Exploring the Use of Evidence From the Development and Evaluation of an Electronic Health (eHealth) Trial: Case Study

Background: Evidence-based practice refers to building clinical decisions on credible research evidence, professional experience, and patient preferences. However, there is a growing concern that evidence in the context of electronic health (eHealth) is not sufficiently used when forming policies and practice of health care. In this context, using evaluation and research evidence in clinical or policy decisions dominates the discourse. However, the use of additional types of evidence, such as professional experience, is underexplored. Moreover, there might be other ways of using evidence than in clinical or policy decisions. Objective: This study aimed to analyze how different types of evidence (such as evaluation outcomes [including patient preferences], professional experiences, and existing scientific evidence from other research) obtained within the development and evaluation of an eHealth trial are used by diverse stakeholders. An additional aim was to identify barriers to the use of evidence and ways to support its use. Methods: This study was built on a case of an eHealth trial funded by the European Union. The project included 4 care centers, 2 research and development companies that provided the web-based physical exercise program and an activity monitoring device, and 2 science institutions. The qualitative data collection included 9 semistructured interviews conducted 8 months after the evaluation was concluded. The data analysis concerned (1) activities and decisions that were made based on evidence after the project ended, (2) evidence used for those activities and decisions, (3) in what way the evidence was used, and (4) barriers to the use of evidence. Results: Evidence generated from eHealth trials can be used by various stakeholders for decisions regarding clinical integration of eHealth solutions, policy making, scientific publishing, research funding applications, eHealth technology, and teaching. Evaluation evidence has less value than professional experiences to local decision making regarding eHealth integration into clinical practice. Professional experiences constitute the evidence that is valuable to the highest variety of activities and decisions in relation to eHealth trials. When using existing scientific evidence related to eHealth trials, it is important to consider contextual relevance, such as location or disease. To support the use of evidence, it is suggested to create possibilities for health care professionals to gain experience, assess a few rather than a large number of variables, and design for shorter iterative cycles of evaluation. Conclusions: Initiatives to support and standardize evidence-based practice in the context of eHealth should consider the complexities in how the evidence is used in order to achieve better uptake of evidence in practice. However, one should be aware that the assumption of fact-based decision making in organizations is misleading. In order to create better chances that the evidence produced would be used, this should be addressed through the design of eHealth trials

Planning a holistic summative eHealth evaluation in an interdisciplinary and multi-national setting: a case study and propositions for guideline development

Background: Summative eHealth evaluations frequently lack quality, which affects the generalizability of the evidence, and its use in practice and further research. To guarantee quality, a number of activities are recommended in the guidelines for evaluation planning. This study aimed to examine a case of an eHealth evaluation planning in a multi-national and interdisciplinary setting and to provide recommendations for eHealth evaluation planning guidelines. Methods: An empirical eHealth evaluation process was developed through a case study. The empirical process was compared with selected guidelines for eHealth evaluation planning using a pattern-matching technique. Results: Planning in the interdisciplinary and multi-national team demanded extensive negotiation and alignment to support the future use of the evidence created. The evaluation planning guidelines did not provide specific strategies for different set-ups of the evaluation teams. Further, they did not address important aspects of quality evaluation, such as feasibility analysis of the outcome measures and data collection, monitoring of data quality, and consideration of the methods and measures employed in similar evaluations. Conclusions: Activities to prevent quality problems need to be incorporated in the guidelines for evaluation planning. Additionally, evaluators could benefit from guidance in evaluation planning related to the different set-ups of the evaluation teams

Identifying the Value of an eHealth Intervention Aimed at Cognitive Impairments: Observational Study in Different Contexts and Service Models

BACKGROUND: Value is one of the central concepts in health care, but it is vague within the field of summative eHealth evaluations. Moreover, the role of context in explaining the value is underexplored, and there is no explicit framework guiding the evaluation of the value of eHealth interventions. Hence, different studies conceptualize and operationalize value in different ways, ranging from measuring outcomes such as clinical efficacy or behavior change of patients or professionals to measuring the perceptions of various stakeholders or in economic terms. OBJECTIVE: The objective of our study is to identify contextual factors that determine similarities and differences in the value of an eHealth intervention between two contexts. We also aim to reflect on and contribute to the discussion about the specification, assessment, and relativity of the "value" concept in the evaluation of eHealth interventions. METHODS: The study concerned a 6-month eHealth intervention targeted at elderly patients (n=107) diagnosed with cognitive impairment in Italy and Sweden. The intervention introduced a case manager role and an eHealth platform to provide remote monitoring and coaching services to the patients. A model for evaluating the value of eHealth interventions was designed as monetary and nonmonetary benefits and sacrifices, based on the value conceptualizations in eHealth and marketing literature. The data was collected using the Mini-Mental State Examination (MMSE), the clock drawing test, and the 5-level EQ-5D (EQ-5D-5L). Semistructured interviews were conducted with patients and health care professionals. Monetary data was collected from the health care and technology providers. RESULTS: The value of an eHealth intervention applied to similar types of populations but differed in different contexts. In Sweden, patients improved cognitive performance (MMSE mean 0.85, SD 1.62, P<.001), reduced anxiety (EQ-5D-5L mean 0.16, SD 0.54, P=.046), perceived their health better (EQ-5D-5L VAS scale mean 2.6, SD 9.7, P=.035), and both patients and health care professionals were satisfied with the care. However, the Swedish service model demonstrated an increased cost, higher workload for health care professionals, and the intervention was not cost-efficient. In Italy, the patients were satisfied with the care received, and the health care professionals felt empowered and had an acceptable workload. Moreover, the intervention was cost-effective. However, clinical efficacy and quality of life improvements have not been observed. We identified 6 factors that influence the value of eHealth intervention in a particular context: (1) service delivery design of the intervention (process of delivery), (2) organizational setup of the intervention (ie, organizational structure and professionals involved), (3) cost of different treatments, (4) hourly rates of staff for delivering the intervention, (5) lifestyle habits of the population (eg, how physically active they were in their daily life and if they were living alone or with family), and (6) local preferences on the quality of patient care. CONCLUSIONS: Value in the assessments of eHealth interventions need to be considered beyond economic terms, perceptions, or behavior changes. To obtain a holistic view of the value created, it needs to be operationalized into monetary and nonmonetary outcomes, categorizing these into benefits and sacrifices

Seasonal changes in chemical and mineralogical composition of sewage sludge incineration residues and their potential for metallic elements and valuable components recovery

The incineration products composition is dependent on the incineration technology, operating conditions and also on the waste feed composition, which can change seasonally, depending on the temporal growth of the population due to tourism, micro-industry seasonality, intensity of atmospheric precipitation and other factors. Seasonal variations in potentially valuable elements concentrations in incineration products are visible but their overall content is low, therefore this material should not be considered as a source of valuable elements. Due to high content of phosphorus (7.5 wt%) only the fly ash can be considered as a potential source of this critical raw material

Work-loss years among people diagnosed with diabetes : a reappraisal from a life course perspective

Aims Early exit from the workforce has been proposed to be one of the unfavorable consequences of diabetes. We examined whether early exit from the workforce differed between persons who were and were not diagnosed with diabetes during their work career. Methods The cohort included 12,726 individuals of the Helsinki Birth Cohort Study, born between 1934 and 1944. Using data from nationwide registers, the cohort was followed up from early adulthood until they transitioned into retirement or died. Work- loss years were estimated using the restricted mean work years method. Results During a follow-up of 382,328 person-years for men and 349 894 for women, 36.8% transitioned into old age pension and 63.2% exited workforce early. Among men, 40.5% of those with and 32.8% of those without diabetes transitioned into old age pension (p=0.003). The corresponding numbers for women were 48.6% and 40.4% (p = 0.013), respectively. Mean age at exit from the workforce was 60.1 (95% confidence interval [CI], 59.6 to 60.7) years among men with diabetes and 57.6 (95% CI, 57.2 to 58.0) years among men without diabetes (p = 0.016). Among women, corresponding ages were 61.4 (95% CI, 60.8 to 61.9) years for those with diabetes and 59.5 (95% CI, 59.3 to 59.7) years for those without diabetes (p <0.001). The difference in mean restricted work-loss years according to diabetes was 2.5 (95% CI 0.5 to 4.6) for men and 1.9 (95% CI 1.0 to 2.8) for women. Among individuals followed up throughout their work career, those with a diabetes diagnosis exited the workforce approximately two years later compared to those without diabetes.Peer reviewe

On the influence of serotonin- and sex steroid-related genetic variation on mood, anxiety, personality, autism and transsexualism

Background: The neurotransmitter serotonin has been related to mood and anxiety, and variation in genes that encode important members of the serotonergic system may hence affect mood- and anxiety-related traits. Sex steroids influence brain development, and variation in genes encoding androgen and estrogen receptors, or enzymes needed for sex steroid synthesis, may be of importance for both personality traits and risk for psychiatric disorders. The specific aims of this thesis were: (i) to investigate the possible influence of serotonin-related genetic variation on the neural correlates of anxiety, and on mood- and anxiety-related phenotypes, including premenstrual dysphoric disorder (PMDD), depression and anxiety-related personality traits, (ii) to investigate the possible influence of sex steroid-related genetic variation on personality, autism spectrum disorder and transsexualism, and (iii) to try to ameliorate the chance of detecting effects of combinations of genetic variations by restricting the statistical analysis to particular patterns. Results: (i) The serotonin transporter (5-HTT) linked polymorphic region (5-HTTLPR) and a polymorphism in an important enzyme for serotonin synthesis (tryptophan hydroxylase 2; TPH2) were associated with amygdala response during presentation of angry faces in subjects with social phobia and controls. (ii) The same polymorphisms were associated with response to placebo and also with placebo-induced changes in amygdala activity during public speaking in subjects with social phobia. (iii) In men, genetic variation in the neurotrophic factor BDNF, which is closely related to the serotonergic system, was associated with the amount of serotonin transporter in the brain. (iv) Polymorphisms in genes that encode proteins important for the development of the serotonergic system (GATA2), for serotonin synthesis (TPH2) and for serotonergic transmission (5-HT3B) were associated with PMDD. (v) The 5-HTTLPR was shown to influence reports of controllable stressful life events in combination with the BDNF Val66Met polymorphism or anxiety-related personality traits in non-depressed men. (vi) Variants that may increase the function of the androgen receptor were associated with extraversion and spiritual acceptance in men. (vii) A variant that is associated with increased androgen receptor function was more common in women with autism spectrum disorder than in controls. (viii) The same androgen receptor polymorphism was associated with transsexualism in combination with polymorphisms in the genes encoding the estrogen receptor β or the testosterone-converting aromatase enzyme. (ix) A method that restricts the search for genetic combinations to monotone effect patterns was shown to increase the probability of finding gene-gene effects. Conclusions: The results support the notion that variation in genes that encode serotonin-related and sex steroid-related proteins are of importance for the psychiatric traits studied in this thesis

Work careers in adults separated temporarily from their parents in childhood during World War II

Introduction: Traumatic experiences, such as separation from parents in childhood causing early life stress (ELS) may increase the risk of adverse long-term health outcomes and biological age-related changes. This may have an impact on work career. Our aim was to examine long term consequences of ELS due to temporary separation from parents during World War II (WWII) in relation to work career. Material and methods: The Helsinki Birth Cohort Study comprises 13,345 individuals born in Helsinki, Finland, between the years 1934-1944. From the original cohort, 1781 individuals were identified as being separated temporarily from their parents due to World War II. Information on date and type of pension was provided by the Finnish Centre for Pensions and the Social Insurance Institution of Finland. The cohort members either transitioned into old age pension at the statutory retirement age or retired earlier and transitioned into disability, unemployment, part-time pension or died before retirement. Results: Those who were separated were more likely to have transitioned into disability pension (RRR: 1.26: 95% CI: 1.06-1.48), especially due to diseases of the musculoskeletal system (OR: 1.57; 95% CI: 1.20-2.07), or into unemployment pension (RRR: 1.25; 95% CI: 1.02-1.53) compared with those not separated from their parents. Longer duration of separation was associated with early exit from the workforce compared with non-separation. Conclusions: Exposure to ELS may have an impact upon lifetime work career. Early interventions preventing exposure to ELS or mitigating its negative effects may prolong future work careers along with healthier aging across the life-span.Peer reviewe

Assessing eHealth initiatives: Do theoretical frameworks matter in practice?

In the last years, a variety of theoretical frameworks have been proposed to support decision-makers while assessing eHealth initiatives. These frameworks aim at guaranteeing a rational, efficient and fair assessment to select those initiatives that are value-for-money. This study, by means of a systematic literature review, investigates the actual application of the theoretical frameworks when assessing eHealth initiatives. Results show that empirical studies do not rely on theoretical frameworks and prefer tailor-made approaches, thus reducing the comparability of current assessments

Early Life Origins of All-Cause and Cause-Specific Disability Pension : Findings from the Helsinki Birth Cohort Study

Background There is some evidence linking sub-optimal prenatal development to an increased risk of disability pension (DP). Our aim was to investigate whether body size at birth was associated with transitioning into all-cause and cause-specific DP during the adult work career. Methods 10 682 people born in 1934-44 belonging to the Helsinki Birth Cohort Study had data on birth weight extracted from birth records, and on time, type and reason of retirement between 1971 and 2011 extracted from the Finnish Centre for Pensions. Results Altogether 21.3% transitioned into DP during the 40-year follow-up, mainly due to mental disorders, musculoskeletal disorders and cardiovascular disease. Average age of transitioning into DP was 51.3 (SD 8.4) for men and 52.2 (SD 7.6) for women. Cohort members who did not transition into DP retired 10 years later on average. Among men, higher birth weight was associated with a lower hazard of transitioning into DP, adjusted hazard ratio (HR) being 0.94 (95% confidence interval [CI] 0.88-0.99 for 1 SD increase in birth weight). For DP due to mental disorders the adjusted HR was 0.90, 95% CI 0.81, 0.99. A similar but non-significant trend was found for DP due to cardiovascular disease. Among women there were no associations between body size at birth and all-cause DP (p for interaction gender*birth weight on DP p = 0.007). Conclusions Among men disability pension, particularly due to mental disorders, may have its origins in prenatal development. Given that those who retire due to mental health problems are relatively young, the loss to the workforce is substantial.Peer reviewe

Cohort profile : InTraUterine sampling in early pregnancy (ITU), a prospective pregnancy cohort study in Finland: study design and baseline characteristics

Purpose The InTraUterine sampling in early pregnancy (ITU) is a prospective pregnancy cohort study. The overarching aim of ITU is to unravel genomic, epigenomic, transcriptomic, endocrine, inflammatory and metabolic maternal-placental-fetal mechanisms involved in the programming of health and disease after exposure to prenatal environmental adversity, such as maternal malnutrition, cardiometabolic disorders, infections, medical interventions, mental disorders and psychosocial stress. This paper describes the study protocol, design and baseline characteristics of the cohort. Participants We included 944 pregnant Finnish women, their partners and children born alive between April 2012 and December 2017. The women were recruited through the national, voluntary trisomy 21 screening between 9(+0) and 21(+6) gestational weeks. Of the participating women, 543 were screen positive and underwent fetal chromosomal testing. Test result of these women suggested no fetal chromosomal abnormality. Further, we recruited 401 women who were screen negative and who did not undergo fetal chromosomal testing. Findings to date We have collected chorionic villi and amniotic fluid from the screen-positive women; blood, urine, buccal swabs and diurnal salivary samples from all women; blood and buccal swabs from all partners; and placenta, cord blood and buccal swabs from all newborns for analyses of the genome, epigenome, transcriptome, and endocrine, inflammatory and metabolic markers. These data are coupled with comprehensive phenotypes, including questions on demographic characteristics, health and well-being of the women and their partners during pregnancy and of the women and their children at the child's age of 1.7 and 3 years. Data also come from patient records and nationwide registers covering health, lifestyle and medication data. Future plans Multiple layers of ITU data allow integrative data analyses, which translate to biomarker identification and allow risk stratification and understanding of the biological mechanisms involved in prenatal programming of health and disease.Peer reviewe