scholarly journals Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Vichithranie W. Madurasinghe ◽  
Peter Bower ◽  
Sandra Eldridge ◽  
David Collier ◽  
Jonathan Graffy ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Meta Analysis ◽  
Recruitment Strategies ◽  
User Testing ◽  
Research Teams ◽  
Comprehensive Information ◽  
Key Issues ◽  
To Receive ◽  
Trial Participants ◽  
Participant Information

Abstract Background The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded ‘studies within a trial’ (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. Methods Seven ‘host’ trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. Results Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). Conclusions Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. Trial registration Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133)

scholarly journals Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 417 ◽  
Author(s):  
Peter Knapp ◽  
Simon Gilbody ◽  
Janet Holt ◽  
Ada Keding ◽  
Natasha Mitchell ◽  
...  
Keyword(s):  
Information Design ◽  
User Testing ◽  
Study Within A Trial ◽  
Information Group ◽  
Standard Information ◽  
Information Materials ◽  
Randomised Controlled ◽  
Participant Understanding ◽  
To Receive ◽  
Participant Information

Background: Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Conclusions: Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. Registration: ISRCTN ID ISRCTN02202951; registered on 3 June 2009.

scholarly journals Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT)

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 779
Author(s):  
Rebecca Sheridan ◽  
Peter Knapp ◽  
Peter Bower ◽  
Vichithranie Madurasinghe ◽  
Deborah M Broadbent ◽  
...  
Keyword(s):  
Information Design ◽  
User Testing ◽  
Diabetic Retinopathy Screening ◽  
Study Within A Trial ◽  
Information Group ◽  
Standard Information ◽  
Information Materials ◽  
Participant Understanding ◽  
To Receive ◽  
Participant Information

Background: Printed participant information about trials is often technical, long and difficult to navigate. Optimisation and user testing can improve information materials, and may improve participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the ISDR trial. Potential participants in the ISDR trial were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 3,169 patients were randomised in the SWAT. Recruitment rates to the ISDR trial were 25.3% in the optimised information group and 26.1% in the standard information group (odds ratio 0.951; 95% CI 0.752 to 1.201; p=0.672). Clinic attendance rates were 71.6% in the optimised information group and 69.3% in the standard information group (OR 1.145; 95% CI 0.885 to 1.480; p=0.304). Conclusions: Optimisation of participant information through information design and user testing did not affect rate of recruitment to the host ISDR trial. Registration: ISRCTN ID ISRCTN87561257; registered on 08 May 2014.

scholarly journals Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hanne Bruhn ◽  
Elle-Jay Cowan ◽  
Marion K. Campbell ◽  
Lynda Constable ◽  
Seonaidh Cotton ◽  
...  
Keyword(s):  
Scoping Review ◽  
Health Care Professionals ◽  
Search Strategy ◽  
Phase Iii ◽  
Future Research ◽  
To Receive ◽  
Emotional Effects ◽  
Trial Participants ◽  
Narrative Description ◽  
Do So

Abstract Background There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. Methods A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Results Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. Conclusions This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

Nasal Intermittent Positive Pressure Ventilation versus Continuous Positive Airway Pressure and Apnea of Prematurity: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Bayane Sabsabi ◽  
Ava Harrison ◽  
Laura Banfield ◽  
Amit Mukerji
Keyword(s):  
Systematic Review ◽  
Continuous Positive Airway Pressure ◽  
Airway Pressure ◽  
Primary Outcome ◽  
Positive Pressure Ventilation ◽  
Positive Airway Pressure ◽  
Meta Analysis ◽  
Intermittent Positive Pressure Ventilation ◽  
Positive Pressure ◽  
Apnea Of Prematurity

Objective The study aimed to systematically review and analyze the impact of nasal intermittent positive pressure ventilation (NIPPV) versus continuous positive airway pressure (CPAP) on apnea of prematurity (AOP) in preterm neonates. Study Design In this systematic review and meta-analysis, experimental studies enrolling preterm infants comparing NIPPV (synchronized, nonsynchronized, and bi-level) and CPAP (all types) were searched in multiple databases and screened for the assessment of AOP. Primary outcome was AOP frequency per hour (as defined by authors of included studies). Results Out of 4,980 articles identified, 18 studies were included with eight studies contributing to the primary outcome. All studies had a high risk of bias, with significant heterogeneity in definition and measurement of AOP. There was no difference in AOPs per hour between NIPPV versus CPAP (weighted mean difference = −0.19; 95% confidence interval [CI]: −0.76 to 0.37; eight studies, 456 patients). However, in a post hoc analysis evaluating the presence of any AOP (over varying time periods), the pooled odds ratio (OR) was lower with NIPPV (OR: 0.46; 95% CI: 0.32–0.67; 10 studies, 872 patients). Conclusion NIPPV was not associated with decrease in AOP frequency, although demonstrated lower odds of developing any AOP. However, definite recommendations cannot be made based on the quality of the published evidence. Key Points

scholarly journals Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu
Keyword(s):  
Relapse Rate ◽  
Large Scale ◽  
Primary Outcome ◽  
Response Rate ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
History Of ◽  
Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

scholarly journals Intraosseous versus intravenous vascular access during cardiopulmonary resuscitation for out-of-hospital cardiac arrest: a systematic review and meta-analysis of observational studies

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Yu-Lin Hsieh ◽  
Meng-Che Wu ◽  
Jon Wolfshohl ◽  
James d’Etienne ◽  
Chien-Hua Huang ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Cardiopulmonary Resuscitation ◽  
Hospital Discharge ◽  
Vascular Access ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Hospital Cardiac Arrest

Abstract Introduction This study is aimed to investigate the association of intraosseous (IO) versus intravenous (IV) route during cardiopulmonary resuscitation (CPR) with outcomes after out-of-hospital cardiac arrest (OHCA). Methods We systematically searched PubMed, Embase, Cochrane Library and Web of Science from the database inception through April 2020. Our search strings included designed keywords for two concepts, i.e. vascular access and cardiac arrest. There were no limitations implemented in the search strategy. We selected studies comparing IO versus IV access in neurological or survival outcomes after OHCA. Favourable neurological outcome at hospital discharge was pre-specified as the primary outcome. We pooled the effect estimates in random-effects models and quantified the heterogeneity by the I2 statistics. Time to intervention, defined as time interval from call for emergency medical services to establishing vascular access or administering medications, was hypothesized to be a potential outcome moderator and examined in subgroup analysis with meta-regression. Results Nine retrospective observational studies involving 111,746 adult OHCA patients were included. Most studies were rated as high quality according to Newcastle-Ottawa Scale. The pooled results demonstrated no significant association between types of vascular access and the primary outcome (odds ratio [OR], 0.60; 95% confidence interval [CI], 0.27–1.33; I2, 95%). In subgroup analysis, time to intervention was noted to be positively associated with the pooled OR of achieving the primary outcome (OR: 3.95, 95% CI, 1.42–11.02, p: 0.02). That is, when the studies not accounting for the variable of “time to intervention” in the statistical analysis were pooled together, the meta-analytic results between IO access and favourable outcomes would be biased toward inverse association. No obvious publication bias was detected by the funnel plot. Conclusions The meta-analysis revealed no significant association between types of vascular access and neurological outcomes at hospital discharge among OHCA patients. Time to intervention was identified to be an important outcome moderator in this meta-analysis of observation studies. These results call for the need for future clinical trials to investigate the unbiased effect of IO use on OHCA CPR.

scholarly journals A DATA-DRIVEN APPROACH TO USER-EXPERIENCE-FOCUSED MODEL-BASED ROADMAPPING FOR NEW PRODUCT PLANNING

2021 ◽  
Vol 1 ◽  
pp. 61-70
Author(s):  
Ilia Iuskevich ◽  
Andreas-Makoto Hein ◽  
Kahina Amokrane-Ferka ◽  
Abdelkrim Doufene ◽  
Marija Jankovic
Keyword(s):  
New Product Development ◽  
User Experience ◽  
Planning Process ◽  
New Product ◽  
Data Driven ◽  
User Needs ◽  
User Testing ◽  
Model Based ◽  
Data Driven Approach ◽  
To Receive

AbstractUser experience (UX) focused business needs to survive and plan its new product development (NPD) activities in a highly turbulent environment. The latter is a function of volatile UX and technology trends, competition, unpredictable events, and user needs uncertainty. To address this problem, the concept of design roadmapping has been proposed in the literature. It was argued that tools built on the idea of design roadmapping have to be very flexible and data-driven (i.e., be able to receive feedback from users in an iterative manner). At the same time, a model-based approach to roadmapping has emerged, promising to achieve such flexibility. In this work, we propose to incorporate design roadmapping to model-based roadmapping and integrate it with various user testing approaches into a single tool to support a flexible data-driven NPD planning process.

scholarly journals Enteral Feeding Strategies in Preterm Neonates ≤32 weeks Gestational Age: A Systematic Review and Network Meta-Analysis

2021 ◽  
pp. 1-17
Author(s):  
Viraraghavan Vadakkencherry Ramaswamy ◽  
Tapas Bandyopadhyay ◽  
Javed Ahmed ◽  
Prathik Bandiya ◽  
Sanja Zivanovic ◽  
...  
Keyword(s):  
Enteral Feeding ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Credible Interval ◽  
Stage Ii ◽  
Preterm Neonates ◽  
Feeding Strategies ◽  
Moderate Volume ◽  
Full Enteral Feeding ◽  
Critical Aspects

<b><i>Introduction:</i></b> Critical aspects of time of feed initiation, advancement, and volume of feed increment in preterm neonates remain largely unanswered. <b><i>Methods:</i></b> Medline , Embase, CENTRAL and CINAHL were searched from inception until 25th September 2020. Network meta-analysis with the Bayesian approach was used. Randomized controlled trials (RCTs) evaluating preterm neonates ≤32 weeks were included. Feeding regimens were divided based on the following categories: initiation day: early (&#x3c;72 h), moderately early (72 h–7 days), and late (&#x3e;7 days); advancement day: early (&#x3c;72 h), moderately early (72 h–7 days), and late (&#x3e;7 days); increment volume: small volume (SV) (&#x3c;20 mL/kg/day), moderate volume (MoV) (20–&#x3c; 30 mL/kg/day), and large volume (≥30 mL/kg/day); and full enteral feeding from the first day. Sixteen regimens were evaluated. Combined outcome of necrotizing enterocolitis (NEC) stage ≥ II or mortality before discharge was the primary outcome. <b><i>Results:</i></b> A total of 39 studies enrolled around 6,982 neonates. Early initiation (EI) with moderately early or late advancement using MoV increment enteral feeding regimens appeared to be most efficacious in decreasing the risk of NEC or mortality when compared to EI and early advancement with SV increment (risk ratio [95% credible interval]: 0.39 [0.12, 0.95]; 0.34 [0.10, 0.86]) (GRADE–very low). <b><i>Conclusions:</i></b> Early initiated, moderately early, or late advanced with MoV increment feeding regimens might be most appropriate in decreasing the risk of NEC stage ≥II or mortality. In view of the certainty of evidence being very low, adequately powered RCTs evaluating these 2 strategies are warranted.

Caring in the recruitment of older African American adults with chronic health disease: An integrative review

2020 ◽  
pp. 174239532090566
Author(s):  
Charlene J Gamboa ◽  
Wrenetha A Julion
Keyword(s):  
African American ◽  
Chronic Illness ◽  
Meta Analysis ◽  
Integrative Review ◽  
Recruitment Strategies ◽  
Caring Behaviors ◽  
Related Research ◽  
African American Adults ◽  
Recruitment Activities ◽  
Research Studies

Objectives The aim of this integrative review is to accrue a comprehensive understanding of caring behavioral characteristics in the recruitment of older African-American adults into health-related research studies centered on chronic diseases. Methods Combined methodologies, Whittemore & Knafl and Kable, Pich & Maslin-Prothero in accordance with preferred items for systematic reviews and meta-analysis, were used to guide the data collection and to report the findings. The data were analyzed based upon recruitment categorization and Kristen Swanson’s middle-range theory of caring. Results Ten out of 260 publications comprised the final sample. They were analyzed and then aggregated by chronic illnesses, recruitment activities, contact level, and Swanson’s five caring behavioral concepts. Select cancers, diabetes, hypertension, and Alzheimer’s disease were the chronic illness foci of eight publications. Cardiovascular disease and stroke were the focus of two publications. Only three studies utilized all five Swanson’s caring concepts, and the frequently used concept throughout all 10 studies was enabling. Discussion Recruitment approaches employed to accrue older African-American adults into chronic illness-related research studies necessitate proactive recruitment strategies that incorporate caring behaviors. Future researchers ought to develop multi-modality recruitment strategies to improve older African-American adults’ representation.

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