Background Data extraction forms link systematic reviews with primary research and provide the foundation for appraising, analysing, summarising and interpreting a body of evidence. This makes their development, pilot testing and use a crucial part of the systematic reviews process. Several studies have shown that data extraction errors are frequent in systematic reviews, especially regarding outcome data. Methods We reviewed guidance on the development and pilot testing of data extraction forms and the data extraction process. We reviewed four types of sources: 1) methodological handbooks of systematic review organisations (SRO); 2) textbooks on conducting systematic reviews; 3) method documents from health technology assessment (HTA) agencies and 4) journal articles. HTA documents were retrieved in February 2019 and database searches conducted in December 2019. One author extracted the recommendations and a second author checked them for accuracy. Results are presented descriptively. Results Our analysis includes recommendations from 25 documents: 4 SRO handbooks, 11 textbooks, 5 HTA method documents and 5 journal articles. Across these sources the most common recommendations on form development are to use customized or adapted standardised extraction forms (14/25); provide detailed instructions on their use (10/25); ensure clear and consistent coding and response options (9/25); plan in advance which data are needed (9/25); obtain additional data if required (8/25); and link multiple reports of the same study (8/25). The most frequent recommendations on piloting extractions forms are that forms should be piloted on a sample of studies (18/25); and that data extractors should be trained in the use of the forms (7/25). The most frequent recommendations on data extraction are that extraction should be conducted by at least two people (17/25); that independent parallel extraction should be used (11/25); and that procedures to resolve disagreements between data extractors should be in place (14/25). Conclusions Overall, our results suggest a lack of comprehensiveness of recommendations. This may be particularly problematic for less experienced reviewers. Limitations of our method are the scoping nature of the review and that we did not analyse internal documents of health technology agencies.
Background: Evidence syntheses provide the basis for evidence-based decision making in healthcare. To judge the certainty of findings for the specific decision context evidence syntheses should consider context suitability (ie, generalizability, external validity, applicability or transferability). Our objective was to determine the status quo and to provide a comprehensive overview of existing methodological recommendations of Health Technology Assessment (HTA) and Systematic Review (SR) producing organizations in assessing context suitability of evidence on effectiveness of health care interventions. Additionally, we analyzed similarities and differences between the recommendations. Methods: In this Integrative Review we performed a structured search for methods documents from evidence synthesis producing organizations that include recommendations on appraising context suitability in effectiveness assessments. Two reviewers independently selected documents according to predefined eligibility criteria. Data were extracted in standardized and piloted tables by one reviewer and verified by a second reviewer. We performed a thematic analysis to identify and summarize the main themes and categories regarding recommended context suitability assessments. Results: We included 14 methods documents of 12 organizations in our synthesis. Assessment approaches are very heterogeneous both regarding the general concepts (eg, integration in the evidence synthesis preparation process) and the content of assessments (eg, assessment criteria). Conclusion: Some heterogeneity seems to be justified because of the need to tailor the assessment to different settings and medical areas. However, most differences were inexplicable. More harmonization is desirable and appears possible.
Background Previous research on data extraction methods in systematic reviews has focused on single aspects of the process. We aimed to provide a deeper insight into these methods by analysing a current sample of reviews. Methods We included systematic reviews of health interventions in humans published in English. We analysed 75 Cochrane reviews from May and June 2020 and a random sample of non-Cochrane reviews published in the same period and retrieved from Medline. We linked reviews with protocols and study registrations. We collected information on preparing, piloting, and performing data extraction and on use of software to assist review conduct (automation tools). Data were extracted by one author, with 20% extracted in duplicate. Data were analysed descriptively. Results Of the 152 included reviews, 77 reported use of a standardized extraction form (51%); 42 provided information on the type of form used (28%); 24 on piloting (16%); 58 on what data was collected (38%); 133 on the extraction method (88%); 107 on resolving disagreements (70%); 103 on methods to obtain additional data or information (68%); 52 on procedures to avoid data errors (34%); and 47 on methods to deal with multiple study reports (31%). Items were more frequently reported in Cochrane than non-Cochrane reviews. The data extraction form used was published in 10 reviews (7%). Use of software was rarely reported except for statistical analysis software and use of RevMan and GRADEpro GDT in Cochrane reviews. Covidence was the most frequent automation tool used: 18 reviews used it for study selection (12%) and 9 for data extraction (6%). Conclusions Reporting of data extraction methods in systematic reviews is limited, especially in non-Cochrane reviews. This includes core items of data extraction such as methods used to manage disagreements. Few reviews currently use software to assist data extraction and review conduct. Our results can serve as a baseline to assess the uptake of such tools in future analyses.
Registration: PROSPERO: CRD42020210645 Introduction: We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control. Methods: We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses. Results: We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89–1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01–1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75–1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas. Plain language summary Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes Introduction: We performed the review to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older type 2 diabetes patients with blood sugar outside the normal level. Methods: To answer the question, we searched various electronic databases. We included studies in older (⩾65 years) patients with type 2 diabetes that assessed the safety of DPP-4 inhibitors. The data from the different studies were quantitatively summarized using statistical methods. We assessed the quality of the data to judge the certainty of the findings. Results: We identified 16 studies that included 19,317 patients with a mean age greater than 70 years. The average blood sugar level of patients in the included studies was slightly or moderately increased. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia, but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas. DPP-4s probably reduce the risk of hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase the risk that blood sugar falls below normal. Adding DPP-4 inhibitorss to standard care in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case additional treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.
Objective For assessing cost-effectiveness, Health Technology Assessment (HTA) organisations may use primary economic evaluations (P-HEs) or Systematic Reviews of Health Economic evaluations (SR-HEs). A prerequisite for meaningful results of SR-HEs is that the results from existing P-HEs are transferable to the decision context (e.g, HTA jurisdiction). A particularly pertinent issue is the high variability of costs and resource needs across jurisdictions. Our objective was to review the methods documents of HTA organisations and compare their recommendations on considering transferability in SR-HE. Methods We systematically hand searched the webpages of 158 HTA organisations for relevant methods documents from 8th January to 31st March 2019. Two independent reviewers performed searches and selected documents according to pre-defined criteria. One reviewer extracted data in standardised and piloted tables and a second reviewer checked them for accuracy. We synthesised data using tabulations and in a narrative way. Results We identified 155 potentially relevant documents from 63 HTA organisations. Of these, 7 were included in the synthesis. The included organisations have different aims when preparing a SR-HE (e.g. to determine the need for conducting their own P-HE). The recommendations vary regarding the underlying terminology (e.g. transferability/generalisability), the assessment approaches (e.g. structure), the assessment criteria and the integration in the review process. Conclusion Only few HTA organisations address the assessment of transferability in their methodological recommendations for SR-HEs. Transferability considerations are related to different purposes. The assessment concepts and criteria are heterogeneous. Developing standards to consider transferability in SR-HEs is desirable.
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