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Systematic review and evidence- based guidance ... - ECDC - Europa

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<strong>Systematic</strong> <strong>review</strong> <strong>and</strong> <strong>evidence</strong>-<strong>based</strong> <strong>guidance</strong> on perioperative antibiotic prophylaxisTECHNICAL REPORT2 Methodology2.1 <strong>Systematic</strong> <strong>review</strong>2.1.1 ObjectivesThe objective of the systematic <strong>review</strong> was to identify the effectiveness of key modalities of PAP delivery <strong>and</strong> toprovide a shortlist of 10 PAP modalities.Effectiveness is defined as the effect of an already established efficacious therapy [13] at the population level,reflecting real-life circumstances. In contrast, efficacy is characterised by strong control, in that a st<strong>and</strong>ardisedprogramme is delivered in a uniform fashion to a specific, often narrowly defined, homogeneous target audience.Due to the strict st<strong>and</strong>ardisation of efficacy trials, any positive (or negative) effect can be directly attributed to theintervention being studied [14].Questions addressedIn this systematic <strong>review</strong> effectiveness of PAP was evaluated by addressing the following questions:Is the appropriate use of PAP associated with a decrease in the incidence of SSI?What are the factors that contribute to increased compliance with PAP?What are the obstacles that prevent the implementation of adequate PAP?Does timing, dosage or duration of PAP have an influence on the incidence of SSIs?Does PAP have an impact on the incidence of Clostridium difficile infection (CDI) <strong>and</strong> the development ofantimicrobial resistance?2.1.2 Inclusion/exclusion criteriaIncluded studies (in general)All prospective RCTs were included, as were non-r<strong>and</strong>omised clinical trials, such as controlled before–after studies(CBA), non-controlled before–after studies (non-CBA), interrupted-time-series analyses (ITS), case-control studies,cohort studies <strong>and</strong> other observational cohort studies, in addition to all systematic <strong>review</strong>s <strong>and</strong> meta-analyses.Excluded studiesExclusion criteria were developed for articles identified in the systematic search 1 . Thus, studies retrieved from thesystematic <strong>review</strong> were excluded if any of the following were present:Antibiotics were administered as treatment for known or suspected infection.Retrieved studies were conference papers without detailed descriptions of methods <strong>and</strong> results.Pre-operative antibiotic prophylaxis was administered topically (i.e. ear drops, irrigation with antimicrobialsolution, etc.).Antibiotic prophylaxis was started postoperatively <strong>and</strong> not pre- or perioperatively.PAP administration extended for longer than 72 hours after surgery.Antibiotics were administered for selective digestive decontamination.Preoperative antibiotic prophylaxis was administered in burn patients.The outcome of the studies was not the incidence of SSIs, but calculation of the antibiotic concentration invarious organ compartments.Inclusion criteria for the type of surgeryThe following surgical procedures for which the efficacy of PAP has been previously shown were included in thesearch strategy:Neurosurgery, including craniotomy, spinal <strong>and</strong> shunt surgery.Orthopaedic surgery, including hip, long bone <strong>and</strong> open limb fractures.Gastrointestinal surgery, including endoscopic retrograde cholangiopancreatography (ERCP), hernia repairwith placement of a mesh plug, percutaneous endoscopic gastrostomy (PEG) placement, colorectal surgery,<strong>and</strong> appendectomy.Gynaecological surgery, including caesarean section <strong>and</strong> breast cancer surgery.Urological surgery, including transrectal prostate biopsy.Vascular surgery, including arterial reconstruction.Cardiothoracic surgery.1 For a list of excluded studies, please see Annex 2.4

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