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Background The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is an important tool for assessing teacher skill and aspects of the fidelity of mindfulness-based interventions, but prior research on and implementation of the MBI:TAC has used video recordings, which can be difficult to obtain, share for assessments, and which increase privacy concerns for participants. Audio-only recordings might be a useful alternative, but their reliability is unknown. Objective To assess evaluator perception of the rating process and inter-rater reliability of MBI:TAC ratings using audio-only recordings. Methods We prepared audio-only files from video recordings of 21 previously rated Mindfulness-Based Stress Reduction teachers. Each audio recording was rated by 3 trained MBI:TAC assessors drawn from a pool of 12 who had previously participated in rating the video recordings. Teachers were rated by evaluators who had not viewed the video recording and did not know the teacher. We then conducted semi-structured interviews with evaluators. Results On the 6 MBI:TAC domains, the intraclass correlation coefficients (ICCs) for audio recordings ranged from .53 to .69 using an average across 3 evaluators. Using a single rating resulted in lower ICCs (.27-.38). Bland-Altman plots showed audio ratings had little consistent bias compared to video recordings and agreed more closely for teachers with higher ratings. Qualitative analysis identified 3 themes: video recordings were particularly helpful when rating less skillful teachers, video recordings tended to provide a more complete picture for rating, and audio rating had some positive features. Conclusions Inter-rater reliability of the MBI:TAC using audio-only recordings was adequate for many research and clinical purposes, and reliability is improved when using an average across several evaluators. Ratings using audio-only recordings may be more challenging when rating less experienced teachers.

•Consistent intervention dose delivery is critically important in complementary health approach (CHA) research.•Few studies testing CHA intervention describe intervention fidelity monitoring methodological process.•The dose, delivery and duration of Urban Zen Integrative Therapy, a multi-component CHA intervention can be established.•Intervention fidelity monitoring of multi-component CHA can be standardized to ensure intervention fidelity. Systematic and consistent dose delivery is critical in intervention research. Few studies testing complementary health approach (CHA) interventions describe intervention fidelity monitoring (IFM) and measurement. To describe methodological processes in establishing and measuring consistent dose, delivery, and duration of a multi-component CHA intervention. Adults with pulmonary hypertension received six weekly, 1-hour Urban Zen Integrative Therapy (UZIT) sessions. A total of 78 sessions were delivered and 33% of these sessions were audited. Intervention dose (time allocated to each component), intervention consistency (protocol adherence audits), and intervention delivery (performance and sequence of components) were captured using remote video observation and review of the recorded video. IFM audits were performed at the beginning (n = 16), middle (n = 5), and end (n = 5) of the study. UZIT interventionists adhered to the intervention protocol (99.3%) throughout the study period. Interventionists delivered UZIT components within the prescribed timeframe: 1) Beginning: gentle body movement (18.9 ± 5.8 min.), restorative pose with guided body awareness meditation (21.3 ± 2.7 min.), and Reiki (22.8 ± 3.1 min.); 2) Middle: gentle body movement (15.9 ± 1.5 min.), pose/body awareness meditation (30.1 ± 6.5 min.), and Reiki (30.1 ± 7.0 min.); 3) End: gentle body movement (18.1 ± 3.6 min.), pose/body awareness meditation (35.3 ± 6.4 min.), and Reiki (34.5 ± 7.0 min.). Essential oil inhalation was delivered during UZIT sessions 100% of the time. Interventionists adhered to treatment delivery behaviors throughout the study period: beginning (98.86%), middle (100%), and end (100%). In this pilot study, we demonstrated that the dose, consistency, and delivery of multi-component CHA therapy can be standardized and monitored to ensure intervention fidelity.

Background: Interventions to change behaviour have substantial potential to impact positively on individual and overall public health. Despite an increasing focus on health behaviour change intervention research, interventions do not always have the desired effect on outcomes, while others have diluted effects once implemented into real-life settings. There is little investment into understanding how or why such interventions work or do not work. Methodological inadequacies of trials of behavioural interventions have been previously suggested as a barrier to the quality and advancement of behavioural research, with intervention fidelity acknowledged as a key area for improvement. However, there is much ambiguity regarding the terminology and conceptualisation of intervention fidelity and a lack of practical guidance regarding how to address it sufficiently, particularly within trials of complex behavioural interventions. Objectives: This article outlines specific issues concerning intervention fidelity within trials of health behaviour change interventions and suggests practical considerations and specific recommendations for researchers, with examples from the literature presented. Conclusions: Recommendations pertain to (1) clarifying how fidelity is defined and conceptualised, (2) considering fidelity beyond intervention delivery, (3) considering strategies to both enhance and assess fidelity, (4) making use of existing frameworks and guidance, (5) considering the quality and comprehensiveness of fidelity assessment strategies, (6) considering the balance between fidelity and adaptation and (7) reporting the use of fidelity enhancement and assessment strategies and their results. Suggestions for future research to improve our understanding of, and ability to, address fidelity in behaviour change interventions are also provided.

Treatment fidelity data (descriptive and statistical) are critical to interpreting and generalizing outcomes of intervention research. Despite recommendations for treatment fidelity reporting from funding agencies and researchers, past syntheses have found treatment fidelity is frequently unreported (e.g., Swanson, The Journal of Special Education, 47, 3-13, 2011) in educational interventions and fidelity data are seldom used to analyze its relation to student outcomes (O'Donnell, Review of Educational Research, 78(1), 33-84, 2008). The purpose of this synthesis was to examine how treatment fidelity is supported, measured, and reported in reading intervention studies conducted with students at risk or with reading difficulties in grades K–3 from 1995 through 2015. All studies (k = 175) were coded to extract and classify information related to (a) the characteristics of the intervention study (e.g., publication year, research design); (b) treatment implementer training and support; (c) treatment fidelity data collection procedures, dimensions (i.e., adherence, quality, receipt dosage, and differentiation), and levels of treatment fidelity data; and (d) the use of fidelity scores in the analysis of treatment effects. Results indicated that less than half (47%) of the reading intervention studies synthesized reported treatment fidelity data (numeric or narrative). Exploratory analyses showed that several study features were associated with the prevalence of fidelity reporting. Studies reporting treatment fidelity largely measured treatment adherence, and scores were, on average, high. Other dimensions of treatment fidelity (e.g., treatment differentiation), and analyses relating fidelity data to outcomes, were consistently absent from the corpus of reading intervention studies reviewed. Recommendations for enhancing how treatment fidelity data in intervention studies are collected and reported are presented.

Randomized clinical trials (RCTs) provide the most reliable estimates of treatment effectiveness for therapeutic interventions. However, flaws in their design and conduct may bias treatment effect estimates, leading to overestimation or underestimation of the true intervention effect. This is especially relevant for complex interventions, such as those in rehabilitation, which are multifaceted and tailored for individual patients or providers, leading to variations in delivery and treatment effects. To assess whether poor intervention fidelity, the faithfulness of the intervention delivered in an RCT to what was intended in the trial protocol, influences (biases) estimates of treatment effects derived from meta-analysis of rehabilitation RCTs. In this metaepidemiological study of 19 meta-analyses and 204 RCTs published between 2010 and 2020, we evaluated the difference in intervention effects between RCTs in which intervention fidelity was monitored and those in which it was absent. We also conducted random-effects metaregression to measure associations between intervention fidelity, risk of bias, study sample size, and treatment effect estimates. There was a linear relationship between fidelity and treatment effect sizes across RCTs, even after adjusting for risk of bias and study sample size. Higher degrees of fidelity were associated with smaller but more precise treatment effect estimates (d = −0.23 95% CI: −0.38, −0.74). Lower or absent fidelity was associated with larger, less precise estimates. Adjusting for fidelity reduced pooled treatment effect estimates in 4 meta-analyses from moderate to small or from small to no negligible or no effect, highlighting how poor fidelity can bias meta-analyses’ results. Poor or absent intervention fidelity in RCTs may lead to overestimation of observed treatment effects, skewing the conclusions from individuals studies and systematic reviews with meta-analyses when pooled. Caution is needed when interpreting the results of complex intervention RCTs when fidelity is not monitored or is monitored but not reported. Patients, the public, and health-care providers rely on clinical trials for information about how effective treatments are when making decisions about health care. However, the way that clinical trials are conducted may alter the evidence that clinical trials provide about how effective interventions truly are. In this study, we investigated whether how closely health-care providers monitor how they deliver rehabilitation treatments to patients in clinical studies, and how closely those treatments match the treatment that the researchers had planned, influences the results of those studies. We found that when researchers or health-care providers don’t closely monitor how they deliver treatments during a study, those studies may provide exaggerated estimates of the effectiveness of the treatments studies. This is important, because it may mean that some health-care providers and patients may opt for treatments that are less effective than they appeared in clinical studies, or may overlook treatments that are more effective than they appeared in other studies. •Fidelity represents the quality and accuracy of intervention delivery in an RCT.•Poor intervention fidelity may lead to overestimated treatment effect estimates.•Poor fidelity may skew the conclusions of intervention meta-analyses.•Intervention fidelity is crucial for accurately interpreting RCTs and informing practice changes.•Caution is needed when interpreting the results of RCTs when fidelity is not reported.

Background The Template for Intervention Description and Replication (TIDieR) checklist and guide was developed by an international team of experts to promote full and accurate description of trial interventions. It is now widely used in health research. The aim of this paper is to describe the experience of using TIDieR outside of trials, in a range of applied health research contexts, and make recommendations on its usefulness in such settings. Main body We used the TIDieR template for intervention description in six applied health research projects. The six cases comprise a diverse sample in terms of clinical problems, population, settings, stage of intervention development and whether the intervention was led by researchers or the service deliverers. There was also variation in how the TIDieR description was produced in terms of contributors and time point in the project. Researchers involved in the six cases met in two workshops to identify issues and themes arising from their experience of using TIDieR. We identified four themes which capture the difficulties or complexities of using TIDieR in applied health research: (i) fidelity and adaptation: all aspects of an intervention can change over time; (ii) voice: the importance of clarity on whose voice the TIDieR description represents; (iii) communication beyond the immediate context: the usefulness of TIDieR for wider dissemination and sharing; (iv) the use of TIDieR as a research tool. Conclusion We found TIDieR to be a useful tool for applied research outside the context of clinical trials and we suggest four revisions or additions to the original TIDieR which would enable it to better capture these complexities in applied health research: An additional item, ‘voice’ conveys who was involved in preparing the TIDieR template, such as researchers, service users or service deliverers. An additional item, ‘stage of implementation’ conveys what stage the intervention has reached, using a continuum of implementation research suggested by the World Health Organisation. A new column, ‘modification’ reminds authors to describe modifications to any item in the checklist. An extension of the ‘how well’ item encourages researchers to describe how contextual factors affected intervention delivery.

Background Making Every Contact Count (MECC) is a public health strategy which strives to enable brief interventions to be implemented through opportunistic healthy lifestyle conversations. In a mental health inpatient setting a bespoke MECC training package has been developed to encourage cascade training through a train the trainer model and to incorporate an additional regional health strategy A Weight Off Your Mind into Core MECC training to provide a focus on healthy weight management. This study evaluated the fidelity of design of MECC in the mental health inpatient setting and fidelity of the training package currently being cascaded across the region. Methods Initially a documentary analysis of six documents shared through the mental health inpatient setting including MECC implementation guide, logic model, checklist and evaluation framework. Documents were analysed using the Template for Intervention Description and Replication (TIDieR) checklist and coded using the Behaviour Change Technique (BCT) Taxonomy version one (BCTTv1) and the Expert Recommendations for Implementing Change (ERIC) Taxonomy. Coding was compared against MECC guidance documents to complete the fidelity assessment. A training delivery guide, training slides and two recordings of both train the trainer and Core MECC + A Weight Off Your Mind training were analysed for behaviour change techniques (BCTs) and compared to conduct a fidelity training assessment. Results Overall the implementation of MECC in the mental health inpatient setting had moderate fidelity to the MECC guidance, with a total of 31 BCTs identified across guidance and provider documents and a 77% adherence of provider documents to guidance. The highest level of fidelity applied to the MECC implementation guide where 86% of identified BCTs were also present. The training package showed high fidelity that both training programmes were being delivered as intended with 100% of BCT matched from training materials to training transcripts. Potential loss of fidelity through additional BCTs was present across provider documents and training transcripts. Conclusion The implementation of MECC across the mental health inpatient setting and the training package appear to be delivered as intended therefore demonstrating good fidelity and potential benefits to public health. Future research would benefit from assessing cascade training sessions from those who have completed train the trainer to evaluate ongoing fidelity of training across the trust.

Background Meta-analyses have identified promising behavior change techniques (BCTs) in changing obesity-related behaviors from intervention descriptions. However, it is unclear whether these BCTs are used by intervention participants and are related to outcomes. Purpose The purpose of this study is to investigate BCT use by participants of an intervention targeting physical activity and diet and whether BCT use was related to behavior change and weight loss. Methods Intervention participants ( N  = 239; 40–69 years) with recently diagnosed type 2 diabetes in the ADDITION - Plus trial received a theory-based intervention which taught them a range of BCTs. BCT usage was reported at 1 year. Results Thirty-six percent of the participants reported using all 16 intervention BCTs. Use of a higher number of BCTs and specific BCTs (e.g., goal setting) were associated with a reduction in body mass index (BMI). Conclusions BCT use was associated with weight loss. Future research should identify strategies to promote BCT use in daily life. (Trial Registration: ISRCTN99175498.)

Educational researchers and school-based practitioners are increasingly infusing motivational interviewing (MI) into new and existing intervention protocols to provide support to students, parents, teachers, and school administrators. To date, however, the majority of the research in this area has focused on feasibility of implementation rather than fidelity of implementation. In this manuscript, we will present MI fidelity data from 245 audio-recorded conversations with 113 unique caregivers and 20 coaches, who implemented a school-based, positive parenting intervention. The aggregate fidelity scores across coaches, parents, and sessions provide evidence the training and support procedures were effective in assisting school-based personnel to implement MI with reasonable levels of fidelity in practice settings. Further, results suggest that MI fidelity varied between sessions and coaches and that within-coach variation (e.g., session-level variation in the quality of MI delivered) greatly exceeded between-coach variation. Implications for practice and future research are discussed.

As the most common setting where youth access behavioral healthcare, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the implementation of evidence-based practices (EBPs). However, these strategies alone are not sufficient to promote desirable implementation (e.g., intervention fidelity) and youth behavioral outcomes (e.g., mitigated externalizing behaviors). Theory-informed pragmatic pre-implementation enhancement strategies (PIES) are needed to prevent the lackluster outcomes of training and consultation. Specifically, social cognitive theory explicates principles that inform the design of PIES content and specify mechanisms of behavior change (e.g., “intentions to implement” (ITI)) to target increasing providers’ responsiveness to training and consultation. This triple-blind parallel randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES based on social cognitive theories (SC-PIES) to improve implementation and youth behavioral outcomes from universal preventive EBPs in the education sector. Teachers from a diverse urban district were recruited and randomly assigned to the treatment (SC-PIES; ntreatment = 22) or active control condition (administrative meeting; ncontrol = 21). Based on the condition assigned, teachers received the SC-PIES or met with administrators before their EBP training. We assessed teachers’ ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) at baseline, immediately after training, and 6 weeks afterward. A series of ANCOVAs detected sizeable effects of SC-PIES, where teachers who received SC-PIES demonstrated significantly larger improvement in their ITI, intervention fidelity, and youth behaviors as compared to the control. Conditional analyses indicated that teachers’ ITI partially mediated the effect of SC-PIES on intervention fidelity, which in turn led to improved youth behaviors. Findings suggest that theory-informed pragmatic PIES targeting providers’ ITI can boost their responsiveness to implementation strategies, as reflected in improved implementation behaviors and youth behavioral outcomes. The results have implications for targeting motivational mechanisms of behavior change and situating preventive implementation strategies at the intersection between the preparation and active implementation stages of an implementation process. Limitations and implications for research and practice are discussed. Clinicaltrials.gov: NCT05240222. Registered on: 2/14/2022. Retrospectively registered. https://clinicaltrials.gov/show/NCT05240222