Quality control and assurance in hematopoietic stem cell transplantation data registries in Japan and other countries

Kuwatsuka, Yachiyo

doi:10.1007/s12185-015-1896-8

Cited by 12 publications

(6 citation statements)

References 35 publications

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“…Benchmarks to gauge the level of data agreement and data completeness between the registry and replicated data sets for the ANZHFR were predetermined by a preceding literature review 5–10. Data agreement and data completeness are determined to be very high if ≥95%, high if 94%–90%, high-moderate if 89%–85%, moderate if 84%–80%, low-moderate if 79%–75%, low if 74%–70% and very low if >70%.…”

Section: Methodsmentioning

confidence: 99%

Data quality audit of a clinical quality registry: a generic framework and case study of the Australian and New Zealand Hip Fracture Registry

Tan

Armstrong

et al. 2019

BMJ Open Qual

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ObjectivesThe value of a clinical quality registry is contingent on the quality of its data. This study aims to pilot methodology for data quality audits of the Australian and New Zealand Hip Fracture Registry, a clinical quality registry of hip fracture clinical care and secondary fracture prevention.MethodsA data quality audit was performed by independently replicating the data collection and entry process for 163 randomly selected patient records from three contributing hospitals, and then comparing the replicated data set to the registry data set. Data agreement, as a proxy indicator of data accuracy, and data completeness were assessed.ResultsAn overall data agreement of 82.3% and overall data completeness of 95.6% were found, reflecting a moderate level of data accuracy and a very high level of data completeness. Half of all data disagreements were caused by information discrepancies, a quarter by missing discrepancies and a quarter by time, date and number discrepancies. Transcription discrepancies only accounted for 1 in every 50 data disagreements. The sources of inaccurate and incomplete data have been identified with the intention of implementing data quality improvement.ConclusionsRegular audits of data abstraction are necessary to improve data quality, assure data validity and reliability and guarantee the integrity and credibility of registry outputs. A generic framework and model for data quality audits of clinical quality registries is proposed, consisting of a three-step data abstraction audit, registry coverage audit and four-step data quality improvement process. Factors to consider for data abstraction audits include: central, remote or local implementation; single-stage or multistage random sampling; absolute, proportional, combination or alternative sample size calculation; data quality indicators; regular or ad hoc frequency; and qualitative assessment.

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Section: Methodsmentioning

confidence: 99%

Data quality audit of a clinical quality registry: a generic framework and case study of the Australian and New Zealand Hip Fracture Registry

Tan

Armstrong

et al. 2019

BMJ Open Qual

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“…As a result, 7473 patients (153, 78, and 7242 in the MSD-homo, hetero-to-homo, and MSD-hetero groups, respectively) were included in this study. Clinical data on hematopoietic stem cell transplantation recipients were collected by the Japan Society for Hematopoietic Cell Transplantation and the Japanese Data Center for Hematopoietic Cell Transplantation using the Transplant Registry Unified Management Program (TRUMP) [15][16][17]. The study was approved by the data management committee of TRUMP and by the Institutional Review Board of the Saitama Medical Center, Jichi Medical University, where this study was organized.…”

Section: Data Collectionmentioning

confidence: 99%

Haploidentical and Matched Sibling Donor Hematopoietic Cell Transplantation for Patients with HLA-Homozygous Haplotypes

Kanda

Ikegame

Fuji³

et al. 2016

Biology of Blood and Marrow Transplantation

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More than 1% of the Japanese population has HLA-homozygous haplotypes. For patients with such haplotypes, HLA-haploidentical family members who have no HLA mismatch in the graft-versus-host direction are readily available donor candidates for hematopoietic cell transplantation (HCT). In this study, the outcomes of patients with homozygous HLA-A, -B, and -DRB1 antigens who received HCT without T cell depletion from a haploidentical related donor with mismatches in the host-versus-graft direction only (hetero-to-homo, n = 78) or from an HLA-matched sibling donor (MSD) (MSD-homo, n = 153) were compared with those in patients with heterozygous haplotypes who received HCT from an MSD (MSD-hetero, n = 7242). Transplant outcomes in the hetero-to-homo group were similar to those in the MSD-hetero group regarding neutrophil engraftment, grades III to IV acute graft-versus-host disease (aGVHD), nonrelapse mortality (NRM), relapse, and overall survival. On the other hand, the incidences of severe aGVHD and NRM in the MSD-homo group were significantly lower than those in the MSD-hetero group (grades III to IV aGVHD: aHR .50, P = .034; NRM: aHR .48, P = .004). In conclusion, patients with HLA-homozygous haplotypes achieved lower GVHD and NRM rates for MSD transplantation than those with HLA-heterozygous haplotypes. When an MSD or an appropriate alternative donor is not available for patients with HLA-homozygous haplotypes who need immediate transplantation, transplantation from a haploidentical donor without T cell depletion is a viable option, given the comparable transplant outcomes for hetero-to-homo HCT and MSD-hetero HCT.

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“…We excluded patients who lacked data on survival status, CMV infection, and genotyping for HLA-A, HLA-B, and HLA-DRB1. Clinical data on HSCT recipients were collected by the Japan Society for Hematopoietic Cell Transplantation and the Japanese Data Center for Hematopoietic Cell Transplantation using the Transplant Registry Unified Management Program (TRUMP) [21][22][23]. The study was approved by the data management committee of TRUMP and by the Institutional Review Board of Hiroshima University.…”

Section: Data Collectionmentioning

confidence: 99%

“…Histocompatibility data for genotyping for HLA-A, HLA-B, and HLA-DRB1 were obtained from the TRUMP database [21][22][23]. HLA-A-B-DRB1 haplotypes were estimated using the maximum probability algorithm.…”

Section: Hla-a-b-drb1 Haplotype Estimationmentioning

confidence: 99%

Impact of High-Frequency HLA Haplotypes on Clinical Cytomegalovirus Reactivation in Allogeneic Hematopoietic Stem Cell Transplantation

Kawase

Tanaka²,

Kojima³

et al. 2019

Biology of Blood and Marrow Transplantation

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Some studies support the hypothesis that HLA genes and haplotypes evolved by natural selection through their protective abilities against specific infectious pathogens. However, very little is known regarding the impact of high-frequency HLA haplotypes on the risk of relevant infectious diseases among a given ethnic group. We evaluated the impact of high-frequency HLA haplotypes on cytomegalovirus (CMV) reactivation and infection in allogeneic hematopoietic stem cell transplantation (allo-HSCT) in a Japanese population as a model of infectious disease that has coexisted with humans. A total of 21,127 donor-patient pairs were analyzed. HLA-A-B-DRB1 haplotypes were estimated using the maximum probability algorithm. Seven haplotypes with >1% frequency were defined as high-frequency haplotypes (HfHPs). Homozygotes of HfHP and heterozygotes had significantly lower risk of CMV reactivation and infection (hazard ratio [HR] = 0.88, P = .009 and HR = 0.93, P = .003, respectively) than homozygotes of low-frequency HLA haplotypes (LfHPs). In subgroup analyses of a different donor source, these associations were statistically significant in unrelated donor transplants. Finally, CMV risk for homozygotes and heterozygotes of each HfHP was compared with that of homozygotes of LfHPs. The 2 most predominant HfHP groups (A*24:02-B*52:01-DRB1*15:02 group and A*24:02-B*07:02-DRB1*01:01 group) had a significantly lower risk of CMV reactivation and infection (HR = 0.86, P < .001 and HR = 0.91, P = .033, respectively). Our findings suggest that HfHPs may be protective against CMV reactivation and infection and that increased care regarding CMV reactivation and infection may be necessary for patients with LfHP after allo-HSCT.

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Quality control and assurance in hematopoietic stem cell transplantation data registries in Japan and other countries

Cited by 12 publications

References 35 publications

Data quality audit of a clinical quality registry: a generic framework and case study of the Australian and New Zealand Hip Fracture Registry

Data quality audit of a clinical quality registry: a generic framework and case study of the Australian and New Zealand Hip Fracture Registry

Haploidentical and Matched Sibling Donor Hematopoietic Cell Transplantation for Patients with HLA-Homozygous Haplotypes

Impact of High-Frequency HLA Haplotypes on Clinical Cytomegalovirus Reactivation in Allogeneic Hematopoietic Stem Cell Transplantation

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