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  • We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations in conducting this systematic review (PROSPERO 2016: CRD42016033762) [15]. With the assistance of a medical research librarian (MC), we performed serial literature searches for English language articles. MEDLINE via PubMed, CINAHL, EMBASE, and PsychInfo were searched for studies published prior to August 1, 2016 using Medical Subject Headings (MeSH) and keywords based on primary care settings and treatment of OUDs (S1 Table). All human studies published in full-text were eligible for inclusion, and no publication date or status restrictions were placed. Additional studies of interest were identified by hand searches of bibliographies. Authors were contacted by email if further clarification was needed. Two authors (KK and CB) independently screened titles and abstracts for eligibility. Given the complexity of designing and evaluating care models [16], we included both experimental (RCTs) and observational studies (cohort, case-control, cross-sectional) if they met inclusion criteria. Articles were included if the intervention: (1) evaluated a primary care-based health delivery model where primary care was defined as care delivered in a general practice setting (i.e. private practice, academic primary care clinic) by a general medical internist and/or family medicine physician only, (2) targeted adults (18 years or older) with OUD defined as patients engaged in care to treat their opioid addiction, (3) evaluated patient-level outcomes (e.g. patient retention, urine toxicology screens, satisfaction, effect on health screening for comorbidities, etc. ), and (4) evaluated the care model using qualitative or quantitative methods. Studies that did not include a description of the care delivery model evaluated (i.e. only discussed physician perceptions of OUD or drug dosage efficacy studies), focused exclusively on comparing intervention settings (e.g. specialty care versus primary care settings) without a detailed description of the primary care intervention/program design, and concentrated on specialty-based primary care (e.g. HIV care) outside of a primary care physician (PCP) led primary care practice were excluded (S2 Table). In the event of a disagreement in exclusion or inclusion between the two reviewers, a third reviewer (PL) resolved the discrepancy. Data extraction and quality assessment: Two authors (KK and CB) used a standardized form adapted from the Cochrane Collaboration [17, 18] to extract data from the included studies, independently and in duplicate. The following data was extracted for all studies: location, study design, intervention design and duration, care model structures and processes, classification, delivery staff, sample size, patient population, and primary/secondary outcomes as stated by the authors of each study. Two authors (KK and CB) independently assessed risk of bias via the validated Downs and Black tool which utilizes the following elements to assess risk of bias in both experimental and observational studies: quality of reporting, internal validity of the study and its power, and external validity and confounding [19]. The tool evaluates each of these elements using 27 questions, allowing each article to receive a sum score of up to 32 points. For the purposes of this study, the last question assessing statistical power was interpreted as a dichotomous outcome: 0 for insufficient/no power calculation and 1 for studies that provided evidence of power calculation or reference to statistical power. From this alteration, 28 was the highest score possible. As previously reported [20] [21] the following were the final score ranges: excellent (26–28); good (20–25); fair (15–19); and poor (⩽ 14). Any discrepancies or disagreements in data review, extraction, or assessment of risk of bias were resolved by a third author (PL). Given substantial clinical heterogeneity in patient outcomes reported (i.e. retention, relapse rates, comorbidity management, satisfaction, etc.) and variability in the drug treatments and dosages used in the models (e.g. methadone versus buprenorphine) within the included studies, formal meta-analyses were not performed.
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