scholarly journals Recruitment strategies in randomised controlled trials of men aged 50 years and older: a systematic review

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025580 ◽  
Author(s):  
Karen Bracken ◽  
Lisa Askie ◽  
Anthony C Keech ◽  
Wendy Hague ◽  
Gary Wittert
Keyword(s):  
Systematic Review ◽  
Media Coverage ◽  
Randomised Controlled Trials ◽  
Quantitative Methods ◽  
Assessment Tools ◽  
Statistical Testing ◽  
Controlled Trials ◽  
Recruitment Strategies ◽  
Cost Study ◽  
Randomised Controlled

ObjectivesTo identify and review evaluations of strategies to recruit men aged 50 years and over to randomised controlled trials (RCTs).DesignSystematic review and narrative synthesis.Data sourcesMEDLINE, EMBASE, CINAHL and ORRCA databases were searched to 1 December 2017.Eligibility criteriaStudies using quantitative methods to evaluate recruitment strategies to RCTs of men aged 50 years and older.Data extraction and synthesisA single reviewer extracted data (for each strategy, number of participants approached, screened and randomised, and cost). Study quality was assessed using National Heart, Lung and Blood Institute Quality Assessment Tools and considered study design, description of interventions, description and measurement of outcomes, completeness of outcome reporting, performance of statistical testing and consideration of confounders. Recruitment strategies were categorised by the recruitment stage they addressed.ResultsSixteen studies (n >14 000) were included: one good quality, ten fair quality and five poor quality. Studies evaluated strategies to identify prospective participants, and to improve the processes for assessing participant eligibility, providing participant information and seeking consent. In good and fair quality studies, the most effective strategies for identifying participants were referral from an affiliated health service provider (two studies), mass mailing (five studies) and media coverage (two studies). Community outreach activities such as displaying posters and attending local community events were not effective (two studies). Trial-specific training of site recruitment staff, developed using qualitative analysis of recruitment visits (two studies), and provision of study information to prospective participants at a multidisciplinary, group information session (one study) both improved recruitment.ConclusionImproved engagement of men aged 50 years and older in RCTs is needed. A gender-sensitised approach to RCT recruitment may help to address this need. We have identified several promising recruitment strategies that merit further evaluation.PROSPERO registration numberCRD42017060301.

scholarly journals Perioperative liberal versus restrictive fluid strategies and postoperative outcomes: a systematic review and metanalysis on randomised-controlled trials in major abdominal elective surgery

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Antonio Messina ◽  
Chiara Robba ◽  
Lorenzo Calabrò ◽  
Daniel Zambelli ◽  
Francesca Iannuzzi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Postoperative Complications ◽  
Randomised Controlled Trials ◽  
Elective Surgery ◽  
Fluid Management ◽  
Risk Difference ◽  
Controlled Trials ◽  
Perioperative Fluid Management ◽  
Liberal Approach ◽  
Randomised Controlled

Abstract Background Postoperative complications impact on early and long-term patients’ outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality. Methods Systematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded. Results After full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (− 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0–66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02–0.09); p value  = 0.001]. We found no difference in either early (p value  = 0.33) or late (p value  = 0.22) postoperative mortality between restrictive and liberal subgroups Conclusions In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive. Trial Registration CRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059.

scholarly journals Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alice MacLachlan ◽  
Karen Crawford ◽  
Shona Shinwell ◽  
Catherine Nixon ◽  
Marion Henderson
Keyword(s):  
Pregnant Women ◽  
Randomised Controlled Trials ◽  
Social Care ◽  
Early Years ◽  
Controlled Trials ◽  
Recruitment Strategies ◽  
Recruitment Activities ◽  
Research Nurses ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014

Do sleep interventions change sleep duration in children aged 0-5 years? A systematic review and meta-analysis of randomised controlled trials

2021 ◽  
pp. 101498
Author(s):  
LouiseJ. Fangupo ◽  
Jillian J. Haszard ◽  
Andrew N. Reynolds ◽  
Albany W. Lucas ◽  
Deborah R. McIntosh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sleep Duration ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomised Controlled
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