Table 1Reporting items for systematic reviews of implantable medical devices

Reporting ItemDefinition for Adequate Reporting
Items for Key Question 1
Search termsKeywords for identifying relevant studies for the research questions (i.e., population, interventions, comparator, outcomes, and study design [PICOD]), or complete search strategy (e.g., keywords, medical subject headings) were described or referred to elsewhere.
Searches in multiple databasesSearch was conducted in more than one electronic database.
Search yearsTime period of the articles searched and included was explicitly described.
Searches in multiple languagesSearch was conducted in English and other languages.
Searching for unpublished dataAuthors explicitly stated the efforts to include unpublished data (e.g., contact with study authors, searching meeting abstracts or conference preceding, dissertations, etc.[also known as a “grey literature” search]).
Inclusion or exclusion criteriaDefinitions of at least two of the PICOD criteria (e.g., randomized controlled trials of drug-eluting stents were included) were reported.
Baseline description of the populationHealth status of the population at baseline (i.e., hypertension, diabetes, or coronary artery disease).
Types of interventions/exposuresInterventions or exposures were described (usually includes device name, or a brief description, or type of device).
Types of comparatorsComparators were described (can include another device, or medical treatment, or surgical treatment).
Types of outcomesOutcomes or endpoints were defined.
Types of study designsDesign of the included studies was described.
Number of included and excluded studiesNumber of eligible and ineligible studies identified from the search was reported.
Reasons for exclusionReasons for exclusions were described.
Flow diagram for the number of included and excluded studiesA flow diagram showing the progress of study selection was presented.
The total number of primary studies included in the systematic review/meta-analysisThe total number of studies that met inclusion criteria (often reported in the text, tables, or figures).
Graphical presentation of the resultsGraphics (e.g., forest plots, trends in outcomes over time, and regression plots) summarizing individual study estimates and overall estimates were presented.
Meta-analyses were performedDescription of whether a meta-analysis was performed.
Costs or cost-effectivenessSpecific discussion of costs of devices or analyses of cost-effectiveness.
Items for Key Question 2
Device or operator-specific
Data on differences across device characteristics were discussedWhen multiple devices are used, the differences among devices (e.g., sirolimus-eluting stents, paclitaxel-eluting stents, or bare-metal stents) were discussed across primary studies included.
Data on differences within device characteristics were discussedDifferences within devices (e.g., differences in programming within implantable cardiac defibrillator) were discussed across primary studies included.
Evolution of devices over time were discussedDiscussions within systematic reviews about evolution (change or development) of devices across primary studies evaluated.
Details of training/certification of operator were reportedDetails within systematic reviews can include training, prior experience in procedures performed, or any other performance standards.
Ramp-up in provider technique (i.e. learning curve) was discussedThere was a relevant discussion about how the surgeon's experience with the device may affect outcomes.
Level of expertise of team/site were consideredDiscussions were made related to the levels of expertise of a team within hospital where operators practice that may impact outcomes.
Practitioner variability were discussedVariability among operators because different sets of operators are involved in each arm of the trial was discussed.
“Volume at sites” effect were discussedThere was a relevant discussion about how site experience with the device may affect outcomes.
Items for Key Question 3
Handling of heterogeneity
Models for meta-analyses were reportedThe methods of combining estimates (e.g., fixed- or random-effects models) were reported.
Meta-analyses used accepted methodologyAccepted methods were used when two or more studies were combined in meta-analysis or five studies or more studies were included in meta-regression analyses. Additionally studies were grouped by design or studies were grouped across similar interventions.
Heterogeneity was assessed or discussedSources of heterogeneity within population or among devices were discussed or quantified using statistical methods.
Sensitivity analyses were assessedDetails of the range of treatment estimates and confidence intervals resulting from the various sensitivity analyses were described.
Results by subgroups were considered or quantifiedPotentially important subgroup results were discussed (qualitatively) or quantified using accepted methods.
Items for Key Question 4
Assessment of risk of biasPotential impacts of the biases present in included primary studies were evaluated.
Publication bias was assessedQuantitative assessment of publication bias (e.g., funnel plot, Begg and Egger tests) was used.
Use of specific checklist for quality itemsThe list of quality items for the validity (or quality) assessment of studies were applied and reported for each included study.
Study limitations were describedSpecific limitations either relating to primary studies or relating to the systematic review methodology were described.
Overall strength of the body of evidence was assessedSpecific methods were used to assess the overall body of evidence (i.e., other than for example “strong evidence”).
Specific future research recommendations were madeSpecific suggestions for future research agenda (i.e., other than “more research is needed”) were made.
Funding source was declaredSpecific funding source to conduct the systematic review was identified or absence of funding was made explicit.
Sub-item: Authors' affiliation to industry was reportedWhether authors of the systematic review were on the board or employees of a device industry or had received current or previous funding from an industry relevant to the device reviewed was reported.

PICOD = Population, intervention, comparator, outcome, and study design

From: Background

Cover of Quality of Reporting in Systematic Reviews of Implantable Medical Devices
Quality of Reporting in Systematic Reviews of Implantable Medical Devices [Internet].
Raman G, Gaylor JM, Rao M, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.