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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. [ABSTRACT FROM AUTHOR]

The article discusses the need for a proper career pathway for clinical trial managers in the UK. It highlights the different pathways currently available for trial managers employed in Higher Education Institutions (HEIs) and the challenges they face in terms of recognition, professional development, and career progression. The article presents survey data from trial managers and Clinical Trials Units (CTUs) to demonstrate the dissatisfaction with the current pathways and the need for change. It also mentions the University of Liverpool's alternative pathway, called the Research Technical Professional (RTP) career pathway, as a potential solution. The article emphasizes the importance of recognizing the specialist skills of trial managers and providing them with opportunities for career development. [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract Background Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient’s preference on outcome measures. The aims of this study were to examine whether patients’ treatment preference affected clearance of plantar warts and explore whether there were any associations between patients’ treatment preference and baseline variables in the EverT trial. Methods Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher’s exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient’s self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group. Results Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) Conclusions This secondary analysis showed no evidence to suggest that patients’ baseline preferences affected verruca clearance rates or adherence with the treatment. Trial registration Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

Background: In Great Britain, 100,000 injuries due to slips, trips and falls on the level (as opposed to falls from a height, e.g. a ladder) occur in the workplace each year. They are the most common cause of non-fatal injury in the workplace, accounting for 30% of all those injuries reported to the Health and Safety Executive. Nearly 1 million working days are lost because of slips, trips and falls each year. Objectives: To assess the clinical effectiveness and cost-effectiveness of 5-star, GRIP-rated, slip-resistant footwear in preventing slips in the workplace compared with usual footwear. Design: A two-arm, multicentre, randomised controlled trial with an economic evaluation and qualitative study. Setting: Seven NHS trusts in England. Participants: NHS staff aged = 18 years, working at least 22.5 hours per week in clinical, general or catering areas who owned a mobile phone. Staff required to wear protective footwear were excluded. Interventions: Intervention participants were offered 5-star, GRIP-rated, slip-resistant footwear. The waiting list control group were asked to wear their usual work shoes for the duration of the study and were offered the trial footwear at the end of their participation. Main outcome measures: The primary outcome was the incidence rate of self-reported slips in the workplace over 14 weeks. Secondary outcomes included the incidence rate of falls either resulting from a slip or not resulting from a slip, proportion of participants reporting a slip, fall or fracture, time to first slip and fall, health-related quality of life and cost-effectiveness. Results: A total of 4553 eligible NHS staff were randomised (2275 to the intervention arm and 2278 to the control arm). In total, 6743 slips were reported [2633 in the intervention group (mean 1.16 per participant, range 0-36 per participant) and 4110 in the control group (mean 1.80 per participant, range 0-83 per participant)]. There was a statistically significant reduction in the slip rate in the intervention group relative to the control group (incidence rate ratio 0.63, 95% confidence interval 0.57 to 0.70; p < 0.001). Statistically significant reductions were observed in falls from a slip (incidence rate ratio 0.51, 95% confidence interval 0.28 to 0.92; p = 0.03), the proportion of participants who reported a slip (odds ratio 0.58, 95% confidence interval 0.50 to 0.66; p < 0.001) or fall (odds ratio 0.73, 95% confidence interval 0.54 to 0.99; p = 0.04) and the time to first slip (hazard ratio 0.73, 95% confidence interval 0.67 to 0.80; p < 0.001). Half of the intervention participants wore the shoes all the time at work. Incremental cost per quality-adjusted life-year in the base case was £38,900 from the NHS perspective and -£60,400 (i.e. cost saving) from the societal perspective. Limitations: This was an unblinded trial in which outcome data were participant self-reported, which may have led to inaccuracies in the reported slip data. Exposure to the trial footwear was lower than hoped. Conclusions: The offer and provision of 5-star, GRIP-rated footwear reduced slips in the workplace, was acceptable to participants and could be cost-effective. [ABSTRACT FROM AUTHOR]

Abstract Background Postal questionnaires are widely used to collect outcome data on participants. However, a poor response to questionnaires will reduce the statistical power of the study and may introduce bias. A meta analysis of ten trials offering study results, largely in the fields of education and marketing, was shown to be ineffective, with the odds ratio for response with offering research findings is 0.92 (95% CI 0.75 to 1.11). However uncertainty still exists as it is uncertain whether results from such trials can be extrapolated to that of a health care setting. The aim of this study was to assess whether offering participants study results increases the response rates to postal questionnaires. Methods 1038 women aged over 70 years were remotely randomised by computer in a 3:1 ratio. 250 participants did not receive the offer of knowing the results of the trial and 788 participants were offered the results of the trial in a postal questionnaire. The main outcome measure was response rate. Chi square test was used to evaluate the overall differences in response rate between the two groups. An adjusted analysis, adjusting for whether the participant was taking calcium and age was also undertaken. Results The response rates were not significantly different Odds Ratio 0.88 (95% confidence intervals 0.48 to 1.63) p = 0.69. Conclusion Offering study results to women living in the community aged over 70 does not increase response rates to postal questionnaires. Although researchers have an ethical obligation to offer participants study results, since 10% of women did not wish to receive the results, investigators should give participants the option to opt out of receiving the study's results.

Aims: Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost‐effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. Methods and results: Parallel group, double‐blind, randomized, placebo‐controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between‐group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment‐emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39–89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, −0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change‐from‐baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between‐group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise‐related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment‐emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. Conclusions: We could not answer our primary objectives due to inadequate power. However, we provide novel placebo‐controlled medium‐term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects. [ABSTRACT FROM AUTHOR]

Introduction Slips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments. Methods and analysis A two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance. Ethics and dissemination This protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Trial registration number ISRCTN33051393; Pre results. [ABSTRACT FROM AUTHOR]