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Clinical outcomes of hemodialysis patients in a public-private partnership care framework in Italy: a retrospective cohort study.

ABSTRACT: BACKGROUND:Innovative care models such as public-private partnerships (PPPs) may help meet the challenge of providing cost-effective high-quality care for the steadily growing and complex chronic kidney disease population since they combine the expertise and efficiency of a specialized dialysis provider with the population care approach of a public entity. We report the five-years main clinical outcomes of a population of patients treated on hemodialysis within a PPP-care model in Italy. METHODS:This descriptive retrospective cohort study consisted of all consecutive hemodialysis patients treated in the NephroCare-operated Nephrology and Dialysis unit of the Seriate Hospital in 2012-2016, which exercises a PPP-care model. Clinical and treatment information was obtained from the European Clinical Database. Hospitalization outcomes and cumulative all-cause mortality incidences that accounted for competing risks were calculated. RESULTS:We included 401 hemodialysis patients (197 prevalent and 204 incident patients) in our study. The mean cohort age and age-adjusted Charlson Comorbidity Index were 67.0?years and 6.7, respectively. Patients were treated with online high-volume hemodiafiltration or high-flux hemodialysis. Parameters of treatment efficiency were above the recommended targets throughout the study period. Patients in the PPP experienced benefits in terms of hospitalization (average number of hospital admissions/patient-year: 0.79 and 1.13 for prevalent and incident patients, respectively; average length of hospitalization: 8.9?days for both groups) and had low cumulative all-cause mortality rates (12?months: 10.6 and 7.8%, 5?years: 42.0 and 35.9%, for prevalent and incident patients, respectively). CONCLUSIONS:Results of our descriptive study suggest that hemodialysis patients treated within a PPP-care model framework received care complying with recommended treatment targets and may benefit in terms of hospitalization and mortality outcomes.

SUBMITTER: Pedrini LA

PROVIDER: S-EPMC6359808 | biostudies-other | 2019 Feb

REPOSITORIES: biostudies-other

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Clinical outcomes of hemodialysis patients in a public-private partnership care framework in Italy: a retrospective cohort study.

Pedrini L A LA Winter A C AC Cerino F F Zawada A M AM Garbelli M M Feuersenger A A Feliciani A A Ruggiero P P Civardi S S Amato C C Canaud B B Stuard S S Karch A A Gauly A A

BMC nephrology 20190201 1

<h4>Background</h4>Innovative care models such as public-private partnerships (PPPs) may help meet the challenge of providing cost-effective high-quality care for the steadily growing and complex chronic kidney disease population since they combine the expertise and efficiency of a specialized dialysis provider with the population care approach of a public entity. We report the five-years main clinical outcomes of a population of patients treated on hemodialysis within a PPP-care model in Italy. ...[more]

PMID: 30709341

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Project description:BackgroundHaemodialysis (HD) is one of the life-saving options for patients with end stage renal disease but demand for this treatment exceeds capacity in publicly funded hospitals. One novel approach to addressing this problem is through a shared-care model whereby government hospitals partner with qualified private HD service providers to increase the accessibility of HD for needy patients. The aim of this study is to evaluate and enhance the quality of care (QOC) provided in such a shared-care programme in Hong Kong, the Haemodialysis Public-Private Partnership Programme (HD-PPP).Methods/designThis is a longitudinal study based on Action Learning and Audit Spiral methodologies to measure the achievement of pre-set target standards for the HD-PPP programme over three evaluation cycles. The QOC evaluation framework is comprised of structure, process and outcome criteria with target standards in each domain developed from review of the evidence and in close collaboration with the HD-PPP working group. During each evaluation cycle, coordinators of each study site complete a questionnaire to determine adherence with structural criteria of care. Process and clinical outcomes, such as adverse events and dialysis adequacy, are extracted from the patient records of consenting study participants while face-to-face interviews are conducted to ascertain patient-reported outcomes such as self-efficacy and health-related quality of life.DiscussionThe study relies on the successful implementation of partnership-based action research to develop an evidence-based and pragmatic framework for evaluation of quality of care in an iterative fashion, and to use it to identify possible areas of quality enhancements in a shared-care programme for HD patients. The approach we take in this study emphasizes partnership and engagement with the clinical and administrative programme team, a robust but flexible evaluation framework, direct observation and the potential to realize positive change. The experience will be useful to inform the process of coordinating research studies involving multiple stakeholders and results will help to guide service planning and policy decision making.Trial registrationUS Clinical Trial Registry NCT02307903.

Project description:BACKGROUND:Immunoglobulin light chain (AL) amyloidosis is a rare, multi-systemic disorder characterized by two disease processes: an underlying plasma cell dyscrasia that provides the source of pathologic light chains, and the resulting organ dysfunction caused by deposition of amyloid light chain fibrils. There are no FDA approved treatments for AL amyloidosis; regimens developed for multiple myeloma are used off-label to treat the plasma cell disorder and no therapies are directed at organ deposition. Thus, an unmet medical need persists despite advances in disease management. A public-private partnership was recently formed between the Amyloidosis Research Consortium (ARC) and the US Food and Drug Administration (FDA) to bridge scientific gaps in drug development for the treatment of AL amyloidosis. MAIN BODY:The inaugural Amyloidosis Forum was convened at FDA on 12 November 2019 and led by a multidisciplinary panel of physicians, health outcomes professionals, and representatives from the FDA, ARC, and pharmaceutical companies. Patients provided important perspectives on the pathway to diagnosis, challenges of rigorous treatment, and the burden of disease. The panel reviewed the epidemiology, pathobiology, and clinical features of AL amyloidosis. Hematologic characteristics, staging systems, and response criteria were examined with clear consensus that a "deep response" to plasma cell-directed treatments was critical to overall survival. Emphasis was placed on the heterogeneous clinical phenotypes of AL amyloidosis, including cardiovascular, renal, neurological, and gastrointestinal system manifestations that contribute to morbidity and/or mortality, but render challenges to clinical trial endpoint selection. FDA representatives discussed regulatory perspectives regarding demonstration of clinical benefits of investigational therapies in the context of a rare disease with multi-systemic manifestations. The panel also highlighted the potential importance of well-designed health-related quality of life instruments, quantification of system organ effects, the potential of advanced imaging technologies, and survival prediction models. CONCLUSIONS:The Amyloidosis Forum identified a clear need for novel trial designs that are scientifically rigorous, feasible, and incorporate clinically meaningful endpoints based on an understanding of the natural history of the disease in an evolving therapeutic landscape. Future forums will delve into these issues and seek to include participation from additional stakeholders.

Dataset Information

Clinical outcomes of hemodialysis patients in a public-private partnership care framework in Italy: a retrospective cohort study.

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Clinical outcomes of hemodialysis patients in a public-private partnership care framework in Italy: a retrospective cohort study.

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