Outcomes for clinical trials involving adults with chronic kidney disease: a multinational Delphi survey involving patients, caregivers and health professionals.

BACKGROUND: Many outcomes of high priority to patients and clinicians are infrequently and inconsistently reported across trials in chronic kidney disease (CKD), which generates research waste and limits evidence-informed decision making. We aimed to generate consensus among patients/caregivers and health professionals on critically important outcomes for trials in CKD prior to kidney failure and the need for kidney replacement therapy, and to describe the reasons for their choices. METHODS: This was an online two-round international Delphi survey. Adult patients with CKD (all stages and diagnoses), caregivers and health professionals who could read English, Spanish or French were eligible. Participants rated the importance of outcomes using a Likert scale (7-9 indicating critical importance) and a Best-Worst Scale. The scores for the two groups were assessed to determine absolute and relative importance. Comments were analysed thematically. RESULTS: In total, 1399 participants from 73 countries completed Round 1 of the Delphi survey, including 628 (45%) patients/caregivers and 771 (55%) health professionals. In Round 2, 790 participants (56% response rate) from 63 countries completed the survey including 383 (48%) patients/caregivers and 407 (52%) health professionals. The overall top five outcomes were: kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death. In the final round, patients/caregivers indicated higher scores for most outcomes (17/22 outcomes), and health professionals gave higher priority to mortality, hospitalization and cardiovascular disease (mean difference >0.3). Consensus was based upon the two groups yielding median scores of ≥7 and mean scores >7, and the proportions of both groups rating the outcome as 'critically important' being >50%. Four themes reflected the reasons for their priorities: imminent threat of a health catastrophe, signifying diminishing capacities, ability to self-manage and cope, and tangible and direct consequences. CONCLUSION: Across trials in CKD, the outcomes of highest priority to patients, caregivers and health professionals were kidney function, need for dialysis/transplant, life participation, cardiovascular disease and death.

A framework for outcome-level evaluation of in-service training of health care workers.

BACKGROUND: In-service training is a key strategic approach to addressing the severe shortage of health care workers in many countries. However, there is a lack of evidence linking these health care worker trainings to improved health outcomes. In response, the United States President's Emergency Plan for AIDS Relief's Human Resources for Health Technical Working Group initiated a project to develop an outcome-focused training evaluation framework. This paper presents the methods and results of that project. METHODS: A general inductive methodology was used for the conceptualization and development of the framework. Fifteen key informant interviews were conducted to explore contextual factors, perceived needs, barriers and facilitators affecting the evaluation of training outcomes. In addition, a thematic analysis of 70 published articles reporting health care worker training outcomes identified key themes and categories. These were integrated, synthesized and compared to several existing training evaluation models. This formed an overall typology which was used to draft a new framework. Finally, the framework was refined and validated through an iterative process of feedback, pilot testing and revision. RESULTS: The inductive process resulted in identification of themes and categories, as well as relationships among several levels and types of outcomes. The resulting framework includes nine distinct types of outcomes that can be evaluated, which are organized within three nested levels: individual, organizational and health system/population. The outcome types are: (1) individual knowledge, attitudes and skills; (2) individual performance; (3) individual patient health; (4) organizational systems; (5) organizational performance; (6) organizational-level patient health; (7) health systems; (8) population-level performance; and (9) population-level health. The framework also addresses contextual factors which may influence the outcomes of training, as well as the ability of evaluators to determine training outcomes. In addition, a group of user-friendly resources, the Training Evaluation Framework and Tools (TEFT) were created to help evaluators and stakeholders understand and apply the framework. CONCLUSIONS: Feedback from pilot users suggests that using the framework and accompanying tools may support outcome evaluation planning. Further assessment will assist in strengthening guidelines and tools for operationalization.