title: Prospective Swiss cohort study of living-kidney donors: study protocol.
abstract: Background Offering living kidney donation raised the concern that donors are exposed to unknown risks. All Swiss transplant centres therefore decided to start a prospective cohort study of living kidney donors in Switzerland. This paper describes the rationale for and implementation of this cohort study.  Methods/design All kidney donors in Switzerland are registered and examined before donation and biennially after donation starting in the first year after nephrectomy. Before each follow-up visit, the study centre sends a package to the kidney donor containing the health questionnaire, blood and urine tubes and a prepaid envelope for sending the samples to the central laboratory. The donor makes an appointment with their family physician, who examines the donor and reports findings such as pain and other complaints, blood pressure, creatinine, albumin, all major health events and the state of mental and social well-being to the study centre. The family doctor draws the blood sample and mails it with the urine sample in the prepaid envelope. All data are centrally managed. All abnormal findings in the follow-up of individual donors are regularly discussed with the principal investigator, and necessary clinical changes made and recorded in the database. The health insurance of the recipient covers all costs of the donor follow-up. The main outcomes are the occurrence of albuminuria, hypertension and renal insufficiency. The secondary outcomes are major somatic and social events such as death, cardiovascular disease, stroke and depression.  Discussion This prospective cohort offers unique opportunities to assess the risks of living kidney donation and will allow us to examine the risks associated with the methods used for nephrectomy in Switzerland (various forms of open surgery and laparoscopic nephrectomy). The prospective collection of all clinically relevant data and the regular monitoring of donors will allow timely interventions at early stages before serious kidney and general health problems occur.
authors.affiliation: Swiss Organ Living Donor Health Registry, Division of Transplant Immunology and Nephrology, University Hospital of Basel, Basel, Switzerland.
authors.forename: Gilbert T
authors.initials: GT
authors.lastname: Thiel
authors.forename: Christa
authors.initials: C
authors.lastname: Nolte
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Tsinalis
references.citation: Transpl Int. 2010 Feb;23(2):121-30
references.pmid: 20003169
references.citation: J Endourol. 2010 Nov;24(11):1783-7
references.pmid: 20919917
references.citation: Lancet. 1992 Oct 3;340(8823):807-10
references.pmid: 1357243
references.citation: Transplant Proc. 1987 Apr;19(2):2840-4
references.pmid: 3551223
references.citation: Transplant Proc. 1988 Oct;20(5):1051-8
references.pmid: 3055482
references.citation: Ann Surg. 2004 Aug;240(2):205-13
references.pmid: 15273542
references.citation: Urology. 2000 Dec 20;56(6):926-9
references.pmid: 11113733
references.citation: Kidney Int. 1986 May;29(5):1072-6
references.pmid: 3523003
references.citation: Arch Surg. 1970 Aug;101(2):226-31
references.pmid: 4916014
references.citation: Int J Urol. 2010 Feb;17(2):158-62
references.pmid: 20377836
references.citation: Ann Surg. 1986 Jun;203(6):637-43
references.pmid: 3521509
references.citation: Clin Chem. 2007 Apr;53(4):766-72
references.pmid: 17332152
references.citation: Kidney Int. 2005 Jun;67(6):2089-100
references.pmid: 15882252
references.citation: N Engl J Med. 2009 Jan 29;360(5):459-69
references.pmid: 19179315
references.citation: Transplant Proc. 2011 Jan-Feb;43(1):353-6
references.pmid: 21335221
references.citation: Prev Med. 1997 Jul-Aug;26(4):523-33
references.pmid: 9245675
references.citation: Am J Kidney Dis. 2009 Aug;54(2):205-26
references.pmid: 19577347
references.citation: Kidney Int. 1993 May;43(5):1110-5
references.pmid: 8510390
references.citation: Schweiz Med Wochenschr Suppl. 1993;48:13-20
references.pmid: 8446867
references.citation: Kidney Int. 1984 Jun;25(6):930-6
references.pmid: 6381857
references.citation: Transplantation. 2010 Apr 15;89(7):858-63
references.pmid: 20065916
references.citation: Transplantation. 2011 Feb 27;91(4):462-9
references.pmid: 21169880
references.citation: Ann Intern Med. 2006 Aug 1;145(3):185-96
references.pmid: 16880460
references.citation: Ann Intern Med. 1987 May;106(5):719-27
references.pmid: 3551714
references.citation: N Engl J Med. 1986 Apr 3;314(14):914-6
references.pmid: 3513017
references.citation: N Engl J Med. 2009 Jan 29;360(5):522-3
references.pmid: 19179321
references.citation: Eur Urol. 2005 Jul;48(1):90-6; discussion 96
references.pmid: 15967257
references.citation: Nephrol Dial Transplant. 1993;8(10):1146-50
references.pmid: 7818616
references.citation: Am J Med. 1985 Aug;79(2):201-8
references.pmid: 3895908
references.citation: BMC Surg. 2010 Mar 25;10:11
references.pmid: 20338030
references.citation: Transplantation. 1997 Oct 15;64(7):976-8
references.pmid: 9381544
references.citation: Am J Transplant. 2011 Mar;11(3):463-9
references.pmid: 21342446
references.citation: Am J Kidney Dis. 1986 Oct;8(4):223-33
references.pmid: 3532770
references.citation: Urology. 2011 Mar;77(3):607-11
references.pmid: 20708224
references.citation: Kidney Int. 1987 Jun;31(6):1383-90
references.pmid: 3302507