Treatment Fidelity Research Articles

Monitoring Treatment Fidelity in a Pragmatic Pediatric Rehabilitation Trial Comparing Two Physical Therapy Schedules: Analysis and Unexpected Findings.

This study aimed to describe the monitoring of treatment fidelity in a pragmatic pediatric rehabilitation trial using the National Institutes of Health Behavior Change Consortium framework, and to identify child and therapist factors that influence treatment fidelity. Therapists (n = 28) were trained in the key ingredients (1-on-1, functional, goal-directed, motor learning intervention) and study protocol for a comparative effectiveness trial titled: A Comparison: High Intensity periodic vs. Every week therapy in children with cerebral palsy (ACHIEVE) for children ages 2 to 8years with cerebral palsy. Therapists were instructed to record every tenth hour of treatment. A subset of recordings were used to monitor treatment fidelity so that each therapist was rated twice using the study- specific ACHIEVE Treatment Fidelity Checklist. Generalized linear mixed effects modeling and logistic regression were used to analyze child and therapist factors related to treatment fidelity. Median treatment fidelity scores were high (>80%). With training, therapist's years of experience and specialty certification do not significantly impact treatment fidelity. There is a trend toward lower treatment fidelity scores for children with communication difficulties, particularly for therapist's use of multi-modal instructions to direct the child in the desired activity. Functional, goal-directed, motor learning intervention can be delivered with high fidelity for children with cerebral palsy within a busy clinical setting. Motor learning principles may be implemented differently for children with communication difficulties. More research is needed to explore optimal motor learning strategies for these children. With training, physical therapists can deliver high-fidelity intervention to children with cerebral palsy across all Gross Motor Function Classification System levels within a busy clinical setting. Therapists may use motor learning principles differently in children with communication delays.

Mobility Intensive Training (Mob-IT) Protocol for Children with Cerebral Palsy: Feasibility and Fidelity Results

The Mobility Intensive Training (Mob-IT) protocol is an innovative intervention focused on motor learning to improve the mobility of children with cerebral palsy (CP). The objective was to describe the feasibility and intervention fidelity of Mob-IT. A single-subject experimental study was conducted with four children with CP, a median age of 11 (7–13) years, and a Gross Motor Function Classification System I–III. The Mob-IT included 24 h of practice of mobility goals, delivered three times a week in 2 h sessions over four weeks. Feasibility was assessed using the Qualitative Feedback Questionnaire (QFQ), evaluating adherence, acceptability, adverse effects, the clarity of procedures, and intervention time. The Canadian Occupational Performance Measure (COPM) was used to assess participant and caregiver satisfaction. Fidelity was measured by the type of feedback provided (intrinsic vs. extrinsic), task challenge level, and intervention volume. Participants reported good acceptance, few adverse effects, and satisfaction with the outcomes. The intervention adhered to the proposed principles, with a focus on extrinsic feedback and tasks showing progression over time. Time was well spent, being 78% focused on activities and using mostly extrinsic-focused feedback. The Mob-IT protocol was considered feasible and faithful to its principles. As this is a feasibility study, the results indicate the need to expand the intervention to a larger, randomized study.

Effectiveness of the User-Centered "Healthcare CEO" App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial.

Young patients aged 16 to 25 years with type 1 diabetes (T1D) often encounter challenges related to deteriorating disease control and accelerated complications. Mobile apps have shown promise in enhancing self-care among youth with diabetes. However, inconsistent findings suggest that further evidence is necessary to confirm the effectiveness of app-based interventions. This study aims to evaluate the effectiveness of the Healthcare CEO app in patients with T1D transitioning from adolescence to early adulthood. A 2 arms, double-blind, randomized controlled trial will be conducted over a 9-month period, with strategies designed to enhance treatment fidelity. The study expects to enroll 96 patients with T1D, aged 16 to 25 years. Participants will be randomly assigned to either the experimental or control group through central randomization. The intervention will be implemented using the Healthcare CEO app, which consists of 11 interfaces. The research will compare differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the 2 groups at baseline and 3, 6, and 9 months after intervention. Additionally, changes within the experimental group will be analyzed before and after the intervention. The study was funded in August 2020. It was originally scheduled from August 2020 to July 2022 but was interrupted by the COVID-19 pandemic after enrolling 38 participants, with preliminary results anticipated for publication by November 2024. Recruitment resumed in August 2023, with findings expected to be finalized by July 2025. The Healthcare CEO app is a comprehensive solution tailored specifically for individuals with T1D transitioning from adolescence to early adulthood. This innovative app has the potential to improve the quality of care for adolescents with T1D during this critical stage and may serve as valuable evidence in support of app-based intervention strategies. ClinicalTrials.gov NCT05022875; https://www.clinicaltrials.gov/study/NCT05022875. DERR1-10.2196/59871.

An implementation trial to mAnage siCkle CELl disEase through incReased AdopTion of hydroxyurEa in Nigeria (ACCELERATE): Study protocol.

Despite the proven efficacy of evidence-based healthcare interventions in reducing adverse outcomes and mortality associated with Sickle Cell Disease (SCD), a vast majority of affected individuals in Africa remain deprived of such care. Hydroxyurea (HU) utilization among SCD patients in Sub-Saharan Africa (SSA) stands at less than 1%, while in Nigeria, approximately 13% of patients benefit from HU therapy. To enhance HU utilization, targeted implementation strategies addressing provider-level barriers are imperative. Existing evidence underscores the significance of addressing barriers such as inadequate healthcare worker training to improve HU adoption. The ACCELERATE study aims to evaluate the adoption of HU among providers through the Screen, Initiate, and Maintain (SIM) intervention, facilitated by healthcare worker training, clinical reminders, and task-sharing strategies, thereby enhancing patient-level SCD management in Nigeria. This study will implement the SIM intervention, encompassing patient screening, initiation of HU treatment, and maintenance of dosage, which will be implemented via the TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH TCP), derived from our team's TAsk-Strengthening Strategy for Hypertension control (TASSH) trials. Employing a sequential exploratory mixed-methods approach within the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, this study will assess SIM adoption by providers in Nigeria. The primary outcome is the rate of SIM adoption at clinical sites at 12 months, with secondary outcomes including sustainability/maintenance of SIM intervention and implementation fidelity. This study's findings will offer crucial insights into effective SCD management strategies, leveraging existing SCD clinical networks and resources in Nigeria to enhance HU adoption among providers in a scalable and sustainable manner. Additionally, the study will inform best practices for implementing HU therapy in resource-constrained settings, benefiting healthcare providers, policymakers, and stakeholders invested in improving SCD care delivery. NCT06318143.

Identifying and Mapping Canadian Registered Dietitians' Perceptions and Knowledge of and Experiences with Weight-Related Evidence: A Scoping Review.

In this scoping review, "weight-related evidence" is an umbrella for various terms, phrases, and ways in which weight, body size, fatness, and/or obesity present in research and dietetic practice. Canadian Registered Dietitians' perceptions of, experiences with, and/or knowledge of weight-related evidence in nutrition care was identified and mapped. Implementing JBI scoping review methodology, four databases were searched: (i) CINAHL (EBSCO); (ii) Medline (Ovid); (iii) Embase (Elsevier); and (iv) Scopus (Elsevier). Google and Bing were searched for grey literature. Three JBI-trained independent reviewers completed screening to extraction. Community consultation was conducted using the Delphi Method. Of 2217 results, 67 were included in the review (29 peer-reviewed; 38 grey). Identified frequencies were 67 examples of perception, 54 of experience, and 51 of knowledge. This review identified diverse definitions/perspectives of weight-related evidence, highlighting the benefits of continuing to discuss and explore this topic within and beyond dietetics. Weight-related evidence was identified in nutrition care in various settings, representing nutrition assessment, diagnoses, interventions, monitoring, and evaluation. Focused on dietetic research and practice, this work provides a foundation for future evaluation of dietitian-led intervention fidelity, utility, and effectiveness, using systematic review or other research designs. These Canadian findings can serve as a foundation for a global/international review.

The influence of intervention fidelity on treatment effect estimates in clinical trials of complex interventions: A meta-epidemiological study

BackgroundRandomized clinical trials (RCT) 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 over 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. ObjectiveTo 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. MethodsIn this meta-epidemiological study of 19 meta-analyses and 204 RCTs published between 2010–2020, 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 meta-regression to measure associations between intervention fidelity, risk of bias (ROB), study sample size, and treatment effect estimates. ResultsThere was a linear relationship between fidelity and treatment effect sizes across RCTs, even after adjusting for ROB 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. ConclusionPoor 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.

Teaching Early Reading Skills to Adults With Intellectual Disabilities Using a Support Worker/Family Carer Mediated Online Reading Programme: A Feasibility Randomised Controlled Trial.

There is a paucity of research into interventions that help people with intellectual disabilities learn to read. This feasibility study examines whether an online reading programme, Headsprout, with additional support strategies and supervision (the intervention), can be delivered by support workers/family carers and the feasibility of conducting a later large-scale effectiveness trial. The study used a 2-arm randomised controlled trial (RCT) design with an embedded process evaluation using a mixed methods approach. Thirty-six adults with intellectual disabilities were recruited. Informed consent and data were obtained remotely. Progression criteria for recruitment, retention, randomisation and usual practice were met; intervention adherence and fidelity were poor. Pressure on support services was a key barrier. Whilst progression to a large-scale effectiveness trial was not recommended, the success of conducting an RCT and remotely obtaining informed consent and data from adults with intellectual disabilities opens opportunities for increased participation in research for a currently under-represented group. ISRCTN11409097.

USING GENERATIVE AI TO ENHANCE BEHAVIORAL INTERVENTIONS FOR CARE PARTNERS OF OLDER ADULTS

Abstract Care partners play an essential role in providing long-term care to community-dwelling older adults, offering vital support to individuals who require or desire assistance with instrumental and other activities of daily living. However, care partners’ responsibilities often entail significant physical, emotional, and financial strain, resulting in compromised health and well-being. Numerous studies support the efficacy of behavioral interventions in reducing the deleterious health outcomes often associated with serving as a care partner, but the resource-intensive nature of many such interventions introduces numerous implementation barriers. This presentation will explore the promise and potential pitfalls of using generative AI to enhance the delivery of behavioral interventions for care partners of older adults. Presenters will supplement a review of relevant literature with specific examples drawn from their own research using a large language model (ChatGPT 3.5) to enhance the delivery of PISCES (Problem-solving Intervention to Support Caregivers in Everyday Situations), a cognitive-behavioral intervention developed for care partners of older adults with serious illness. Generative AI’s potential as a tool to deliver the intervention’s psychoeducational content and also to monitor intervention fidelity demonstrated by human interventionists will be described, as will researchers’ intentional efforts to ensure the tool does not perpetuate problematic (e.g., ageist) perspectives based on an analysis of 250 transcribed intervention sessions used to train it. The presentation will conclude with actionable practice recommendations that harness the potential of this rapidly emerging technology in an ethically sound manner that enhances the equitable delivery of evidence-based care partner support for all.

IMPLEMENTING AND EVALUATING MULTILINGUAL, COMPETENCY-BASED DEMENTIA TRAINING FOR IHSS CAREGIVERS IN CALIFORNIA

Abstract The rising prevalence of Alzheimer’s dementia in California’s aging population underscores the urgent need for a well-trained direct care workforce to help older adults age in place. This study implemented and evaluated competency-based dementia training for caregivers in California’s Medicaid-Funded In-Home Supportive Services (IHSS) program from 2019 to 2024. The program, offered in English, Spanish, Cantonese, and Mandarin, transitioned from in-person to online delivery due to COVID-19, providing an opportunity to assess this novel online approach. Using a quasi-experimental, mixed-methods design guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance), we evaluated training outcomes, curriculum, staff roles, and delivery logistics. Of 722 caregivers who completed the training, 488 were included in the analytic sample, and 50 participated in interviews. Additionally, 11 key informant stakeholders were interviewed. Mean scores from validated instruments evaluating caregivers’ dementia knowledge (Toye et al., 2014) and self-efficacy (Fortinsky et al., 2002) showed statistically significant increases between pre-post-training and pre-3-month follow-up (p< 0.001). Thematic analysis of caregiver interviews revealed diverse pathways into caregiving, emotional rewards, enhanced advocacy skills, and improved interactions with medical providers. Stakeholder interviews uncovered implementation barriers and facilitators to intervention fidelity, and strategies for addressing the critical need for a skilled dementia direct care workforce. The training’s adaptability to online formats and multiple languages demonstrates its real-world efficacy and potential readiness for trial design. This study highlights the importance of evidence-informed, culturally and linguistically appropriate training for IHSS caregivers in managing the health and well-being of older adults living with Alzheimer’s dementia.

Intervention description of pharmacist-facilitated medication reviews in Nordic primary care settings: a scoping review

Background Multicomponent interventions are increasingly utilized to tackle the complexity of aging and co-morbid patients. However, descriptions of interventions are generally poor, making it difficult for healthcare providers to implement successful programs. Objectives This study aimed to explore the completeness of intervention description of pharmacist-facilitated medication reviews (MRs) in Nordic primary care settings. Methods We performed a scoping review of studies reporting on pharmacist-facilitated MRs in Nordic primary care settings. Medline, Embase, CINAHL and Web of Science were searched on 24 January 2024. We used Arksey and O’Mally’s framework for scoping studies and applied an adapted version of the Template for Intervention Description and Replication (TIDieR) checklist to evaluate intervention reporting. The Pharmaceutical Care Network Europe (PCNE) classification of MR levels was used to identify the components of different MRs. Results Sixteen studies were included in this scoping review. The studies were conducted in Sweden (n = 7), Norway (n = 6), Finland (n = 2) and Denmark (n = 1). Information on the participating pharmacists’ expertise, qualifications and training was fully reported in only two studies. Twelve studies did not provide any information related to intervention cost, dose or duration, making it challenging to estimate the economic impact of the intervention. Only one study made an evaluation of intervention fidelity. Conversely, 15 studies lacked information on this topic which can lead to inaccurate conclusions about the program’s effectiveness. Conclusion The studies included in this scoping review do not provide sufficient MR information for intervention replication. We recommend that pharmacy trials use reporting checklists to increase the replicability and transferability of effective interventions.

Delivering evidence-based treatment via telehealth for Anorexia Nervosa in rural health settings: a multi-site feasibility implementation study

BackgroundAccess to evidence-based treatments such as family-based therapy (FBT) is difficult for adolescents diagnosed with Anorexia Nervosa (AN) living in rural or regional areas due to a limited trained workforce, high staff turnover and inconsistent treatment fidelity. Telehealth offers a potential access solution by facilitating care irrespective of family or service location. The disruption to the health system caused by COVID-19 amplified an existing need and increased the use of telehealth to deliver FBT before its efficacy and safety was fully evaluated. This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of telehealth-FBT delivered by community-based clinicians within rural services directly into the home to reduce the eating disorder symptoms of adolescents diagnosed with AN.MethodsA pre- and post-implementation multi-site case series delivered up to 20 sessions of telehealth-FBT to 28 adolescents (89.29% female, M = 14.68 ± 1.58 years) living in rural or regional Australia. The RE-AIM framework guided the evaluation, with Reach (treatment uptake and completion); Efficacy (change in weight, global eating disorder symptoms, and remission from baseline to end of treatment and six-month follow-up); Adoption (patient characteristics and drop out); Implementation (intervention fidelity) and Maintenance (outcomes and intervention during the follow-up period) used to assess the feasibility and preliminary efficacy of telehealth-FBT.ResultsThere was a high level of interest in telehealth-FBT, with two-thirds of eligible families consenting to participate. Both treatment engagement and completion rates were over 60%, and treatment was delivered with acceptable fidelity. Twenty adolescents (71.43%) met the diagnostic criteria for AN (baseline 86.03%mBMI ± 7.14), and eight (28.57%) for Atypical AN (baseline 101.34%mBMI ± 8.28), with an overall mean duration of illness of 8.53 months (SD = 5.39, range 2–24 months). There was a significant increase in %mBMI at the end of treatment compared to the baseline (p = 0.007, 95%CI: 1.04–6.65), with over 68% of adolescents weight restored and 36.8% of these achieving both weight and psychological remission criteria. Weight remained significantly improved at six-month follow-up (p = 0.005, 95%CI: 1.57–8.65). Also, there was a decrease in adolescents’ global eating disorder symptoms, as rated by their parents, at the end of treatment compared to the baseline of 0.735 (p = 0.028, 95%CI: 0.079–1.385).ConclusionsTelehealth-FBT was feasibly implemented into rural services and delivered by community clinicians with reach, adoption, preliminary efficacy, and fidelity scores comparable to those reported by specialist studies.Trial registrationThe study was conducted according to the HREC-approved protocol (HREC 2020/ETH00186) and registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR # 12620001107910).

A physiotherapist-led biopsychosocial education and exercise programme for patients with chronic low back pain in Ghana: a mixed-methods feasibility study

BackgroundLow back pain is a common musculoskeletal condition which causes substantial disability globally. The biopsychosocial model of management has been recommended in national and international guidelines for the management of patients with chronic low back pain (CLBP). However, biopsychosocial approaches are predominantly delivered in high income countries (HICs), although the prevalence of LBP is substantially higher in low- and middle-income countries (LMICs) especially in Africa (39%; 95% CI 30–47). Understanding the effectiveness of BPS interventions in LMICs especially in Africa is underexplored, with substantial inequity between research from HICs and LMICs. Ghana is a LMIC where the effectiveness of biopsychosocial interventions has been underexplored. Therefore, the aim of this study was to explore the feasibility of delivering a physiotherapist-led BPS programme for the management of patients with CLBP in Ghana.MethodsThis was a mixed-methods, sequential, pretest-posttest feasibility study. Participants involved thirty patients with CLBP. The biopsychosocial intervention involved an exercise and patient education programme based on principles of cognitive behavioural strategies with emphasis on self-management. The biopsychosocial intervention was delivered for six weeks for each participant. Feasibility outcomes regarding management and processes were captured pre-intervention, post-intervention, and three-months post intervention. Semi-structured interviews were conducted post-intervention to explore participants’ experiences with the biopsychosocial intervention. Patients’ demographics were collected at baseline. Patient reported outcome measures such as intensity of pain, disability, pain catastrophising, kinesiophobia, self-efficacy, and general quality of life, were collected pre-intervention, post-intervention and at three-months follow-up. Qualitative analysis explored participants’ experiences regarding the acceptability of the biopsychosocial intervention.ResultsThe results of this feasibility study demonstrated that the training programme was acceptable to physiotherapists. Recruitment rate (5 patient participants per week − 100% recruitment met), retention rate post-intervention (90%), data completion rate post-intervention (99.8%) and intervention fidelity (83.1%), all met feasibility thresholds. There were no adverse events. Qualitative data also demonstrated that the biopsychosocial intervention was acceptable to participants.ConclusionThis study has established the potential to deliver a biopsychosocial intervention programme in a Ghanaian hospital setting. This biopsychosocial intervention therefore shows promise, and the result of the study provides a platform to develop future clinical studies.

Pilot Implementation of a Primary Care Disease Management Concept for Venous Leg Ulceration: Results of a Mixed-Methods Process Evaluation.

Within the project "Ulcus Cruris Care", a disease management intervention to improve general practice care for patients with venous leg ulcer was developed, comprising online teaching for practice teams, standardized patient education, and case management. Implementation of the intervention was piloted and evaluated via a process evaluation. This study aims to evaluate contentedness with the intervention, implementation effort, implementation determinants, intervention fidelity, and perceived intervention effects using a mixed-methods process evaluation. The mixed-methods process evaluation explored the views of general practitioners, medical assistants and patients regarding the intervention components. Data were collected through semi-structured telephone interviews and a survey questionnaire. Qualitative data were first analyzed inductively, followed by a deductive-inductive approach based on the Theoretical Domains Framework. Survey data were analyzed descriptively. Participants (n = 21) reported a strong contentedness with the intervention, high intervention fidelity, low implementation effort, and a change in perception of compression therapy as the central treatment element. Healthcare professionals emphasized increased patient education and patient and family involvement. Patients reported feeling better informed and empowered to take an active role in their treatment, primarily due to increased knowledge and skills in compression therapy. As a result, they were more content with their care and reported positive experiences with wound healing since trial participation. The Ulcus Cruris Care intervention can lead to a noticeable change in knowledge and potentially influence practice teams' approach to venous leg ulcer management, facilitating a significantly more frequent use of compression therapy in VLU care. A confirmatory evaluation of potential effects in a definitive RCT seems warranted.

Evaluating a screening-to-intervention model with caregiver training for response to name among children with autism.

Among the developmental milestones related to language and communication in early childhood, one that has been the subject of considerable research is response to name (RTN). Delayed or absent RTN in early childhood is a diagnostic marker for autism spectrum disorder and a target behavior in many early intervention curricula. This article describes two related studies. Study 1 evaluated the efficacy and efficiency of a behavioral screening-to-intervention model for RTN proposed by recent research. Overall, trials to mastery were reduced relative to previous research. Study 2 evaluated the efficacy of using behavioral skills training to teach caregivers to implement a RTN intervention with their child after that intervention was successful in a clinical setting. Generalized improvements in RTN with caregivers sometimes occurred but did not maintain without programmed reinforcement. Subsequent behavioral skills training was associated with increases in both child RTN and caregiver intervention fidelity.

Parent-Implemented Interventions for Children with Special Needs in Türkiye: An Analysis of Single-Subject Research Studies.

This article summarizes single-subject research studies that investigated the impact of interventions implemented by parents or family members of children with special needs living in Türkiye. In this study, 22 research studies conducted between 2013 and 2023 were analyzed in terms of their participants, methodological characteristics, characteristics of the training program implemented, and outcomes. Most of the child participants were boys, and most of the children were of school age. Mothers dominated parental involvement, but siblings also played an important role. The most frequently used design in the research methods was a multiple probe across participants design. While intervention fidelity data are reported in many research studies, implementation fidelity data are often omitted. The outcomes of the reviewed research show that parents successfully implemented the intervention and taught target skills to their children after the intervention they performed. However, generalization and maintenance findings were limited. The lack of clear reporting of parent training procedures makes it difficult to draw inferences about the effectiveness of the training. In general, although there is methodological diversity in the research reviewed, there is a need to be more rigorous about the clarity of the processes.

지적장애인을 대상으로 한 AAC 활용 국내 중재 연구 동향

Objectives This study analyzes intervention research trends using AAC for individuals with intellectual disabilities to suggest educational practices and future research directions. Methods 17 domestic journal articles from 1999 to August 2024 were selected to analyze overall research trends (publication year, research participants, research design, dependent variables, validity, and fidelity), as well as characteristics of AAC-based interventions (intervention setting, tools, strategies and communication function of AAC). Results First, the analysis of overall trends showed that AAC interventions for individuals with intellectual disabilities started in 1999, with no published papers after 2022. Participants were mostly elementary school students, with pre-intervention communication levels falling below age 3 for expressive language and below age 5 for receptive language, except for adults. Research designs primarily included single subject, with multiple probe design across subjects being the most common. Communication was generally set as a dependent variable. Social validity and intervention fidelity were often omitted, while maintenance and generalization were measured in over 60% of studies. Second, detailed characteristics revealed that researchers often conducted interventions themselves, most commonly in classrooms and for less than 20 minutes. Non-electronic tools were used more than electronic ones, with MyTalkie program being the most actively used software. Various AAC interventions were applied along with script activities, with requesting/re-requesting being the most frequent communication function. Conclusions First, interventions should be applied to a wider range of ages, communication levels, and dependent variables. Enhancements in social validity, intervention fidelity, and generalization are needed to ensure research validity. In particular, training communication partners to ensure the generalization and continuity of AAC use for participants with intellectual disabilities is crucial. Second, the selection of AAC tools should consider participant preferences, and interventions should incorporate natural practice contexts to enhance the efficiency of learned AAC usage.

Afraid of the dentist? There's an app for that: Development and usability testing of a cognitive behavior therapy-based mobile app.

Although several brief cognitive behavior therapy (CBT)-based treatments for dental fear have proven efficacious, these interventions remain largely unavailable outside of the specialty clinics in which they were developed. Leveraging technology, we sought to increase access to treatment for individuals with dental fear through the development of a mobile application (Dental FearLess). To assess the resonance of our app as an avenue for dental fear treatment, we conducted a study assessing the usability, feasibility, and acceptability of the beta app. Participants with moderate to severe dental fear (N = 80) completed the app and reported on the perceived usability of the mobile interface (Systems Usability Scale, SUS; α = .82) and credibility of the intervention (Credibility and Expectancy Questionnaire, CEQ; α = .88). A sub-sample of participants naïve to the app (n = 10) completed the app during a think-aloud procedure, sharing their candid thoughts and reactions while using the app, prior to reporting on usability and credibility metrics. Overall usability (M = 78.5, SD = 17.7) and credibility (M = 21.7, SD = 5.5) of the beta version of the app were good. The think-aloud data further corroborated the app's acceptability, while highlighting several areas for user improvement (i.e., aesthetics, navigation, engagement). Usability and acceptability results are promising for the viability of an accessible, feasible, self-administered intervention for dental fear. Refinements made based on user feedback have produced a clinical-trial-ready mobile application. App refinement decisions, informed by user feedback, are representative of the larger literature-that is, of the ubiquitous negotiations m-health developers must make across treatment fidelity, usability, and engagement. Implications for future research are discussed.

Innovations in Practice: Brief behavioral parent training for children with impairing ADHD characteristics - a pilot study.

Behavioral parent training (BPT) is a well-established intervention for children with attention-deficit/hyperactivity disorder (ADHD), but most programs are long, which may limit their accessibility. This could be improved by making programs shorter. Here, we studied (1) the feasibility of a new brief BPT program and its procedures, and (2) pre-post changes in daily rated problem behaviors (primary outcome), children's disruptive behaviors, ADHD/ODD characteristics, impairment, and parents' sense of parenting competence (secondary outcomes). We conducted a nonrandomized pilot study including parents of 28 children (4-12 years) with impaired ADHD characteristics. We examined treatment dropout, parent and therapist satisfaction, recruitment rates, study drop-out, measurement response and completion rates, acceptability of measurements according to parents, and treatment fidelity. Pre-post changes in the treatment group were compared to those in a historical control group using mixed model analysis, except for those outcomes that were not assessed in the control group. Within-group differences were analyzed for all outcomes. Feasibility of the program and study procedures were good. Treatment dropout was 14.2%, parents and therapists were satisfied with the new program. We recruited 1.5 participants per month, study dropout was 10.7%, response/completion rates ranged from 82% to 100%, measurements were acceptable for parents, and treatment fidelity was 96%. We found substantial within-group changes (d's = .68-.77) and medium-sized between-group changes (d's = .46-.48) on daily rated problem behaviors. We observed no changes on most of the secondary outcomes, except for disruptive behaviors and impairment. Our newly developed brief BPT program was feasible and we observed improvements in children's daily-rated problem behaviors. These results suggest that brief BPT might be beneficial for clinical practice if the findings are confirmed in large-scale randomized controlled trials.

Firm, yet flexible: a fidelity debate paper with two case examples

BackgroundIn healthcare research and practice, intervention and implementation fidelity represent the steadfast adherence to core components of research-supported interventions and the strategies employed for their implementation. Evaluating fidelity involves determining whether these core components were delivered as intended. Without fidelity data, the results of complex interventions cannot be meaningfully interpreted. Increasingly, the necessity for firmness and strict adherence by implementers and their organizations has been questioned, with calls for flexibility to accommodate contextual conditions. This shift makes contemporary fidelity a balancing act, requiring researchers to navigate various tensions. This debate paper explores these tensions, drawing on experiences from developing fidelity assessments in two ongoing effectiveness-implementation hybrid trials.Main bodyFirst, given often scarce knowledge about the core components of complex interventions and implementation strategies, decisions about fidelity requirements involve a degree of subjective reasoning. Researchers should make these decisions transparent using theory or logic models. Second, because fidelity is context-dependent and applies to both interventions and implementation strategies, researchers must rethink fidelity concepts with every study while balancing firmness and flexibility. This is particularly crucial for hybrid studies, with their differing emphasis on intervention and implementation fidelity. Third, fidelity concepts typically focus on individual behaviors. However, since organizational and system factors also influence fidelity, there is a growing need to define fidelity criteria at these levels. Finally, as contemporary fidelity concepts prioritize flexible over firm adherence, building, evaluating, and maintaining fidelity in healthcare research has become more complex. This complexity calls for intensified efforts to expand the knowledge base for pragmatic and adaptive fidelity measurement in trial and routine healthcare settings.ConclusionContemporary conceptualizations of fidelity place greater demands on how fidelity is examined, necessitating the expansion of fidelity frameworks to include organizational and system levels, the service- and study-specific conceptualizations of intervention and implementation fidelity, and the development of pragmatic approaches for assessing fidelity in research and practice. Continuing to build knowledge on how to balance requirements for firmness and flexibility remains a crucial task within the field of implementation science.

Audit and Feedback Interventions for Antibiotic Prescribing in Primary Care: A Systematic Review and Meta-analysis.

This systematic review evaluates the effect of audit and feedback (A&F) interventions targeting antibiotic prescribing in primary care and examines factors that may explain the variation in effectiveness. Randomized controlled trials (RCTs) involving A&F interventions targeting antibiotic prescribing in primary care were included in the systematic review. Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and ClinicalTrials.gov were searched up to May 2024. Trial, participant, and intervention characteristics were extracted independently by two researchers. Random effects meta-analyses of trials that compared interventions with and without A&F were conducted for four outcomes: 1) total antibiotic prescribing volume; 2) unnecessary antibiotic initiation; 3) excessive prescription duration, and 4) broad-spectrum antibiotic selection. A stratified analysis was also performed based on study characteristics and A&F intervention design features for total antibiotic volume. A total of 56 RCTs fit the eligibility criteria and were included in the meta-analysis. A&F was associated with an 11% relative reduction in antibiotic prescribing volume (N=21 studies, rate ratio [RR]=0.89; 95% confidence interval [CI] 0.84, 0.95; I2=97); 23% relative reduction in unnecessary antibiotic initiation (N=16 studies, RR=0.77; 95%CI 0.68, 0.87; I2=72); 13% relative reduction in prolonged duration of antibiotic course (N=4 studies, RR=0.87 95%CI 0.81, 0.94; I2=86); and 17% relative reduction in broad-spectrum antibiotic selection (N=17 studies, RR=0.83 95%CI 0.75, 0.93; I2=96). A&F interventions reduce antibiotic prescribing in primary care. However, heterogeneity was substantial, outcome definitions were not standardized across the trials, and intervention fidelity was not consistently assessed. Canadian Institutes of Health Research FRN 173704. Prospero (CRD42022298297).