The nature of the intervention s and comparator s should be specified in detail. It is the sequence of interventions that is randomised. Cluster randomised trials A cluster randomised trial is a trial where clusters of people rather than single individuals are randomised to different interventions.
Methodological quality As previously stated, a review should be based on the best quality evidence available see Box 1. Therefore, if information from controlled trials is not available, cohort studies are eligible for inclusion provided that data from a comparison group are reported.
The essence of a systematic review lies in being systematic. For further information see Section 1. When non-English language literature is included in a review, its influence on the estimation and precision of effect may be explored in a sensitivity analysis.
However, the protocol should outline how heterogeneity will be explored and quantified, under what circumstances a meta-analysis would be considered appropriate and whether a fixed or random-effects model or both would be used.
Outcomes Study design The review question can be framed in terms of the population, intervention scomparator s and outcomes of the studies that will be included in the review. As with study selection the protocol should state the procedure for data extraction including the number of researchers who will extract the data and how discrepancies will be resolved.
Factors usually specified include the precise nature of the intervention e. Studies of adults where childhood retinoblastoma was followed up into adulthood. In the example in Box 1. Where appropriate, the approach to narrative synthesis should also be outlined. In reviews of one year or more duration, or reviews in rapidly evolving fields, provision for repeating the searches towards the end of the review process should also be considered.
Language The ideal for most systematic reviews is to include all available relevant evidence. Alternatively, they can include quasi-experimental or observational studies. The use of surrogate outcomes may be misleading, giving an over or underestimate of the true clinical outcome.
For example, whole clinics or geographical locations may be randomised to receive particular interventions, rather than individuals.
The protocol should specify the review question. To ensure that your work is efficient and effective, you should follow a clear process: Outcomes Any clinical outcome, including but not restricted to survival, progression-free survival, tumour response, preservation of the eye, visual acuity, disease remission and adverse effects.
Ideally a review should aim to include all relevant studies, regardless of publication status, in order to avoid publication bias. A young researcher's guide to a systematic review Series: Therefore researchers need to be clear about their own definitions and what elements are acceptable.
Language bias arises because studies with statistically significant results that have been conducted in non-English speaking countries may be more likely to be published in English language journals than those with nonsignificant results. Population The included population should be relevant to the population to which the review findings will be applied, and explicit inclusion criteria should be defined in terms of the disease or condition of interest.
Systematic reviews are regarded as the best source of research evidence.Writing Your Protocol Guidance notes for registering a systematic review protocol with PROSPERO This guide outlines the registration process for PROSPERO protocols, including full descriptions of each field on the registration form.
distillation of the Cochrane Handbook for Systematic Reviews of Interventions, review group policies, recommendations from the CPHG Editorial Team and also This is the program which you must use to write your protocol and later your review. It is free at both the protocol and the review stage to help you identify the impact of.
Writing a protocol for a Cochrane Systematic Review: Athens, Greece This is the 5th workshop organized in Athens, Greece by members (authors and editors) of the Cochrane Gynaecology and Fertility Group, and the Gynaecological, Neuro-oncology.
Systematic Reviews requires the submission of a populated PRISMA-P checklist for all study protocols.
The checklist should be provided as an additional file and should be referenced in the text. Submissions received without this element will be returned to the authors as. Appendix 1 Systematic Review Protocol Example: Smoking Cessation Interventions and Strategies for Hospitalised Patients J.
Briggs Background Smoking has been identiﬁed as the primary cause of avoidable death and disease. protocol is entitled “Systematic review to evaluate the evidence for an association between perfluorooctanoic. acid (PFOA) or perfluorooctane sulfonate (PFOS) exposure and immunotoxicity.” These two case studies will be.
conducted as guidance for .Download