The Growth of Clinical Trials and Systematic Reviews in Informing Dermatological Patient Care (original) (raw)

Outcome assessment in dermatology clinical trials and cochrane reviews: call for a dermatology‐specific outcome taxonomy

Journal of the European Academy of Dermatology and Venereology, 2020

is involved in performing clinical trials with many pharmaceutical industries including Novartis, Abbvie, Lilly, Regeneron, Sanofi, Boehringer, Leopharma, UCB, Pfizer, Amgen, Celgene that manufacture drugs used for the treatment of Accepted Article This article is protected by copyright. All rights reserved e.g. psoriasis and atopic dermatitis for which we get financial compensation paid to the department/hospital. The other authors declare that they have no competing interests.

The Cochrane Skin Group: a vanguard for developing and promoting evidence‐based dermatology

Journal of Evidence-Based Medicine, 2013

Aim: The Cochrane Skin Group (CSG) is part of the international Cochrane Collaboration (http://www.cochrane.org/). The CSG prepares, maintains and disseminates high quality evidence-based summaries on the prevention, diagnosis and treatment of skin diseases. We present a synopsis of the history, scope and priorities of the CSG. In addition, we report outcomes of CSG reviews and critically assess clinical value. Methods: Descriptive analysis of systematic reviews published by the CSG since its inception including output, impact factor, associated methodological studies, and influence in clinical guidelines, promoting patient and public engagement and in triggering new primary research. Results: The CSG started in 1997, and has published 61 reviews, 34 protocols and 31 registered titles by August 2013. The CSG scope includes 1000 skin diseases; 80% of reviews cover the top ten diagnoses and 40% of reviews provide clear guidance for clinical practice. CSG reviews had an impact factor of 6.1 in 2011 which places it alongside top dermatology journals. CSG reviews are typically broad in focus and have been shown to be of better quality than non-Cochrane reviews. They are highly cited in clinical guidelines. Several reviews have identified evidence gaps that have led to better primary research. Conclusions: The CSG has emerged as a vanguard of evidence-based dermatology by growing a community interested in applying best external evidence to the care of skin patients and by identifying topics for research. CSG reviews are high impact, clinically relevant and have tangibly influenced international dermatology clinical practice guidelines and new research.

How Often Do Comparative Randomised Controlled Trials in the Field of Eczema Fail to Directly Compare the Treatments Being Tested?

Journal of Clinical Medicine, 2015

The objective of the study was to identify all parallel design randomised controlled trials (RCTs) comparing treatments for eczema in recent dermatology literature that have failed to report a between-group analysis. The GREAT database (www.greatdatabase.org.uk) was searched to identify parallel group RCTs comparing two or more interventions published in the English language in the last decade, 2004 to 2013. The primary outcome was the number of studies that had not reported a between-group analysis for any of the outcomes. Where possible we re-analysed the data to determine whether a between-group analysis would have given a different conclusion to that reported. Out of a total of 304 RCTs in the study period, 173 (56.9%) met the inclusion criteria. Of the 173 eligible studies, 12 (6.9%) had not conducted a between-group analysis for any of the reported outcomes. There was no clear improvement over time. Five of the eight studies that were re-analysed yielded non-significant between-group differences yet reported significant within-group comparisons. All but one of the 12 studies implied that the experimental intervention was successful despite not undertaking any between-group comparisons. Although the proportion of all RCTs that fail to report an appropriate between-group analysis is small, the fact that any scientist who purports to compare one treatment against another then chooses to omit the key comparison statistic is worrying.

Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews

JAMA dermatology, 2014

Research prioritization should be guided by impact of disease. To determine whether systematic reviews and protocol topics in Cochrane Database of Systematic Reviews (CDSR) reflect disease burden, measured by disability-adjusted life years (DALYs) from the Global Burden of Disease (GBD) 2010 project. Two investigators independently assessed 15 skin conditions in the CDSR for systematic review and protocol representation from November 1, 2013, to December 6, 2013. The 15 skin diseases were matched to their respective DALYs from GBD 2010. An official publication report of all reviews and protocols published by the Cochrane Skin Group (CSG) was also obtained to ensure that no titles were missed. There were no study participants other than the researchers, who worked with databases evaluating CDSR and GBD 2010 skin condition disability data. Relationship of CDSR topic coverage (systematic reviews and protocols) with percentage of total 2010 DALYs, 2010 DALY rank, and DALY percentage cha...

Lack of "appropriately assessed" Patient-Reported Outcomes in randomised controlled trials assessing the effectiveness of interventions for rosacea.

Rosacea is a chronic skin disease and psychological problems are fairly common in people affected by rosacea. The persistent red pimply rash on the face can be a source of embarrassment, anxiety and low self-esteem, may instil a lack of confidence and may even lead to depression or body dysmorphic disorder. Rosacea can also have a significant negative impact on health-related quality of life (HRQoL).We have documented the patient-reported outcomes (PRO) used in clinical trials identified in the Cochrane Review on the effectiveness of interventions for rosacea published in the Cochrane Library March 2011 and reported their measurement properties.(1) Here we discuss the results

Global Guidelines in Dermatology Mapping Project (GUIDEMAP), a systematic review of atopic dermatitis clinical practice guidelines: are they clear, unbiased, trustworthy and evidence based (CUTE

Background: Clinical practice guidelines (CPGs) are essential in delivering optimum healthcare, such as for atopic dermatitis (AD), a highly prevalent skin disease. Although many CPGs are available for AD, their quality has not been critically appraised. Objectives: To identify CPGs on AD worldwide and to assess with validated instruments whether those CPGs are clear, unbiased, trustworthy and evidence based (CUTE). Methods: We searched MEDLINE, Embase, PubMed, Web of Science, Cochrane Library, Emcare, Epistemonikos, PsycINFO and Academic Search Premier for CPGs on AD published between 1 April 2016 and 1 April 2021. Additionally we hand searched prespecified guideline resources. Screening, data extraction and quality assessment of eligible guidelines were independently carried out by two authors. Instruments used for quality assessment were the AGREE II Reporting Checklist, the US Institute of Medicine (IOM) criteria of trustworthiness and Lenzer's Red Flags. Results: Forty CPGs were included, mostly from countries with a high sociodemographic index. The reporting quality varied enormously. Three CPGs scored 'excellent' on all AGREE II domains and three scored 'poor' on all domains. We found no association between AGREE II scores and a country's gross domestic product. One CPG fully met all nine IOM criteria and two fully met eight. Three CPGs had no red flags. 'Applicability' and 'rigour of development' were the lowest scoring AGREE II domains; 'external review', 'updating procedures' and 'rating strength of recommendations' were the IOM criteria least met; and most red flags were for 'limited or no involvement of methodological expertise' and 'no external review'. Management of conflicts of interest (COIs) appeared challenging. When constructs of the instruments overlapped, they showed high concordance, strengthening our conclusions. Conclusions: Overall, many CPGs are not sufficiently clear, unbiased, trustworthy or evidence based (CUTE) and lack applicability. Therefore improvement is warranted, for which using the AGREE II instrument is recommended. Some improvements can be easily accomplished through robust reporting. Others, such as transparency, applicability, evidence foundation and managing COIs, might require more effort.