Reiniging, desinfectie en sterilisatie (herbruikbare) medische hulpmiddelen - Module 8 Quality-assessment-tabel

Table of quality assessment for systematic reviews of diagnostic studies

Based on AMSTAR checklist (Shea et al.; 2007, BMC Methodol 7: 10; doi:10.1186/1471-2288-7-10) and PRISMA checklist (Moher et al 2009, PLoS Med 6: e1000097; doi:10.1371/journal.pmed1000097)

Research question:

Study First author, year	Appropriate and clearly focused question?1 Yes/no/unclear	Comprehensive and systematic literature search?2 Yes/no/unclear	Description of included and excluded studies?3 Yes/no/unclear	Description of relevant characteristics of included studies?4 Yes/no/unclear	Assessment of scientific quality of included studies?5 Yes/no/unclear	Enough similarities between studies to make combining them reasonable?6Yes/no/unclear	Potential risk of publication bias taken into account?7 Yes/no/unclear	Potential conflicts of interest reported?8 Yes/no/unclear
Olafsdottir, 2017	Yes	Yes	Yes	Yes	Yes. Risk of bias was present in the included studies - Risk of design bias The studies were conducted in high-volume centers. High-volume institutions might have more proficient reprocessing staff with higher quality of cleaning. - It is unclear if the age and condition of the duodenoscopes affected the relationship between ATP Adenosinetrifosfaat (Adenosinetrifosfaat) RLU Relative Light Unit (Relative Light Unit) and culture results -Sampling bias: convenience sampling only -Misclassification bias: different cut-offs used	Not relevant. Studies were not pooled	Yes	Yes In 2 of the studies, the authors reported a potential conflict of interest as a consultant, inventor of a proprietary ATP-related testing assay, and/or invited speaker sponsored by a company involved with duodenoscopes or ATP testing assays (Olympus and 3M)

1. Research question (PICO) and inclusion criteria should be appropriate (in relation to the research question to be answered in the clinical guideline) and predefined.
2. Search period and strategy should be described; at least Medline searched.
3. Potentially relevant studies that are excluded at final selection (after reading the full text) should be referenced with reasons.
4. Characteristics of individual studies relevant to the research question (PICO) should be reported.
5. Quality of individual studies should be assessed using a quality scoring tool or checklist (preferably QUADAS-2; COSMIN checklist for measuring instruments) and taken into account in the evidence synthesis.
6 Clinical and statistical heterogeneity should be assessed; clinical: enough similarities in patient characteristics, diagnostic tests (strategy) to allow pooling? For pooled data: at least 5 studies available for pooling; assessment of statistical heterogeneity and, more importantly (see Note), assessment of the reasons for heterogeneity (if present)? Note: sensitivity and specificity depend on the situation in which the test is being used and the thresholds that have been set, and sensitivity and specificity are correlated; therefore, the use of heterogeneity statistics (p-values; I²) is problematic, and rather than testing whether heterogeneity is present, heterogeneity should be assessed by eye-balling (degree of overlap of confidence intervals in Forest plot), and the reasons for heterogeneity should be examined.
7. There is no clear evidence for publication bias in diagnostic studies, and an ongoing discussion on which statistical method should be used. Tests to identify publication bias are likely to give false-positive results, among available tests, Deeks’ test is most valid. Irrespective of the use of statistical methods, you may score “Yes” if the authors discuss the potential risk of publication bias.
8. Sources of support (including commercial co-authorship) should be reported in both the systematic review and the included studies. Note: To get a “yes,” source of funding or support must be indicated for the systematic review AND for each of the included studies.