The effectiveness of mindfulness-based cognitive therapy for social anxiety symptoms in people living with alopecia areata: a single-group case-series design.

BACKGROUND: Alopecia areata (AA) is an immunological disorder characterised by hair loss. Individuals with AA report high levels of social anxiety. One intervention that holds potential for reducing social anxiety in individuals with AA is mindfulness-based cognitive therapy (MBCT). AIMS: Our key aim was to investigate whether MBCT reduces social anxiety in individuals with AA. The study also investigated whether MBCT reduces depression, general anxiety, and increases quality of life and increases trait mindfulness in individuals with AA. METHOD: Five participants with AA took part in an 8-session in-person MBCT intervention. A multiple-baseline single-group case series design was adopted. Idiographic measures of social anxiety were measured each day from baseline, through intervention, to follow-up. Standardised questionnaires of trait mindfulness, social anxiety, depression, anxiety, and quality of life were completed at baseline, post-intervention, and at 4-week follow-up. RESULTS: All participants completed the MBCT course, but one participant was excluded from the idiographic analysis due to a high amount of missing data. The remaining four participants demonstrated reductions in idiographic measures of social anxiety from baseline to follow-up. These effects were larger between baseline and follow-up, than between baseline and post-intervention. Two participants demonstrated significant improvement in standardised measures of wellbeing from baseline to follow-up - they also practised mindfulness most regularly at home between sessions. CONCLUSION: MBCT may be effective in reducing social anxiety and improving wellbeing in individuals with AA, although this might be dependent on the extent to which participants regularly practise mindfulness exercises.

Relationship between age, workplace slips and the effectiveness of slip-resistant footwear among healthcare workers.

OBJECTIVES: To explore any age-related trend in workplace slip rate and assess the effectiveness of appropriate slip-resistant footwear in preventing workplace slips by age. METHODS: Secondary data analysis of the Stopping Slips among Healthcare Workers trial, a two-arm randomised controlled trial conducted between March 2017 and May 2019. 4553 National Health Service (NHS) staff across seven sites in England were randomised 1:1 to the intervention group (provision of 5* GRIP-rated slip-resistant footwear) or the control group (usual work footwear). The primary outcome was self-reported workplace slips, ascertained primarily through weekly text messages throughout the 14-week trial follow-up and analysed using mixed-effects negative binomial regression. This paper reports a control group-only analysis of the association between age and slip rate, and a full intention-to-treat analysis of the effectiveness of slip-resistant footwear by age. RESULTS: The mean age of participants was 43 years (range 18-74). In the control group-only analysis, slip rate differed by age (p<0.001) with those aged 60+ having double the slip rate of those aged <30 years (95% CI 1.40 to 2.87). In the intention-to-treat analysis, the interaction between allocation and age was statistically significant (p=0.002). In addition, for all age groups except those aged <30 years, the slip rate in the intervention group was statistically significantly lower than the control group; the smallest incidence rate ratio (ie, the biggest effect) was 0.39 (95% CI 0.24 to 0.64) in the 60+ age group. CONCLUSION: The provision of appropriate slip-resistant footwear was more effective at reducing workplace slips for older NHS staff.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial.

OBJECTIVES: Assess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group). METHODS: A multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall. RESULTS: 6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001). CONCLUSIONS: The offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace. TRIAL REGISTRATION NUMBER: ISRCTN33051393.

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.

Can routine assessment of older people's mental health lead to improved outcomes: A regression discontinuity analysis.

OBJECTIVE: To assess whether case finding for depression among people aged 65 and above improves mental health. DESIGN: Opportunistic evaluation using a regression discontinuity analysis with data from a randomised controlled trial. SETTING: The REFORM trial, a falls prevention study that recruited patients from NHS podiatry clinics. PARTICIPANTS: 1010 community-dwelling adults over the age of 65 with at least one risk factor for falling (recent previous fall or fear of falling). INTERVENTION: Letter sent to patient's General Practitioner if they scored 10 points or above on the 15-item Geriatric Depression Scale (GDS-15) informing them of the patient's risk of depression. MAIN OUTCOME MEASURE: GDS-15 score six months after initial completion of GDS-15. RESULTS: 895 (88.6%) of the 1010 participants randomised into REFORM had a valid baseline and six-month GDS-15 score and were included in this study. The mean GDS-15 baseline score was 3.5 (SD 3.0, median 3.0, range 0-15); 639 (71.4%) scored 0-4, 204 (22.8%) scored 5-9 indicating mild depression, and 52 (5.8%) scored 10 or higher indicating severe depression. At six months follow-up, those scoring 10 points or higher at baseline had, on average, a reduction of 1.08 points on the GDS-15 scale (95% confidence interval -1.83 to -0.33, p = 0.005) compared to those scoring less than 10, using the simplest linear regression model. CONCLUSION: Case finding of depression in podiatry patients based on a GDS-15 score of 10 or more followed by a letter to their General Practitioner significantly reduced depression severity. Whether this applies to all older patients in primary care is unknown. Further research is required to confirm these findings. Regression discontinuity analyses could be prespecified and embedded within other existing research studies.

A network analysis of psychological flexibility, coping, and stigma in dermatology patients.

Introduction: Despite the negative effects of stigma in individuals with skin conditions, interventions to address its effects are rare. This might be in part due to a continued lack of understanding as to how individuals respond to stigma. Methods: In this study, we employed a step-case analytic method, using traditional regression, moderation, and network analyses, to examine the role of psychological flexibility (PF) with stigmatized experiences, and stigma-related outcomes. We run a cross-sectional study (n = 105 individuals with various skin conditions) and analyzed stigma-related variables. We included variables examining perceived stigmatization (PSQ), anxiety (GAD-7), depression (PHQ-9), well-being (EQ5D5L), and variables stemming from the PF model (CompACT), presented as three coping with stigma responses, namely "open," "aware," and "active.". Results: Using network analysis, the most influential or central variables that contributed to stigma were generalized anxiety, perceived stigmatization, and valued actions. In relation to PF, being open to the experience of stigma (as opposed to avoidance), keeping a distance from stigmatized thoughts (as opposed to self-stigmatizing), and bringing attention to value-based committed actions (as opposed to passivity) were all found to contribute to less stigmatized experiences. Discussion: The results indicate that two of the three skills of the PF model ("open" and "active") may be important targets for interventions targeting stigma in people living with skin conditions.

Evaluating an intervention to improve the safety and experience of transitions from hospital to home for older people (Your Care Needs You): a protocol for a cluster randomised controlled trial and process evaluation.

BACKGROUND: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. METHODS: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus.

BACKGROUND: Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. METHODS: We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. RESULTS: In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. CONCLUSIONS: Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care.

BACKGROUND: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. METHODS: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. RESULTS: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. CONCLUSIONS: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. TRIAL REGISTRATION: ISRCTN: 51154948.

Schöpf-Schulz-Passarge syndrome resulting from a homozygous nonsense mutation, p.Cys107X, in WNT10A.

Schöpf-Schulz-Passarge syndrome (SSPS; MIM224750) is a rare autosomal recessive form of ectodermal dysplasia that was recently shown to result from mutations in the WNT10A gene. We now report a 59-year-old woman with SSPS in whom a homozygous nonsense mutation (p.Cys107X) in WNT10A was detected. Mutations in this gene may also underlie odonto-onycho-dermal dysplasia and other ectodermal dysplasia syndromes. To date, 16 different WNT10A mutations have been reported, although considerable clinical and molecular overlap exists. This report demonstrates the molecular basis of a further case of SSPS and highlights the clinical features of this unusual ectodermal dysplasia syndrome.

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.

BACKGROUND: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care. DESIGN: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study. SETTING: Eight NHS trusts in primary and secondary care in England. PARTICIPANTS: In total, 1331 participants were randomised (intervention group, n = 430; usual-care group, n = 901) via a secure, remote service. Blinding was not possible. INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. MAIN OUTCOME MEASURES: The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. RESULTS: The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38; p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss -0.0042, 95% confidence interval -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree. LIMITATIONS: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data. CONCLUSIONS: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care. FUTURE WORK: An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22202133. FUNDING: 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. 25, No. 46. See the NIHR Journals Library website for further project information.

Falling is a common problem among older people. In fact, up to half of people aged over 80 years fall each year, with most falls happening inside the home. Unfortunately, some falls cause serious injuries, such as broken bones. People often think that falls are part of getting older and that little can be done to stop them from falling. However, there are many ways to reduce falls. The Occupational Therapist Intervention Study (OTIS) explored whether or not a home assessment visit by an NHS occupational therapist could reduce falls among older people who are likely to be at risk of falling. In total, 1331 people aged 65 years or older living in England took part in the study. These people were all sent an Age UK leaflet about how to prevent falls, and 430 people were selected at random to receive a visit from an occupational therapist. The occupational therapist assessed their homes for hazards, such as slippery floors or poor lighting, and made suggestions for changes. We collected information from participants using monthly falls calendars and postal questionnaires to ask them about their falls, their quality of life, how often they used NHS services and how often they used paid care workers. We also asked them about whether they had had equipment and adaptations installed as a result of the assessments. We found that the home assessment visits did not reduce the number of falls people had or make any difference to participants' quality of life. However, many of the recommendations made by the occupational therapists were not carried out. The home assessment visits by an occupational therapist were not good value for money.

An evaluation of a personalised text message reminder compared to a standard text message on postal questionnaire response rates: an embedded randomised controlled trial.

Background: Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods: A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results: A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions: Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration: ISRCTN22202133; SWAT 35.

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

BACKGROUND: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. DESIGN: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. SETTING: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. PARTICIPANTS: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. RESULTS: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants' views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. CONCLUSIONS: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011.

Including a pen and/or cover letter, containing social incentive text, had no effect on questionnaire response rate: a factorial randomised controlled Study within a Trial.

Background: Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a postal follow-up questionnaire increased response rates in a trial. Method: A two-by-two factorial randomised controlled trial was embedded within the OTIS host trial. Participants due their 12-month (final) follow-up questionnaire were randomised to be sent: a pen; a social incentive text cover letter; both; or neither. The primary outcome measure was the proportion of participants in each group who returned the questionnaire. Secondary outcomes were: time to return, completeness of the questionnaire, necessity of a reminder letter, and the cost effectiveness. Results: The overall 12-month questionnaire response rate was 721 out of 755 (95.5%). Neither the pen nor social incentive cover letter had a statistically significant effect on response rate: pen 95.2% vs. no pen 95.8%, adjusted OR 0.90 (95% CI 0.45 to 1.80; p=0.77); social incentive cover letter 95.2% vs. no social incentive cover letter 95.8%, adjusted OR 0.84 (95% CI 0.42 to 1.69, p=0.63). No statistically significant differences were observed between either of the intervention groups on time to response, need for a reminder or completeness. Therefore, neither intervention was cost-effective. Conclusions: We found no evidence of a difference in response rates associated with the inclusion of a pen and/or social incentive cover letter with the final follow-up postal questionnaire of the host trial. However, when these results are combined with previous SWATs, the meta-analysis evidence remains that including a pen increases response rates. The social incentive cover letter warrants further investigation to determine effectiveness. Trial registration: ISRCTN22202133 (21st June 2020).

An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P.

Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods: A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results: Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions: PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.

Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial.

BACKGROUND: Patients, particularly older people, often experience safety issues when transitioning from hospital to home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions that support patient involvement may be more effective. The 'Your Care Needs You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to reduce emergency hospital readmissions and improve safety and experience during the transition to home. METHODS: As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT.Ten acute hospital wards (the clusters) from varying medical specialties including older peoples' medicine, trauma and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a 3:2 basis. Up to 200 patients aged 75 years and over and discharged to their own homes will be recruited to the study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data up to 90-days post-discharge will be extracted from their medical records.Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to 24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the definitive cRCT. DISCUSSION: This study will establish the feasibility of the YCNY intervention which aims to improve safety and experience during transitions of care. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled trial. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948. Registered 16/07/2019.

Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial.

Background: Poor response to questionnaires collecting outcome data in randomised controlled trials (RCTs) can affect the validity of trial results. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of including a pen with a follow-up postal questionnaire on response rate. Methods: A two-armed RCT was embedded within SSHeW (Stopping Slips among Healthcare Workers), a trial of slip-resistant footwear to reduce slips in NHS staff.  Participants were randomised 1:1 to receive a pen or no pen with their follow-up questionnaire. The primary outcome was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, and whether a postal reminder notice was required. Data were analysed using logistic regression, linear regression and Cox proportional hazards regression. Results: Overall, 1466 SSHEW trial participants were randomised into the SWAT. In total, 13 withdrew from the host trial before they were due to be sent their follow-up questionnaire, 728 participants received a pen with their questionnaire, and 725 did not receive a pen.  A questionnaire was returned from 67.7% of the pen group and 64.7% of the group who did not receive a pen. There was no significant difference in return rates between the two groups (OR 1.15, 95% CI 0.92 to 1.43, p=0.22), nor level of completeness of the questionnaires (AMD -0.01, 95% CI 0.06 to 0.05, p=0.77).  There was weak evidence of a reduction in the proportion of participants requiring a reminder and in time to response in the pen group. Conclusion: Inclusion of a pen with the follow-up postal questionnaire sent to participants in the SSHeW trial did not statistically significantly increase the response rate. These results add to the body of evidence around improving response rates in trials. Trial registration: ISRCTN 33051393 (for SSHEW). Registered on 14/03/2017.

Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial.

Background: Meeting recruitment targets for randomised controlled trials is challenging.  This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial.  Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio.  The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial.  To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar.  Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86).  There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.

Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial.

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial.  Secondary outcomes related to trial eligibility and retention.  Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.