Does the design of the NHS Low-Calorie Diet Programme have fidelity to the programme specification? A documentary review of service parameters and behaviour change content in a type 2 diabetes intervention.

BACKGROUND: NHS England commissioned four independent service providers to pilot low-calorie diet programmes to drive weight loss, improve glycaemia and potentially achieve remission of Type 2 Diabetes across 10 localities. Intervention fidelity might contribute to programme success. Previous research has illustrated a drift in fidelity in the design and delivery of other national diabetes programmes. AIMS: (1) To describe and compare the programme designs across the four service providers; (2) To assess the fidelity of programme designs to the NHS England service specification. METHODS: The NHS England service specification documents and each provider's programme design documents were double-coded for key intervention content using the Template for Intervention Description and Replication Framework and the Behaviour Change Technique (BCT) Taxonomy. RESULTS: The four providers demonstrated fidelity to most but not all of the service parameters stipulated in the NHS England service specification. Providers included between 74% and 87% of the 23 BCTs identified in the NHS specification. Twelve of these BCTs were included by all four providers; two BCTs were consistently absent. An additional seven to 24 BCTs were included across providers. CONCLUSIONS: A loss of fidelity for some service parameters and BCTs was identified across the provider's designs; this may have important consequences for programme delivery and thus programme outcomes. Furthermore, there was a large degree of variation between providers in the presence and dosage of additional BCTs. How these findings relate to the fidelity of programme delivery and variation in programme outcomes and experiences across providers will be examined.

A Pre-Implementation Enhancement Strategy to Increase the Yield of Training and Consultation for School-Based Behavioral Preventive Practices: a Triple-Blind Randomized Controlled Trial.

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.

Intervention Fidelity to VITAL Start (Video Intervention to Inspire Treatment Adherence for Life) in a Randomized Controlled Trial Among Women Living With HIV in Malawi.

BACKGROUND: Intervention effectiveness in a randomized controlled trial is attributed to intervention fidelity. Measuring fidelity has increasing significance to intervention research and validity. The purpose of this article is to describe a systematic assessment of intervention fidelity for VITAL Start (Video intervention to Inspire Treatment Adherence for Life)-a 27-minute video-based intervention designed to improve antiretroviral therapy adherence among pregnant and breastfeeding women. METHOD: Research Assistants (RAs) delivered VITAL Start to participants after enrolment. The VITAL Start intervention had three components: a pre-video orientation, video viewing, and post-video counseling. Fidelity assessments using checklists comprised self (RA assessment) and observer (Research Officers, also known as ROs) assessment. Four fidelity domains (adherence, dose, quality of delivery, and participant responsiveness) were evaluated. Score scale ranges were 0 to 29 adherence, 0 to 3 dose, 0 to 48 quality of delivery and 0 to 8 participant responsiveness. Fidelity scores were calculated. Descriptive statistics summarizing the scores were performed. RESULTS: In total, eight RAs delivered 379 VITAL Start sessions to 379 participants. Four ROs observed and assessed 43 (11%) intervention sessions. The mean scores were 28 (SD = 1.3) for adherence, 3 (SD = 0) for dose, 40 (SD = 8.6) for quality of delivery, and 10.4 (SD = 1.3) for participant responsiveness. CONCLUSION: Overall, the RAs successfully delivered the VITAL Start intervention with high fidelity. Intervention fidelity monitoring should be an important element of randomized control trial design of specific interventions to ensure having reliable study results.

Fidelity Assessment of Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression.

OBJECTIVE: Fidelity assessment of peer-administered interventions (PAIs) by expert therapists can be costly and limit scalability. This study's objective was to determine whether peer facilitators could assess the fidelity of peer-delivered group cognitive-behavioral therapy (CBT) for postpartum depression as effectively as an expert psychiatrist or a trained graduate student. METHODS: Intervention adherence and competence were assessed by three peers (N=9 sessions) and by one expert psychiatrist and one graduate student (N=18 sessions). Interrater reliability was assessed with intraclass correlation coefficients (ICCs). RESULTS: ICCs were good to excellent (0.88-0.98) for adherence and competence ratings among the three types of raters (psychiatrist vs. peers, psychiatrist vs. student, and student vs. peers). CONCLUSIONS: Trained peers may be able to reliably rate the fidelity of a PAI for postpartum depression. This preliminary study represents the first step toward peer-led feedback as an alternative to expert-led supervision of peer-delivered group CBT for postpartum depression.

Dignity therapy intervention fidelity: a cross-sectional descriptive study with older adult outpatients with cancer.

OBJECTIVES: Intervention fidelity is imperative to ensure confidence in study results and intervention replication in research and clinical settings. Like many brief protocol psychotherapies, Dignity Therapy lacks sufficient evidence of intervention fidelity. To overcome this gap, our study purpose was to examine intervention fidelity among therapists trained with a systematized training protocol. METHODS: For preliminary fidelity evaluation in a large multi-site stepped wedge randomized controlled trial, we analyzed 46 early transcripts of interviews from 10 therapists (7 female; 7 White, 3 Black). Each transcript was evaluated with the Revised Dignity Therapy Adherence Checklist for consistency with the Dignity Therapy protocol in terms of its Process (15 dichotomous items) and Core Principles (6 Likert-type items). A second rater independently coded 26% of the transcripts to assess interrater reliability. RESULTS: Each therapist conducted 2 to 10 interviews. For the 46 scored transcripts, the mean Process score was 12.4/15 (SD = 1.2), and the mean Core Principles score was 9.9/12 (SD = 1.8) with 70% of the transcripts at or above the 80% fidelity criterion. Interrater reliability (Cohen's kappa and weighted kappa) for all Adherence Checklist items ranged between .75 and 1.0. For the Core Principles items, Cronbach's alpha was .92. CONCLUSIONS: Preliminary findings indicate that fidelity to Dignity Therapy delivery was acceptable for most transcripts and provide insights for improving consistency of intervention delivery. The systematized training protocol and ongoing monitoring with the fidelity audit tool will facilitate consistent intervention delivery and add to the literature about fidelity monitoring for brief protocol psychotherapeutic interventions.

Implementation of a hospital-wide multidisciplinary blunt chest injury care bundle (ChIP): Fidelity of delivery evaluation.

BACKGROUND: Ineffective intervention for patients with blunt chest wall injury results in high rates of morbidity and mortality. To address this, a blunt chest injury care bundle protocol (ChIP) was developed, and a multifaceted plan was implemented using the Behaviour Change Wheel. OBJECTIVE: The purpose of this study was to evaluate the reach, fidelity, and dose of the ChIP intervention to discern if it was activated and delivered to patients as intended at two regional Australian hospitals. METHODS: This is a pretest and post-test implementation evaluation study. The proportion of ChIP activations and adherence to ChIP components received by eligible patients were compared before and after intervention over a 4-year period. Sample medians were compared using the nonparametric median test, with 95% confidence intervals. Differences in proportions for categorical data were compared using the two-sample z-test. RESULTS/FINDINGS: Over the 19-month postimplementation period, 97.1% (n = 440) of eligible patients received ChIP (reach). The median activation time was 134 min; there was no difference in time to activation between business hours and after-hours; time to activation was not associated with comorbidities and injury severity score. Compared with the preimplementation group, the postimplementation group were more likely to receive evidence-based treatments (dose), including high-flow nasal cannula use (odds ratio [OR] = 6.8 [95% confidence interval {CI} = 4.8-9.6]), incentive spirometry in the emergency department (OR = 7.5, [95% CI = 3.2-17.6]), regular analgesia (OR = 2.4 [95% CI = 1.5-3.8]), regional analgesia (OR = 2.8 [95% CI = 1.5-5.3]), patient-controlled analgesia (OR = 1.8 [95% CI = 1.3-2.4]), and multiple specialist team reviews, e.g., surgical review (OR = 9.9 [95% CI = 6.1-16.1]). CONCLUSIONS: High fidelity of delivery was achieved and sustained over 19 months for implementation of a complex intervention in the acute context through a robust implementation plan based on theoretical frameworks. There were significant and sustained improvements in care practices known to result in better patient outcomes. Findings from this evaluation can inform future implementation programs such as ChIP and other multidisciplinary interventions in an emergency or acute care context.

Intervention fidelity and its determinants of focused antenatal care package implementation, in south Wollo zone, Northeast Ethiopia.

BACKGROUND: Focused antenatal care is directed at sustaining maternal health and improving fetal wellbeing to ensure birth of a healthy neonate. Failure to implement focused antenatal care can result in inability to reduce maternal and perinatal morbidity and mortality in low income countries. Due to evidence-practice gaps, however, thousands of maternal, fetal and neonatal lives are still lost every day, mostly from preventable causes. This study aimed to assess focused antenatal care package's intervention fidelity and its determinant factors in South Wollo Zone, Northeast Ethiopia. METHODS: A cross-sectional study design was employed and a total of 898 women who gave birth in the last 6 months prior to data collection were included. Also 16 health extension workers, working in ten selected health posts, were included. Interviews and self-administered questionnaires were used to collect data from mothers and health extension workers. Ten [10] health posts were audited to assess availability and functionality of drugs and supplies to provide focused antenatal care. Mothers were asked whether or not the required level of care was provided. Health extension workers were provided with self-administered questionnaires to assess socio-demographic characteristics, reception of training, facilitation strategies for the implementation of focused antenatal care and ability to classify danger signs. Multilevel linear regression analysis was performed to identify individual and organizational level's factors influencing focused antenatal care package intervention fidelity. RESULTS: Overall weighted average focused antenatal care package intervention fidelity (implemented as intended/planned) was 49.8% (95% CI: 47.7-51.8), which means the average number of focused antenatal care package interventions women received is 49.8%. Health extension workers implemented 55.1% and skilled providers (nurses, midwives, health officers or medical doctors) 44.9% of focused antenatal care package interventions. Overall antenatal care coverage, irrespective of frequency (at least one visit), was 752/898 women (83.7%; 95% CI: 81.3-86.1); 263/752 women (35.0%; 95% CI: 31.6-38.4) received at least four antenatal visits and only 46/752 women (6.1%; 95% CI: 4.4-7.8) received all recommended components of focused antenatal care. Previous pregnancy-related problems, paternal education and implementation of facilitation strategies were found to be significant factors enhancing focused antenatal care package intervention fidelity. CONCLUSION: Focused antenatal care package intervention fidelity in the study area was low; this may imply that the current level of maternal, perinatal and neonatal mortality might be partly due to the low level of focused antenatal care intervention fidelity. Improving implementation of facilitation strategies is highly required to contribute to the reduction of those mortalities.

An Evaluation of Strategies Used to Maximize Intervention Fidelity in a Randomized Controlled Trial of a Sexual Assault Resistance Program for University Women.

In this paper, we describe and evaluate the strategies used to maximize intervention fidelity in a randomized controlled trial to examine the efficacy of a sexual assault resistance intervention. The EAAA program was based on the best available theory and evidence on how women can successfully resist sexual coercion from male acquaintances. Extensive protocols for hiring, training, and supervising facilitators were established a priori. Detailed intervention manuals were developed that clearly described program goals, learning objectives, core elements, troubleshooting tips, sections that must be delivered verbatim, adaptations that could be made if necessary, and the ideal and minimum dose. Program sessions were audio-recorded, and a subsample of recordings were scored for adherence to the manuals using detailed Intervention Fidelity Checklists (IFC) developed specifically for this research. The Gearing et al. (2011) Comprehensive Intervention Fidelity Guide (CFIG) was employed retrospectively to provide objectivity to our analysis and help identify what we did well and what we could have done better. The SARE (Sexual Assault Resistance Education) Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity. Although a potential for bias on the part of the two raters was an obvious limitation, as was our neglection to include measures of implementation receipt, which Gearing et al. (2011) recommended, our analysis underscores the utility in employing methods recommended to enhance intervention fidelity when developing and evaluating evidence-based interventions.

Fidelity of Motivational Interviewing in School-Based Intervention and Research.

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.

Verifying intervention fidelity procedures for a palliative home care intervention with pilot study results.

Fidelity (consistency of intervention implementation) is essential to rigorous research. Intervention fidelity maintains study internal validity, intervention reproducibility, and transparency in the research conduct. The purpose of this manuscript is to describe intervention fidelity strategies/procedures developed for a pilot study testing a new palliative care nursing intervention (FamPALcare) for families managing advanced lung disease. The procedures described herein are based on the fidelity best practices recommendations from the NIH Consortium. An evidence-based checklist guided observational ratings of the fidelity procedures used and the intervention content implemented in each intervention session. Descriptive data on how participants understood (received), enacted, or used the intervention information were summarized. The fidelity checklist observational scores found ≥93% of the planned intervention content was implemented, and the fidelity strategies were adhered to consistently during each intervention session. The small variation (7%) in implementation was expected and related to participants' varying experiences, input, and/or questions. The helpfulness scale items include participants' ability to use home care resources, to anticipate and manage end-of-life symptoms, and to use Advance Directive forms. The high ratings (M = 4.4) on the 1-5 (very helpful) Likert Helpfulness Scale verified participants utilized the information from the intervention. Furthermore, there was an improvement in patients' breathlessness scores and completion of Advance Directive forms at 3 months after baseline. It is essential to plan intervention fidelity strategies to use throughout a study and to report fidelity results.

World Health Organization Surgical Safety Checklist Modification: Do Changes Emphasize Communication and Teamwork?

BACKGROUND: The World Health Organization's (WHO) surgical safety checklist is meant to be customized to facilitate local implementation, encourage full-team participation, and promote a culture of safety. Although it has been globally adopted, little is known about the extent of checklist modification and the type of changes made. METHODS: Nonsubspecialty surgical checklists were obtained through online search and targeted hospital requests. A detailed coding scheme was created to capture modifications to checklist content and formatting. Descriptive statistics were performed. RESULTS: Of 155 checklists analyzed, all were modified. Compared with the WHO checklist, those in our sample contained more lines of text (median: 63 [interquartile range: 50-73] versus 56) and items (36 [interquartile range: 30-43] versus 28). A median of 13 new items were added. Items most frequently added included implants/special equipment (added by 84%), deep vein thrombosis prophylaxis/anticoagulation (added by 75%), and positioning (added by 63%). Checklists removed a median of 5 WHO items. The most frequently removed item was the pulse oximeter check (removed in 75%), followed by 4 items (each removed in 39%-48%) that comprise part of the WHO Checklist's "Anticipated Critical Events" section, which is intended for exchanging critical information. The surgeon was not explicitly mentioned in the checklist in 12%; the anesthesiologist/certified registered nurse anesthetist in 14%, the circulator in 10%, and the surgical tech/scrub in 79%. CONCLUSIONS: Checklists are highly modified but often enlarged with items that may not prompt discussion or teamwork. Of concern is the frequent removal of items from the WHO's "Anticipated Critical Events" section.

Investigation of ward fidelity to a multicomponent delirium prevention intervention during a multicentre, pragmatic, cluster randomised, controlled feasibility trial.

BACKGROUND: delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging. OBJECTIVE: to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial. SETTING: five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales. DATA COLLECTION: research nurse observations of ward practice; case note reviews and examination of documentation. ASSESSMENT: 10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). RESULTS: the mean score (range) for each domain was: installation 4.5 (3.5-5); delivery 32.6 (range 27.3-38.3); coverage 7.9 (range 4.2-10.1); and duration 0.38 (0-1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51-79%) in five wards and low (≤50%) in one ward. CONCLUSION: the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes.

Establishing fidelity for the creating opportunities for personal empowerment: Symptom and technology management resources (COPE-STAR) intervention.

AIM: To establish intervention fidelity for the Creating Opportunities for Personal Empowerment: Symptom and Technology Management Resources web-based intervention to assist caregivers of children aged 1-5 years in managing their child's symptoms and medical technology of tracheostomies and feeding tubes at home. DESIGN: Descriptive study of the strategies used to establish intervention fidelity, specifically using expert and caregiver reviewers. METHODS: To establish fidelity of the intervention, experts and caregivers were asked to evaluate the usefulness, ease of use, and acceptability of the intervention and provide any suggestions for the modules. Caregivers provided caregiver and child characteristics and were administered a health literacy measure, the Newest Vital Sign. Intervention fidelity was established from April 2019-July 2019. RESULTS/FINDINGS: Expert and caregiver reviewers (N = 13) all agreed or strongly agreed that the intervention was useful, easy to use, and acceptable. In addition, caregiver reviewers provided care to children who required multiple technologies and a variety of care needs at home and confirmed adequate health literacy (N = 5). CONCLUSION: The use of expert and caregiver reviewers was very beneficial in establishing intervention fidelity. Caregivers are experts in the care of their child and provide valuable feedback based on their daily experiences at home. Experts provided evidence-based feedback. IMPACT: This nursing intervention addresses caregivers of children who require medical technology by targeting caregiver management for common symptoms, related technologies, and resources for the child and caregiver in the home setting. Intervention fidelity was established and expert and caregiver reviewers confirmed the usefulness, ease of use, and acceptability of the intervention. This study is essential to nursing, other healthcare providers, and healthcare systems in planning and implementing programmes and services for children and their caregivers and for nurse researchers establishing intervention fidelity. TRIAL REGISTRATION: This study is not designated as a clinical trial per NIH/NINR study and grant proposal guidelines.

A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery.

The benefits of pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) are restricted by poor uptake and completion. Lay health workers (LHWs) have been effective in improving access to treatment and services for other health conditions. We have successfully shown the feasibility of this approach in a PR setting and its acceptability to the LHWs and COPD patients. We present here the feasibility of assessment, and the fidelity of delivery of LHW support achieved for COPD patients referred for PR. LHWs, volunteer COPD patients experienced in PR, received training in the intervention including communication skills, confidentiality and behaviour change techniques (BCTs). Interactions between LHWs and patients were recorded, transcribed and coded for delivery style and BCTs. Inter-rater agreement on the coding of delivery style and BCTs was high at >84%. LHWs built rapport and communicated attentively in over 80% of interactions. LHWs most consistently delivered BCTs concerning information provision about the consequences of PR often making those consequences salient by referring to their own positive experience of PR. Social support BCTs were also used by the majority of LHWs. The use of BCTs varied between LHWs. The assessment of intervention delivery fidelity by LHWs was feasible. LHW training in the setting of PR should add emphasis to the acquisition of BCT skills relating to goal setting and action planning.

The impact of chlorhexidine bathing on hospital-acquired bloodstream infections: a systematic review and meta-analysis.

BACKGROUND: Chlorhexidine gluconate (CHG) bathing of hospitalized patients may have benefit in reducing hospital-acquired bloodstream infections (HABSIs). However, the magnitude of effect, implementation fidelity, and patient-centered outcomes are unclear. In this meta-analysis, we examined the effect of CHG bathing on prevention of HABSIs and assessed fidelity to implementation of this behavioral intervention. METHODS: We undertook a meta-analysis by searching Medline, EMBASE, CINAHL, Scopus, and Cochrane's CENTRAL registry from database inception through January 4, 2019 without language restrictions. We included randomized controlled trials, cluster randomized trials and quasi-experimental studies that evaluated the effect of CHG bathing versus a non-CHG comparator for prevention of HABSIs in any adult healthcare setting. Studies of pediatric patients, of pre-surgical CHG use, or without a non-CHG comparison arm were excluded. Outcomes of this study were HABSIs, patient-centered outcomes, such as patient comfort during the bath, and implementation fidelity assessed through five elements: adherence, exposure or dose, quality of the delivery, participant responsiveness, and program differentiation. Three authors independently extracted data and assessed study quality; a random-effects model was used. RESULTS: We included 26 studies with 861,546 patient-days and 5259 HABSIs. CHG bathing markedly reduced the risk of HABSIs (IRR = 0.59, 95% confidence interval [CI]: 0.52-0.68). The effect of CHG bathing was consistent within subgroups: randomized (0.67, 95% CI: 0.53-0.85) vs. non-randomized studies (0.54, 95% CI: 0.44-0.65), bundled (0.66, 95% CI: 0.62-0.70) vs. non-bundled interventions (0.51, 95% CI: 0.39-0.68), CHG impregnated wipes (0.63, 95% CI: 0.55-0.73) vs. CHG solution (0.41, 95% CI: 0.26-0.64), and intensive care unit (ICU) (0.58, 95% CI: 0.49-0.68) vs. non-ICU settings (0.56, 95% CI: 0.38-0.83). Only three studies reported all five measures of fidelity, and ten studies did not report any patient-centered outcomes. CONCLUSIONS: Patient bathing with CHG significantly reduced the incidence of HABSIs in both ICU and non-ICU settings. Many studies did not report fidelity to the intervention or patient-centered outcomes. For sustainability and replicability essential for effective implementation, fidelity assessment that goes beyond whether a patient received an intervention or not should be standard practice particularly for complex behavioral interventions such as CHG bathing. TRIAL REGISTRATION: Study registration with PROSPERO CRD42015032523 .

A group randomized control trial to test the efficacy of the Road to Mental Readiness (R2MR) program among Canadian military recruits.

BACKGROUND: Despite increased interest in workplace mental health interventions, the evidence for beneficial effects is mixed. Furthermore, many existing studies lack methodological rigor. We report results from a group randomized control trial to test the efficacy of a vastly popular intervention in Canada, the Road to Mental Readiness (R2MR) program, which has been widely disseminated in military, first responder, and civilian settings. METHODS: The trial took place among Canadian Armed Forces military recruits completing their basic military qualification (BMQ) training, and randomized 65 platoons (N = 2831) into either (a) an Intervention (R2MR at week 2 of BMQ), or (b) a delayed Intervention Control (R2MR at week 9 of BMQ) condition. The principal investigator, participants, and data collection staff were blinded to platoon condition. Individual-level psychological functioning, resilience, mental health service use attitudes, intentions, and behaviours, and additional covariates were assessed with questionnaires around week 2 (a day or two before Intervention platoons received R2MR), at week 5, and at week 9 (a day or two before the Control platoons received R2MR). Military performance outcomes were obtained from administrative databases. RESULTS: The full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time. Analyses among two subsamples (Group 1: Intervention platoons with a Fidelity Check and their Controls, and Group 2: Intervention platoons without Fidelity Check and their Controls) indicated that for some outcomes (attitudes and help-seeking), under high fidelity conditions, the beneficial effects of R2MR were increased and better sustained; Conversely, under poor fidelity conditions, decreased beneficial effects or even iatrogenic effects were observed. Analyses across three training divisions indicated the larger organizational climate further influences efficacy. CONCLUSIONS: Our findings paint a very complex picture in which it is made evident that sensible, evidence-informed workplace mental health interventions such as R2MR may work under high fidelity conditions, but may yield no discernable benefit or even inadvertent iatrogenic effects if implemented poorly or without sufficient consideration to the larger organizational context. TRIAL REGISTRATION: ISRCTN 52557050 Registered 13 October 2016.

Promotion of physical activity-related health competence in physical education: study protocol for the GEKOS cluster randomized controlled trial.

BACKGROUND: One central goal of physical education in many countries is to empower students to be physically active throughout their lifespan. Physical activity-related health competence (PAHCO) encompasses physical, cognitive, and motivational elements associated with the individuals' ability to be physically active in a health-enhancing way. To date, there is a lack of empirical evidence concerning effective programs and methods to promote PAHCO in physical education. The purpose of this study is to examine to what extent a health and physical fitness-related program that includes learning tasks integrating theoretical and practical elements promotes students' PAHCO in physical education. DESIGN/METHODS: This study is a cluster randomized controlled trial that compares two physical education intervention programs on health and physical fitness (IG-run, IG-game play) with regular physical education lessons (CG-run, CG-game play) in secondary schools in Germany. Forty-eight physical education classes (ninth grade) were recruited and randomly allocated to the four study groups. The intervention programs include six physical education lessons on health and physical fitness and only differ in the type of physical activity that is executed (running and jumping vs. small-sided games). The students' PAHCO is examined both pre- and post-intervention and after 8-12 weeks of follow-up. We also determine various process variables during the intervention period to analyze the intervention fidelity. DISCUSSION: The results of this study provide evidence on whether a combination of theoretical and practical elements in physical education can enhance students' PAHCO. Beyond that, our process analyses will allow differentiated insights into the mechanism of how the intervention programs work. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00016349 . Retrospectively registered on 10 January 2019.

The Daily Mile as a public health intervention: a rapid ethnographic assessment of uptake and implementation in South London, UK.

BACKGROUND: Existing evidence identifies health benefits for children of additional daily physical activity (PA) on a range of cardiovascular and metabolic outcomes. The Daily Mile (TDM) is a popular scheme designed to increase children's PA within the school day. Emerging evidence indicates that participation in TDM can increase children's PA, reduce sedentarism and reduce skinfold measures. However, little is known about the potential effects of TDM as a public health intervention, and the benefits and disbenefits that might flow from wider implementation in 'real world' settings. METHODS: We aimed to identify how TDM is being implemented in a naturalistic setting, and what implications this has for its potential impact on population health. We undertook a rapid ethnographic assessment of uptake and implementation in Lewisham, south London. Data included interviews (n = 22) and focus groups (n = 11) with stakeholders; observations of implementation in 12 classes; and analysis of routine data sources to identify school level factors associated with uptake. RESULTS: Of the 69 primary schools in one borough, 33 (48%) had adopted TDM by September 2018. There were no significant differences between adopters and non-adopters in mean school population size (means 377 vs 397, P = 0.70), mean percentage of children eligible for free school meals (16.2 vs 14.3%, P = 0.39), or mean percentage of children from Black and Minority Ethnic populations (76.3 vs 78.2%, P = 0.41). Addressing obesity was a key incentive for adoption, although a range of health and educational benefits were also hypothesised to accrue from participation. Mapping TDM to the TIDierR-PHP checklist to describe the intervention in practice identified that considerable adaption happened at the level of borough, school, class and pupil. Population health effects are likely to be influenced by the interaction of intervention and context at each of these levels. CONCLUSIONS: Examining TDM in 'real world' settings surfaces adaptions and variations in implementation. This has implications for the likely effects of TDM, and points more broadly to an urgent need for more appropriate methods for evaluating public health impact and implementation in complex contexts.

Intervention fidelity in Qigong randomized controlled trials: A method review.

Intervention fidelity has important implications for the reliability and validity of a study. Despite the widely reported health benefits of Qigong exercise interventions, the quality of intervention fidelity is less clear. The purpose of this paper is to use a valid intervention fidelity assessment tool to evaluate how intervention fidelity has been addressed in five areas-design, training, delivery, receipt, and enactment-in Qigong randomized controlled studies. A total of 86 articles were drawn from CINAHL, PubMed, AMED, and Scopus, and 32 were selected for the review. The adherence to intervention fidelity strategies within the intervention design, training, delivery, receipt, and enactment was 0.66, 0.32, 0.22, 0.12, and 0.21, respectively. The findings suggest that intervention fidelity is inadequately implemented or reported in published Qigong studies. Developing a consistent intervention fidelity plan for Qigong interventions is needed. To this aim, we propose a treatment fidelity plan specific to Qigong research.

Getting messier with TIDieR: embracing context and complexity in intervention reporting.

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.