Mona Nasser

GRADE guidelines: 8. Rating the quality of evidence-Indirectness

Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness). Secondly, the intervention tested may differ from the intervention of interest. Decisions regarding indirectness of patients and interventions depend on an understanding of whether biological or social factors are sufficiently different that one might expect substantial differences in the magnitude of effect. Thirdly, outcomes may differ from those of primary interest-for instance, surrogate outcomes that are not themselves important, but measured in the presumption that changes in the surrogate reflect changes in an outcome important to patients. A fourth type of indirectness, conceptually different from the first three, occurs when clinicians must choose between interventions that have not been tested in head-to-head comparisons. Making comparisons between treatments under these circumstances requires specific statistical methods and will be rated down in quality one or two levels depending on the extent of differences between the patient populations, co-interventions, measurements of the outcome, and the methods of the trials of the candidate interventions.

GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.

In the GRADE approach, the strength of a recommendation reflects the extent to which we can be confident that the composite desirable effects of a management strategy outweigh the composite undesirable effects. This article addresses GRADEs approach to determining the direction and strength of a recommendation. The GRADE describes the balance of desirable and undesirable outcomes of interest among alternative management strategies depending on four domains, namely estimates of effect for desirable and undesirable outcomes of interest, confidence in the estimates of effect, estimates of values and preferences, and resource use. Ultimately, guideline panels must use judgment in integrating these factors to make a strong or weak recommendation for or against an intervention.

Increasing value and reducing waste in biomedical research: who's listening?

The biomedical research complex has been estimated to consume almost a quarter of a trillion US dollars every year. Unfortunately, evidence suggests that a high proportion of this sum is avoidably wasted. In 2014, The Lancet published a series of five reviews showing how dividends from the investment in research might be increased from the relevance and priorities of the questions being asked, to how the research is designed, conducted, and reported. 17 recommendations were addressed to five main stakeholders-funders, regulators, journals, academic institutions, and researchers. This Review provides some initial observations on the possible effects of the Series, which seems to have provoked several important discussions and is on the agendas of several key players. Some examples of individual initiatives show ways to reduce waste and increase value in biomedical research. This momentum will probably move strongly across stakeholder groups, if collaborative relationships evolve between key players; further important work is needed to increase research value. A forthcoming meeting in Edinburgh, UK, will provide an initial forum within which to foster the collaboration needed.

Development quality criteria to evaluate nontherapeutic studies of incidence, prevalence, or risk factors of chronic diseases: Pilot study of new checklists

OBJECTIVE To develop two checklists for the quality of observational studies of incidence or risk factors of diseases. STUDY DESIGN AND SETTING Initial development of the checklists was based on a systematic literature review. The checklists were refined after pilot trials of validity and reliability were conducted by seven experts, who tested the checklists on 10 articles. RESULTS The checklist for studies of incidence or prevalence of chronic disease had six criteria for external validity and five for internal validity. The checklist for risk factor studies had six criteria for external validity, 13 criteria for internal validity, and two aspects of causality. A Microsoft Access database produced automated standardized reports about external and internal validities. Pilot testing demonstrated face and content validities and discrimination of reporting vs. methodological qualities. Interrater agreement was poor. The experts suggested future reliability testing of the checklists in systematic reviews with preplanned protocols, a priori consensus about research-specific quality criteria, and training of the reviewers. CONCLUSION We propose transparent and standardized quality assessment criteria of observational studies using the developed checklists. Future testing of the checklists in systematic reviews is necessary to develop reliable tools that can be used with confidence.

A systematic review of medical interventions for oral submucous fibrosis and future research opportunities.

Oral Diseases (2011) 17 (Suppl. 1), 42-57 Oral submucous fibrosis (OSF) is a chronic, insidious disease caused by areca nut use, and is associated with both significant morbidity (including pain and reduced oral opening) and an increased risk for malignancy. This systematic review explored and updated the current medical (i.e., non-surgical) interventions available for the management of OSF. Of the 27 published medical interventions, there were four randomized controlled trials. The overall quality of these randomized controlled studies was assessed using the GRADE approach and significant limitations that challenged the conclusions were found. However, this review was valuable in terms of identifying opportunities to provide recommendations for future research, in terms of the populations to research, the types of interventions needed, the types of outcomes to be measured, the study designs needed, and the infrastructure required to conduct studies. The next step is to initiate a pathway for a low-cost research plan leading to the development of a brief protocol for future clinical trials in this field, with an emphasis on conducting studies in regions of the world where OSF is prevalent.

Mouthrinses for the treatment of halitosis

Reason for withdrawal from publication Cochrane Oral Health withdrew this review as of Issue 5, 2016. This review is being updated and replaced following the publication of a new expanded protocol on the effects of different interventions for the management of halitosis (Pedrazzi V, do Nascimento C, Mardegan Issa JP, Fedorowicz Z. Interventions for managing halitosis (Protocol). Cochrane Database of Systematic Reviews 2016, Issue 5. Art. No.: CD012213. DOI: 10.1002/14651858.CD012213.). It will remain withdrawn when the new review is published.

When and how to update systematic reviews: consensus and checklist.

Updating of systematic reviews is generally more efficient than starting all over again when new evidence emerges, but to date there has been no clear guidance on how to do this. This guidance helps authors of systematic reviews, commissioners, and editors decide when to update a systematic review, and then how to go about updating the review.

Global Burden of Skin Disease as Reflected in Cochrane Database of Systematic Reviews

IMPORTANCE Research prioritization should be guided by impact of disease. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. MAIN OUTCOMES AND MEASURES Relationship of CDSR topic coverage (systematic reviews and protocols) with percentage of total 2010 DALYs, 2010 DALY rank, and DALY percentage change from 1990 to 2010 for 15 skin conditions. RESULTS All 15 skin conditions were represented by at least 1 systematic review in CDSR; 69% of systematic reviews and 67% of protocols by the CSG covered the 15 skin conditions. Comparing the number of reviews/protocols and disability, dermatitis, melanoma, nonmelanoma skin cancer, viral skin diseases, and fungal skin diseases were well matched. Decubitus ulcer, psoriasis, and leprosy demonstrated review/protocol overrepresentation when matched with corresponding DALYs. In comparison, acne vulgaris, bacterial skin diseases, urticaria, pruritus, scabies, cellulitis, and alopecia areata were underrepresented in CDSR when matched with corresponding DALYs. CONCLUSIONS AND RELEVANCE Degree of representation in CDSR is partly correlated with DALY metrics. The number of published reviews/protocols was well matched with disability metrics for 5 of the 15 studied skin diseases, while 3 skin diseases were overrepresented, and 7 were underrepresented. Our results provide high-quality and transparent data to inform future prioritization decisions.

Ibn Sina's Canon of Medicine: 11th century rules for assessing the effects of drugs

In his Al Hammadi Lecture at the Royal College of Physicians of Edinburgh, John Urquhart,1 professor of biopharmaceutical sciences at the University of California at San Francisco, contrasted Ibn Sinas Canon of Medicine (c. 1012) with Oslers Principles and Practice of Medicine.2 Urquhart asked himself which of the two books he would want if he was marooned and in need of a guide for practical medicine. He opted for Ibn Sinas Canon because the book presents an integrated view of surgery and medicine. Ibn Sina tells his readers, for example, how to judge the margin of healthy tissue to remove with an amputation.a In contrast, Osler shunned intervention in his Principles and Practice of Medicine. The enduring respect in the 21st century for a book written a millennium earlier is testimony to Ibn Sinas achievement.

An equity lens can ensure an equity-oriented approach to agenda setting and priority setting of Cochrane Reviews

OBJECTIVES This study aimed to develop and pilot an equity lens that could help researchers in developing a more equity-oriented approach toward priority setting and agenda setting in systematic reviews. STUDY DESIGN AND SETTING We developed an equity lens to guide the development and evaluation of a prioritization process and evaluate its outcomes based on the information derived from a discussion workshop and a comparison with the existing literature on the topic. We piloted the process section of the equity lens across the 13 structured priority-setting approaches in the Cochrane Collaboration. RESULTS We devised an equity lens with two checklists: one to guide the process of priority setting (nine questions) and the other to evaluate the outcomes of priority setting (eight questions). Of the nine questions, seven questions were partially addressed by at least one of the prioritization projects. Two questions were not considered in any of them. The prioritization projects did not report sufficient outcome data, thus we could not explore the eight question on evaluating outcomes. CONCLUSION Currently, there are few strategies in the Cochrane Collaboration that explicitly address the research priorities of individuals from different sociodemographic groups. The equity lens for priority setting and agenda setting can help project teams to develop a more equity-oriented approach to set a research agenda and/or prioritize research topics. However, further studies are needed to evaluate its impact on the prioritization process.