http://rua.ua.es/dspace/bitstream/10045/57307/1/2016_Estarli_etal_RevEspNutrHumDiet.pdf

Ítems de referencia para publicar Protocolos de Revisiones Sistemáticas y Metaanálisis: Declaración PRISMA-P 2015 Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

/pdf/consort-2010-statement-updated-guidelines-for-reporting-4ae3ljk2ki.pdf

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

High quality protocols facilitate proper conduct, reporting, and external review
 of clinical trials. However, the completeness of trial protocols is often
 inadequate. To help improve the content and quality of protocols, an
 international group of stakeholders developed the SPIRIT 2013 Statement
 (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT
 Statement provides guidance in the form of a checklist of recommended items to
 include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important
 information to promote full understanding of the checklist recommendations. For
 each checklist item, we provide a rationale and detailed description; a model
 example from an actual protocol; and relevant references supporting its
 importance. We strongly recommend that this explanatory paper be used in
 conjunction with the SPIRIT Statement. A website of resources is also available
 (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement,
 should help with the drafting of trial protocols. Complete documentation of key
 trial elements can facilitate transparency and protocol review for the benefit
 of all stakeholders.

https://www.bmj.com/content/bmj/346/bmj.e7586.full.pdf

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Background: Depression is a prevalent and disabling condition in older persons (≥60 years) that increases the risk of mortality and negatively influences quality

/pdf/depression-and-quality-of-life-in-older-persons-a-review-1ndnuv1p2t.pdf

Depression and Quality of Life in Older Persons: A Review

Background: The Internet is increasingly used as a medium for the delivery of interventions designed to promote health behavior change. However, reviews of these interventions to date have not systematically identified intervention characteristics and linked these to effectiveness. Objectives: The present review sought to capitalize on recently published coding frames for assessing use of theory and behavior change techniques to investigate which characteristics of Internet-based interventions best promote health behavior change. In addition, we wanted to develop a novel coding scheme for assessing mode of delivery in Internet-based interventions and also to link different modes to effect sizes. Methods: We conducted a computerized search of the databases indexed by ISI Web of Knowledge (including BIOSIS Previews and Medline) between 2000 and 2008. Studies were included if (1) the primary components of the intervention were delivered via the Internet, (2) participants were randomly assigned to conditions, and (3) a measure of behavior related to health was taken after the intervention. Results: We found 85 studies that satisfied the inclusion criteria, providing a total sample size of 43,236 participants. On average, interventions had a statistically small but significant effect on health-related behavior (d+ = 0.16, 95% CI 0.09-0.23). More extensive use of theory was associated with increases in effect size (P = .049), and, in particular, interventions based on the theory of planned behavior tended to have substantial effects on behavior (d+ = 0.36, 95% CI 0.15-0.56). Interventions that incorporated more behavior change techniques also tended to have larger effects compared to interventions that incorporated fewer techniques (P < .001). Finally, the effectiveness of Internet-based interventions was enhanced by the use of additional methods of communicating with participants, especially the use of short message service (SMS), or text, messages. Conclusions: The review provides a framework for the development of a science of Internet-based interventions, and our findings provide a rationale for investing in more intensive theory-based interventions that incorporate multiple behavior change techniques and modes of delivery. [J Med Internet Res 2010;12(1):e4]

Using the Internet to promote health behavior change: A systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy

Provide a structured summary including, as applicable, background, objectives, data sources, study eligibility criteria, participants, interventions, study appraisal and synthesis methods, results, limitations, conclusions and implications of key findings, systematic review registration number 2 Structured summary

Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement (Chinese edition)

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

K F Schulz

Papers

Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement (Chinese edition)

SPIRIT 2013 statement: Defining standard protocol items for clinical trials