Systematic Reviews and Meta-Analysis of Prognosis Studies (REVAMP): development of core methods, reporting guidelines and a methodology handbook

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Healthcare research is in an exciting new phase. Researchers now have access to large amounts of information to link an individual's characteristics (such as age, family history or genetic information) with health outcomes (such as death, pain level, depression score). Researchers are using this information to help health professionals and patients understand and predict future outcomes. Such research is called prognosis research, and covers four types: overall prognosis (what is the average outcome risk in a population?), prognostic factors (what characteristics of patients help understand their outcome risk?), prognostic models (can we predict an individual's risk using multiple prognostic factors?), and predictors of treatment effect (can we predict which treatments work best for individual patients?). Prognosis research findings allow health professionals to more accurately predict and therefore intervene to improve the health outcomes of individuals.Thousands of prognosis studies are published each year, and many have unclear or contradictory findings. This makes it difficult for healthcare professionals to know how best to use these findings to improve the care of their patients. This motivates the need for systematic reviews of prognosis studies. These aim to identify all existing prognosis studies on a particular topic, and to appraise their quality and, if appropriate, combine their results (using meta-analysis) to provide overall answers for healthcare professionals. Systematic review methods are well-established in other areas of medical research, but are only just emerging for prognosis research. In our project, we will develop and make freely available reliable methods to undertake systematic reviews of prognosis studies. We have named this initiative REVAMP, which stands for Systematic Reviews and Meta-Analysis of Prognosis Studies.We propose a series of five work projects (WPs) to be delivered by researchers with considerable expertise in prognosis research and systematic reviews. In WP1, we will develop and disseminate guidance for reviews of overall prognosis; which aim to provide a summary of the average risk in a particular population (e.g. those diagnosed with breast cancer). A step-by-step guide will be produced, covering aspects such as searching for relevant studies, data extraction, critical appraisal, and meta-analysis. Clear reporting is essential for those interpreting, critically appraising, and implementing prognosis research findings. However, no reporting guidelines currently exist for systematic reviews of prognosis studies. Therefore, in WP2 we will provide three reporting guidelines (checklists) for prognosis reviews: one for each of overall prognosis, prognostic factors and prognostic models. These will be developed through a consensus process involving researchers, healthcare professionals, organisations developing clinical guidelines, and patients.In WP3 and 5, we will develop new ways for researchers to calculate how many individuals are needed for a prognosis study. Current studies are often too small and so may have misleading results. We will use mathematical techniques to produce a new way to calculate sample size, so that it will be easier to judge (i) whether an existing prognostic model study was large enough to be fit-for-purpose, and (ii) what size a new prognosis study needs to be to contribute usefully to a future updated review. In WP4 we will produce step-by-step guidance for conducting reviews of predictors of treatment effect, particularly how to do critical appraisal and meta-analysis when the aim is to summarise whether a treatment's effect depends on patient characteristics such as age.Our project's findings will be disseminated in a Methodology Handbook for Prognosis Reviews and through a new UK-based research training course, in addition to publications in journals and via blogs and tutorial videos at websites including www.prognosisresearch.com.