scholarly journals Does pre-notification increase questionnaire response rates: a randomised controlled trial nested within a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin Woolf ◽  
Phil Edwards
Keyword(s):  
Systematic Review ◽  
Controlled Trial ◽  
Response Rates ◽  
Open Science ◽  
Outcome Data ◽  
Absolute Difference ◽  
Questionnaire Response ◽  
Link Type ◽  
Science Framework ◽  
Randomised Controlled

Abstract Background Missing outcome data can lead to bias in the results of systematic reviews. One way to address missing outcome data is by requesting the data from the trial authors, but non-response is common. One way to potentially improve response rates is by sending study participants advance communication. During the update of a systematic review examining the effect of pre-notification on response rates, study authors needed to be contacted for further information. This study was nested within the systematic review by randomising authors to receive a notification of the upcoming request for information. The objective was to test if pre-notification increased response rates. Methods The participants were study authors included in the systematic review, whose studies were at unclear risk of bias. The intervention was a pre-notification of the request for further information, sent 1 day before the request. The outcome was defined as the proportion of authors who responded to the request for information. Authors were randomised by simple randomisation. Thirty three authors were randomised to the pre-notification arm, and 42 were randomised to the control arm. Authors were blinded to the possibility of an alternative condition. Results All authors randomised were analysed. 14/33 (42.4%) authors in the pre-notification arm had returned responses to the questionnaire, and 18/42 (42.9%) in the control arm. There was no evidence of a difference between these groups (absolute difference = − 0.5, 95% CI (− 23.4 to 22.5%), p = 1). We received no complaints about receiving the pre-notification. Conclusions This study’s results do not support the hypothesis that pre-notification increases response from study authors being contacted for a request for more information. However, the study has a low power, and the results may not generalise to other contexts, methods of administering a pre-notification, or study populations. Trial registration Registration and protocol: This trial is not registered with any trial registry. However, the protocol was posted in advance on the Open Science Framework website and is available on the Open Science Framework website: DOI: 10.17605/OSF.IO/MSV2W or https://osf.io/msv2w/

scholarly journals Including a pen and/or cover letter, containing social incentive text, had no effect on questionnaire response rate: a factorial randomised controlled Study within a Trial

F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 623
Author(s):  
Sophie James ◽  
Adwoa Parker ◽  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Caroline Fairhurst ◽  
...  
Keyword(s):  
Statistical Power ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Outcome Data ◽  
Controlled Study ◽  
Cover Letter ◽  
Questionnaire Response ◽  
Randomised Controlled

Background: Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a postal follow-up questionnaire increased response rates in a trial. Method: A two-by-two factorial randomised controlled trial was embedded within the OTIS host trial. Participants due their 12-month (final) follow-up questionnaire were randomised to be sent: a pen; a social incentive text cover letter; both; or neither. The primary outcome measure was the proportion of participants in each group who returned the questionnaire. Secondary outcomes were: time to return, completeness of the questionnaire, necessity of a reminder letter, and the cost effectiveness. Results: The overall 12-month questionnaire response rate was 721 out of 755 (95.5%). Neither the pen nor social incentive cover letter had a statistically significant effect on response rate: pen 95.2% vs. no pen 95.8%, adjusted OR 0.90 (95% CI 0.45 to 1.80; p=0.77); social incentive cover letter 95.2% vs. no social incentive cover letter 95.8%, adjusted OR 0.84 (95% CI 0.42 to 1.69, p=0.63). No statistically significant differences were observed between either of the intervention groups on time to response, need for a reminder or completeness. Therefore, neither intervention was cost-effective. Conclusions: We found no evidence of a difference in response rates associated with the inclusion of a pen and/or social incentive cover letter with the final follow-up postal questionnaire of the host trial. However, when these results are combined with previous SWATs, the meta-analysis evidence remains that including a pen increases response rates. The social incentive cover letter warrants further investigation to determine effectiveness. Trial registration: ISRCTN22202133 (21st June 2020).

scholarly journals Including a pen and/or cover letter, containing social incentive text, had no effect on questionnaire response rate: a factorial randomised controlled Study within a Trial

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 623
Author(s):  
Sophie James ◽  
Adwoa Parker ◽  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Caroline Fairhurst ◽  
...  
Keyword(s):  
Statistical Power ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Outcome Data ◽  
Controlled Study ◽  
Cover Letter ◽  
Questionnaire Response ◽  
Randomised Controlled

Background: Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a postal follow-up questionnaire increased response rates in a trial. Method: A two-by-two factorial randomised controlled trial was embedded within the OTIS host trial. Participants due their 12-month (final) follow-up questionnaire were randomised to be sent: a pen; a social incentive text cover letter; both; or neither. The primary outcome measure was the proportion of participants in each group who returned the questionnaire. Secondary outcomes were: time to return, completeness of the questionnaire, necessity of a reminder letter, and the cost effectiveness. Results: The overall 12-month questionnaire response rate was 721 out of 755 (95.5%). Neither the pen nor social incentive cover letter had a statistically significant effect on response rate: pen 95.2% vs. no pen 95.8%, adjusted OR 0.90 (95% CI 0.45 to 1.80; p=0.77); social incentive cover letter 95.2% vs. no social incentive cover letter 95.8%, adjusted OR 0.84 (95% CI 0.42 to 1.69, p=0.63). No statistically significant differences were observed between either of the intervention groups on time to response, need for a reminder or completeness. Therefore, neither intervention was cost-effective. Conclusions: We found no evidence of a difference in response rates associated with the inclusion of a pen and/or social incentive cover letter with the final follow-up postal questionnaire of the host trial. However, when these results are combined with previous SWATs, the meta-analysis evidence remains that including a pen increases response rates. The social incentive cover letter warrants further investigation to determine effectiveness. Trial registration: ISRCTN22202133 (21st June 2020).

scholarly journals A nested randomised controlled trial of a newsletter and Post-it® note did not increase postal questionnaire response rates in a falls prevention trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1083
Author(s):  
Sara Rodgers ◽  
Illary Sbizzera ◽  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Sarah E. Lamb ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Statistical Power ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Response Rates ◽  
Postal Questionnaire ◽  
Falls Prevention ◽  
Controlled Trials ◽  
Questionnaire Response ◽  
Randomised Controlled

Background: Attrition (i.e. when participants do not return the questionnaires) is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can lead to bias. The aim of this study was to assess whether a pre-notification newsletter and/or a handwritten or printed Post-it® note sticker, as a reminder, increased postal questionnaire response rates for participants of randomised controlled trials. Method: This study was a factorial trial embedded within a trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in a meta-analysis. Results: The 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). Pre-notification with a newsletter had a detrimental effect on response rates (adjusted odds ratio (OR), 0.14; 95% CI, 0.04 to 0.48; p<0.01) and time to return the questionnaire (adjusted hazard ratio, 0.86; 95% CI, 0.75 to 0.99; p=0.04). No other statistically significant differences were observed between the intervention groups on response rates, time to response, and the need for a reminder. Conclusions: Post-it® notes have been shown to be ineffective in three embedded trials, whereas the evidence for newsletter reminders is still uncertain.

scholarly journals An evaluation of a personalised text message reminder compared to a standard text message on postal questionnaire response rates: an embedded randomised controlled trial

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 154 ◽  
Author(s):  
Ann Cochrane ◽  
Charlie Welch ◽  
Caroline Fairhurst ◽  
Sarah Cockayne ◽  
David J. Torgerson ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Binary Data ◽  
Controlled Trial ◽  
Text Message ◽  
Response Rates ◽  
Postal Questionnaire ◽  
Text Messages ◽  
Link Type ◽  
Standard Text ◽  
Randomised Controlled

Background: Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods: A two-arm, parallel group ‘Study within a Trial’ (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results: A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions: Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration: ISRCTN22202133; SWAT 35.

scholarly journals A study update newsletter or Post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial

F1000Research ◽  
2019 ◽  
Vol 7 ◽  
pp. 1083
Author(s):  
Sara Rodgers ◽  
Illary Sbizzera ◽  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Sarah E. Lamb ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Statistical Power ◽  
Controlled Trial ◽  
Response Rates ◽  
Postal Questionnaire ◽  
Falls Prevention ◽  
Controlled Trials ◽  
Questionnaire Response ◽  
Factorial Trial ◽  
Randomised Controlled

Background: Participants not returning data collection questionnaires is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can result in bias. The aim of this study was to assess whether the use of a study update newsletter and/or a handwritten or printed Post-it® note sticker increased postal questionnaire response rates for participants of a randomised controlled trial. Method: This study was a factorial trial embedded within a host trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in meta-analyses. Results: The overall 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). The study update newsletter had a detrimental effect on response rates (adjusted odds ratio 0.14, 95% CI 0.04 to 0.48, p<0.01) and time to return the questionnaire (adjusted hazard ratio 0.86, 95% CI 0.75 to 0.99, p=0.04). No other statistically significant differences were observed between the intervention groups on response rates, time to response, and the need for a reminder. Conclusions: Post-it® notes have been shown to be ineffective in three embedded trials, whereas the evidence for newsletter reminders is still uncertain.

scholarly journals Efficacy and Safety of Medicines Targeting Neurotrophic Factors in the Management of Low Back Pain: Protocol for a Systematic Review and Meta-Analysis (Preprint)

2020 ◽  
Author(s):  
Rodrigo RN Rizzo ◽  
Michael C Ferraro ◽  
Michael A Wewege ◽  
Aidan G Cashin ◽  
Hayley B Leake ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Open Science ◽  
Controlled Trials ◽  
Low Back ◽  
Efficacy And Safety ◽  
Science Framework ◽  
Randomised Controlled ◽  
Regulatory Actions

BACKGROUND Low back pain (LBP) is the leading cause of years lived with disability worldwide. Most people with LBP receive the diagnosis of non-specific LBP or sciatica. Medications are commonly prescribed but have limited analgesic effects and are associated with adverse events. A novel treatment approach is to target neurotrophins such as nerve growth factor (NGF) to reduce pain intensity. NGF-inhibitors have been tested in some randomised controlled trials in recent years. These medicines show promise for the treatment of chronic LBP, but their efficacy and safety need to be evaluated to guide regulatory actions. OBJECTIVE To evaluate the efficacy and safety of medicines targeting neurotrophins in patients with LBP and sciatica. METHODS In this systematic review, we will include published and unpublished records of parallel randomised controlled trials (RCTs) and the first phase of cross-over RCTs that compare the effects of medicines targeting neurotrophins with any control group. We will search CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, the EU Clinical Trials Register and the WHO International Clinical Registry Platform from inception. Pairs of authors will independently screen the records for eligibility, and we will independently extract data in duplicate. We will conduct a quantitative synthesis (meta-analysis) with the studies that report sufficient data and compared the medicines of interest versus placebo. We will use random-effects models and calculate estimates of effects and heterogeneity for each outcome. We will assess the risk of bias for each study using Cochrane Collaboration’s tool, and form judgements of confidence in the evidence according to GRADE recommendations. We will use the PRISMA statement to report the findings. We plan to conduct a subgroup analyses by condition, type of medication and timepoint. We will assess the impact of a potential new trial on an existing meta-analysis. Data from studies that meet inclusion criteria but cannot be meta-analysed will be reported narratively. RESULTS The protocol was registered on the Open Science Framework on 19 May 2020. As of August 2020, we have identified 1818 records. CONCLUSIONS This systematic review with meta-analysis will provide evidence for the efficacy and safety of NGF-inhibitors for reducing pain in non-specific LBP and sciatica. The inclusion of new studies and unpublished data may improve the precision of the effect estimates and guide regulatory actions of the medications for LBP and sciatica. CLINICALTRIAL Open Science Framework (osf.io/b8adn)

scholarly journals Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edmund Juszczak ◽  
Oliver Hewer ◽  
Christopher Partlett ◽  
Madeleine Hurd ◽  
Vasha Bari ◽  
...  
Keyword(s):  
Response Rate ◽  
Response Rates ◽  
Absolute Difference ◽  
Controlled Study ◽  
Multiple Birth ◽  
Questionnaire Response ◽  
Link Type ◽  
Premature Babies ◽  
To Receive

Abstract Background Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading to potentially biased and misleading results. Evidence that incentives are effective at improving response rates exists, but there is little evidence regarding the best approach, especially in the field of perinatal medicine. The NIHR-funded SIFT trial follow-up of infants at 2 years of age provided an ideal opportunity to address this remaining uncertainty. Methods Participants: parents of infants from participating neonatal units in the UK and Ireland followed up for SIFT (multicentre RCT investigating two speeds of feeding in babies with gestational age at birth < 32 weeks and/or birthweight < 1500 g). Interventions: parents were randomly allocated to receive incentives (£15 gift voucher) before or after questionnaire return. The objective was to establish whether offering an unconditional incentive in advance or promising an incentive on completion of a questionnaire (conditional) improved the response rate in parents of premature babies. The primary outcome was questionnaire response rate. Permuted block randomisation was performed (variable size blocks), stratified by SIFT allocation (slower/faster feeds) and single/multiple birth. Multiple births were given the same incentives allocation. Parents were unaware that they were in an incentives SWAT; SIFT office staff were not blinded to allocation. Results Parents of 923 infants were randomised: 459 infants allocated to receive incentive before, 464 infants allocated to receive incentive after; analysis was by intention to treat. Allocation to the incentive before completion led to a significantly higher response rate, 83.0% (381/459) compared to the after-completion group, 76.1% (353/464); adjusted absolute difference of 6.8% (95% confidence interval 1.6% to 12.0%). Giving an incentive in advance is the more costly approach, but the mean difference of ~£3 per infant is small given the higher return. Conclusions An unconditional incentive in advance led to a significantly higher response rate compared to the promise of an incentive on completion. Against a backdrop of falling response rates to questionnaires, incentives can be an effective way to increase returns. Trial registration SIFT (ISRCTN76463425). Registered on March 5, 2013.; SWAT registration (SWAT 69 available from http://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,864297,en.pdf). Registered on June 27, 2016.

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