Participants' decision to enroll in cohort studies with biobanks: quantitative insights from two German studies.

AIM: To understand participants' actual motivations to enroll in cohort studies with biobanks. METHODS: Participants of two such studies currently ongoing in Germany were invited to fill in a questionnaire about their decision to enroll. RESULTS: From the 623 questionnaires completed, contributing to scientific knowledge appeared as a main motive for enrollment, followed by learning about personal health status and receiving personal medical advice. CONCLUSION: Motivating participation as a way to contribute to the common good rather than as a way to obtain personal benefits appears to be particularly appropriate to ensure participants' long-term commitment and should therefore be further investigated in this setting.

Challenges and Opportunities for Harmonizing Research Methodology: Raw Accelerometry.

OBJECTIVES: Raw accelerometry is increasingly being used in physical activity research, but diversity in sensor design, attachment and signal processing challenges the comparability of research results. Therefore, efforts are needed to harmonize the methodology. In this article we reflect on how increased methodological harmonization may be achieved. METHODS: The authors of this work convened for a two-day workshop (March 2014) themed on methodological harmonization of raw accelerometry. The discussions at the workshop were used as a basis for this review. RESULTS: Key stakeholders were identified as manufacturers, method developers, method users (application), publishers, and funders. To facilitate methodological harmonization in raw accelerometry the following action points were proposed: i) Manufacturers are encouraged to provide a detailed specification of their sensors, ii) Each fundamental step of algorithms for processing raw accelerometer data should be documented, and ideally also motivated, to facilitate interpretation and discussion, iii) Algorithm developers and method users should be open about uncertainties in the description of data and the uncertainty of the inference itself, iv) All new algorithms which are pitched as "ready for implementation" should be shared with the community to facilitate replication and ongoing evaluation by independent groups, and v) A dynamic interaction between method stakeholders should be encouraged to facilitate a well-informed harmonization process. CONCLUSIONS: The workshop led to the identification of a number of opportunities for harmonizing methodological practice. The discussion as well as the practical checklists proposed in this review should provide guidance for stakeholders on how to contribute to increased harmonization.

The improved physical activity index for measuring physical activity in EPIC Germany.

In the European Investigation into Cancer and Nutrition study (EPIC), physical activity (PA) has been indexed as a cross-tabulation between PA at work and recreational activity. As the proportion of non-working participants increases, other categorization strategies are needed. Therefore, our aim was to develop a valid PA index for this population, which will also be able to express PA continuously. In the German EPIC centers Potsdam and Heidelberg, a clustered sample of 3,766 participants was re-invited to the study center. 1,615 participants agreed to participate and 1,344 participants were finally included in this study. PA was measured by questionnaires on defined activities and a 7-day combined heart rate and acceleration sensor. In a training sample of 433 participants, the Improved Physical Activity Index (IPAI) was developed. Its performance was evaluated in a validation sample of 911 participants and compared with the Cambridge Index and the Total PA Index. The IPAI consists of items covering five areas including PA at work, sport, cycling, television viewing, and computer use. The correlations of the IPAI with accelerometer counts in the training and validation sample ranged r = 0.40-0.43 and with physical activity energy expenditure (PAEE) r = 0.33-0.40 and were higher than for the Cambridge Index and the Total PA Index previously applied in EPIC. In non-working participants the IPAI showed higher correlations than the Cambridge Index and the Total PA Index, with r = 0.34 for accelerometer counts and r = 0.29 for PAEE. In conclusion, we developed a valid physical activity index which is able to express PA continuously as well as to categorize participants according to their PA level. In populations with increasing rates of non-working people the performance of the IPAI is better than the established indices used in EPIC.

Cross-sectional associations of objectively measured physical activity, cardiorespiratory fitness and anthropometry in European adults.

OBJECTIVE: To quantify the independent associations between objectively measured physical activity (PA), cardiorespiratory fitness (CRF), and anthropometry in European men and women. METHODS: 2,056 volunteers from 12 centers across Europe were fitted with a heart rate and movement sensor at 2 visits 4 months apart for a total of 8 days. CRF (ml/kg/min) was estimated from an 8 minute ramped step test. A cross-sectional analysis of the independent associations between objectively measured PA (m/s(2)/d), moderate and vigorous physical activity (MVPA) (%time/d), sedentary time (%time/d), CRF, and anthropometry using sex stratified multiple linear regression was performed. RESULTS: In mutually adjusted models, CRF, PA, and MVPA were inversely associated with all anthropometric markers in women. In men, CRF, PA, and MVPA were inversely associated with BMI, whereas only CRF was significantly associated with the other anthropometric markers. Sedentary time was positively associated with all anthropometric markers, however, after adjustment for CRF significant in women only. CONCLUSION: CRF, PA, MVPA, and sedentary time are differently associated with anthropometric markers in men and women. CRF appears to attenuate associations between PA, MVPA, and sedentary time. These observations may have implications for prevention of obesity.

Counseling reproductive health issues in women with congenital heart disease.

OBJECTIVES: This study reports on current information sources of women with Congenital Heart Disease (CHD) regarding sexuality, pregnancy and contraception. STUDY DESIGN: 536 women with CHD, aged 29 years (18-75 years) underwent clinical assessment and completed a questionnaire regarding sources of information they had received about sexuality, pregnancy and contraception. RESULTS: The sources where affected women sought information regarding sexuality, pregnancy or contraception were wide spread and varied between the different age groups. Not only the treating physician, but also friends were the main information sources. Written information from sources such as newspapers, magazines, books and also the internet were used less often. Only few women received information from affected patients. The women rated their level of information (on a level up to 10) regarding sexuality with a median of 3.5, and with a median of only 5 regarding contraception as well as pregnancy. CONCLUSIONS: Current counseling practice for pregnancy and contraception in women with CHD is inadequate. Failure to give knowledgeable family planning advice appropriate for the individual risk profile in this high-risk patient group can have hazardous consequences and cause an unnecessary risk for mother and child. Many doctors fail to confront their patients with congenital heart defects early with issues of regarding sexuality, pregnancy and contraception and to advise them adequately. A cooperative approach involving congenital cardiologists as well as experienced gynecological endocrinologists with appropriate knowledge about CHD is indispensable.

The importance of socio-demographic factors for the quality of life of adults with congenital heart disease.

PURPOSE: We conducted a study to measure the associations of socio-demographic factors with quality of life outcomes among adults with congenital heart disease (CHD). METHODS: Results are drawn from a questionnaire-based survey in 676 adults with CHD and compared to age and sex-matched controls of a representative national survey. Subjective outcomes were measured as health-related quality of life (hrQoL), health and life satisfaction. The associations of the subjective well-being with the degree of severity of the underlying heart defect and socio-demographic factors such as educational and employment status were quantified in multiple linear regression models. RESULTS: A significant correlation of the degree of severity of the heart defect was limited to the physical scale of the hrQoL, whereas for the mental scale of the hrQoL and the satisfaction scales, socio-demographic factors showed a stronger association. Furthermore, the associations of socio-demographic factors and subjective well-being were stronger in the patient group than in the control group. CONCLUSIONS: Socio-demographic factors can be significantly associated with the subjective well-being of adults with CHD. In order to assist the surgical successes of the past decades, which have ensured the survival of most of these patients into adulthood, increased attention should be paid to these domains in the care of adults with CHD.

Contraception in women with congenital heart disease.

The present study reports on contraceptive use, methods used, and counseling received on contraceptive issues for women with congenital heart disease and provides a brief review of current knowledge of the risks in relation to the different cardiac situations encountered with these specific patients. A total of 536 consecutive adult women with congenital heart disease (median age 29 years) were recruited from 2 tertiary care centers. They underwent a clinical assessment and completed a questionnaire regarding their contraceptive use. Oral contraceptives, condoms, and intrauterine devices were the most commonly used methods. Pregnancy occurred in almost every tenth woman despite the use of contraception. We identified a substantial number of women (20%) who were presently using contraceptive methods that were contraindicated for their specific cardiac condition. Additionally, a high proportion of patients (28%), in the group with high pregnancy-associated risks, were not using contraception despite having a sexual relationship. In our study, 43% of the women had not been counseled about contraception, and 48% had not been informed of the pregnancy-related risks by their treating physician. In conclusion, timely and competent counseling about contraception is important for women with congenital heart disease. Collaboration between cardiologists and gynecologists should be strengthened. Failure to give adequate family planning advice to this patient group could have hazardous consequences, causing an unnecessary risk to mother and child.

Sexuality and reproductive health in women with congenital heart disease.

The different biopsychosocial periods in a woman's life are all interactively associated with the cardiovascular system. The present study was designed to address questions related to sexuality and reproductive health in a large cohort of women with congenital heart disease. Overall, 536 women (median age 29 years, range 18 to 75) completed a questionnaire during their visit at 2 tertiary care centers for congenital heart disease. Patients were categorized according to their functional class and according to the degree of severity of the underlying heart defect. The median age at menarche was significantly delayed in patients with functional class III-IV and in women with complex or cyanotic anomalies. More than 1/4 of the women (29%) had at least once sought medical advice for menstrual discomforts, and the proportion was significantly increased for those in the worst functional class (49%, p <0.001) and for patients with a cyanotic heart defect (43%, p = 0.03). Overall, 9% reported increased or altered symptoms related to their heart defect during sexual activity. This proportion increased significantly with worsening functional class (6%, 11%, and 26% in functional class I, II, and III-IV, respectively; p = 0.001), increased severity (5%, 8%, and 17% for simple, moderate, and severe heart defects, respectively; p = 0.005), and in women with cyanosis (8% and 28% in acyanotic and cyanotic patients, respectively; p <0.001). In conclusion, to ensure high-quality care for this demanding and growing patient population, physicians must be aware that issues related to the entire reproductive cycle should be considered when counseling these patients.

Prospective study of physical activity and risk of primary adenocarcinomas of the oesophagus and stomach in the EPIC (European Prospective Investigation into Cancer and nutrition) cohort.

OBJECTIVE: To analyse the association between types of physical activity (occupational, recreational and household, vigorous and overall) and risk of primary oesophageal (OAC) or gastric adenocarcinoma (GAC). METHODS: From nine European countries, 420,449 participants were recruited between 1991 and 2000 and followed-up for a mean of 8.8 years to register incident GAC and OAC. Information on physical activity (PA), diet, lifestyle and health-related variables was obtained at baseline. Helicobacter pylori infection status was considered in a subset of 1,211 participants. Analyses were repeated by tumour site (cardia/non-cardia) and histological type (intestinal/diffuse). RESULTS: During the follow-up, 410 GAC and 80 OAC occurred. A lower risk of overall and non-cardia GAC was found for increasing levels of a PA index which combined occupational PA with weekly time spent in sports and cycling. The hazard ratio (HR) of GAC was 0.69, 95% CI: 0.50-0.94, for the comparison between active and inactive participants according to the PA index (HR = 0.44, 95% CI:0.26-0.74, for non-cardia GAC). No effect was found for cardia tumours or histological subtypes of GAC. PA of any kind was not associated with OAC. CONCLUSIONS: Overall and distal (non-cardia) gastric tumours were inversely associated with time spent on cycling and sports and a total PA index. No association was found for any type of PA and risk of cardia cancers of the stomach.

Clinical and parasitological response of Plasmodium falciparum to chloroquine and sulfadoxine/pyrimethamine in rural Uganda.

Following the WHO protocol for in-vivo tests in areas with intense transmission of uncomplicated falciparum malaria, a randomized comparison of the invivo efficacy of chloroquine alone, sulfadoxine/pyrimethamine alone, and their combined administration was carried out in the third quarter of 2001 in Kaberamaido District, northeastern Uganda. Malaria in the study area is hyper-endemic, with a high prevalence of Plasmodium falciparum. The patients were infants and young children with a median age of 15 months. Of the 117 originally enrolled patients, 104 had a complete follow-up with presentation at all scheduled examinations. In the chloroquine group (n = 42), 55% were classified as adequate clinical response, 26% as early treatment failure, and 19% as late clinical failure. In the sulfadoxine/pyrimethamine group (n = 30), the respective figures were 83%, 13% and 3%, and in the group with combined treatment (n = 32), 88%, 6% and 6%. In terms of clinical cure rate, speed of clinical relief and parasite clearance the combined treatment proved to be the most effective of the three drug regimens. In the patients with adequate clinical response, a significant post-therapeutic increase of the haematocrit was observed, which was particularly marked in patients who had also cleared their parasitaemia. Increase of the efficacy of chloroquine with age indicates the early development of semi-immunity in the study area, with conserved efficacy of chloroquine in semi-immune persons.