The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae

<p>Abstract</p> <p>Background</p> <p>Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. Secondary objectives include a comparison of the cost-effectiveness of the treatments, and an investigation of time to clearance of verrucae, recurrence/clearance of verrucae at six months, patient satisfaction with treatment, pain associated with treatment, and use of painkillers for the treatments.</p> <p>Methods/Design</p> <p>This is an open, pragmatic, multicentre, randomised controlled trial with two parallel groups: cryotherapy using liquid nitrogen delivered by a healthcare professional for a maximum of 4 treatments (treatments 2-3 weeks apart) or daily self-treatment with 50% salicylic acid for a maximum of 8 weeks. Two hundred and sixty-six patients aged 12 years and over with a verruca are being enrolled into the study. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks compared with baseline and assessed by an independent healthcare professional. Secondary outcomes include self-reported time to clearance of verrucae, self-reported clearance of verrucae at 6 months, cost-effectiveness of the treatments compared to one another, and patient acceptability of both treatments including possible side effects such as pain. The primary analysis will be intention to treat. It is planned that recruitment will be completed by December 2009 and results will be available by June 2010.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN18994246.</p

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

Abstract 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 Keywords: SWAT, Randomised Controlled Trial, personalised, SMS text, postal questionnaire, reminde

It’s more than just food: the role of food among Chinese international students’ acculturation experiences in the UK and USA

Food is an indispensable element in every culture. However, it is often regarded as trivial, mundane, and inconspicuous in daily life and, in turn, its role has often been overlooked in intercultural research. Through the lens of food culture, this paper draws insights from three independent yet related studies which investigated Chinese international students’ acculturation experiences in the United Kingdom (UK) and the United States (USA). Semi-structured individual interviews analyzed thematically were conducted with 23 participants in the UK and 29 participants in the USA. By applying the concepts of “invisible learning” and “unconscious competence” to food in Chinese international students’ acculturation experiences, we highlight the crucial hidden learning and engagement opportunities to enrich the current appreciation of student sojourners’ acculturation experiences. Findings in this paper suggest that food serves as a meaningful invisible or unconscious but powerful acculturation pathway in the personal, psychological, and social domains, which support these learners’ acculturation experiences and facilitate their competence development in new cultural environments. Arguably, understanding this nuanced dimension could better assist student sojourners in developing more effective acculturative strategies, and for host universities or other stakeholders to better support international students with more diverse opportunities and resources

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

An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P [version 1; peer review: 2 approved]

Introduction 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

A randomised controlled trial to assess the effectiveness of offering study results as an incentive to increase response rates to postal questionnaires [ISRCTN26118436]

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

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-toface 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. Keywords: Process evaluation, Randomised controlled trials, Fidelity, Mixed methods, Falls, Elderly, Ageing, Qualitativ

Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Methods We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen’s kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. Results Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. Conclusions Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori

No difference found in time to publication by statistical significance of trial results: a methodological review

Objective: Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results.Design: Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine). Setting: Methodological review of four general medical journals. Participants: Original research articles presenting the primary analyses from phase 2, 3 and 4 parallel-group randomised controlled trials were included. Main outcome measures: Time from trial completion to publication.Results: The median time from trial completion to publication was 431 days (n ¼ 208, interquartile range 278–618). A multivariable adjusted Cox model found no statistically significant difference in time to publication for trials reporting positive or negative results (hazard ratio: 0.86, 95% CI 0.64 to 1.16, p ¼ 0.32). Conclusion: In contrast to previous studies, this review did not demonstrate the presence of time-lag bias in time to publication. This may be a result of these articles being published in four high-impact general medical journals that may be more inclined to publish rapidly, whatever the findings. Further research is needed to explore the presence of time-lag bias in lower quality studies and lower impact journals