Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.

Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.

The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

/pdf/the-prisma-statement-for-reporting-systematic-reviews-and-3j53e5oe33.pdf

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.

/pdf/cochrane-handbook-for-systematic-reviews-of-interventions-1xbdy6uvru.pdf

Cochrane Handbook for Systematic Reviews of Interventions

Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

/pdf/the-prisma-statement-for-reporting-systematic-reviews-and-48ibbzju0k.pdf

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

https://caltcm.memberclicks.net/assets/documents/acc_aha_chf_2013_guidelines.pdf

2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

世界経済・社会統計 = World development indicators

/pdf/drug-initiation-and-escalation-strategies-of-vasodilator-5dyovd3lic.pdf

Drug initiation and escalation strategies of vasodilator therapies for Raynaud's phenomenon: can we treat to target?

The question of when to start antiretroviral therapy (ART) for infection with HIV has been much discussed, and treatment management guidelines have oscillated from the “hit hard, hit early” philosophy to conservative approaches of deferring treatment in asymptomatic patients until CD4 cell counts are 200 cells/ L [1, 2], despite their being few data on the subject [3] In this issue of the Journal, results from a subgroup analysis [4] of a randomized trial, the Strategies for Management of Antiretroviral Therapy (SMART) study, are presented that provide some insight into this question Major reasons why, in recent years, guidelines have tended to be more conservative and have recommended deferring treatment until CD4 cell counts are 200 cells/ L include the following [5]: the low absolute risk of AIDS-defining clinical events at higher CD4 cell counts; the negative impact of side effects on quality of life as well as the occasional occurrence of life-threatening adverse effects, including ones that have been associated with long-term use of ART (such as myocardial infarction); and the inconvenience of drug regimens, leading to reduced adherence, an increased risk of drug resistance, and limitations on future drug options Revisiting these issues, Phillips et al [5] recently concluded that advances in drug development and an improved understanding of the durability and adverse effects of specific drugs has led to renewed interest in the possibility that initiation of ART at CD4 cell counts 200 cells/ L might be preferable The SMART study [6] enrolled HIVinfected subjects with CD4 cell counts 350 cells/ L (including subjects with prior AIDS events) and randomized participants to a continuous ART strategy versus a CD4 cell count– guided strategy for interrupting therapy during periods of higher CD4 cell counts The study population was predominantly and extensively ART experienced In this issue, results are presented for a subgroup of SMART participants not receiving ART at the time of enrollment [4] Specifically, participants who were ART naive (n 249) or who had not received ART for at least 6 months (n 228) were included Per the SMART study design, the subjects in the continuous ART arm were in effect randomized to (re)initiate ART immediately, and those in the CD4 cell count– guided arm were randomized to defer (re)initiation until their CD4 cell count fell to 250 cells/ L Follow-up was for a mean of 18 months In this subgroup, as in the overall SMART population, subjects who immediately (re)initiated ART experienced fewer grade 4 symptomatic adverse events than did those deferring (re)initiation In addition, also as in the overall study population, fewer subjects randomized to (re)initiate ART immediately experienced opportunistic disease (OD) events or died (5 vs 15 participants; P 02) or experienced major cardiovascular, renal, or hepatic events (the so-called serious non-AIDS events; 2 vs 12 participants; P 01) Of importance, this comparison was driven primarily by events among subjects who had previously received ART (for a median of 4 years) The data that more truly address the question of when first to start ART were limited Of the 249 ART-naive participants, 1 versus 4 participants experienced OD events or died in the immediate versus deferred ART arms, and 1 versus 4 experienced serious non-AIDS events That use of ART at higher CD4 cell counts might reduce the incidence of OD is not surprising: randomized trials conducted in the early 1990s showed a benefit [7], and observational studies have suggested that this is true for regimens in use more recently [8] What is more important is that this subgroup analysis raises Received 11 January 2008; accepted 11 January 2008; electronically published 26 March 2008 Potential conflicts of interest: MDH currently has consultancy agreements with the following companies that have anti-HIV products: Boehringer Ingelheim, Tibotec, and Virionyx HRR reports no potential conflicts Financial support: National Institutes of Health (grant AI068634) Reprints or correspondence: Dr Michael Hughes, Harvard University, School of Public Health, Center for Biostatistics in AIDS Research, 655 Huntington Ave, Boston, MA 02115 (mhughes@sdacharvardedu) The Journal of Infectious Diseases 2008; 197:1084–6 © 2008 by the Infectious Diseases Society of America All rights reserved 0022-1899/2008/19708-0003$1500 DOI: 101086/586712 E D I T O R I A L C O M M E N T A R Y

The search for data on when to start treatment for HIV infection.

Pulmonology Unit, Department of Medical Surgical and Health Sciences. University Hospital of Cattinara, University of Trieste, Trieste, Italy, Unit of Immunology, Rheumatology, Department of Experimental and Clinical Medicine, IRCCS San Raffaele Hospital, University of Florence and Division of Rheumatology AOUC & Scleroderma Unit, Allergy and Rare Diseases (UnIRAR), Milan, Italy, Department of Radiology, Department of Medicine, Surgery and Health Science, University of Trieste, Trieste, Italy, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester & Salford Royal NHS Foundation Trust, Manchester, United Kingdom

Editorial: Pulmonary fibrosis: One manifestation, various diseases

Excessive dental wear (pathological attrition and/or abfractions) is a frequent complication in bruxing patients. The parafunction causes heavy occlusal loads. The aim of this study is the early detection and monitoring of occlusal overload in bruxing patients. En-face optical coherence tomography was used for investigating and imaging of several extracted tooth, with a normal morphology, derived from patients with active bruxism and from subjects without parafunction. We found a characteristic pattern of enamel cracks in patients with first degree bruxism and with a normal tooth morphology. We conclude that the en-face optical coherence tomography is a promising non-invasive alternative technique for the early detection of occlusal overload, before it becomes clinically evident as tooth wear.

Early detection of tooth wear by en-face optical coherence tomography

This paper is based on a conference presentation in which several authors presented results from analyses of the same dataset concerning the evaluation of progression-free survival (PFS) as a surrogate endpoint for overall survival in advanced colorectal cancer clinical trials. In evaluating a potential surrogate endpoint, there is a hierarchy of information that might usually be considered desirable: 1) a biological rationale for surrogacy, 2) demonstration of the prognostic value of the surrogate endpoint in untreated patients and 3) in treated patients and 4) demonstration across randomized comparisons that differences in the effect of randomized treatments on the surrogate endpoint are associated with the corresponding differences in the effect on the clinical endpoint of interest. Results from analyses that might be used to address the third and four requirements are presented and some of the practical issues that arise in evaluating a surrogate endpoint, which would be relevant to many diseases, are illustrated. Although the results presented should not be seen as a definitive analysis of the value of PFS as a surrogate endpoint, concerns are identified about the potential lack of standardization of the definition of PFS or the frequency of evaluation of disease progression and the high leverage of one study in evaluating the association in addressing the fourth requirement.

Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer.

Michael Hughes

Papers

Drug initiation and escalation strategies of vasodilator therapies for Raynaud's phenomenon: can we treat to target?

The search for data on when to start treatment for HIV infection.

Editorial: Pulmonary fibrosis: One manifestation, various diseases

Early detection of tooth wear by en-face optical coherence tomography

Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer.