Pub Date : 2022-06-09DOI: 10.1177/26320843221106952
Lauren A Moreau, I. Holloway, Seline Ozer, A. Forster, C. Hulme, S. Hartley, A. Farrin
Background: Improving outcome data collection rates is an essential part of managing clinical trials and ensures statistical power and generalisability of results are maintained. Studies within a trial (SWATs) provide a robust methodology to investigate the most efficient methods to maximise outcome follow-up. Methods: LoTS2Care, a feasibility cluster Randomised Controlled Trial, recruited 269 stroke survivors across 10 services, and incorporated a SWAT to evaluate the effect of questionnaire booklet format (one booklet or two) on follow-up rates for self-reported postal outcomes at 6 and 9 months post-recruitment. Available participants were individually randomised (1 : 1) by the Clinical Trials Research Unit and follow-up rates in the two groups were compared. Results: At 6 months post-recruitment, 254 participants were randomised: 126 to receive (125 posted) the single booklet; 128 to receive two booklets. By 9 months post-recruitment, 116 and 123 participants were still available in each group, respectively. For participants randomised to two booklets, return of at least one of the booklets was considered as ‘followed-up’. At 6 months, 114/125 (91.2%) participants sent the single booklet returned it, compared to 108/128 (84.4%) sent two (odds ratio (OR) 1.92, 95% confidence interval (CI) 0.88 to 4.19). By 9 months, 108/116 (93.1%) participants returned the single booklet, compared to 105/123 (85.4%) sent two (OR 2.31, 95% CI 0.97 to 5.55). Conclusions: The SWAT was an inexpensive, straightforward way to test how booklet format affected follow-up rates. Larger participant numbers would be required for conclusive results. These initial findings, however, suggest that including all outcome measures in a single booklet may maximise return rates, especially in trials with similar populations, such as those living with brain injury, cognitive or speech impairment or older people.
{"title":"Is two better than one? Maximising follow-up of self-reported outcome measures for a stroke survivor population: Results from a study within a trial in the LoTS2Care feasibility study","authors":"Lauren A Moreau, I. Holloway, Seline Ozer, A. Forster, C. Hulme, S. Hartley, A. Farrin","doi":"10.1177/26320843221106952","DOIUrl":"https://doi.org/10.1177/26320843221106952","url":null,"abstract":"Background: Improving outcome data collection rates is an essential part of managing clinical trials and ensures statistical power and generalisability of results are maintained. Studies within a trial (SWATs) provide a robust methodology to investigate the most efficient methods to maximise outcome follow-up. Methods: LoTS2Care, a feasibility cluster Randomised Controlled Trial, recruited 269 stroke survivors across 10 services, and incorporated a SWAT to evaluate the effect of questionnaire booklet format (one booklet or two) on follow-up rates for self-reported postal outcomes at 6 and 9 months post-recruitment. Available participants were individually randomised (1 : 1) by the Clinical Trials Research Unit and follow-up rates in the two groups were compared. Results: At 6 months post-recruitment, 254 participants were randomised: 126 to receive (125 posted) the single booklet; 128 to receive two booklets. By 9 months post-recruitment, 116 and 123 participants were still available in each group, respectively. For participants randomised to two booklets, return of at least one of the booklets was considered as ‘followed-up’. At 6 months, 114/125 (91.2%) participants sent the single booklet returned it, compared to 108/128 (84.4%) sent two (odds ratio (OR) 1.92, 95% confidence interval (CI) 0.88 to 4.19). By 9 months, 108/116 (93.1%) participants returned the single booklet, compared to 105/123 (85.4%) sent two (OR 2.31, 95% CI 0.97 to 5.55). Conclusions: The SWAT was an inexpensive, straightforward way to test how booklet format affected follow-up rates. Larger participant numbers would be required for conclusive results. These initial findings, however, suggest that including all outcome measures in a single booklet may maximise return rates, especially in trials with similar populations, such as those living with brain injury, cognitive or speech impairment or older people.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"127 - 133"},"PeriodicalIF":0.0,"publicationDate":"2022-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42402027","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 : 2022-06-08DOI: 10.1177/26320843221106961
C. Boxall, S. Treweek, K. Gillies
Background Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research. Methods In November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings. Results 125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them. Conclusions This study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.
{"title":"Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials","authors":"C. Boxall, S. Treweek, K. Gillies","doi":"10.1177/26320843221106961","DOIUrl":"https://doi.org/10.1177/26320843221106961","url":null,"abstract":"Background Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research. Methods In November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings. Results 125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them. Conclusions This study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"121 - 126"},"PeriodicalIF":0.0,"publicationDate":"2022-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44844301","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 : 2022-06-04DOI: 10.1177/26320843221106957
Y. Wu, Y. Tu
Background: Network meta-analysis computes treatment ranking to assist with clinical decision making, but it is not always clear how reliable the ranking is and how likely the accumulation of new evidence may alter the ranking. Uncertainty and robustness of ranking are two concepts related to the reliability of ranking. However, it is still unclear whether these two approaches would always yield similar conclusions on the reliability of ranking, i.e., a robust ranking is also one of low uncertainty. Purpose: This study aimed to investigate the relationship between the uncertainty and robustness of treatment ranking by using normalized entropy and quadratic weighted Cohen’s kappa, respectively. Data. We used datasets of previously published NMAs from a database maintained by Petropoulou et al. at the University of Bern. Analysis. Scatter plots and Pearson’s correlation coefficients were used to demonstrate the direction and strength of the association between uncertainty and robustness of ranking for NMA-level and treatment-level evaluation. Results: We found that when the uncertainty of ranking is very low, treatment ranking is unlikely to be altered by deleting a trial from the complete data. However, network meta-analysis with robust treatment ranking may have high uncertainty of treatment ranking. Conclusions: Therefore, although the robustness of the ranking can find the trial that has the most significant impact on the ranking, the high robustness of ranking does not mean that the ranking would not easily change when new trials are added in the future.
{"title":"High robustness does not always imply low uncertainty of treatment rankings: An empirical study of 60 network meta-analyses","authors":"Y. Wu, Y. Tu","doi":"10.1177/26320843221106957","DOIUrl":"https://doi.org/10.1177/26320843221106957","url":null,"abstract":"Background: Network meta-analysis computes treatment ranking to assist with clinical decision making, but it is not always clear how reliable the ranking is and how likely the accumulation of new evidence may alter the ranking. Uncertainty and robustness of ranking are two concepts related to the reliability of ranking. However, it is still unclear whether these two approaches would always yield similar conclusions on the reliability of ranking, i.e., a robust ranking is also one of low uncertainty. Purpose: This study aimed to investigate the relationship between the uncertainty and robustness of treatment ranking by using normalized entropy and quadratic weighted Cohen’s kappa, respectively. Data. We used datasets of previously published NMAs from a database maintained by Petropoulou et al. at the University of Bern. Analysis. Scatter plots and Pearson’s correlation coefficients were used to demonstrate the direction and strength of the association between uncertainty and robustness of ranking for NMA-level and treatment-level evaluation. Results: We found that when the uncertainty of ranking is very low, treatment ranking is unlikely to be altered by deleting a trial from the complete data. However, network meta-analysis with robust treatment ranking may have high uncertainty of treatment ranking. Conclusions: Therefore, although the robustness of the ranking can find the trial that has the most significant impact on the ranking, the high robustness of ranking does not mean that the ranking would not easily change when new trials are added in the future.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"116 - 120"},"PeriodicalIF":0.0,"publicationDate":"2022-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47995941","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 : 2022-05-08DOI: 10.1177/26320843221085649
Mohammad Ehsanul Karim, M. B. Hossain
Last Observation Carried Forward (LOCF) is an ad-hoc method, with known limitations. In recent years, several methods publications have used LOCF in estimating the per-protocol effect via inverse probability of adherence weighted (IPAW) model, when a time-varying factor is partially measured by the study design. We compare the statistical performances of LOCF and multiple imputation approaches for estimating the per-protocol effects via the IPAW model in the presence of incomplete treatment adherence. We used a validated pragmatic trial data generating simulation algorithm to generate datasets under 7 different simulation scenarios, where a post-randomization prognostic factor was measured after regular intervals. Unmeasured values of a partially observed factor were imputed using LOCF and multiple imputation approaches, and IPAW model was fitted on the imputed data to obtain the estimates, and statistical performances were assessed. When confounding exists, for higher variability of the time-varying factor, multiple imputation approach shows desirable statistical properties under MCAR assumption; otherwise, LOCF approach can be adequate. Both imputation methods performed well in terms of statistical properties, when there is no confounding or when all necessary confounders are adjusted. A case study from Coronary Primary Prevention Trial data was presented, which included some participants with incomplete treatment adherence.
{"title":"Considerations for choosing an imputation method for addressing sparse measurement issues dictated by the study design - An illustration from per-protocol analysis in pragmatic trials","authors":"Mohammad Ehsanul Karim, M. B. Hossain","doi":"10.1177/26320843221085649","DOIUrl":"https://doi.org/10.1177/26320843221085649","url":null,"abstract":"Last Observation Carried Forward (LOCF) is an ad-hoc method, with known limitations. In recent years, several methods publications have used LOCF in estimating the per-protocol effect via inverse probability of adherence weighted (IPAW) model, when a time-varying factor is partially measured by the study design. We compare the statistical performances of LOCF and multiple imputation approaches for estimating the per-protocol effects via the IPAW model in the presence of incomplete treatment adherence. We used a validated pragmatic trial data generating simulation algorithm to generate datasets under 7 different simulation scenarios, where a post-randomization prognostic factor was measured after regular intervals. Unmeasured values of a partially observed factor were imputed using LOCF and multiple imputation approaches, and IPAW model was fitted on the imputed data to obtain the estimates, and statistical performances were assessed. When confounding exists, for higher variability of the time-varying factor, multiple imputation approach shows desirable statistical properties under MCAR assumption; otherwise, LOCF approach can be adequate. Both imputation methods performed well in terms of statistical properties, when there is no confounding or when all necessary confounders are adjusted. A case study from Coronary Primary Prevention Trial data was presented, which included some participants with incomplete treatment adherence.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"74 - 85"},"PeriodicalIF":0.0,"publicationDate":"2022-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42572788","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 : 2022-05-07DOI: 10.1177/26320843221098427
C. Sutton, S. Cotterill, Denise Forshaw, S. Rhodes, Alexandra Haig, A. Hammond
Background Retention is considered the second highest trial methods priority in the UK after recruitment. There is limited evidence on whether notifying trial participants that a follow-up questionnaire will be sent soon (‘pre-notification’) affects retention. Methods This Study Within a Trial (SWAT) evaluated whether sending a pre-notification letter or email around 2 weeks before sending a self-report questionnaire increased retention, in terms of provision of the host trial primary outcome. The SWAT was a randomised, two-arm, parallel-design (1:1 allocation ratio) trial, controlled by ‘no pre-notification letter’. It was embedded within the WORKWELL host trial, which evaluated the impact of job retention vocational rehabilitation on work-related and health-related outcomes of employed people with inflammatory arthritis. The SWAT primary outcome was a valid response for the WORKWELL primary outcome. Results Two hundred forty-four trial participants took part in the SWAT. All were included in the analysis. Among those sent a pre-reminder, 100/121 (83%) provided a valid response for the WORKWELL primary outcome, compared to 97/123 (79%) of those not sent a pre-reminder. The estimated adjusted odds ratio was 1.28 (95% confidence interval 0.67–2.42), with a risk difference of 3.8% (95% CI -6.1 to 13.6%), favouring the prereminder. The estimated intervention cost per additional participant retained was £53.42, and the total cost per additional participant retained was £46.52. Conclusion Researchers may have a small improvement in trial retention by using pre-notification. The cost per additional participant retained is relatively low. However, further evaluations are merited.
{"title":"Randomised evaluation of pre-notification of trial participants before self-report outcome data collection to improve retention: SWAT86","authors":"C. Sutton, S. Cotterill, Denise Forshaw, S. Rhodes, Alexandra Haig, A. Hammond","doi":"10.1177/26320843221098427","DOIUrl":"https://doi.org/10.1177/26320843221098427","url":null,"abstract":"Background Retention is considered the second highest trial methods priority in the UK after recruitment. There is limited evidence on whether notifying trial participants that a follow-up questionnaire will be sent soon (‘pre-notification’) affects retention. Methods This Study Within a Trial (SWAT) evaluated whether sending a pre-notification letter or email around 2 weeks before sending a self-report questionnaire increased retention, in terms of provision of the host trial primary outcome. The SWAT was a randomised, two-arm, parallel-design (1:1 allocation ratio) trial, controlled by ‘no pre-notification letter’. It was embedded within the WORKWELL host trial, which evaluated the impact of job retention vocational rehabilitation on work-related and health-related outcomes of employed people with inflammatory arthritis. The SWAT primary outcome was a valid response for the WORKWELL primary outcome. Results Two hundred forty-four trial participants took part in the SWAT. All were included in the analysis. Among those sent a pre-reminder, 100/121 (83%) provided a valid response for the WORKWELL primary outcome, compared to 97/123 (79%) of those not sent a pre-reminder. The estimated adjusted odds ratio was 1.28 (95% confidence interval 0.67–2.42), with a risk difference of 3.8% (95% CI -6.1 to 13.6%), favouring the prereminder. The estimated intervention cost per additional participant retained was £53.42, and the total cost per additional participant retained was £46.52. Conclusion Researchers may have a small improvement in trial retention by using pre-notification. The cost per additional participant retained is relatively low. However, further evaluations are merited.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"107 - 115"},"PeriodicalIF":0.0,"publicationDate":"2022-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46687169","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 : 2022-04-21DOI: 10.1177/26320843221089628
C. Terwee, E. Elsman, L. Roorda
Background There is little consensus on how to measure fatigue. Objectives To standardize the measurement of fatigue across populations, we aimed to assess the psychometric properties of the PROMIS Fatigue item bank in the Dutch general population and obtain reference values. Methods A sample of 1006 people participating in an internet panel completed the full v1.0 PROMIS Fatigue item bank (95 items). Structural validity (item response theory (IRT) assumptions and IRT model fit), measurement invariance/cross-cultural validity (absence of differential items functioning (DIF) for demographic variables and language, compared to data from US participants in PROMIS wave 1), and (internal) reliability (percentage of respondents with reliable estimates) were assessed. Results The IRT model assumptions were considered met (ECV 0.86, Omega-H 0.92), all items fitted the IRT model, no items showed DIF for demographic variables and seven for language, but with negligible impact on T-scores. Reliable fatigue T-scores were found for 98.3%, 69.8–82.6%, and 96.5% of the respondents with the full item bank, the standard short forms, and a simulated computerized adaptive test (CAT), respectively. The CAT administered on average only five items. A T-score of 49.1 represented the average score of the Dutch general population, T-scores <55 are considered within normal limits, T-scores of 55–59 indicate mild fatigue, T-scores of 60–70 indicate moderate fatigue, and T-scores >70 indicate severe fatigue. Conclusions The PROMIS Fatigue item bank showed sufficient structural validity, no measurement invariance for demographic characteristics, sufficient cross-cultural validity, and sufficient (internal) reliability in the Dutch general population.
{"title":"Towards standardization of fatigue measurement: Psychometric properties and reference values of the PROMIS Fatigue item bank in the Dutch general population","authors":"C. Terwee, E. Elsman, L. Roorda","doi":"10.1177/26320843221089628","DOIUrl":"https://doi.org/10.1177/26320843221089628","url":null,"abstract":"Background There is little consensus on how to measure fatigue. Objectives To standardize the measurement of fatigue across populations, we aimed to assess the psychometric properties of the PROMIS Fatigue item bank in the Dutch general population and obtain reference values. Methods A sample of 1006 people participating in an internet panel completed the full v1.0 PROMIS Fatigue item bank (95 items). Structural validity (item response theory (IRT) assumptions and IRT model fit), measurement invariance/cross-cultural validity (absence of differential items functioning (DIF) for demographic variables and language, compared to data from US participants in PROMIS wave 1), and (internal) reliability (percentage of respondents with reliable estimates) were assessed. Results The IRT model assumptions were considered met (ECV 0.86, Omega-H 0.92), all items fitted the IRT model, no items showed DIF for demographic variables and seven for language, but with negligible impact on T-scores. Reliable fatigue T-scores were found for 98.3%, 69.8–82.6%, and 96.5% of the respondents with the full item bank, the standard short forms, and a simulated computerized adaptive test (CAT), respectively. The CAT administered on average only five items. A T-score of 49.1 represented the average score of the Dutch general population, T-scores <55 are considered within normal limits, T-scores of 55–59 indicate mild fatigue, T-scores of 60–70 indicate moderate fatigue, and T-scores >70 indicate severe fatigue. Conclusions The PROMIS Fatigue item bank showed sufficient structural validity, no measurement invariance for demographic characteristics, sufficient cross-cultural validity, and sufficient (internal) reliability in the Dutch general population.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"86 - 98"},"PeriodicalIF":0.0,"publicationDate":"2022-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43046049","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 : 2022-04-16DOI: 10.1177/26320843221080734
Sadia Ahmed, Jennifer Airlie, A. Clegg, Bethan Copsey, B. Cundill, A. Forster, Anne Heaven, J. F. Johansson, N. Kime, Lauren A Moreau, Seline Ozer, Catriona Parker, S. Richards, E. Thompson, A. Farrin
Background A study within a trial (SWAT) is a self-contained research study embedded within one or more host trials to evaluate or explore alternative ways of delivering or organising a particular trial process. There is limited evidence of SWATs evaluating trial processes other than recruitment and retention. Purpose Embedding a SWAT into a host trial provides a potential method of evaluating an aspect of intervention implementation, such as engagement or compliance with the intervention. Research Design This paper presents two case studies of SWATs which aim to test the use of video animations to improve intervention implementation, with particular focus on enhancing understanding, engagement and compliance. These are important aspects of intervention implementation as they are directly linked to intervention effectiveness and therefore, important to study. Results In this paper, we present the potential benefits of conducting SWATs of intervention implementation processes as well as discussing the methodological considerations for embedding a SWAT of this nature within a host trial. Benefits include the opportunity to test minor refinements to intervention implementation within trials through robust randomised SWATs, and the possibility of increasing trial efficiency by maximising the quality or quantity of intervention implementation. Methodological considerations surrounding the design and conduct of the SWAT as well as statistical and health economics considerations are discussed in this paper. Conclusions This paper presents a novel application of SWAT methodology in investigating intervention implementation processes within trial conduct.
{"title":"A new opportunity for enhancing trial efficiency: Can we investigate intervention implementation processes within trials using SWAT (study within a trial) methodology?","authors":"Sadia Ahmed, Jennifer Airlie, A. Clegg, Bethan Copsey, B. Cundill, A. Forster, Anne Heaven, J. F. Johansson, N. Kime, Lauren A Moreau, Seline Ozer, Catriona Parker, S. Richards, E. Thompson, A. Farrin","doi":"10.1177/26320843221080734","DOIUrl":"https://doi.org/10.1177/26320843221080734","url":null,"abstract":"Background A study within a trial (SWAT) is a self-contained research study embedded within one or more host trials to evaluate or explore alternative ways of delivering or organising a particular trial process. There is limited evidence of SWATs evaluating trial processes other than recruitment and retention. Purpose Embedding a SWAT into a host trial provides a potential method of evaluating an aspect of intervention implementation, such as engagement or compliance with the intervention. Research Design This paper presents two case studies of SWATs which aim to test the use of video animations to improve intervention implementation, with particular focus on enhancing understanding, engagement and compliance. These are important aspects of intervention implementation as they are directly linked to intervention effectiveness and therefore, important to study. Results In this paper, we present the potential benefits of conducting SWATs of intervention implementation processes as well as discussing the methodological considerations for embedding a SWAT of this nature within a host trial. Benefits include the opportunity to test minor refinements to intervention implementation within trials through robust randomised SWATs, and the possibility of increasing trial efficiency by maximising the quality or quantity of intervention implementation. Methodological considerations surrounding the design and conduct of the SWAT as well as statistical and health economics considerations are discussed in this paper. Conclusions This paper presents a novel application of SWAT methodology in investigating intervention implementation processes within trial conduct.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"66 - 73"},"PeriodicalIF":0.0,"publicationDate":"2022-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42174225","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 : 2022-03-01DOI: 10.1177/26320843221074344
A. Ooms, S. Parsons, S. Dutton, Angela Garrett, B. Fordham, C. Hing, S. Lamb, Toby O Smith
Background Missing data is a common issue in randomised controlled trials. There is a need to rigorously test means of participant retention. This embedded trial aims to examine the effect on postal response rates of printing a randomised controlled trial’s primary outcome on pink versus white paper. Methods Our randomised Study Within A Trial (SWAT) was run within a behaviour-change intervention host trial for patients following hip or knee replacements. Participants were randomised to receive the host trial’s primary outcome measure printed on either a sheet of pink or white paper within the 11 sheet (21 page) 6-month follow-up questionnaire. The SWAT’s primary outcome was host trial primary outcome measure completion. Number of reminders sent, proportion of remaining questions completed and overall questionnaire returns were secondary outcomes. Results 176 participants were randomised: 88 received pink paper, 88 white paper. Host trial primary outcome measures were returned by 84.1% (74/88 participants) in the pink paper group and in 90.9% (80/88 participants) in the white paper group (risk ratio, 0.92 (95% CI 0.80, 1.06); p = .24). Reminders were sent to 48.9% (43/88 participants) in the pink paper group and in 30.7% (27/88 participants) in the white paper group (risk ratio 1.59 (95% CI 1.09, 2.33); p = .01). No other results were statistically significant. Conclusion Printing the primary outcome on pink paper does not increase data return. From this small randomised study, there is some evidence that it potentially decreases response and is more burdensome to collect postal data by increasing the necessity for reminders.
{"title":"SWAT 110: Printing the primary outcomE on Pink PapER versus standard paper to increase participant engagement to postal questionnaires (PEPPER)","authors":"A. Ooms, S. Parsons, S. Dutton, Angela Garrett, B. Fordham, C. Hing, S. Lamb, Toby O Smith","doi":"10.1177/26320843221074344","DOIUrl":"https://doi.org/10.1177/26320843221074344","url":null,"abstract":"Background Missing data is a common issue in randomised controlled trials. There is a need to rigorously test means of participant retention. This embedded trial aims to examine the effect on postal response rates of printing a randomised controlled trial’s primary outcome on pink versus white paper. Methods Our randomised Study Within A Trial (SWAT) was run within a behaviour-change intervention host trial for patients following hip or knee replacements. Participants were randomised to receive the host trial’s primary outcome measure printed on either a sheet of pink or white paper within the 11 sheet (21 page) 6-month follow-up questionnaire. The SWAT’s primary outcome was host trial primary outcome measure completion. Number of reminders sent, proportion of remaining questions completed and overall questionnaire returns were secondary outcomes. Results 176 participants were randomised: 88 received pink paper, 88 white paper. Host trial primary outcome measures were returned by 84.1% (74/88 participants) in the pink paper group and in 90.9% (80/88 participants) in the white paper group (risk ratio, 0.92 (95% CI 0.80, 1.06); p = .24). Reminders were sent to 48.9% (43/88 participants) in the pink paper group and in 30.7% (27/88 participants) in the white paper group (risk ratio 1.59 (95% CI 1.09, 2.33); p = .01). No other results were statistically significant. Conclusion Printing the primary outcome on pink paper does not increase data return. From this small randomised study, there is some evidence that it potentially decreases response and is more burdensome to collect postal data by increasing the necessity for reminders.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"49 - 54"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45812323","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 : 2022-03-01DOI: 10.1177/26320843221085744
{"title":"Editorial","authors":"","doi":"10.1177/26320843221085744","DOIUrl":"https://doi.org/10.1177/26320843221085744","url":null,"abstract":"","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"32 - 32"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48604169","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 : 2022-02-23DOI: 10.1177/26320843221080733
Chane Anne Roodt, P. Keeley, Mary Turner, Amanda J Edmondson, S. Kendal
Purpose Trichotillomania (TTM) is characterised by the recurrent pulling out of one’s own hair, resulting in hair loss. It is a poorly understood disorder with no consensus on aetiology or epidemiology. Nested within a larger qualitative study exploring a wide range of TTM topics, the aim of this paper is to report and consider participant views on the acceptability and feasibility of the asynchronous email interview method. Method Cross-cultural qualitative research on TTM is sparse; therefore, an international qualitative study with a geographically diverse sample was conducted using an asynchronous email interview method. Results Participant perspectives highlighted three themes related to the study method: the value in creating personal connections, cathartic reflections, and perceived strengths and weaknesses. This paper highlights the potential of the asynchronous email interview method for sustaining remote research across multiple locations, using a sample of 20 adults with TTM (18–55 years) from 15 different countries. Conclusions This was an acceptable and feasible method for data collection, facilitating remote access while yielding rich data from an often hidden and hard-to-reach population.
{"title":"Perspectives of an international sample of adults with Trichotillomania on the acceptability and feasibility of an asynchronous qualitative email interview method","authors":"Chane Anne Roodt, P. Keeley, Mary Turner, Amanda J Edmondson, S. Kendal","doi":"10.1177/26320843221080733","DOIUrl":"https://doi.org/10.1177/26320843221080733","url":null,"abstract":"Purpose Trichotillomania (TTM) is characterised by the recurrent pulling out of one’s own hair, resulting in hair loss. It is a poorly understood disorder with no consensus on aetiology or epidemiology. Nested within a larger qualitative study exploring a wide range of TTM topics, the aim of this paper is to report and consider participant views on the acceptability and feasibility of the asynchronous email interview method. Method Cross-cultural qualitative research on TTM is sparse; therefore, an international qualitative study with a geographically diverse sample was conducted using an asynchronous email interview method. Results Participant perspectives highlighted three themes related to the study method: the value in creating personal connections, cathartic reflections, and perceived strengths and weaknesses. This paper highlights the potential of the asynchronous email interview method for sustaining remote research across multiple locations, using a sample of 20 adults with TTM (18–55 years) from 15 different countries. Conclusions This was an acceptable and feasible method for data collection, facilitating remote access while yielding rich data from an often hidden and hard-to-reach population.","PeriodicalId":74683,"journal":{"name":"Research methods in medicine & health sciences","volume":"3 1","pages":"55 - 64"},"PeriodicalIF":0.0,"publicationDate":"2022-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42046051","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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