase, Scopus, CINAHL and CNKI) were searched from inception to December 2021. REVIEW METHODS: Experimental/quasi-experimental studies involving patients with CRC for the improvement of aforementioned outcomes were included. Two reviewers screened and extracted the data, and assessed studies' methodological quality using risk of bias tools. Meta-analyses and narrative syntheses were performed. RESULTS: Nineteen studies consisting of 1386 participants were identified. Cognitive-behavioural therapy delivered online was the most common trialled web-based psychosocial intervention. Meta-analyses revealed no positive effect for self-efficacy (standardized mean difference 0.93, 95% CI: 0.52 to 1.35, p < .01) and minimal benefit for QoL (mean difference [MD] 2.83, 95% CI: -0.31 to 5.98, p = .08) but significant positive effects for anxiety (MD -2.23, 95% CI: -3.31 to -1.14, p < .01) and depression (MD -2.84, 95% CI: -4.09 to -1.59, p < .01) among CRC survivors in the intervention group as compared with the control group. Narrative synthesis suggested possible benefits in reducing distress. CONCLUSION: Web-based psychosocial interventions are promising alternatives to conventional delivery methods in reducing patients' anxiety, depression and distress. However, evidence on self-efficacy and QoL remains inconsistent. More adequately powered, well-designed trials with targeted and theory-based interventions are required to ascertain findings. IMPACT: By highlighting the potential of web-based psychosocial interventions in reducing anxiety and depression among CRC survivors, this review has put forth beneficial information supporting the use and acceptance of web-based care delivery in light of COVID-19 restrictions and nationwide lockdowns. Meanwhile, the paucity of empirical support reflects the necessity of more extensive research to test and improve other health outcomes.

We study whether structured management practices affect the uptake and impact of industrial energy efficiency measures, which are widely considered important for mitigating climate change. In a randomized experiment that provides small- and medium-sized metal machining firms with tailored recommendations to improve energy efficiency, we find that the likelihood of recommendation adoption increases with a firm’s management practice score. However, the intervention’s main effect—a reduction in the unit cost of electricity—is larger in firms with less developed structured practices. We find that this effect can be traced to managers’ suboptimal selection of transformer-related parameters at baseline, which resulted in higher electricity costs. This “energy management gap” is most strongly associated with low monitoring, target-setting, and incentive practice scores. Our findings suggest that structured management practices may help firms absorb new ideas that are expected to reduce physical energy use and greenhouse gas emissions, while tailoring interventions to address management practice gaps in low-scoring firms may unlock opportunities to save energy cost. However, impact on greenhouse gas emissions may be limited.

BACKGROUND: Extended reality, which encompasses virtual reality (VR), augmented reality (AR), and mixed reality (MR), is increasingly used in medical education. Studies assessing the effectiveness of these new educational modalities should measure relevant outcomes using outcome measurement tools with validity evidence. OBJECTIVE: Our aim is to determine the choice of outcomes, measurement instruments, and the use of measurement instruments with validity evidence in randomized controlled trials (RCTs) on the effectiveness of VR, AR, and MR in medical student education. METHODS: We conducted a systematic mapping review. We searched 7 major bibliographic databases from January 1990 to April 2020, and 2 reviewers screened the citations and extracted data independently from the included studies. We report our findings in line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. RESULTS: Of the 126 retrieved RCTs, 115 (91.3%) were on VR and 11 (8.7%) were on AR. No RCT on MR in medical student education was found. Of the 115 studies on VR, 64 (55.6%) were on VR simulators, 30 (26.1%) on screen-based VR, 9 (7.8%) on VR patient simulations, and 12 (10.4%) on VR serious games. Most studies reported only a single outcome and immediate postintervention assessment data. Skills outcome was the most common outcome reported in studies on VR simulators (97%), VR patient simulations (100%), and AR (73%). Knowledge was the most common outcome reported in studies on screen-based VR (80%) and VR serious games (58%). Less common outcomes included participants' attitudes, satisfaction, cognitive or mental load, learning efficacy, engagement or self-efficacy beliefs, emotional state, competency developed, and patient outcomes. At least one form of validity evidence was found in approximately half of the studies on VR simulators (55%), VR patient simulations (56%), VR serious games (58%), and AR (55%) and in a quarter of the studies on screen-based VR (27%). Most studies used assessment methods that were implemented in a nondigital format, such as paper-based written exercises or in-person assessments where examiners observed performance (72%). CONCLUSIONS: RCTs on VR and AR in medical education report a restricted range of outcomes, mostly skills and knowledge. The studies largely report immediate postintervention outcome data and use assessment methods that are in a nondigital format. Future RCTs should include a broader set of outcomes, report on the validity evidence of the measurement instruments used, and explore the use of assessments that are implemented digitally.

Postpartum depression (PPD) is one of the most common disorders following childbirth. This systematic review and meta-analysis (SR/MA) aimed to assess the effectiveness of psychological interventions in preventing PPD in non-depressed women. PRISMA guidelines were followed. MEDLINE (Ovid and PubMed), PsycINFO, Web of Science, Scopus, CINAHL, CENTRAL, OpenGrey, Australian New Zealand Clinical Trial Registry and clinicaltrial.gov were searched. Randomized controlled trials (RCTs) conducted with pregnant or postpartum (up to 12 months) women who were non-depressed at baseline were selected. The outcomes were the incidence of PPD and/or the reduction of postpartum depressive symptoms. The standardized mean difference (SMD) using random-effect models was calculated. Sensitivity, sub-group and meta-regression analyses were performed. 17 RCTs were included in the SR and 15 in the MA, representing 4958 participants from four continents. The pooled SMD was -0.175 [95% confidence interval (CI) -0.266 to -0.083; p < 0.001] and sensitivity analyses confirmed the robustness of this result. Heterogeneity was low (I2 = 21.20%) and was fully explained by a meta-regression model including one variable (previous deliveries). The meta-regression model and MA stratified by previous deliveries indicated that interventions focused on primiparous women are more effective. There was no evidence of publication bias. Few RCTs had an overall low risk of bias. According to GRADE, the quality of evidence was moderate. Psychological interventions have very little effectiveness in preventing PPD in non-depressed women, although this effectiveness is greater in interventions focused on primiparous women. Further RCTs with a low risk of bias and more effective interventions are needed.

(1) BACKGROUND: The COVID-19 outbreak has caused psychological problems worldwide. This review explored the psychological effects of online-based mindfulness programs during the COVID-19 pandemic. (2) METHODS: This systematic review was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials that were published in the English language from 1 January 2020 to 31 May 2021 on online-based mindfulness programs for psychological problems due to the COVID-19 pandemic were searched in electronic databases. Quality assessment was conducted on the retrieved RCTs using the Cochrane risk of bias tool for RCTs. (3) RESULTS: Six RCTs were included in this review. Quality appraisal of included RCTs ranged from 1 for low risk of bias to 5 for high risk of bias. There is evidence from the six RCTs that online-based mindfulness interventions may have favorable effects for reducing the levels of psychological problems, such as anxiety, depression, and stress. (4) CONCLUSIONS: Online-based mindfulness programs may be used as complementary interventions for clinical populations, healthy individuals, and healthcare workers with psychological problems due to the COVID-19 pandemic.

Integrating digital interventions in healthcare has gained increasing popularity among clinical pharmacists (CPs) due to advances in technology. The purpose of this study was to systematically review CP-led digital interventions to improve patients' health-related clinical outcomes. PubMed and the Cochrane Database were searched to select studies that had conducted a randomized controlled trial to evaluate clinical outcomes in adults following a CP-led digital intervention for the period from January 2005 to August 2021. A total of 19 studies were included in our analysis. In these 19 studies, the most commonly used digital intervention by CPs was telephone use (n = 15), followed by a web-based tool (n = 2) and a mobile app (n = 2). These interventions were provided to serve a wide range of purposes in patients' outcomes: change in lab values (e.g., blood pressure, HbA1c) (n = 23), reduction in health service use (n = 8), enhancing adherence (n = 6), improvement in drug-related outcomes (n = 6), increase in survival (n = 3), and reduction in health-related risk (e.g., CVD risk) (n = 2). Although the impacts of telephone-based interventions on patients' outcomes were decidedly mixed, web-based interventions and mobile apps exerted generally positive influences. To date, little research has investigated the cost-effectiveness of digital interventions. Future studies are warranted.

OBJECTIVE: We evaluated the effects of mental health interventions among people hospitalized with COVID-19. METHODS: We conducted a systematic review and searched 9 databases (2 Chinese-language) from December 31, 2019 to June 28, 2021. Eligible randomized controlled trials assessed interventions among hospitalized COVID-19 patients that targeted mental health symptoms. Due to the poor quality of trials, we sought to verify accuracy of trial reports including results. RESULTS: We identified 47 randomized controlled trials from China (N = 42), Iran (N = 4) and Turkey (N = 1) of which 21 tested the efficacy of psychological interventions, 5 physical and breathing exercises, and 21 a combination of interventions. Trial information could only be verified for 3 trials of psychological interventions (cognitive behavioral, guided imagery, multicomponent online), and these were the only trials with low risk of bias on at least 4 of 7 domains. Results could not be pooled or interpreted with confidence due to the degree of poor reporting and trial quality, the frequency of what were deemed implausibly large effects, and heterogeneity. CONCLUSION: Trials of interventions to address mental health in hospitalized COVID-19 patients, collectively, are not of sufficient quality to inform practice. Health care providers should refer to existing expert recommendations and standard hospital-based practices.

BACKGROUND: During adolescence, suicide risk increases; effective treatments are needed to reduce risk. METHODS: Databases were searched (1995-2020) for randomized controlled trials (RCTs) concerning psychosocial treatments for suicide prevention in adolescents (10-18 yrs). Data were extracted from the timepoint closest to 6 months. Cohen's ds were estimated for reducing suicidal ideation (SI), self-harming behaviors (SHB) excluding strictly non-suicidal self-injury, and suicide attempts (SA) and analyzed using generalized least square regression. Meta-analytic innovations included within-person correlations to reflect trait suicidality; annualization to control for exposure; estimated lifetime risk based on ages; and modeling inclusion/exclusion criteria. Alternate approaches included relative risk and comparison of intervention and control treatments to baseline. RESULTS: Of 30 RCTs, 6 assessing SHB (4 measuring SA), and 7 assessing SI demonstrated treatment effectiveness. Overall, interventions decreased SI (n=25) with low effect size (d=0.08, p=0.01), non-significant after controlling for publication bias (d=0.05, p=0.1); interventions were non-significant for SHB (n=25, d=0.001, p=0.97) or SA (n=18, d=0.03, p=0.52). To prevent one SHB, the number needed to treat (NNT) was 45[26, 156]; for SA, NNT=42[24, 149]. Non-superiority may relate to effectiveness of control treatments. Thus, experimental and control treatments also were compared to baseline: both reduced SI (p<0.0001), and effectiveness improved for SHB (NNT=12) and SA (NNT=11). LIMITATIONS: Study heterogeneity and inconsistent statistical reporting limited meta-analysis. CONCLUSIONS: Psychosocial interventions for suicide risk in adolescents showed little effectiveness compared with control treatments; suicide outcomes improved in both groups compared to baseline. Different approaches may be needed, including precision medicine methodologies and standardized statistical reporting criteria.

BACKGROUND: Mobile technology has become a necessity in the lives of people in many countries. Its characteristics and advantages also make it a potential medium of intervention for people with autism spectrum disorder (ASD). OBJECTIVE: The objective of this review was to evaluate previous evidence, obtained in randomized controlled trials (RCTs), on the effectiveness of using mobile devices as the medium of intervention targeting social and cognitive skills among individuals with ASD. METHODS: Literature search was conducted on electronic databases including Medline, PsycInfo, PsycArticles, Education Resources Information Centre, and Social Science Citation Index. Only RCTs published in English and after year 2000 were included for this review. Data extraction was carried out by 2 independent reviewers using constant comparative methods. RESULTS: Totally 10 RCTs were identified. Most of the findings indicated that mobile devices could be an effective medium of intervention for people with ASD, among which 6 indicated significant intervention effects and 2 showed mixed findings. Effective intervention was more likely to be achieved in the studies that recruited older participants (aged over 9 years), targeting practical skills that could be readily applied in real life, or using pictures or materials that were highly relevant in daily life in the apps or mobile devices. Furthermore, the use of mobile devices was also reported to promote participation in the intervention among individuals with ASD. CONCLUSIONS: The results suggested that mobile devices could be a promising means for the delivery of interventions targeting people with ASD. Although including a small number of studies was a limitation of this review, the results provided useful implications for designing effective mobile technology-assisted interventions for the ASD population in future studies.

Objective: This study collected randomized controlled trials (RCTs) published in the social sciences in China and assessed their risk of bias and reporting quality. Study design and setting: Three databases were systematically searched for publications from January 2000 to June 2020 for RCTs in the social sciences published by Chinese researchers. The risk of bias was assessed using the Cochrane Collaboration Risk of Bias Tool, and reporting quality was assessed using the Consolidated Standards of Reporting Trials for Social and Psychological Interventions (CONSORT-SPI). Results: A total of 316 RCTs were identified, including 204 articles in English and 112 articles in Chinese. The most frequently researched interventions focused on education (33.9%), and the most frequently studied population were students (32.9%). Eighty-seven percent of RCTs had intermediate reporting quality. Twenty-four of the 43 CONSORT-SPI sub-items had a compliance rate of less than 50%. Most RCTs had an unclear risk of bias for blinding outcome assessors (84.5%), blinding participants and personnel (82.9%), allocation concealment (73.1%), and random sequence generation (68.0%). A low proportion of CONSORT-SPI items were reported and, high proportion of the papers had unclear risk of bias. Conclusion: The quality and reporting of RCTs in the social sciences needs improvement in China, especially for reporting methods and results. Most studies had an unclear risk of bias as they lacked important methodological information. (c) 2021 Elsevier Inc. All rights reserved.

Objective: To describe the characteristics of Covid-19 randomized clinical trials (RCTs) and examine the association between trial characteristics and the likelihood of finding a significant effect. Study design: We conducted a systematic review to identify RCTs (up to October 21, 2020) evaluating drugs or blood products to treat or prevent Covid-19. We extracted trial characteristics (number of centers, funding sources, and sample size) and assessed risk of bias (RoB) using the Cochrane RoB 2.0 tool. We performed logistic regressions to evaluate the association between RoB due to randomization, single vs. multicentre, funding source, and sample size, and finding a statistically significant effect. Results: We included 91 RCTs (n = 46,802); 40 (44%) were single-center, 23 (25.3%) enrolled < 50 patients, 28 (30.8%) received industry funding, and 75 (82.4%) had high or probably high RoB. Thirty-eight trials (41.8%) reported a statistically significant effect. RoB due to randomization and being a single-center trial were associated with increased odds of finding a statistically significant effect. Conclusions: There is high variability in RoB among Covid-19 trials. Researchers, funders, and knowledge-users should be cognizant of the impact of RoB due to randomization and single-center trial status in designing, evaluating, and interpreting the results of RCTs. (C) 2021 Elsevier Inc. All rights reserved.

BACKGROUND In recent years, intraoperative radiotherapy (IORT) has been increasingly used for the treatment of rectal cancer. However, the efficacy and safety of IORT for the treatment of rectal cancer are still controversial. AIM To evaluate the value of IORT for patients with rectal cancer. METHODS We searched PubMed, Embase, Cochrane Library, Web of Science databases, and conference abstracts and included randomized controlled trials and observational studies on IORT vs non-IORT for rectal cancer. Dichotomous variables were evaluated by odds ratio (OR) and 95% confidence interval (CI), hazard ratio (HR) and 95%CI was used as a summary statistic of survival outcomes. Statistical analyses were performed using Stata V.15.0 and Review Manager 5.3 software. RESULTS In this study, 3 randomized controlled studies and 12 observational studies were included with a total of 1460 patients, who are mainly residents of Europe, the United States, and Asia. Our results did not show significant differences in 5-year overall survival (HR = 0.80, 95%CI = 0.60-1.06; P = 0.126); 5-year disease-free survival (HR = 0.94, 95%CI = 0.73-1.22; P = 0.650); abscess (OR = 1.10, 95%CI = 0.67-1.80; P = 0.713), fistulae (OR = 0.79, 95%CI = 0.33-1.89; P = 0.600); wound complication (OR = 1.21, 95%CI = 0.62-2.36; P = 0.575); anastomotic leakage (OR = 1.09, 95%CI = 0.59-2.02; P = 0.775); and neurogenic bladder dysfunction (OR = 0.69, 95%CI = 0.31-1.55; P = 0.369). However, the meta-analysis of 5-year local control was significantly different (OR = 3.07, 95%CI = 1.66-5.66; P = 0.000). CONCLUSION The advantage of IORT is mainly reflected in 5-year local control, but it is not statistically significant for 5-year overall survival, 5-year disease-free survival, and complications.

OBJECTIVES: The diabetes self-management education (DSME) program is one of the strategies to maintain healthy behaviors. Nevertheless, limited evidence has been systematically evaluated about DSME integrated with peer support's effect on glycemic control. This study aimed to review the effectiveness of DSME interventions integrated with peer support on glycemic control in patients with type 2 diabetes. METHODS: Systematically searching was carried out on electronic databases, including PubMed, Cochrane Library, ProQuest, Springer link, Science direct, Scopus, and Google scholar for English language articles published from 2005 until 2020. The effect size was estimated as standard mean difference (SMD). The Cochrane Collaboration's tool were employed to assess the risk of bias. RESULTS: Twelve studies were included in this study. DSME integrated with peer support effectively reduced HbA1c, and it was statistically significant (SMD= -0.41 95%CI= -0.69 to -0.13; p<0.001). Program with sample size <100 (SMD= -0.45; 95%CI= -0.79 to -0.11; p= 0.009), dura¬tion of intervention ≤6 month (SMD= -0.52; 95%CI= -0.96 to -0.07; p=0.020), baseline at HbA1c <8.5% (SMD= -0.42; 95%CI= -0.77 to -0.07; p=0.020), delivery by group (SMD= -0.28; 95%CI=-0.51 to -0.06; p=0.010), and high frequency of contact (SMD= -0.29; 95%CI= -0.48 to -0.10; p=0.003) were effective and statistically significant to reduce HbA1c level in patients with type 2 diabetes. CONCLUSION: DSME integrated with peer support effectively enhances glycemic control in patients with type 2 diabetes. Program with smaller study sizes, shorter duration of intervention, weekly meetings and closer group sessions are improving glycemic control in patients with type 2 diabetes.