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Table 1 Summary of methodology used in each systematic review

From: A comparison between two recommendations to conduct and report systematic reviews on drug’s safety

Step/review A—Cochrane Collaboration B—Centre for Reviews and Dissemination
Introduction
 Background Description of the condition, description of the intervention, how the intervention might work, why it is important to do this research. Description of intervention, description of the condition, rationale for review.
 Eligibility criteria -Type of participants: patients for whom a PDE5 inhibitor is indicated in one of the three approved therapeutic indications.
-Type of interventions: PDE5 inhibitors (avanafil, lodenafil, mirodenafil, sildenafil, tadalafil, udenafil, and vardenafil) comparing with placebo, active treatment, or no treatment.
-Type of outcome measures: development of NAION.
-Population: patients for whom a PDE5 inhibitor is indicated in one of the three approved therapeutic indications.
-Intervention: PDE5 inhibitors (avanafil, lodenafil, mirodenafil, sildenafil, tadalafil, udenafil, and vardenafil).
-Comparators: placebo, active treatment, or no treatment.
-Outcomes: development of NAION.
 Review question PICO strategy: to assess the risk of NAION associated with PDE5 inhibitors exposure. A systematic review is carried out based on pre- and post-marketing data. PICO strategy: the objective of this systematic review is to assess the risk of NAION associated with PDE5 inhibitors exposure, based on pre- and post-marketing data.
Identifying evidence
 Type of studies Randomized controlled trials (RCT), cohort studies, case-control studies, case reports or series of cases, and spontaneous reports. Randomized controlled trials (RCT), cohort studies, case-control studies, case reports or series of cases, and spontaneous reports.
 Databases MEDLINE, EMBASE, Cochrane Controlled Register of Trials (CENTRAL), TRIP*, SCOPUS*, Google Scholar, Web of Science, Open Grey, International Clinical Trials Register Platform, and VigiBase. MEDLINE, EMBASE, Toxline, Pharmline*, websites of the manufacturers of drugs, and VigiBase.
 Search strategy Search terms comprised the drug name (including the pharmacotherapeutic class, international non-proprietary name (INN), and brand name) and the ophthalmic adverse drug reaction term. A combination of thesaurus terms and free terms was used. No filters were applied to the literature search. Search terms comprised the drug name (including the pharmacotherapeutic class, international non-proprietary name (INN), and brand name) and the ophthalmic adverse drug reaction term. A combination of thesaurus terms and free terms was used. No filters were applied to the literature search.
 Data selection Two researchers independently screened by hand the titles and abstracts and selected full articles for inclusion. Two researchers independently screened by hand the titles and abstracts and selected full articles for inclusion.
 Data extraction Data was extracted from each included study by two researchers independently. Data was extracted from each included study by two researchers independently.
 Quality assessment Included studies were independently assessed for bias according to the methods described in Chapter 13.5 and Chapter 14.6 of the Cochrane Handbook for Systematic Reviews of Interventions. For observational studies, the checklist proposed by Downs and Black was used.
The case reports were evaluated according to the questions elaborated on the Chapter 4 of the CRD’s guidance for undertaking reviews in health care.
 Data synthesis Data analysis followed the guidelines set out in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions. Data from case and spontaneous reports were analyzed using descriptive statistics. A meta-analysis was conducted to analyze data from observational studies.
Reporting
 Flowchart A predefined flowchart was used.
37 studies were included in the review, 4 observational studies and 33 case reports (and 608 spontaneous reports).
The PRISMA flowchart was used.
35 studies were included in the review, 4 observational studies and 31 case reports (and 608 spontaneous reports).
 Characteristics of studies A descriptive table was elaborated. The following information was extracted: reference, country, study design, population (number and demographic data), intervention (and comparator), number of individuals with the ophthalmic adverse drug reaction, risk factor, and medical history. A descriptive table was elaborated. The following information was extracted: reference, country, study design, population (number and demographic data), intervention (and comparator), number of individuals with the ophthalmic adverse drug reaction, risk factor, and medical history.
 Outcome analysis A meta-analysis was conducted to assess observational studies. A descriptive statistic was used for case reports and spontaneous reports. A meta-analysis was conducted to assess observational studies. A descriptive statistic was used for case reports and spontaneous reports.
 Quality assessment A table describing the results of risk of bias assessment was developed. A table describing the results of risk of bias assessment was developed.
 Discussion Summary of main results, overall completeness and applicability of evidence, potential biases in the review process, agreements and disagreements with other studies or reviews. Principal findings, comparison with other research, strengths and weaknesses of the research.
 Conclusion Implications for practice/research. Recommendations/implications for practice/further research.
 Funding A financial disclosure was described. A financial disclosure was described.
 Appendix Search strategy, list of included and excluded studies, Vigibase results, characteristics of studies and quality assessment results. Search strategy, list of included and excluded studies, Vigibase results, quality assessment results.
  1. *Databases not accessible to the authors of the reviews