METHODS
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MEDLINE via PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) were systematically searched for all indexed articles published between January 1, 1998, and May 23, 2014. The search strategy combined different terms applied to Harmonic devices [Title or Abstract] with comparative study, controlled clinical trial or randomized trial [Publication Type], and Humans [MeSH] (Supplementary material). A search ranging from November 23, 2013, through May 23, 2014, identical to that detailed earlier, without human or publication type limits, was also conducted in PubMed to capture publisher-supplied citations not yet indexed in MEDLINE. In addition, a manual search of reference lists from accepted studies and recent reviews was performed to supplement the electronic search. No language restrictions were applied in this systematic review, and meeting abstracts were not searched.
The PICOS categories (ie, population, intervention, comparator, outcomes, and study design) were used to describe specific inclusion criteria. Studies were deemed eligible for inclusion if they were RCTs comparing the use of Harmonic surgical technology to conventional methods, such as traditional scalpel, ligation, and electrosurgery (Table 1), in human subjects for mastectomy or BCS with lymph node dissection procedures. Full-text articles were then excluded if they were not an RCT. The eligibility of each publication was evaluated by two independent reviewers, and a third reviewer was consulted in the case of disagreements regarding study inclusion.
Study details (ie, baseline characteristics and outcomes) of included publications were extracted using a data extraction form. Data were extracted by a single reviewer and subsequently cross-checked for accuracy, consistency, and completeness by a second reviewer. Discrepancies were resolved through consensus. The following data elements were extracted onto a standardized data collection sheet: type of surgical procedure, key patient characteristics, region, study design, devices and/or techniques utilized, number of patients, and included outcomes.
