Pilot and Feasibility Studies最新文献

{"title":"DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study.","authors":"M Mueller, M Visini, S A Mueller, T Stadler, G P Rajan, G B Morand, S-L Hool, D H Schanne, P Balermpas, A Limacher, S Chan, S Trelle, O Elicin, R Giger","doi":"10.1186/s40814-025-01651-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01651-3","url":null,"abstract":"<p><strong>Background: </strong>Around 70% of head and neck cancer (HNC) cases are diagnosed in an advanced stage. Improvements in treatment have led to a cure rate of up to 80-90% for early-stage and 40-50% for advanced-stage disease. However, routine follow-up involves social and financial burdens, including frequent imaging associated with radiation exposure and costs. Currently, there is no consensus on the follow-up strategy after HNC treatment, and no conclusive evidence shows a survival advantage for routine follow-up over symptom-driven self-referrals. The DeintensiF study aims to provide robust evidence, comparing standard follow-up with a tailored deintensified approach. Additionally, it seeks to explore whether early detection of recurrence/second primary malignancy in asymptomatic patients impacts survival and quality of life. The pilot phase aims to assess feasibility of patients' recruitment and adherence to the assigned follow-up strategy and patient-reported outcomes (PROs) questionnaire in the first 2 years.</p><p><strong>Methods: </strong>This randomized-controlled, multicenter, open-label, pilot study has the goal to randomize a minimum of 16 patients across three Swiss sites into two arms within 1 year. The Experimental Arm A: scheduled clinical exams every 6 months and monthly PRO with evaluation and possibility to alert for open urgent appointments; and the Control Arm B: regular visits every 3 months for the first 2 years and less frequent thereafter plus multiple scheduled imaging appointments for head and neck magnet resonance imaging (MRI) and computed tomography (CT) with contrast and chest CT scans. Patients' motivation for participation or not will be explored by additional questionnaire before randomization. The primary objective during the pilot phase is to evaluate the feasibility of recruiting and randomizing patients with complete remission 6 months after treatment of head and neck squamous cell carcinoma to a deintensified and to a conventional follow-up. The secondary objective is to assess adherence to the two different follow-up strategies.</p><p><strong>Discussion: </strong>If feasible, the DeintensiF pilot study will expand from the recruited patients (detailed in the \"Methods\" section) to a larger cohort of advanced HNC cases in the main trial, integrating electronic PRO tailored follow-up care. This approach aims to reshape follow-up practices, enhancing patient-centered strategies and outcomes in head and neck oncology.</p><p><strong>Trial-registration: </strong>ClinicalTrials.gov (NCT05388136); Swiss National Clinical Trial Portal (SNCTP000005198).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"69"},"PeriodicalIF":1.5,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A multidisciplinary, cross-sectorial management program for people living with hand osteoarthritis (HANDY): protocol for a feasibility study.","authors":"Ulla Andersen, Vita Hagelskjær, Cecilie von Bülow, Henrik Gudbergsen, Henning Bliddal, Anna Døssing, Eva Ejlersen Wæhrens","doi":"10.1186/s40814-025-01653-1","DOIUrl":"10.1186/s40814-025-01653-1","url":null,"abstract":"<p><strong>Background: </strong>People with hand osteoarthritis (HOA) experience difficulties performing activities of daily living (ADL). Referral for occupational therapy is rare despite support for non-pharmacological interventions by international treatment recommendations. HANDY, a multidisciplinary cross-sectorial management program for people with HOA, includes procedures for needs evaluation and referral for occupational therapy performed by general practitioners (GPs) as well as a group-based occupational therapy intervention delivered in municipal rehabilitation settings. The present study aimed to evaluate the feasibility of this first version of the HANDY program (HANDY 1.0).</p><p><strong>Methods: </strong>A feasibility study will be conducted in two municipalities and related general practices to evaluate aspects of the content and delivery of the HANDY program. In accordance with international guidelines for evaluation of feasibility, the aspects evaluated include: intervention development, intervention components, perceived values, benefits, harms or unintended consequences, acceptability in principle, feasibility and acceptability in practice, and fidelity, reach, and dose. Participants will be recruited among people with HOA when visiting their GP, GPs themselves, and occupational therapy clinicians employed in municipal rehabilitation settings. Each municipality will offer the group-based occupational therapy intervention twice, each time involving up to eight participants with HOA. Qualitative and quantitative data will be collected based on registration forms, logbooks, assessments of ADL ability, and qualitative interviews.</p><p><strong>Conclusions: </strong>This study will be the first to examine the feasibility of the content and delivery of the multidisciplinary, cross-sectorial management program HANDY for people living with HOA. It will enable us to determine whether to proceed to a pilot randomized controlled trial evaluating aspects related to trial design, conduct, and processes.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov PRS registry, registration number NCT06254105. Registered 22nd January 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06254105 . Estimated date of study completion was 28th June 2024. However, participant follow-up is still ongoing at the time of submission of the present paper.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"68"},"PeriodicalIF":1.5,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079567","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":"Results of a feasibility study of the FReSH START intervention to improve quality of life and other outcomes in people who repeatedly self-harm (Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy).","authors":"Bethan Copsey, Alexandra Wright-Hughes, Amanda Farrin, Cara Gates, Kate Farley, Cathy Brennan, Dean McMillan, Christopher D Graham, Chris Bojke, Richard Mattock, Adam Martin, Petra Bijsterveld, Judith Horrocks, Suzanne Hartley, Marsha McAdam, Dafydd Hammond-Jones, Louise D Bryant, Allan House, Elspeth Guthrie","doi":"10.1186/s40814-025-01644-2","DOIUrl":"10.1186/s40814-025-01644-2","url":null,"abstract":"<p><strong>Background: </strong>Self-harm is a major public health challenge with estimated lifetime prevalence of 5-6% and 220,000 hospital attendances annually in England and Wales. Repetition of self-harm is common with 70% of hospital attenders reporting previous self-harm. Multiple repetition bears a significant cost to individuals and healthcare systems. A recent Cochrane review showed little evidence for the benefit of existing psychological therapies for people who repeatedly self-harm. Considering multiple possible functions of self-harm, we modified three existing psychological therapies for use with people who self-harm multiple times. To inform the design of a definitive multi-centre randomised controlled trial (RCT) and assess the feasibility of an RCT, this mixed-methods feasibility study assessed intervention delivery and acceptability.</p><p><strong>Methods: </strong>A single arm (comprising three modalities), non-controlled, multi-centre feasibility trial aimed to recruit 30 participants aged 16 years or older and reporting both recent and recurring self-harm episodes. The FReSH START intervention included 12 individual sessions over a maximum 6 months comprising one of three psychological therapies, each modified specifically for use with people who have self-harmed multiple times: Cognitive Behavioural Therapy, Acceptance and Commitment Therapy, and Psychodynamic Interpersonal Therapy. Follow-up was via participant reported outcomes using postal questionnaires at 6 months and monthly text messages. A parallel qualitative study interviewed a sample of therapists and participants to refine the intervention and logic model ahead of a definitive RCT.</p><p><strong>Results: </strong>We reached our target of 30 recruited participants and 15 therapists delivered the intervention in a way that was acceptable to participants. However, follow-up rates for the 6-month questionnaire were lower than expected at 53.3% (n = 16/30). To improve follow-up, in the definitive RCT, we plan to use online questionnaires, provide vouchers and behaviourally-informed letters to incentivise questionnaire return, and include follow-up via routinely collected data. Intervention fidelity also requires some improvement in specific areas; thus we plan to amend the intervention therapist training accordingly.</p><p><strong>Conclusions: </strong>Despite disruption due to the COVID-19 pandemic, we conclude that delivery of a definitive trial of adapted psychological therapies for people who repeatedly self-harm is feasible with modifications to study processes to improve intervention fidelity and participant retention.</p><p><strong>Trial registration: </strong>ISRCTN16049211.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"67"},"PeriodicalIF":1.5,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12080260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079568","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":"Implementation of the Cognitive Daisy (COG-D) for improving care planning and delivery for residents with dementia in care homes: results of a feasibility randomised controlled trial.","authors":"Petra M J Pollux, Claire Surr, Judith Cohen, Chao Huang, Emma Wolverson, Pauline Mountain, Rebecca Clarke, Emma Hawkesford-Webb, Bethany Winter, John M Hudson","doi":"10.1186/s40814-025-01637-1","DOIUrl":"https://doi.org/10.1186/s40814-025-01637-1","url":null,"abstract":"<p><strong>Background: </strong>Many residents in care homes for older adults live with dementia. Understanding the unique profiles of cognitive impairments for each resident is important for person-centred care, yet information about specific cognitive problems is limited, and knowledge varies. This study explored the feasibility of implementing the Cognitive Daisy (COG-D) intervention, which provide a visual summary in the shape of a 15-petal flower derived from the scores on a neuropsychological assessment battery, in care homes for older adults.</p><p><strong>Methods: </strong>A parallel-group feasibility cluster randomised controlled trial (cRCT) was conducted over 24 months. Eight care homes were randomised in a 1:1 ratio to either usual care plus the Cognitive Daisy intervention (COG-D) or usual care (control). Care staff were trained on how to use Cognitive Daisies and/or on how to conduct the COG-D assessments with residents. Cognitive Daisies were displayed in residents' rooms and included in care plans. COG-D assessments were repeated after 6 months. The primary objective was to explore areas of uncertainty for a future large-scale trial including recruitment rates and intervention implementation and adherence. Secondary objectives were to explore signals of effects in candidate outcome measures for residents and staff, obtained at baseline and 6- and 9-month post-randomisation. A process evaluation explored barriers and facilitators to intervention implementation through care-plan audits (to explore recommendations in response to COG-D assessments), interviews and focus groups with staff, residents and relatives.</p><p><strong>Results: </strong>Resident recruitment (n = 115) and staff recruitment (n = 99) in 8 care homes exceeded targets (100 and 50, respectively, in 8-10 care homes). Staff training was perceived positively with high completion rates (77.1% and 83.3% for basic and advanced training, respectively). Completion rates were also high for COG-D assessments (75.5% for assessment 1, and 72.5% of these residents completed assessment 2), and COG-D scores remained stable across the two assessment points. No clear signals of effects were found for candidate outcome measures. Number of recommendations in care plans varied across care homes, and interviews/focus groups highlighted several barriers to staff's use of the Cognitive Daisies in daily practice.</p><p><strong>Conclusion: </strong>Findings indicate trial delivery was feasible. However, the COG-D requires modification if it is to be feasibly implemented in care home settings.</p><p><strong>Trial registration: </strong>This trial was registered on (date) (ISRCTN15208844).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"66"},"PeriodicalIF":1.5,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12065304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144035666","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":"Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas.","authors":"Carolyn Y Fang, Marisol Cora-Cruz, Pratistha Koirala, Sophia Perez, Minzi Li, Brian L Egleston, Yuku Chen, Gina Mantia-Smaldone, Omar Martinez","doi":"10.1186/s40814-025-01648-y","DOIUrl":"https://doi.org/10.1186/s40814-025-01648-y","url":null,"abstract":"<p><strong>Background: </strong>Rates of cervical cancer incidence and mortality are persistently higher among Latina women in the continental United States (US) and women in Puerto Rico (a US territory) compared with non-Hispanic White (NHW) women. Multiple factors contribute to low participation in cancer screening, including structural barriers (e.g., low access to healthcare services, racism/discrimination, lack of culturally and linguistically adequate information), cultural concerns, and low perceived risk and awareness of cervical cancer. Although community-based education and navigation support can be effective in overcoming some barriers to screening, structural barriers and limited access remain formidable challenges to overcome. Emerging technologies supporting self-sampling for high-risk human papillomavirus (HPV) testing may offer a valuable evidence-based strategy for empowering Latina women to engage in cervical cancer screening. Thus, the objective of this study is to assess the feasibility and acceptability of a novel HPV self-sampling intervention for underscreened Latina women.</p><p><strong>Methods: </strong>The study will be a randomized controlled feasibility trial involving 100 Latina women who have not received cervical cancer screening within the recommended guidelines. Participants will be randomly assigned to the intervention condition, which includes a synchronous three-session group cervical cancer educational program delivered virtually along with a mailed HPV self-sampling kit (to obtain self-collected cervical samples for HPV testing), or to a comparison condition that involves receipt of the mailed HPV self-sampling kit with written information about cervical cancer screening and nearby clinics. Study assessments will be obtained at baseline (i.e., study entry) and 1-month post-program. The primary outcome of feasibility will be measured through study enrollment and intervention completion. In addition, acceptability of study materials and the self-sampling procedures will be assessed using self-report surveys at 1-month post-program.</p><p><strong>Discussion: </strong>Provision of a mailed HPV self-sampling kit may present new options for encouraging participation in cervical cancer screening among underscreened Latina women. This study will evaluate the feasibility and acceptability of such an approach, which will inform the subsequent design of a full-scale randomized trial to assess intervention effectiveness on screening behavior.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov no. NCT06439706. Registered 28 May 2024 - retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"65"},"PeriodicalIF":1.5,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12065264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028760","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":"Rationale and protocol of the LEAD 2.0 study: a randomized controlled trial assessing the feasibility of a virtually delivered 6-month exercise and nutrition intervention in older adults with subjective cognitive decline (SCD).","authors":"Bobby Neudorf, Noah Koblinsky, Krista Power, Malcom Binns, Alexandra J Fiocco, Shlomit Rotenberg, Susan Marzolini, Paul Oh, Jane Thornton, Fatim Ajwani, Kylie Sullivan, Stéphanie Chevalier, Caryl Russell, Guylaine Ferland, Nicole D Anderson, Laura E Middleton","doi":"10.1186/s40814-025-01626-4","DOIUrl":"https://doi.org/10.1186/s40814-025-01626-4","url":null,"abstract":"<p><strong>Background: </strong>With growing prevalence of dementia worldwide, dementia risk reduction is a key interest of the World Health Organization's Global Dementia Action Plan. Subjective cognitive decline (SCD) is a prominent predictor of future dementia diagnosis. Therefore, people with SCD are an important group for dementia prevention intervention. Exercise and healthy diet are associated with a 30-60% decrease in dementia risk in longitudinal studies. Technological advances yield the potential of trials that deliver lifestyle interventions virtually, reaching people in a wide geographical spread. However, the feasibility of large-scale virtual trials still needs to be established.</p><p><strong>Objective: </strong>This trial aims to examine the feasibility of a factorial randomized controlled trial exploring a 6-month virtual, exercise and healthy diet intervention. Secondary objectives will examine whether feasibility outcomes vary by gender or technology access.</p><p><strong>Methods: </strong>We will recruit 140 older adults (65 + years) with SCD, who will receive a combination of Aerobic and Resistance Exercise (EX) or Stretching and Toning (STRETCH) and either Diet Counseling (DIET) or Brain Health Education (ED). Participants will be randomized to four weekly hours of one of four intervention arms: (1) EX and DIET; (2) EX and ED; (3) STRETCH and DIET; or (4) STRETCH and ED. EX will include moderate intensity aerobic and resistance training. DIET will instruct participants in brain healthy food choices. Assessments will be performed virtually at baseline, 6 months (post-intervention), and 12 months. Feasibility will be measured by recruitment rate, adherence, and retention.</p><p><strong>Discussion: </strong>Established feasibility will set the stage for a definitive trial. Feasibility results will also inform future virtual programs/services. In the long-term, if the interventions are feasible and beneficial, this intervention model could scale up and spread quickly to reach at-risk individuals for the purpose of dementia risk reduction.</p><p><strong>Trial registration: </strong>The Lifestyle, Exercise, and Diet (LEAD 2.0) study is registered with the US National Institutes of Health clinical trials registry (ClinicalTrials.gov identifier NCT06078748). This report complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"64"},"PeriodicalIF":1.5,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12065297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144063604","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":"Rationale for a 4-month, parallel-group, randomized controlled trial to assess the Feasibility and Efficacy of a Remotely delivered exercise training intervention for Hispanics/Latinos with Multiple Sclerosis (FERLA MS).","authors":"Victoria A Flores, Stephanie L Silveira, David X Marquez, Dominique Kinnett-Hopkins, Augusto Miravalle, Fabian Sierra-Morales, Zulma Hernández-Peraza, Robert W Motl","doi":"10.1186/s40814-025-01641-5","DOIUrl":"https://doi.org/10.1186/s40814-025-01641-5","url":null,"abstract":"<p><strong>Background: </strong>Hispanic/Latino individuals with multiple sclerosis (MS) face greater disease burden and comorbidity due to limited healthcare access, underrepresentation in research, and social determinants of health (SDOH). Exercise training could manage health outcomes, but existing intervention research lacks Hispanic/Latino representation.</p><p><strong>Methods: </strong>We propose a feasibility and efficacy study of a theory-based, remotely delivered exercise training intervention for enhancing health outcomes in Hispanics/Latinos with MS. This study involves a randomized controlled trial (RCT) design and compares an MS-specific exercise training program with an active control condition over a 4-month period in a sample of 50 individuals who self-identified as Hispanic/Latino with MS. The sample will be recruited through MS networks and healthcare organizations serving a high proportion of Hispanics/Latinos with MS. The primary outcomes include feasibility metrics (i.e., process, resources, management, and scientific), secondary outcomes include potential effects of the exercise training program on health-related outcomes (i.e., physical and cognitive function, MS symptoms, and quality of life), and tertiary outcomes include the potential association of SDOH on feasibility and intervention efficacy on health-related outcomes.</p><p><strong>Discussion: </strong>The anticipated results of this study will provide evidence for the feasibility and initial efficacy of a remote exercise training intervention for Hispanics/Latinos with MS, a demographic often facing significant barriers to healthcare and rehabilitation. This research lays the groundwork for a fully powered RCT to support the efficacy of the approach and subsequent wider implementation. If successful, this project may significantly improve health and MS disease outcomes for Hispanics/Latinos with MS.</p><p><strong>Protocol version: </strong>April 7, 2025, Version 2; World Health Organization Trial Registration Data Set (see Appendix 1); SPIRIT Checklist (see Appendix 2).</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT05998616).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"62"},"PeriodicalIF":1.5,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060554/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144042023","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 feasibility of conducting a randomized controlled trial that compares immediate versus optional delayed surgical repair for treatment of acute Anterior cruciate ligament injury-results of the IODA pilot trial.","authors":"Feryal Ghafelzadeh Ahwaz, Annemie Smeets, Stijn Bogaerts, Pieter Berger, Koen Peers","doi":"10.1186/s40814-025-01652-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01652-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Standard care for anterior cruciate ligament (ACL) injuries often includes surgical reconstruction of the ACL. However, two randomized controlled trials (RCT) concluded that conservative treatment does not result in inferior clinical outcomes compared to immediate ACL reconstruction. More research is needed to verify these results and to assess whether patient-specific parameters can predict whether a patient would benefit from immediate surgery or conservative treatment. However, before running such an RCT, we performed this pilot study to assess the feasibility of recruiting patients for such an RCT.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a pragmatic, multicenter, randomized, controlled pilot trial with two parallel groups funded by the Belgian Health Care Knowledge Centre (KCE trials). Patients with an acute ACL injury were recruited from two Belgian hospitals. They were randomized to either conservative treatment (e.g., rehabilitation with optional delayed surgery in case of persistent instability) or immediate surgery (&lt; 12 weeks post-injury). The primary aim of this pilot study was to assess the feasibility of participant recruitment. Furthermore, we evaluated adherence to the protocol and the allocated treatment arm and the feasibility of recruiting a representative sample of ACL patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Out of the initial 70 screened patients, 29 were included in the pilot study, 15 were randomized in the conservative treatment group, and 14 were in the surgical treatment group. This yielded a recruitment rate of 41%. However, the investigators could not screen many potential patients due to inadequate referrals within the recruiting hospitals. Seven cross-overs were observed between the treatment arms: 3 patients who were assigned to the conservative treatment group insisted on immediate surgery, while four patients allocated to immediate surgery chose not to undergo surgery. Of the initial 29 patients, 5 dropped out after randomization. The recruited sample confirmed the typically young and physically active sample of ACL patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot study confirmed the challenging recruitment process for an RCT that compares a surgical and a non-surgical treatment option. While encountering substantial recruitment challenges, our pilot study revealed that transitioning to a full-scale RCT is feasible, with some essential modifications. Key adjustments encompassed augmenting the number of participating sites, optimizing patient recruitment processes, and extending the recruitment period. Furthermore, this study showed a high completion rate, affirming the feasibility of the study protocol. However, there was a high cross-over rate (7/29 patients) between treatment arms. This should be avoided when progressing to the full trial. The recruited sample reflects a young and active population, which represents the ACL population well.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registratio","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"63"},"PeriodicalIF":1.5,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976433","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":"Quantitative results of SonoSpeech Cleft Pilot: a mixed-methods pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip.","authors":"Maria Cairney, Lisa Crampin, Linsay Campbell, Joanne Cleland","doi":"10.1186/s40814-025-01640-6","DOIUrl":"https://doi.org/10.1186/s40814-025-01640-6","url":null,"abstract":"<p><strong>Background: </strong>Despite its growing popularity, there is limited evidence of the effectiveness of ultrasound visual biofeedback speech therapy for children with cleft palate ± cleft lip (CP ± L). This study reports on the findings of a pilot feasibility study of ultrasound visual biofeedback versus standard care. Results will be used to determine if a full-scale randomised controlled trial (RCT) is feasible.</p><p><strong>Methods: </strong>We used a mixed-methods pilot RCT. Participants were children aged 5-16 with repaired CP ± L and at least one compensatory articulation. Participants were randomised, stratified for age, to receive six sessions of either articulation therapy (standard care) or ultrasound visual biofeedback (U-VBF) therapy. Outcome indicators for progression to full trial were measured as percentage targets achieved including the following: participants recruited and retained; outcome measure completion; and therapy protocol adherence. Due to the nature of treatment, the treating Speech and Language Therapists (SLTs) and families were not blinded; however, the assessing SLTs were blinded to treatment allocation until the end of the trial.</p><p><strong>Results: </strong>Eight participants were randomised to articulation therapy and eleven to ultrasound. All participants' data was included for analysis. All but one of the pre-determined criteria for moving to full trial were fully met and the remaining indicator was partially met. At least 75% of the following were achieved: outcome measure completion; therapy protocol adherence; participant retention in each arm of the study. The target number of participants, 20 per treatment arm, was not reached.</p><p><strong>Conclusion: </strong>Most feasibility measures were successful. This study suggests that a full RCT comparing articulation therapy to U-VBF therapy would be possible if the current recruitment strategy is addressed.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN17441953. Registered 22 March 2021.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"61"},"PeriodicalIF":1.5,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976430","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":"\"Take-home\" functional electrical stimulation for depression: protocol for a prototype development and proof of concept randomized controlled trial.","authors":"Fatemeh Gholamali Nezhad, Vanessa K Tassone, Ilya Demchenko, Jia Xi Mary Chen, Stephanie N Iwasa, Josh Martin, Naaz Desai, Hani E Naguib, Milos R Popovic, Venkat Bhat","doi":"10.1186/s40814-025-01642-4","DOIUrl":"https://doi.org/10.1186/s40814-025-01642-4","url":null,"abstract":"<p><strong>Background: </strong>One-third of patients with major depressive disorder (MDD) will not achieve a clinically meaningful response to available conventional treatments. More effective neurostimulation treatments are difficult to access and are associated with high hospital delivery costs. Patients would benefit from more efficacious and well-tolerated home-based neurostimulation treatments, which could be self-administered at a frequency required to treat MDD, maintain response, and reduce relapse. A potential novel intervention for MDD is bilateral functional electrical stimulation (FES) of the facial muscles. The portable FES stimulator delivers electrical current to excitable tissues and is suitable for home-based use. Based on the preliminary work demonstrating the feasibility of FES for MDD, the proposed study will develop a viable prototype for a \"take-home\" FES device and perform a proof-of-concept feasibility trial for participants with MDD.</p><p><strong>Methods: </strong>This is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial, where 20 participants will receive 20 sessions of FES over 4 weeks. The trial will evaluate the feasibility, tolerability, and safety of home-based FES for MDD. We will also collect data on the preliminary therapeutic effects of FES on depressive symptoms and associated anxiety, quality of life, and sleep. Eligible participants will have three on-site visits including one mask development visit, one mask delivery visit, and one follow-up visit at the end of the study. They will also attend 25 online visits including a screening visit, a baseline visit, 20 days of FES treatment (sham or active), and three post-stimulation follow-up visits.</p><p><strong>Discussion: </strong>Data obtained from this trial will be used to optimize the home-based FES prototype and design a follow-up, multi-site, large-scale randomized control trial to assess the effectiveness of take-home FES. The existing evidence suggests that FES of the facial muscles can reduce MDD symptoms by enhancing positive facial feedback and altering the interoceptive bias associated with MDD, but its exact mechanism of action is still under debate. Additional trials with neuroimaging outcomes are needed to elucidate the mechanism of action of FES and the corresponding changes in the central nervous system.</p><p><strong>Trial registration: </strong>This trial has been registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT06261177 . Registered on January 4, 2024).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"60"},"PeriodicalIF":1.5,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049065/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025263","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}