ORCID Profile
0000-0003-0694-3854
Current Organisation
University of York
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Publisher: Informa UK Limited
Date: 23-04-2023
Publisher: BMJ
Date: 12-2014
Publisher: Springer Science and Business Media LLC
Date: 28-03-2017
Publisher: F1000 Research Ltd
Date: 25-08-2020
DOI: 10.12688/F1000RESEARCH.25372.1
Abstract: Background : Community pharmacies support a range of patients and medical conditions, and form an important part of comprehensive, holistic healthcare services. The role of a community pharmacist has changed significantly over recent years, developing to include research activities. The CHAMP-1 ( C ommunity pharmacy: H ighlighting A lcohol use in M edication a P pointments) pilot trial aimed to explore an intervention discussing alcohol during medication consultations. It presented various challenges regarding patient retention, and various actions were taken to address these, which are discussed in this manuscript. Methods : Community pharmacists recruited patients aged 18 and over, attending a Medicine Use Review (MUR) or New Medicine Service (NMS) consultation, and drinking alcohol at least twice per week. Pharmacies were randomised to conduct their consultations as usual (control), or to incorporate the Medicines and Alcohol Consultation (MAC) intervention. All participants were followed-up by a researcher after two months to complete data collection via telephone or post. Results : Forty-seven of 51 participants (92%) completed the two month follow-up. Thirty-eight (81%) responses were provided by telephone and nine (19%) by post. Of the 38 follow-up calls completed by telephone, 17 (45%) participants were reached at first attempt 16 (42%) at second attempt and five (13%) at the third attempt. Conclusions : The results suggest that patients recruited to a trial by community pharmacists are willing to take part in data collection activities, and follow-up can be successfully conducted by researchers. The techniques employed to encourage high levels of retention should be investigated further in a larger study.
Publisher: Public Library of Science (PLoS)
Date: 20-01-2017
Publisher: BMJ
Date: 09-2019
DOI: 10.1136/BMJOPEN-2019-032924
Abstract: The majority of older patients with a transtibial utation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any in idual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related utations and other health issues compared with a standard prosthesis. This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target s le size is 90 patients, who are aged 50 years and over, and have a transtibial utation, where utation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future s le size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT. Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group. ISRCTN15043643 .
Publisher: BMJ
Date: 03-2021
DOI: 10.1136/BMJOPEN-2020-045195
Abstract: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot. Multicentre parallel group feasibility RCT. Five prosthetics centres in England recruiting from July 2018 to August 2019. Adults aged ≥50 years with a vascular-related or non-traumatic transtibial utation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot. Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. Feasibility measures: recruitment, consent and retention rates and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire. Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively. This feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ following a transtibial utation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery. ISRCTN15043643 .
Publisher: National Institute for Health and Care Research
Date: 04-2017
DOI: 10.3310/HTA21240
Abstract: Falls are a serious cause of morbidity and cost to in iduals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. Nine NHS trusts in the UK and one site in Ireland. In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493 usual care, n = 517) via a secure, remote service. Blinding was not possible. All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05 p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00 p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants. Owing to the difficulty in calculating a s le size for a count outcome, the s le size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care. The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective. Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients. Current Controlled Trials ISRCTN68240461. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 21, No. 24. See the NIHR Journals Library website for further project information.
Publisher: S. Karger AG
Date: 2018
DOI: 10.1159/000489171
Abstract: b i Background: /i /b Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. b i Objective: /i /b To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. b i Methods: /i /b REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland 1,010 participants (& #x3e 65 years) were randomised to receive either a podiatry intervention ( i n /i = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet ( i n /i = 517). Primary outcome: incidence of falls per participant in the 12 months following randomisation. Secondary outcomes: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. b i Results: /i /b There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73–1.05, i /i = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI –0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP –69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. b i Conclusion: /i /b The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2018
End Date: 2020
Funder: National Institute for Health Research
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