From Pandemic to Epidemic: Lessons Learned From COVID-19 Applied to Mpox Outbreak Response, Westchester County, Metropolitan New York.

The COVID-19 pandemic vaccination infrastructure was redeployed to address the Mpox epidemic. The Westchester County Department of Health coordinated an effective vaccine distribution, tracking, and data collection process with community partners with real-time feedback of operational challenges and updated public health directives. Westchester County, which comprises 9% of the New York State population, administered 24% (6770 doses) of JYNNEOS (smallpox and monkeypox vaccine) across the state. Among first-dose recipients, 13% were Black and 25% were Hispanic, approaching countywide US Census race and ethnicity breakdowns. The operational template designed during COVID-19 can be readily redeployed for subsequent epidemics of even seemingly dissimilar infections like Mpox.

Living with an artificial eye: qualitative insights into patient and family member experiences.

PURPOSE: Artificial eye users (AEUs) can experience a negative impact on psychological and emotional wellbeing, including reduced social functioning, which may be a consequence of living with one eye removed, and/or of having a prosthetic eye. This may have wider consequences for their families. We aimed to explore what it means to live with a prosthetic eye, for both AEUs and their families-and how any quality of life (QoL) issues impact on their day-to-day functioning. METHODS: A subset of AEUs and their family members taking part in a feasibility randomised controlled trial comparing hand-painted to digitally printed artificial eyes were invited for semi-structured interviews. Transcripts were analysed using reflexive thematic analysis. Qualitative results related to trial participation are covered elsewhere. Here, we focus on QoL and day-to-day functioning. RESULTS: Twelve AEUs (eight males) and five spouses (one male) who had worn artificial eyes for 2-65 years took part, and four themes were identified. (1) Impact on day-to-day life: AEUs and their spouses have to adapt to (partial) sight loss, reduced levels of confidence, and social withdrawal. (2) Impact on psychological and emotional wellbeing: distress among AEUs and their spouses can be severe and prolonged, highlight unmet support needs. (3) Challenges with treatment experiences: AEUs experienced negative impact of fragmentation of care and long waiting times. (4) Worries about the future: AEUs mentioned fragility of remaining sight, and concerns around potential need for further treatment. CONCLUSION: Patients and their family members experience negative impact of being an AEU on their everyday lives and quality of life. There is a potential role for psychosocial support services in supporting AEUs and their families even long after eye loss.

Preferences for interventions designed to increase cervical screening uptake in non-attending young women: How findings from a discrete choice experiment compare with observed behaviours in a trial.

BACKGROUND: Young women's attendance at cervical screening in the UK is continuing to fall, and the incidence of invasive cervical cancer is rising. OBJECTIVES: We assessed the preferences of non-attending young women for alternative ways of delivering cervical screening. DESIGN: Postal discrete choice experiment (DCE) conducted during the STRATEGIC study of interventions for increasing cervical screening uptake. Attributes included action required to arrange a test, location of the test, availability of a nurse navigator and cost to the National Health Service. SETTING AND PARTICIPANTS: Non-attending young women in two UK regions. MAIN OUTCOME MEASURES: Responses were analysed using a mixed multinomial logit model. A predictive analysis identified the most preferable strategy compared to current screening. Preferences from the DCE were compared with observed behaviours during the STRATEGIC trial. RESULTS: The DCE response rate was 5.5% (222/4000), and 94% of respondents agreed screening is important. Preference heterogeneity existed around attributes with strong evidence for test location. Relative to current screening, unsolicited self-sampling kits for home use appeared most preferable. The STRATEGIC trial showed this same intervention to be most effective although many women who received it and were screened, attended for conventional cytology instead. CONCLUSIONS: The DCE and trial identified the unsolicited self-sampling kit as the most preferred/effective intervention. The DCE suggested that the decision of some women receiving the kit in the trial to attend for conventional cytology may be due to anxieties around home testing coupled with a knowledge that ignoring the kit could potentially have life-changing consequences.

The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK.

BACKGROUND: People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK. METHOD: The RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers. RESULTS: Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22). CONCLUSIONS: The target of 100 participants was not achieved within the study's timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex. STUDY REGISTRATION: ISRCTN Registry ISRCTN15747739 prospectively registered 5th July 2016.

A pilot cluster randomised trial of the medicines and alcohol consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services.

BACKGROUND: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial. METHODS: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates. RESULTS: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption. CONCLUSIONS: The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service. TRIAL REGISTRATION: ISRCTN57447996.

Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.

BACKGROUND: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. OBJECTIVE: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. METHODS: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 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 (n = 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. RESULTS: 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, p = 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. CONCLUSION: 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.

Effectiveness and Cost-effectiveness of Opportunistic Screening and Stepped-care Interventions for Older Alcohol Users in Primary Care.

AIMS: To compare the clinical effectiveness and cost-effectiveness of a stepped-care intervention versus a minimal intervention for the treatment of older hazardous alcohol users in primary care. METHOD: Multi-centre, pragmatic RCT, set in Primary Care in UK. Patients aged ≥ 55 years scoring ≥ 8 on the Alcohol Use Disorders Identification Test were allocated either to 5-min of brief advice or to 'Stepped Care': an initial 20-min of behavioural change counselling, with Step 2 being three sessions of Motivational Enhancement Therapy and Step 3 referral to local alcohol services (progression between each Step being determined by outcomes 1 month after each Step). Outcome measures included average drinks per day, AUDIT-C, alcohol-related problems using the Drinking Problems Index, health-related quality of life using the Short Form 12, costs measured from a NHS/Personal Social Care perspective and estimated health gains in quality adjusted life-years measured assessed EQ-5D. RESULTS: Both groups reduced alcohol consumption at 12 months but the difference between groups was small and not significant. No significant differences were observed between the groups on secondary outcomes. In economic terms stepped care was less costly and more effective than the minimal intervention. CONCLUSIONS: Stepped care does not confer an advantage over a minimal intervention in terms of reduction in alcohol use for older hazardous alcohol users in primary care. However, stepped care has a greater probability of being more cost-effective. TRIAL REGISTRATION: Current controlled trials ISRCTN52557360. SHORT SUMMARY: A stepped care approach was compared with brief intervention for older at-risk drinkers attending primary care. While consumption reduced in both groups over 12 months there was no significant difference between the groups. An economic analysis indicated the stepped care which had a greater probability of being more cost-effective than brief intervention.

The acceptability and feasibility of a brief psychosocial intervention to reduce blood-borne virus risk behaviours among people who inject drugs: a randomised control feasibility trial of a psychosocial intervention (the PROTECT study) versus treatment as usual.

BACKGROUND: While opiate substitution therapy and injecting equipment provision (IEP) have reduced blood-borne viruses (BBV) among people who inject drugs (PWID), some PWID continue to share injecting equipment and acquire BBV. Psychosocial interventions that address risk behaviours could reduce BBV transmission among PWID. METHODS: A pragmatic, two-armed randomised controlled, open feasibility study of PWID attending drug treatment or IEP in four UK regions. Ninety-nine PWID were randomly allocated to receive a three-session manualised psychosocial group intervention and BBV transmission information booklet plus treatment as usual (TAU) (n = 52) or information booklet plus TAU (n = 47). The intervention was developed from evidence-based literature, qualitative interviews with PWID, key stakeholder consultations, and expert opinion. Recruitment rates, retention in treatment, follow-up completion rates and health economic data completion measured feasibility. RESULTS: Fifty-six percent (99/176) of eligible PWID were recruited. More participants attended at least one intervention session in London (10/16; 63%) and North Wales (7/13; 54%) than in Glasgow (3/12; 25%) and York (0/11). Participants who attended no sessions (n = 32) compared to those attending at least one (n = 20) session were more likely to be homeless (56 vs 25%, p = 0.044), injected drugs for a greater number of days (median 25 vs 6.5, p = 0.019) and used a greater number of needles from an IEP in the last month (median 31 vs 20, p = 0.056). No adverse events were reported. 45.5% (45/99) were followed up 1 month post-intervention. Feedback forms confirmed that the intervention was acceptable to both intervention facilitators and participants who attended it. Follow-up attendance was associated with fewer days of injecting in the last month (median 14 vs 27, p = 0.030) and fewer injections of cocaine (13 vs 30%, p = 0.063). Analysis of the questionnaires identified several service use questionnaire categories that could be excluded from the assessment battery in a full-randomised controlled trial. CONCLUSIONS: Findings should be interpreted with caution due to small sample sizes. A future definitive RCT of the psychosocial intervention is not feasible. The complex needs of some PWID may have limited their engagement in the intervention. More flexible delivery methods may have greater reach. TRIAL REGISTRATION: ISRCTN66453696.

Randomised trials comparing different healthcare settings: an exploratory review of the impact of pre-trial preferences on participation, and discussion of other methodological challenges.

BACKGROUND: We recently published a systematic review of different healthcare settings (such as outpatient, community or home) for administering intravenous chemotherapy, and concluded that performing conventionally designed randomised trials was difficult. The main problems were achieving adequate trial accrual rates and recruiting a study population which adequately represented the target population of interest. These issues stemmed from the fact that potential participants may have had pre-trial perceptions about the trial settings they may be allocated; such preferences will sometimes be strong enough for patients to decline an invitation to participate in a trial. A patient preference trial design (in which patients can choose, or be randomised to, an intervention) may have obviated these recruitment issues, although none of the trials used such a design. METHODS: In order to gain a better understanding of the broader prevalence and extent of these preference issues (and any other methodological challenges), we undertook an exploratory review of settings trials in any area of healthcare treatment research. We searched The Cochrane Library and Google Scholar and used snowballing methods to identify trials comparing different healthcare settings. RESULTS: Trial accrual was affected by patient preferences for a setting in 15 of the 16 identified studies; birth setting trials were the most markedly affected, with between 68 % and 85 % of eligible women declining to participate specifically because of preference for a particular healthcare setting. Recruitment into substance abuse and chemotherapy setting studies was also notably affected by preferences. Only four trials used a preference design: the proportion of eligible patients choosing to participate via a preference group ranged from between 33 % and 67 %. CONCLUSIONS: In trials of healthcare settings, accrual may be seriously affected by patient preferences. The use of trial designs which incorporate a preference component should therefore strongly be considered. When designing such trials, investigators should consider settings to be complex interventions, which are likely to have linked components which may be difficult to control for. Careful thought is also needed regarding the choice of comparator settings and the most appropriate outcome measures to be used.

A survey of the treatment and management of ingrown toenails by UK podiatrists: A cross-sectional survey.

BACKGROUND: Ingrown toenails are a common pathology. Although a range of conservative and surgical measures are widely used for this condition, little is known about their use in practice. This study explored current practice relating to the treatment or management of ingrown toenails by podiatrists in the UK. METHODS: A cross-sectional online survey (Qualtrics, Provo, UT, USA) conducted between March to June 2020 was distributed to practicing podiatrists treating or managing ingrown toenails in the UK. RESULTS: A total of 396 practicing podiatrists responded (60.1% based in the private sector). The majority (88.6%) performed nail surgery most commonly (54.3%) less than five a month. Nearly all (95%) only performed nail avulsion with or without chemical matrixectomy, universally using phenol (97.2%). Application time and number of applications varied but was most commonly applied three times (61.5%) for a total of 3 minutes (75%). Aftercare varied considerably between public and private sectors, with public sectors offering fewer follow-up appointments. CONCLUSIONS: Although there is a variation in clinical practice throughout the treatment pathway, almost all respondents offered nail avulsion with phenol matrixectomy, whereas very few provided incisional nail surgery. This data provides the most comprehensive description of how UK podiatrists conduct nail surgery for onychocryptosis.

'A whole different ball game': the qualitative experience of older adults with a transtibial amputation and the use of a self-aligning prosthetic ankle-foot on the STEPFORWARD trial.

BACKGROUND: Older patients with lower limb amputation, categorised as having "limited community mobility", are under-researched. Understanding their experience with a new prosthetic ankle-foot is important when designing clinical trials. The aim of this qualitative study was to explore the adjustments they made after amputation and the acceptability of a self-aligning ankle-foot (SA-AF) to older adults. METHODS: Fourteen participants, who took part in the STEPFORWARD randomised controlled feasibility trial (ISRCTN15043643), were purposively recruited; nine were intervention participants and five were standard care participants. They were asked to reflect on their life prior to and consider the adjustments they made following their amputation. Participants in the intervention group were also asked about their views of the new SA-AF compared to their standard non-SA-AF. A thematic analysis was undertaken. RESULTS: Three broad themes were identified: The impact of the amputation; Role of clinical support; and Experiences of the SA-AF. The findings tell a narrative of the long-term impact that amputation has on these individuals' lives. Participants randomised to receive the SA-AF were very positive about it, reporting less pain, greater mobility and being able to do more. CONCLUSION: Participants who used the SA-AF found it an acceptable intervention. These findings suggest that a full-scale RCT is warranted.

There is a high degree of acceptability among an older patient group with a transtibial amputation to use a self-aligning ankle foot.Patients reported experiencing better mobility and more prosthetic comfort with the self-aligning ankle-foot.Key outcomes important to participants include engagement in social and daily activities and balance confidence.

Cost-utility analysis of Social Stories™ for children with autism spectrum disorder in mainstream primary schools: results from a randomised controlled trial.

BACKGROUND: One in 57 children are diagnosed with autism in the UK, and the estimated cost for supporting these children in education is substantial. Social Stories™ is a promising and widely used intervention for supporting children with autism in schools and families. It is believed that Social Stories™ can provide meaningful social information to children that can improve social understanding and may reduce anxiety. However, no economic evaluation of Social Stories has been conducted. AIMS: To assess the cost-effectiveness of Social Stories through Autism Spectrum Social Stories in Schools Trial 2, a multi-site, pragmatic, cluster-randomised controlled trial. METHOD: Children with autism who were aged 4-11 years were recruited and randomised (N = 249). Costs measured from the societal perspective and quality-adjusted life-years (QALYs) measured by the EQ-5D-Y-3L proxy were collected at baseline and at 6-month follow-up for primary analysis. The incremental cost-effectiveness ratio was calculated, and the uncertainty around incremental cost-effectiveness ratios was captured by non-parametric bootstrapping. Sensitivity analyses were performed to evaluate the robustness of the primary findings. RESULTS: Social Stories is likely to result in a small cost savings (-£191 per child, 95% CI -767.7 to 337.7) and maintain similar QALY improvements compared with usual care. The probability of Social Stories being a preferred option is 75% if society is willing to pay £20 000 per QALY gained. The sensitivity analysis results aligned with the main study outcomes. CONCLUSIONS: Compared with usual care, Social Stories did not lead to an increase in costs and maintained similar QALY improvements for primary-aged children with autism.

A systematic review and meta-analysis of randomised controlled trials of surgical treatments for ingrown toenails part II: healing time, post-operative complications, pain, and participant satisfaction.

BACKGROUND: When performing nail surgery, clinicians must choose from a multitude of procedures and variations within each procedure. Much has been published to guide this decision making, but there are a lack of up to date robust systematic reviews to assess the totality of this evidence. METHODS: Five databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.gov and ISRCTN) were searched to January 2022 for randomised trials evaluating the effects of a surgical intervention(s) for ingrown toenails. Two independent reviewers screened records, extracted data, assessed risk of bias and certainty of evidence. Data on co-primary outcomes of symptom relief and symptomatic regrowth were presented in our first paper. This paper presents data for the secondary outcomes and further discussion. RESULTS: Of 3,928 records identified, 36 randomised trials were included in the systematic review. Healing time appears to be reduced with shorter application of phenol. A reduced healing time was also apparent was with the addition of curettage, although this may also increase the risk of post-operative bleeding and pain. Post operative bleeding was also reportedly lower in people who received local anaesthetic with epinephrine but no tourniquet. Use of phenol with nail bed excision may decrease the risk of infection. Lower pain scores were reported when using partial matrixectomy and surgical interventions with phenol. Shorter duration of pain was reported with phenolisation and wedge resection. Participant satisfaction was high overall. CONCLUSION: This second paper reports secondary outcomes from a robust systematic review of randomised trials on surgical treatment of ingrown toenails. Despite the large volume of clinical trials conducted on the topic, few clinical conclusions can be drawn due to the poor quality of these studies. Further high-quality clinical trials are needed to answer fundamental questions in the surgical treatment of ingrown toenails.

A systematic review and meta-analysis of randomised controlled trials on surgical treatments for ingrown toenails part I: recurrence and relief of symptoms.

BACKGROUND: Ingrown toenails are a common nail pathology. When conservative treatments are ineffective, a surgical approach is often utilised. Despite recent narrative reviews, there is a need for an up-to-date and rigorous systematic review of surgical methods for treating ingrown toenails. METHODS: Five databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.gov and ISRCTN) were searched to January 2022 for randomised trials evaluating the effects of a surgical intervention(s) for ingrown toenails with a follow-up of at least 1 month. Two independent reviewers screened records, extracted data, assessed risk of bias and certainty of evidence. RESULTS: Of 3,928 records identified, 36 (3,756 participants; 62.7% males) surgical interventions were included in the systematic review and 31 studies in the meta-analysis. There was very low quality evidence that using phenol with nail avulsion vs nail avulsion without phenol reduces the risk of recurrence (risk ratio [RR] 0.13 [95% CI 0.06 to 0.27], p < 0.001). No favourable effect was observed between chemical or surgical vs conservative management (0.55 [0.19 to 1.61], p = 0.280; 0.72 [0.33 to 1.56], p = 0.410), chemical or surgical vs other (e.g., CO2 laser, electrocautery) (1.61 [0.88 to 2.95], p = 0.120; 0.58 [0.25 to 1.37], p = 0.220), chemical vs surgical (0.75 [0.46 to 1.21], p = 0.230), surgical vs surgical (0.42 [0.21 to 0.85]), chemical vs chemical (0.19 [0.01 to 3.80], p = 0.280), surgical vs surgical + chemical (3.68 [0.20 to 67.35], p = 0.380), chemical vs surgical + chemical (1.92 [0.06 to 62.30], p = 0.710), local anaesthetic vs local anaesthetic + adrenaline (1.03 [0.22 to 4.86], p = 0.970), chemical timings 30 s vs 60 s (2.00 [0.19 to 21.41]) or antibiotics vs no antibiotics (0.54 [0.12 to 2.52], p = 0.430). Central toenail resection was the only procedure to significantly relieve symptoms (p = 0.001) but data were only available up to 8 weeks post-surgery. CONCLUSION: Despite the high number of publications, the quality of research was poor and the conclusions that can be inferred from existing trials is limited. Phenolisation of the nail matrix appears to reduce the risk of recurrence following nail ablation, and with less certainty 1 min appears to be the optimum time for application. Despite this being a widely performed procedure there remains a lack of good quality evidence to guide practice.

A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

OBJECTIVE: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. METHODS: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. RESULTS: Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. CONCLUSION: Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. TRIAL REGISTRATION: ISRCTN80441309 (prospectively registered on 24/01/2019).

A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S - a study protocol [version 2; peer review: 2 approved].

Background/objectives: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure. Manufacturing delays as well as necessary repainting to obtain adequate colour matching, may severely impact a patient's rehabilitation pathway to a normal home, social and work life. However, advances in technology mean alternatives are now possible. The aim of this study is to establish the feasibility of conducting a large-scale study of the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes. Methods: A cross-over, randomised feasibility study evaluating a digitally-printed artificial eye with a hand-painted eye, in patients aged ≥18 years with a current artificial eye. Participants will be identified in clinic, via ophthalmology clinic databases and two charity websites. Qualitative interviews will be conducted in the later phases of the study and focus on opinions on trial procedures, the different artificial eyes, delivery times, and patient satisfaction. Discussion: Findings will inform the feasibility, and design, of a larger fully powered randomised controlled trial. The long-term aim is to create a more life-like artificial eye in order to improve patients' initial rehabilitation pathway, long term quality of life, and service experience. This will allow the transition of research findings into benefit to patients locally in the short term and National Health Service wide in the medium to long term._. ISRCTN registration: ISRCTN85921622 (prospectively registered on 17/06/2021).

Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis.

AIMS: To test the efficacy of 'MiQuit', a tailored, self-help, text message stop smoking programme for pregnancy, as an adjunct to usual care (UC) for smoking cessation in pregnancy. DESIGN: Multicentre, open, two-arm, parallel-group, superiority randomised controlled trial (RCT) and a trial sequential analysis (TSA) meta-analysis combining trial findings with two previous ones. SETTING: Twenty-four English hospital antenatal clinics. PARTICIPANTS: A total of 1002 pregnant women who were ≥16 years old, were ≤25 weeks gestation and smoked ≥1 daily cigarette and accepted information on cessation with no requirement to set quit dates. INTERVENTIONS: UC or UC plus 'MiQuit': 12 weeks of tailored, smoking cessation text messages focussed on inducing and aiding cessation. MEASUREMENTS: Primary outcome: biochemically validated cessation between 4 weeks after randomisation and late pregnancy. SECONDARY OUTCOMES: shorter and non-validated abstinence periods, pregnancy outcomes and incremental cost-effectiveness ratios. FINDINGS: RCT: cessation was 5.19% (26/501) and 4.59% (23/501) in MiQuit and UC groups (adjusted odds ratio [adj OR] for quitting with MiQuit versus UC, 95% CI = 1.15 [0.65-2.04]); other abstinence findings were similar, with higher point estimates. Primary outcome ascertainment was 61.7% (309) and 67.3% (337) in MiQuit and UC groups with 71.1% (54/76) and 69.5% (41/59) abstinence validation rates, respectively. Pregnancy outcomes were similar and the incremental cost per quality-adjusted life year was -£1118 (95% CI = -£4806-£1911). More MiQuit group women reported making at least one quit attempt (adj OR [95% CI]) for making an attempt, 1.50 (1.07-2.09). TSA meta-analysis: this found no significant difference in prolonged abstinence between MiQuit and UC (pooled OR = 1.49, adjusted 95% CI = 0.62-3.60). CONCLUSIONS: Irrespective of whether they want to try quitting, when offered a tailored, self-help, text message stop smoking programme for pregnancy (MiQuit) as an adjunct to usual care, pregnant women are not more likely to stop smoking until childbirth but they report more attempts at stopping smoking.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

OBJECTIVE: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. DESIGN: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). SETTING: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. PARTICIPANTS: 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services. INTERVENTIONS: Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. MAIN OUTCOME MEASURES: Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. RESULTS: From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. CONCLUSIONS: The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15236311.

STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations.

OBJECTIVES: 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. DESIGN: Multicentre parallel group feasibility RCT. SETTING: Five prosthetics centres in England recruiting from July 2018 to August 2019. PARTICIPANTS: Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having 'limited community mobility' and using a non-self-aligning ankle-foot. INTERVENTION: Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. OUTCOMES: 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. RESULTS: 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. CONCLUSIONS: This feasibility trial recruited and retained participants who were categorised as having 'limited community mobility' following a transtibial amputation. 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. TRIAL REGISTRATION NUMBER: ISRCTN15043643.

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR).

OBJECTIVE: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service. DESIGN: Randomised controlled, open feasibility trial with embedded economic and process evaluations. SETTING: Audiology departments in two hospitals in two UK cities. PARTICIPANTS: Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid. INTERVENTIONS: Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group). PRIMARY OUTCOME MEASURES: The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery. SECONDARY OUTCOME MEASURES: International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible. RESULTS: Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size. CONCLUSIONS: While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point. TRIAL REGISTRATION NUMBER: ISRCTN28090877.