Introduction: Electronic search filters on family medicine or general practice studies have been developed and validated in previous work. However, there has been no systematic effort to specifically identify and record protocols of randomized controlled trials (RCT) protocols in primary health care (PHC). The aim of the present study was to systematically identify published RCT protocols in PHC and capture information about specific protocol characteristics that may describe this field. Methods: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus from inception to December 2014 were systematically searched. Protocols of RCTs that were published in English and were relevant to PHC were considered as eligible. Protocols referred either to a mixed population, or to an intervention including a specialized part as well as pilot or feasibility trial protocols, were excluded. Specific protocol characteristics including publication year, country, prospective registration, funding, and publication sources were extracted. Results:The final database included 628 published RCT protocols (median publication year 2011; interquartile range 2009-2013). The majority of protocols were designed in the UK (n=141, 22.5%), the Netherlands (n=105, 16.7%), and USA (n=93, 14.8%). Research was mainly funded by the government (n=408, 65.0%) while 45 protocols (7.2%) included industry as the funding source. Two registries -International Standard Randomised Controlled Trials Number Registry (245 (42.9%)) and ClinicalTrials.gov (209 (36.6%))-indexed most of the protocols. Journals from several scientific fields published the articles; the field of 'Primary Health Care Medicine, General and Internal' included 69 (11.0%) articles. Conclusion:A compilation of published RCT protocols on PHC was feasible. The majority of protocols on PHC were published over the past 10 years, funded by the government and designed in three main countries.

Rationale: Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives:The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design.Methods: Using the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI).Interrater reliability was assessed by weighted κ-coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results:We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p < 0.001). Higher sample sizes were correlated to a pragmatic design (odds ratio: 6.86, 95% CI: 1.64, 28.75; p = 0.04). Conclusion:Most RCT protocols were rated as intermediate in the pragmaticexplanatory continuum. Future research may guide all stakeholders on how best to incorporate the level of pragmatism in the interpretation of the results so that the trials are more likely to be applicable in real-world settings.