BackgroundSystematic reviews of health interventions are increasingly incorporating evidence outside of randomized controlled trials (RCT). While non-randomized study (NRS) types may be more prone to bias compared to RCT, the tools used to evaluate risk of bias (RoB) in NRS are less straightforward and no gold standard tool exists. The objective of this study was to evaluate the planned use of RoB tools in systematic reviews of health interventions, specifically for reviews that planned to incorporate evidence from RCT and/or NRS.MethodsWe evaluated a random sample of non-Cochrane protocols for systematic reviews of interventions registered in PROSPERO between January 1 and October 12, 2018. For each protocol, we extracted data on the types of studies to be included (RCT and/or NRS) as well as the name and number of RoB tools planned to be used according to study design. We then conducted a longitudinal analysis of the most commonly reported tools in the random sample. Using keywords and name variants for each tool, we searched PROSPERO records by year since the inception of the database (2011 to December 7, 2018), restricting the keyword search to the “Risk of bias (quality) assessment” field.ResultsIn total, 471 randomly sampled PROSPERO protocols from 2018 were included in the analysis. About two-thirds (63%) of these planned to include NRS, while 37% restricted study design to RCT or quasi-RCT. Over half of the protocols that planned to include NRS listed only a single RoB tool, most frequently the Cochrane RoB Tool. The Newcastle-Ottawa Scale and ROBINS-I were the most commonly reported tools for NRS (39% and 33% respectively) for systematic reviews that planned to use multiple RoB tools. Looking at trends over time, the planned use of the Cochrane RoB Tool and ROBINS-I seems to be increasing.ConclusionsWhile RoB tool selection for RCT was consistent, with the Cochrane RoB Tool being the most frequently reported in PROSPERO protocols, RoB tools for NRS varied widely. Results suggest a need for more education and awareness on the appropriate use of RoB tools for NRS. Given the heterogeneity of study designs comprising NRS, multiple RoB tools tailored to specific designs may be required.

CONTEXT: Palivizumab prophylaxis is used as passive immunization for respiratory syncytial virus (RSV). However, because of its high cost, the value of this intervention is unclear. OBJECTIVE: To systematically review the cost-effectiveness of palivizumab prophylaxis compared with no prophylaxis in infants <24 months of age. DATA SOURCES: Medline, Embase, and Cochrane Library up to August 2018. STUDY SELECTION: Two reviewers independently screened results to include economic evaluations conducted between 2000 and 2018 from Organization for Economic Cooperation and Development countries. DATA EXTRACTION: Two reviewers independently extracted outcomes. Quality appraisal was completed by using the Joanna Briggs Institute checklist. Costs were adjusted to 2017 US dollars. RESULTS: We identified 28 economic evaluations (20 cost-utility analyses and 8 cost-effectiveness analyses); most were from the United States (n = 6) and Canada (n = 5). Study quality was high; 23 studies met >80% of the Joanna Briggs Institute criteria. Palivizumab prophylaxis ranged from a dominant strategy to having an incremental cost-effectiveness ratio of $2 526 203 per quality-adjusted life-year (QALY) depending on study perspective and targeted population. From the payer perspective, the incremental cost-effectiveness ratio for preterm infants (29–35 weeks’ gestational age) was between $5188 and $791 265 per QALY, with 90% of estimates <$50 000 per QALY. Influential parameters were RSV hospitalization reduction rates, palivizumab cost, and discount rate. LIMITATIONS: Model design heterogeneity, model parameters, and study settings were barriers to definitive conclusions on palivizumab’s economic value. CONCLUSIONS: Palivizumab as RSV prophylaxis was considered cost-effective in prematurely born infants, infants with lung complications, and infants from remote communities.

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Immunization with a safe and effective vaccine could hasten control of the coronavirus disease 2019 (COVID-19) pandemic and minimize morbidity, death and societal disruption that have resulted from it.Early release, published at www.cmaj.ca on November 3, 2020. Subject to revision. CMAJ GUIDELINETo achieve this objective, this guideline identifies key populations for early COVID-19 immunization. Sequencing of key populations will be determined once more information about SARS-CoV-2 vaccines is available from late-phase clinical trial data. At the time of writing, it is too early to tell how these vaccines will perform in terms of efficacy and duration of protection. These factors will be reflected in NACI's vaccine-specific guideline, which will be developed when vaccine(s) become authorized for use in Canada. ScopeNACI recommendations on key populations for early COVID-19 immunization apply to publicly funded immunization programs and not to individuals wishing to prevent COVID-19 with privately purchased vaccines. Although the target users for these recommendations are policy-makers (e.g., federal, provincial and territorial decision-makers for public health program planning), health care providers and the public are also users of NACI guidance.Specific recommendations for SARS-CoV-2 vaccines in key popu lations will depend on as yet unknown factors such as vaccine efficacy in different populations, the epidemiologic context at the time vaccine(s) become(s) accessible and total vaccine supply. When this information is available, NACI will provide additional evidence-informed guidance on options for COVID-19 immunization, which will inform publicly funded immunization programs, as well as individuals and health care providers wishing to advise their patients on options for publicly funded SARS-CoV-2 vaccines. NACI does not provide advice on vaccine stockpiling, procurement or allocation of vaccine among provinces and territories.