Eine Skorbutepidemie unter Kindern im Alter von 6 bis 14 Jahren

Ohne ZusammenfassungBericht an das Lister-Institut und den Medical Research Council, London.Mit 1 Textabbildung     

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives

There are many consequences of heart failure (HF), including symptoms, impaired health-related quality of life (HRQoL), and physical and social limitations (functional status). These have a substantial impact on patients' lives, yet are not routinely captured in clinical trials. Patient-reported outcomes (PROs) can quantify patients' experiences of their disease and its treatment. Steps can be taken to improve the use of PROs in HF trials, in regulatory and payer decisions, and in patient care. Importantly, PRO measures (PROMs) must be developed with involvement of patients, family members, and caregivers from diverse demographic groups and communities. PRO data collection should become more routine not only in clinical trials but also in clinical practice. This may be facilitated by the use of digital tools and interdisciplinary patient advocacy efforts. There is a need for standardization, not only of the PROM instruments, but also in procedures for analysis, interpretation and reporting PRO data. More work needs to be done to determine the degree of change that is important to patients and that is associated with increased risks of clinical events. This ‘minimal clinically important difference’ requires further research to determine thresholds for different PROMs, to assess consistency across trial populations, and to define standards for improvement that warrant regulatory and reimbursement approvals. PROs are a vital part of patient care and drug development, and more work should be done to ensure that these measures are both reflective of the patient experience and that they are more widely employed.     

A scoping review of heart failure transitional care quality indicators and outcomes for use in clinical care and research

Aims

There are no accepted quality indicators for transitional care following hospitalization for heart failure (HF). Current quality measures focus on 30-day readmissions without accounting for competing risks such as death. In this scoping review of clinical trials, we aimed to develop a set of HF transitional care quality indicators for clinical or research applications following hospitalization for HF.

Methods and results

We performed a scoping review using MEDLINE, Embase, CINAHL, HealthSTAR, reference lists and grey literature from January 1990 to November 2022. We included randomized controlled trials (RCTs) of adults hospitalized for HF who received a healthcare service or strategy intervention that aimed to improve patient-reported or clinical outcomes. We independently extracted data and performed a qualitative synthesis of the results. We generated a list of process, structure, patient-reported, and clinical measures that could be used as quality indicators. We highlighted process indicators that were associated with improved clinical outcomes and patient-reported outcomes that had high adherence to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and United States Food and Drug Administration standards. From 42 RCTs included in the study, we identified a set of process, structure, patient-reported, and clinical indicators that could be used as transitional care measures in clinical or research settings.

Conclusion

In this scoping review, we developed a list of quality indicators that could guide clinical efforts or serve as research endpoints in transitional care in HF. Clinicians, researchers, institutions, and policymakers can use the indicators to guide management, design research, allocate resources, and fund services that improve clinical outcomes.