Background With the exponential growth of published systematic reviews (SR), there is a high potential for overlapping and redundant duplication of work. Prospective protocol registration gives the opportunity to assess the added value of a new study or review, thereby potentially reducing research waste and simultaneously increasing transparency and research quality. The PROSPERO database for SR protocol registration was launched 10 years ago. This study aims to assess the proportion SRs of intervention studies with a protocol registration (or publication) and explore associations of SR characteristics with protocol registration status. Methods PubMed was searched for SRs of human intervention studies published in January 2020 and January 2021. After random-stratified sampling and eligibility screening, data extraction on publication and journal characteristics, and protocol registration status, was performed. Both descriptive and multivariable comparative statistical analyses were performed. Results A total of 357 SRs (2020: n = 163; 2021: n = 194) were included from a random sample of 1267 publications. Of the published SRs, 38% had a protocol. SRs that reported using PRISMA as a reporting guideline had higher odds of having a protocol than publications that did not report PRISMA (OR 2.71; 95% CI: 1.21 to 6.09). SRs with a higher journal impact factor had higher odds of having a protocol (OR 1.12; 95% CI 1.04 to 1.25). Publications from Asia had a lower odds of having a protocol (OR 0.43; 95% CI 0.23 to 0.80, reference category = Europe). Of the 33 SRs published in journals that endorse PROSPERO, 45% did not have a protocol. Most SR protocols were registered in PROSPERO (n = 129; 96%). Conclusions We found that 38% of recently published SRs of interventions reported a registered or published protocol. Protocol registration was significantly associated with a higher impact factor of the journal publishing the SR and a more frequent self-reported use of the PRISMA guidelines. In some parts of the world, SR protocols are more often registered or published than others. To guide strategies to increase the uptake of SR protocol registration, further research is needed to gain understanding of the benefits and informativeness of SRs protocols among different stakeholders. Systematic review registration osf.io/9kj7r/
Background Patients with chronic kidney disease (CKD) require a personalised strategy for cardiovascular risk management (CVRM) to reduce their high risk of cardiovascular morbidity and mortality. Despite their high risk, patients with CKD appear to be underrepresented in randomised controlled trials (RCTs) for pharmacological CVRM interventions to reduce cardiovascular risk (pharmacological CVRM interventions). As a result, it remains unclear whether the efficacy of these interventions found in patients without CKD is similarly applicable to patients with CKD. This evidence map aims to provide an overview of the availability of the evidence from pharmacological CVRM trials for patients with CKD by assessing how often patients with reduced kidney function are specifically excluded or included from RCTs on pharmacological CVRM interventions and whether studies report efficacy estimates of interventions specifically for kidney patients. Methods We will perform a systematic literature search in ClinicalTrials.gov to identify relevant planned, ongoing, and completed RCTs on a broad range of CVRM medications after which we will retrieve the published protocols and papers via ClinicalTrials.gov itself, Embase, MEDLINE, or Google Scholar. We will include RCTs that investigate the efficacy of platelet inhibitors, anticoagulants, antihypertensives, glucose-lowering medication, and lipid-lowering medication on all-cause mortality, cardiovascular mortality, cardiovascular morbidity, and end-stage kidney disease in patients with a cardiovascular history or a major risk factor for cardiovascular disease. Two reviewers will independently screen trial records and their corresponding full-text publications to determine eligibility and extract data. Outcomes of interest are the exclusion of patients with reduced kidney function from RCTs and whether the study population was restricted to kidney patients or subgroup analyses were performed on kidney function. Results will be visualised in an evidence map. Discussion The availability of evidence on the efficacy and safety of pharmacological CVRM interventions in patients with CKD might be limited. Hence, we will identify knowledge gaps for future research. At the same time, the availability of evidence, or lack thereof, might warrant caution from healthcare decision-makers in making strong recommendations based on the extrapolation of results from studies to patients who were explicitly excluded from participation. Systematic review registration PROSPERO CRD42022296746.
Rationale: Pulmonary rehabilitation (PR) has major benefits for patients with chronic obstructive pulmonary disease (COPD). The availability of PR in Canada is low. To facilitate implementation, a standardized and enhanced PR Program has been developed with a self-management education intervention that has been validated and shown to be effective. The objectives of our study were to assess the implementation of this program into a single site; determine the sustainability 18 months after implementation; and to identify the satisfaction with, facilitators of and barriers to implementation and sustainability of the program as perceived by patients with COPD and HCPs. Methods: We conducted a prospective pre-post study which consisted of two phases: 1) the implementation phase (first six months after implementation) and 2) the sustainability phase (18 months after implementation). Guided by the RE-AIM framework, outcomes including: Reach (number of patients enrolled and demographics), Effectiveness (Change in patient outcomes), Adoption (HCPs' characteristics), Implementation (Program fidelity) and Maintenance (Patient outcomes at 3-month follow-up). Additional outcomes were: satisfaction with, facilitators of and barriers to implementation and sustainability of the program as perceived by patients with COPD and HCPs. Results: Reach -Twenty-six patients were included for both phases (two different samples). Effectiveness -Clinically important improvements in patient outcomes were found for functional exercise capacity, knowledge, functional status and selfefficacy in both phases of the study (See table). Adoption -All HCPs involved in PR (N=8) agreed to participate and used the program in both phases of the study. Implementation -Fidelity for the group education sessions ranged from 76-95% in the implementation phase and from 82-88% in the sustainability phase. Maintenance -Clinical important improvements at 3-month follow-up measured in the implementation phase were found in knowledge, self-efficacy for exercise and walking. Satisfaction -Patients and HCPs were highly satisfied with the program. 'Lack of time' was reported as the most common barrier and 'having longstanding procedures' as the most common facilitator by HCPs to implementation and sustainability of the program.Conclusions: The enhanced PR program was accepted by the patients and HCPs and could be reliably implemented and maintained at a single expert center. The program provided clinical benefits for patients in terms of functional capacity, knowledge and self-efficacy for walking. These findings will guide planning for wide scale dissemination and implementation of the program.
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