Electronic Health Record-Triggered Research Infrastructure Combining Real-world Electronic Health Record Data and Patient-Reported Outcomes to Detect Benefits, Risks, and Impact of Medication:Development Study

BACKGROUND: Real-world data from electronic health records (EHRs) represent a wealth of information for studying the benefits and risks of medical treatment. However, they are limited in scope and should be complemented by information from the patient perspective. OBJECTIVE: The aim of this study is to develop an innovative research infrastructure that combines information from EHRs with patient experiences reported in questionnaires to monitor the risks and benefits of medical treatment. METHODS: We focused on the treatment of overactive bladder (OAB) in general practice as a use case. To develop the Benefit, Risk, and Impact of Medication Monitor (BRIMM) infrastructure, we first performed a requirement analysis. BRIMM’s starting point is routinely recorded general practice EHR data that are sent to the Dutch Nivel Primary Care Database weekly. Patients with OAB were flagged weekly on the basis of diagnoses and prescriptions. They were invited subsequently for participation by their general practitioner (GP), via a trusted third party. Patients received a series of questionnaires on disease status, pharmacological and nonpharmacological treatments, adverse drug reactions, drug adherence, and quality of life. The questionnaires and a dedicated feedback portal were developed in collaboration with a patient association for pelvic-related diseases, Bekkenbodem4All. Participating patients and GPs received feedback. An expert meeting was organized to assess the strengths, weaknesses, opportunities, and threats of the new research infrastructure. RESULTS: The BRIMM infrastructure was developed and implemented. In the Nivel Primary Care Database, 2933 patients with OAB from 27 general practices were flagged. GPs selected 1636 (55.78%) patients who were eligible for the study, of whom 295 (18.0% of eligible patients) completed the first questionnaire. A total of 288 (97.6%) patients consented to the linkage of their questionnaire data with their EHR data. According to experts, the strengths of the infrastructure were the linkage of patient-reported outcomes with EHR data, comparison of pharmacological and nonpharmacological treatments, flexibility of the infrastructure, and low registration burden for GPs. Methodological weaknesses, such as susceptibility to bias, patient selection, and low participation rates among GPs and patients, were seen as weaknesses and threats. Opportunities represent usefulness for policy makers and health professionals, conditional approval of medication, data linkage to other data sources, and feedback to patients. CONCLUSIONS: The BRIMM research infrastructure has the potential to assess the benefits and safety of (medical) treatment in real-life situations using a unique combination of EHRs and patient-reported outcomes. As patient involvement is an important aspect of the treatment process, generating knowledge from clinical and patient perspectives is valuable for health care providers, patients, and policy makers. The developed methodology can easily be applied to other treatments and health problems

Ethics, space, and somatic sensibilities: comparing relationships between scientific researchers and their human and animal experimental subjects

Drawing on geographies of affect and nature-society relations, we propose a radical rethinking of how scientists, social scientists, and regulatory agencies conceptualise human and animal participants in scientif ic research. The scientific rationale for using animal bodies to simulate what could be done in human bodies emphasises shared somatic capacities that generate comparable responses to clinical interventions. At the same time, regulatory guidelines and care practices stress the differences between human and animal subjects. In this paper we consider the implications of this differentiation between human and animal bodies in ethical and welfare protocols and practices. We show how the bioethical debates around the use of human subjects tend to focus on issues of consent and language, while recent work in animal welfare reflects an increasing focus on the affectual dimensions of ethical practice. We argue that this attention to the more-than-representational dimensions of ethics and welfare might be equally important for human subjects. We assert that paying attention to these somatic sensibilities can offer insights into how experimental environments can both facilitate and restrict the development of more care-full and response-able relations between researchers and their experimental subjects. <br/

Male Sexual Health and Reproduction in Cutaneous Immune-Mediated Diseases: A Systematic Review

Introduction: Information about the possible effects of cutaneous immune-mediated diseases (cIMDs) on male sexual function and reproduction is scarce. Factors known to impair sexual health and reproduction, such as inflammation, medication use, and hypogonadism, can be present in a significant proportion of male patients with cIMD. Objectives: To systematically review the literature for the influence of paternal cIMD on many aspects of male sexual and reproductive health, such as sexual function, reproductive hormones, fertility, and pregnancy and offspring outcomes. Methods: A systematic literature search was performed. The searches combined keywords regarding male sexual function and fertility, pregnancy outcomes, and offspring's health with a list of cIMDs. Results: The majority of the identified studies included patients with psoriasis (22 of 27), and sexual function was the most common outcome of interest (20 of 27). For patients diagnosed with psoriasis, the prevalence of male sexual dysfunction reported in these studies ranged from 34 to 81%. Hypogonadism in patients with psoriasis was reported in 2 of 3 studies. Sperm analysis abnormalities in patients with psoriasis were reported in 3 of 4 studies. No information about the effect of paternal disease on pregnancy and offspring outcomes was identified. Conclusions: Disease activity in psoriasis might play an important role in the development of sexua

The effect of paternal exposure to immunosuppressive drugs on sexual function, reproductive hormones, fertility, pregnancy and offspring outcomes: A systematic review

BACKGROUND: Information regarding the possible influence of immunosuppressive drugs on male sexual function and reproductive outcomes is scarce. Men diagnosed with immune-mediated diseases and a wish to become a father represent an important neglected population since they lack vital information to make balanced decisions about their treatment. OBJECTIVE AND RATIONALE: The aim of this research was to systematically review the literature for the influence of paternal immunosuppressive drug use on many aspects of male sexual health, such as sexual function, fertility, pregnancy outcomes and offspring health outcomes. SEARCH METHODS: A systematic literature search was performed in the bibliographic databases: Embase (via Elsevier embase.com), MEDLINE ALL via Ovid, Cochrane Central Register of Trials (via Wiley) and Web of Science Core Collection. Additionally, Google Scholar and the Clinical trial registries of Europe and the USA were searched. The databases were searched from inception until 31 August 2019. The searches combined keywords regarding male sexual function and fertility, pregnancy outcomes and offspring health with a list of immunosuppressive drugs. Studies were included if they were published in English and if they included original data on male human exposure to immunosuppressive drugs. A meta-analysis was not possible to perform due to the heterogeneity of the data. OUTCOMES: A total of 5867 references were identified, amongst which we identified 161 articles fulfilling the eligibility criteria. Amongst these articles, 50 included pregnancy and offspring outcomes and 130 included sexual health outcomes. Except for large Scandinavian cohorts, most of the identified articles included a small number of participants. While a clear negative effect on sperm quality was evident for sulfasalazine and cyclophosphamide, a dubious effect was identified for colchicine, methotrexate and sirolimus. In three articles, exposure to tumour necrosis factor-a inhibitors in patients diagnosed with ankylosing spondylitis resulted in improved sperm quality. The information regarding pregnancy and offspring outcomes was scant but no large negative effect associated with paternal immunosuppressiv

Forest as Stronghold of Local Ecological Practice: Currently Used Wild Food Plants in Polesia, Northern Ukraine

Local ecological practice (LEP, e.g., the everyday practice of collecting and using plants, including wild food plants) is shaped by nature (available local resources) and culture (local perceptions and knowledge on their usability), including a multitude of factors, among which language and geographical or cultural separation have been found to play crucial roles in affecting biocultural diversity. Also, proximity to the forest has been shown to increase the use of plants. We conducted ethnobotanical fieldwork within eastern and western regions of Ukrainian Polesia, during which we interviewed 118 people. Through semi-structured interviews, we recorded the distribution of the current uses of 70 wild food taxa. The analysis of use records revealed homogeneous distribution of use despite the geographical distance and different spoken dialects; however, we were able to single out the highly sylvan region of eastern Polesia as the area with highest biocultural diversity for the use of wild food plants. The results suggest that in the context of the overall homogenization of local ecological knowledge, the continued existence of unintended contact with nature through living and working in the forest may be the primary factor maintaining the broader LEP in the sylvan area of eastern Polesia. Місцева екологічна практика (MЕП, що включає повсякденну практику збору та використання дикорослих рослин у їжу) формується природою (місцевими ресурсами) та культурою (місцеві знання про їх використання), що включає безліч чинників, серед яких мова та географічне або культурне відокремлення відіграють вирішальну роль у впливі на біокультурне різноманіття. Також показано, що близькість до лісу збільшує використання рослин. Ми проводили етноботанічні польові роботи у двох областях Українського Полісся, в ході яких ми провели інтерв’ю з 118 людьми. За допомогою напівструктурованих інтерв’ю ми задокументували поточне використання 70 таксонів дикорослих рослин у їжу. Аналіз записів про вживання свідчить про однорідний розподіл використання, незважаючи на географічне розташування та різні розмовні діалекти; однак, ми змогли виділити лісистий регіон Східного Полісся як територію з найвищим біокультурним різноманіттям використання дикорослих рослин уїжу. Результати свідчать, що в контексті загальної гомогенізації місцевих екологічних знань, продовження існування контакту з природою живучи та працюючи в лісі може бути основним чинником, який підтримує ширшу MЕПу в лісовій зоні Східного Полісся

Famine food of vegetal origin consumed in the Netherlands during World War II

Background: Periods of extreme food shortages during war force people to eat food that they normally do not consider edible. The last time that countries in Western Europe experienced severe scarcities was during World War II. The so-called Dutch famine or Hunger Winter (1944-1945) made at least 25,000 victims. The Dutch government took action by opening soup kitchens and providing information on wild plants and other famine food sources in "wartime cookbooks." The Dutch wartime diet has never been examined from an ethnobotanical perspective. Methods: We interviewed 78 elderly Dutch citizens to verify what they remembered of the consumption of vegetal and fungal famine food during World War II by them and their close surroundings. We asked whether they experienced any adverse effects from consuming famine food plants and how they knew they were edible. We identified plant species mentioned during interviews by their local Dutch names and illustrated field guides and floras. We hypothesized that people living in rural areas consumed more wild species than urban people. A Welch t test was performed to verify whether the number of wild and cultivated species differed between urban and rural citizens. Results: A total number of 38 emergency food species (14 cultivated and 21 wild plants, three wild fungi) were mentioned during interviews. Sugar beets, tulip bulbs, and potato peels were most frequently consumed. Regularly eaten wild species were common nettle, blackberry, and beechnuts. Almost one third of our interviewees explicitly described to have experienced extreme hunger during the war. People from rural areas listed significantly more wild species than urban people. The number of cultivated species consumed by both groups was similar. Negative effects were limited to sore throats and stomachache from the consumption of sugar beets and tulip bulbs. Knowledge on the edibility of famine food was obtained largely by oral transmission; few people remembered the written recipes in wartime cookbooks. Conclusion: This research shows that 71years after the Second World War, knowledge on famine food species, once crucial for people's survival, is still present in the Dutch society. The information on famine food sources supplied by several institutions was not distributed widely. For the necessary revival of famine food knowledge during the 1940s, people needed to consult a small group of elders. Presumed toxicity was a major reason given by our participants to explain why they did not collect wild plants or mushrooms during the war