ORCID Profile
0000-0002-1958-3897
Current Organisation
The University of Edinburgh
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Publisher: BMJ
Date: 08-2023
DOI: 10.1136/BMJOPEN-2023-075187
Abstract: The top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was ‘Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people diagnosed with a cavernoma?’ This pilot randomised controlled trial (RCT) aims to determine the feasibility of answering this question in a main phase RCT. We will perform a pilot phase, parallel group, pragmatic RCT involving approximately 60 children or adults with mental capacity, resident in the UK or Ireland, with an unresected symptomatic brain cavernoma. Participants will be randomised by web-based randomisation 1:1 to treatment with medical management and with surgery (neurosurgery or stereotactic radiosurgery) versus medical management alone, stratified by prerandomisation preference for type of surgery. In addition to 13 feasibility outcomes, the primary clinical outcome is symptomatic intracranial haemorrhage or new persistent rogressive focal neurological deficit measured at 6 monthly intervals. An integrated QuinteT Recruitment Intervention (QRI) evaluates screening logs, audio recordings of recruitment discussions, and interviews with recruiters and patients arents/carers to identify and address barriers to participation. A Patient Advisory Group has codesigned the study and will oversee its progress. This study was approved by the Yorkshire and The Humber—Leeds East Research Ethics Committee (21/YH/0046). We will submit manuscripts to peer-reviewed journals, describing the findings of the QRI and the Cavernomas: A Randomised Evaluation (CARE) pilot trial. We will present at national specialty meetings. We will disseminate a plain English summary of the findings of the CARE pilot trial to participants and public audiences with input from, and acknowledgement of, the Patient Advisory Group. ISRCTN41647111 .
Publisher: National Institute for Health and Care Research
Date: 2022
DOI: 10.3310/YOWK7214
Abstract: The impact of parental drug use on children is a major public health problem. However, opioid-dependent fathers have been largely ignored in parenting research. To implement and test the feasibility and acceptability of the Parents under Pressure programme (PuP4Dads) for opioid-dependent fathers and their families, and to determine whether or not a full-scale evaluation could be conducted. A mixed-methods feasibility study. Two non-NHS family support services for parents who use drugs in Scotland. Fathers prescribed opioid substitution therapy ( n = 25), their partners ( n = 17) and children, as well as practitioners, supervisors, service managers and referrers. A home-visiting programme, including an integrated theoretical framework, case formulation, collaborative goal-setting and modules designed to improve parenting, the caregiving environment and child welfare. The programme was delivered flexibly over 6 months by accredited practitioners. Feasibility progression criteria included the recruitment target ( n = 24 fathers), acceptability of PuP4Dads, father engagement in the study (including a minimum of 66% of fathers completing PuP and a minimum of 10 fathers completing baseline and post-treatment research interviews), engagement in qualitative interviews (including a minimum of 10 fathers and 90% practitioner uptake and 80% manager uptake), focus groups (with a minimum of 80% referrer uptake), adequate fidelity and no adverse events. The following researcher-administered validated questionnaires were used: the Brief Child Abuse Potential Inventory, the Parenting Sense of Competence Scale, the Difficulties in Emotion Regulation Scale, the Paternal Antenatal Attachment Scale, the Maternal Antenatal Attachment Scale, the Emotional Availability Scale, the Brief Infant Toddler Social and Emotional Assessment, the Strengths and Difficulties Questionnaire, the Conflict Tactics Scale, Treatment Outcome Profile and the EuroQol-5 Dimensions, five-level version. Other sources included parent-completed service use (an economic measure), social work child protection data, NHS opioid substitution therapy prescription data and practitioner-reported attendance data. We also conducted interviews with fathers ( n = 23), mothers ( n = 14), practitioners ( n = 8), supervisors ( n = 2) and service managers ( n = 7) conducted focus groups with referrers ( n = 28) and held an ‘expert event’ with stakeholders ( n = 39) . The PuP4Dads was successfully delivered within non-NHS settings and was considered acceptable and suitable for the study population. Referrals ( n = 44) resulted in 38 (86%) eligible fathers, of whom 25 (66%) fathers and 17 partners/mothers consented to participate. Most fathers reported no previous parenting support. A total of 248 sessions was delivered to the 20 fathers and 14 mothers who started the intervention. Fourteen fathers (and 10 mothers) completed ≥ 6 sessions and six fathers (and four mothers) completed ≤ 5 sessions. Father and mother attendance rates were equal (mean 71%). Median length of engagement for fathers was 26 weeks and for mothers it was 30 weeks. Twenty-three fathers completed interviews at baseline, 16 fathers completed interviews at follow-up 1 and 13 fathers completed interviews at follow-up 2. Outcome measures were well tolerated however, the suitability of some measures was dependent on family circumstances. The researcher-administered questionnaires had few missing data. The perceived benefits of PuP4Dads reported by parents, practitioners and managers included the following: the therapeutic focus on fathers improved parental emotion regulation, there was improved understanding and responding to child’s needs, there was better multiagency working and the programme was a good fit with practice ‘ethos’ and policy agenda. Learning highlighted the importance of service-wide adoption and implementation support, strategies to improve recruitment and retention of fathers, managing complex needs of both parents concurrently, understanding contextual factors affecting programme delivery and variables affecting intervention engagement and outcomes. Lack of emotional availability and economic (service use) data. A larger evaluation of PuP4Dads is feasible. Further work is required to demonstrate the effectiveness of PuP4Dads and the cost implications. A better understanding is needed of how the intervention works, for whom, under what circumstances and why. Current Controlled Trials ISRCTN43209618. This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research Vol. 10, No. 3. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 13-10-2020
DOI: 10.1136/BMJ.M3576
Abstract: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty. Parallel group randomised controlled trial. 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy. 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol. All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist). Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery. 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval −0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, −0.78 to 0.28, P=0.36) or worst pain (0.22 points, −0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval −14.25 to 4.96, P=0.34). Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445 .
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Andrew Stoddart.