Real World Data in Health Technology Assessments –Use of Routinely Collected Data to Address Epidemiologic Questions in Kidney Transplantation in the Amnog Process in Germany

Herrmann, K; Neubauer, AS; Dombrowsky, Wolf R.; Koenig, T.

doi:10.1016/j.jval.2016.09.1010

Cited by 2 publications

(3 citation statements)

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“…The study population constitutes one of the largest transplant collectives investigated during the pandemic and comprises about 30% of the estimated total number of kidney transplant recipients with a functioning graft in Germany (41,42). Regarding most patient characteristics, our collective is highly similar to other studies on long-term kidney transplant recipients in Germany and other countries (43,44). Despite its strengths, our study has several limitations.…”

Section: Discussionsupporting

confidence: 79%

“…41,42 Regarding most patient characteristics our collective is highly similar to other studies on long-term kidney transplant recipients in Germany and other countries. 43,44 Despite its strengths, our study has several limitations. Our study investigates patients in a long-term situation after kidney transplantation during the early COVID-19 pandemic in Germany.…”

Section: Discussionmentioning

confidence: 97%

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Collateral Effects and Mortality of Kidney Transplant Recipients during the COVID-19 Pandemic

et al. 2022

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Background: Collateral effects and consequences of the coronavirus disease 19 (COVID-19) pandemic on kidney transplant recipients remain widely unknown. Methods: This retrospective cohort study examines changes in admission rates, incidences of diseases leading to hospitalization, in-patient procedures, and maintenance medication in long-term kidney transplant recipients with functioning graft during the early COVID-19 pandemic in Germany. Data derived from a nationwide health insurance database. Analysis was performed from March 15th to September 30th and compared the years 2019 and 2020. Effects on mortality and adverse allograft events were compared to COVID-19 attributed effects. Results: 7,725 patients were included in the final analysis. Admissions declined in 2020 by 17% with a main dip during a 3-month lockdown (-31%) but without a subsequent rebound. Incidences for hospitalization did not increase for any investigated disease entities, while decreasing trends were noted for non-COVID-19 pulmonary and urogenital infections (incidence rate ratio 0.8, 95%-CI 0.62-1.03, and 0.82, 95%-CI 0.65-1.04, respectively). Non-COVID-19 hospital stays were 0.6 days shorter (p = 0.034) and not complicated by increased dialysis, ventilation, or intensive care treatment rates. In-hospital and 90-day mortality remained stable. Incidence of severe COVID-19 requiring hospitalization was 0.09 per 1,000 patient-days and in-hospital mortality was 9.2%. 31% of patients with calcineurin-inhibitor medication and without being hospitalized for COVID-19 reduced doses by at least 25%, which was associated with an increased allograft rejection risk (adjusted hazard ratios 1.29, 95%-CI 1.02-1.63). COVID-19 caused 16.9% of all deaths but had no significant association with allograft rejections. All-cause mortality remained stable (rate ratio 1.15, 95%-CI 0.91-1.46), also when restricting analysis to patients with no or outpatient-treated COVID-19 (0.97, 95%-CI 0.76-1.25). Conclusion: Despite significant collateral effects, mortality remained unchanged during the early COVID-19 pandemic. Considerable temporary reductions in admissions are safe whereas reducing immunosuppression results in increased allograft rejection risk.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 97%

Collateral Effects and Mortality of Kidney Transplant Recipients during the COVID-19 Pandemic

et al. 2022

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“…In most instances, these examples were explicit about their rationale for incorporating unpublished data, primarily because the published data was sparse or lacked granularity (i.e., to increase certainty of findings by addressing strength of evidence), and/or to determine whether the published data were applicable to health system populations (i.e., to increase the certainty of findings by addressing the applicability of evidence). [5][6][7][8][9][10][11][12][13][14][15][16][17][18] For example, we identified several times that the Mayo Clinic combined local health system data with systematically reviewed published data to support various clinical groups' patient care management decisions, that illustrate different reasons for combining unpublished local data and published data:…”

Section: Inform Strength Application or Implementation Of Evidencementioning

confidence: 99%

Integrating Health System Data With Systematic Reviews: A Framework for When and How Unpublished Health System Data Can Be Used With Systematic Reviews

Lin¹,

Murad²,

Leas³

et al. 2020

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ii Key MessagesPurpose of Report Given that health-system decision making would benefit from both traditional systematic reviews and health-system-specific data, this report investigates when and how to use primary data from health systems in real time with systematic reviews and articulates a framework for using health system data with systematic reviews to support health system decision making. Key MessagesBased on our review of examples and methodologic guidance, as well as our experience conducting systematic reviews for various stakeholders, we recommend five basic principles regarding when and how to use unpublished health system data alongside of systematically reviewed data.• Explicitly state the rationale for using unpublished data (i.e., to improve the strength and applicability of evidence, and/or to inform its implementation).

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Real World Data in Health Technology Assessments –Use of Routinely Collected Data to Address Epidemiologic Questions in Kidney Transplantation in the Amnog Process in Germany

Cited by 2 publications

References 0 publications

Collateral Effects and Mortality of Kidney Transplant Recipients during the COVID-19 Pandemic

Collateral Effects and Mortality of Kidney Transplant Recipients during the COVID-19 Pandemic

Integrating Health System Data With Systematic Reviews: A Framework for When and How Unpublished Health System Data Can Be Used With Systematic Reviews

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