Recruitment prior to conception for pregnancy studies: a systematic review and meta-analysis.

<h3>Objectives</h3> Recruitment in randomised controlled trials (RCTs) is a complex process and includes several stages including the assessment of potential participants for eligibility and successively converting the number of eligible people into consenting, randomised participants. In behavioural RCTs of smoking cessation interventions, poor recruitment is common. In our pool of trials with data available eligibility rates were 61% (95% confidence interval 54% to 66%) and recruitment rates were 69% (95% confidence interval 64% to 73%). However, evidence on which factors predicts poor recruitment in behavioural RCTs of smoking cessation interventions is limited. Individual studies have suggested that participant characteristics (e.g. older age), recruitment strategies (e.g. via internet) and intervention characteristics (e.g. face-to-face) may influence the recruitment process. Therefore, our aim was to identify predictors of eligibility and recruitment rates in smoking cessation RCTs by performing meta-regression analyses on the studies within the IC-SMOKE systematic review project. <h3>Method</h3> The IC-SMOKE project is a systematic reviews project of 173 behavioural RCTs of smoking cessation interventions; the protocol is published on PROSPERO (CRD42019121453). Relevant studies were identified in the Cochrane Tobacco Addiction Group Specialized Register. We identified RCTs testing behavioural interventions (with or without pharmacological support) directed at adult smokers (&gt; 18years old) and assessing smoking cessation with a biochemically verified outcome at a minimum of 6 months follow-up between 1996 and 2018. We identified 20 potential predictors based on previous evidence of their predictive value in the published literature and consultation with experts in the field. Predictors were grouped into participant characteristics, recruitment strategy and intervention characteristics and were pre-specified with the meta-regression analyses (https://osf.io/5er49/). Univariate meta-regression analyses were used to investigate the association of predictors on logit-transformed eligibility rates ([#randomised + #declined]/#assessed for eligibility) and recruitment rates (#randomised/#eligible) as the outcomes. <h3>Results</h3> 137 and 118 out of 173 studies had complete data and were included in the analyses for eligibility and recruitment rates, respectively. We found no evidence for the recruitment strategy (classified as targeted vs. non-targeted and direct vs. indirect or a combination of both) to predict eligibility rates. Studies including self-help interventions for smoking cessation were associated with 89% lower odds of recruiting eligible participants than person-delivered interventions for smoking cessation (OR 0.11, 95% confidence interval 0.02 to 0.54, p-value 0.007). Additionally, studies recruiting participants with an ongoing mental condition (OR 2.48, 95% confidence interval 0.93 to 6.61, p-value 0.070) and older age (OR 1.04, 95% confidence interval 0.99 to 1.09, p-value 0.094) were associated with higher, but not statistically significant, odds. Participants characteristics such as having a low socioeconomic status or being motivated to quit smoking and the recruitment strategy were not associated with recruitment rates. <h3>Conclusions</h3> Our findings suggest that behavioural RCTs of smoking cessation that test interventions without person-to-person contact have more difficulties converting the number of eligible people into consenting, randomised participants. No other participant, recruitment strategy or intervention characteristics were found to be associated with recruitment rates. Due to considerable heterogeneity in trial recruitment and eligibility rates, this study provides little guidance other than intervention mode of delivery, to enhance these rates. Furthermore, we noted that 32% and 21% of eligible RCTs did not report enough data to allow the investigation of recruitment and eligibility rates, respectively. We encourage researchers to follow available guidelines on reporting RCTs (e.g. CONSORT-SPI) to improve reporting of recruitment data, such as the number of people approached or assessed for eligibility, so that their data can contribute to evidence on optimising RCT participation.

Network meta-analysis of antidepressants

Performing and evaluating meta-analyses

Introduction: There is a strong need to conduct rigorous and robust trials for children and adolescents in mental health settings. One of the main barriers to meeting this requirement is the poor recruitment rate. Effective recruitment strategies are crucial for the success of a clinical trial, and therefore, we reviewed recruitment strategies in clinical trials on children and adolescents in mental health with a focus on prevention programs. Methods: We reviewed the literature by searching PubMed/Medline, the Cochrane Library database, and Web of Science through December 2022 as well as the reference lists of relevant articles. We included only studies describing recruitment strategies for pediatric clinical trials in mental health settings and extracted data on recruitment and completion rates. Results: The search yielded 13 studies that enrolled a total of 14,452 participants. Overall, studies mainly used social networks or clinical settings to recruit participants. Half of the studies used only one recruitment method. Using multiple recruitment methods (56.6%, 95%CI: 24.5–86.0) resulted in higher recruitment. The use of monetary incentives (47.0%, 95%CI: 24.6–70.0) enhanced the recruitment rate but not significantly (32.6%, 95%CI: 15.7–52.1). All types of recruitment methods showed high completion rates (82.9%, 95%CI: 61.7–97.5) even though prevention programs showed the smallest recruitment rate (76.1%, 95%CI: 50.9–94.4). Conclusions: Pediatric mental health clinical trials face many difficulties in recruitment. We found that these trials could benefit from faster and more efficient recruitment of participants when more than one method is implemented. Social networks can be helpful where ethically possible. We hope the description of these strategies will help foster innovation in recruitment for pediatric studies in mental health.

Positive effects of music therapy for people with dementia and their family carers are reported in a growing number of studies. However, small sample sizes or low recruitment rates often limit the success of these research studies. More adequately powered evidence-based studies are needed to impact policy and funding in dementia care. This systematic review examined recruitment strategies in music therapy clinical trials involving people living with dementia and/or their family carers. Eligible studies described enrolment, consent, accrual, or recruitment methods as well as recruitment or consent rates. Thirty studies with a total of 1,192 participants were included. Recruitment and conversion rates in residential aged care facilities (RACFs) (14 studies) were substantially higher than in community-based studies (16 studies). Whereas studies in RACFs most commonly recruited participants through staff approaching residents face-to-face or conversing with residents' legal guardians, community-based studies utilized a vast array of strategies, including staff referral, demonstrations/information sessions by researchers, advertisements, and direct contact with residents. Recruitment rates are likely to be higher when recruiters have an existing relationship with potential participants and when an independent third-party dementia organization is involved. Randomized controlled trials led to equally or greater recruitment conversion rates than other designs. Findings suggest that recruitment in dementia trials is complex, challenging, and needs thorough planning and consideration to be time- and cost-effective. Future studies should include reporting of recruitment strategies, enrolment rates, and related aspects so that researchers can better design recruitment strategies and estimate resources needed to reach the target sample size.

BackgroundObtaining access to a demographically and geographically diverse sample for health-related research can be costly and time consuming. Previous studies have reported mixed results regarding the potential of using social media-based advertisements to overcome these challenges.ObjectiveOur aim was to develop and assess the feasibility, benefits, and challenges of recruiting for research studies related to consumer health information technology (IT) by leveraging the social structures embedded in the social networking platform, Facebook.MethodsTwo recruitment strategies that involved direct communication with existing Facebook groups and pages were developed and implemented in two distinct populations. The first recruitment strategy involved posting a survey link directly to consenting groups and pages and was used to recruit Filipino-Americans to a study assessing the perceptions, use of, and preferences for consumer health IT. This study took place between August and December 2013. The second recruitment strategy targeted individuals with type 2 diabetes and involved creating a study-related Facebook group and asking administrators of other groups and pages to publicize our group to their members. Group members were then directly invited to participate in an online pre-study survey. This portion of a larger study to understand existing health management practices as a foundation for consumer health IT design took place between May and June 2014. In executing both recruitment strategies, efforts were made to establish trust and transparency. Recruitment rate, cost, content of interaction, and characteristics of the sample obtained were used to assess the recruitment methods.ResultsThe two recruitment methods yielded 87 and 79 complete responses, respectively. The first recruitment method yielded a rate of study completion proportionate to that of the rate of posts made, whereas recruitment successes of the second recruitment method seemed to follow directly from the actions of a subset of administrators. Excluding personnel time, the first recruitment method resulted in no direct costs, and the second recruitment method resulted in a total direct cost of US $118.17. Messages, posts, and comments received using both recruitment strategies reflected ten themes, including appreciation, assistance, clarification, concerns, encouragement, health information, interest, promotion, solicitations, and support. Both recruitment methods produced mixed results regarding sample representativeness with respect to characteristics such as gender, race, and ethnicity.ConclusionsThe results of the study demonstrate that leveraging the social structures of Facebook for health-related research was feasible for obtaining small samples appropriate for qualitative research but not for obtaining large samples needed for quantitative research. The content of interactions with members of the target population prompted ethical deliberations concerning suitable target communities and appropriate boundaries between researchers and participants. Widespread replication of this method would benefit from a broad discussion among researchers, social media users, social media companies, and experts in research ethics to address appropriate protocols for such interactions.

Purpose: The purpose of this study was to investigate which treatment method for abdominal aortic aneurysm (AAA), endovascular or open repair, has better outcomes in young patients. Materials and Methods: A systematic review was conducted to identify observational studies or randomized controlled trials (RCTs) that compared endovascular and open repair of intact AAA in young patients. MEDLINE, EMBASE, and CENTRAL were searched up to March 2022 using the Ovid interface. The risk of bias was assessed with the Newcastle-Ottawa scale (NOS), with a maximum score of 9, or version 2 of the Cochrane risk of bias tool. The certainty of evidence was assessed with the GRADE framework. Primary outcomes were perioperative, overall, and aneurysm-related mortality. Secondary outcomes were reintervention, hospital length of stay, and perioperative complications. Effect measures in syntheses were the odds ratio (OR), risk difference (RD), mean difference (MD), or hazard ratio (HR) and were calculated with the Mantel-Haenszel or inverse variance statistical method and random-effects models. Results: Fifteen observational studies and 1 RCT were included, reporting a total of 48 976 young patients. Definitions of young ranged from 60 to 70 years. The median score on the NOS was 8 (range: 4–9), and the RCT was judged to be high risk of bias. The perioperative mortality was lower after EVAR (RD: −0.01, 95% CI: −0.02 to −0.00), but the overall and aneurysm-related mortality was not significantly different between EVAR and open repair (HR: 1.38, 95% CI: 0.81 to 2.33; HR: 4.68, 95% CI: 0.71 to 31.04, respectively), as was the hazard of reintervention (HR: 1.50, 95% CI: 0.88 to 2.56). The hospital length of stay was shorter after EVAR (MD: −4.44 days, 95% CI: −4.79 to −4.09), and the odds of cardiac (OR: 0.22, 95% CI: 0.13 to 0.35), respiratory (OR: 0.17, 95% CI: 0.11 to 0.26), and bleeding complications were lower after EVAR (OR: 0.26, 95% CI: 0.11 to 0.64). The level of evidence was low or very low. Conclusion: Patient preferences and perspectives should be considered during shared decision-making process considering the available evidence. EVAR may be considered in young and fit patients with a suitable anatomy. Protocol registration: PROSPERO, CRD42022325051 Clinical Impact Uncertainty surrounds the optimal treatment strategy for abdominal aortic aneurysm in young patients. Meta-analysis of some 48,976 young patients showed that endovascular aneurysm repair (EVAR) has a lower perioperative mortality and morbidity and a shorter hospital and intensive care unit stay than open surgical repair, but the overall and aneurysm-related mortality in the short to medium term are not significantly different between EVAR and open repair. EVAR can be considered in young patients.

Antimicrobial Prophylaxis for Postoperative Urinary Tract Infections in Transurethral Resection of Bladder Tumors: A Systematic Review and Meta-Analysis.

Effect of preconception antibiotics exposure on female reproductive health and pregnancy outcomes: a systematic review and meta-analysis

PROTOCOL: Nutrition interventions and programs for reducing mortality and morbidity in pregnant and lactating women and women of reproductive age: a systematic review

Background: Bacterial infections represent one of the most serious infections in the world, which may bring about consequences such as miscarriage, premature birth, stillbirth, and ectopic pregnancy in pregnant women. The aim of this study was to investigate the relationship between bacterial infections and pregnancy outcomes through a meta-analysis. Methods: The present study was a systematic review and meta-analysis of international databases (PubMed, Scopus, Web of Science, Embase, and Ovid) to find case control and cohort studies between 2000 and 2018. Each process of screening, selection, data extraction and risk of bias done by two researchers, individually. The risk of bias was assessed by the Newcastle-Ottawa Scale (NOS). The pooled odds ratio (OR) in case control studies and risk ratio (RR) in cohort studies were calculated through random effect model approach. Results: After the pooled of cohort studies, the results of analysis showed that the risk ratio of preterm delivery in pregnant women with vaginal infections is 1.57 (% 95 CI; 1.46 - 1.67), while the risk ratio of abortion is 2.02 (% 95 CI; 1.72 to 2.38). After the pooled of case control studies, the odds ratio of ectopic pregnancy in pregnant women with vaginal infections, 1.12 times more likely than pregnant women without such infections (OR: 1.12; % 95 CI; 1.05 – 1.19) to develop ectopic pregnancy. Discussion: Bacterial infections increase risk outcomes of pregnancy such as miscarriage, premature birth, ectopic pregnancy and stillbirth, giving rise to unimaginable and irreparable complications in the fetus with enormous economic costs. A key measure to reduce or prevent the adverse outcomes of genital infections is to monitor and screen pregnant women regularly to detect these infections. Funding: Funding provided by Kurdistan University of Medical Sciences. Declaration of Interest: This study doesn't include any conflict of interest for the authors. Ethical Approval: The study protocol was approved by the Ethics Committee of Kurdistan University of Medical Sciences. The approval number is: IR.MUK.REC.1397.317.

PurposeInvestigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long‐term benefit–risk profiles. However, generating such evidence in real‐world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data.MethodsFollowing an initiative launched by the International Society for Pharmacoepidemiology in May 2014, a working group including members of the private and public sectors, was formed to assess the value of conducting feasibility assessments as a necessary step before embarking on larger‐scale post‐licensure studies. Based on five real‐life examples of feasibility assessments, lessons learned and recommendations were issued by the working group to support scientific reasoning and decision making when designing pharmacoepidemiologic vaccine studies.ResultsThe working group developed a toolbox to provide a pragmatic approach to conducting feasibility assessments. The toolbox contains two main components: the scientific feasibility and the operational feasibility. Both components comprise a series of specific questions aimed at overcoming methodological and operational challenges.ConclusionsA feasibility assessment should be formalized as a necessary step prior to the actual start of any pharmacoepidemiologic study. It should remain a technical evaluation and not a hypothesis testing. The feasibility assessment report may facilitate communication with regulatory agencies toward improving the quality of study protocols and supporting the endorsement of study objectives and methods addressing regulatory commitments. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

BackgroundInfertility represents a major global public health challenge. Identifying modifiable factors to optimize the outcomes of assisted reproductive technology (ART) is therefore crucial. Seasonal exposure has been reported to be correlated with natural conception rates, birth patterns, and adverse pregnancy outcomes. However, the potential associations between seasonal exposure and pregnancy outcomes among women undergoing fresh embryo transfer cycles remain controversial. This study aims to determine whether an association exists between seasonal exposure and pregnancy outcomes following fresh embryo transfer cycles, thereby providing evidence-based guidance on whether seasonal considerations should be integrated into ART treatment planning.MethodsThis review adhered to the PRISMA guidelines. Literature searches were conducted across seven major electronic databases. Data synthesis employed either fixed-effects models. Subgroup analyses were performed according to the Köppen climate classification. The risk of bias in the included studies was assessed using the Newcastle-Ottawa Scale (NOS). Associations are reported as odds ratios (ORs) with corresponding 95% confidence intervals (CIs), and heterogeneity was quantified using the I2 statistic.ResultsA total of 19 retrospective studies encompassing 159,696 fresh embryo transfer cycles were included. Overall, no significant associations were found between season and clinical pregnancy or live birth. Subgroup analyses, however, revealed climate-specific variations: In Cwa (humid subtropical) climates, live birth rates were significantly higher in summer than in winter (OR = 1.05; 95% CI, 1.01–1.10; I2 = 0%, P heterogeneity < 0.05). In Dfb (warm–summer humid continental) climates, live birth rates were significantly higher in spring than in summer (OR = 1.07; 95% CI, 1.01–1.14).ConclusionSeasonal variation exhibits no significant association with pregnancy outcomes following fresh embryo transfer cycles. The observed variations within specific climate subgroups may result from multifactorial influences and require further research for validation. Clinicians and patients can prioritize medical indications and personal readiness without concern that seasonal timing may adversely impact pregnancy outcomes.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251077751, Identifier: CRD420251077751.

Fertility and pregnancy outcomes after a uterine niche resection in women with and without infertility: a systematic review and meta-analysis

#35 Paternal exposure to immunosuppressive drugs: possible influence on pregnancy outcome and infant's health, a systematic review