Pilot and Feasibility Studies最新文献

{"title":"Group-based versus one-to-one occupational therapy to improve ADL ability in people with chronic conditions: a pilot and feasibility RCT of the Go:OT study.","authors":"Cecilie von Bülow, Signe B Bojesen, Vita Hagelskjær, Kristina T Nielsen, Eva E Wæhrens","doi":"10.1186/s40814-026-01855-1","DOIUrl":"10.1186/s40814-026-01855-1","url":null,"abstract":"<p><strong>Background: </strong>Occupational therapy interventions can improve the ability to perform activities of daily living (ADL) in individuals with chronic conditions. The group-based ADAPT program was developed as an alternative to usual one-to-one occupational therapy (UOT), aiming to enhance ADL ability through structured problem-solving processes and implementation of adaptational strategies. This pilot and feasibility study evaluated the feasibility of delivering ADAPT 3.0 in a municipal setting and informed the design of a future full-scale randomised controlled trial (RCT).</p><p><strong>Methods: </strong>A two-armed pilot RCT was conducted in a Danish municipality, comparing outcomes of ADAPT 3.0 to UOT. Eligible clients (≥ 18 years, chronic conditions, decreased ADL ability) were randomised to either intervention or control group. Outcomes included recruitment and retention, trial participation, impact on staff, access to UOT documentation, completion of outcome measures, and fidelity to the ADAPT manual. Descriptive statistics, logbook notes, and predefined progression criteria guided the evaluation.</p><p><strong>Results: </strong>Twelve clients and four ADAPT-trained occupational therapists participated. ADAPT 3.0 was delivered with high fidelity and dose. Most progression criteria were met, including access to UOT documentation and successful delivery of ADAPT 3.0. However, recruitment was slower than anticipated, and clients in the UOT group reported to receive limited trial-related information. Completion rates of follow-up evaluations were acceptable in the ADAPT group but lower in the UOT group. Minor structural and procedural challenges were identified.</p><p><strong>Conclusion: </strong>The study supports the feasibility of delivering ADAPT 3.0 in a municipal setting and progressing to a full-scale RCT. To ensure robust trial conduct, key refinements are needed in recruitment procedures, participant information for the UOT group, and clarity of outcome measures.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05775653.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13459274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148176651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participants' and physiotherapists' views on the delivery of a randomised controlled feasibility trial investigating a bespoke dynamic elastomeric fabric orthosis for women with chronic pelvic girdle pain: a qualitative exploration.","authors":"Bradley Halliday, Jennifer Freeman, Sarah Chatfield, Lee Cameron, Kirsty Carter, Jo Hosking, Jill Shawe","doi":"10.1186/s40814-026-01847-1","DOIUrl":"10.1186/s40814-026-01847-1","url":null,"abstract":"<p><strong>Background: </strong>Chronic pregnancy-related pelvic girdle pain (PPGP) affects approximately 10-30% of postpartum women beyond 3 months. Such pain is typically recalcitrant to standard care. A dynamic elastomeric fabric orthosis (DEFO) is one option. A feasibility randomised controlled trial (fRCT) assessed the feasibility and acceptability of trial design, interventions and data collection. The aim of this qualitative sub-study was to explore the experience of women participating in the feasibility trial, and physiotherapists delivering the trial intervention.</p><p><strong>Methods: </strong>An embedded qualitative study within a fRCT. The fRCT randomised participants to either control (standard care involving advice and exercise) or intervention (standard care and DEFO), across three healthcare trusts in three regions of England. Delivery of all interventions and data collection was undertaken remotely. Participants were encouraged to wear the DEFO for a maximum of 12 h a day over the 24-weeks of the trial. The qualitative approach involved online, semi-structured interviews supported by a topic guide. Data was recorded, transcribed verbatim, and analysed using thematic analysis.</p><p><strong>Results: </strong>Seven (n = 5 intervention, n = 2 control) of 24 participants recruited to the fRCT and five of the seven physiotherapists involved in the trial intervention delivery participated. Four main themes were identified: \"acceptability of trial methods\", \"intervention acceptability\", \"impact of intervention\" and \"adherence to exercise\". Data collection methods were acceptable using the web-based app. The virtual nature of the trial was acceptable; however, women and physiotherapists would have preferred at least one face-to-face intervention session. The DEFO was acceptable to women, providing them with a sense of support \"holding them together\". They felt it increased awareness of their ability to move, enabling them to be more physically active. Physiotherapists' felt the process of delivery of the DEFO was acceptable but felt the range of available exercises they could prescribe was restrictive. Physiotherapists and participants found the advice component required further development. Participants struggled to maintain adherence to the prescribed exercise programme over the 24-week period.</p><p><strong>Conclusions: </strong>The remote trial procedures and interventions were generally acceptable to both participants and physiotherapists, supporting the overall trial design and implementation, but a future design should incorporate an in-person treatment component. The participant's experiences and suggestions will be considered in the design and delivery of a future definitive trial.</p><p><strong>Trial registration: </strong>ISRCTN67232113.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13455307/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148163963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility and impact of personalized therapy for obstructive sleep apnea in patients with acute coronary syndrome: a pilot randomized controlled trial.","authors":"Benjamin K Tong, Glenn M Stewart, Hasthi Dissanayake, Anna Mohammadieh, Peter A Cistulli","doi":"10.1186/s40814-026-01849-z","DOIUrl":"10.1186/s40814-026-01849-z","url":null,"abstract":"<p><strong>Background: </strong>Recent neutral randomized controlled trials have created clinical equipoise around the treatment of obstructive sleep apnea (OSA) for the secondary prevention of cardiovascular disease. These findings are in part limited by poor compliance, lack of treatment optimization and personalization strategies with OSA therapy. This pilot study aims to assess the feasibility and impact of a personalized OSA treatment program on therapy compliance and cardiovascular health in patients with acute coronary syndrome (ACS) diagnosed with OSA.</p><p><strong>Methods: </strong>Patients with ACS and OSA (oxygen desaturation index 3% > 10 events/hour) will be recruited and randomized to receive either personalized OSA therapy (PT) or usual care (UC) with six-month follow-up. The PT group will receive standard medical care for ACS plus the choice of continuous positive airway pressure and/or mandibular advancement device therapy for OSA. Treatment optimization strategies including treatment acclimatization, augmented support and patient engagement tools will be implemented. The UC group will receive standard medical care for ACS but no treatment for OSA. The primary outcome is the feasibility of personalized treatment for OSA assessed by study and treatment acceptance, and treatment compliance. Secondary outcomes include treatment effectiveness, cardiovascular health markers and patient reported outcomes across the six-months intervention.</p><p><strong>Discussion: </strong>This study will provide novel findings on the impact of personalized and optimized OSA therapy on patient compliance, preliminary treatment effectiveness and health outcomes in patients with established cardiovascular disease. Such novel data will inform the design and delivery of future large scale randomized clinical trials to assess cardiovascular disease benefit in patients with OSA.</p><p><strong>Trial registration: </strong>ACTRN 12620000050954. Registered 22 January 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378536&isReview=true .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148163958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual GERAS DANcing for Cognition Exercise (DANCE) for older adults at home: a randomized feasibility trial.","authors":"Patricia Hewston, Caroline Marr, Ali Dashti, George Ioannidis, Courtney C Kennedy, Genevieve Hladysh, Joye St Onge, Sharon Marr, Steven R Bray, Michael Noseworthy, Lehana Thabane, Alexandra Papaioannou","doi":"10.1186/s40814-026-01851-5","DOIUrl":"10.1186/s40814-026-01851-5","url":null,"abstract":"<p><strong>Background: </strong>Background GERAS DANcing for Cognition and Exercise (DANCE) was developed with rehabilitation and geriatric medicine expertise for older adults (age 60 +) looking to improve brain health or mobility. This trial aimed to assess the feasibility, acceptability, and safety of delivering virtual GERAS DANCE to older adults in a home-based setting.</p><p><strong>Methods: </strong>A single-center, prospective, parallel-group randomized feasibility trial was conducted to assess the feasibility of virtual GERAS DANCE. Fifty older adults were randomized to the virtual GERAS DANCE intervention group or a control group receiving usual care. The progressive dance curriculum was live-streamed with videoconference by a certified GERAS DANCE instructor in 1-h sessions held twice weekly for 6 weeks. Participants used their personal tablets, desktop computers, and laptops. Feasibility was evaluated based on predefined criteria, including process measures (e.g., recruitment and retention rates), outcome measures, resource utilization, and the acceptability of the intervention to participants.</p><p><strong>Results: </strong>One hundred ninety three of 206 individuals met the eligibility criteria, indicating that the inclusion criteria were well-defined and suitable for the target population. The enrollment-to-screening ratio was 25:103, with recruitment completed in 8 weeks. Fifty older adults were randomized, and 46 completed baseline assessments (mean age = 75.02(5.89) years, range 63-92, 92% female). Twelve percent of participants (6 out of 50) required phone support to access the virtual GERAS DANCE classes due to device or Zoom navigation issues. The retention rate was 84%, with participants attending an average of 78% of the virtual classes. Ninety percent of participants rated the program as good to excellent, and 93% felt it provided the right level of challenge. The program was delivered with high fidelity, maintaining consistent, high-quality sessions and adhering to the standardized curriculum. Outcome assessments were completed by 46/50 (92%) participants, with an average duration of 41 min, well below the 60-min target. There were no adverse events related to the program.</p><p><strong>Conclusions: </strong>Pre-determined thresholds for feasibility were met for all outcomes. This study demonstrates that virtual GERAS DANCE is feasible, well accepted, and safe for older adults, laying the groundwork for a future definitive trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05202522.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13455421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148164015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The reporting of CONSORT items and key feasibility elements in pilot and feasibility studies in hip and knee arthroplasty is suboptimal: a methodological survey.","authors":"Zinnia Chung, Leigh-Ann Grant, Lawrence Mbuagbaw, Lipalo Mokete, Mohit Bhandari, Lehana Thabane","doi":"10.1186/s40814-026-01859-x","DOIUrl":"10.1186/s40814-026-01859-x","url":null,"abstract":"<p><strong>Background: </strong>As the global demand for hip and knee arthroplasty procedures grow, advancements in orthopedic research are vital for progress. Pilot and feasibility trials play a critical role in optimising research efficiency, highlighting methodological gaps, and maximising study insights. However, the completeness of reporting in hip and knee arthroplasty pilot and feasibility trials remains unclear.</p><p><strong>Objectives: </strong>The primary objective was to evaluate reporting completeness, assessed using the CONSORT checklist extension to pilot and feasibility trials. Secondary objectives included evaluating the reporting of key feasibility items and exploring factors associated with reporting completeness.</p><p><strong>Setting and methods: </strong>This methodological survey analysed pilot and feasibility trials in hip and knee arthroplasty. A PubMed search identified relevant manuscripts published between January 1, 2017, and December 31, 2023. A minimum acceptable sample size of 147 (of 278 eligible) was identified, based on a calculation involving an estimated reporting completeness of 25% of the CONSORT checklist, a 95% confidence interval, and a 5% margin of error. Descriptive statistics were reported, and a multivariable linear regression with robust (HC1) standard errors was completed.</p><p><strong>Results: </strong>Of 278 eligible publications identified from PubMed, a random sample of 147 studies was included. Reporting completeness was low, with studies accounting for a mean of 54.98% (16.95) of applicable CONSORT extension items. Notably, pilot-specific objectives and future study implications were often underreported. Similarly, manuscripts missed approximately 71.35% (10/14) of key feasibility elements. Studies that referenced reporting guidelines in the manuscript text were associated with better reporting, while those that failed to disclose their funding sources and lacked more key feasibility items demonstrated weaker reporting completeness.</p><p><strong>Conclusion: </strong>Hip and knee arthroplasty pilot and feasibility trials exhibit suboptimal reporting completeness with several missing feasibility elements. Improved adherence to CONSORT guidelines and enhanced transparency are needed.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148157281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Richards Trauma Process: a before-after single-arm feasibility trial of a novel psychotherapy.","authors":"Petrina Barson, Peter MacIsaac, Lena Sanci, Meredith Temple-Smith, Judy Trevena, Adrian Laughlin, Patty Chondros","doi":"10.1186/s40814-026-01856-0","DOIUrl":"10.1186/s40814-026-01856-0","url":null,"abstract":"<p><strong>Background: </strong>The Richards Trauma Process (TRTP) is a novel, very brief transdiagnostic psychotherapy that uses innovative methods to work with parts of the self to reprocess traumatic memories without using exposure techniques. Our objectives were to explore the feasibility of studying this therapy in a community setting, to document the safety and acceptability of TRTP, and to gather preliminary indications of outcomes in adults presenting with elevated levels of psychological distress.</p><p><strong>Methods: </strong>This was a before-after single-arm trial of TRTP in consecutive new adult clients presenting to a psychotherapist in Australia. Inclusion criteria were at least mildly elevated levels of depression, anxiety, stress or trauma symptoms; no previous diagnosis of psychosis, Bipolar Disorder or Personality Disorder; and ability to maintain sobriety during the therapy. Feasibility was assessed against 15 criteria relating to 5 broad objectives, evaluating: (1) recruitment and retention capability, (2) data collection procedures, (3) resourcing, (4) acceptability and safety of TRTP, and (5) change in scores. Regarding objective 5, we estimated the mean change in scores on the Depression, Anxiety and Stress Scales (DASS21) and PTSD Checklist for DSM-5 (PCL-5) between follow-up and baseline; and to check for harms (objective 4) we used descriptive statistics to look for clinically meaningful deterioration in individual scores or participants.</p><p><strong>Results: </strong>Of 40 new clients, 23 (58%; 95% Confidence Interval (CI) 41% to 73%) were eligible, consented to the study and commenced TRTP. Of these, 20 (87%; 95% CI 65% to 97%) completed TRTP (averaging six hours of therapy) and follow-up 1-month post-therapy. Eleven of 15 feasibility criteria were met. Unmet criteria could be addressed in a future efficacy trial by modifications to study procedures. All mean scores changed in the desired direction, with no individual scores or participants demonstrating clinically meaningful deterioration.</p><p><strong>Conclusions: </strong>This is the first study that supports the feasibility of a larger trial of TRTP in a community setting. We demonstrated that recruitment and retention of participants, and data collection, were feasible, and that the intervention was acceptable, safe, and worthy of further study. Learnings for a future trial were identified.</p><p><strong>Trial registration: </strong>Retrospectively registered with The Australian and New Zealand Clinical Trials Registry (ACTRN12625001423404).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148163970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DECIDE for MOM Provider Training to improve healthcare providers' competency in engaging and communicating with perinatal individuals: protocol for a non-randomized feasibility study.","authors":"Christina D Kang-Yi, Ora Nakash","doi":"10.1186/s40814-026-01857-z","DOIUrl":"10.1186/s40814-026-01857-z","url":null,"abstract":"<p><strong>Background: </strong>Appropriate perinatal mental health care is an important public health concern as mental health disorders are common pregnancy complications. Perinatal and mental health care providers' competencies in meeting mental health needs of perinatal individuals can increase access to appropriate mental health care. Despite the importance, perinatal and mental health care providers report discomfort in treating perinatal individuals with mental health needs due to the lack of evidence-based guidance for mental health treatment decisions, differences in beliefs and attitudes, and concerns about adverse effects on mental health and pregnancy outcomes. The proposed study aims to adapt the DECIDE provider training to improve care providers' competencies in effectively engaging and communicating with perinatal individuals for shared decision making across pregnancy and postpartum stages in perinatal care settings. DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution.</p><p><strong>Methods: </strong>The proposed study with a single-arm prospective design will make content adaptation (i.e., adding topical training content to fit perinatal mental health care) and process adaptation (i.e., creating asynchronous training modules to reduce the burden for care providers) to the DECIDE provider training. The acceptability, appropriateness, and usability of adapted DECIDE provider training for wide dissemination and rapid implementation in health systems will be assessed.</p><p><strong>Discussion: </strong>DECIDE teaches healthcare providers skills for perspective-taking, reducing attributional errors, and increasing receptivity to the client population. An adapted DECIDE provider training is expected to be an effective guiding tool for perinatal and mental health providers in delivering competent care for perinatal individuals with mental health disorders. This study will determine the acceptability, appropriateness, and usability of the adapted DECIDE provider training to support high quality perinatal mental health care delivery.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT07098260. Registered on 17 August 2025. https://clinicaltrials.gov/study/NCT07098260.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449509/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148157254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A feasibility randomised controlled trial of water-only fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer.","authors":"Georgia Herbert, Clare England, Ellie Shingler, Rachel M Barker, Claire M Perks, Aidan Searle, Alex Whitmarsh, Andy Ness, Mark Saunders, Charlotte Atkinson","doi":"10.1186/s40814-026-01848-0","DOIUrl":"10.1186/s40814-026-01848-0","url":null,"abstract":"<p><strong>Background: </strong>Capecitabine and Oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer but is associated with dose-limiting toxicities. Short-term fasting may protect healthy cells from chemotherapy-related side effects via differential stress resistance. However, it is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would adhere to the intervention. The aim was to test the feasibility and acceptability of a pre-chemotherapy, 36-h, water-only fast prior to the first three cycles of chemotherapy in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer.</p><p><strong>Methods: </strong>A two-armed randomised controlled feasibility trial with an embedded qualitative interview study conducted in two NHS foundation trust hospital sites in England. Participants were randomly allocated, in a 1:1 ratio using random permuted blocks, by a secure online randomisation system, to either a 36-h fast immediately prior to chemotherapy administration or standard dietary advice. The intervention was delivered during chemotherapy cycles 1-3. Primary outcomes were adherence, recruitment, retention, data completion, and acceptability. Secondary outcomes included chemotherapy side effects, quality of life, metabolic and inflammatory markers, appetite, and sarcopenia.</p><p><strong>Results: </strong>Seventy-nine patients were screened, of whom44 were eligible. Twelve consented and were randomised (intervention: n = 6; control: n = 6). The retention rates for chemotherapy cycles 1, 2, and 3 were 100%, 83%, and 83% for the intervention group and 100%, 100%, and 100% for the control. Five out of six participants adhered to the fast. The trends observed in levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor binding proteins 2 and 3 (IGFBP-2 and IGFBP-3) were consistent with effective fasting. Qualitative findings indicated that fasting was achievable but sometimes perceived as an additional burden alongside chemotherapy. Recruitment challenges were influenced by site-level factors, including competing priorities, COVID-19-related disruptions, and perceptions of the intervention.</p><p><strong>Conclusion: </strong>The SWiFT study was feasible to deliver and adherence to the fast was high. In a future definitive trial, success in recruitment appears to depend more on specific local factors rather than the intervention being unattractive to most potential participants.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN17994717, registered 23 October 2018, https://www.isrctn.com/ISRCTN17994717.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449517/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148157163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spin reporting is common in pilot and feasibility trials in hip and knee arthroplasty: a methodological analysis of a cross-sectional sample.","authors":"Zinnia Chung, Leigh-Ann Grant, Jeslyn Chen, Lawrence Mbuagbaw, Lipalo Mokete, Lehana Thabane","doi":"10.1186/s40814-026-01846-2","DOIUrl":"10.1186/s40814-026-01846-2","url":null,"abstract":"<p><strong>Background: </strong>Pilot and feasibility trials help identify methodological and logistical challenges. However, biased reporting, known as \"spin,\" may distort overall study findings and mislead readers, presenting content through a subjective lens. Accurate assessments of feasibility are critical in orthopedic research, where the continued popularity of procedures such as hip and knee arthroplasties emphasizes a need for rapid advancement through research and development. The prevalence of spin practices among pilot and feasibility trials in hip and knee arthroplasties remains unclear. To evaluate the prevalence of spin reporting practices in pilot and feasibility trials focused on hip and knee arthroplasty. The secondary objective is to identify factors associated with the level of spin featured in the analyzed manuscripts.</p><p><strong>Methods: </strong>A search of PubMed identified 147 trials published between 2017 and 2023, selected using stratified random sampling. Studies were screened for the presence of three spin criteria defined in previous literature, and summarized descriptively.</p><p><strong>Results: </strong>Spin appeared in 88.4% of studies (95% CI 83.3-93.6). Emphasis on intervention effectiveness (81.6%) and statistical significance rather than feasibility (60.5%) were the most common types. Spin was frequent in abstracts (78.9%) and discussions (79.6%), with the highest rates also observed in privately funded (95.7%) and pharmacologic (100%) studies. No clear trend was observed over time.</p><p><strong>Conclusions: </strong>Spin is widespread in pilot and feasibility trials involving hip and knee arthroplasty, particularly in abstracts and discussions. Greater adherence to reporting guidelines and explicit communication of feasibility objectives and study limitations are necessary to improve transparency and reduce interpretive bias in this field.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13425915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148056295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pragmatic adaptive trial of hope-focused mentoring to improve mental health and social outcomes for young women who are not in education, employment or training in deprived coastal areas (The Looking Forward Project): feasibility trial stage protocol.","authors":"Clio Berry, Jessica C Bird, Stephen Bremner, Saskia Eddy, Lindsay Forbes, Julia Fountain, Paul McCrone, Charlotte Rawlinson, Jon Wilson, Daniel Michelson","doi":"10.1186/s40814-026-01852-4","DOIUrl":"10.1186/s40814-026-01852-4","url":null,"abstract":"<p><strong>Background: </strong>A large number of young women are not in education, employment, or training (NEET) in England. This group experiences poorer mental health and social outcomes than young women who work and study, and NEET young men. Gender disparities are compounded in deprived and coastal areas, where young women especially lack self-agency and aspirations. Research suggests that greater hope lowers risks of staying NEET and developing mental health problems. We co-developed a hope-focused intervention (HOPEFUL) for this group. HOPEFUL is a flexible modular programme, designed to help develop a more hopeful mindset that facilitates setting and pursuing personally meaningful goals. It is designed to be supported by a mentor, if possible selected by the participant from their existing social network. We aim to understand the feasibility of involving NEET young women and mentors in a trial of HOPEFUL conducted in coastal and adjacent local authority areas in Sussex, Kent and Medway, and East Anglia.</p><p><strong>Methods: </strong>This protocol describes the feasibility stage of an adaptive assessor-blind pragmatic randomised controlled trial (RCT) with 1:1 allocation (stratified by age group and local authority area) to (1) mentor-supported HOPEFUL plus usual support versus (2) usual support with waitlist access to HOPEFUL materials. NEET young women (aged 16-25 years) are recruited from local authority, charity and voluntary, and primary care services, as well as directly from the community using outreach, local advertising, social media, and peer networks. Our adaptive trial design incorporates a preliminary feasibility trial (N = 70) with progression to a definitive RCT (N = 248), as warranted. Feasibility outcomes (corresponding to the recruitment and retention of young women and mentors) will be assessed post-intervention (16 weeks) against pre-specified progression criteria.</p><p><strong>Discussion: </strong>Feasibility trial results will inform decisions about progression to a definitive RCT of the HOPEFUL intervention. If warranted, the latter will test whether HOPEFUL improves hope (primary outcome) and secondary outcomes (including mental health symptoms and social outcomes) compared to usual support services at 16 weeks (primary endpoint) and 12-month follow-up. We will disseminate feasibility results using tailored outputs. In the longer term, we anticipate practice impacts through scaled-up access to HOPEFUL.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13425958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148056178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}