Danielle Varley

Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs.

Diabet. Med. 29, 855–862 (2012)

Effectiveness of probiotics on the duration of illness in healthy children and adults who develop common acute respiratory infectious conditions: a systematic review and meta-analysis

Recent systematic reviews have reported a positive, although modest, effect of probiotics in terms of preventing common cold symptoms. In this systematic review, the effect of probiotics, specifically Lactobacillus and Bifidobacterium strains, on the duration of acute respiratory infections in otherwise healthy children and adults was evaluated. To identify relevant trials, eight databases, including MEDLINE, Embase, the Cochrane Database of Systematic Reviews (CDSR), the Cochrane Central Register of Controlled Trials (CENTRAL), the Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA), Science Citation Index (SCI) and OAISTER, were searched from inception to 20 July 2012. Details regarding unpublished studies/databases were also obtained from probiotic manufacturers. Study selection, data extraction and quality assessment were carried out by two reviewers. Risk of bias was assessed using criteria adapted from those published by the Centre for Reviews and Dissemination. In this review, twenty randomised controlled trials (RCT) were included, of which twelve were considered to have a low risk of bias. Meta-analysis revealed significantly fewer numbers of days of illness per person (standardised mean difference (SMD) − 0·31 (95 % CI − 0·41, − 0·11), I 2= 3 %), shorter illness episodes by almost a day (weighted mean difference − 0·77 (95 % CI − 1·50, − 0·04), I 2= 80 %) (without an increase in the number of illness episodes), and fewer numbers of days absent from day care/school/work (SMD − 0·17 (95 % CI − 0·31, − 0·03), I 2= 67 %) in participants who received a probiotic intervention than in those who had taken a placebo. Reasons for heterogeneity between the studies were explored in subgroup analysis, but could not be explained, suggesting that the effect sizes found may differ between the population groups. This systematic review provides evidence from a number of good-quality RCT that probiotics reduce the duration of illness in otherwise healthy children and adults.

Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches?

BACKGROUND Since 2005, International Committee of Medical Journal Editors (ICMJE) member journals have required that clinical trials be registered in publicly available trials registers before they are considered for publication. OBJECTIVES The research explores whether it is adequate, when searching to inform systematic reviews, to search for relevant clinical trials using only public trials registers and to identify the optimal search approaches in trials registers. METHODS A search was conducted in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) for research studies that had been included in eight systematic reviews. Four search approaches (highly sensitive, sensitive, precise, and highly precise) were performed using the basic and advanced interfaces in both resources. RESULTS On average, 84% of studies were not listed in either resource. The largest number of included studies was retrieved in ClinicalTrials.gov and ICTRP when a sensitive search approach was used in the basic interface. The use of the advanced interface maintained or improved sensitivity in 16 of 19 strategies for Clinicaltrials.gov and 8 of 18 for ICTRP. No single search approach was sensitive enough to identify all studies included in the 6 reviews. CONCLUSIONS Trials registers cannot yet be relied upon as the sole means to locate trials for systematic reviews. Trials registers lag behind the major bibliographic databases in terms of their search interfaces. IMPLICATIONS For systematic reviews, trials registers and major bibliographic databases should be searched. Trials registers should be searched using sensitive approaches, and both the registers consulted in this study should be searched.

An evaluation of the impact of the key information summary on GPs and out-of-hours clinicians in NHS Scotland:

Background and aims Key information summary is one of the first national shared electronic patient records enabling GPs to share clinical information with unscheduled care providers, including out-of-hours. Implemented during 2013, over 90,000 patient records have been created. This evaluation identified the impact of key information summary on healthcare services. Methods Evidence was collected using online questionnaires and structured telephone interviews. Opinions providing a numerical estimate of value were analysed using statistical methods, while qualitative responses were synthesised using thematic analysis. Results The vast majority of respondents from 441 GP practices and 33 out-of-hours clinicians show that key information summary enhances patient safety, improves clinical management, reduces hospital admissions, empowers clinicians, aids communication across services and enables decisions to be responsive to patients’ wishes. Conclusions Patients willingly consent to share data with unscheduled care clinicians. Patients benefitting include those with palliative, complex or multiple conditions, at high risk of using emergency services. Out-of-hours clinicians would welcome more key information summaries, all well-completed and including social care information. Improvements include software enhancements and wider sharing of information with all unscheduled care services.

Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial

Objectives To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. Design A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. Setting 37 primary schools in York, UK. Participants 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Outcome measures Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. Results An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Conclusions Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. Trial registration number ISRCTN96286707; Results.

An Autism Spectrum Disorders Forum: A Model for the Effective Use ofMultidisciplinary Assessment and Intervention Planning with LimitedClinical Resources

Increasing numbers of young people are coming forward for assessment of autism spectrum disorders (ASD). Staff from pediatrics and child health services need to work together closely with Local Authority staff and child and adolescent mental health services (CAMHS). This paper describes the functioning of an ASD Forum, which allows for careful use of resources whilst providing comprehensive assessment and intervention planning services in an integrated way.

A feasibility and pilot trial of computerised cognitive behaviour therapy for depression in adolescents: lessons learned from planning and conducting a randomised controlled trial

Purpose The purpose of this paper is to focus upon the challenges faced by a research team when conducting a computerised cognitive behaviour therapy (CCBT) trial for adolescents with low mood/depression and how solutions were sought to eliminate these difficulties in future child and adolescent mental health clinical research. Design/methodology/approach The authors have presented a number of problems faced by the research team when conducting a randomised controlled trial (RCT) concerning adolescents with low mood/depression. Findings From examining the problems faced by the research team, the authors have provided key pieces of advice for prospective adolescent mental health RCTs. This advice includes developing clear project plans, setting strategies to encourage and maintain study information in the community and support recruitment, and keeping your organisation appraised of study needs and network and involve governance departments, IT and finance departments in these discussions early. Originality/value RCTs, particularly those focusing on child and adolescent mental health, can face a number of difficulties throughout its stages of completion (from protocol development to follow-up analysis). Studies involving the use of technologies add a layer of complexity to this. This review will be of value to researchers aiming to run a high-quality RCT concerning child and adolescent mental health.