Do Cochrane systematic reviews report patient-important outcomes?

Tags: Oral
Howell M1, Tong A1, Wong G2, Howard K1, Webster A1, Craig J1
1University of Sydney, Australia, 2Westmead Hospital, Australia

Background: Despite the proliferation of trial evidence, uncertainty remains about the effect of interventions on outcomes that are important and relevant to patients. Many studies report endpoints that have little meaning for patients.

Objectives: To assess the concordance between the prioritised outcomes associated with immunosuppressant medications among kidney transplant recipients with outcomes reported in Cochrane systematic reviews.

Methods: Identification and ranking of outcomes important to kidney transplant recipients was undertaken using the nominal group technique. Each group, which involved 6 to 10 participants, developed and ranked in order of importance a list of outcomes considered relevant to immunosuppressant medications. For the participant rankings, a maximum priority score was calculated and data presented as a percentage of the maximum possible priority score. The top 15 patient-important outcomes were compared with outcomes reported in Cochrane systematic reviews on immunosuppressive regimens in kidney transplantation.

Results: Across the eight groups, we identified 48 outcomes considered relevant to kidney transplant recipients. The top ranked 15 were: graft loss, kidney function, damage to other organs, death, all cancers, diabetes, skin cancer, cardiovascular disease, susceptibility to infection, night tremors, weight gain, bone disease, impact on family, depression, and gastrointestinal problems. Across the five Cochrane systematic reviews, 5 (33%) to 9 (60%) of the top 15 patient ranked outcomes were reported. No reviews included damage to other organs, night tremors, impact on family and depression outcomes. Only one review addressed the following outcomes: skin cancer, cardiovascular disease, weight gain, bone disease and gastrointestinal problems.

Conclusions: Patient-important outcomes following kidney transplantation include serious and fatal consequences as well as emotional and physical side effects. Strategies to integrate patient priorities for immunosuppressive treatment outcomes in clinical trials and systematic reviews are needed.