Nursing Students' Perceptions of a Novel Education Approach to Prevention and Control of Healthcare-Associated Infections: Insights from PrevInf Pilot Study.

BACKGROUND: Healthcare-associated infections (HAIs) pose a significant global threat, particularly in developing regions such as Southeast Asia. International bodies emphasize the role of formal undergraduate training in the prevention and control of HAIs. To address this, we aimed to explore the perceptions of Southeast Asian nursing students regarding a novel educational approach developed by a European-Southeast Asian project consortium. METHODS: A pilot study was conducted in four nursing higher education institutions from Cambodia and Vietnam. First, local nursing educators conducted a 2 h classroom-based training session. Then, students were invited to participate for the first time in one of twelve evidence-based simulation scenarios developed by the research team, covering a range of nursing care situations related to the prevention and control of HAIs. After attending both components, students were asked to complete a paper-based questionnaire and rate their agreement with a set of statements on the appropriateness and meaningfulness of both components. RESULTS: A total of 430 nursing students enrolled in the pilot study; 77.4% were female, with an average age of 19.8 years. The PrevInf educational intervention received positive feedback from participating students across settings, with strong agreement on the importance of proactiveness in competency development (M = 5.9, SD = 1.4). Notable differences between Cambodian and Vietnamese students were observed in terms of their receptiveness to the pre-selected teaching materials (p = 0.001) and strategies (p = 0.01) used by the nursing educators during their experience with the simulation scenarios. CONCLUSIONS: The PrevInf educational intervention shows promise in engaging Southeast Asian nursing students and fostering a deeper understanding of the prevention and control of HAIs. Further studies are warranted to refine the learning content and standardize the pedagogical strategies used by nursing educators across settings. This study was not registered.

A novel test and treat program for hepatitis C virus infection utilizing HCV core antigen testing, among police and general population, Islamabad, Pakistan, 2022.

Hepatitis C virus core antigen (HCVcAg) testing can simplify and decrease costs of HCV infection confirmation compared to molecular testing (nucleic acid testing). We piloted HCVcAg testing for the confirmation of active infection. The study was conducted during June through December 2022 among the police and the general population of Islamabad, Pakistan age 18 years and older. Initial screening for HCV antibody was conducted using a rapid diagnostic test (RDT) for all consenting participants. Those who tested positive had venous blood samples tested for HCVcAg, platelets and aspartate aminotransferase (AST). Persons with HCVcAg values ≥3 fmol/L were defined as viremic, and they were offered treatment with direct acting antiviral (DAA) medications, sofosbuvir and daclatasvir. Aspartate aminotransferase to platelet ratio index (APRI) was calculated for each HCV infected person, and those with an APRI score <1.5 received treatment for 12 weeks, while those with APRI ≥ to 1.5 received 24 weeks of treatment. A total of 15,628 persons were screened for anti-HCV using RDT and 643 (4.1%) tested positive. HCVcAg values of ≥3 fmol/L was found in 399/643 (62.1%), and all were offered and accepted treatment. Of those treated, 273/399 (68.4%) returned for a follow-up SVR and HCVcAg was not detected in 261/273, a 95.6% cure rate. The pilot study demonstrated the effectiveness of reaching and treating an urban population using RDT for screening and HCVcAg for confirmation of infection and test of cure.

Addressing barriers and identifying facilitators to support informed consent and recruitment in the Cavernous malformations A Randomised Effectiveness (CARE) pilot phase trial: insights from the integrated QuinteT recruitment intervention (QRI).

Background: It was anticipated that recruitment to the Cavernous malformations: A Randomised Effectiveness (CARE) pilot randomised trial would be challenging. The trial compared medical management and surgery (neurosurgical resection or stereotactic radiosurgery) with medical management alone, for people with symptomatic cerebral cavernous malformation (ISRCTN41647111). Previous trials comparing surgical and medical management for intracranial vascular malformations failed to recruit to target. A QuinteT Recruitment Intervention was integrated during trial accrual, September 2021-April 2023 inclusive, to improve informed consent and recruitment. Methods: The QuinteT Recruitment Intervention combined iterative collection and analysis of quantitative data (28 trial site screening logs recording numbers/proportions screened, eligible, approached and randomised) and qualitative data (79 audio-recorded recruitment discussions, 19 interviews with healthcare professionals, 11 interviews with patients, 2 investigator workshops, and observations of study meetings, all subject to thematic, content or conversation analysis). We triangulated quantitative and qualitative data to identify barriers and facilitators to recruitment and how and why these arose. Working with the chief investigators and trial management group, we addressed barriers and facilitators with corresponding actions to improve informed consent and recruitment. Findings: Barriers identified included how usual care practices made equipoise challenging, multi-disciplinary teams sometimes overrode recruiter equipoise and logistical issues rendered symptomatic cavernoma diagnosis and assessment for stereotactic radiosurgery challenging. Facilitators identified included the preparedness of some neurosurgeons' to offer surgery to people otherwise offered medical management alone, multi-disciplinary team equipoise, and effective information provision presenting participation as a solution to equipoise regarding management. Actions, before and during recruitment, to improve inclusivity of site screening, approach and effectiveness of information provision resulted in 72 participants recruited following a 5-month extension, exceeding the target of 60 participants. Interpretation: QuinteT Recruitment Intervention insights revealed barriers and facilitators, enabling identification of remedial actions. Recruitment to a definitive trial would benefit from further training/support to encourage clinicians to be comfortable approaching patients to whom medical management is usually offered, and broadening the pool of neurosurgeons and multi-disciplinary team members prepared to offer surgery, particularly stereotactic radiosurgery. Funding: National Institute for Health and Care Research.

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study.

Objectives: Posttraumatic stress disorder (PTSD) is a prevalent mental health condition, and techniques using sensory stimulation in processing traumatic memories have gained attention. The Emotional Freedom Techniques (EFT) is a psychotherapy that combines tapping on acupoints with exposure to cognitive reframing. This pilot study aimed to assess the feasibility of EFT as a treatment for PTSD by answering the following research questions 1) What is the compliance and completion rate of patients with PTSD with regard to EFT protocol? Is the dropout rate reasonable? 2) Is the effect size of EFT protocol for PTSD sufficient to justify a future trial? Methods: Thirty participants diagnosed with PTSD were recruited. They received weekly EFT sessions for five weeks, in which they repeated a statement acknowledging the problem and accepting themselves while tapping the SI3 acupoint on the side of their hand. PTSD symptoms were evaluated using the PTSD Checklist for DSM-5 (PCL-5) before and after the intervention. Results: Of the 30 PTSD patients (mean age 34.1 ± 9.1, 80% female), 96.7% showed over 80% compliance to the EFT sessions, and 86.7% completed the entire study process. The mean PCL-5 total score decreased significantly after the intervention, with a large effect size (change from baseline -14.33 [95% CI -19.79, -8.86], p < 0.0001, d = 1.06). Conclusion: The study suggests that EFT is a feasible treatment for PTSD, with high session compliance and low dropout rates. The effect size observed in this study supports the need for a larger trial in the future to further investigate EFT as a treatment for PTSD. However, the lack of a control group and the use of a self-rated questionnaire for PTSD symptoms are limitations of this study. The findings of this pilot study can be used to plan a future trial.

Estimating the prevalence and predictors of musculoskeletal disorders in Tanzania: a cross-sectional pilot study.

Introduction: musculoskeletal (MSK) disorders account for approximately 20% of all years lived with disability worldwide however studies of MSK disorders in Africa are scarce. This pilot study aimed to estimate the community-based prevalence of MSK disorders, identify predictors, and assess the associated disability in a Tanzanian population. Methods: a cross-sectional study was conducted in one village in the Kilimanjaro region from March to June 2019. The Gait, Arms, Legs, Spine (GALS) or paediatric GALS (pGALS) examinations were used during household and school visits. Individuals positive in GALS/pGALS screening were assessed by the regional examination of the musculoskeletal system (REMS) and Modified Health Assessment Questionnaire (MHAQ). Results: among the 1,172 individuals enrolled in households, 95 (8.1%, 95% CI: 6.6 - 9.8) showed signs of MSK disorders using the GALS/pGALS examination and 37 (3.2%, 95% CI: 2.2 - 4.3) using the REMS. Among 682 schools enrolled children, seven showed signs of MSK disorders using the GALS/pGALS examination (1.0%, 95% CI: 0.4 - 2.1) and three using the REMS (0.4%, 95% CI: 0.0 - 1.3). In the household-enrolled adult population, female gender and increasing age were associated with GALS and REMS-positive findings. Among GALS-positive adults, increasing age was associated with REMS-positive status and increasing MHAQ score. Conclusion: this Tanzanian study demonstrates a prevalence of MSK disorders and identifies predictors of MSK disorders comparable to those seen globally. These findings can inform the development of rheumatology services and interventions in Tanzania and the design of future investigations of the determinants of MSK disorders, and their impacts on health, livelihoods, and well-being.

Intercontinental translatability of a peer-led GP education model from New Zealand to the United Kingdom: a pilot study.

BACKGROUND: Pegasus Small Group education for General Practitioners (GPs) is a professional development programme that has been delivered in Canterbury, New Zealand for over 30 years. Peer developed content is delivered in small groups supporting interactive discussions informed by evidence and locally relevant data. AIM: An international collaboration between South Tyneside Clinical Commissioning Group (CCG) in the UK and Pegasus Health in Canterbury New Zealand aimed to determine whether the Canterbury model of Small Group (SG) professional development for GPs was transferrable to the South Tyneside context. DESIGN & SETTING: This was a pilot qualitative study testing proof of concept for the Pegasus Small Group GP education model of professional development in another country. METHOD: To test the concept, three pilot sessions on Persistent Pain, Screening, and Optimising Treatment were delivered between November 2021, and March 2022. Four UK GPs were trained as SG leaders and a member of the Pegasus team liaised with various UK GPs in South Tyneside to adapt topics for the local context. The use of videoconferencing (MSTeams, Zoom) to deliver support, training, and the programme itself had been developed and refined in the pandemic so that it could be run entirely online without losing its core components or interactive nature. RESULTS: Thirty-one, 50 and 61 GPs respectively from the 68 registered GPs attended the three sessions, 90% of whom rated the overall quality as good or excellent. These results and other positive feedback from attendees provided a mandate for a further extension over the following months. CONCLUSION: The pilot proved the potential for health systems to collaborate globally despite geographical distance. A wider evaluation to assess the impact of the education initiative is needed to determine the impact on patient care and to demonstrate the benefits of supporting the small group peer education model.

Developing and evaluating an evidence-based practice research competency enhancement program for clinical nurses in Korea: a pilot study.

BACKGROUND: Evidence-based practice (EBP) is crucial for delivering high-quality healthcare and effective self-care. Enhancing clinical nurses' research competencies through structured mentorship is key to the widespread application of EBP. This study evaluated a newly developed Research Competency Enhancement Program (RCEP), aimed at bolstering EBP among experienced nurses. METHODS: Conducted in a tertiary university hospital in Korea, this single-group study employed a pretest-post-test design and a mixed-methods approach. The RCEP involved 11 experienced clinical nurses in an 8-week intervention, featuring mentor-led workshops, interactive sessions, and resource-driven activities. Data were collected using the Evidence-Based Practice Beliefs Scale (EBPB), the Evidence-Based Practice Attitude Scale (EBPA), and the Research Practice Ability (RPA) tool, alongside qualitative feedback. These measures assessed the program's feasibility, acceptability, and preliminary effectiveness. RESULTS: The quantitative analysis indicated significant improvements in research competency post-intervention. Mean scores on the EBPB and RPA scales increased (Z = -2.53, p = .011; Z = -2.66, p = .008). Participants described the RCEP as inspirational and challenging, creating an environment conducive to research. Facilitators included mentor support and innovative learning tools, while barriers were internet connectivity and scheduling conflicts. Suggestions for improvement included more hands-on sessions, small team collaborations, and integration with academic institutions. CONCLUSION: The RCEP, facilitated by EBP mentors, significantly improved the research competencies and attitudes of clinical nurses towards EBP. The study underscores the importance of continual RCEP refinement, integrating structured, interactive, and collaborative elements to further empower nurses in evidence-based practice. The program shows promise in enhancing research competencies and fostering a commitment to EBP in clinical settings.

Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

Smartphone-delivered approach bias modification for reducing harmful drinking amongst middle-older age adults: Secondary analyses of a single-arm pilot study.

INTRODUCTION: Novel, scalable, low-cost interventions are needed to reduce harmful drinking amongst middle-older adults. Approach bias modification (ApBM) is a promising form of cognitive training for preventing/reducing alcohol use that can be delivered via smartphone. This study explored the acceptability and preliminary effectiveness of smartphone delivered and personalised ApBM amongst Australians ≥55 years, an age cohort at risk of alcohol-related harms. METHODS: Secondary analyses in a middle-older adult subsample (≥55 years, n = 289) of an open-label pilot study using a retrospective, repeated measures design. We explored acceptability (adherence, user mobile acceptability ratings, free-text responses) and preliminary effectiveness (changes in drinking quantity and frequency, craving, dependence and proportion drinking within government-recommended guidelines) of two sessions/week over 4 weeks of evidence-based ApBM training, adapted to include personalisation and smartphone delivery amongst Australians ≥55 years. RESULTS: Although minor adaptations to training were suggested, the intervention was acceptable amongst survey completers, with 72% training adherence. Relative to baseline, there was a significant increase in the proportion of drinking within recommended single-session and weekly guidelines post-training (from 25% to 41% and 6% to 28%, respectively, p < 0.001), with past-week standard drinks significantly decreasing by 18% (p < 0.001) and significant reductions in drinking days, mean craving and dependence scores (p < 0.001). DISCUSSION AND CONCLUSIONS: Findings suggest smartphone ApBM is acceptable amongst middle-to-older aged Australians and may support this 'at risk' cohort to remain within government-recommended alcohol consumption guidelines to optimise healthy aging, although, in the context of a single-arm study, preliminary results should be interpreted cautiously.

Enhancing Diabetes Care through a Mobile Application: A Randomized Clinical Trial on Integrating Physical and Mental Health among Disadvantaged Individuals.

Background: This study examines integrating physical and mental healthcare for disadvantaged persons with type 2 diabetes mellitus and mild-to-moderate depression in the community, using a mobile application within a public-private-academic partnership. Methods: The Korean Diabetes Association has developed a mobile application combining behavioral activation for psychological well-being and diabetes self-management, with conventional medical therapy. Participants were randomly assigned to receive the application with usual care or only usual care. Primary outcomes measured changes in psychological status and diabetes selfmanagement through questionnaires at week 12 from the baseline. Secondary outcomes assessed glycemic and lipid control, with psychological assessments at week 16. Results: Thirty-nine of 73 participants completed the study (20 and 19 in the intervention and control groups, respectively) and were included in the analysis. At week 12, the intervention group showed significant reductions in depression severity and perceived stress compared to the control group. Additionally, they reported increased perceived social support and demonstrated improved diabetes self-care behavior. These positive effects persisted through week 16, with the added benefit of reduced anxiety. While fasting glucose levels in the intervention group tended to improve, no other significant differences were observed in laboratory assessments between the groups. Conclusion: This study provides compelling evidence for the potential efficacy of a mobile application that integrates physical and mental health components to address depressive symptoms and enhance diabetes self-management in disadvantaged individuals with type 2 diabetes mellitus and depression. Further research involving larger and more diverse populations is warranted to validate these findings and solidify their implications.

A randomised controlled pilot study of a Nintendo Ring Fit Adventure™ balance and strengthening exercise program in community-dwelling older adults with a history of falls.

OBJECTIVES: This pilot study examined the feasibility, acceptability, and effects of a Nintendo Ring Fit Adventure™-based balance and muscle strengthening exercise program in community-dwelling older adults with a history of falls. METHODS: Older adults who have had at least one fall in the past year were randomly assigned to an experimental (n = 21) or control group (n = 21). The experimental group performed 16 exercise sessions in total, lasting 60 min each, twice a week for 8 weeks, whereas the control group received usual care. Feasibility was evaluated based on the scores of participants in the exercises. Acceptance was evaluated using a customised questionnaire examining participants' self-perceived enjoyment, feasibility and improvements. Clinical outcomes including balance (Mini-BESTest), lower limb muscle strength (Five-Time Sit-to-Stand test), mobility (Timed-Up and Go test), dual-task ability (Timed-Up and Go test-Dual Task), fear of falling (Icon-FES) and executive function (Color Trails Test) were evaluated at baseline and 8 weeks. RESULTS: Thirty-one participants (74%) finished the 8-week assessment. The experimental group significantly improved their scores in six out of eight exercises (all p < .031). The mean scores of the self-perceived enjoyment, feasibility and improvement domains of the acceptability questionnaire were 3.46 ± .53, 3.08 ± .59, and 3.47 ± .57 respectively. A significant improvement in the anticipatory subscore of the Mini-BESTest was found in the experimental group compared to the control group (p = .02; Partial eta squared = .14). CONCLUSIONS: The Nintendo Ring Fit Adventure™-based exercise program was feasible, acceptable, and potentially effective in community-dwelling older adults with a history of falls.

A multidisciplinary, shared care clinic using personalized medicine and coordinated care in patients with concomitant type 2 diabetes and cardiovascular disease. Protocol and baseline characteristics.

Background: Concomitant type 2 diabetes (T2DM) and cardiovascular disease (CVD) is frequent with a poor prognosis with high risk of comorbidities. Strict risk factor control reduces the risk for complications - yet many people do not achieve treatment targets. The complexity and fragmentation of the healthcare system may, together with the vulnerability of these patients, be a reason. Objective: The purpose of this paper is to describe the protocol of a non-randomized interventional pilot study testing the feasibility and effect of a multidisciplinary, shared care clinic using personalized medicine and coordinated care in people living with concomitant T2D and CVD. Methods: Participants were included from the Holbaek area in Denmark. People suffered from T2DM and CVD and were dysregulated regarding to HbA1c, cholesterol, micro/macroalbuminuaria or blood pressure. Participants went through a thorough evaluation to identify their needs and resources and received consultations every three months for one year. Results: A total of 63 participants with T2DM and CVD were enrolled in the clinic. The participants had a mean age of 69 years and a BMI of 30.9 kg/m2. Almost 50 % had heart failure, 95 % dyslipidemia and 91 % hypertension. Around 54 % received GLP-1 agonists and 39 % received SGLT-2-inhibitors. Perspectives: To our knowledge, a similar study with a multidisciplinary, shared care, outpatient clinic treating people living with concomitant T2DM and CVD, has not been performed previously. This study will provide information about the feasibility and efficacy of a multidisciplinary clinic based on changes in cardiovascular risk factors and medication.

Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

The bruxism screener (BruxScreen): Development, pilot testing and face validity.

BACKGROUND: To assess awake and sleep bruxism, the Standardised Tool for the Assessment of Bruxism (STAB) is currently being developed. The STAB will be a comprehensive tool for the detailed assessment of bruxism behaviour itself as well as of its possible consequences, causes, and comorbid conditions. OBJECTIVE: Since the STAB cannot fully meet the 'A4 principle' for a bruxism assessment tool, i.e., being Accurate (reliable and valid), Applicable (feasible), Affordable (cost-effective), and Accessible (suitable for everyday clinical use), the Bruxism Screener (BruxScreen) has been developed to be used in large-scale epidemiological research projects and, especially, in general, dental practices. METHODS: The BruxScreen consists of two parts: a questionnaire (BruxScreen-Q) to be completed by patients, and a clinical assessment form (BruxScreen-C) to be completed by dentists. RESULTS: This paper describes the development of the BruxScreen and provides the outcomes of the pilot testing phase and the face validity assessment (i.e. that the first impressions of the tool indicate that it adequately reflects the construct to be measured). CONCLUSION: The resulting BruxScreen is considered ready for more profound psychometric testing in the general dental setting.

Pregnancy-specific dietary guidelines for Americans are not met: Findings from a pilot study.

Objective: To assess maternal dietary intake during pregnancy and adherence to the 2020-2025 pregnancy-specific Dietary Guidelines for Americans (DGA). Methods: This was a retrospective observational study. The study population consisted of women who gave birth to term infants (>37 weeks of gestation). Participants were given the Dietary Screener Questionnaire (DSQ) after birth and asked to recall their dietary intake in the last month of pregnancy. Participants' estimated dietary intakes were then compared to the 2020-2025 DGA which includes specific recommendations for pregnant women. Results: Out of 51 women who completed the DSQ, none consumed the recommended amounts of all surveyed dietary factors. Specifically, only one woman (2%) met the recommended intake of fruits, 11 women (22%) met the recommended intake of calcium, 25 women (49%) exceeded the recommended upper limit for added sugar intake, and none of the women (0%) met the intake of vegetables, whole grains, dairy and fiber. Conclusion: Women in our study did not adhere to the pregnancy-specific DGA recommendations in the last month of pregnancy. Our findings underscore the need to increase maternal nutritional awareness and education to improve adherence to the DGA.

Challenges in catalyzing and sustaining research in translational science.

Advancing the new field of translational science and developing innovative solutions to overcome translational roadblocks are key priorities of the Clinical and Translational Science Awards (CTSA) Program of the National Center for Advancing Translational Science (NCATS). However, interpreting this emerging concept of "translational science" (TS) as a field of inquiry distinct from "translational research" (TR) and developing real-world investigations in TS can be challenging. The goal of this paper is to share the obstacles the Einstein-Montefiore CTSA hub has faced in generating institutional interest and research in TS and to present potential strategies for addressing them. The aim is to stimulate dialog within the wider CTSA community and beyond about the need to systematically examine how TS should be efficiently and effectively pursued, that is, the science of translational science. The collective sharing of experiences and innovative approaches to overcoming TS challenges that arise at CTSA hubs is critical if the field is to grow and gain wider recognition and acceptance by the scientific and broader communities.

Supporting professionals to implement integrated, person-centered care for people with chronic conditions: the TARGET pilot study.

OBJECTIVE: The TARGET program for integrated, person-centered care for people with chronic conditions offers primary care (PC) professionals a set of tools and trainings to actively engage in population segmentation and person-centered needs assessments (PCNAs). A pilot study was conducted to gain insight into the program's feasibility and acceptability, and identify preconditions for successful implementation. DESIGN AND SETTING: Seven Dutch PC practices participated in a half-year pilot study starting in August 2020. We performed a review of the population segmentation tool, observed four training sessions and 15 PCNAs, and interviewed 15 professionals and 12 patients. RESULTS: Regarding feasibility and acceptability, we found that the tools and trainings provided professionals with skills to use the segmentation tool and take a more coaching role in the well-appreciated PCNAs. Concerning implementation preconditions, we found that team commitment and network connections need improvement, although work pleasure increased and professionals generally wanted the program to continue. CONCLUSIONS: While the content of the TARGET program is supported by its users, the implementation process, for instance team commitment to the program, needs more attention in future upscaling efforts.

Key PointsTo implement integrated care in practice, primary care professionals (PCPs) need concrete tools, skills and confidence.PCPs consider the tools and trainings of the TARGET program as feasible and acceptable to organize integrated careTARGET's success depends on commitment from professionals to its implementation and the strength of ties with professionals in other domains.Based on qualitative insights, TARGET improves work pleasure and patient experience, but it takes time to decrease work pressure effectively.

Implementation and evaluation of a complex intervention to improve information availability at the interface between inpatient and outpatient care in older patients with multimorbidity and polypharmacy (HYPERION-TransCare) - study protocol for a pilot and feasibility cluster-randomized controlled trial in general practice in Germany.

BACKGROUND: Despite attempts to improve the cross-sectoral flow of information, difficulties remain in routine healthcare. The resulting negative impact on continuity of care is often associated with poor health outcomes, especially in older patients. Our intervention aims to increase information availability with respect to medications and health conditions at the interface between inpatient and outpatient care and to contribute towards improving the quality of care in older patients. This pilot study focuses on feasibility and implementability. METHODS: The idea of the complex intervention has been developed in a previous study. This intervention will be tested in a prospective, multicenter, cluster-randomized (via web tool), controlled pilot trial with two parallel study arms (intervention and control group). The pilot study will be conducted in 20 general practices in Hesse and Saxony (Germany) and include 200 patients (≥ 65 years of age with multimorbidity and polypharmacy) recruited by the practices. Practice staff and patients will be blinded. We will use qualitative and quantitative methods to assess the feasibility and implementability of the intervention and the study design in a process evaluation covering topics ranging from expectations to experiences. In addition, the feasibility of proposed outcome parameters for the future definitive trial will be explored. The composite endpoint will include health-related patient outcomes (hospitalization, falls, and mortality using, e.g., the FIMA questionnaire), and we will assess information on medications (SIMS questionnaire), symptoms and side effects of the medication (pro-CTCAE questionnaire), and health literacy (HLQ questionnaire). Data will be collected at study begin (baseline) and after 6 months. Furthermore, the study will include surveys and interviews with patients, general practitioners, and healthcare assistants. DISCUSSION: The intervention was developed using a participatory approach involving stakeholders and patients. It aims to empower general practice teams as they provide patient-centered care and play a key role in the coordination and continuity of care. We aim to encourage patients to adopt an active role in their health care. Overall, we want to increase the availability of health-related information for patients and healthcare providers. The results of the pilot study will be used in the design and implementation of the future definitive trial. TRIAL REGISTRATION: The study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022). Date and version identifier 10.07.2023; Version 1.3.

The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences.

BACKGROUND: The number of preliminary studies conducted and published has increased in recent years. However, there are likely many preliminary studies that go unpublished because preliminary studies are typically small and may not be perceived as methodologically rigorous. The extent of publication bias within preliminary studies is unknown but can prove useful to determine whether preliminary studies appearing in peer-reviewed journals are fundamentally different than those that are unpublished. The purpose of this study was to identify characteristics associated with publication in a sample of abstracts of preliminary studies of behavioral interventions presented at conferences. METHODS: Abstract supplements from two primary outlets for behavioral intervention research (Society of Behavioral Medicine and International Society of Behavioral Nutrition and Physical Activity) were searched to identify all abstracts reporting findings of behavioral interventions from preliminary studies. Study characteristics were extracted from the abstracts including year presented, sample size, design, and statistical significance. To determine if abstracts had a matching peer-reviewed publication, a search of authors' curriculum vitae and research databases was conducted. Iterative logistic regression models were used to estimate odds of abstract publication. Authors with unpublished preliminary studies were surveyed to identify reasons for nonpublication. RESULTS: Across conferences, a total of 18,961 abstracts were presented. Of these, 791 were preliminary behavioral interventions, of which 49% (388) were published in a peer-reviewed journal. For models with main effects only, preliminary studies with sample sizes greater than n = 24 were more likely to be published (range of odds ratios, 1.82 to 2.01). For models including interactions among study characteristics, no significant associations were found. Authors of unpublished preliminary studies indicated small sample sizes and being underpowered to detect effects as barriers to attempting publication. CONCLUSIONS: Half of preliminary studies presented at conferences go unpublished, but published preliminary studies appearing in peer-reviewed literature are not systematically different from those that remain unpublished. Without publication, it is difficult to assess the quality of information regarding the early-stage development of interventions. This inaccessibility inhibits our ability to learn from the progression of preliminary studies.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study).

BACKGROUND: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-2015, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. METHODS: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. RESULTS: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. CONCLUSIONS: A future RCT of the coMforT TS-MBCT intervention should have an internal pilot, recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. TRIAL REGISTRATION: ISRCTN64458065 11/01/2019.