Pub Date : 2023-01-01DOI: 10.1177/26320843221106949
C. Arundel, Laura Clark, Elizabeth Coleman, Laura Doherty, Adwoa Parker, D. Torgerson
Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is however limited evidence available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers an opportunity to fill this evidence gap. While SWATs are generally easy to implement, a range of challenges to undertaking SWATs have also been identified, however there is limited detail regarding practical solutions to tackle these. Methods Information and observations collected from PROMETHEUS members and participating trials, focusing on SWATs across a wide range of questions and settings, was reviewed to identify the challenges and solutions of delivery of a programme of SWATs. Results A range of challenges to undertaking SWATs (e.g., obtaining governance approvals) were identified along with potential solutions to these, which were implemented accordingly during programme delivery. Central to the solutions to resolve SWAT challenges is education to develop knowledge and understanding in the wider research community on the importance, purpose, and key methodological principles in relation to SWATs. In addition, the sharing of experience, best practice or resources to prevent or help negotiate the barriers to undertaking SWAT evaluation is also recommended. Conclusions Potential solutions to the barriers experienced in the design, conduct and implementation of a programme of SWATs have been identified. As more SWATs are completed, this will further develop evidence to support the mitigation or removal of barriers and in doing so this should increase the efficiency of randomised controlled trials.
{"title":"Challenges and solutions to the implementation of studies within a trial: The experiences of the PROMETHEUS programme","authors":"C. Arundel, Laura Clark, Elizabeth Coleman, Laura Doherty, Adwoa Parker, D. Torgerson","doi":"10.1177/26320843221106949","DOIUrl":"https://doi.org/10.1177/26320843221106949","url":null,"abstract":"Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is however limited evidence available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers an opportunity to fill this evidence gap. While SWATs are generally easy to implement, a range of challenges to undertaking SWATs have also been identified, however there is limited detail regarding practical solutions to tackle these. Methods Information and observations collected from PROMETHEUS members and participating trials, focusing on SWATs across a wide range of questions and settings, was reviewed to identify the challenges and solutions of delivery of a programme of SWATs. Results A range of challenges to undertaking SWATs (e.g., obtaining governance approvals) were identified along with potential solutions to these, which were implemented accordingly during programme delivery. Central to the solutions to resolve SWAT challenges is education to develop knowledge and understanding in the wider research community on the importance, purpose, and key methodological principles in relation to SWATs. In addition, the sharing of experience, best practice or resources to prevent or help negotiate the barriers to undertaking SWAT evaluation is also recommended. Conclusions Potential solutions to the barriers experienced in the design, conduct and implementation of a programme of SWATs have been identified. As more SWATs are completed, this will further develop evidence to support the mitigation or removal of barriers and in doing so this should increase the efficiency of randomised controlled trials.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"16 - 23"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46879060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2022-12-13DOI: 10.1177/26320843221141056
Leonidas E Bantis, Kate J Young, John V Tsimikas, Brian R Mosier, Byron Gajewski, Sharon Yeatts, Renee L Martin, William Barsan, Robert Silbergleit, Gaylan Rockswold, Frederick K Korley
Studies that investigate the performance of prognostic and predictive biomarkers are commonplace in medicine. Evaluating the performance of biomarkers is challenging in traumatic brain injury (TBI) and other conditions when both the time factor (i.e. time from injury to biomarker measurement) and different levels or doses of treatments are in play. Such factors need to be accounted for when assessing the biomarker's performance in relation to a clinical outcome. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial seeks to determine the dose of hyperbaric oxygen therapy (HBOT) for treating severe TBI that has the highest likelihood of demonstrating efficacy in a phase III trial. Hyperbaric Oxygen in Brain Injury Treatment will study up to 200 participants with severe TBI. This paper discusses the statistical approaches to assess the prognostic and predictive performance of the biomarkers studied in this trial, where prognosis refers to the association between a biomarker and the clinical outcome while the predictiveness refers to the ability of the biomarker to identify patient subgroups that benefit from therapy. Analyses based on initial biomarker levels accounting for different levels of HBOT and other baseline clinical characteristics, and analyses of longitudinal changes in biomarker levels are discussed from a statistical point of view. Methods for combining biomarkers that are of complementary nature are also considered and the relevant algorithms are illustrated in detail along with an extensive simulation study that assesses the performance of the statistical methods. Even though the discussed approaches are motivated by the HOBIT trial, their applications are broader. They can be applied in studies assessing the predictiveness and prognostic ability of biomarkers in relation to a well-defined therapeutic intervention and clinical outcome.
{"title":"Statistical assessment of the prognostic and the predictive value of biomarkers-A biomarker assessment framework with applications to traumatic brain injury biomarker studies.","authors":"Leonidas E Bantis, Kate J Young, John V Tsimikas, Brian R Mosier, Byron Gajewski, Sharon Yeatts, Renee L Martin, William Barsan, Robert Silbergleit, Gaylan Rockswold, Frederick K Korley","doi":"10.1177/26320843221141056","DOIUrl":"10.1177/26320843221141056","url":null,"abstract":"<p><p>Studies that investigate the performance of prognostic and predictive biomarkers are commonplace in medicine. Evaluating the performance of biomarkers is challenging in traumatic brain injury (TBI) and other conditions when both the time factor (i.e. time from injury to biomarker measurement) and different levels or doses of treatments are in play. Such factors need to be accounted for when assessing the biomarker's performance in relation to a clinical outcome. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial seeks to determine the dose of hyperbaric oxygen therapy (HBOT) for treating severe TBI that has the highest likelihood of demonstrating efficacy in a phase III trial. Hyperbaric Oxygen in Brain Injury Treatment will study up to 200 participants with severe TBI. This paper discusses the statistical approaches to assess the prognostic and predictive performance of the biomarkers studied in this trial, where prognosis refers to the association between a biomarker and the clinical outcome while the predictiveness refers to the ability of the biomarker to identify patient subgroups that benefit from therapy. Analyses based on initial biomarker levels accounting for different levels of HBOT and other baseline clinical characteristics, and analyses of longitudinal changes in biomarker levels are discussed from a statistical point of view. Methods for combining biomarkers that are of complementary nature are also considered and the relevant algorithms are illustrated in detail along with an extensive simulation study that assesses the performance of the statistical methods. Even though the discussed approaches are motivated by the HOBIT trial, their applications are broader. They can be applied in studies assessing the predictiveness and prognostic ability of biomarkers in relation to a well-defined therapeutic intervention and clinical outcome.</p>","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"34-48"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10061824/pdf/nihms-1863888.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9282937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-22DOI: 10.1177/26320843221147841
Laura Doherty, Adwoa Parker, C. Arundel, Laura Clark, Elizabeth Coleman, C. Hewitt, David J Beard, P. Bower, P. Brocklehurst, Cindy L. Cooper, L. Culliford, D. Devane, R. Emsley, S. Eldridge, Sandra Galvin, K. Gillies, A. Montgomery, C. Sutton, S. Treweek, D. Torgerson
Aim PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions. Methods Ten Clinical Trials Units (CTUs) and one Primary Care Research Centre formed a network to conduct randomised SWATs of recruitment and/or retention strategies. We identified promising recruitment and retention interventions from various sources, which were reviewed by patient and public (PPI) partners to generate an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement, and report SWATs. We additionally tested the feasibility of undertaking coordinated SWATs across multiple host trials simultaneously. Results PROMETHEUS funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The SWAT cost per SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT in multiple trials (simultaneous SWAT design) and eight tested a factorial SWAT design. PROMETHEUS will add 18% and 79% more SWATs to the Cochrane systematic review of recruitment strategies and the Cochrane review of retention strategies respectively. Conclusion The PROMETHEUS programme substantially increased the evidence base for both recruitment and retention strategies within RCTs. Future research should adopt a systematic approach to identifying and targeting gaps in the evidence base and focus on translating SWAT evidence into recruitment and retention practice.
{"title":"PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely","authors":"Laura Doherty, Adwoa Parker, C. Arundel, Laura Clark, Elizabeth Coleman, C. Hewitt, David J Beard, P. Bower, P. Brocklehurst, Cindy L. Cooper, L. Culliford, D. Devane, R. Emsley, S. Eldridge, Sandra Galvin, K. Gillies, A. Montgomery, C. Sutton, S. Treweek, D. Torgerson","doi":"10.1177/26320843221147841","DOIUrl":"https://doi.org/10.1177/26320843221147841","url":null,"abstract":"Aim PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions. Methods Ten Clinical Trials Units (CTUs) and one Primary Care Research Centre formed a network to conduct randomised SWATs of recruitment and/or retention strategies. We identified promising recruitment and retention interventions from various sources, which were reviewed by patient and public (PPI) partners to generate an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement, and report SWATs. We additionally tested the feasibility of undertaking coordinated SWATs across multiple host trials simultaneously. Results PROMETHEUS funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The SWAT cost per SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT in multiple trials (simultaneous SWAT design) and eight tested a factorial SWAT design. PROMETHEUS will add 18% and 79% more SWATs to the Cochrane systematic review of recruitment strategies and the Cochrane review of retention strategies respectively. Conclusion The PROMETHEUS programme substantially increased the evidence base for both recruitment and retention strategies within RCTs. Future research should adopt a systematic approach to identifying and targeting gaps in the evidence base and focus on translating SWAT evidence into recruitment and retention practice.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"113 - 122"},"PeriodicalIF":0.0,"publicationDate":"2022-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43079517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-21DOI: 10.1177/26320843221148131
Grace Maina, D. Pollock, C. Lockwood
Objective To assess the reporting quality of observational studies included in a systematic review of the management of chronic otitis media with effusion in children with non-syndromic cleft lip and palate using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. Methods Medline, CINAHL, Scopus and Embase, were searched for studies comparing the use of ventilation tubes to surveillance. Two reviewers screened potential eligible articles, extracted data independently and assessed reporting quality using the STROBE checklist. Results The median compliance rate with individual STROBE items was low at 25% (range:0-100%) with 11 of the 22 items not reported in any of the studies. Items reported inconsistently pertained to potential sources of bias, sample size calculations, how loss to follow-up was addressed and management of missing data. Conclusion The development of this systematic review highlights the inadequate reporting standards in this field. Differences in the way the outcomes are defined, reported, and measured leads to variability in the observed intervention effects and difficulty in interpreting the true effect size. Future researchers are encouraged to use STROBE guidelines for the design and reporting of observational studies in this field.
{"title":"Poor reporting quality of observational studies in children with non-syndromic cleft palate makes evidence synthesis difficult","authors":"Grace Maina, D. Pollock, C. Lockwood","doi":"10.1177/26320843221148131","DOIUrl":"https://doi.org/10.1177/26320843221148131","url":null,"abstract":"Objective To assess the reporting quality of observational studies included in a systematic review of the management of chronic otitis media with effusion in children with non-syndromic cleft lip and palate using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. Methods Medline, CINAHL, Scopus and Embase, were searched for studies comparing the use of ventilation tubes to surveillance. Two reviewers screened potential eligible articles, extracted data independently and assessed reporting quality using the STROBE checklist. Results The median compliance rate with individual STROBE items was low at 25% (range:0-100%) with 11 of the 22 items not reported in any of the studies. Items reported inconsistently pertained to potential sources of bias, sample size calculations, how loss to follow-up was addressed and management of missing data. Conclusion The development of this systematic review highlights the inadequate reporting standards in this field. Differences in the way the outcomes are defined, reported, and measured leads to variability in the observed intervention effects and difficulty in interpreting the true effect size. Future researchers are encouraged to use STROBE guidelines for the design and reporting of observational studies in this field.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"87 - 93"},"PeriodicalIF":0.0,"publicationDate":"2022-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49524091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-21DOI: 10.1177/26320843221147838
A. Gkekas, Alex Evans, Adwoa Parker, S. Ronaldson, D. Torgerson
Aim To review the cost-effectiveness of strategies to improve participant recruitment and retention in randomised controlled trials. Methods All included studies from the latest Cochrane recruitment and retention reviews were considered. To identify articles published since the Cochrane reviews, electronic databases were searched until March 2021. Hand searching of conference databases and journals was also undertaken. The inclusion criteria included Studies within a Trial (SWATs). The main outcome was the incremental cost-effectiveness ratio (ICER). Quality assessment of papers used the Cochrane risk of bias 1 tool. The CRD guidance was used to assess the quality of economic evaluation. Random-effect meta-analyses were undertaken. The GRADE certainty of evidence was applied for each strategy, and Trial Forge Guidance 2 was used for strategies included in meta-analyses to evaluate the uncertainty of the findings. Cost-effectiveness ranks summarise the cost-effectiveness of all strategies. Results We identified 6569 records and included 29 SWATs (earliest conducted in 1999 and latest in 2021) including more than 35,800 participants. There is no strategy we would recommend trial teams and researchers adopt with complete statistical certainty. Recruitment strategies which could be cost-effective include financial incentives, trial-branded pens, telephone reminders and pre-notification leaflets. Retention strategies which could be cost-effective include vouchers and trial-branded pens. Conclusion Future SWATs should replicate existing recruitment and retention strategies, rather than evaluate novel ones. We recommend that economic evaluations be carried out alongside all future SWATs, costs and benefits be recorded transparently, and the cost-effectiveness of existing recruitment or retention strategies be evaluated.
{"title":"A systematic review of economic evaluations alongside studies within a trial (SWATs) for improving recruitment and retention in randomised controlled trials","authors":"A. Gkekas, Alex Evans, Adwoa Parker, S. Ronaldson, D. Torgerson","doi":"10.1177/26320843221147838","DOIUrl":"https://doi.org/10.1177/26320843221147838","url":null,"abstract":"Aim To review the cost-effectiveness of strategies to improve participant recruitment and retention in randomised controlled trials. Methods All included studies from the latest Cochrane recruitment and retention reviews were considered. To identify articles published since the Cochrane reviews, electronic databases were searched until March 2021. Hand searching of conference databases and journals was also undertaken. The inclusion criteria included Studies within a Trial (SWATs). The main outcome was the incremental cost-effectiveness ratio (ICER). Quality assessment of papers used the Cochrane risk of bias 1 tool. The CRD guidance was used to assess the quality of economic evaluation. Random-effect meta-analyses were undertaken. The GRADE certainty of evidence was applied for each strategy, and Trial Forge Guidance 2 was used for strategies included in meta-analyses to evaluate the uncertainty of the findings. Cost-effectiveness ranks summarise the cost-effectiveness of all strategies. Results We identified 6569 records and included 29 SWATs (earliest conducted in 1999 and latest in 2021) including more than 35,800 participants. There is no strategy we would recommend trial teams and researchers adopt with complete statistical certainty. Recruitment strategies which could be cost-effective include financial incentives, trial-branded pens, telephone reminders and pre-notification leaflets. Retention strategies which could be cost-effective include vouchers and trial-branded pens. Conclusion Future SWATs should replicate existing recruitment and retention strategies, rather than evaluate novel ones. We recommend that economic evaluations be carried out alongside all future SWATs, costs and benefits be recorded transparently, and the cost-effectiveness of existing recruitment or retention strategies be evaluated.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"94 - 112"},"PeriodicalIF":0.0,"publicationDate":"2022-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44909269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-17DOI: 10.1177/26320843221134480
B. Nouriani, J. Zeitzer, O. Palesh, C. Koopman, Arianna Aldridge-Gerry, E. Neri, Johnna L Medina, D. Spiegel
Background Previous findings indicate important effects of stress, disrupted sleep, and dysregulated circadian rhythms on the progression of cancer. Our understanding of these relationships, however, has been limited by the absence of data from 24-h continuous physiologic monitoring of hormonal and immune activity with simultaneous collection of objective sleep data. The present study successfully employed such an intensive protocol among women with advanced breast cancer. Purpose In this paper we describe our protocol in detail. We provide methodological and practical suggestions for assessing sleep and circadian rhythms in the medically ill. Finally, we offer psychological and physical safety guidelines for future studies that aim to utilize similar protocols. Results We enrolled 123 women with advanced breast cancer; 18 dropped out, 105 participated (6 provided incomplete data, and 99 completed the protocol). The protocol included: (1) psychological/medical screenings and assessments; (2) a 2-week at-home sleep study, including wrist actigraphy and two nights of polysomnography (PSG); and (3) 28 h in-hospital collection of measures of hormones and immune function, in conjunction with one night of PSG for assessing sleep stages, respiration, and leg movement. Based on the implementation challenges we faced, protocol adjustments were made to address feasibility limitations and to accommodate participant preferences and medical/physiological needs. Conclusions By combining and modifying the gold standard protocols for sleep and circadian assessments, researchers can compassionately optimize participant enrollment and protocol compliance, and minimize attrition.
{"title":"Assessment of sleep and circadian rhythms of endocrine and immune function among women With advanced breast cancer","authors":"B. Nouriani, J. Zeitzer, O. Palesh, C. Koopman, Arianna Aldridge-Gerry, E. Neri, Johnna L Medina, D. Spiegel","doi":"10.1177/26320843221134480","DOIUrl":"https://doi.org/10.1177/26320843221134480","url":null,"abstract":"Background Previous findings indicate important effects of stress, disrupted sleep, and dysregulated circadian rhythms on the progression of cancer. Our understanding of these relationships, however, has been limited by the absence of data from 24-h continuous physiologic monitoring of hormonal and immune activity with simultaneous collection of objective sleep data. The present study successfully employed such an intensive protocol among women with advanced breast cancer. Purpose In this paper we describe our protocol in detail. We provide methodological and practical suggestions for assessing sleep and circadian rhythms in the medically ill. Finally, we offer psychological and physical safety guidelines for future studies that aim to utilize similar protocols. Results We enrolled 123 women with advanced breast cancer; 18 dropped out, 105 participated (6 provided incomplete data, and 99 completed the protocol). The protocol included: (1) psychological/medical screenings and assessments; (2) a 2-week at-home sleep study, including wrist actigraphy and two nights of polysomnography (PSG); and (3) 28 h in-hospital collection of measures of hormones and immune function, in conjunction with one night of PSG for assessing sleep stages, respiration, and leg movement. Based on the implementation challenges we faced, protocol adjustments were made to address feasibility limitations and to accommodate participant preferences and medical/physiological needs. Conclusions By combining and modifying the gold standard protocols for sleep and circadian assessments, researchers can compassionately optimize participant enrollment and protocol compliance, and minimize attrition.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"71 - 85"},"PeriodicalIF":0.0,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48220598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-12DOI: 10.1177/26320843221131293
A. D. De Nardi, L. O. Pfeifer, N. Oliveira, C. Botton, L. Santos, D. Umpierre
Background Communicating and disseminating individual results to research participants is an ethical imperative, however, this practice is still unusual. In the present study, we investigated two delivery formats of individual results to older participants on the perspectives of understanding (main outcome), satisfaction, and short-term psychological impact. Methods This Study Within A Trial (SWAT) is a randomized, single-blinded (outcome assessors), parallel-group intervention hosted by “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, two-arm, randomized trial (HAEL Study). Participants who entered the HAEL Study in July 2019 or after were eligible. Randomization was generated by computer and allocation concealment by an independent investigator. The delivery of individual results was carried out in individual or group meetings between December 2019 and September 2020 at a Clinical Research Center. Outcomes were assessed by an unvalidated questionnaire on a 5-point Likert scale and multiple choice questions. Results Of the 20 participants who agreed to participate in the SWAT, 10 from the individual format and 7 from the group format, with a mean age of 68 years old, were evaluated through per-protocol analysis. Most participants showed good understanding of their results in both delivery formats - individual 70% (7/10) and group 71% (5/7) (p=1.00). Satisfaction with the results delivery format was reported in both groups, with moderate negative emotional impact. Any research-related physical harms were not identified. Conclusion Both formats for delivering individual results generated adequate understanding and satisfaction with low negative emotional impact to a partial sample of older participants in the HAEL Study.
{"title":"Perspectives of older participants on the delivery of individual results: Study within a trial (SWAT) hosted by the HAEL Study","authors":"A. D. De Nardi, L. O. Pfeifer, N. Oliveira, C. Botton, L. Santos, D. Umpierre","doi":"10.1177/26320843221131293","DOIUrl":"https://doi.org/10.1177/26320843221131293","url":null,"abstract":"Background Communicating and disseminating individual results to research participants is an ethical imperative, however, this practice is still unusual. In the present study, we investigated two delivery formats of individual results to older participants on the perspectives of understanding (main outcome), satisfaction, and short-term psychological impact. Methods This Study Within A Trial (SWAT) is a randomized, single-blinded (outcome assessors), parallel-group intervention hosted by “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, two-arm, randomized trial (HAEL Study). Participants who entered the HAEL Study in July 2019 or after were eligible. Randomization was generated by computer and allocation concealment by an independent investigator. The delivery of individual results was carried out in individual or group meetings between December 2019 and September 2020 at a Clinical Research Center. Outcomes were assessed by an unvalidated questionnaire on a 5-point Likert scale and multiple choice questions. Results Of the 20 participants who agreed to participate in the SWAT, 10 from the individual format and 7 from the group format, with a mean age of 68 years old, were evaluated through per-protocol analysis. Most participants showed good understanding of their results in both delivery formats - individual 70% (7/10) and group 71% (5/7) (p=1.00). Satisfaction with the results delivery format was reported in both groups, with moderate negative emotional impact. Any research-related physical harms were not identified. Conclusion Both formats for delivering individual results generated adequate understanding and satisfaction with low negative emotional impact to a partial sample of older participants in the HAEL Study.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"61 - 70"},"PeriodicalIF":0.0,"publicationDate":"2022-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48303091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-17DOI: 10.1177/26320843221122342
Ahtisham Younas, Maria Pedersen, S. Inayat
Integration of qualitative and quantitative data in mixed methods research generates confirmed, discordant, and expanded findings. Guidance is available about the methods and strategies for the meaningful integration of data. However, little has been written about strategies for managing discordant findings in mixed methods. This paper describes and illustrates practical strategies for managing and integrating discordant findings in mixed methods analyses based on researchers reflections and experiences of managing and integrating discordant findings in convergent and sequential exploratory mixed methods studies. Two strategies, namely, comprehensive case and variable analysis and sociocultural exploration are proposed. Comprehensive case analysis involves identifying discordant findings in quantitative data, identifying supportive data in qualitative data, and selecting variables for mixed analysis and interpretation. Sociocultural exploration comprises qualitative code and quantitative data matrix for themes, identification of discordant findings under each theme, and development of sociocultural profile. Identifying and addressing discordant findings in mixed methods is an essential step of rigorous mixed methods analysis. The comprehensive case and variable analysis and sociocultural exploration strategies emphasize the need to examine discordance in data at an early stage of analysis. Further use and evaluation of these strategies are warranted to expand the body of knowledge about practical methods of mixed methods data analysis.
{"title":"Practical strategies to identify and address discordant findings in mixed methods research","authors":"Ahtisham Younas, Maria Pedersen, S. Inayat","doi":"10.1177/26320843221122342","DOIUrl":"https://doi.org/10.1177/26320843221122342","url":null,"abstract":"Integration of qualitative and quantitative data in mixed methods research generates confirmed, discordant, and expanded findings. Guidance is available about the methods and strategies for the meaningful integration of data. However, little has been written about strategies for managing discordant findings in mixed methods. This paper describes and illustrates practical strategies for managing and integrating discordant findings in mixed methods analyses based on researchers reflections and experiences of managing and integrating discordant findings in convergent and sequential exploratory mixed methods studies. Two strategies, namely, comprehensive case and variable analysis and sociocultural exploration are proposed. Comprehensive case analysis involves identifying discordant findings in quantitative data, identifying supportive data in qualitative data, and selecting variables for mixed analysis and interpretation. Sociocultural exploration comprises qualitative code and quantitative data matrix for themes, identification of discordant findings under each theme, and development of sociocultural profile. Identifying and addressing discordant findings in mixed methods is an essential step of rigorous mixed methods analysis. The comprehensive case and variable analysis and sociocultural exploration strategies emphasize the need to examine discordance in data at an early stage of analysis. Further use and evaluation of these strategies are warranted to expand the body of knowledge about practical methods of mixed methods data analysis.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"24 - 33"},"PeriodicalIF":0.0,"publicationDate":"2022-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41633415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-06-15DOI: 10.1177/26320843221106950
Adwoa Parker, C. Arundel, N. Mills, L. Rooshenas, M. Jepson, J. Donovan, J. Blazeby, Elizabeth Coleman, Laura Clark, Laura Doherty, C. Hewitt, P. Partha Sarathy, David Beard, P. Bower, S. Brealey, P. Brocklehurst, Cindy L. Cooper, J. Croft, L. Culliford, Joseph Dias, D. Devane, S. Eldridge, R. Emsley, Sandra Galvin, E. Gemperle-Mannion, D. Jayne, Andrew J Metcalfe, A. Montgomery, A. Rangan, C. Sutton, P. Tharmanathan, S. Treweek, D. Torgerson
Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Study design and setting Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later. Results Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p = 0.002). There was no effect on recruitment rate. Conclusion It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.
{"title":"Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously","authors":"Adwoa Parker, C. Arundel, N. Mills, L. Rooshenas, M. Jepson, J. Donovan, J. Blazeby, Elizabeth Coleman, Laura Clark, Laura Doherty, C. Hewitt, P. Partha Sarathy, David Beard, P. Bower, S. Brealey, P. Brocklehurst, Cindy L. Cooper, J. Croft, L. Culliford, Joseph Dias, D. Devane, S. Eldridge, R. Emsley, Sandra Galvin, E. Gemperle-Mannion, D. Jayne, Andrew J Metcalfe, A. Montgomery, A. Rangan, C. Sutton, P. Tharmanathan, S. Treweek, D. Torgerson","doi":"10.1177/26320843221106950","DOIUrl":"https://doi.org/10.1177/26320843221106950","url":null,"abstract":"Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Study design and setting Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later. Results Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p = 0.002). There was no effect on recruitment rate. Conclusion It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"4 1","pages":"2 - 15"},"PeriodicalIF":0.0,"publicationDate":"2022-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44531182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-06-10DOI: 10.1177/26320843221089632
Laura Clark, C. Arundel, Elizabeth Coleman, Laura Doherty, Adwoa Parker, C. Hewitt, David J Beard, P. Bower, P. Brocklehurst, Cindy L. Cooper, L. Culliford, D. Devane, R. Emsley, S. Eldridge, Sandra Galvin, K. Gillies, A. Montgomery, C. Sutton, S. Treweek, D. Torgerson
Introduction The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present observations from this work. Observations The PROMETHUS programme funded 42 SWATs, the average cost of each SWAT was £4007. A central coordination point enabled a concentrated effort in SWAT research activity leading to a rapid increase in the evidence base. The methodological feasibility of undertaking a coordinated SWAT design was established. The international Trial Forge SWAT Network was developed in 2021 to connect research groups in response for the need to connect teams undertaking methodological research. A SWAT reporting template and a database of researchers willing to peer review SWATs are also needed to improve the reporting of SWATs. Discussion There is a need to develop a strategy to aid teams to identify a suitable SWAT for their host trial populations and a mechanism to communicate SWAT research priorities. Work is needed to increase the awareness of the methodological importance of SWAT research with research teams and develop engagement strategies to increase SWAT activity. Continued collaboration with the HRA is necessary to refine the SWAT approvals process. Conclusion The coordination PROMETHEUS provided is crucial to increasing the recruitment retention evidence base. The Trial Forge Network will be key to provide ongoing networking and dissemination opportunities.
{"title":"The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs","authors":"Laura Clark, C. Arundel, Elizabeth Coleman, Laura Doherty, Adwoa Parker, C. Hewitt, David J Beard, P. Bower, P. Brocklehurst, Cindy L. Cooper, L. Culliford, D. Devane, R. Emsley, S. Eldridge, Sandra Galvin, K. Gillies, A. Montgomery, C. Sutton, S. Treweek, D. Torgerson","doi":"10.1177/26320843221089632","DOIUrl":"https://doi.org/10.1177/26320843221089632","url":null,"abstract":"Introduction The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present observations from this work. Observations The PROMETHUS programme funded 42 SWATs, the average cost of each SWAT was £4007. A central coordination point enabled a concentrated effort in SWAT research activity leading to a rapid increase in the evidence base. The methodological feasibility of undertaking a coordinated SWAT design was established. The international Trial Forge SWAT Network was developed in 2021 to connect research groups in response for the need to connect teams undertaking methodological research. A SWAT reporting template and a database of researchers willing to peer review SWATs are also needed to improve the reporting of SWATs. Discussion There is a need to develop a strategy to aid teams to identify a suitable SWAT for their host trial populations and a mechanism to communicate SWAT research priorities. Work is needed to increase the awareness of the methodological importance of SWAT research with research teams and develop engagement strategies to increase SWAT activity. Continued collaboration with the HRA is necessary to refine the SWAT approvals process. Conclusion The coordination PROMETHEUS provided is crucial to increasing the recruitment retention evidence base. The Trial Forge Network will be key to provide ongoing networking and dissemination opportunities.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"100 - 106"},"PeriodicalIF":0.0,"publicationDate":"2022-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46538794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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