Modified intention to treat reporting in randomised controlled trials: systematic review

Objectives To determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described

Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of intraoperative neuromonitoring (IONM) versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery

Evidence of and recommendations for non-pharmacological interventions for common geriatric conditions: the SENATOR-ONTOP systematic review protocol.

Introduction: Non-pharmacological therapies for common chronic medical conditions in older patients are underused in clinical practice. We propose a protocol for the assessment of the evidence of non-pharmacological interventions to prevent or treat relevant outcomes in several prevalent geriatric conditions in order to provide recommendations. Methods and analysis: The conditions of interest for which the evidence about efficacy of non-pharmacological interventions will be searched include delirium, falls, pressure sores, urinary incontinence, dementia, heart failure, orthostatic hypotension, sarcopaenia and stroke. For each condition, the following steps will be undertaken: (A) prioritising clinical questions; (B) retrieving the evidence (MEDLINE, the Cochrane Library, CINAHL and PsychINFO will be searched to identify systematic reviews); (C) assessing the methodological quality of the evidence (risk of bias according to the Cochrane method will be applied to the primary studies retrieved from the systematic reviews); (D) developing recommendations based on the evidence (Grading of Recommendations Assessment, Development and Evaluation (GRADE) items—risk of bias, imprecision, inconsistency, indirectness and publication bias—will be used to rate the overall evidence and develop recommendations). Dissemination: For each target condition, at least one systematic overview concerning the evidence of non-pharmacological interventions will be produced and published in peer-reviewed journals

Evidence of and recommendations for non-pharmacological interventions for common geriatric conditions : the SENATOR-ONTOP systematic review protocol

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.Peer reviewedPublisher PD

Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat.</p> <p>Methods</p> <p>To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Trials were categorized based on the "type" of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a "modified intention-to-treat" approach; and "no ITT", trials not reporting the use of any intention-to-treat approach. Two pairs of reviewers independently extracted the data in duplicate. The strength of the associations between the "type" of intention-to-treat reporting and the quality of reporting (sample size calculation, flow-chart, lost to follow-up), the methodological quality of the trials (sequence generation, allocation concealment, and blinding), the funding source, and the findings was determined. Odds ratios (OR) were calculated with 95% confidence intervals (CI).</p> <p>Results</p> <p>Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as "no ITT" trials. The quality of reporting and the methodological quality of the mITT trials were similar to those of the ITT trials; however, the mITT trials were more likely to report post-randomization exclusions (adjusted OR 3.43 [95%CI, 1.70 to 6.95]; <it>P </it>< 0.001). We found a strong association between trials classified as mITT and for-profit agency sponsorship (adjusted OR 7.41 [95%CI, 3.14 to 17.48]; <it>P </it>< .001) as well as the presence of authors' conflicts of interest (adjusted OR 5.14 [95%CI, 2.12 to 12.48]; <it>P </it>< .001). There was no association between mITT reporting and favourable results; in general, however, trials with for-profit agency sponsorship were significantly associated with favourable results (adjusted OR 2.30; [95%CI, 1.28 to 4.16]; <it>P </it>= 0.006).</p> <p>Conclusion</p> <p>We found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.</p

Non-pharmacological, non-surgical interventions for urinary incontinence in older persons : A systematic review of systematic reviews. The SENATOR project ONTOP series

This work was supported by the European Union Seventh Framework program (FP7/2007–2013) under grant agreement n° 305930Peer reviewedPostprin

Nonpharmacologic Management of Orthostatic Hypotension in Older People : A Systematic Review. The SENATOR ONTOP Series

The research leading to these results was supported by the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 305930 (SENATOR project). The sponsor did not play any role in the study design, methods, data collection and analysis, and preparation of the article.Peer reviewedPostprin

Effectiveness of Non-Pharmacological Interventions to Prevent Falls in Older People : A Systematic Overview. The SENATOR Project ONTOP Series

Funding: This work was supported by the European Union Seventh Framework program (FP7/2007–2013) under grant agreement n° 305930 (SENATOR; http://www.senator-project.eu/) and by the ICT PSP (Policy Support Program) as part of the Competitiveness and Innovation Framework Program of the EU under grant agreement n° 325087 (ProFouND; http://profound.eu.com/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer reviewedPublisher PD

The Current State of Validation of Administrative Healthcare Databases in Italy: A Systematic Review

Background: Administrative healthcare databases are widely present in Italy. Our aim was to describe the current state of healthcare databases validity in terms of discharge diagnoses (according to the International Classification of Diseases, ICD-9 code) and their output in terms of research.Methods: A systematic search of electronic databases including Medline and Embase (1995-2013) and of local sources was performed. Inclusion criteria were: healthcare databases in any Italian territory routinely and passively collecting data; medical investigations or procedures at patient level data; the use of a validation process. The quality of studies was evaluated using the STARD criteria. Citations of the included studies were explored using Scopus and Google Scholar.Results: The search strategy allowed the identification of 16 studies of which 3 were in Italian. Thirteen studies used regional administrative databases from Lombardia, Piemonte, Lazio, Friuli-Venezia Giulia and Veneto. The ICD-9 codes of the following diseases were successfully validated: amyotrophic lateral sclerosis (3 studies in four different regional administrative databases), stroke (3 studies), gastrointestinal bleeding (1 study), thrombocytopenia (1 study), epilepsy (1 study), infection (1 study), chronic obstructive pulmonary disease (1 study), Guillain-Barre syndrome (1 study), and cancer diseases (4 studies). The quality of reporting was variable among the studies. Only 6 administrative databases produced further research related to the validated ICD-9 codes.Conclusion: Administrative healthcare databases in Italy need an extensive process of validation for multiple diagnostic codes to perform high quality epidemiological and health services research

Efficacy of Non-Pharmacological Interventions to Prevent and Treat Delirium in Older Patients : A Systematic Overview. The SENATOR project ONTOP Series

The research leading to these results has received funding from the European Union Seventh Framework program (FP7/2007-2013) under grant agreement n° 305930 (SENATOR). The funders had no role in the study design, data collection and analysis, the decision to publish, or the preparation of the manuscript.Peer reviewedPublisher PD