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IntroductionPaediatric anxiety disorders (AD) are prevalent and persistent mental health conditions worldwide affecting between 10% and 20% of children and adolescents. Despite the high prevalence of paediatric AD, there is limited understanding of which treatments work best. Outcome heterogeneity across paediatric mental health trials has been a significant factor in hindering the ability to compare results and assess the efficacy of such trials. This scoping review will help to identify and synthesise the outcomes reported in paediatric AD trials to date.Methods and analysisFollowing the Joanna Briggs Institute scoping review methodology, a comprehensive electronic bibliographic database search (MEDLINE, APA PsycINFO, Embase, CINAHL) strategy will be applied to identify articles examining interventions for children diagnosed with an AD. Articles will be eligible for inclusion if they assess at least one AD intervention (eg, psychological), in children 4–18 years of age inclusive. Initial title and abstract screening will be completed by two trained reviewers independently and in duplicate. Full-text screening of each included article will be completed independently and in duplicate by two of three trained reviewers. Identified outcomes will be mapped to a standard outcome taxonomy developed for core outcome sets. Trial and outcome characteristics will be synthesised using quantitative metrics (counts and frequencies).Ethics and disseminationAs this is a scoping review of the literature and patient information or records were not accessed, institutional ethics approval was not required. Results of this scoping review will be disseminated to clinicians, researchers inclusive of trialists and other stakeholders invested in outcome selection, measurement and reporting in paediatric AD trials. In addition, scoping review results will inform the development of a Core Outcome Set for paediatric AD trials—a minimum set of outcomes that should be measured across trials in an area of health, without precluding the inclusion of other outcomes.

ObjectiveIn evidence synthesis practice, researchers often face the problem of how to deal with zero-events. Inappropriately dealing with zero-events studies may lead to research waste and mislead healthcare practice. We propose a framework to guide researchers to better deal with zero-events in meta-analysis. Study Design and SettingWe used two dimensions, one with respect to the total events count across all studies in the comparative arms in a meta-analysis, and a second with respect to whether included studies have single or both arms with zero-events, to establish the framework for the classification of meta-analysis with zero-events studies. A dataset from Cochrane systematic reviews was used to evaluate the classification. ResultsThe proposed framework classifies meta-analysis with zero-events studies into six subtypes. The classification matched well to the large real-world dataset. The applicability of existing methods for zero-events were then presented under each meta-analysis subtype based on this framework, with a 5-step principle to help researchers in evidence synthesis practice. ConclusionsThe proposed framework should be considered by researchers when making decisions on the selection of the synthesis methods in a meta-analysis. It also provides a reasonable basis for the development of methodological guidelines to deal with zero-events in meta-analysis.

Additional file 2: Supplementary Material II. Parents survey.

Additional file 1. Additional materials including the research protocol, search strategy, list of included studies, and additional figures for the main context.

Additional file 1: Supplementary Material I. Exclusion criteria.

Additional file 3. Informed consent.

Additional file 2. Parents’ opinions on the intervention.

Additional file 1. Data collection case report.

Additional file 1.

Objectives: To: 1) develop/adapt and validate an instrument to measure patient safety attitudes and opinions of community-based spinal manipulative therapy (SMT) providers; 2) implement the instrument; and 3) compare results among healthcare professions.Methods: A review of the literature and content validation were used for the survey development. Community-based chiropractors and physiotherapists in 4 Canadian provinces were invited.Results: The Agency for Healthcare Research and Quality's (AHRQ) Medical Office Survey on Patient Safety Culture was the preferred instrument. The survey was modified and validated, measuring 14 patient safety dimensions. 276 SMT providers volunteered to respond to the survey. Generally, SMT providers had similar or better patient safety dimension scores compared to the AHRQ 2016 medical offices database.Discussion: We developed the first instrument measuring patient safety attitudes and opinions of community-based SMT providers. This instrument provides understanding of SMT providers' opinions and attitudes on patient safety and identifies potential areas for improvement.

International audience

Focus group discussions guide for medical students. (DOCX 37 kb)

In-depth interview guide for Medical School Lecturers, and traditional and complementary medicine practitioners. (DOCX 40 kb)

Level 3 Data Extraction Questions. (DOC 31 kb)

© 2016 Elsevier Inc. Objectives To evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials. Study Design and Setting Through a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus. Results We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16–87%), and the median percentage in the Results was 38% (range, 32–93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004). Conclusion The quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future.

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Table S1. Group membership for the development of the Instrument for Reporting of Planned Endpoints in Clinical Trials (InsPECT). (DOCX 22 kb)

Guideline for selecting outcome measurement instruments for outcomes included in a COS. (PDF 194 kb)

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOCX 61 kb)

Search strategies for MEDLINE, EMBASE, PsycINFO and Cinahl. (DOCX 19 kb)

Passive Surveillance Trigger List. (PDF 365 kb)

Active Surveillance Study Forms. (PDF 23072 kb)

Search strategies for MEDLINE, EMBASE, PsycINFO and Cinahl. (DOCX 19 kb)

Passive Surveillance Trigger List. (PDF 365 kb)

Guideline for selecting outcome measurement instruments for outcomes included in a COS. (PDF 194 kb)

CONSORT 2010Â Checklist. (PDF 137 kb)

SPIRIT 2013 Checklist. (PDF 48 kb)

Table S1. Group membership for the development of the Instrument for Reporting of Planned Endpoints in Clinical Trials (InsPECT). (DOCX 22 kb)

CONSORT 2010Â Checklist. (PDF 137 kb)

SPIRIT 2013 Checklist. (PDF 48 kb)

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOCX 61 kb)

Randomized controlled trials (RCTs) are the gold standard for evaluating new interventions. Different RCT designs apply depending on the patient population, clinical setting, and intervention being evaluated. A design that may help to generate evidence in some clinical areas where recruitment is a challenge is aggregated n-of-1 trials. N-of-1 trials are randomized, double-blind, and multiple crossover comparisons of an intervention and a control treatment. Methodologically robust n-of-1 trials provide an objective means of testing the effectiveness of treatments within individual participants. Aggregation of multiple cycle identically conducted n-of-1 trials yield a population estimate of effect, which potentially commensurate with that derived from other RCT designs. Trial participants contribute data for both intervention and control treatments creating matched data sets while using generally smaller sample sizes than conventional RCT trials. Careful choice of symptoms and medications are required for n-of-1 trials to be feasible. A validated and reliable outcome measure sensitive to change is still required. This article reviews the utility and limitations of aggregated n-of-1 trials to gather evidence in populations where conducting formal RCTs is difficult because of the low prevalence of the underlying condition or the clinical condition making recruitment and retention difficult. The article examines a proposed palliative care trial as a test case. Refereed/Peer-reviewed