Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

Early integration of palliative care for outpatients with advanced cancer in general practice: how is the situation?-a cohort study.

BACKGROUND: Compared with standard care alone, early integration of specialist palliative care in the treatment of patients with advanced cancer offers significant benefit with respect of symptom control, healthrelated quality of life and survival. The early integration of specialist palliative care means that patients receive palliative care concurrent with, or shortly after, the diagnosis of advanced cancer. METHODS: Using data from 2015 compiled from a large German statutory health insurance company (AOK Baden-Wuerttemberg) which insures 3.87 million people, we evaluated how many patients were identified with advanced metastatic cancer and at what point in time, if ever, general practitioners referred them to a specialist palliative home care team. The data were collected exclusively from general practices in the BadenWürttemberg province of Germany. Patients with advanced cancer where identified using all ICD-10 codes for cancer and the ICD-10 codes for metastases. Patients receiving care from a palliative care team were identified using the codes 01425 or 01426 of the German medical fee schedule. RESULTS: We identified 3,535 patients diagnosed with advanced cancer as having palliative care needs. 669 (18.9%) of these were referred to a specialist home care team. Of these, 302 (45.1%) where referred to a palliative care team on the day they were diagnosed but 367 (54.9%) were referred only at a later point in time. Two hundred and six (30.8%) patients had a delayed referral after 8 weeks or more and 153 (22.9%) after more than 12 weeks. CONCLUSIONS: Over half of the cancer patients in general practice who are referred for specialist palliative care are done so very late. General practitioners appear to need encouragement for the early integration of palliative care for patients with advanced cancer and to initiate early referrals to palliative care teams.

Identifying Palliative Patients in General Practice: Focusing on the Place of Death and the Vital Role of Specialized Home Palliative Care: An Observational Study.

Objectives: Specialist palliative care was introduced into the German health care system for patients at the end of life. The primary objective of this study was to assess whether the provision of specialist home palliative care (SHPC) for outpatients increased the likelihood of patients dying at home. Methods: We studied data collected in 2015 from a German statutory health insurance company covering 3.872 million people. We evaluated how many patients were identified as needing palliative care and whether these patients were able to stay at home until death. The data were ascertained from general practices in Baden-Wuerttemberg, a part of Germany. Palliative care patients were identified using the International Classification of Diseases (ICD)-10 code Z51.5 or the assigned medical billing code of the German fee schedule. Patients receiving care from an SHPC team were identified using the billing codes 01425 or 01426. Adjusted odds ratios were calculated for the place of death with multivariable logistic regression. Results: We found 21,190 (0.55%) palliative patients in the whole population. Of these, 19,507 (92.05%) patients received general palliative care and 1683 (7.95%) patients received specialist palliative care. Mortality rate across all patients was 1.08% (41,800) and mortality rate of palliative patients was 44.08% (9494). In total, 19,833 (47.5%) of the general population died in hospitals, as opposed to only 2208 (23.2%) among palliative patients. Further analysis revealed that of those palliative patients receiving SHPC, 160 (13.3%) died in hospitals as opposed to 2048 (24.7%) of those receiving general care. The probability of dying at home increases already with the label "palliative patient" and gets stronger if care is provided by a specialist palliative care team. Conclusion: Most palliative patients are able to die at home. Palliative care teams are responsible for a small part of these patients. Despite the high symptom burden in this group, most are able to die at home.

Anticholinergic and sedative medications and the risk of vertigo or dizziness in the German primary care setting-A matched case-control study from the CONTENT registry.

PURPOSE: To date, there is little information on the utilization of anticholinergic and sedative (AS) medications to vertigo or dizziness (VoD) patients in the German primary care setting. The objective of this study was to evaluate AS medication use and its association with VoD within the German primary care setting. METHODS: Cases with VoD from the CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) database were 1:1 matched to controls on age, sex, and comorbidities by propensity score matching. AS medication was defined using the fourth level of Anatomical Therapeutic Chemical Classification (ATC) Codes. A prescription of AS medication any time within the study period formed the primary exposure. Multivariable conditional logistic regression examined the association between AS use and VoD. RESULTS: Of a total of N = 151 446 patients, 6971 (4.6%) cases and 6971 corresponding controls were analyzed (mean age (sd): 59.9 years (20.9), 64.2% female). Dizziness and giddiness (ICD-10 Code R42) were diagnosed most prominently (87.2%). AS medication was prescribed on 1072 of 10 552 (10.2%) consultation days with VoD diagnoses. After adjusting for covariates, AS use was significantly and independently associated with VoD, adjusted odds ratio (1.37; 95% CI: 1.18-1.58), compared with no AS use. CONCLUSION: Primary care practitioners should consider AS medication as a risk factor for VoD and avoid prescribing AS medications after a VoD diagnosis. Caution should also be taken when prescribing AS medications to older adults (≥65 years). Systematical calculations of AS medication burden for patients could help acknowledge this issue and raise awareness for prescription habits in primary care.

Identification of physicians with unusual performance in screening colonoscopy databases: a Bayesian approach.

BACKGROUND: The adenoma detection rate (ADR) is an important surrogate measure of performance quality for screening colonoscopies. OBJECTIVE: To demonstrate how physicians with unusual performance concerning the adenoma detection rate may be identified in screening colonoscopy databases. DESIGN: Bayesian random-effects modeling and Winsorization of potential outliers were applied to develop a robust model for the majority of providers. Divergence was assessed with adjustment for multiple testing. The steps in the analysis were visualized by using funnel plots. Additionally, minimum requirements for the number of colonoscopies with 1 or more detected adenomas were derived. SETTING: Data from 422 physicians offering screening colonoscopy and participating in a quality assurance program in Bavaria, Germany, were used. PATIENTS: A total of 69,738 asymptomatic individuals 55 to 79 years of age. INTERVENTION: Screening colonoscopy. MAIN OUTCOME MEASUREMENTS: Physician-specific ADRs. RESULTS: The overall ADR in the sample was 26%. From an initial model, 62 physicians (15%) were identified as potential outliers. A model with normally distributed random effects was then chosen as the robust null model. Of the potential outliers, 10 (16%) were confirmed as physicians with unusual performance at a false discovery rate of 5%. For all of them, the observed ADR was lower than expected, and together they accounted for 1.4% of all included colonoscopies. LIMITATIONS: Analysis of routine data. CONCLUSION: The applied statistical approach appears suitable to identify unusual performance in screening colonoscopy databases. Its application may help to evaluate and improve the quality of colonoscopy in population-based colorectal cancer screening programs.

[Evaluation of family doctor centred medical care based on AOK routine data in Baden-Württemberg]. / Evaluation der Hausarztzentrierten Versorgung in Baden-Württemberg auf der Basis von Routinedaten der AOK.

The agreement on family-doctor centred care (Hausarztzentrierte Versorgung, "HzV") pursuant to Sect. 73b, Volume V of the German Social Security Code became effective in Baden-Wuerttemberg, Germany, on July 1(st), 2008. This complex intervention, which is voluntary for both family doctors and patients, aims to strengthen the coordinative function of family practices. As a result, this intervention is believed to increase the quality of medical health care for persons insured - in the medium to long-term - and thereby, ideally, to additionally save expenses. Working package 1 was one out of a total of four working packages and focused on the evaluation of potential intervention effects of the HzV intervention based on the analyses of AOK routine data in Baden-Wuerttemberg. A total of 1.44 million insured persons were eligible for the present analyses. Insured adults voluntarily participating in the family doctor-centred health care intervention (HzV insured persons: n=580,924 in the intervention group) of the AOK were compared to those not participating in this intervention (non-HzV insured persons: n=862,237 in the control group). For both HzV and non-HzV insured persons, a comparison of each outcome of interest (encounters with family doctors, encounters with specialists, rate of hospitalisations, duration of hospitalisations, rate of re-hospitalisations, costs of pharmacotherapy, rate of polypharmacy, rate of Me-Too pharmaceuticals) was conducted for quarters 3 and 4 of 2008 as well as for quarters 3 and 4 in 2010. Both groups of insured persons differed in that they either participated in the HzV intervention between January 1, 2009 and June 30, 2011 or not. Before January 1, 2009 individuals in both groups did not participate in the HzV intervention. This design allowed for both longitudinal and cross-sectional comparisons. Moreover, the design implicitly controlled for potential seasonal bias. In order to adjust for relevant covariates (insured persons' age, gender, nationality, insurance state, morbidity), multivariate multilevel regression models were developed and applied. On average, HzV insured persons were about 3 years older (56.2 ± 27.3 vs. 53.1 ± 18.4 years) and had higher levels of comorbidity (Charlson Comorbidity Index: 1.45 ± 1.86 vs. 1.19 ± 1.71). No significant differences in terms of rate and duration of hospitalisations were observed. The same applied to the number of rehospitalisations within 30 days. After adjustment for covariates, however, an increase in visits to the respective family doctor of 38% was found in the intervention group. Moreover, a decrease of encounters to specialists with and without referrals from family doctors could be observed (-29.8 % and -12.5%, respectively). Interestingly, even costs of pharmacotherapy, polypharmacy and prescriptions of Me-Too drugs were statistically significantly lower or less frequent, respectively, in the group of HzV insured persons. In conclusion, besides the observed associations in terms of pharmacotherapy, the HzV intervention appears to have advantageous effects in terms of family doctor centred health care.

[How chronically ill patients evaluate their care: results of an evaluation study of the family doctor-centred health care model]. / Wie beurteilen chronisch kranke Patienten Ihre Versorgung? Ergebnisse aus einer Patientenbefragung im Rahmen der Evaluation der Hausarztzentrierten Versorgung in Baden-Württemberg.

Considering the demographic development models for primary care have to be focused on chronic illness care especially. The so called "Hausarztzentrierte Versorgung" (HzV) in Baden-Wuerttemberg constitutes such a model of an implementation of family doctor-centred health care. For evaluation purposes the perspective of patients is of particular interest. Therefore the aim of this study was to analyse how chronically ill patients assess their medical care. Altogether 53 primary care practices in Baden-Wuerttemberg took part in a patient survey. The quality of chronic illness care from the patients' perspective was assessed by means of the PACIC short form. Furthermore the general satisfaction with care as well as sociodemographic characteristics were determined. For analysis two different groups were regarded: HzV-doctor and HzV-patient with a chronic condition (group 1) and non-HzV-doctor and non-HzV-patient with a chronic condition (group 2). Altogether 2,535 patients were recruited for the survey (response rate 47.8%). Out of these, 836 patients could be assigned to group 1 and 319 patients could be assigned to group 2. Patients in both groups were very satisfied with their care. The patients in group 1 stated more frequently that they received a written treatment plan from their general practitioner and that they were asked about their state of health when leaving the practice. Overall satisfaction was positively associated with organisation of care (ß= 0.484), support in difficult situations (ß= 0.171) and information on the usefulness of consulting other doctors (ß= 0.163) with an explained variation of R(2)=0.459. Irrespective of their group affiliation patients rate the medical care of their chronic condition very positively. Especially the assessment of the quality of care from the perspective of different patient groups (HzV participants and non-HzV participants) could contribute essentially as a feedback for physicians concerning the implementation of the main contents of the HzV for participating physicians.

Varicose veins are a risk factor for deep venous thrombosis in general practice patients.

BACKGROUND: The role of varicose veins (VV) as a risk factor for development of deep venous thrombosis (DVT) is still controversial. The aim of this study in primary care was to determine the impact of varicosity as a potential risk factor for developing DVT. PATIENTS AND METHODS: During the observation period between 01-Jan-2008 and 01-Jan-2011, all cases with VV (ICD code I83.9) and DVT (ICD codes I80.1 - I80.9) were identified out of the CONTENT primary care register (Heidelberg, Germany). The exposure of VV and DVT was based solely on ICD coding without regarding the accuracy of the diagnosis. The covariates age, gender, surgery, hospitalization, congestive heart failure, malignancy, pregnancy, hormonal therapy, and respiratory infection were extracted for each patient. Multivariate binary logistic regression was performed in order to assess potential risk factors for DVT. The SAS procedure "PROC GENMOD" (SAS version 9.2, 64-bit) was parameterised accordingly. A potential cluster effect (patients within practices) was regarded in the regression model. RESULTS: There were 132 out of 2,357 (5.6 %) DVT episodes among patients with VV compared to 728 out of 80,588 (0.9 %) in the patient cohort without VV (p < 0.0001). An increased risk of DVT was associated with previous DVT (adjusted odds ratio (OR): 9.07, 95 % confidence interval (CI): 7.78 - 10.91), VV (OR 7.33 [CI 6.14 - 8.74]), hospitalization during the last 6 months (OR 1.69 [CI 1.29 - 2.22]), malignancy (OR 1.55 [CI 1.19 - 2.02]), and age (OR 1.02 [CI 1.01 - 1.03]). CONCLUSIONS: There are strong associations between VV and DVT in a general practice population with documented VV. Special medical attention is required for patients with VV, a history of previous venous thromboembolism, comorbid malignancy, and recent hospital discharge, particularly those with a combination of these factors.

Recording of risk-factors and lifestyle counselling in patients at high risk for cardiovascular diseases in European primary care.

BACKGROUND: Detection and registration of high risk for cardiovascular diseases (CVD) by assessing individual's absolute cardiovascular risk is recommended in clinical guidelines. Effective interventions to reduce cardiovascular risk are available, but not optimally implemented. The aim of this study was to assess the quality of cardiovascular risk-factor recording and lifestyle counselling in high-risk patients in European primary care and to identify factors related to these clinical processes. METHODS: An international cross-sectional observational study was conducted in stratified samples of primary care practices in nine European countries. Patient records were audited, using a structured data-abstraction tool based on internationally developed quality indicators. To identify factors associated with the recording, additional data were collected in a patient survey. Descriptive and multilevel data analyses were conducted. RESULTS: In 268 general practices across Europe, 3723 records of individuals at high risk for cardiovascular diseases were audited. We found important variations in the quality of documentation of risk factors and lifestyle interventions. Recording of risk factors was best for blood pressure (92.5% of audited records, 95% CI 0.89-0.96). Lifestyle advice was recorded best for smoking cessation (65.6%, 95% CI 0.58-0.73) and worst for physical activity (38.8%, 95% CI 0.31-0.47). Of the study population, 50.6% (0.42-0.59) had elevated blood pressure levels, 59.8% (0.51-0.69) had total cholesterol >5 mmol/l, and 30.5% (0.22-0.39) were smokers. Multivariate analyses showed that recording of risk factors and counselling were related to specific patient characteristics more than to country effects. CONCLUSIONS: Analysis of different country results can be helpful for developing quality-improvement strategies.

[Needs assessment of a longitudinal training course in vocational training within the Verbundweiterbildung(plus)]. / Weiterbildung mit Inhalt - Bedarfsanalyse zur Konzeption eines überregionalen Schulungsprogramm in der Verbundweiterbildung(plus).

BACKGROUND: In Germany content-related vocational training mostly is the responsibility of the trainees themselves. The aim of this needs assessment is to explore the requirements of a longitudinal training course in vocational training. METHODS: A combined quantitative-qualitative needs assessment was chosen. We used data of a continuous record keeping system in primary care to assess the occupational field, and the needs of vocational trainees were explored in a qualitative survey. RESULTS: Data of more than 120,000 consulting problems in primary care were attributed to different medical expertises by frequency (orthopaedics 22.1%; internal medicine 17.2%; dermatology 12.2%; ear, nose, and throat medicine 11.9%). They revealed a high concordance between the needs derived from the consulting problems and the vocational trainees' needs identified in the qualitative survey (421 text units in the categories: medical expertise, competencies and skills and reflection on one's own performance). CONCLUSION: The results of this needs assessment demonstrate the importance of vocational trainees' needs and the findings of health services research for improvement of content-related vocational training. Furthermore, the results form the basis for longitudinal training courses in vocational training, as shown in the approach of the training course within the training programme Verbundweiterbildung(plus).

[Using routine data for quality of care assessments: a critical review, taking quality indicators for the "National Disease Management Guideline for Chronic Heart Failure" as an example]. / Nutzung von Routinedaten zur Einschätzung der Versorgungsqualität: Eine kritische Beurteilung am Beispiel von Qualitätsindikatoren für die "Nationale Versorgungsleitlinie Chronische Herzinsuffizienz"

In December 2009, the first version of the German Disease Management Guideline (DM-CPG) for chronic heart failure was completed, including a set of proposed quality indicators for heart failure. This article explores whether proposed indicators can be derived from data collected routinely in general practices. For this purpose, previous experiences and data from the research project CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) conducted under guidance of the Department of General Medicine and Health Services Research at the University of Heidelberg, Germany, were applied. The availability of numerators and denominators needed for calculating the four quality indicators for diagnosis and pharmacotherapy proposed in the DM-CPG was checked within so-called "routine data" from the existing dataset of the CONTENT project. Within the given context, routine data are defined as data that are periodically transmitted from health care providers to cost units within the health care system. A thorough assessment has revealed that within the given context only one indicator could be deduced from routine data collection. This was the indicator measuring the proportion of patients receiving beta receptor antagonists, compared to all patients with heart failure NYHA class II to IV. Indeed, this single indicator will only be computable if the NYHA grade of heart failure severity and the presence or absence of contraindications to beta receptor antagonist therapy are routinely collected and the data merged into a central database. Against the background of these results it is obvious that a fully developed, transsectoral concept for data collection and data transfer needs to be implemented.

Patient- and provider-related determinants of generic and specific health-related quality of life of patients with chronic systolic heart failure in primary care: a cross-sectional study.

BACKGROUND: Identifying the determinants of health-related quality of life (HRQOL) in patients with systolic heart failure (CHF) is rare in primary care; studies often lack a defined sample, a comprehensive set of variables and clear HRQOL outcomes. Our aim was to explore the impactof such a set of variables on generic and disease-specific HRQOL. METHODS: In a cross-sectional study, we evaluated data from 318 eligible patients. HRQOL measures used were the SF-36 (Physical/Mental Component Summary, PCS/MCS) and four domains of the KCCQ (Functional status, Quality of life, Self efficacy, Social limitation). Potential determinants (instruments) included socio-demographical variables (age, sex, socio-economic status: SES), clinical (e.g. NYHA class, LVEF, NT-proBNP levels, multimorbidity (CIRS-G)), depression (PHQ-9), behavioural (EHFScBs and prescribing) and provider (e.g. list size of and number. of GPs in practice) variables. We performed linear (mixed) regression modelling accounting for clustering. RESULTS: Patients were predominantly male (71.4%), had a mean age of 69.0 (SD: 10.4) years, 12.9% had major depression, according to PHQ-9. Across the final regression models, eleven determinants explained 27% to 55% of variance (frequency across models, lowest/highest ß): Depression (6×, -0.3/-0.7); age (4×, -0.1/-0.2); multimorbidity (4×, 0.1); list size (2×, -0.2); SES (2×, 0.1/0.2); and each of the following once: no. of GPs per practice, NYHA class, COPD, history of CABG surgery, aldosterone antagonist medication and Self-care (0.1/-0.2/-0.2/0.1/-0.1/-0.2). CONCLUSIONS: HRQOL was determined by a variety of established individual variables. Additionally the presence of multimorbidity burden, behavioural (self-care) and provider determinants may influence clinicians in tailoring care to individual patients and highlight future research priorities.

[Antihypertensive pharmacotherapy of patients in primary care with either a statutory or private health insurance]. / Antihypertensive medikamentöse Therapie von gesetzlich und privat versicherten Patienten in der Primärversorgung.

BACKGROUND AND PURPOSE: In Germany, hypertension has a prevalence of about 20%. Cardiovascular morbidity and mortality are closely associated with hypertension. Therefore, antihypertensive medical treatment is of crucial importance. Currently, five groups of drugs for the medical treatment of hypertension are available: diuretics, beta-receptor blockers, calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers. Besides medical considerations for the treatment of hypertension costs of treatment and other economic aspects become more and more important. Within this article, the antihypertensive treatment of insurants of the statutory health insurance and the private health insurance is compared with regard to the medical treatment and associated costs. METHODS: The analyzed data derive from the general practice morbidity research network CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork). The implementation of this network is funded by the German Federal Ministry of Research and Education (BMBF) for a continuous registration of health-care utilization, morbidity, course of disease, and outcome parameters within primary care. RESULTS: Altogether 4,842 patients from the participating general practitioners were regularly treated with antihypertensive drugs in 2007 and corresponding episodes were documented within electronic medical records. The proportion of insurants of the private health insurance was 7.6%. The costs of the antihypertensive medical treatment within the total sample in 2007 constituted 1.03 million Euros overall and per patient on average 212.82 Euros. Although the regarded sample of private health insurants was less morbid and the sum of defined daily doses (DDDs) within the observation period was notably lower (582.6 vs. 703.1; p < 0.0001), the annual therapy costs of the private health insurants compared to the statutory health insurants were 35.2% higher (280.29 Euros vs. 207.29 Euros; p < 0.0001). Hence, costs per DDD for antihypertensive medical treatment for private health insurants were 63.2% higher than for statutory health insurants. This refers to the great proportion of angiotensin II receptor blockers as well as the low proportion of generic drugs prescribed for private health insurants. CONCLUSION: Antihypertensive treatment with original drugs and/or angiotensin II receptor blockers is an expensive option. Based on the actual state of knowledge it must be questioned critically whether this constitutes a superior treatment option concerning the potential for lowering high blood pressure levels and organ protection.

Osteoarthritis: quality of life, comorbidities, medication and health service utilization assessed in a large sample of primary care patients.

OBJECTIVE: To assess the gender related impact of osteoarthritis (OA) on quality of life (QoL) and health service utilization (HSU) of primary care patients in Germany. METHODS: Cross sectional study with 1250 OA patients attending 75 primary care practices from March to May 2005. QoL was assessed using the GERMAN-AIMS2-SF. Data about comorbidities, prescriptions, health service utilization, and physical activity were obtained by questioning patients or from the patients' medical files. Depression was assessed by means of the Patient Health Questionnaire (PHQ-9). RESULTS: 1021 (81.7%) questionnaires were returned. 347 (34%) patients were male. Impact of OA on QoL was different between gender: women achieved significantly higher scores in the AIMS 2-SF dimensions lower body (p < 0.01), symptom (p < 0.01), affect (p < 0.01) and work (p < 0.05). Main predictors of pain and disability were a high score in the "upper body "scale of the AIMS2-SF (beta = 0.280; p < 0.001), a high score in the PHQ-9 (beta = 0.214; p < 0.001), duration of OA (beta = 0.097; p = 0.004), age (beta = 0.090; p = 0.023) and the BMI (beta = 0.069; p = 0.034). Predictors of pain and disability did not differ between gender. 18.8 % of men and 19.7% of women had a concomitant depression. However, no gender differences occurred. Women visited their GP (mean 5.61 contacts in 6 months) more often than men (mean 4.08; p < 0.01); visits to orthopedics did not differ between gender. CONCLUSION: The extent to which OA impacts men and women differs in primary care patients. This might have resulted in the revealed differences in the pharmacological treatment and the HSU. Further research is needed to confirm our findings and to assess causality.

No association of factor V Leiden, prothrombin G20210A, and MTHFR C677T gene polymorphisms with kidney allograft survival: a multicenter study.

BACKGROUND: It has been proposed that inherited risk factors of venous thromboembolism, such as factor V G1691A (FV-Leiden), prothrombin G20210A, and methylenetetrahydrofolate reductase (MTHFR) C677T, might be associated with poorer survival rates of transplanted kidneys. On the basis of this hypothesis, we performed a multicenter study, involving recipients of primary and repeat kidney transplants, to investigate the potential effect of these three single nucleotide polymorphisms (SNP) on graft survival. METHODS: The study consisted of 676 first and 651 retransplant patients. Using the polymerase chain reaction-sequence specific primers method, we typed all patients for the three SNP and analyzed graft survival. RESULTS: We could not find a statistically significant association between graft survival and factor V Leiden or MTHFR C677T genotypes. A better 3-yr graft survival was found for first transplant recipients with the genotype prothrombin 20210 G/G as compared to those with the G/A genotype (P=0.031). However, Bonferroni correction for the three SNPs investigated in this series rendered the P value insignificant (P(corrected)=0.093). CONCLUSION: We did not find a statistically significant association of SNP factor V Leiden G1691A and MTHFR C677T with renal graft survival. Prothrombin G20210A resulted in a significant association that was not sustained after Bonferroni correction. This SNP might be an interesting candidate for future studies.

Relevance of IL10, TGFbeta1, TNFalpha, and IL4Ralpha gene polymorphisms in kidney transplantation: a collaborative transplant study report.

Single nucleotide polymorphisms (SNPs) of cytokine genes have been shown to influence cytokine plasma levels. Cytokines are important mediators during organ graft rejection. It was reported that certain cytokine genotypes are associated with improved kidney graft survival. In the present study, SNPs within the IL10 promoter gene, the first exon of the TGFbeta1 gene, the TNFalpha promoter gene, and the IL4Ralpha gene were analyzed in 2298 first and 1901 repeat cadaver kidney recipients. We found no significant effect on the survival rate of first grafts. Among retransplants, we observed that recipients who were homozygous for the high TNFalpha producer genotype -308 A had a significantly lower graft survival rate than patients who were carriers of the low producer genotype -308 G (at 3 years: 63.0% vs. 79.5%; pcorrected = 0.0116). The results of this large-scale study suggest that IL10, TGFbeta1, TNFalpha, and IL4Ralpha cytokine genotypes do not affect the survival of primary kidney grafts. The outcome of retransplants appears to be affected by TNFalpha genotypes only.