BACKGROUND: Children with intellectual disability are less physically active and more sedentary than typically developing peers. To date no studies have tested the feasibility of a school-based walking intervention for children with Intellectual Disability.
METHODS: A clustered randomised controlled trial (cRCT), with an embedded process evaluation, was used to test the feasibility of a school-based walking intervention. Eight schools (n = 161 pupils aged 9-13 years) were randomised into either an intervention arm or an \'exercise as usual\' arm. Measures included physical activity, physical fitness and emotional wellbeing. Baseline and 3-month follow-up data were collected.
RESULTS: The \'Walk Buds\' intervention was found to be acceptable to teaching staff and pupils, with an uptake rate of the walking sessions offered of 84%.
CONCLUSIONS: A number of challenges were experienced, relating to the COVID-19 pandemic, and difficulties collecting accelerometer data. Barriers, facilitators and required changes identified through the mixed methods process evaluation are discussed.

BACKGROUND: Evidence-based practice (EBP) implementation represents a strategic change that requires alignment of leadership and support throughout organizations. Leadership and Organizational Change for Implementation (LOCI) is a multifaceted implementation strategy that aims to improve implementation leadership and climate within organizations through iterative cycles of leadership and climate assessment and feedback, leadership training and coaching, and strategic planning with upper-level leaders. This study tested the effects of LOCI on transformational and implementation leadership, implementation climate, implementation citizenship behavior, and EBP reach.
METHODS: A multiple cohort, cluster randomized trial tests the effect of LOCI in 60 clinics across nine behavioral health organizations in California and Arizona, USA. The study randomized clinics within organizations to either LOCI or a leadership training webinar control condition in three consecutive cohorts. Repeated web-based surveys of direct service providers (nLOCI = 201, nControl = 179) assessed leadership, implementation climate, and implementation citizenship over time. Multilevel autoregressive modeling was the primary statistical analysis such that providers (level-1) were nested within clinics (level-2). The study predicted between-condition differences at 4-, 8-, and 12-month follow-up assessments. Provider engagement in a fidelity monitoring process assessed reach of motivational interviewing (i.e., number of sessions recorded/submitted for fidelity coding). An independent sample t-test explored between condition differences in motivational interviewing reach.
RESULTS: Results indicated between condition differences at 4 months for implementation leadership, implementation climate, and implementation citizenship behavior such that greater improvements were evidenced in the LOCI condition compared to the control condition. Reach of MI was significantly greater in the LOCI vs control condition such that LOCI providers were significantly more likely to engage in the fidelity monitoring process (chi-square (1, n = 370) = 5.59, p = .018).
CONCLUSIONS: LOCI was developed based on organizational theories of strategic leadership and climate to affect organizational change processes that communicate that innovation implementation is expected, supported, and recognized as a value of the organization. The LOCI implementation strategy resulted in more positive hypothesized outcomes compared to the control condition. Organizational change strategies have utility for implementing health innovations in complex, multilevel contexts and for greater sustainment of facilitative leader behaviors, strategic implementation climate, and improved implementation outcomes.
BACKGROUND: This study is registered with Clinicaltrials.gov gov (NCT03042832, 2 February 2017; retrospectively registered).

BACKGROUND: Intervention fidelity in health services research has been poor with a reported lack of understanding about what constitutes pragmatic adaptation of interventions and what constitutes failure to maintain intervention fidelity. However, the challenges facing those delivering such interventions have not been thoroughly explored. The aims of this study were to critically explore the challenges in maintaining fidelity experienced by physiotherapy staff and support workers when delivering a complex intervention for older people living with frailty.
METHODS: This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data.
RESULTS: Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary.
CONCLUSIONS: It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.

BACKGROUND: Advance care planning (ACP) is critical among primary care patients with cognitive impairment, but few interventions have tested ACP with this population.
OBJECTIVE: Describe the development and evaluation of a tool for assessing ACP fidelity within the context of cognitive impairment, including inter-rater reliability, convergent validity, and overall fidelity using clinical trial data.
METHODS: SHARE is a multicomponent intervention inclusive of facilitated ACP conversations. From a two group, single blind, randomized controlled trial, recorded ACP conversations were rated for fidelity. 145 primary care patients and their care partners were randomized to receive the intervention. Participating patients were 80+ years, had a care partner, and indications of cognitive impairment. An ACP Fidelity Checklist was developed with three subscales: Meeting Set-Up; ACP Meeting Topics; and Communication Skills. Scores were converted to percentages (100% = perfect fidelity) with a target of ≥80% fidelity. A post-ACP meeting report completed by ACP facilitators was used to assess convergent validity of the checklist. Intra-class correlation (ICC) was to evaluate inter-rater reliability.
RESULTS: ACP conversations averaged 33.6 minutes (SD = 14.1). The mean fidelity score across N = 91 rated meetings was 82.9%, with a range of 77.3%-90.6% for subscales. 63.7% of meetings achieved a rating of ≥80%. Cognitive function was positively associated with patient participation (rho = .59, P < 0.001). For checklist items, ICC scores ranged from 0.43-0.96. Post-ACP meeting form scores were correlated with the checklist Meeting Topics subscale (r = 0.36, P = 0.001).
CONCLUSIONS: Assessing the fidelity of ACP conversations involving primary care patients living with cognitive impairment and their care partners is feasible.

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BACKGROUND: Despite significant success in the fight against malaria over the past two decades, malaria control programmes rely on only two insecticidal methods: indoor residual spraying and insecticidal-treated nets. House improvement (HI) can complement these interventions by reducing human-mosquito contact, thereby reinforcing the gains in disease reduction. This study assessed the implementation fidelity, which is the assessment of how closely an intervention aligns with its intended design, feasibility, and sustainability of community-led HI in southern Malawi.
METHODS: The study, conducted in 22 villages (2730 households), employed a mixed-methods approach. Implementation fidelity was assessed using a modified framework, with longitudinal surveys collecting data on HI coverage indicators. Quantitative analysis, employing descriptive statistics, evaluated the adherence to HI implementation. Qualitative data came from in-depth interviews, key informant interviews, and focus groups involving project beneficiaries and implementers. Qualitative data were analysed using content analysis guided by the implementation fidelity model to explore facilitators, challenges, and factors affecting intervention feasibility.
RESULTS: The results show that HI was implemented as planned. There was good adherence to the intended community-led HI design; however, the adherence could have been higher but gradually declined over time. In terms of intervention implementation, 74% of houses had attempted to have eaves closed in 2016-17 and 2017-18, compared to 70% in 2018-19. In 2016-17, 42% of houses had all four sides of the eaves closed, compared to 33% in 2018-19. Approximately 72% of houses were screened with gauze wire in 2016-17, compared to 57% in 2018-19. High costs, supply shortages, labour demands, volunteers\' poor living conditions and adverse weather were reported to hinder the ideal HI implementation. Overall, the community described community-led HI as feasible and could be sustained by addressing these socioeconomic and contextual challenges.
CONCLUSIONS: Our study found that although HI was initially implemented as planned, its fidelity declined over time. Using trained volunteers facilitated the fidelity and feasibility of implementing the intervention. A combination of rigorous community education, consistent training, information, education and communication, and intervention modifications may be necessary to address the challenges and enhance the intervention\'s fidelity, feasibility, and sustainability.

BACKGROUND: A multi-component self-management intervention \'CFHealthHub\' was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes.
METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform.
RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant.
CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care.
BACKGROUND: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).

OBJECTIVE: Rating of perceived exertion (RPE) is a convenient and cost-effective tool that can be used to monitor high-intensity interval exercise (HIIE). However, no methodological study has demonstrated the validity of RPE in this context. Therefore, the aim of this study was to validate and calibrate RPE for monitoring HIIE in adolescents.
METHODS: RPE, heart rate (HR), and oxygen uptake (V˙O2) data were retrospectively extracted from 3 lab-based crossover studies, with a pooled sample size of 45 adolescents, performing either cycling-based or running-based HIIE sessions. Within-participant correlations were calculated for RPE-HR and RPE-V˙O2, and receiver operator characteristic curve analysis was used to establish RPE cut points.
RESULTS: The results showed that RPE-HR demonstrated acceptable criterion validity (r = .53-.74, P < .01), while RPE-V˙O2 had poor validity (r = .40-.48, P < .01), except for HIIE at 100% peak power (r = .59, P < .01). RPE cut points of 4 and 5 were established in corresponding to HR/V˙O2 based thresholds.
CONCLUSIONS: RPE has some utility in evaluating intensity during lab-based running or cycling HIIE in adolescents. Future studies should expand the validation and calibration of RPE for prescribing and monitoring HIIE in children and adolescents in field-based contexts.

OBJECTIVE: Auditory-perceptual measurements of voice are among the most common diagnostic tools used during a voice evaluation and are considered a gold standard for documenting voice disorders. The goal of this pilot study was to examine the fidelity of clinicians in the administration of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and its published protocol. This investigation aimed to determine how the CAPE-V is being used by clinicians and researchers and the extent to which users deviate from the published procedure.
METHODS: Survey METHODS: Data were collected by surveying a group (N = l7) of speech-language pathologists who regularly evaluate and treat patients with voice disorders. Survey results revealed that few of the sampled speech-language pathologists follow exactly the standardized instructions for administering the CAPE-V. Considerable variability in CAPE-V administration, including tasks and stimuli examined, was found across respondents.
CONCLUSIONS: This exploratory project may be used to develop a larger national survey study investigating fidelity to the CAPE-V and to motivate recommendations for possible revisions to the instrument and its protocol for administration.

BACKGROUND: Human Immunodeficiency Virus (HIV) is a major public health problem that continues to pose an enormous challenge to mankind\'s survival worldwide. In urban Ethiopia, the HIV prevalence among adults aged 15-49 years is 2.9%, while in Addis Ababa, it is 3.4%. To take the edge off, the Ethiopian government has been implementing the 90-90-90 strategy also known as the surge project, in urban cities. However, the implementation of the program has not been evaluated. Thus, we evaluated the process of the 90-90-90 targets of the surge project in Addis Ababa, Ethiopia.
METHODS: We conducted a case study with concurrent mixed-methods evaluation. We used indicator-driven evaluation dimensions -availability and accommodation dimensions from the health services access and compliance and fidelity from implementation fidelity frameworks to test the program process theory with a total of 52 indicators. We interviewed a total of 419 clients and 210 healthcare providers and reviewed 417 clients\' cards and 17 registries. We also conducted 30 key informant interviews and resource inventory. A binary logistic regression analysis was done to identify factors associated with clients\' satisfaction. We transcribed and translated the qualitative data and analysed thematically. Finally, we judged the overall process of the surge project based on the pre-seated judgmental criteria as; needs urgent improvement, needs improvement and well implemented.
RESULTS: We found that 90% of the project process was as per the program process theory measured by the availability of resources (95.8%), compliance (88.0%), fidelity (84.7%), and accommodation of services (89.3%). We found a shortage of human power, test kits, and viral load testing machines. The commitment of health care providers, provider-client interaction, and clients\' satisfaction with the service at card rooms were found to be poor. Moreover, being aged 15-24, being married and government government-employed were negatively associated with clients\' satisfaction with antiretroviral therapy services.
CONCLUSIONS: The process of the surge project needs improvement. Moreover, the achievements of the first two 90-90 targets were poor. Therefore, implementers need to take intensified action for the availability of resources and to improve the commitment of healthcare providers through refreshment training.