Physicians' perspectives on family caregivers' roles in elderly cancer patients' therapies: a qualitative, interview-based study.

PURPOSE: Clinical communication and facilitating informed and sound medical decisions become challenging as patients age and suffer from age-associated impairments. Family caregivers are perceived as essential actors in addressing these challenges. Here, we explore physicians' perspectives on family caregivers' roles and their involvement in consultations and therapy decision-making situations of elderly cancer patients. METHODS: We examined 38 semi-structured interviews with physicians from different specialities (oncologists, non-oncology specialists, and general practitioners) in Germany who treated elderly cancer patients. Data were analyzed using reflexive thematic analysis. RESULTS: We identified five general and distinct perspectives on the involvement of family caregivers in the therapy process. Family caregivers are seen as (1) translators of medical information; (2) providers of support for the patient; (3) providers of information about the patient; (4) stakeholders with relevant points of view regarding the treatment decision; or (5) individuals who have a disruptive influence on the consultation. The interviewed physicians rarely involved family caregivers closely in consultations. CONCLUSIONS: Although physicians frequently attribute supportive roles to family caregivers, they rarely include them in consultations. Previous studies have found that a triadic setting is often better suited to agreeing upon a patient-centered and needs-based treatment decision for older cancer patients. We infer that physicians too rarely recognize the potential importance of family caregivers. Educators should further integrate family caregiver involvement and its implications in general medical education and professional training.

Use of novel artificial intelligence computer-assisted detection (AI-CAD) for screening mammography: an analysis of 17,884 consecutive two-view full-field digital mammography screening exams.

BACKGROUND: Novel artificial intelligence computer-assisted detection (AI-CAD) systems based on deep learning (DL) promise to support screen reading. PURPOSE: To test a DL-AI-CAD system compared to human reading on consecutive screening mammograms. MATERIAL AND METHODS: In this retrospective study, 17,884 consecutive anonymized screening mammograms, double-read from January to November 2018, were processed by the DL-AI-CAD system. AI-CAD reading was considered positive if the AI-CAD case scores exceeded 30 (range = 1-100) and the lesion was correctly marked. Likewise, human reading (R1 or R2, respectively) was considered positive if the lesion was correctly identified and called. Receiver operating characteristic (ROC) analysis was performed and accuracy data were calculated. Ground truth for benign lesions: absence of malignancy after cancer registry matching (2022); for malignancy: histopathologic proof; evaluation was patient-based. RESULTS: In total, 114 screen-detected and 17 interval cancers (ICA) occurred. ROC analysis of screen-detected cancers yielded an AUC of 89% for AI-CAD. Sensitivity/specificity was 81.7%/80.2% for AI-CAD; 77.1%/91.7% for R1; 78.6/91.6% for R2. Combining each human reading with AI-CAD was as sensitive as human double-reading (all approximately 88%), but less specific (approximately 75%) compared to human double-reading (approximately 87%). These AI-CAD combinations required consensus readings for twice as many cases as the human combination. Four of 17 ICA exceeded a case score of 30; two of four CAD correctly marked the quadrant of the subsequent ICA. CONCLUSION: Including ICA cases, this AI-CAD achieved comparable sensitivity to human reading at lower specificity. Combining human reading and AI-CAD allows increasing sensitivity compared to single-reading.

Validation of the German version of the Family Reported Outcome Measure (FROM-16) to assess the impact of disease on the partner or family member.

BACKGROUND: The Family Reported Outcome Measure (FROM-16) assesses the impact of a patient's chronic illness on the quality of life (QoL) of the patient's partner or family members. The aim of the study was to translate, explore the structure of and validate the FROM-16. METHODS: The questionnaire was translated from English into German (forward, backward, four independent translators). Six interviews with family members were conducted to confirm the questionnaire for linguistic, conceptual, semantic and experiential equivalence and its practicability. The final German translation was tested for internal consistency, reproducibility and test validity. Criterion validity was tested by correlating the scores of the FROM-16 and the Global Health Scale (GHS). Principal component analysis, factor analysis, and confirmatory factor analysis was used to assess the questionnaire's structure and its domains. Reliability and reproducibility were tested computing the intraclass correlation coefficient (ICC) using one sample t-test for testing the hypothesis that the difference between the scores was not different from zero. RESULTS: Overall, 83 family members (61% female, median age: 61 years) completed the questionnaire at two different times (mean interval: 22 days). Internal consistency was good for the FROM-16 scores (Cronbach's α for total score = 0.86). In those with stable GHS, the ICC for the total score was 0.87 and the difference was not different from zero (p = 0.262) indicating reproducible results. A bi-factor model with a general factor including all items, and two sub-factors comprising the items from the original 2-factor construct had the best fit. CONCLUSIONS: The German FROM-16 has good reliability, test validity and practicability. It can be considered as an appropriate and generic tool to measure QoL of a patient's partner or family member. Due to the presence of several cross-loadings we do not recommend the reporting of the scores of the two domains proposed for the original version of FROM-16 when using the German version. Thus, in reporting the results emphasis should be put on the total score. TRIAL REGISTRATION: Retrospectively registered: DRKS00021070.

A comparison of metabolic health parameters in ICSI-conceived and naturally conceived adolescents.

RESEARCH QUESTION: Are there differences in the cardiometabolic health of ICSI-conceived adolescents compared with a control group, taking parental risk factors into account? DESIGN: ICSI-conceived adolescents (n = 272), their mothers (n = 273) and naturally conceived control adolescents (n = 273) and their mothers (n = 273) provided a blood test and answered a health-related questionnaire. The adolescents also attended a physical examination. RESULTS: ICSI-conceived males showed significantly higher mean weight (72.6 ± 15.1 versus 67.7 ± 12.6 kg, P = 0.005), body mass index (BMI) (22.2 ± 3.7 versus 21.0 ± 3.2 kg/m2, P = 0.007) and waist circumference (79.1 ± 11.6 versus 74.5 ± 8.7 cm, P < 0.001). The mean values for weight and BMI were also significantly higher in the ICSI parents. In the ICSI-conceived females significant differences in high-density lipoprotein cholesterol (1.5 ± 0.3 versus 1.6 ± 0.3 mmol/l, P = 0.033) and triglyceride values (1.1 ± 0.5 versus 1.0 ± 0.4 mmol/l, P = 0.013) were observed. ICSI mothers also had significantly higher triglycerides (P = 0.002), higher glutamate pyruvate transaminase/alanine aminotransferase (P < 0.001) and higher alkaline phosphatase values (P < 0.001). CONCLUSIONS: Increased values for weight were found in the male and differences in lipid parameters in the female ICSI-conceived adolescents, which were reflected in the values of their parents. Adjustment for parental risk factors generally attenuated the differences between the ICSI and the control groups, but did not completely remove them. Whether these observed differences are clinically relevant for the future health of the participants requires further study. To increase knowledge in this area, future studies should also include parental data.

Urinary incontinence in women: treatment barriers and significance for Danish and German GPs.

BACKGROUND: Female urinary incontinence (UI) is common. Only scant information exists on the significance of UI for GPs' consultations. OBJECTIVES: (i) To assess the significance of female UI for GPs and to look at barriers that could be detrimental to treatment by comparing GPs from Denmark and Germany, with different health systems and access to UI guidelines. (ii) To assess whether GPs' gender and age were relevant to the discussion of UI. METHODS: We conducted a cross-sectional survey. In the Fehmarn belt-region, a Danish-German border region, a self-developed questionnaire was sent to all the GPs (n = 930). RESULTS: In total, 407 GPs returned the questionnaire (43%); 403 questionnaires were analysed. Using a scale from 0 (never) to 10 (always), addressing UI was reported with an average score of 3.8 (SD: 2.1) among Danish and 3.5 (SD: 2.1) among German GPs. The topic was discussed more frequently with female (4.2; SD 2.2) than with male GPs (3.2; SD 2.0). Danish GPs estimated the prevalence among their female patients at 10% (SD: 8.0) and German GPs at 14% (SD: 11.2). 61% of the Danish and 19% of the German GPs used UI guidelines. German GPs significantly more often reported the barrier 'uncertainty of how to treat UI' [OR = 5.39 (95% CI: 2.8; 10.4)]. CONCLUSIONS: In consultations with female GPs, UI was discussed significantly more frequently than with male GPs. Compared with the Danish GPs, German GPs stated significantly more uncertainties regarding UI treatment measures, and tended not to use UI guidelines.

Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark.

INTRODUCTION: Urinary incontinence (UI) is a prevalent condition that interferes with women's health-related quality of life. Prevalence rates from earlier studies are wide-ranging, due to heterogeneity in methodology, definition of UI and the populations included. We aimed to determine the prevalence of UI and associated risk factors in Germany and Denmark using the same methodology, definition and population. MATERIAL AND METHODS: A postal survey was conducted in two regions in Germany and Denmark, including 8000 women aged 18+ years. UI was defined as any complaint of involuntary loss of urine. The questionnaire contained socio-demographic questions and the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF). RESULTS: The response rate in Germany and Denmark was 46.2 and 66.6% (p < 0.001) and the prevalence rate of UI was 48.3 and 46.4% (p = 0.188), respectively. Stress urinary incontinence dominated among younger women, and urgency urinary incontinence and mixed urinary incontinence among women 80+ years in Germany and Denmark, respectively. The subgroup of women with body mass index (BMI) ≥35 had the highest prevalence of UI (67.3%). The subgroup of women with BMI <35 were more likely to have stress urinary incontinence, and the subgroup of women with BMI ≥35 were more likely to have mixed urinary incontinence. UI was significantly associated with age as with BMI, vaginal delivery, chronic obstructive pulmonary disease, and having at least one co-morbidity. CONCLUSIONS: Prevalence rates in the two regions in Germany and Denmark were similar, despite significantly different response rates. This difference may reflect various attitudes towards answering a questionnaire, but the response rate on questions concerning UI seemed consistent.

Contributing and limiting factors to guideline-adherent therapy in senior and elderly breast cancer patients: a questionnaire-based cross-sectional study using clinical and cancer registry data in Germany.

PURPOSE: Elderly cancer patients are less likely to be treated in accordance with evidence-based guideline recommendations. This study examines patient-related factors associated with deviations from guideline recommendations. METHODS: Using medical documentation and cancer registry data, we investigated the treatment courses of female breast cancer patients aged 50 and older in Germany regarding compliance with German guidelines. Participants completed a questionnaire querying factors hypothesized to be associated with guideline adherence. We conducted univariate analyses to explore the data and select variables for multivariate logistic regression to estimate adjusted odds ratios. RESULTS: Of 1150 participants, 206 (17.9%) were treated in deviation from guideline recommendations. Patients 70 years and older were more likely to be treated deviating from guideline recommendations than patients 50-69 years old (OR: 2.07; 95% CI: 1.52-2.80). Patients aged 50-69 years who reported that quality of life guided their treatment decision were more likely to be treated in deviation from guideline recommendations (AOR: 2.08; 95% CI: 1.11-3.92) than the elderly. In older patients, higher age was associated with an increased chance of receiving guideline-discordant care (AOR: 1.06; 95% CI: 1.01-1.11), as was depression diagnosed prior to cancer (AOR: 1.84; 95% CI: 1.00-3.40). CONCLUSION: Reasons for deviations from guideline recommendations in breast cancer patients differ by age. In decision-making concerning elderly patients, particular attention should be paid to those with pre-existing depressive disorders. Adequately addressing their needs and concerns could prevent inappropriate deviations from guideline recommendations.

[Quality assurance follow-up survey of the ELISA cohort study on the prevalence of COVID-19: The view of study participants - What is well received?] / Nachbefragung zur Qualitätssicherung der ELISA-Kohortenstudie zur COVID-19-Prävalenz: Die Sicht von Studienteilnehmerinnen und Studienteilnehmern ­ Was kommt gut an?

INTRODUCTION: With the outbreak of the Corona pandemic, the LübEcker longitudinal study on infections with SARS-CoV-2 (ELISA study) was conducted in the Lübeck area to provide information on the prevalence, unreported cases and symptoms of COVID-19. The aim of the present study is to evaluate defined structure and process indictors of the study conduct of the ELISA study by subjects. METHODS: After defining and operationalizing participant-oriented quality indicators, 3,710 participants were surveyed online via LimeSurvey. Indicators defined were access to the study, time requirements, reporting of findings, ratings of the study apps used, communication, study center, tolerability of sample collection, and willingness to re-participate. In addition, comments on push and pull factors of study participation could be made. The evaluation was both quantitative and qualitative. RESULTS: 45% of the follow-up respondents (n=1,684) answered the questions on the defined structural and process indicators. In the quantitative part of the survey, tolerability of venous blood sampling was rated as significantly better than that of nasopharyngeal smears. 91% of the follow-up respondents welcomed the offer to view their findings in the personal results portal. Overall, the indicators were mostly rated positively. According to the qualitative data, the study participants found the win-win situation of the test opportunity to contribute to research, the local relevance of the study, the small incentives, and the low-threshold nature of the study registration to be positive aspects of the study. According to the quantitative data, participants suggested improving the usability of the digital applications in terms of more user-friendly identification solutions, reminder functions, announcements of software updates and avoidance of double entries. DISCUSSION: The defined structure and process indicators appear to be suitable for assessing the quality of study implementation from the subjects' point of view and indicate a good quality of study implementation under pandemic conditions. The lowest participation rate (75%) was measured at the fifth test time of strongly declining COVID-19 infections during the summer holidays in Schleswig-Holstein. Obviously, the benefit and meaningfulness of further study participation as well as competing factors were weighted differently by the subjects at this point. The follow-up survey suggests a variety of options for motivating participants to maintain a high level of participation. Possible limitations are that a non-response bias cannot be excluded for the follow-up survey and that no suitable standardised questionnaire was available. CONCLUSION: The present study provides recommendations for the planning of future cohort studies. It makes sense to continuously evaluate the motives for participation or non-participation and to explicitly consider them in the course of the study. Therefore, the definition of general quality indicators for the practical implementation of studies seems desirable. Positive experiences of the participants in connection with study participation are important, such as good time management, short response times, technical support offers and additional services such as a study homepage with frequently asked questions (FAQs), timely individual notifications of results and transparent, generally understandable information about study results during the study. Digital solutions are well received, but can still be improved for specific studies.

Cardiovascular Health Status And Genetic Risk In Survivors of Childhood Neuroblastoma and Nephroblastoma Treated With Doxorubicin: Protocol of the Pharmacogenetic Part of the LESS-Anthra Cross-Sectional Cohort Study.

BACKGROUND: In childhood cancer survivors (survival of 5 years or more after diagnosis), cardiac toxicity is the most common nonmalignant cause of death attributed to treatment-related consequences. Identifying patients at risk of developing late cardiac toxicity is therefore crucial to improving treatment outcomes. The use of genetic markers has been proposed, together with clinical risk factors, to predict individual risk of cardiac toxicity from cancer therapies, such as doxorubicin. OBJECTIVE: The primary aim of this study is to evaluate the value of multimarker genetic testing for RARG rs2229774, UGT1A6 rs17863783, and SLC28A3 rs7853758 for predicting doxorubicin-induced cardiotoxicity. The secondary aim is to replicate previously described associations of candidate genetic markers with doxorubicin-induced cardiotoxicity. Moreover, we will evaluate the prevalence of cardiovascular dysfunction in childhood cancer survivors after neuroblastoma or nephroblastoma. METHODS: This is the pharmacogenetic substudy of the research project Structural Optimization for Children With Cancer After Anthracycline Therapy (LESS-Anthra). We invited 2158 survivors of childhood neuroblastoma or nephroblastoma treated with doxorubicin according to the trial protocols of SIOP 9/GPOH, SIOP 93-01/GPOH, SIOP 2001/GPOH, NB 90, NB 97, or NB 2004 to participate in this prospective cross-sectional cohort study. The study participants underwent a cardiological examination and were asked to provide a blood or saliva sample for genotyping. The study participants' health statuses and cardiovascular diagnoses were recorded using a questionnaire completed by the cardiologist. Digital echocardiographic data were centrally evaluated to determine the contractile function parameters. Medical data on the tumor diagnosis and treatment protocol were taken from the study documentation. Survivors were screened for variants of several candidate genes by TaqMan genotyping. RESULTS: This study includes 657 survivors treated with doxorubicin for childhood cancer, the largest German cohort assembled to date to investigate cardiovascular late effects. Data analyses are yet to be completed. CONCLUSIONS: This study will define the genetic risk related to 3 marker genes proposed in a pharmacogenetic guideline for risk assessment. Moreover, the results of this study will show the prevalence of cardiovascular dysfunction in survivors of pediatric neuroblastoma or nephroblastoma who were treated with doxorubicin. The results will help to improve primary treatment and follow-up care, thus reducing cardiovascular late effects in the growing population of childhood cancer survivors. TRIAL REGISTRATION: German Clinical Trials Register DRKS00015084; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015084. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27898.

One-year surveillance of SARS-CoV-2 transmission of the ELISA cohort: A model for population-based monitoring of infection risk.

With newly rising coronavirus disease 2019 (COVID-19) cases, important data gaps remain on (i) long-term dynamics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection rates in fixed cohorts (ii) identification of risk factors, and (iii) establishment of effective surveillance strategies. By polymerase chain reaction and antibody testing of 1% of the local population and >90,000 app-based datasets, the present study surveilled a catchment area of 300,000 inhabitants from March 2020 to February 2021. Cohort (56% female; mean age, 45.6 years) retention was 75 to 98%. Increased risk for seropositivity was detected in several high-exposure groups, especially nurses. Unreported infections dropped from 92 to 29% during the study. "Contact to COVID-19-affected" was the strongest risk factor, whereas public transportation, having children in school, or tourism did not affect infection rates. With the first SARS-CoV-2 cohort study, we provide a transferable model for effective surveillance, enabling monitoring of reinfection rates and increased preparedness for future pandemics.

The role of family confidants and caregivers in the care of older cancer patients: Extending the concept of "shared decision-making".

BACKGROUND AND AIMS: Family caregivers play an important role in assisting their family members with cancer, but their influence on the treatment decision-making process has not yet been adequately investigated. This exploratory study approached this topic via reconstructive methodology, focusing on assessing patient-caregiver relationships. METHODS: We conducted semi-structured interviews with 37 mostly elderly cancer patients (median age: 74 years) about the context of their diagnosis, treatment decision, and family support. Additionally, we interviewed 34 caregivers of cancer patients. Of these, 25 were related to patients interviewed. We analyzed the interviews via a multi-step coding method informed by Grounded Theory methodology toward characterizing patient-caregiver relationships, the treatment decision-making process, and the caregivers' role therein. RESULTS: In the majority of cases (86%), patients were being supported by caregivers. We categorized patient-caregiver relationships in regards to the caregivers' involvement in the therapy decision-making process. We found patient-caregiver interaction patterns that indicate the potential of caregivers to decidedly influence the therapy decision-making process. Yet, only in 38% of cases, a caregiver attended relevant patient-physician-consultations. CONCLUSION: Depending on the nature of the patient-caregiver relationship, the traditional concept of shared decision-making, which assumes a dyadic relationship, needs to be extended toward a more dynamic concept in which caregivers should be involved more frequently. This could enable physicians to better understand a patient's reasons for or against a therapy proposal and ensure that the patient's wishes are communicated and considered. On the other hand, strong caregiver-involvement bears risks of over-stepping elderly patients' wishes, thus violating patient autonomy.

Usefulness of current candidate genetic markers to identify childhood cancer patients at risk for platinum-induced ototoxicity: Results of the European PanCareLIFE cohort study.

BACKGROUND: Irreversible sensorineural hearing loss is a common side effect of platinum treatment with the potential to significantly impair the neurocognitive, social and educational development of childhood cancer survivors. Genetic association studies suggest a genetic predisposition for cisplatin-induced ototoxicity. Among other candidate genes, thiopurine methyltransferase (TPMT) is considered a critical gene for susceptibility to cisplatin-induced hearing loss in a pharmacogenetic guideline. The aim of this cross-sectional cohort study was to confirm the genetic associations in a large pan-European population and to evaluate the diagnostic accuracy of the genetic markers. METHODS: Eligibility criteria required patients to be aged less than 19 years at the start of chemotherapy, which had to include cisplatin and/or carboplatin. Patients were assigned to three phenotype categories: no, minor and clinically relevant hearing loss. Fourteen variants in eleven candidate genes (ABCC3, OTOS, TPMT, SLC22A2, NFE2L2, SLC16A5, LRP2, GSTP1, SOD2, WFS1 and ACYP2) were investigated. Multinomial logistic regression was performed to model the relationship between genetic predictors and platinum ototoxicity, adjusting for clinical risk factors. Additionally, measures of the diagnostic accuracy of the genetic markers were determined. RESULTS: 900 patients were included in this study. In the multinomial logistic regression, significant unique contributions were found from SLC22A2 rs316019, the age at the start of platinum treatment, cranial radiation and the interaction term [platinum compound]∗[cumulative dose of cisplatin]. The predictive performance of the genetic markers was poor compared with the clinical risk factors. CONCLUSIONS: PanCareLIFE is the largest study of cisplatin-induced ototoxicity to date and confirmed a role for the polyspecific organic cation transporter SLC22A2. However, the predictive value of the current genetic candidate markers for clinical use is negligible, which puts the value of clinical factors for risk assessment of cisplatin-induced ototoxicity back into the foreground.

Association of candidate pharmacogenetic markers with platinum-induced ototoxicity: PanCareLIFE dataset.

Genetic association studies suggest a genetic predisposition for cisplatin-induced ototoxicity. Among other candidate genes, thiopurine methyltransferase (TPMT) is considered a critical gene for susceptibility to cisplatin-induced hearing loss in a pharmacogenetic guideline. The PanCareLIFE cross-sectional cohort study evaluated the genetic associations in a large pan-European population and assessed the diagnostic accuracy of the genetic markers. 1,112 pediatric cancer survivors who had provided biomaterial for genotyping were screened for participation in the pharmacogenetic association study. 900 participants qualified for inclusion. Based on the assessment of original audiograms, patients were assigned to three phenotype categories: no, minor, and clinically relevant hearing loss. Fourteen variants in eleven candidate genes (ABCC3, OTOS, TPMT, SLC22A2, NFE2L2, SLC16A5, LRP2, GSTP1, SOD2, WFS1, and ACYP2) were genotyped. The genotype and phenotype data represent a resource for conducting meta-analyses to derive a more precise pooled estimate of the effects of genes on the risk of hearing loss due to platinum treatment.

Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR).

BACKGROUND AND PURPOSE: There is no consensus about indicators for measuring quality of acute stroke care in Germany. Therefore, a standardized process was initiated recently to develop and implement evidence-based indicators for the measurement of quality of acute hospital stroke care. METHODS: Quality indicators were developed by a multidisciplinary board between November 2003 and December 2005. The process was initiated by the German Stroke Registers Study Group in cooperation with the German Stroke Society, the German Society of Neurology, the German Stroke Foundation, Regional Offices for Quality Assurance and other experts proven in the field. National and international recommendations were considered during the development process. The process was based on a systematic literature review, an independent external evaluation of the process and its results, and a prospective pilot study to evaluate the defined indicators in clinical practice. RESULTS: Overall a set of 24 indicators was developed to measure performance of acute care hospitals in the 3 health care dimensions structure, process and outcome as well as in 3 treatment phases prehospital, in-hospital/acute and postacute. Practicability of the derived indicators was tested in a prospective pilot study. During a 2-month period, 1006 patients in 13 hospitals were documented. Application of the new indicator set was found to be feasible by participating physicians and hospitals. Median time to document the required information for 1 patient was 5 minutes. Nationwide implementation of the new indicator set within regional registers in Germany started since April 2006. CONCLUSIONS: The development of indicators to measure hospital performance in stroke care is an important step toward improving stroke care on a national level. The chosen standardized evidence-based approach ensures maximal transparency, acceptance and sustainability of the developed indicators in Germany.