Energized devices in thyroideal surgery: an example of a standardized data extraction sheet for surgical system­atic reviews

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Contin P, Diener M, Jensen K, Rahbari N, Seiler C

Background: Systematic reviews evaluating the benefits and harms of surgical interventions are an example for non-pharmacological complex interventions focusing on specific methodological and clinical challenges. Data extraction of eligible studies is an essential step and therefore validated tools are a prerequisite. This study gives an example of the development of a data extraction sheet for surgical interventions. Methods: The Cochrane Handbook (chapter 7.6) recommends pilot testing of data extraction sheets on a representative sample of studies to be reviewed. Therefore a team of two reviewers and one biostatistician developed a draft of an extraction sheet for the evaluation of energized devices in thyroidal surgery. Results: Two checklists are of importance for the evaluation of surgical interventions: QUORUM and CONSORT for non-pharmacological interventions (CLEAR NPT). The structure of a data extraction sheet for a surgical review therefore includes in general: basic items (study name, publication year, journal, country, funding); study design (randomization, number of participating centres, number of treatment arms, blinding, allocation concealment, study duration); participants (inclusion and exclusion criteria, sample size, baseline data such as age, gender, BMI, etc.); interventions (intervention groups, surgical experience, learning curves); outcomes (primary endpoints, secondary endpoints); and notes (further comments of the review authors). Conclusions: Both checklists allow a critical appraisal of the included studies focusing on internal and external validity and are essential for the interpretation of the analyzed data. We present the development of our extraction sheet, its modification after piloting and our general recommendations for reviews focusing on surgical interventions.