Systematic review of the clinical effectiveness of biomarkers as cancer screening test offered as self-pay service in Austria and Germany [Abstract]

Background: Individual health services (IGeL) are medical self-pay services that are not under the liability of the German statutory health insurance. Up to 14% of IGeL are blood or laboratory and cancer screening tests, which are offered to asymptomatic individuals [1]. The aim was to investigate the clinical effectiveness of eleven biomarkers that are the most often offered biomarkers for cancer screening by physicians and laboratories on the internet in Germany (i.e., AFP, CA125, CA15-3, CA19-9, CEA, Cyfra21-1, β-HCG, NMP22, M2-PK, NSE and PCA3). Research Question: What is the benefit-harm-balance regarding patient relevant outcomes (mortality, morbidity, quality of life) for using these biomarkers as cancer screening test in comparison to usual care? Methods: Firstly, searches for Health Technology Assessment (HTA) reports and systematic reviews (SR) were performed in three different databases in spring 2012. Secondly, randomized controlled trials (RCT) that were published after the end of the research period of the most recent included secondary study were searched. We included publications in English or German which compared cancer screening with one of these biomarkers in asymptomatic persons to unscreened controls. References were independently screened by two reviewers. One reviewer extracted relevant characteristics from full text and evaluated the quality of included studies. Results: Five HTA or SR dealing with CA125 (4) or NMP22 (1) and 2 RCTs (CA125) were included. For ten biomarkers, incl. NMP22, no direct evidence on patient relevant outcomes was available. One RCT combining CA125 and vaginal ultrasound for ovarian cancer screening provided results of interest [2]. Screening compared with usual care did not reduce ovarian cancer mortality (RR, 1.18; 95% CI, 0.82-1.71) [2]. Harms occurred through overdiagnosis and false-positive results, e.g., 20.6 complications occurred per 100 surgical procedures in women who underwent surgery after a false-positive result [2]. About 4.5 surgeries were performed per one case of invasive cancer identified through CA125 screening [3]. Conclusion: While ovarian cancer screening with CA125 showed no survival benefit, false-positive tests, overdiagnosis and -treatment resulted in harm. For ten biomarkers no sufficient evidence was available. When IGeL are offered, patients should get comprehensive information about the lack of evidence on patient-relevant outcomes and potential harm caused by biomarker screening

automated detection of non-wear time in comparison to diary information

Estimation of physical activity using 24 h-accelerometry requires detection of accelerometer non-wear time (NWT). It is common practice to define NWT as periods >60 minutes of consecutive zero-accelerations, but this algorithm was originally developed for waking hours only and its applicability to 24 h-accelerometry is unclear. We investigated sensitivity and specificity of different algorithms to detect NWT in 24 h-accelerometry compared to diary in 47 ActivE and 559 KORA participants. NWT was determined with algorithms >60, >90, >120, >150, or >180 minutes of consecutive zero-counts. Overall, 9.1% (ActivE) and 15.4% (KORA) of reported NWT was >60 minutes. Sensitivity and specificity were lowest for the 60-min algorithm in ActivE (0.72 and 0.00) and KORA (0.64 and 0.08), and highest for the 180-min algorithm in ActivE (0.88 and 0.92) and for the 120-min algorithm in KORA (0.76 and 0.74). Nevertheless, when applying these last two algorithms, the overlap of accelerometry with any diary based NWT minutes was around 20% only. In conclusion, only a small proportion of NWT is >60 minutes. The 60-min algorithm is less suitable for NWT detection in 24 h-accelerometry because of low sensitivity, specificity, and small overlap with reported NWT minutes. Longer algorithms perform better but detect lower proportions of reported NWT

Which early life events or current environmental and lifestyle factors influence lung function in adolescents? - results from the GINIplus & LISAplus studies

BACKGROUND: Various factors may affect lung function at different stages in life. Since investigations that simultaneously consider several factors are rare, we examined the relative importance of early life, current environmental/lifestyle factors and allergic diseases on lung function in 15-year-olds. METHODS: Best subset selection was performed for linear regression models to investigate associations between 21 diverse early life events and current factors with spirometric parameters (forced vital capacity, forced expiratory volume in 1 s and maximal mid-expiratory flow (FEF25-75)) in 1326 participants of the German GINIplus and LISAplus birth cohorts. To reduce model complexity, one model for each spirometric parameter was replicated 1000 times in random subpopulations (N = 884). Only those factors that were included in >70% of the replication models were retained in the final analysis. RESULTS: A higher peak weight velocity and early lung infections were the early life events prevalently associated with airflow limitation and FEF25-75. Current environmental/lifestyle factors at age 15 years and allergic diseases that were associated with lung function were: indoor second-hand smoke exposure, vitamin D concentration, body mass index (BMI) and asthma status. Sex and height captured the majority of the explained variance (>75%), followed by BMI (</=23.7%). The variance explained by early life events was comparatively low (median: 4.8%; range: 0.2-22.4%), but these events were consistently negatively associated with airway function. CONCLUSIONS: Although the explained variance was mainly captured by well-known factors included in lung function prediction equations, our findings indicate early life and current factors that should be considered in studies on lung health among adolescents

A life course examination of the physical environmental determinants of physical activity behaviour: A “Determinants of Diet and Physical Activity” (DEDIPAC) umbrella systematic literature review

Background: Participation in regular physical activity is associated with a multitude of health benefits across the life course. However, many people fail to meet PA recommendations. Despite a plethora of studies, the evidence regarding the environmental (physical) determinants of physical activity remains inconclusive. Objective: To identify the physical environmental determinants that influence PA across the life course. Methods: An online systematic literature search was conducted using MEDLINE, ISI Web of Science, Scopus and SPORTDiscus. The search was limited to studies published in English (January 2004 to April 2016). Only systematic literature reviews (SLRs) and meta-analyses (MAs) of observational studies, that investigated the association between physical determinants and physical activity outcomes, were eligible for inclusion. The extracted data were assessed on the importance of determinants, strength of evidence and methodological quality. Results: The literature search identified 28 SLRs and 3 MAs on 67 physical environmental characteristics potentially related to physical activity that were eligible for inclusion. Among preschool children, a positive association was reported between availability of backyard space and outdoor toys/equipment in the home and overall physical activity. The availability of physical activity programs and equipment within schools, and neighbourhood features such as pedestrian and cyclist safety structure were positively associated with physical activity in children and adolescents. Negative street characteristics, for example, lack of sidewalks and streetlights, were negatively associated with physical activity in adults. Inconsistent associations were reported for the majority of reviewed determinants in adults. Conclusion: This umbrella SLR provided a comprehensive overview of the physical environment determinants of physical activity across the life course and has highlighted, particularly amongst youth, a number of key determinants that may be associated with overall physical activity. Given the limited evidence drawn mostly from cross-sectional studies, longitudinal studies are needed to further explore these associations. Registration: PROSPERO CRD42015010616

Socio-cultural determinants of physical activity across the life course: A \u27Determinants of Diet and Physical Activity\u27 (DEDIPAC) umbrella systematic literature review

Objective: Regular physical activity (PA) reduces the risk of disease and premature death. Knowing factors associated with PA might help reducing the disease and economic burden caused by low activity. Studies suggest that socio-cultural factors may affect PA, but systematic overviews of findings across the life course are scarce. This umbrella systematic literature review (SLR) summarizes and evaluates available evidence on socio-cultural determinants of PA in children, adolescents, and adults. Methods: This manuscript was drafted following the recommendations of the \u27Preferred Reporting Items for Systematic reviews and Meta-Analyses\u27 (PRISMA) checklist. The MEDLINE, Web of Science, Scopus, and SPORTDiscus databases were searched for SLRs and meta-analyses (MAs) on observational studies published in English that assessed PA determinants between January 2004 and April 2016. The methodological quality was assessed and relevant information on socio-cultural determinants and any associations with PA was extracted. The available evidence was evaluated based on the importance of potential determinants and the strength of the evidence. Results: Twenty SLRs and three MAs encompassing 657 eligible primary studies investigated potential socio-cultural PA determinants, with predominantly moderate methodological quality. Twenty-nine potential PA determinants were identified that were primarily assessed in children and adolescents and investigated the micro-environmental home/household level. We found probable evidence that receiving encouragement from significant others and having a companion for PA were associated with higher PA in children and adolescents, and that parental marital status (living with partner) and experiencing parental modeling were not associated with PA in children. Evidence for the other potential determinants was limited, suggestive, or non-conclusive. In adults, quantitative and conclusive data were scarce. Conclusions: A substantial number of SLRs and MAs investigating potential socio-cultural determinants of PA were identified. Our data suggest that receiving social support from significant others may increase PA levels in children and adolescents, whereas parental marital status is not a determinant in children. Evidence for other potential determinants was limited. This was mainly due to inconsistencies in results on potential socio-cultural determinants of PA across reviews and studies. Trial registrations: This umbrella SLR was recorded on PROSPERO (Record ID: CRD42015010616)