Dataset Information

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

ABSTRACT:

Background

Clinical trials often struggle to retain the number of participants required to make valid and reliable assessments about the effectiveness of treatments. Several individual randomised comparisons of interventions to improve retention in trials have been shown to be effective. Many of these retention interventions target participants' behaviour (e.g. returning questionnaires or attending a follow-up visit). Although not designed as such, these interventions can be thought of as behaviour change interventions. By coding the constituent behaviour change components of effective retention interventions, the interventions' potential 'active ingredients' responsible for improvements in retention can be identified and maximised for future gains.

Methods

Studies reporting effective retention interventions were identified from existing meta-analyses in the literature. Published manuscripts and intervention and comparator group material were coded into their behaviour change techniques (BCTs) using the BCT taxonomy version 1. Two authors independently coded materials using a standardised coding manual and discussed any disagreements to reach consensus. Data on study characteristics including host trial context, timing, mode of delivery and dosage of retention intervention were recorded.

Results

Two intervention types were identified as having evidence of improving retention in existing meta-analyses: monetary incentives and electronic prompts. None of the interventions identified from the included studies explicitly stated a theoretical rationale for their development. BCTs were identified in both intervention and comparator groups across both intervention types and there was heterogeneity with regard to their presentation within and across interventions. The BCTs identified in the 'monetary incentive' interventions differed to the comparator group. Contrastingly, the BCTs identified in 'electronic prompts' interventions were identical in both the control and intervention groups (within studies) and differed only in terms of mode of delivery and dosing.

Conclusions

Attending a measurement visit or returning a questionnaire is a behaviour and trialists should be mindful of this when designing retention interventions. Our work in this area provides some of the first evidence of the impact of implicit use of BCTs in retention interventions and highlights their potential promise for future trials.

SUBMITTER: Duncan EM

PROVIDER: S-EPMC7035706 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

Duncan Eilidh M EM Bennett Tina T Gillies Katie K

Trials 20200221 1

<h4>Background</h4>Clinical trials often struggle to retain the number of participants required to make valid and reliable assessments about the effectiveness of treatments. Several individual randomised comparisons of interventions to improve retention in trials have been shown to be effective. Many of these retention interventions target participants' behaviour (e.g. returning questionnaires or attending a follow-up visit). Although not designed as such, these interventions can be thought of a ...[more]

PMID: 32085717

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Project description:ObjectiveTo describe and evaluate the use of cognitive-based behaviour change techniques as interventions to improve medication adherence.DesignSystematic review and meta-analysis of interventions to improve medication adherence.Data sourcesSearch of the MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases from the earliest year to April 2013 without language restriction. References of included studies were also screened to identify further relevant articles.Review methodsWe used predefined criteria to select randomised controlled trials describing a medication adherence intervention that used Motivational Interviewing (MI) or other cognitive-based techniques. Data were extracted and risk of bias was assessed by two independent reviewers. We conducted the meta-analysis using a random effects model and Hedges' g as the measure of effect size.ResultsWe included 26 studies (5216 participants) in the meta-analysis. Interventions most commonly used MI, but many used techniques such as aiming to increase the patient's confidence and sense of self-efficacy, encouraging support-seeking behaviours and challenging negative thoughts, which were not specifically categorised. Interventions were most commonly delivered from community-based settings by routine healthcare providers such as general practitioners and nurses. An effect size (95% CI) of 0.34 (0.23 to 0.46) was calculated and was statistically significant (p?<?0.001). Heterogeneity was high with an I(2) value of 68%. Adjustment for publication bias generated a more conservative estimate of summary effect size of 0.21 (0.08 to 0.33). The majority of subgroup analyses produced statistically non-significant results.ConclusionsCognitive-based behaviour change techniques are effective interventions eliciting improvements in medication adherence that are likely to be greater than the behavioural and educational interventions largely used in current practice. Subgroup analyses suggest that these interventions are amenable to use across different populations and in differing manners without loss of efficacy. These factors may facilitate incorporation of these techniques into routine care.

Project description:BackgroundDecreasing ineffective or harmful healthcare practices (de-implementation) may require different approaches than those used to promote uptake of effective practices (implementation). Few psychological theories differentiate between processes involved in decreasing, versus increasing, behaviour. However, it is unknown whether implementation and de-implementation interventions already use different approaches. We used the behaviour change technique (BCT) taxonomy (version 1) (which includes 93 BCTs organised into 12 groupings) to investigate whether implementation and de-implementation interventions for clinician behaviour change use different BCTs.MethodsIntervention descriptions in 181 articles from three systematic reviews in the Cochrane Library were coded for (a) implementation versus de-implementation and (b) intervention content (BCTs) using the BCT taxonomy (v1). BCT frequencies were calculated and compared using Pearson's chi-squared (χ2), Yates' continuity correction and Fisher's exact test, where appropriate. Identified BCTs were ranked according to frequency and rankings for de-implementation versus implementation interventions were compared and described.ResultsTwenty-nine and 25 BCTs were identified in implementation and de-implementation interventions respectively. Feedback on behaviour was identified more frequently in implementation than de-implementation (Χ2(2, n=178) = 15.693, p = .000057). Three BCTs were identified more frequently in de-implementation than implementation: Behaviour substitution (Χ2(2, n=178) = 14.561, p = .0001; Yates' continuity correction); Monitoring of behaviour by others without feedback (Χ2(2, n=178) = 16.187, p = .000057; Yates' continuity correction); and Restructuring social environment (p = .000273; Fisher's 2-sided exact test).ConclusionsThere were some significant differences between BCTs reported in implementation and de-implementation interventions suggesting that researchers may have implicit theories about different BCTs required for de-implementation and implementation. These findings do not imply that the BCTs identified as targeting implementation or de-implementation are effective, rather simply that they were more frequently used. These findings require replication for a wider range of clinical behaviours. The continued accumulation of additional knowledge and evidence into whether implementation and de-implementation is different will serve to better inform researchers and, subsequently, improve methods for intervention design.

Project description:Behaviour change interventions are likely to be reproducible only if reported clearly. We assessed whether the behaviour change technique taxonomy version 1 (BCTTv1), with and without training in identifying BCTs, improves the clarity and replicability of written reports of observed behaviour change interventions.Three studies assessed effects of using and training in the use of BCTTv1 on the clarity and replicability of intervention descriptions written after observing videos of smoking cessation interventions. Study 1 examined the effects of using and not using BCTTv1. Study 2 examined the effects of using BCTTv1 and training in use of BCTTv1 compared no use and no training. Study 3 employed a within-group design to assess change in descriptions written before and after training. One-hundred and 66 'writers' watched videos of behaviour change interventions and wrote descriptions of the active components delivered. In all studies, the participants' written descriptions were evaluated by (i) 12 'raters' (untrained in BCTTv1) for clarity and replicability and (ii) 12 'coders' (trained in BCTTv1) for reliability of BCT coding. Writers rated the usability and accessibility of using BCTTv1 to write descriptions.Ratings of clarity and replicability did not differ between groups in study 1 (all ps > 0.05), were poorer for trained users in study 2 (all ps < 0.01) and improved following training in study 3 (all ps < 0.05). BCT identification was more reliable from descriptions written by trained BCTTv1 users (p < 0.05; study 2) but not simple use of BCTTv1 (p = 0.93; study 1) or by writers who had written a description without BCTTv1, before training (p = 0.50; study 3). Writers reported that using BCTTv1 was difficult but 'useful', 'good' and 'desirable' and that their descriptions would be clear and replicable (all means above mid-point of the scale).Effects of training to use BCTTv1 on the quality of written reports of observed interventions were mixed, with some suggestion of improved clarity and replicability of reporting in the within- (study 3) but not the between-group studies (studies 1 and 2). Potential benefits of using BCTTv1 may have been limited by the artificial nature and time constraints of the task.

Project description:Mediterranean diet interventions have demonstrated positive effects in the prevention and management of several chronic conditions in older adults. Understanding the effective components of behavioural interventions is essential for long-term health behaviour change and translating evidence-based interventions into practice. The aim of this scoping review is to provide an overview of the current Mediterranean diet interventions for older adults (≥55 years) and describe the behaviour change techniques used as part of the interventions. A scoping review systematically searched Medline, Embase, CINAHL, Web of Science, Scopus, and PsycINFO from inception until August 2022. Eligible studies were randomized and non-randomized experimental studies involving a Mediterranean or anti-inflammatory diet intervention in older adults (average age > 55 years). Screening was conducted independently by two authors, with discrepancies being resolved by the senior author. Behaviour change techniques were assessed using the Behaviour Change Technique Taxonomy (version 1), which details 93 hierarchical techniques grouped into 16 categories. From 2385 articles, 31 studies were included in the final synthesis. Ten behaviour change taxonomy groupings and 19 techniques were reported across the 31 interventions. The mean number of techniques used was 5, with a range from 2 to 9. Common techniques included instruction on how to perform the behaviour (n = 31), social support (n = 24), providing information from a credible source (n = 16), information about health consequences (n = 15), and adding objects to the environment (n = 12). Although behaviour change techniques are commonly reported across interventions, the use of the Behaviour Change Technique Taxonomy for intervention development is rare, and more than 80% of the available techniques are not being utilised. Integrating behaviour change techniques in the development and reporting of nutrition interventions for older adults is essential for effectively targeting behaviours in both research and practice.

Project description:BackgroundE- and m-health interventions are promising to change health behaviour. Many of these interventions use a large variety of behaviour change techniques (BCTs), but it's not known which BCTs or which combination of BCTs contribute to their efficacy. Therefore, this experimental study investigated the efficacy of three BCTs (i.e. action planning, coping planning and self-monitoring) and their combinations on physical activity (PA) and sedentary behaviour (SB) against a background set of other BCTs.MethodsIn a 2 (action planning: present vs absent) × 2 (coping planning: present vs absent) × 2 (self-monitoring: present vs absent) factorial trial, 473 adults from the general population used the self-regulation based e- and m-health intervention 'MyPlan2.0' for five weeks. All combinations of BCTs were considered, resulting in eight groups. Participants selected their preferred target behaviour, either PA (n = 335, age = 35.8, 28.1% men) or SB (n = 138, age = 37.8, 37.7% men), and were then randomly allocated to the experimental groups. Levels of PA (MVPA in minutes/week) or SB (total sedentary time in hours/day) were assessed at baseline and post-intervention using self-reported questionnaires. Linear mixed-effect models were fitted to assess the impact of the different combinations of the BCTs on PA and SB.ResultsFirst, overall efficacy of each BCT was examined. The delivery of self-monitoring increased PA (t = 2.735, p = 0.007) and reduced SB (t = - 2.573, p = 0.012) compared with no delivery of self-monitoring. Also, the delivery of coping planning increased PA (t = 2.302, p = 0.022) compared with no delivery of coping planning. Second, we investigated to what extent adding BCTs increased efficacy. Using the combination of the three BCTs was most effective to increase PA (x2 = 8849, p = 0.003) whereas the combination of action planning and self-monitoring was most effective to decrease SB (x2 = 3.918, p = 0.048). To increase PA, action planning was always more effective in combination with coping planning (x2 = 5.590, p = 0.014; x2 = 17.722, p < 0.001; x2 = 4.552, p = 0.033) compared with using action planning without coping planning. Of note, the use of action planning alone reduced PA compared with using coping planning alone (x2 = 4.389, p = 0.031) and self-monitoring alone (x2 = 8.858, p = 003), respectively.ConclusionsThis study provides indications that different (combinations of) BCTs may be effective to promote PA and reduce SB. More experimental research to investigate the effectiveness of BCTs is needed, which can contribute to improved design and more effective e- and m-health interventions in the future.Trial registrationThis study was preregistered as a clinical trial (ID number: NCT03274271 ). Release date: 20 October 2017.

Dataset Information

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

Background

Methods

Results

Conclusions

Publications

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

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