A randomized trial of a lab-embedded discourse intervention to improve research ethics.
Ontology highlight
ABSTRACT:
SUBMITTER: Plemmons DK
PROVIDER: S-EPMC6983427 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
Publications
A randomized trial of a lab-embedded discourse intervention to improve research ethics.
Plemmons Dena K DK Baranski Erica N EN Harp Kyle K Lo David D DD Soderberg Courtney K CK Errington Timothy M TM Nosek Brian A BA Esterling Kevin M KM
Proceedings of the National Academy of Sciences of the United States of America 20200109 3
We report a randomized trial of a research ethics training intervention designed to enhance ethics communication in university science and engineering laboratories, focusing specifically on authorship and data management. The intervention is a project-based research ethics curriculum that was designed to enhance the ability of science and engineering research laboratory members to engage in reason giving and interpersonal communication necessary for ethical practice. The randomized trial was fie ...[more]
Similar Datasets
Project description:BackgroundNearly 1 in 3 clinical trials end prematurely due to underenrollment. Strategies to enhance recruitment are often implemented without scientific rigor to evaluate efficacy. Evidence-based, cost-effective behavioral economic strategies designed to influence decision-making may be useful to promote clinical trial enrollment.ObjectiveThis study evaluated 2 behavioral economic strategies to improve enrollment and retention rates across 4 clinical trials: information provision (IP) and contingency management (CM; ie, lottery). IP targets descriptive and injunctive norms about participating in research and CM provides participants incentives to reinforce a target behavior.MethodsA sample of 212 participants was enrolled across 4 clinical trials focused on tobacco use: 2 focused on HIV and 2 focused on neuroimaging. The CM condition included a lottery: for each study visit completed, participants received 5 "draws" from a bowl containing 500 "chips" valued at US $0, US $1, US $5, or US $100. In the IP condition, text messages that targeted injunctive norms about research (eg, "Many find it a rewarding way to advance science and be part of a community") were sent through the Way to Health platform before all study visits. Participants were randomized to 1 of 4 conditions: IP, CM, IP+CM, or standard recruitment (SR). We performed logistic regression, controlling for sex and study, with condition as a between-subject predictor. Outcomes were the percentage of participants who attended a final eligibility visit (primary), met intent-to-treat (ITT) criteria (secondary), and completed the study (secondary). Recruitment was evaluated by the percentage of participants who attended a final eligibility visit, enrollment by ITT status, and retention by the percentage of participants who completed the study.ResultsRates of attending the eligibility visit and meeting ITT status were 58.9% (33/56) and 33.9% (19/56) for IP+CM; 45.5% (25/55) and 18.2% (10/55) for IP only; 41.5% (22/53) and 18.9% (10/53) for CM only; and 37.5% (18/48) and 12.5% (6/48) for SR, respectively. In the logistic regression, females were more likely to meet ITT status than males (odds ratio [OR] 2.7, 95% CI 1.2-5.7; P=.01). The IP+CM group was twice as likely to attend the final eligibility visit than the SR group (OR 2.4, 95% CI 1.1-5.2; P=.04). The IP+CM group was also significantly more likely to reach ITT status than the SR condition (OR 3.9, 95% CI 1.3-11.1; P=.01). Those who received any active intervention (IP, CM, or IP+CM) had a higher study completion rate (33/53, 63.5%) compared to those who received SR (5/12, 41.7%), but this difference was not significant (P=.26).ConclusionsCombining IP and CM strategies may motivate participants to participate in research and improve recruitment and retention rates. Evidence from this study provides preliminary support for the utility of behavioral economics strategies to improve enrollment and reduce attrition in clinical trials.
| S-EPMC10403799 | biostudies-literature
Project description: Not available
| S-EPMC4838154 | biostudies-literature
Project description:ObjectivesTo assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant's accessed; 3) to assess satisfaction and understanding.DesignObservational study with an embedded randomised controlled trial.SettingLow risk intervention study based in primary care.ParticipantsWhite British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study.InterventionsPDF copy of the standard paper participant information sheet (PDF-PIS) and an electronic Interactive Information Sheet (IIS) where participants could choose both the type and level of detail accessed.Main outcome measures1) Proportion of participants providing an email address and accessing electronic information 2) Willingness to participate in a recruitment clinic. 3) Type and depth of information accessed on the IIS. 4) Participant satisfaction and understanding.Results1160 participants were eligible for the study. Of these, 276 (24%) provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4). Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59%) who chose not to access any electronic information also booked an appointment.ConclusionsCurrent written information about research may not be read, emphasising the importance of the consent interview and consideration of new ways of presenting complex information.
| S-EPMC3789820 | biostudies-literature
Project description:BackgroundEmerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment gap exists, where a considerable proportion of students do not seek help for mood and anxiety symptoms. Offering internet interventions to students with mental health problems could reduce the treatment gap, increase mental health, and improve academic performance. A meta-analysis on internet interventions for university students showed small effects for depression and none for anxiety. Larger trials are recommended to further explore effects of guidance, transdiagnostic approaches, and individual treatment components.MethodsThis study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Those at risk will be randomized to an adaptive treatment strategy, or to continue the treatment as originally randomized. Primary outcomes are symptoms of depression and anxiety. Follow-ups will occur at post-treatment and at 6-, 12-, and 24-month post-randomization. Between-group outcome analyses will be reported, and qualitative interviews about treatment experiences are planned.DiscussionThis study investigates the effects of a transdiagnostic internet intervention among university students in Sweden, with an adaptive treatment strategy employed during the course of treatment to minimize the risk of treatment failure. The study will contribute knowledge about longitudinal trajectories of mental health and well-being following treatment, taking into account possible gender differences in responsiveness to treatment. With time, effective internet interventions could make treatment for mental health issues more widely accessible to the student group.
| S-EPMC10908025 | biostudies-literature
Project description:BACKGROUND:New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. OBJECTIVE:The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. METHODS:This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. RESULTS:In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). CONCLUSIONS:Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW).
| S-EPMC6234332 | biostudies-other
Project description:The primary aim of this study was to develop an American Indian and Alaska Native (AIAN) tailored research with human subjects curriculum that would increase the participation of AIAN members in research affecting their communities. We used a community-engaged research approach to co-design and evaluate a culturally tailored online human subjects curriculum among a national sample of AIAN community members (n = 244) with a standard nationally used online curriculum (n = 246). We evaluated pre-and post-test measures to assess group differences in ethics knowledge, perceived self-efficacy to apply such knowledge to protocol review, and trust in research. Analysis of regional tribal differences assessed curriculum generalizability. Using an 80% correct item cut-off at first attempt as passing criterion, the tailored curriculum achieved a 59.3% passing rate versus 28.1% in the standard curriculum (p < .001). For both arms, participants reported a significant increase in trust in research and in research review efficacy. Participants took less time to complete the training and reported significantly higher acceptability, satisfaction, and understandability of the curriculum for the tailored curriculum. This culturally tailored research ethics curriculum has the potential to increase participation in AIAN communities in research affecting tribal members. The AIAN curriculum achieved significantly higher levels of participants' research ethics knowledge, self-efficacy in reviewing research protocols, trust in research, and completion of the training requirements. Culturally grounded training curricula may help remedy the impact of historical research ethics abuses involving AIAN communities that have contributed to mistrust of research and lack of community engagement in research.
| S-EPMC6320230 | biostudies-literature
Project description:Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs).We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC.RECs in the UK.Number of REC granting favourable opinions.The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid.A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials.
| S-EPMC5537508 | biostudies-other
Project description:OBJECTIVE:We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). STUDY DESIGN:This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured. RESULTS:Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50). CONCLUSION:A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
| S-EPMC5446277 | biostudies-literature
Project description:ImportanceIncentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals.ObjectiveTo determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements.Design, setting, and participantsTwo RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020.InterventionsPatients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial.Main outcomes and measuresThe primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes.ResultsThere were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions.Conclusions and relevanceIn these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial.Trial registrationClinicalTrials.gov Identifier: NCT02697799.
| S-EPMC8453363 | biostudies-literature
Project description:Background: We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke.Methods and results: Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ?18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm?Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm?Hg, P=0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm?Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm?Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm?Hg at 12 months.Conclusions: THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors.Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01900756.
| S-EPMC7139215 | biostudies-literature