ObjeCtiveTo compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants.Design Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs.

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Background:Reducing post-operative infections among kidney transplant patients is critical to improve long-term outcomes. With shifting disease demographics and implementation of new transplantation protocols, frequent evaluation of infection rate and type is necessary.Objective:Our objectives were to assess the incidence and types of post-operative infections in kidney transplant recipients at a large tertiary-care facility and determine sample sizes needed for future intervention trials.Design:Retrospective cohort study.Setting:The Ottawa Hospital, Ottawa, Ontario.Patients:Adult kidney transplant patients, N = 142.Measurements:Demographic data, transplant protocol, infections up to 2 years following transplantation.Methods:Infections within 2 years following transplantation in all kidney transplant recipients between January 2011 and December 2012 were reviewed. Sample sizes were determined using all-cause infection rates and infection-free survival data.Results:Of 142 patients, 44 (31.0%) had at least one infection. The incidence of infection was 36.2 per 100 patient-years by 2 years post-transplant. A total of 32 (22.5%) patients had 56 infection-related hospitalizations with 73.2% occurring in the first year. In the first 2 years, urinary tract infections had the highest incidence (18.1 per 100 patient-years) followed by skin (3.9 per 100 patient-years), cytomegalovirus (3.9 per 100 patient-years), and bacteremia (3.9 per 100 patient-years). Results indicate that 206 patients per study arm would be needed to show a 30% reduction in the 2-year incidence of infection post-transplantation.Limitations:Infection rates may be slightly underestimated due to the relatively short 2-year follow-up; however, the highest infection-risk period was captured within this time frame.Conclusions:Infections post-kidney transplant are still common, particularly urinary tract infections. They are associated with significant morbidity and hospitalization. Given the feasible sample sizes calculated in this study, intervention trials are indicated to further reduce infection rates within the first 2 years post-kidney transplantation.

BackgroundTransplantation is often the best, if not the only treatment for end-stage organ failure; however, the quality metrics for determining whether a transplant program is delivering safe, high quality care remains unknown. The purpose of this study is to identify and describe quality indicators or metrics in patients who have received a solid organ transplant.Methods/designWe will conduct a systematic scoping review to evaluate and describe quality indicators or metrics in patients who have received a solid organ transplant. We will search MEDLINE, Embase, and the Cochrane Central Register for Controlled Trials. Two reviewers will conduct all screening and data extraction independently. The articles will be categorized according to the six domains of quality, and the metrics will be appraised using criteria for a good quality measure.DiscussionThe results of this review will guide the development, selection, and validation of appropriate quality metrics necessary to drive quality improvement in transplantation.Systematic review registrationPROSPERO CRD42016035353.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0279-4) contains supplementary material, which is available to authorized users.