title: Independent Pre-Transplant Recipient Cancer Risk Factors after Kidney Transplantation and the Utility of G-Chart Analysis for Clinical Process Control.
abstract: BACKGROUND
  The aim of this study is to identify independent pre-transplant cancer risk factors after kidney transplantation and to assess the utility of G-chart analysis for clinical process control. This may contribute to the improvement of cancer surveillance processes in individual transplant centers.
  
  
  METHODS
  1655 patients after kidney transplantation at our institution with a total of 9,425 person-years of follow-up were compared retrospectively to the general German population using site-specific standardized-incidence-ratios (SIRs) of observed malignancies. Risk-adjusted multivariable Cox regression was used to identify independent pre-transplant cancer risk factors. G-chart analysis was applied to determine relevant differences in the frequency of cancer occurrences.
  
  
  RESULTS
  Cancer incidence rates were almost three times higher as compared to the matched general population (SIR = 2.75; 95%-CI: 2.33-3.21). Significantly increased SIRs were observed for renal cell carcinoma (SIR = 22.46), post-transplant lymphoproliferative disorder (SIR = 8.36), prostate cancer (SIR = 2.22), bladder cancer (SIR = 3.24), thyroid cancer (SIR = 10.13) and melanoma (SIR = 3.08). Independent pre-transplant risk factors for cancer-free survival were age <52.3 years (p = 0.007, Hazard ratio (HR): 0.82), age >62.6 years (p = 0.001, HR: 1.29), polycystic kidney disease other than autosomal dominant polycystic kidney disease (ADPKD) (p = 0.001, HR: 0.68), high body mass index in kg/m2 (p<0.001, HR: 1.04), ADPKD (p = 0.008, HR: 1.26) and diabetic nephropathy (p = 0.004, HR = 1.51). G-chart analysis identified relevant changes in the detection rates of cancer during aftercare with no significant relation to identified risk factors for cancer-free survival (p<0.05).
  
  
  CONCLUSIONS
  Risk-adapted cancer surveillance combined with prospective G-chart analysis likely improves cancer surveillance schemes by adapting processes to identified risk factors and by using G-chart alarm signals to trigger Kaizen events and audits for root-cause analysis of relevant detection rate changes. Further, comparative G-chart analysis would enable benchmarking of cancer surveillance processes between centers.
authors.affiliation: General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.|Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.
authors.forename: Harald
authors.identifier: http://orcid.org/0000-0002-5527-7555
authors.initials: H
authors.lastname: Schrem
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.
authors.forename: Valentin
authors.initials: V
authors.lastname: Schneider
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.|Gynecology and Obstetrics, KRH Klinikum Nordstadt, Hannover, Germany.
authors.forename: Marlene
authors.initials: M
authors.lastname: Kurok
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.|Lean Six Sigma Black Belt, Amstelveen, The Netherlands.
authors.forename: Alon
authors.initials: A
authors.lastname: Goldis
authors.affiliation: Institute of Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany.
authors.forename: Maren
authors.initials: M
authors.lastname: Dreier
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.|Trauma and Orthopedic Surgery, Federal Armed Forces Hospital Westerstede, Medical Service of the Federal Armed Forces, Westerstede, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kaltenborn
authors.affiliation: Nephrology, Hannover Medical School, Hannover, Germany.
authors.forename: Wilfried
authors.initials: W
authors.lastname: Gwinner
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Barthold
authors.affiliation: Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Liebeneiner
authors.affiliation: General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Winny
authors.affiliation: General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Klempnauer
authors.affiliation: General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany.|Core Facility Quality Management & Health Technology Assessment in Transplantation, Integrated Research and Treatment Center Transplantation (IFB-Tx), Hannover Medical School, Hannover, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Kleine
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D002648:Child; D018572:Disease-Free Survival; D062665:Epidemiological Monitoring; D005260:Female; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology* / Q000628:therapy; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D055815:Young Adult