[Further Development and Interoperability in Oncological Care Structures, Quality Control and Research]. / Weiterentwicklung und Vernetzung der onkologischen Versorgungsstrukturen, der Qualitätssicherung und der Forschung.

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.

Colposcopy non-attendance following an abnormal cervical cancer screening result: a prospective population-based cohort study.

BACKGROUND: A considerable proportion of cervical cancer diagnoses in high-income countries are due to lack of timely follow-up of an abnormal screening result. We estimated colposcopy non-attendance, examined the potential factors associated and described non-attendance reasons in a population-based screening study. METHODS: Data from the MARZY prospective cohort study were analysed. Co-test screen-positive women (atypical squamous cells of undetermined significance or worse [ASC-US+] or high-risk human papillomavirus [hrHPV] positive) aged 30 to 65 years were referred to colposcopy within two screening rounds (3-year interval). Women were surveyed for sociodemographic, HPV-related and other data, and interviewed for non-attendance reasons. Logistic regression was used to examine potential associations with colposcopy attendance. RESULTS: At baseline, 2,627 women were screened (screen-positive = 8.7%), and 2,093 again at follow-up (screen-positive = 5.1%; median 2.7 years later). All screen-positives were referred to colposcopy, however 28.9% did not attend despite active recall. Among co-test positives (ASC-US+ and hrHPV) and only hrHPV positives, 19.6% were non-attendees. Half of only ASC-US+ screenees attended colposcopy. Middle age (adjusted odds ratio [aOR] = 1.55, 95% CI 1.02, 4.96) and hrHPV positive result (aOR = 3.04, 95% CI 1.49, 7.22) were associated with attendance. Non-attendance was associated with having ≥ 3 children (aOR = 0.32, 95% CI 0.10, 0.86). Major reasons for non-attendance were lack of time, barriers such as travel time, need for childcare arrangements and the advice against colposcopy given by the gynaecologist who conducted screening. CONCLUSIONS: Follow-up rates of abnormal screening results needs improvement. A systematic recall system integrating enhanced communication and addressing follow-up barriers may improve screening effectiveness.

Fatigue in survivors of malignant melanoma and its determinants: a register-based cohort study.

PURPOSE: Fatigue has found increasing attention as a debilitating and lasting condition of cancer patients. However, it has remained unclear to what degree long-term survivors of malignant melanoma suffer from fatigue. Therefore, this study aimed to determine fatigue and its link with quality of life, aftercare behavior, and mental and physical symptoms among melanoma survivors. METHODS: A register-based sample of 684 long-term survivors an average of 8.4 (SD = 1.72; range 5.67-12.17) years after diagnosis was compared to 2049 participants from a representative survey by the Multidimensional Fatigue Inventory. In a hierarchical linear regression, statistical predictors for fatigue were ascertained. RESULTS: Overall fatigue was not increased in melanoma survivors except for younger melanoma survivors under 40 years. As in the general population, fatigue increased with age, and it was higher in women compared to men. Fatigue was associated with decreased quality of life, reduced functioning, and increased physical and mental symptoms. Substantial predictors (30% explained variance) were higher age, additional chronic illness, self-blame, detrimental interactions and lack of social support, and also fear of recurrence. There was neither an effect of medical parameters (clinical stage, time since diagnosis) nor of participation in follow-up care. CONCLUSIONS: Fatigue needs to be taken seriously in the aftercare of melanoma survivors as it is associated with multiple functional and quality of life impairments and heightened distress. Reduction of fatigue in melanoma patients should address younger survivors (under 40 years) and older survivors (over 60 years) with additional chronic illness and focus on illness coping and social support.

Determinants of illness-specific social support and its relation to distress in long-term melanoma survivors.

BACKGROUND: Social support is considered to be one of the most important resources for coping with cancer. However, social interactions may also be detrimental, e. g. disappointing or discouraging. The present study explored: 1. the extent of illness-specific positive aspects of social support and detrimental interactions in melanoma survivors, 2. their relationships to mental health characteristics (e. g. distress, quality of life, fatigue, coping processes, and dispositional optimism) and 3. Combinations of positive social support and detrimental interactions in relation to depression and anxiety. METHODS: Based on the cancer registry of Rhineland-Palatinate, Germany, melanoma patients diagnosed at least 5 years before the survey were contacted by their physicians. N = 689 melanoma patients filled out the Illness-specific Social Support Scale ISSS (German version) and standardised instruments measuring potential psychosocial determinants of social support. RESULTS: Using principal component analysis, the two factor structure of the ISSS could be reproduced with acceptable reliability; subscales were "Positive Support" (PS) and "Detrimental Interactions" (DI); Cronbach's α = .95/.72. PS was rated higher than DI. Multivariable linear regressions identified different associations with psychosocial determinants. Survivors living in a partnership and those actively seeking out support had a higher probability of receiving PS, but not DI. PS and DI interacted regarding their association with distress: Survivors reporting high DI but low PS were the most depressed and anxious. High DI was partly buffered by PS. When DI was low, high or low PS made no difference regarding distress. CONCLUSION: Psycho-oncologic interventions should take into account both positive and negative aspects of support in order to promote coping with the disease.

Fear of recurrence in long-term breast cancer survivors-still an issue. Results on prevalence, determinants, and the association with quality of life and depression from the cancer survivorship--a multi-regional population-based study.

BACKGROUND: Fear of recurrence (FoR) is a widespread problem among breast cancer survivors. So far, little is known about prevalence, determinants, and consequences of FoR specifically in long-term breast cancer survivors, even though it was found to be one of the most important concerns in this group. METHODS: Analyses are based on data of several population-based cohorts of long-term breast cancer survivors, recruited by six German cancer registries. Overall, 2671 women were included in the analyses. FoR was assessed using the short form of the Fear of Progression Questionnaire. Potential determinants of moderate/high FoR and the association with depression and quality of life (QoL) were explored via multiple logistic and linear regression. RESULTS: Even though the majority of women reported low levels of FoR (82%), a substantial percentage experienced moderate (11%) and high (6%) FoR. Younger age (odds ratio = 3.00, confidence intervals = 1.91-4.73 for women below age 55 years) and considering oneself as a tumor patient (odds ratio = 3.36, confidence intervals = 2.66-4.25) were found to exhibit the strongest associations with moderate/high FoR. Overall, psychosocial and sociodemographic factors played a far bigger role in FoR than clinical factors. Higher FoR was associated with higher depression and lower QoL. CONCLUSION: Fear of recurrence (mostly low levels) is highly prevalent among long-term breast cancer survivors and can negatively affect QoL and well-being. Therefore, it should be given appropriate consideration in research and clinical practice. As specifically younger women tended to be impacted by FoR, it is crucial to be particularly attentive to specific needs of younger survivors.

The joint impact of donor and recipient parameters on the outcome of heart transplantation in Germany after graft allocation.

Organ shortage in heart transplantation (HTx) results in increased use of grafts from donors with substantial risk factors. It is discussed controversially which donor characteristics may be detrimental. Therefore, we evaluated the joint impact of donor- and patient-related risk factors in HTx on patient survival by multiple analysis in a nationwide multicentre study after donor selection was carried out. The research database consists of data concerning hearts donated and transplanted in Germany between 2006 and 2008 as provided by Deutsche Stiftung Organtransplantation and the BQS Institute. Multiple Cox regression (significance level 5%, hazard ratio [95% CI]) was conducted (n = 774, recipient age ≥ 18 years). Survival was significantly decreased by donor age (1.021 [1.008-1.035] per year), nontraumatic cause of death (1.481 [1.079-2.034]), troponin >0.1 ng/ml (2.075 [1.473-2.921]), ischaemia time (1.197 [1.041-1.373] per hour), recipient age (1.017 [1.002-1.031] per year) and in recipients with pulmonary vascular resistance ≥ 320 dyn*s*cm(-5) (1.761 [1.115-2.781]), with ventilator dependency (3.174 [2.211-6.340]) or complex previous heart surgery (1.763 [1.270-2.449]). After donor selection had been conducted, multiple Cox regression revealed donor age, nontraumatic cause of death, troponin and ischaemia time as well as recipient age, pulmonary hypertension, ventilator dependency and previous complex heart surgery as limiting risk factors concerning patient survival.

The impact of surgical-oncologic textbook outcome in patients with stage I to III pancreatic ductal adenocarcinoma: A cross-validation study of two national registries.

BACKGROUND: Using national registries, we aimed to evaluate oncologic textbook outcomes in pancreatic ductal adenocarcinoma patients. METHODS: Patients with stage I to III pancreatic ductal adenocarcinoma and surgical resection from 2010 to 2020 in the US and Germany were identified using the National Cancer Database and National Cancer Registries data. The surgical-oncologic textbook outcome was defined as complete oncologic resection with no residual tumor and ≥12 harvested lymph nodes. The composite endpoint was defined as surgical-oncologic textbook outcome and receipt of perioperative systemic and/or radiation therapy. RESULTS: In total, 33,498 patients from the National Cancer Database and 14,589 patients from the National Cancer Registries were included. In the National Cancer Database, 28,931 (86%) patients had complete oncologic resection with no residual tumor, and 11,595 (79%) in the National Cancer Registries. 8,723 (26%) patients in the National Cancer Database and 556 (4%) in the National Cancer Registries had <12 lymph nodes harvested. The National Cancer Database shows 26,135 (78%) underwent perioperative therapy and 8,333 (57%) in the National Cancer Registries. Surgical-oncologic textbook outcome was achieved in 21,198 (63%) patients in the National Cancer Database and in 11,234 (77%) patients from the National Cancer Registries. 16,967 (50%) patients in the National Cancer Database and 7,878 (54%) patients in the National Cancer Registries had composite textbook outcome. Median overall survival in patients with composite textbook outcomes was 32 months in the National Cancer Database and 27 months in the National Cancer Registries (P < .001). In contrast, those with non-textbook outcomes had a median overall survival of 23 months in the National Cancer Database and 20 months in the National Cancer Registries (P < .001). CONCLUSION: Surgical-oncologic textbook outcomes were achieved in > 50% of stage I to III pancreatic ductal adenocarcinoma for both the National Cancer Database and the National Cancer Registries. Failure to achieve textbook outcomes was associated with impaired survival across both registries.

Clinical and sociodemographic determinants of disease-specific health-related quality of life in long-term breast cancer survivors.

PURPOSE: It is important to monitor disease-specific health-related quality of life (HRQoL) in breast cancer (BC) survivors to identify potential unmet supportive care needs. However, previous studies were characterized by small samples of mostly short-term survivors and were limited to certain age ranges, stages and/or treatments. METHODS: We used data from 3045 long-term BC survivors (5-15 years post-diagnosis) recruited in a German multi-regional population-based study. We assessed disease-specific HRQoL with the EORTC QLQ-BR23, scoring from 0 to 100. Differences in functioning and symptoms according to age at survey, self-reported treatments, stage, and disease status (disease-free vs. active disease) were assessed with multiple regression. Active disease was defined as any self-report of recurrence, metastasis or second primary cancer after the index cancer. RESULTS: Older BC survivors reported a higher body image and a better future perspective, but lower sexual functioning. Survivors aged 30-49 years who had breast-conserving therapy or mastectomy with breast reconstruction reported a better body image compared to those who had mastectomy only. We also found differences in symptoms according to treatments in some age groups. Stage at diagnosis was not associated with HRQoL overall and in most age subgroups. Disease-free BC survivors aged 30-79 years reported a better future perspective and less systemic therapy side effects than those with active disease. CONCLUSION: Several treatment-associated symptoms and functioning detriments were found 5-15 years after diagnosis. The results emphasize the need of a comprehensive, individualized survivorship care, recognizing differential needs of long-term BC survivors according to age, treatment modalities, and disease status.

Concepts and Outcomes of Perioperative Therapy in Stage IA-III Pancreatic Cancer-A Cross-Validation of the National Cancer Database (NCDB) and the German Cancer Registry Group of the Society of German Tumor Centers (GCRG/ADT).

(1) Background: The aim of this study is to assess perioperative therapy in stage IA-III pancreatic cancer cross-validating the German Cancer Registry Group of the Society of German Tumor Centers-Network for Care, Quality, and Research in Oncology, Berlin (GCRG/ADT) and the National Cancer Database (NCDB). (2) Methods: Patients with clinical stage IA-III PDAC undergoing surgery alone (OP), neoadjuvant therapy (TX) + surgery (neo + OP), surgery+adjuvantTX (OP + adj) and neoadjuvantTX + surgery + adjuvantTX (neo + OP + adj) were identified. Baseline characteristics, histopathological parameters, and overall survival (OS) were evaluated. (3) Results: 1392 patients from the GCRG/ADT and 29,081 patients from the NCDB were included. Patient selection and strategies of perioperative therapy remained consistent across the registries for stage IA-III pancreatic cancer. Combined neo + OP + adj was associated with prolonged OS as compared to neo + OP alone (17.8 m vs. 21.3 m, p = 0.012) across all stages in the GCRG/ADT registry. Similarly, OS with neo + OP + adj was improved as compared to neo + OP in the NCDB registry (26.4 m vs. 35.4 m, p < 0.001). (4) Conclusion: The cross-validation study demonstrated similar concepts and patient selection criteria of perioperative therapy across clinical stages of PDAC. Neoadjuvant therapy combined with adjuvant therapy is associated with improved overall survival as compared to either therapy alone.

Cervical Cancer Screening: Comparison of Conventional Pap Smear Test, Liquid-Based Cytology, and Human Papillomavirus Testing as Stand-alone or Cotesting Strategies.

BACKGROUND: Some countries have implemented stand-alone human papillomavirus (HPV) testing while others consider cotesting for cervical cancer screening. We compared both strategies within a population-based study. METHODS: The MARZY cohort study was conducted in Germany. Randomly selected women from population registries aged ≥30 years (n = 5,275) were invited to screening with Pap smear, liquid-based cytology (LBC, ThinPrep), and HPV testing (Hybrid Capture2, HC2). Screen-positive participants [ASC-US+ or high-risk HC2 (hrHC2)] and a random 5% sample of screen-negatives were referred to colposcopy. Post hoc HPV genotyping was conducted by GP5+/6+ PCR-EIA with reverse line blotting. Sensitivity, specificity (adjusted for verification bias), and potential harms, including number of colposcopies needed to detect 1 precancerous lesion (NNC), were calculated. RESULTS: In 2,627 screened women, cytological sensitivities (Pap, LBC: 47%) were lower than HC2 (95%) and PCR (79%) for CIN2+. Cotesting demonstrated higher sensitivities (HC2 cotesting: 99%; PCR cotesting: 84%), but at the cost of lower specificities (92%-95%) compared with HPV stand-alone (HC2: 95%; PCR: 94%) and cytology (97% or 99%). Cotesting versus HPV stand-alone showed equivalent relative sensitivity [HC2: 1.06, 95% confidence interval (CI), 1.00-1.21; PCR: 1.07, 95% CI, 1.00-1.27]. Relative specificity of Pap cotesting with either HPV test was inferior to stand-alone HPV. LBC cotesting demonstrated equivalent specificity (both tests: 0.99, 95% CI, 0.99-1.00). NNC was highest for Pap cotesting. CONCLUSIONS: Cotesting offers no benefit in detection over stand-alone HPV testing, resulting in more false positive results and colposcopy referrals. IMPACT: HPV stand-alone screening offers a better balance of benefits and harms than cotesting.See related commentary by Wentzensen and Clarke, p. 432.

Age-specific prevalence and determinants of depression in long-term breast cancer survivors compared to female population controls.

BACKGROUND: Depression is more prevalent in breast cancer (BC) survivors than in the general population. However, little is known about depression in long-term survivors. Study objectives were: (1) to compare the age-specific prevalence of depressive symptoms (a) in BC survivors vs female population controls, (b) in disease-free BC survivors vs BC survivors with self-reported recurrence vs controls, and (2) to explore determinants of depression in BC survivors. METHODS: About 3010 BC survivors (stage I-III, 5-16 years post-diagnosis), and 1005 population controls were recruited in German multi-regional population-based studies. Depression was assessed by the Geriatric Depression Scale-15. Prevalence of mild/severe and severe depression only were estimated via logistic regression, controlling for age and education. Multinomial logistic regression was used to explore determinants of mild and severe depression. RESULTS: Compared with population controls, BC survivors were more likely to report mild/severe depression (30.4% vs 23.8%, p = .0003), adjusted for age and education. At all age groups <80 years, prevalence of both mild/severe and severe depression only was significantly higher in BC survivors, while BC survivors ≥80 years reported severe depression less frequently than controls. BC survivors with recurrence reported significantly higher prevalence of mild/severe depression than disease-free survivors and controls, but prevalence in disease-free survivors and controls was comparable. Age, income, living independently, recurrence, and BMI were significant determinants of mild depression in BC survivors. Age, education, employment, income, recurrence, and BMI were significant determinants of severe depression. CONCLUSIONS: Long-term BC survivors <80 years report significantly higher prevalence of depressive symptoms than controls, which might be explained by recurrence and individual factors. The findings suggest that depression in BC survivors is common, and even more after BC recurrence. Clinicians should routinize screening and normalize referral to psychological care.

Long-term relative survival from melanoma in Germany 1997-2013.

Up-to-date melanoma relative survival (RS) estimates and trend analysis facilitate close monitoring of melanoma patients' prognosis. This study aimed to provide recent 5-year and 10-year RS from melanoma, stratified by prognostic factors, and identify latest survival trends. Data from 12 German cancer registries were analysed. We included patients with primary cutaneous malignant melanoma (ICD-10: C43.X) diagnosed in 1997-2013 who were at least 15 years old. Five-year and 10-year RS were estimated by period analysis. For 10-year RS analyses, we excluded patients who were 75 years of age or older. Analyses were stratified by sex, age, histology, tumour stage, and body site. We included 82 901 patients, of whom 51% were women. The median age at diagnosis was 62 years. Five-year and 10-year RS in 2007-2013 were 92.4 and 90.8%, respectively. RS was higher in women. The prognosis worsened with older age and higher stage. In superficial spreading melanoma and lentigo maligna melanoma, RS was high; it was lower in nodular, acral lentiginous and 'other' melanoma. RS was the highest for melanoma on the arms; RS for melanoma on unknown or overlapping sites of the skin was the lowest. Five-year and 10-year RS increased significantly from 2005-2007 and 2008-2010 to 2011-2013, by 3.5 and 3.3 percentage points, respectively. For melanoma of 'other' histology, 5-year and 10-year RS increased significantly. Ten-year RS also increased significantly in men with superficial spreading melanoma and T4 melanoma, and in women with T3 melanoma. Melanoma RS improved, especially in certain subgroups. The reasons for improvements need to be investigated further.

"Still a Cancer Patient"-Associations of Cancer Identity With Patient-Reported Outcomes and Health Care Use Among Cancer Survivors.

BACKGROUND: The concept of cancer identity is gaining attention as more individuals are living with cancer as a chronic illness. Research is limited, and results suggest that a self-identity as "cancer patient" rather than a "cancer survivor" is associated with depression and lower health-related quality of life (HRQL). We aimed to identify factors associated with patient identity and investigate the associations between patient identity and treatment, health care use, psychosocial distress, and HRQL. METHODS: We used data from the population-based CAncEr Survivorship: A multi-Regional (CAESAR) study. Breast, colorectal, and prostate cancer survivors diagnosed during 1994-2004 completed a postal survey on patient identity, HRQL, psychological distress, and health care use in 2009-2011. We calculated odds ratios and the 95% confidence interval of having a patient identity. Analyses were adjusted for age, sex, education, and cancer stage, where appropriate. RESULTS: Of the 6057 respondents, colorectal cancer survivors (25%) were least likely to consider themselves patients, and prostate cancer survivors (36%) the most likely. Being male, younger age, comorbidity, higher cancer stage, and disease recurrence were associated with patient identity. Treatment was associated with patient identity, except among female colorectal cancer survivors. Having a patient identity was associated with higher health care use within the past 12 months. Survivors who still consider themselves patients were more likely to be depressed and reported significantly lower HRQL. CONCLUSIONS: A significant proportion of cancer survivors still consider themselves patients five to 15 years postdiagnosis. Sensitivity to individuals' self-identity should be considered when exploring their cancer experience.

Fear of recurrence in long-term cancer survivors-Do cancer type, sex, time since diagnosis, and social support matter?

OBJECTIVE: Fear of recurrence (FoR) is among the most important concerns for cancer survivors. Studies on potentially influencing variables, like time since diagnosis, cancer type, and sex, have yielded heterogeneous results. Also social support has rarely been examined as an influencing factor. This study aims to increase knowledge on these factors. METHOD: Analyses are based on cross-sectional data of long-term survivors of breast, colorectal, and prostate cancer (5-16 years postdiagnosis), recruited by 6 German population-based cancer registries. Six thousand fifty-seven women and men were included in the analyses. FoR was assessed using the short form of the Fear of Progression Questionnaire (FoP-Q-SF). The associations of cancer type, age, sex, time since diagnosis, and social support with moderate/high FoR were identified via multiple logistic regression analyses. RESULTS: The majority of long-term cancer survivors reported experiencing FoR, mostly in low intensity. Female survivors, survivors ≤54 or 55-59 years of age, 5 to 7 years postdiagnosis, with a lower education, with recurrence/metastases, or being socially isolated were at greater risk to experience moderate/high FoR. Cancer type and stage at diagnosis did not reach statistical significance. CONCLUSION: Our results indicate a potential vulnerability for women to experience FoR in moderate/high severity. Also younger and socially isolated survivors were at greater risk to suffer from moderate/high levels of FoR and should thus be monitored for high levels of FoR and be offered the support needed to manage their fears. (PsycINFO Database Record

Psychosocial Care Needs of Melanoma Survivors: Are They Being Met?

Patients who have survived malignant melanoma for more than five years may lack the opportunity to talk about their burden. As a consequence their psychosocial care needs remain undetected and available supportive interventions may not be utilised. Therefore, the psychosocial burden of this patient group needs to be assessed using specific screening instruments. The aim of this study was to investigate the psychosocial burden of long-term melanoma survivors, their psychosocial care needs and the determinants of these needs. We wanted to find out if the use of professional support corresponds to the care needs defined by experts. Using the cancer registry of Rhineland-Palatinate, melanoma patients diagnosed at least 5 years before the survey were contacted by physicians. N = 689 former patients completed the Hornheide Questionnaire (short form HQ-S) to identify psychosocial support need (scale cut off ≥ 16 or item-based cut-off score) and the potential psychosocial determinants of these needs. Additionally, they were asked about their utilisation of the professional support system. More than one third (36%) of them was in need for professional psychosocial support. The highest burden scores concerned worry about tumour progression. Younger age (< 50), higher general fatigue, higher symptom burden, lower general health, negative social interactions and unfulfilled information needs were significant predictors of the need for psychosocial intervention. Related to the percentage of survivors identified as 'in need', the professional support system was underused. Further studies should investigate whether using the HQ-S to routinely identify burdened melanoma patients could lead to better fulfilment of their intervention needs, ultimately enhancing health-related quality of life.

Depression, anxiety and quality of life in long-term survivors of malignant melanoma: a register-based cohort study.

AIM: The purpose of the study was to determine anxiety and depression, quality of life, and their determinants in long-term survivors of malignant melanoma. METHODS: In a state cancer registry a cohort of survivors of malignant melanoma was contacted via the physician registered. Of 1302 contactable patients, 689 (52.2%) completed a questionnaire including the Patient Health Questionnaire with generalized anxiety (GAD-7) and depression (PHQ-9) and the EORTC Quality of Life Questionnaire (EORTC QLQ 30). Based on multiple regression analysis, predictors of quality of life and distress were identified. Comparison data were assessed in two waves of representative face-to-face household surveys of the adult German population. RESULTS: An average of 8.4 (5.7 to 12.2) years after diagnosis, distress was higher in women compared to men and in middle adulthood (vs. older patients). Symptoms were higher in women than in men, and there was a decline of functioning and increase of symptoms across the age range of both genders. Compared to the general population, there were slightly increased depression and anxiety (only women), but no impaired global quality of life. Yet, survivors evidenced functional decline and more physical symptoms. Distress and reduced quality of life were consistently predicted by lack of social support, fear of recurrence, pessimism and self-blame. Distress was increased by a family history of melanoma, and additional mental and somatic diseases. CONCLUSION: Overall, long-term survivors have adjusted well achieving a global quality of life comparable to the general population. Yet, compromised functional dimensions, physical symptoms and distress indicate the need for integrating psychooncological screening into oncological follow-up, which might be guided by predictors such as family history or social support. Further prospective study is needed to determine the course of adaptation to the disease and corroborate the risk factors identified.

[Quality assurance in an epidemiological cohort study: on-site monitoring in gynaecological practices]. / Qualitätssicherung in einer epidemiologischen Kohortenstudie: Durchführung von on-site Monitoring in gynäkologischen Arztpraxen.

Quality assurance is required for all relevant instruments and procedures in epidemiological studies just like for clinical trials. The structure and complexity of the monitoring was developed based on the monitoring in clinical trials and applied to an epidemiological cohort study on early detection of cervical cancer (MARZY Study). Analyses of the on-site monitoring in participating gynaecological practices during the baseline investigation of the MARZY cohort were presented. The baseline investigation of the MARZY study was conducted between 2005 and 2007 in the city of Mainz, the rural district of Mainz-Bingen and surrounding areas. Women, who were randomly selected via population registries, were invited to attend cervical cancer screening at a gynaecologist's office of their choice. All study participants received a study swab in addition to their routine Pap smear. The on-site monitoring included equipment and support of all participating gynaecological practices during study recruitment. Each participant and physician signed an informed consent form. In addition, the participant completed an epidemiological questionnaire. The gynaecologist took the study swab and completed the study documentation form. Prior to recruitment, standardised processes and documentation forms were developed for the monitoring process. The monitoring visits were carried out every six to eight weeks. During the baseline investigation, participants were included in the study among 121 gynaecological practices. In total, 2,892 monitoring documentation forms from 390 on-site monitoring visits in 96 gynaecological practices from the study region and surrounding areas were analysed. On-site monitoring visits were more frequently conducted during the first year of the study. The average time needed for an on-site visit was 107 minutes (minimum 73 minutes, maximum 200 minutes). Problems such as incomplete study documentation forms or erroneous inclusion into the study occurred among 975 study participants (33.7%). 664 study participants (68.1%) did not fully complete the study forms, and 89 (9.1%) were included in the study despite the fact that they met the exclusion criteria such as hysterectomy or pregnancy. Most of these problems could be sufficiently corrected during the on-site monitoring. Monitoring in epidemiological studies performed at physicians' offices should be carried out in accordance with the monitoring in clinical trials. On-site monitoring helped to avoid missing data and to ensure adherence to exclusion criteria. On-site monitoring considerably contributed to the correct and complete study inclusion of all eligible participants and a high quality of study data.