Gian Paolo Morgano

Vitamin D supplementation in primary allergy prevention: Systematic review of randomized and non-randomized studies

To date, a systematic review of the evidence regarding the association between vitamin D and allergic diseases development has not yet been undertaken.

A systematic survey of the methods literature on the reporting quality and optimal methods of handling participants with missing outcome data for continuous outcomes in randomized controlled trials

OBJECTIVE To conduct (1) a systematic survey of the reporting quality of simulation studies dealing with how to handle missing participant data (MPD) in randomized control trials and (2) summarize the findings of these studies. STUDY DESIGN AND SETTING We included simulation studies comparing statistical methods dealing with continuous MPD in randomized controlled trials addressing bias, precision, coverage, accuracy, power, type-I error, and overall ranking. For the reporting of simulation studies, we adapted previously developed criteria for reporting quality and applied them to eligible studies. RESULTS Of 16,446 identified citations, the 60 eligible generally had important limitations in reporting, particularly in reporting simulation procedures. Of the 60 studies, 47 addressed ignorable and 32 addressed nonignorable data. For ignorable missing data, mixed model was most frequently the best on overall ranking (9 times best, 34.6% of times tested) and bias (10, 55.6%). Multiple imputation was also performed well. For nonignorable data, mixed model was most frequently the best on overall ranking (7, 46.7%) and bias (8, 57.1%). Mixed model performance varied on other criteria. Last observation carried forward (LOCF) was very seldom the best performing, and for nonignorable MPD frequently the worst. CONCLUSION Simulation studies addressing methods to deal with MPD suffered from serious limitations. The mixed model approach was superior to other methods in terms of overall performance and bias. LOCF performed worst.Please cite this article as: Zhang Y, Alyass A, Vanniyasingam T, Sadeghirad B, Flórez ID, Pichika SC, Kennedy SA, Abdulkarimova U, Zhang Y, Iljon T, Morgano GP, Colunga Lozano LE, Aloweni FAB, Lopes LC, Yepes-Nuñez JJ, Fei Y, Wang L, Kahale LA, Meyre D, Akl EA, Thabane L, Guyatt G, Reporting quality and optimal methods of handling participants with missing outcome data for continuous outcomes in randomized controlled trials: a systematic survey of the methods literature, Journal of Clinical Epidemiology (2017), doi: 10.1016/j.jclinepi.2017.05.016.

Comet Assay in Cancer Chemoprevention

The comet assay can be useful in monitoring DNA damage in single cells caused by exposure to genotoxic agents, such as those causing air, water, and soil pollution (e.g., pesticides, dioxins, electromagnetic fields) and chemo- and radiotherapy in cancer patients, or in the assessment of genoprotective effects of chemopreventive molecules. Therefore, it has particular importance in the fields of pharmacology and toxicology, and in both environmental and human biomonitoring. It allows the detection of single strand breaks as well as double-strand breaks and can be used in both normal and cancer cells. Here we describe the alkali method for comet assay, which allows to detect both single- and double-strand DNA breaks.

Prebiotics for the prevention of allergies: A systematic review and meta-analysis of randomized controlled trials

Prevalence of allergic diseases in infants is approximately 10% reaching 20 to 30% in those with an allergic first‐degree relative. Prebiotics are selectively fermented food ingredients that allow specific changes in composition/activity of the gastrointestinal microflora. They modulate immune responses, and their supplementation has been proposed as an intervention to prevent allergies.

Dissemination of Clinical Practice Guidelines : A Content Analysis of Patient Versions

Background. Clinical practice guidelines (CPGs) are typically written for health care professionals but are meant to assist patients with health care decisions. A number of guideline producers have started to develop patient versions of CPGs to reach this audience. Objective. To describe the content and purpose of patient versions of CPGs and compare with patient and public views of CPGs. Design. A descriptive qualitative study with a directed content analysis of a sample of patient versions of CPGs published and freely available in English from 2012 to 2014. Results. We included 34 patient versions of CPGs from 17 guideline producers. Over half of the patient versions were in dedicated patient sections of national/professional agency websites. There was essentially no information about how to manage care in the health care system. The most common purpose was to equip people with information about disease, tests or treatments, and recommendations, but few provided quantitative data about benefits and harms of treatments. Information about beliefs, values and preferences, accessibility, costs, or feasibility of the interventions was rarely addressed. Few provided personal stories or scenarios to personalize the information. Three versions described the strength of the recommendation or the level of evidence. Limitations. Our search for key institutions that produce patient versions of guidelines was comprehensive, but we only included English and freely available versions. Future work will include other languages. Conclusions. This review describes the current landscape of patient versions of CPGs and suggests that these versions may not address the needs of their targeted audience. Research is needed about how to personalize information, provide information about factors contributing to the recommendations, and provide access.

GRADE Evidence to Decision (EtD) framework: un approccio sistematico e trasparente per prendere decisioni informate in ambito sanitario. 1: Introduzione

Following the development of a unifying and transparent approach to grading the certainty of evidence and strength or recommendations, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group has refined its process of moving from Evidence to Decisions. The purpose of its new Evidence to Decision (EtD) frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions. EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences. EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context.Following the development of a unifying and transparent approach to grading the certainty of evidence and strength or recommendations, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group has refined its process of moving from Evidence to Decisions. The purpose of its new Evidence to Decision (EtD) frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions. EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences. EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context.

A systematic survey on reporting and methods for handling missing participant data for continuous outcomes in randomized controlled trials

OBJECTIVE To assess analytic approaches randomized controlled trial (RCT) authors use to address missing participant data (MPD) for patient-important continuous outcomes. STUDY DESIGN AND SETTING We conducted a systematic survey of RCTs published in 2014 in the core clinical journals that reported at least one patient-important outcome analyzed as a continuous variable. RESULTS Among 200 studies, 187 (93.5%) trials explicitly reported whether MPD occurred. In the 163 (81.5%) trials that reported the occurrence of MPD, the median and interquartile ranges of the percentage of participants with MPD were 11.4% (2.5%-22.6%).Among the 147 trials in which authors made clear their analytical approach to MPD, the approaches chosen included available data only (109, 67%); mixed-effect models (10, 6.1%); multiple imputation (9, 4.5%); and last observation carried forward (9, 4.5). Of the 163 studies reporting MPD, 16 (9.8%) conducted sensitivity analyses examining the impact of the MPD and (18, 11.1%) discussed the risk of bias associated with MPD. CONCLUSION RCTs reporting continuous outcomes typically have over 10% of participant data missing. Most RCTs failed to use optimal analytic methods, and very few conducted sensitivity analyses addressing the possible impact of MPD or commented on how MPD might influence risk of bias.Yuqing Zhang, Ivan D. Flórez, Luis E. Colunga Lozano, Fazila Abu Bakar Aloweni, Sean Alexander Kennedy, Aihua Li, Samantha Craigie, Shiyuan Zhang, Arnav Agarwal, Luciane C. Lopes, Tahira Devji, Wojtek Wiercioch, John J. Riva, Mengxiao Wang, Xuejing Jin, Yutong Fei, Paul Alexander, Gian Paolo Morgano, Yuan Zhang, Alonso Carrasco-Labra, Lara A. Kahale, Elie A. Akl, Holger J. Schünemann, Lehana Thabane, Gordon Guyatt

Dissemination of Clinical Practice Guidelines

Background. Clinical practice guidelines (CPGs) are typically written for health care professionals but are meant to assist patients with health care decisions. A number of guideline producers have started to develop patient versions of CPGs to reach this audience. Objective. To describe the content and purpose of patient versions of CPGs and compare with patient and public views of CPGs. Design. A descriptive qualitative study with a directed content analysis of a sample of patient versions of CPGs published and freely available in English from 2012 to 2014. Results. We included 34 patient versions of CPGs from 17 guideline producers. Over half of the patient versions were in dedicated patient sections of national/professional agency websites. There was essentially no information about how to manage care in the health care system. The most common purpose was to equip people with information about disease, tests or treatments, and recommendations, but few provided quantitative data about benefits and harms of treatments. Information about beliefs, values and preferences, accessibility, costs, or feasibility of the interventions was rarely addressed. Few provided personal stories or scenarios to personalize the information. Three versions described the strength of the recommendation or the level of evidence. Limitations. Our search for key institutions that produce patient versions of guidelines was comprehensive, but we only included English and freely available versions. Future work will include other languages. Conclusions. This review describes the current landscape of patient versions of CPGs and suggests that these versions may not address the needs of their targeted audience. Research is needed about how to personalize information, provide information about factors contributing to the recommendations, and provide access.

Dissemination of clinical practice guidelines: A content analysis of patient versions (Forthcoming/Available Online)

Background. Clinical practice guidelines (CPGs) are typically written for health care professionals but are meant to assist patients with health care decisions. A number of guideline producers have started to develop patient versions of CPGs to reach this audience. Objective. To describe the content and purpose of patient versions of CPGs and compare with patient and public views of CPGs. Design. A descriptive qualitative study with a directed content analysis of a sample of patient versions of CPGs published and freely available in English from 2012 to 2014. Results. We included 34 patient versions of CPGs from 17 guideline producers. Over half of the patient versions were in dedicated patient sections of national/professional agency websites. There was essentially no information about how to manage care in the health care system. The most common purpose was to equip people with information about disease, tests or treatments, and recommendations, but few provided quantitative data about benefits and harms of treatments. Information about beliefs, values and preferences, accessibility, costs, or feasibility of the interventions was rarely addressed. Few provided personal stories or scenarios to personalize the information. Three versions described the strength of the recommendation or the level of evidence. Limitations. Our search for key institutions that produce patient versions of guidelines was comprehensive, but we only included English and freely available versions. Future work will include other languages. Conclusions. This review describes the current landscape of patient versions of CPGs and suggests that these versions may not address the needs of their targeted audience. Research is needed about how to personalize information, provide information about factors contributing to the recommendations, and provide access.

Guidelines 2.0: Sviluppo sistematico di una checklist per la realizzazione di linee-guida affidabili

Introduction Guideline developers worldwide are struggling with the lack of guidance for the practical steps in the guideline enterprise. Our objective was to systematically compile a comprehensive checklist of items linked to relevant resources and tools that guideline developers would consider for development and support of implementation. Methods Data sources included manuals of international guideline developers, literature on guidelines for guidelines with a focus on international and national guideline agencies, professional societies, and recent systematic guidance articles. We reviewed these sources in duplicate, extracted items using a sensitive approach and developed overarching topics that are relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions. Results We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers (http://cebgrade.mcmaster.ca/guidecheck.html). The topics and items included cover all stages of the guideline enterprise, from planning to formulating recommendations, to dissemination and evaluation. The final itemized guideline development checklist (GDC) includes links to training material and resources for methodology. Conclusions The GDC will serve as a resource for those involved in guideline development and we will use crowdsourcing to keep the checklist up to date and enhance it.