Acceptability Of Intervention Research Articles

Positive effects of speech and language therapy group interventions in primary progressive aphasia: A systematic review.

Primary progressive aphasia (PPA) is a neurodegenerative condition characterised by a prominent and progressive deterioration in language abilities, which significantly impacts quality of life and interpersonal relationships. Speech and language therapy plays a crucial role in offering interventions. Group intervention is one mode of delivery that could benefit communication functioning and overall wellbeing of people with PPA (pwPPA) and their care partners. Group interventions are also more efficient than one-to-one intervention and may facilitate peer support. The aim of this review was to systematically evaluate the current evidence for the effectiveness of speech and language therapy groups for pwPPA and their care partners. Specifically, this paper considered three questions: 1.What evidence-based speech and language therapy groups for pwPPA and their care partners have been reported to date? 2.Are group communication interventions effective in improving quality of life and communication function for pwPPA and their care partners? 3.Are group communication interventions that are designed for people with communication difficulties of other aetiologies (such as stroke) effective for pwPPA? In addition, this review aimed to describe the structure and content of groups, including aims, disciplines involved, size and frequency of group meetings, and outcome measures. MEDLINE, CINAHL and PsycINFO were used to retrieve articles of interest. A total of 10 studies published between 2009 and 2022 met the eligibility criteria and therefore were included in this study. Data were extracted from the articles regarding the structure and content of groups. Although evidence is currently limited, results suggest that speech and language therapy group intervention can improve specific linguistic processes, the use of communication strategies and psychosocial well-being. The importance of multidisciplinary input and care partners' involvement in groups was highlighted, along with the benefits of creative non-verbal activities as tools for self-expression. There is also initial evidence that telehealth group provision and one-off group sessions may be feasible and can benefit psychosocial well-being. Lastly, intentional recruitment and explicit education on different aphasia types are described as important when pwPPA participate in groups with mixed diagnoses. The literature on speech and language therapy group interventions for PPA shows promise of positive effects on communication function and psychosocial well-being of both pwPPA and their care partners. Speech and language therapists can consider these published interventions when designing and implementing similar groups, but more robust evidence is required to confirm the relative effectiveness of this approach. What is already known on this subject Speech pathology led group intervention shows some promise in benefitting communication functioning and overall well-being of pwPPA and their carers, but there has been no systematic evaluation of all the evidence regarding the efficacy of speech and language therapy led groups. Establishing feasibility, acceptability and efficacy of speech and language therapy group interventions for pwPPA and their carers may present a valuable addition for managing this progressive language disability. What this paper adds to existing knowledge Although evidence is currently limited, results from this systematic review suggest that speech and language therapy led group intervention can improve specific linguistic processes, the use of communication strategies and psychosocial well-being for pwPPA and their carers. The importance of multidisciplinary input and carers' involvement in groups was highlighted, along with the benefits of creative non-verbal activities as tools for self-expression. There is also initial evidence that telehealth group provision for carers may be feasible and can benefit psychosocial wellbeing. Lastly, intentional recruitment and explicit education on different aphasia types are described as important when pwPPA participate in groups with mixed diagnoses. What are the potential or actual clinical implications of this work? A synthesis of the evidence base for speech and language therapy led PPA groups, as well as a description of the group components and formats, will be valuable for clinical service planning, and will guide future examination of group options for pwPPA and their carers. Speech and language therapists can also consider the research findings from this systematic review when designing and implementing similar groups in their local context.

PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study.

The past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention. To evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness. A systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed. This study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention. ISRCTN 15371248, 09/03/2023. Version 2.3, 26th June 2023.

The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial

Pregnant individuals rarely achieve moderate-to-vigorous intensity physical activity recommendations.Purpose The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial aimed to demonstrate feasibility, acceptability, and initial efficacy of a lower intensity intervention targeting reduced sedentary behavior and increased standing and steps.Methods First trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control. Intervention components included biweekly remote health coaching, wearable activity monitor, height-adjustable workstation, and a private Facebook group. Evidence-based behavioral targets included sedentary time < 9 h/day, increasing standing by 2–3 h/day, and ≥ 7500 steps/day. Participants completed all-remote assessments (baseline, second trimester, third trimester) of sedentary behavior and activity (thigh-worn activPAL) along with exploratory pregnancy health outcomes abstracted from medical records. Intervention effects vs. control were evaluated using generalized mixed models and an intention-to-treat approach. Intervention participants also provided feedback on perceived benefits and acceptability.Results Participants (34 intervention; 17 control) had mean age 32 years, were 83% White, with mean pre-pregnancy BMI 28 kg/m2. Retention was high (90% and 83% at second and third trimester follow-up visits). Intervention participants decreased sedentary time (-0.84 h/day, p = 0.019) and increased standing (+0.77 h/day, p = 0.003), but did not increase steps/day (+710, p = 0.257) compared to controls. Intervention participants reported many perceived benefits and identified the wearable, height-adjustable workstation, and behavioral lessons as most useful.Conclusion For pregnant individuals at risk for high sedentary behavior and APOs, a sedentary behavior reduction intervention is feasible, acceptable, and may offer a viable alternative to more intense physical activity recommendations during pregnancy. Further testing in a fully powered clinical trial is warranted.Trial registration NCT05093842 on clinicaltrials.gov

Culturally adapted Turkish version of an internet-based mindfulness intervention for university students: a randomized controlled feasibility trial

Abstract Background Studying at university is a stressful time for many, which might result in the development of mental health problems. In the first wave of Covid-19, university students in Turkey reported suffering from an elevated level of stress compared to their peers in other countries. Mindfulness-based interventions could provide the means of successfully decreasing the stress level of university students. Moreover, offering interventions via the Internet could be a scalable option to prevent and treat mental health problems, while offering time/place flexibility, anonymity, and cost-effectiveness. Method In a randomized controlled trial of parallel design, the feasibility of a culturally adapted internet- and mobile-based intervention (IMI) (StudiCareM-TR) to promote mindfulness among Turkish-speaking university students was tested. Participants (N = 58) of a public university in Istanbul were randomized into an intervention (IG) vs. waitlist control group (WL). Measurements took place at baseline (t0) and 10 weeks post-randomization (t1). Intervention adherence, acceptance, and potential negative effects were feasibility outcomes. Levels of mindfulness, perceived stress, depression, anxiety, and wellbeing were analyzed in linear regression models to assess the potential efficacy of StudiCareM-TR. All analyses were conducted with the intention-to-treat sample, adjusting for baseline values. Results Based on participants’ feedback, StudiCareM-TR was perceived as acceptable, resulted in few negative effects (n = 7), and yielded improvements in mindfulness (β = 0.70) and presenteeism (β = − 0.61) compared to WL. Secondary outcomes of depression, anxiety, stress, and wellbeing did not show significant improvements. Assessment dropout was 31% (IG: 50%: WL: 89%), and intervention dropout was 45%. Conclusions StudiCareM-TR is feasible and acceptable to use among university students in Turkey and has the potential to improve their mindfulness levels. The intervention should be further developed with a focus on engagement-facilitating features in order to reduce intervention dropouts. Trial registration ID DRKS00024557.

North Macedonia interprofessional dementia care (NOMAD) – personalized care plans for people with dementia and caregiver psychoeducation delivered at home by interprofessional teams

IntroductionThe increasing number of people living with dementia and its burden on families and systems particularly in low- and middle-income countries require comprehensive and efficient post-diagnostic management. This study aimed to explore the acceptability and efficacy of a multi-professional case management and psychoeducation model (North Macedonia Interprofessional Dementia Care, or NOMAD) delivered by mobile teams for people with dementia and their caregivers in North Macedonia.MethodWe conducted a two-arm randomized controlled trial comparing the intervention with treatment as usual. Participants were recruited from 12 general practitioner (GP) offices in the Skopje region. The NOMAD intervention included the delivery of a personalized care plan over four home visits to dyads of people with dementia and their caregivers by a team including a dementia nurse and a social worker, in collaboration with GPs and dementia experts, and the introduction of a caregiver manual. We assessed caregivers' depressive symptoms, burden, and quality of life and the neuropsychiatric symptoms, daily living activities, and service utilization of people with dementia at baseline and follow-up; we also assessed the acceptability of the intervention by analyzing case notes and attendance rates.ResultsOne hundred and twenty dyads were recruited and randomized to either the control (n = 60) or the intervention group (n = 60). At follow-up, caregivers in the intervention group had, on average, scores that were 2.69 lower for depressive symptoms (95% CI [−4.75, −0.62], p = 0.012), and people with dementia had, on average, 11.32 fewer neuropsychiatric symptoms (95% CI [−19.74, −2.90], p = 0.009) and used, on average, 1.81 fewer healthcare services (95% CI [−2.61, −1.00], p &amp;lt; 0.001) compared to the control group. The completion of the home visits was 100%, but the intervention's acceptability was underpinned by relationship building, GP competencies, and resources to support families with dementia. There were no differences in the caregivers' quality of life and burden levels or daily living activities in people with dementia. NOMAD is the first case management, non-pharmacological, and multi-professional intervention tested in North Macedonia.DiscussionThe trial showed that it is effective in reducing caregivers' depressive symptoms and neuropsychiatric symptoms in people with dementia and the burden on health and social care services, and it is acceptable for families. Implementing NOMAD in practice will require building primary care capacity and recognizing dementia as a national priority.

Development and feasibility of a mindfulness-based dance/movement therapy intervention for chronic low back pain.

Responding to the need for innovative, multi-modal, non-pharmacological strategies in chronic low back pain (cLBP) care, this article presents the development and a mixed methods feasibility trial of a manualized Mindfulness-based Dance/Movement Therapy (M-DMT) program for cLBP. The 12-week program is designed as a group therapy, integrating mindfulness principles, creative/expressive dance and movement, and psychoeducational content focused on cLBP management. This holistic program seeks to cultivate nonjudgmental awareness of pain experiences, challenge maladaptive pain-related beliefs, enhance emotional well-being, foster social support, and promote effective coping strategies for the daily challenges associated with cLBP. The 12-week M-DMT intervention was administered to individuals with non-specific cLBP (N = 18, aged 51.7 ± 13.9 years, 72% female, 55% Black and 39% White). We assessed feasibility and acceptability through monitoring enrollment and retention rates, attendance, and adverse events. Moreover, we measured the intervention's credibility/expectancy, participants' perception of changes, and overall satisfaction. Additionally, we collected qualitative data, capturing participants' perspectives on the intervention's usefulness and perceived benefits. Specific benchmarks were established to gauge the successful feasibility and acceptability of the program. The adherence rate stood at 80%, with a perfect retention rate of 100%. The study successfully met the benchmarks for treatment acceptability and satisfaction criteria, with 61% of participants reporting "feeling better" or a "great deal better" after the intervention. No adverse events were observed. Participants found the intervention enjoyable and reported that it provided effective tools for cLBP and related symptoms. Notably, participants reported a decrease in fear-avoidance behaviors, increased motivation for physical activity, and a boost in self-efficacy for pain management. These encouraging findings establish a strong basis for considering the M-DMT intervention as a promising approach for cLBP management, warranting further investigation in larger-scale studies.

Lecanemab Questions.

The recently published results of the 18-month randomized controlled trial of lecanemab, reporting the efficacy of the drug in slowing the progression of early Alzheimer disease, quickly led to approval by the FDA and widespread acceptance of lecanemab treatment. However, there are a number of matters that deserve further consideration. The success of blinding was not assessed, even as infusion reactions and the cerebral pathology underlying amyloid-related imaging abnormalities could have signaled to many participants that they were on drug, potentially exerting a potent placebo effect. The value of the outcome to participants is not defined in the absolute terms necessary for clinical decision-making, and the difference attributable to lecanemab was between 18% and 46% of estimates of the minimal clinically important difference on the Clinical Dementia Rating Scale Sum of Boxes. The attenuation of change on the Alzheimer's Disease Assessment Scale-Cognitive 14 achieved by lecanemab at 18 months was 50% of that achieved by donepezil at 6 months. Lecanemab treatment imposes a high treatment burden. The fact that the burden commences at the initiation of lecanemab treatment, whereas the benefit accrues years later requires us to take into account value discounting over time, which would significantly reduce the benefit/burden ratio. Finally, treatment with monoclonal antibodies to cerebral amyloid has consistently been associated with progressive cerebral atrophy. At the least, these issues should be raised in treatment discussions with patients. They also suggest a need to very seriously reconsider how we evaluate clinical trial results preparatory to translating them into clinical practice. Some suggestions are provided.

Optimising Deep Neural Networks for Tumour Diagnosis Algorithms Based on Improved MRFO Algorithm

INTRODUCTION: Cancer has become one of the most prevalent diseases with the highest mortality rate in the world, and timely detection and early acceptance of medical therapeutic interventions are effective means of controlling the progression of cancer patients and improving their post-intervention outcomes.OBJECTIVES: To make the defects of incomplete features, low accuracy and low real-time performance of current tumour diagnosis methods.METHODS: This paper proposes a tumour diagnosis method based on the improved MRFO algorithm to improve the optimization process of DBN network parameters. Firstly, the diagnostic features are extracted by analysing the tumour diagnosis identification problem; then, the manta ray foraging optimization algorithm is improved by combining the good point set initialization strategy, the adaptive control parameter strategy and the distribution estimation strategy, and the tumour diagnostic model based on the improved manta ray foraging optimization algorithm to optimize the parameters of the depth confidence network is constructed; finally, the high accuracy and real-time performance of the proposed method are verified by the analysis of simulation experiments.RESULTS: The results show that the proposed method improves the accuracy of the diagnostic model.CONLUSION: Addresses the problem of poor accuracy and real-time availability of tumour diagnostic methods.

Preoperative spinal education for lumbar spinal stenosis: A feasibility study.

Lumbar spinal stenosis (LSS) is a leading cause of chronic musculoskeletal pain among older adults. A common and costly intervention for the treatment of LSS is lumbar decompression with or without fusion (LSS surgery), which has mixed outcomes among patients. Prehabilitation is a strategy designed to optimize the consistency of positive surgical outcomes and promote patient self-efficacy, while attempting to mitigate postoperative complications. No efforts have investigated the prehabilitation strategies specifically for patients undergoing LSS surgery. To determine the feasibility of delivery and acceptability by participants of a novel prehabilitation intervention for patients undergoing LSS surgery. Feasibility study. Outpatient orthopedic clinic at an academic medical center. Patients at least 50 years of age, who were scheduled for LSS surgery between October 2020 and October 2021. PreOperative Spinal Education for Lumbar Spinal Stenosis (POSE-LSS), is a novel multimodal, education-focused, time-efficient prehabilitation program for patients undergoing LSS surgery. Participants received the following: (1) Educational booklet and video; (2) In-person physical therapy (PT) session; and (3) Telemedicine visit with a physiatrist. The primary outcomes of interest were feasibility and acceptability of intervention by participants. Key potential surgical outcomes were length of stay and discharge disposition. POSE-LSS was completed by all eligible participants enrolled (n = 15) indicating feasibility and acceptability. Potential effectiveness measures including length of stay and discharge disposition were positively associated with the POSE-LSS intervention. This study demonstrates that a novel prehabilitation intervention is feasible, acceptable, and appears positively associated with important short-term measures of postoperative recovery that may impact the trajectory of patient care following LSS surgery.

Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings.

Young men are vastly underrepresented in lifestyle interventions, suggesting a need to develop appealing yet effective interventions for this population. This study aimed to determine the acceptability of a self-guided lifestyle intervention designed specifically for young men (age: 18-35 years old). Semistructured interviews and surveys were completed by 14 men following completion of a remotely delivered, 12-week lifestyle intervention. The intervention included 1 virtual group session, digital tools, access to self-paced web- and mobile-based content, and 12 weekly health risk text messages. We quantitatively and qualitatively examined young men's experiences with the intervention components of a remotely delivered, self-guided lifestyle intervention targeting weight loss. Data were integrated using convergent mixed methods analysis. Men were a mean age of 29.9 (SD 4.9) years with a mean BMI of 31.0 (SD 4.5) kg/m2. The self-guided aspect was not acceptable, and a majority preferred more check-ins. Participants expressed a desire for a social aspect in future lifestyle interventions. All men found the focus on health risks appealing. A majority of men found the study-issued, Bluetooth-enabled scale acceptable. Acceptability of the self-guided lifestyle intervention was perceived as suboptimal by young men. The findings highlight the need to add intervention components that sustain motivation and provide additional social support for young men. ClinicalTrials.gov NCT04267263; https://www.clinicaltrials.gov/study/NCT04267263.

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

IntroductionPersonalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the...

Feasibility of a novel eHealth intervention for Parkinson’s disease targeting motor-cognitive function in the home

BackgroundParkinson’s disease (PD) drastically affects motor and cognitive function, but evidence shows that motor-cognitive training improves disease symptoms. Motor-cognitive training in the home is scarcely investigated and eHealth methods can provide continual support for PD self-management. Feasibility testing is however required.ObjectiveTo assess the feasibility (i) Recruitment capability (ii) Acceptability and Suitability (iii) Demand and Safety of a home-based motor-cognitive eHealth exercise intervention in PD.MethodsThe 10-week intervention was delivered using the ExorLive® application and exercises were individually adapted and systematically progressed and targeted functional strength, cardiovascular fitness, flexibility, and motor-cognitive function. People with mild-to moderate PD were assessed before and after the intervention regarding; gait performance in single and dual-task conditions; functional mobility; dual-task performance; balance performance; physical activity level; health related quality of life and perceived balance confidence and walking ability; global cognition and executive function. Feasibility outcomes were continuously measured using a home-exercise diary and contact with a physiotherapist. Changes from pre- and post-intervention are reported descriptively.ResultsFifteen participants (mean age 68.5 years) commenced and 14 completed the 10-week intervention. In relation to intervention Acceptability, 64% of the motor sessions and 52% of motor-cognitive sessions were rated as “enjoyable”. Concerning Suitability, the average level of exertion (Borg RPE scale) was light (11–12). Adherence was high, with 86% of all (420) sessions reported as completed. No falls or other adverse events occurred in conjunction with the intervention.ConclusionsThis motor-cognitive eHealth home exercise intervention for PD was safe and feasible in terms of Recruitment capability, Acceptability, Safety and Demand. The intensity of physical challenge needs to be increased before testing in an efficacy trial.Trial registrationThis trial is registered at Clinicaltrials.gov (NCT05027620).

Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0–8) across UK early years and children’s services

BackgroundHalf of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience. Originally developed in the context of a local authority mental health service for children in care, it is now also delivered online as a low intensity, scalable, preventative intervention. Although WMP shows promise and is already used in some services, we do not yet know whether it is effective.MethodsA non-randomised single group feasibility study with embedded process evaluation. We propose to recruit up to 40 parents/carers of children aged 0–8 years who have been referred to early years and children’s services in the UK. WMP involves a parent watching the child play and talking to their child about their play (or for babies, observing and following signals) for up to 20 min per session. Some sessions are facilitated by a trained practitioner who provides prompts where necessary, gives feedback, and discusses the child’s play with the caregiver. Services will offer five facilitated sessions, and parents will be asked to do at least 10 additional sessions on their own with their child in a 5-week period. Feasibility outcomes examined are as follows: (i) recruitment, (ii) retention, (iii) adherence, (iv) fidelity of delivery, (v) barriers and facilitators of participation, (vi) intervention acceptability, (vii) description of usual care, and (viii) data collection procedures. Intervention mechanisms will be examined through qualitative interview data. Economic evaluation will be conducted estimating cost of the intervention and cost of service use for child and parents/carers quality-adjusted life years.DiscussionThis study will address feasibility questions associated with progression to a future randomised trial of WMP.Trial registrationISRCTN13644899. Registered on 14th April 2023.

Designing a Novel Digitally Delivered Antiracism Intervention for Mental Health Clinicians: Exploratory Analysis of Acceptability.

There is a great need for evidence-based antiracism interventions targeting mental health clinicians to help mitigate mental health disparities in racially and ethnically minoritized groups. This study provides an exploratory analysis of mental health clinicians' perspectives on the acceptability of a web-based antiracism intervention. Mental health clinicians were recruited from a single academic medical center through outreach emails. Data were collected through individual 30-minute semistructured remote video interviews with participants, then recorded, transcribed, and analyzed using content analysis. A total of 12 mental health clinicians completed the study; 10 out of 12 (83%) were female candidates. Over half (7/12, 58%) of the respondents desired more robust antiracism training in mental health care. Regarding the web-based antiracism intervention, (8/12, 67%) enjoyed the digitally delivered demo module, (7/12, 58%) of respondents suggested web-based content would be further enhanced with the addition of in-person or online group components. Our results suggest a strong need for additional antiracist training for mental health clinicians. Overall, participants responded favorably to novel web-based delivery methods for an antiracism intervention. These findings provide important support for future development and pilot testing of a large-scale digitally enhanced antiracist curriculum targeting mental health clinicians.

Healthy Outcomes through Peer Educators: Feasibility of a peer support diabetes prevention programme for African-American grandmother caregivers.

To assess the protocol feasibility and intervention acceptability of a community-based, peer support diabetes prevention programme (DPP) for African-American (AA) grandmother caregivers at risk for diabetes. Grandmother caregivers were randomized in a 2:1 ratio to DPP (active comparator) or DPP plus HOPE (Healthy Outcomes through Peer Educators; intervention). DPP + HOPE incorporated support from a peer educator who met with participants in person or by telephone every week during the 1-year intervention. Outcomes included: (1) recruitment rates, outcome assessment, and participation adherence rates assessed quantitatively; and (2) acceptability of the programme assessed through end-of-programme focus groups. We successfully consented and enrolled 78% (n = 35) of the 45 AA grandmothers screened for eligibility. Eighty percent of participants (aged 64.4 ± 5.7 years) were retained up to Week 48 (74% for DPP [n = 17] and 92% for DPP + HOPE [n = 11]). All grandmothers identified social support, neighbourhood safety, and access to grocery stores as influences on their health behaviours. At Month 12, the active comparator (DPP) group and the intervention group (DPP + HOPE) had a mean change in body weight from baseline of -3.5 ± 5.5 (-0.68, -6.29) kg and - 4.4 ± 5.7 (-0.59, -8.2) kg, respectively. This viable study met the aim of educating and equipping AA grandmothers with the practical and sustained support needed to work toward better health for themselves and their grandchildren, who may be at risk for diabetes. The intervention was both feasible and acceptable to participating grandmothers and their organizations.

Mass Testing and Treatment to Accelerate Malaria Elimination: A Systematic Review and Meta-Analysis.

In regions where malaria transmission persists, the implementation of approaches aimed at eliminating parasites from the population can effectively decrease both burden of disease and transmission of infection. Thus, mass strategies that target symptomatic and asymptomatic infections at the same time may help countries to reduce transmission. This systematic review assessed the potential benefits and harms of mass testing and treatment (MTaT) to reduce malaria transmission. Searches were conducted in March 2021 and updated in April 2022 and included cluster-randomized controlled trials (cRCTs) as well as nonrandomized studies (NRSs) using malaria infection incidence, clinical malaria incidence, or prevalence as outcomes. The risk of bias was assessed with Cochrane's risk of bias (RoB2) tool and Risk of Bias Tool in Nonrandomized Studies - of Interventions (ROBINS-I), and the certainty of evidence (CoE) was graded for each outcome. Of 4,462 citations identified, seven studies (four cRCTs and three NRSs) contributed outcome data. The analysis revealed that MTaT did not reduce the incidence (risk ratio [RR]: 0.95, 95% CI: 0.87-1.04; 1,181 participants; moderate CoE) or prevalence (RR: 0.83, 95% CI: 0.67-1.01; 7,522 participants; moderate CoE) of malaria infection but resulted in a small reduction in clinical malaria (RR: 0.82; 95% CI: 0.70-0.95; 334,944 participants; moderate CoE). Three studies contributing data on contextual factors concluded that MTaT is an acceptable, feasible, and cost-effective intervention. Mathematical modeling analyses (n = 10) suggested that MTaT effectiveness depends on the baseline transmission level, diagnostic test performance, number of rounds, and other co-interventions. Based on the limited evidence available, MTaT has little to no impact on reducing malaria transmission.

A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol

Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407

Evaluation of Postoperative Complications Following Modified Coronally Advanced Flap as Root Coverage Procedure - A Prospective Clinical Study.

Root coverage procedures are very technique sensitive and require patients' compliance for successful treatment outcomes. Post operative complications can influence patients' acceptance of treatment and compromise further periodontal maintenance. The aim of this study was to evaluate the frequency and severity of complications after a modified coronally advanced flap procedure. A total of 78 modified coronally advanced flap procedures were performed in 42 patients for root coverage. Duration of surgical procedure, history of smoking, gender, and age were recorded for each patient. A questionnaire was given to every patient to fill in at first post operative week regarding their experience of postoperative pain, swelling, and bleeding. Pain and duration of surgery had a correlation (OR: 1.05, P < 0.05). Post operative bleeding was significantly correlated with duration of surgery (OR: 1.03, P < 0.05). Current smokers experienced post operative swelling (P < 0.05). However, post operative pain in current smokers was not significantly different (P > 0.05) as compared to nonsmokers. Descriptive statistics were expressed as mean and standard deviations. Odd's ratio was obtained to evaluate risk indicators for moderate to severe types of complications. P < 0.05 was considered as significant. The duration of the surgery, long duration, and the presence of smoking can increase the frequency and severity of post operative complications.

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction

Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

275 Cultural Adaptation and Implementation of Cognitive Behavior Therapy in a Rural Mental Health Clinic of Puerto Rico

OBJECTIVES/GOALS: Culturally Centered Cognitive-Behavioral Therapy (CCCBT) is a therapeutic approach that acknowledges the effect of cultural values, beliefs, and norms on mental health. Study aims to develop a CCCBT for rural community by enhancing engagement, relevance, and outcomes through culturally tailored interventions, and evaluate its implementation. METHODS/STUDY POPULATION: Diverse mixed methods study with participants ages 18-65 from Partial Hospitalization Program in rural community located in Puerto Rico Mountain region. CCCBT intervention will have a span of 9 consecutive bi-weekly sessions. The study consists of 2 phases: 1. Evaluate intervention acceptability through focus groups (n=12) with repeated measures to learn about enhancing mental health outcomes, 2. Measure intervention effectiveness in reducing mild-moderate depression and anxiety symptoms using validated questionnaires (PHQ-9 and GAD-7) with a 100 participants from same region. Descriptive analysis for sociodemographic characteristics will be used to provide overview of participants characteristics. Qualitative analysis of focus groups will be obtained through feedback and content analysis. RESULTS/ANTICIPATED RESULTS: We anticipate high intervention acceptability through positive participant feedback and cultural relevance feedback from focal groups. We expect to find significant reduction in symptoms of depression and anxiety post-intervention, demonstrating the efficacy of CCCBT in Puerto Rican rural communities. These results will support the feasibility of implementing this approach, addressing mental health disparities, and enhancing treatment engagement and outcomes in underserved populations. The study will inform future research to refine and expand this intervention in rural communities of Hispanics and/or other rural underserved populations in the US. DISCUSSION/SIGNIFICANCE: This study’s success will advance culturally tailored mental health care in underserved rural Puerto Rican communities, reducing disparities and enhancing treatment relevance and engagement, with potential implications for improving mental health outcomes in similar populations in the US and worldwide.