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. |