Importance of patient participation at protocol stage and its impact on outcomes – experience from a network meta-analysis with breast cancer patients

Tags: Oral
Jakob T1, Schwesig G2, Jorzick B2, Kerek-Bodden H2, Wöckel A3, Skoetz N4
1Cochrane Haematological Malignancies, 2Frauenselbsthilfe nach Krebs NRW e. V., 3Department of Gynaecology and Obstetrics, University Hospital of Würzburg, 4Cochrane Cancer

Background: network meta-analysis (NMA) within Cochrane Reviews is a complex method with the intention of comparing all available treatment options (e.g. different types of interventions). The aim is to generate a hierarchy of treatment options. Particularly for the conduct of NMA, patient involvement is of highest relevance, since the different treatment options might be differently efficient and presumably cause different kinds and magnitudes of adverse events, which should be taken into consideration while predefining relevant outcomes. We are conducting a NMA to compare different bone-modifying agents for breast cancer patients to find the best treatment option to prevent therapy-induced skeletal-related events like fractures or bone pain.

Objectives: to involve patients at protocol stage to ensure the patients' view is deeply involved as early as possible and to discuss the prioritisation of outcomes and focus of the review.

Methods: after registering the title “Bone-modifying agents for the prevention of bone loss in women with early or locally advanced breast cancer: a systematic review and network meta-analysis” with Cochrane Breast Cancer, we invited patients and patient representatives to a meeting. We explained our planned analysis and the importance and impact it may have for decision making of patients and clinicians in, for example, national and international breast cancer guidelines. We asked the attendees to provide feedback and evaluate whether we had identified all patient-relevant outcomes and whether we had prioritized them in a correct order. The Federal Ministry of Education and Research Germany (01KG1806) funded this project.

Results: patients and patient representatives of the German patients' support group ‘Frauenselbsthilfe nach Krebs NRW e. V.’ participated in the two-hour meeting. Prior to this, they received some information on the project via email. After a brief round of personal introductions and presentation of the project, we discussed the completeness of our outcomes of interest and the aim of our planned analysis. Through thorough discussion, we changed our primary outcome from ‘fracture rate’ to ‘bone density’ and added two more patient-relevant outcomes to our list of secondary outcomes (‘occurrence of bone metastases’ and ‘bone pain after administration’). All attendees agreed to be involved in the further process of the review, so we continuously report and discuss milestones of the project.

Conclusion: patient preferences need to be considered for the prioritization of outcomes in NMA. It is particularly important to consider them at an early stage, which ensures to set the right focus for all subsequent steps of the review process. Involving patients and patient representatives adds great value and should be an integral part in the conduct of Cochrane Reviews.

Patient or healthcare consumer involvement: patients and patient representatives who attended our meeting are co-authors of this abstract.