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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.

ABSTRACT: 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.

SUBMITTER: Rodgers S

PROVIDER: S-EPMC6402081 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:BackgroundLow completion rates of questionnaires in randomised controlled trials can compromise the reliability of the results, so ways to boost questionnaire completion are often implemented. Although there is evidence to suggest that sending a text message to participants increases completion, there is little evidence around the timing or personalisation of these text messages. Methods: A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to their follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of attempts to contact required. Results In total 194 participants were randomised into the SWAT to receive a text message that was personalised early(n=50), personalised late (n=47), non-personalised early(n=50), or non-personalised late(n=47). There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text message would result in fewer completions compared with a non-personalised text message when data was collected only via the telephone(adjusted OR 0.44, 95% CI 0.22-0.87, p=0.02). However, these results were not significant when looking at completion via any method (adjusted OR 0.61, 95% CI 0.30-1.24, p=0.17). There was no evidence to show that personalisation or not was better for any of the secondary outcomes. Conclusion Timing of the text message does not appear to influence the completion of questionnaires. Personalisation of a text message may be detrimental to questionnaire completion, if data is only collected via the telephone - however, more SWATs should be undertaken in this field.

Project description:Minimising participant non-response in postal surveys helps to maximise the generalisability of the inferences made from the data collected. The aim of this study was to examine the effect of questionnaire length, personalisation and reminder type on postal survey response rate and quality and to compare the cost-effectiveness of the alternative survey strategies.In a pilot study for a population study of travel behaviour, physical activity and the environment, 1000 participants sampled from the UK edited electoral register were randomly allocated using a 2×2 factorial design to receive one of four survey packs: a personally addressed long (24 page) questionnaire pack, a personally addressed short (15 page) questionnaire pack, a non-personally addressed long questionnaire pack or a non-personally addressed short questionnaire pack. Those who did not return a questionnaire were stratified by initial randomisation group and further randomised to receive either a full reminder pack or a reminder postcard. The effects of the survey design factors on response were examined using multivariate logistic regression.An overall response rate of 17% was achieved. Participants who received the short version of the questionnaire were more likely to respond (OR=1.48, 95% CI 1.06 to 2.07). In those participants who received a reminder, personalisation of the survey pack and reminder also increased the odds of response (OR=1.44, 95% CI 1.01 to 1.95). Item non-response was relatively low, but was significantly higher in the long questionnaire than the short (9.8% vs 5.8%; p=.04). The cost per additional usable questionnaire returned of issuing the reminder packs was £23.1 compared with £11.3 for the reminder postcards.In contrast to some previous studies of shorter questionnaires, this trial found that shortening a relatively lengthy questionnaire significantly increased the response. Researchers should consider the trade off between the value of additional questions and a larger sample. If low response rates are expected, personalisation may be an important strategy to apply. Sending a full reminder pack to non-respondents appears a worthwhile, albeit more costly, strategy.

Project description:BackgroundCentral nervous system (CNS) active medications have been consistently linked to falls in older people. However, few randomized trials have evaluated whether CNS-active medication reduction reduces falls and fall-related injuries. The objective of the Reducing CNS-active Medications to Prevent Falls and Injuries in Older Adults (STOP-FALLS) trial is to test the effectiveness of a health-system-embedded deprescribing intervention focused on CNS-active medications on the incidence of medically treated falls among community-dwelling older adults.MethodsWe will conduct a pragmatic, cluster-randomized, parallel-group, controlled clinical trial within Kaiser Permanente Washington to test the effectiveness of a 12-month deprescribing intervention consisting of (1) an educational brochure and self-care handouts mailed to older adults prescribed one or more CNS-active medications (aged 60 + : opioids, benzodiazepines and Z-drugs; aged 65 + : skeletal muscle relaxants, tricyclic antidepressants, and antihistamines) and (2) decision support for their primary health care providers. Outcomes are examined over 18-26 months post-intervention. The primary outcome is first incident (post-baseline) medically treated fall as determined from health plan data. Our sample size calculations ensure at least 80% power to detect a 20% reduction in the rate of medically treated falls for participants receiving care within the intervention (n = 9) versus usual care clinics (n = 9) assuming 18 months of follow-up. Secondary outcomes include medication discontinuation or dose reduction of any target medications. Safety outcomes include serious adverse drug withdrawal events, unintentional overdose, and death. We will also examine medication signetur fields for attempts to decrease medications. We will report factors affecting implementation of the intervention.DiscussionThe STOP-FALLS trial will provide new information about whether a health-system-embedded deprescribing intervention that targets older participants and their primary care providers reduces medically treated falls and CNS-active medication use. Insights into factors affecting implementation will inform future research and healthcare organizations that may be interested in replicating the intervention.Trial registrationClinicalTrial.gov NCT05689554. Registered on 18 January 2023, retrospectively registered.

Project description:BackgroundFalls are a major health burden for older adults with Parkinson's disease (PD), but there is currently no reliable questionnaire to capture the circumstances and consequences of falls in older adults with PD. This study aimed to develop a PD-specific falls questionnaire and to evaluate its test-retest reliability in older adults with PD.MethodsA novel PD-specific falls questionnaire (PDF-Q) was developed in two modes (online and paper-based version) and used to assess falls and near-falls events over the past 12-months. Questions were agreed upon by an expert group, with the domains based on previous falls-related questionnaires. The questions included the number and circumstances (activities, location and direction) of falls and near-falls, and consequences (injuries and medical treatment) of falls. The PDF-Q was distributed to 46 older adults with PD (online n = 30, paper n = 16), who completed the questionnaire twice, 4 weeks apart. Kappa (κ) statistics were used to establish test-retest reliability of the questionnaire items.ResultsPooled results from both questionnaires for all participants were used to assess the overall test-retest reliability of the questionnaire. Questions assessing the number of falls (κ = 0.41) and the number of near-falls (κ = 0.51) in the previous 12-months demonstrated weak agreement, while questions on the location of falls (κ = 0.89) and near-falls (κ = 1.0) demonstrated strong to almost perfect agreement. Questions on the number of indoor (κ = 0.86) and outdoor (κ = 0.75) falls demonstrated moderate to strong agreement, though questions related to the number of indoor (κ = 0.47) and outdoor (κ = 0.56) near-falls demonstrated weak agreement. Moderate to strong agreement scores were observed for the most recent fall and near-fall in terms of the direction (indoor fall κ = 0.80; outdoor fall κ = 0.81; near-fall κ = 0.54), activity (indoor fall κ = 0.70; outdoor fall κ = 0.82; near-fall κ = 0.65) and cause (indoor fall κ = 0.75; outdoor fall κ = 0.62; near-fall κ = 0.56).ConclusionsThe new PDF-Q developed in this study was found to be reliable for capturing the circumstances and consequences of recent falls and near-falls in older adults with PD.

Project description:BackgroundThis is the first randomized controlled trial evaluating the impact of note template design on note quality using a simulated patient encounter and a validated assessment tool.ObjectiveTo compare note quality between two different templates using a novel randomized clinical simulation process.DesignA randomized non-blinded controlled trial of a standard note template versus redesigned template.ParticipantsPGY 1-3 IM residents.InterventionsResidents documented the simulated patient encounter using one of two templates. The standard template was modeled after the usual outpatient progress note. The new template placed the assessment and plan section in the beginning, grouped subjective data into the assessment, and deemphasized less useful elements.Main measuresNote length; time to note completion; note template evaluation by resident authors; note evaluation by faculty reviewers.Key results36 residents participated, 19 randomized to standard template, 17 to new. New template generated shorter notes (103 vs 285 lines, p < 0.001) that took the same time to complete (19.8 vs 21.6 min, p = 0.654). Using a 5-point Likert scale, residents considered new notes to have increased visual appeal (4 vs 3, p = 0.05) and less redundancy and clutter (4 vs 3, p = 0.006). Overall template satisfaction was not statistically different. Faculty reviewers rated the standard note more up-to-date (4.3 vs 2.7, p = 0.001), accurate (3.9 vs 2.6, p = 0.003), and useful (4 vs 2.8, p = 0.002), but less organized (3.3 vs 4.5, p < 0.001). Total quality was not statistically different.ConclusionsResidents rated the new note template more visually appealing, shorter, and less cluttered. Faculty reviewers rated both note types equivalent in the overall quality but rated new notes inferior in terms of accuracy and usefulness though better organized. This study demonstrates a novel method of a simulated clinical encounter to evaluate note templates before the introduction into practice.Trial registrationClinicalTrials.gov ID: NCT04333238.

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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.

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