Pilot and Feasibility Studies最新文献

{"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":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 (< 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>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}

{"title":"A coadapted community-based participatory group programme for parents/carers of children with complex neurodisability (Encompass-2): a pilot and feasibility study protocol.","authors":"Kirsten Prest, Angela Harden, Kirsten Barnicot, Michelle Heys","doi":"10.1186/s40814-025-01619-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01619-3","url":null,"abstract":"<p><strong>Background: </strong>Parents/carers of children with complex neurodisability continue to lack appropriate family-centred care. \"Encompass\" is a community-based group programme that was co-adapted from \"Baby Ubuntu\" in Uganda. It is an example of a \"decolonised healthcare innovation\" as it is a low-cost solution from a low-income country for use in a resource-constrained UK National Health Service (NHS).</p><p><strong>Methods and analysis: </strong>We will conduct a mixed-methods pilot feasibility study to determine the feasibility and acceptability of delivering and evaluating \"Encompass\" with parents/carers of children under 5 years with complex neurodisability in the UK. We aim to recruit 20 parents/carers of children from two NHS trusts in England serving urban areas where there is high social deprivation and ethnic diversity. Recruited parents/carers will attend the 10-modular, participatory group programme over a 6-month period. Groups will be facilitated by a trained allied health professional and an \"expert parent\" with lived experience. The primary outcomes of interest are the feasibility of delivering and evaluating the programme (recruitment, retention rates, acceptability as perceived by the parents/carers, facilitators and wider key NHS partners), intervention fidelity and participant adherence. Results will be collectively assessed against traffic light criteria. Pre-, post- and follow-up data collection questionnaires will include the Family Empowerment Scale (FES), the Power Ladder Question, the Parent Patient Activation Measure (P-PAM), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), EuroQoL-5D-5-level (EQ-5D-5L) and parent/carer greatest needs and goals questionnaire. Post-intervention semi-structured interviews will be conducted with parents/carers, facilitators and key NHS partners.</p><p><strong>Discussion: </strong>A community-based participatory group programme is a potentially affordable and sustainable way for the NHS to provide family-centred support. The programme aims to improve outcomes for parents/carers of children with complex neurodisability. Example outcomes include knowledge, skills, confidence, wellbeing and quality of life. The programme also provides opportunities for peer support and aims to empower parents/carers in navigating community health systems.</p><p><strong>Registration: </strong>The protocol is registered on clinical trials.gov (ID: NCT06310681).</p><p><strong>Ethical approval: </strong>Health Research Authority ref. 23/EM/0213.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"59"},"PeriodicalIF":1.5,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028719","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":"iSupport for rare dementias: a mixed-methods non-randomised feasibility study of an online self-help programme for carers.","authors":"Bethan Naunton Morgan, Gill Windle, Carolien Lamers","doi":"10.1186/s40814-025-01639-z","DOIUrl":"https://doi.org/10.1186/s40814-025-01639-z","url":null,"abstract":"<p><strong>Background: </strong>iSupport for dementia carers is an online education and self-care programme developed by the World Health Organisation for carers of people with the most common forms of dementia (Alzheimer's disease and vascular dementia). iSupport for rare dementias (RDC) is the first adaptation designed specifically to address the challenges faced by carers of individuals with rare dementias (frontotemporal dementia, posterior cortical atrophy, primary progressive aphasia or Lewy body dementia).</p><p><strong>Methods: </strong>A 12-week mixed-methods non-randomised feasibility study assessed the feasibility of recruitment and participant retention, the feasibility of outcome measures and the acceptability of iSupport RDC. Participants were recruited through the Rare Dementia Support Network (target N = 30). Data were collected through online interviews and self-report, including pre and post-intervention measures of depression, anxiety, burden and resilience. A modified version of the NoMAD questionnaire evaluated acceptability of implementation. Scores range from 0 to 4 with > / = 2.5 indicating acceptability. Usability was assessed through self-report and data from Blackboard.</p><p><strong>Results: </strong>Thirty-four (13 males and 21 females) carers of people with frontotemporal dementia, posterior cortical atrophy, primary progressive aphasia or Lewy body dementia consented to the study and given access to iSupport RDC, hosted online by Blackboard Learn. Their ethnicity was reported as white and their mean age was 64.2 (range 35-86). N = 24 completed pre and post outcome measures, N = 10 completed pre-intervention and then withdrew, n = 4 reporting technical difficulties (70.6% completion rate). There were no missing responses. N = 20 completed 3 of the 5 iSupport RDC modules; n = 13 completed five. N = 4 could not access due to technical difficulties. Technical difficulties meant the data from Blackboard Learn were not obtained. The NoMAD total score (3.5) indicated iSupport RDC was acceptable. Qualitative analysis from n = 19 participants revealed themes of 'technical difficulties' (n = 10), 'useful and informative' (n = 7), and 'provide at point of diagnosis' (n = 5).</p><p><strong>Conclusions: </strong>Recruitment targets were met but there were limitations in sample diversity. The extent of attrition warrants strategies to ensure retention to future studies, including testing online interventions on different internet browsers and operating systems. The favourable response to iSupport RDC from the participants indicates its potential as a valuable resource for supporting carers dealing with rare dementias.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"58"},"PeriodicalIF":1.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12042611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037137","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 usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study.","authors":"Norna Abbo, Trina Mitchell, Seyed Hassan Tonekaboni, Evdokia Anagnostou, Brendan F Andrade, Kevin Thorpe, Deryk S Beal","doi":"10.1186/s40814-025-01650-4","DOIUrl":"https://doi.org/10.1186/s40814-025-01650-4","url":null,"abstract":"<p><strong>Background: </strong>Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social communication and self-regulation impairments. Impaired response inhibition and self-regulation in ASD have been shown to be related to abnormal functional network connectivity in the dorsolateral prefrontal cortices (DLPFC). Transcranial direct current stimulation (tDCS) of DLPFC is a safe, tolerable, and precise intervention that has shown promise for the improvement of self-regulatory behavior in ASD. However, clinical translation has been prevented by a lack of effective systematic design, experimental control, and a high participation burden. The proposed protocol aims to evaluate the feasibility and usability of home-based tDCS to promote self-regulation in children with ASD.</p><p><strong>Methods: </strong>Participants will be randomized into an active or sham tDCS group and will receive 20 min of stimulation 5 days per week for 3 weeks. Participants in the sham group receive a negligible amount of stimulation. Sessions will be virtually supported by the study team. Assessments are taken at baseline, 1-week post-treatment, and 18 weeks post-treatment. These assessments include clinical measures of self-regulation and social communication (participant-, parent-, and clinician-reported), a response inhibition task, and magnetic resonance imaging. Recruitment, retention, and adherence rates will be used to assess the feasibility of the protocol. The usability of the remote tDCS device will be assessed via a usability survey, user interviews, and video analysis of device use.</p><p><strong>Discussion: </strong>Home-based tDCS may benefit children by providing an efficient, passive, and tolerable treatment that positively impacts function, activities, and participation. This study will identify potential challenges for the clinical translation of this therapy so that home-based tDCS can be positioned for success in healthcare delivery implementation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06129058. Registered on November 8, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"57"},"PeriodicalIF":1.5,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037945","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":"Investigating the feasibility of an 8-week mindful breathing programme on breathlessness and self-efficacy in chronic obstructive pulmonary disease: an open-label study.","authors":"Shirley Harris, Jennifer Jordan, Amanda Wilkinson, Philippa Seaton","doi":"10.1186/s40814-025-01649-x","DOIUrl":"https://doi.org/10.1186/s40814-025-01649-x","url":null,"abstract":"<p><strong>Background: </strong>High prevalences of anxiety and depression have been found in those with COPD which can exacerbate physically related impacts of increased levels of disability, and reduced enjoyment of life. Of particular concern is the anxiety-breathlessness cycle and reduced self-efficacy, which both adversely affect self-management of symptoms. Recognition of the need to address these issues has led to use of adjunctive psychologically based therapies including mindfulness. Standard mindfulness programmes have been found to be helpful in promoting a less distressing view of breathlessness and increasing self-efficacy in self-management; however, they can be difficult to access due to significant time commitments and need to travel for groups. This study examines a novel, portable, flexible mindfulness intervention for breathlessness that can be self-delivered in the person's home, enabling access to a potentially effective intervention to improve self-efficacy in COPD self-management. The primary aim of this study is to establish the feasibility of delivery of this intervention in terms of uptake and retention in the study, adherence to, and acceptability of the MBI. The secondary aim is to obtain preliminary estimates regarding change in self-efficacy in managing COPD.</p><p><strong>Methods: </strong>This mixed method pre-post-study with 3-month follow-up will assess feasibility of recruitment, acceptability, and report preliminary descriptive data regarding this novel mindful breathing intervention (MBI) in up to 30 adults with COPD. A secondary outcome measure is change in the COPD self-efficacy scale. Other self-report measures include the St. Georges Chronic Respiratory Disease Questionnaire, Five Facet Mindfulness Questionnaire, Hospital Anxiety and Depression Scale, the EQ-5D-5L, and a daily diary recording breathlessness and mindfulness practice. Descriptive statistics and pre-post-change scores will be reported for quantitative data. A qualitative interview exploring participant experiences of the MBI will be undertaken at the 3-month follow-up point with 10 participants. Qualitative data will be analysed using thematic analysis. Data collection is ongoing at the time of submitting this manuscript.</p><p><strong>Discussion: </strong>This study is the first to assess feasibility of a self-delivered MBI for those with COPD in New Zealand. This study will also establish preliminary estimates of change on self-efficacy and other measures of health outcomes. If feasible, with preliminary evidence of positive impact on functioning, this will support the development of a larger clinical trial. Provision of self-delivered in-home mindfulness-based interventions for people with COPD may not only contribute to improved health, but potentially a reduction in resources, costs, and the time required for travel to group treatments), reducing barriers to treatment for people with COPD.</p><p><strong>Trial registration: </strong>Austr","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"56"},"PeriodicalIF":1.5,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006367","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 tolerability of physiologic monitoring among pregnant nurses and nursing teams.","authors":"Isha Agarwal, Madeleine Puissant, Irit Altman, Alexandra Hinton, Tania D Strout, Erika L Sabbath","doi":"10.1186/s40814-025-01647-z","DOIUrl":"https://doi.org/10.1186/s40814-025-01647-z","url":null,"abstract":"<p><strong>Background: </strong>Most studies of stress during pregnancy have relied on self-reported and recalled measures, leaving a knowledge gap about the impact of acute, or momentary, stressors. Heart rate, blood pressure, and cortisol are physiologic measures known to increase acutely in response to acute stress. The feasibility of collecting these measures has not been widely reported among pregnant workers outside of a controlled laboratory setting.</p><p><strong>Methods: </strong>This pilot study assessed the feasibility and tolerability of measuring ambulatory heart rate, blood pressure, and diurnal urine cortisol during periods of work and rest among pregnant nurses, nursing assistants, and clinical technicians.</p><p><strong>Results: </strong>Over a 9-month enrollment period, we received 31 inquiries from potential candidates, of whom 18 met our eligibility criteria and 12 accepted enrollment (67% acceptance rate). Over the study period, 4 enrollees withdrew their participation, and 8 were retained until the end of the study (67% completion rate). Our feasibility threshold was the acquisition of ≥ 80% of expected measurements for heart rate, blood pressure, and urine cortisol among retained participants. We achieved our feasibility target for blood pressure recordings (acquiring 84% of expected measures) but not for heart rate recordings (acquiring 60% of expected measures). Urine cortisol levels were successfully obtained 97% of the time. Through qualitative analysis of comments provided by study participants, we identified three major themes surrounding barriers to completing physiological monitoring: (1) personal discomfort and technical issues with study equipment, (2) work or activity interference, and (3) concerns about study design.</p><p><strong>Conclusions: </strong>While physiologic monitoring of pregnant workers is important for learning about how work might impact pregnancy outcomes, equipment challenges pose a significant barrier to study participation. Future studies should allow for a significant withdrawal rate or explore alternative equipment options.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"55"},"PeriodicalIF":1.5,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12034121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033711","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":"Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study.","authors":"Julie Ashworth, Nicola Cornwall, Sarah A Harrisson, Charlotte Woodcock, Elaine Nicholls, Gillian Lancaster, Simon Wathall, Libby Laing, Toby Helliwell, Sue Jowett, Jesse Kigozi, Christian D Mallen, Anthony Avery, Roger Knaggs, Tamar Pincus, Simon White, Clare Jinks","doi":"10.1186/s40814-025-01636-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01636-2","url":null,"abstract":"<p><strong>Background: </strong>Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial.</p><p><strong>Methods: </strong>A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview.</p><p><strong>Results: </strong>Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83%) completed 3-month follow-up. Of 88 MOPP participants invited for a PROMPPT review, 80 (91%) attended. The review was rated completely acceptable or acceptable in 90% (45/50) of acceptability questionnaires returned. Overall, participants interviewed (n = 15) perceived the review as a good idea and recommended it to others; they preferred face-to-face consultations. Prior to the review, they reported mixed feelings, including feeling 'pleased' to be invited and 'grateful' someone was taking an interest, alongside concerns about what would happen during the review, including opioids being stopped and changes being detrimental. Following the review, those with a clear plan for follow-up/access to the pharmacist felt reassured about making changes to their pain medicines, whilst those advised to arrange follow-up as needed were less satisfied and more likely to report confusion about the plan.</p><p><strong>Conclusions: </strong>PROMPPT reviews appeared acceptable to patients, review uptake was high, and the study demonstrated the feasibility of a large definitive trial to evaluate PROMPPT. The review invitation, patient information, and pharmacist training were refined based on the findings ahead of a large cluster randomised controlled trial.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN87628403 , registered 31 July 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"53"},"PeriodicalIF":1.5,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033712","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":"Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): a randomised controlled feasibility trial.","authors":"Bradley Halliday, Sarah Chatfield, Lee Cameron, Joanne Hosking, Jade Chynoweth, Lauren Stockley, Matthew Bailey, Jill Shawe, Annie Hawton, Chris Hayward, Kirsty Carter, Jennifer Freeman","doi":"10.1186/s40814-025-01638-0","DOIUrl":"https://doi.org/10.1186/s40814-025-01638-0","url":null,"abstract":"<p><strong>Background: </strong>Postpartum pelvic girdle pain (PGP), experienced by approximately 10% of women, is typically refractory to conservative management. Customised dynamic elastomeric fabric orthoses (DEFOs) are one novel option to address this. We assessed the feasibility and acceptability of a randomised controlled trial comparing a DEFO plus standardised advice/exercises (intervention) versus standardised advice/exercise alone (control).</p><p><strong>Methods: </strong>A multicentre randomised controlled feasibility trial with embedded qualitative study and economic evaluation. Participants were randomised to either intervention or control group. All received two remote physiotherapy sessions via videoconferencing separated by 14 days. Primary feasibility outcomes were related to the feasibility and acceptability of methods and interventions, recruitment, intervention fidelity, outcome measure performance and completion. The proposed primary outcome measure for the definitive trial was the Numerical Pain Rating Scale (NPRS) which assessed pain intensity fortnightly over 24 weeks. Secondary outcome measures assessed kinesiophobia, continence, function, health-related quality of life, depression and health/care resource use at baseline, 12 and 24 weeks. Adverse events were recorded. Pre-defined progression criteria were set to decide whether, and how, to proceed with a future definitive trial: (1) Target sample size (60 from 3 centres over a 7-month recruitment period), (2) outcome measure completion (> 60% at 24 weeks), (3) orthosis wear-time compliance (> 70% for 6 h/day) as measured by the Orthotimer, and (4) evidence suggesting efficacy.</p><p><strong>Results: </strong>Of 180 participants sent information sheets, 40 were screened and 24 randomised. At 24 weeks, 95% completed NPRS and 89-95% the secondary outcome measures. Wear-time adherence appeared below the set target of 42 h per week. Outcomes were broadly comparable between groups. Recruitment was insufficient to estimate a signal of efficacy with confidence. Two intervention participants experienced Candida infections, considered possibly due to the DEFO.</p><p><strong>Conclusions: </strong>Trial procedures and interventions were acceptable to participants. Technical Orthotimer issues are resolvable through modification of recording parameters. Recruitment of participants was a major challenge. Work to understand how best to engage women in this research is needed before moving to a definitive trial.</p><p><strong>Trial registration: </strong>ISCRTN, ISRCTN67232113. Registered 08/05/2021, https://www.isrctn.com/ISRCTN67232113 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"54"},"PeriodicalIF":1.5,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006578","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}