Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

10.21203/rs.2.21823/v3 ◽

2020 ◽

Author(s):

Lucy Bradshaw ◽

Alan A Montgomery ◽

Hywel Williams ◽

Joanne Chalmers ◽

Rachel Haines

Keyword(s):

Primary Outcome ◽

Outcome Data ◽

Trial Registration ◽

Prevention Trial ◽

Questionnaire Data ◽

Randomised Study ◽

Invitation Letter ◽

Study Within A Trial ◽

Sms Notification

Abstract Background Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT). Methods Parents of babies included in the host trial were randomised to (1) Short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) £10 voucher sent with the invitation letter for the primary follow up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse. Results Between November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS v. none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before v. at visit 0.89, 95% CI 0.69 to 1.17). Conclusion There was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies. Trial registration: Host trial registration: ISRCTN registry; ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25

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Two-by-two factorial randomised study within a trial to evaluate strategies for follow-up in a randomised prevention trial

10.21203/rs.2.21823/v1 ◽

2020 ◽

Author(s):

Lucy Bradshaw ◽

Alan A Montgomery ◽

Hywel Williams ◽

Joanne Chalmers ◽

Rachel Haines

Keyword(s):

Statistical Power ◽

Primary Outcome ◽

Outcome Data ◽

Trial Registration ◽

Prevention Trial ◽

Randomised Study ◽

Invitation Letter ◽

Study Within A Trial ◽

Sms Notification

Abstract Background Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT). Methods Parents of babies included in the host trial were randomised to (1) Short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) £10 voucher sent with the invitation letter for the primary follow up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse. Results Between November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall 75% of questionnaires were completed in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS v. none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before v. at visit 0.89, 95% CI 0.69 to 1.17). Conclusion There was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies. Trial registration: Host trial registration: ISRCTN registry; ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25

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Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

Trials ◽

10.1186/s13063-020-04373-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Lucy E. Bradshaw ◽

Alan A. Montgomery ◽

Hywel C. Williams ◽

Joanne R. Chalmers ◽

Rachel H. Haines

Keyword(s):

Prevention Trial ◽

Randomised Study ◽

Study Within A Trial

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An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2019-101963 ◽

2020 ◽

pp. bjsports-2019-101963

Author(s):

Nikos Ntoumanis ◽

Eleanor Quested ◽

Laurie Patterson ◽

Stella Kaffe ◽

Susan H Backhouse ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Trial Registration ◽

Perceived Effectiveness ◽

Cluster Randomised ◽

Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

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Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

10.21203/rs.3.rs-262194/v1 ◽

2021 ◽

Author(s):

Lucy Cureton ◽

Ioana Marian ◽

Vicki Barber ◽

Adwoa Parker ◽

David Torgerson ◽

...

Keyword(s):

Response Rate ◽

Text Message ◽

Mobile Telephone ◽

Questionnaire Response ◽

Randomised Study ◽

Study Within A Trial ◽

Standard Text ◽

To Receive ◽

Trial Participants

Abstract Background: Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name), versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires.Methods: Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either: 1) a personalised text message which included their name; 2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire and cost.Results: Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n=309) or standard (n=309) text message and all were included in the analysis. The overall questionnaire response rate was 86.9% (n=537/618); 89.6% (n=277/309) of participants responded in the personalised text message group compared to 84.1% (n=260/309) in the standard text message group (Relative Risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n=185/309; 59.9% vs. n=160/309; 51.8%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8.1%. Post-hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. Conclusion: Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.Trial Registration: GRASP Trial ISRCTN16539266; SWAT Repository ID 35.

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Effects of Acupuncture on Delayed-Onset Muscle Soreness: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5864057 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11 ◽

Cited By ~ 1

Author(s):

Wen-Dien Chang ◽

Nai-Jen Chang ◽

Hung-Yu Lin ◽

Jih-Huah Wu

Keyword(s):

Muscle Soreness ◽

Primary Outcome ◽

Meta Analysis ◽

Outcome Data ◽

Delayed Onset Muscle Soreness ◽

Acupuncture Points ◽

Control Groups ◽

Sham Control ◽

Delayed Onset

Objectives. Evidence for the effects of acupuncture on delayed-onset muscle soreness (DOMS) is inconsistent. The aim of this study was to explore the effects of acupuncture on DOMS. Methods. Studies investigating the effect of acupuncture on DOMS in humans that were published before March 2020 were obtained from eight electronic databases. The affected muscles, groups, acupuncture points, treatment sessions, assessments, assessment times, and outcomes of the included articles were reviewed. The data were extracted and analyzed via a meta-analysis. Results. A total of 15 articles were included, and relief of DOMS-related pain was the primary outcome. The statistical meta-analysis showed that there were no significant differences between acupuncture and sham/control groups, except for acupuncture for DOMS on day 1 (total SMD = −0.62; 95% CI = −1.12∼0.11, P<0.05) by comparing with control groups. Conclusion. Acupuncture for DOMS exhibited very-small-to-small and small-to-moderate effects on pain relief for the sham and no acupuncture conditions, respectively. Evidence indicating the effects of acupuncture on DOMS was little because the outcome data during the follow-up were insufficient to perform an effective meta-analysis.

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Association between Flash Glucose Monitors and A1C: A Retrospective Pre-Post Analysis

INNOVATIONS in pharmacy ◽

10.24926/iip.v12i3.3977 ◽

2021 ◽

Vol 12 (3) ◽

pp. 10

Author(s):

Mustafa Tekarli ◽

Kyle Turner ◽

Daniel Witt

Keyword(s):

Primary Outcome ◽

Insurance Coverage ◽

Outcome Data ◽

University Of Utah ◽

Insulin Requirements ◽

Before And After ◽

The Difference ◽

Outcome Differences ◽

Student’S T

Background: Randomized controlled trials have investigated the effect of continuous glucose monitors on hemoglobin A1C; however, more evidence is needed to justify their use and expand insurance coverage. Additionally, there are few published studies investigating the A1C lowering effect of flash glucose monitors (FGMs) in broad diabetes populations with varying insulin requirements. This analysis aimed to help fill this gap in medical literature and help clinicians evaluate costs/benefits when considering FGMs for their patients with diabetes. Objectives: To determine the association between FGM use and A1C reduction in patients with type 1 or type 2 diabetes mellitus regardless of insulin dependence. Methods: Pharmacy dispensing records were used to identify patients for inclusion. Patients who received a FGM from a University of Utah pharmacy between July 7, 2018 and July 7, 2020 were included. Patients who did not receive at least an 84-day supply of FGM sensors or did not have a baseline or follow-up A1C were excluded. Baseline and follow-up A1Cs, defined as A1Cs that are within one year before and 3-12 months after the FGM dispense date, were collected for each patient. New diabetes medications within a six-month window of the initial FGM dispense date were also recorded. Outcome variables were collected before and after patients received their first FGM (pre-FGM vs. post-FGM, respectively). The primary outcome was the difference between baseline and follow-up A1C for each patient. Secondary outcomes were the difference in baseline and follow-up A1C for various clinical subgroups within the overall sample. Descriptive statistics were used to summarize baseline characteristics and outcome data. Paired Student’s t-tests were used to evaluate outcome differences (α=0.05). Results: Fifty-seven patients (50.8% male; mean age: 49 years) were included. For the primary outcome, the average baseline and follow-up A1Cs were 9.33% and 8.32%, respectively for a difference of -1.01% ([95%CI -1.31:-0.72]; p<0.0001). Conclusions: The use of FGMs is associated with decreases in A1C within a cohort of patients at one health system. Further effort to determine impact of FGM on clinical and economic outcomes is warranted.

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Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Trials ◽

10.1186/s13063-021-05452-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lucy Cureton ◽

Ioana R. Marian ◽

Vicki S. Barber ◽

Adwoa Parker ◽

David J. Torgerson ◽

...

Keyword(s):

Response Rate ◽

Text Message ◽

Mobile Telephone ◽

Questionnaire Response ◽

Randomised Study ◽

Study Within A Trial ◽

Standard Text ◽

To Receive ◽

Trial Participants

Abstract Background Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires. Methods Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost. Results Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. Conclusion Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message. Trial registration GRASP Trial ISRCTN16539266; SWAT Repository ID 35

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The First Decade of Global Trabectome Outcomes

European Ophthalmic Review ◽

10.17925/eor.2014.08.02.113 ◽

2014 ◽

Vol 08 (02) ◽

pp. 113 ◽

Cited By ~ 11

Author(s):

Sameh Mosaed ◽

Keyword(s):

Primary Outcome ◽

Survival Rates ◽

Glaucoma Surgery ◽

Outcome Data ◽

Secondary Glaucoma ◽

Outcome Analysis ◽

Glaucoma Medication ◽

Medical Treatments ◽

End Stage

Purpose:To present available primary outcome results of global Trabectome experience for patients receiving Trabectome procedure including cases with up to 90 months of follow-up.Method:A total of 5,435 cases were included in the study. Baseline demographics were collected and outcome measures included intraocular pressure (IOP), number of glaucoma medications and secondary glaucoma surgery, if any. Survival analysis was performed and success was defined as IOP ≤21 mmHg, at least 20 % of IOP reduction from baseline, and no additional glaucoma surgery.Results:At 90 months, IOP was reduced from 23.0±7.9 mmHg to 16.5±3.8 mmHg (29 %) and the number of glaucoma medications was reduced from 2.6±1.3 to 1.6±1.3 (38 %). At 90 months, the survival rates were 60 % for all cases, 76 % for combined cases and 50 % for Trabectome alone cases.Discussion:These results are generally consistent with previously published outcome results for patients receiving the Trabectome procedure.Conclusion:Considering this outcome analysis of the available global Trabectome experience in combination with outcome data surveyed from the literature, patients receiving Trabectome on average have about a 30 % reduction in IOP and a 60 % reduction in glaucoma medication. The Trabectome procedure can be considered for initial glaucoma therapy, as well as for end-stage patients who have been refractory to other surgical and medical treatments.

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Routine hospital data – is it good enough for trials? An example using England’s Hospital Episode Statistics in the SHIFT trial of Family Therapy vs. Treatment as Usual in adolescents following self-harm

Clinical Trials ◽

10.1177/1740774517751381 ◽

2018 ◽

Vol 15 (2) ◽

pp. 197-206 ◽

Cited By ~ 8

Author(s):

Alexandra Wright-Hughes ◽

Elizabeth Graham ◽

David Cottrell ◽

Amanda Farrin

Keyword(s):

Family Therapy ◽

Data Collection ◽

Primary Outcome ◽

Routine Data ◽

Outcome Data ◽

Hospital Episode Statistics ◽

Hospital Episode ◽

Accident And Emergency ◽

Self Harm

Background: Use of routine data sources within clinical research is increasing and is endorsed by the National Institute for Health Research to increase trial efficiencies; however there is limited evidence for its use in clinical trials, especially in relation to self-harm. One source of routine data, Hospital Episode Statistics, is collated and distributed by NHS Digital and contains details of admissions, outpatient, and Accident and Emergency attendances provided periodically by English National Health Service hospitals. We explored the reliability and accuracy of Hospital Episode Statistics, compared to data collected directly from hospital records, to assess whether it would provide complete, accurate, and reliable means of acquiring hospital attendances for self-harm – the primary outcome for the SHIFT (Self-Harm Intervention: Family Therapy) trial evaluating Family Therapy for adolescents following self-harm. Methods: Participant identifiers were linked to Hospital Episode Statistics Accident and Emergency, and Admissions data, and episodes combined to describe participants’ complete hospital attendance. Attendance data were initially compared to data previously gathered by trial researchers from pre-identified hospitals. Final comparison was conducted of subsequent attendances collected through Hospital Episode Statistics and researcher follow-up. Consideration was given to linkage rates; number and proportion of attendances retrieved; reliability of Accident and Emergency, and Admissions data; percentage of self-harm episodes recorded and coded appropriately; and percentage of required data items retrieved. Results: Participants were first linked to Hospital Episode Statistics with an acceptable match rate of 95%, identifying a total of 341 complete hospital attendances, compared to 139 reported by the researchers at the time. More than double the proportion of Hospital Episode Statistics Accident and Emergency episodes could not be classified in relation to self-harm (75%) compared to 34.9% of admitted episodes, and of overall attendances, 18% were classified as self-harm related and 20% not related, while ambiguity or insufficient information meant 62% were unclassified. Of 39 self-harm-related attendances reported by the researchers, Hospital Episode Statistics identified 24 (62%) as self-harm related while 15 (38%) were unclassified. Based on final data received, 1490 complete hospital attendances were identified and comparison to researcher follow-up found Hospital Episode Statistics underestimated the number of self-harm attendances by 37.2% (95% confidence interval 32.6%–41.9%). Conclusion: Advantages of routine data collection via NHS Digital included the acquisition of more comprehensive and timely trial outcome data, identifying more than double the number of hospital attendances than researchers. Disadvantages included ambiguity in the classification of self-harm relatedness. Our resulting primary outcome data collection strategy used routine data to identify hospital attendances supplemented by targeted researcher data collection for attendances requiring further self-harm classification.

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