Beatriz Goulão

Mindfulness-Based Stress Reduction for Veterans With PTSD

To the Editor Dr Polusny and colleagues1 conducted a randomized clinical trial to compare mindfulness-based stress reduction with present-centered group therapy for the treatment of posttraumatic stress disorder (PTSD). They concluded that mindfulness-based stress reduction therapy reduced PTSD symptom severity compared with present-centered group therapy.

INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial : a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care

BackgroundTraditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group’s systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care.MethodsThis is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life.DiscussionINTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice.Trial registrationISRCTN95933794 (Date assigned 20/08/2008).

‘Is that it?’ Using ‘explorachoc’ to engage the public with clinical trials and health services research

Citation for published version (APA): Rogers, A., Mackenzie, I., Rorie, D., & MacDonald, T. (2017). Successful recruitment to a large online randomised trial: the TIME study. In Trials: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials (Supplement 1 ed., Vol. 18, pp. 222-223). [089] (Trials; Vol. 18, No. Suppl. 1). United Kingdom: BioMed Central. https://doi.org/10.1186/s13063-017-1902-yThe study will address variability in practice, defined in Standard Operating Procedures, that UK Clinical Trials Units (CTU) have in place for: i) defining, ii) classifying, and iii) reporting adverse events in non-CTIMPs. Compared to drug trials, adverse events in non-CTIMPs are not managed well. There is considerable inconsistency in reporting styles between trials of similar design and intervention type. To promote increased consistency, we will conduct a consensus exercise among non-CTIMP experts using a Delphi technique followed by a face-to-face meeting. This method adheres to the recommended sequence outlined by the international network for Enhancing the Quality and Transparency of Health Research (EQUATOR) for developing health research guidelines. A non-CTIMP expert is defined as: a CTU representative, a Chief Investigator or trial manager of non-CTIMPs with >3 trials experience in this role, or a senior member of the Health Research Authority’s Operations team or Ethics Committee. As such, the participants in the consensus exercises will also be the direct beneficiaries from the project maximising its pathway to impact. Following the face-to-face meeting — guidance and explanatory statements will be drafted. The guidance statement will focus on: • how adverse events should be defined in relation to the non-pharmacological intervention, • how CTU standard operating procedures should be designed to reflect the results of the Delphi exercise, • how adverse events should be classified following a judicious causal assessment, and • recommended reporting methods that will promote more effective meta-analyses of non-pharmacological interventions that provide a balanced benefit-harm evaluation. Following study completion, we will work with a selection of UK CTUs to evaluate the implementation of any agreed modifications to current practice.This is the final version of the article. Available from BioMed Central via the DOI in this record.Objective Multi-centre RCT designs provide robust evidence of therapeutic effect of health interventions. However participating centres often differ in how well they conduct the trial and the number of patients successfully recruited. This paper describes barriers different research teams encountered when conducting a complex RCT comparing a surgical procedure with physiotherapy, and the actions taken by the trial management group to overcome obstacles that were hindering recruitment. Methods We conducted 22 interviews with principal investigators and research associates at 14 sites involved in the delivery of a surgical RCT that compared hip arthroscopy and physiotherapy for hip pain. Interview transcripts were analysed thematically and case study approaches were utilised to present results to the trial management group. Results Research teams reported difficulties related to logistics (e.g. Room space); motivation (e.g. PI reluctant to approach patients); and skill (e.g. Lack of knowledge about the treatment arms). Similar Issues were shared by sites that recruited to target and those that did not, however there were differences in the team ’ s response to challenges. Whilst on-target sites found local solutions to issues or support through their research infrastructure or the trial TMG, off-target sites usually did not show proactivity. Site profiles were created and action plans designed based on aspects that were particular to the individual sites. These plans were implemented in collaboration with site teams. Conclusions This qualitative study added to the growing evidence of how aspects of team functioning are important for recruitment to complex RCTs. Trial Management Groups can help research teams identify and ad- dress issues, and therefore contributing to a sense of ownership by the research team. Empowering research teams to find solutions at local level is essential to conduct multi-centre RCTs successfully.

The split-plot design was useful for evaluating complex, multi-level interventions but there is need for improvement in its design and report

OBJECTIVES To describe the sample size calculation, analysis and reporting of split-plot (S-P) randomized controlled trials in health care (trials that use two units of randomization: one at a cluster-level and one at a level lower than the cluster). STUDY DESIGN AND SETTING We carried out a comprehensive search in the EMBASE database from 1946 to 2016. Health care trials with a S-P design in human subjects were included. Three authors screened and assessed the studies, and the data were extracted on methodology and reporting standards based on CONSORT. RESULTS Eighteen S-P studies were included, with authors using nine different designations to describe them. Units of randomization were unclear in nine abstracts. Explicit rationale for choosing the design was not given. Ten studies presented a sample size calculation accounting for clustering; the analyses were coherent with that. Flow of participant diagrams was presented but was incomplete in 14 articles. CONCLUSION S-P designs can be useful complex designs but challenging to report. Researchers need to clearly describe the rationale, sample size calculation, and participant flow. We provide a suggested CONSORT style participant flow diagram to aid reporting. There is need for more research regarding sample size calculation for S-P.