Search

Abstract The industry standard for estimating the quantity of horticultural produce harvested is crop yield. Producing sufficient amounts of high-quality biochemical ingredients crops can therefore aid in resolving concerns with food security and nutrition. Most producers prefer the use of organic substrate over natural soils when growing crops such as peppers in greenhouses, to ensure that there is a sufficient supply of food all year round. The objective of the study was to determine the effect of coconut coir substrate on the yield and biochemical constituents of peppers varieties grown under greenhouse environment. For two successive seasons [2021 and 2022], two sweet pepper types (Sondela and Ilanga) were cultivated on fertigated coconut coir and loamy soil (control). Fruit number, together with their dry weight and some biochemical constituents, were examined. To evaluate the impact of coconut coir substrate on the growth, yield, and biochemical constituents of different pepper cultivars grown in a greenhouse, dry plant materials and freeze-dried fruit samples were analyzed. Results showed that the coconut coir and variety (Ilanga) treatment combination produced more fruits than other treatments. Biochemical constituents such as vitamins, total phenols, total flavonoids, copper, iron and Zinc were in fruits grown under coir substrate when compared to loamy soil (control). Therefore, farmers are encouraged to grow sweet peppers varieties under coconut coir substrate for better yield, nutritional quality and profit maximisation.

Despite the importance of identifying children with developmental language delay, no accurate screening instruments are available for 3-year-olds. The aim of the present study is to compare the accuracy of the General Language Screen (GLS), focusing on receptive and expressive language and intelligibility with the accuracy of the VTO Language Screening Instrument (VTO-LSI)-3-year, focusing on expressive language and intelligibility. We hypothesize that the GLS is more accurate in identifying children with language delay, because it also assesses receptive language. Ninety-seven 3-year-old children were included based on their language screening score at the age of 2. At the age of 3, children were assessed with the VTO-LSI-3-year and the GLS. Diagnostic tests were used as reference tests. The GLS was better than the VTO-LSI-3-year in identifying children with language delay. Receiver operating characteristic analysis of the discriminative power showed higher areas under the receiver operating characteristic curve for the GLS. Moreover, the GLS was better in detecting receptive language concerns. Given these results the GLS may serve as a reliable screening tool, especially for children with receptive problems. Because receptive language problems are persistent, early diagnosis and intervention is very important for these children.

Background: E-visibility embodies the online presence of a researcher and their research, the researcher’s discoverability, and the accessibility of the research. Academic social networking tools (ASNT) enable the creation of altmetrics for research within these academic online research communities. Objectives: This article reports on the correlations between e-visibility and altmetric-bibliometric indicators on ASNTs (Academia.edu and ResearchGate) for the Environmental Sciences researchers at the University of South Africa. Method: Altmetric and bibliometric indicators were collected from the ASNTs (Academia.edu and ResearchGate) and bibliometric data from the traditional citation resources (Scopus, Web of Science and Google Scholar), as part of a longitudinal study exploring research e-visibility and altmetric-bibliometric trends. Statistical analysis (using Spearman’s rank coefficient) was conducted on the altmetric and bibliometric data to identify the altmetric-bibliometric correlations. Results: The altmetric-bibliometric spearman correlation results show positive correlations that translates to increases in bibliometrics and altmetrics on ASNTs and citation resources. Conclusion: This study is significant as it concludes that altmetric-bibliometric indicators correlate positively and translate to the increase in research e-visibility and it allows for the enhancement of research and societal impact for environmental researchers within a South African context. Contribution: The findings of this study are beneficial to all researchers aiming at increasing their citation counts and enhancing their research- and societal impact. The main contribution of the study is the identification of altmetric-bibliometric correlations. Recommendations for researchers include well-maintained research profiles on ASNTs and citation resources for the increase of research e-visibility and the enhancement of research and societal impact.

Abstract Background Since the outbreak of the COVID-19 pandemic, physical distancing and hand washing have been used as effective means to reduce virus transmission in the Netherlands. However, these measures pose a societal challenge as they require people to change their customary behaviours in various contexts. The science of habit formation is potentially useful for informing policy-making in public health, but the current literature largely overlooked the role of habit in predicting and explaining these preventive behaviours. Our research aimed to describe habit formation processes of physical distancing and hand washing and to estimate the influences of habit strength and intention on behavioural adherence. Methods A longitudinal survey was conducted between July and November 2020 on a representative Dutch sample (n = 800). Respondents reported their intentions, habit strengths, and adherence regarding six context-specific preventive behaviours on a weekly basis. Temporal developments of the measured variables were visualized, quantified, and mapped onto five distinct phases of the pandemic. Regression models were used to test the effects of intention, habit strength, and their interaction on behavioural adherence. Results Dutch respondents generally had strong intentions to adhere to all preventive measures and their adherence rates were between 70% and 90%. They also self-reported to experience their behaviours as more automatic over time, and this increasing trend in habit strength was more evident for physical-distancing than for hand washing behaviours. For all six behaviours, both intention and habit strength predicted subsequent adherence (all ps < 2e-16). In addition, the predictive power of intention decreased over time and was weaker for respondents with strong habits for physical distancing when visiting supermarkets (B = -0.63, p

Abstract Background Lifestyle interventions for severe mental illness (SMI) are known to have small to modest effect on physical health outcomes. Little attention has been given to patient-reported outcomes (PROs). Aim To systematically review the use of PROs and their measures, and quantify the effects of lifestyle interventions in patients with SMI on these PROs. Methods Five electronic databases were searched (PubMed/Medline, Embase, PsycINFO, CINAHL, and Web of Science) from inception until 12 November 2020 (PROSPERO: CRD42020212135). Randomised controlled trials (RCTs) evaluating the efficacy of lifestyle interventions focusing on healthy diet, physical activity, or both for patients with SMI were included. Outcomes of interest were PROs. Results A total of 11.267 unique records were identified from the database search, 66 full-text articles were assessed, and 36 RCTs were included, of which 21 were suitable for meta-analyses. In total, 5.907 participants were included across studies. Lifestyle interventions had no significant effect on quality of life (g = 0.13; 95% CI = − 0.02 to 0.27), with high heterogeneity (I 2 = 68.7%). We found a small effect on depression severity (g = 0.30, 95% CI = 0.00 to 0.58, I 2 = 65.2%) and a moderate effect on anxiety severity (g = 0.56, 95% CI = 0.16 to 0.95, I 2 = 0%). Discussion This meta-analysis quantifies the effects of lifestyle interventions on PROs. Lifestyle interventions have no significant effect on quality of life, yet they could improve mental health outcomes such as depression and anxiety symptoms. Further use of patient-reported outcome measures in lifestyle research is recommended to fully capture the impact of lifestyle interventions.

Abstract Background Several interventions have been developed to improve physical health and lifestyle behaviour of people with a severe mental illness (SMI). Recently, we conducted a pragmatic cluster-randomised controlled trial which evaluated the effects of the one-year Severe Mental Illness Lifestyle Evaluation (SMILE) lifestyle intervention compared with usual care in clients with SMI. The SMILE intervention is a 12-month group-based lifestyle intervention with a focus on increased physical activity and healthy food intake. The aim of the current study was to explore the experiences of people with SMI and healthcare professionals (HCPs) regarding implementation feasibility of the SMILE intervention and the fidelity to the SMILE intervention. Methods A process evaluation was conducted alongside the pragmatic randomized controlled trial. The experiences of clients and HCPs in the lifestyle intervention group were studied. First, descriptive data on the implementation of the intervention were collected. Next, semi-structured interviews with clients (n = 15) and HCPs (n = 13) were performed. Interviews were audiotaped and transcribed verbatim. A thematic analysis of the interview data was performed using MAXQDA software. In addition, observations of group sessions were performed to determine the fidelity to the SMILE intervention using a standardised form. Results Ten out of 26 HCPs who conducted the group sessions discontinued their involvement with the intervention, primarily due to changing jobs. 98% of all planned group sessions were performed. Four main themes emerged from the interviews: 1) Positive appraisal of the SMILE intervention, 2) Suggestions for improvement of the SMILE intervention 3) Facilitators of implementation and 4) Barriers of implementation. Both clients and HCPs had positive experiences regarding the SMILE intervention. Clients found the intervention useful and informative. The intervention was found suitable and interesting for all people with SMI, though HCPs sometimes had to tailor the intervention to individual characteristics of patients (e.g., with respect to cognitive functioning). The handbook of the SMILE intervention was perceived as user-friendly and helpful by HCPs. Combining SMILE with daily tasks, no support from other team members, and lack of staff and time were experienced as barriers for the delivery of the intervention. Conclusion The SMILE intervention was feasible and well-perceived by clients and HCPs. However, we also identified some aspects that may have hindered effective implementation and needs to be considered when implementing the SMILE intervention in daily practice.

Abstract Background Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. Methods The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. Discussion This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

Common Approach to Impact Measurement (Common Approach) is a set of four flexible impact measurement standards designed to empower charities, nonprofits, coops, social purpose businesses (collectively referred to as social purpose organizations or SPOs), and those they serve to identify which impacts are most meaningful. These standards are not designed to make measurement more rigorous or more accurate; rather, they make measurement more useful and interoperable, and, eventually, more attuned to the priorities of those impacted.

Abstract The EFSA Panel on Plant Protection Products and their Residues was requested by the European Commission, to conclude based upon available evidence if metabolites 3‐phenoxybenzoic acid (PBA) and 3‐(4′‐hydroxyphenoxy)benzoic acid (PBA(OH)), common to several pyrethroid compounds, have genotoxic properties, if they share the (neuro)toxicity profile of their parent compounds, and if evidence allows to conclude on their health‐based guidance values. Available body of evidence consisted of studies from regulatory dossiers submissions, as well as from public literature. In addition, the data gap for short‐term toxicity profile of PBA was addressed by read‐across. Assessment revealed that PBA and PBA(OH) do not raise a concern with respect to genotoxicity. As regards general toxicity, PBA and PBA(OH) have different qualitative (no neurotoxic mechanism) and quantitative (higher NOAELs) toxicity compared to the parent pyrethroid compounds. For both metabolites, acceptable daily intake (ADI) and acute reference dose (ARfD) values were derived at 0.1 mg/kg body weight (bw) per day and 1 mg/kg bw, respectively.

Abstract Purpose The purpose of this feasibility study was to improve and implement an intervention aimed at enhancing medication adherence in sub-optimally controlled and non-adherent type 2 diabetes (T2DM) patients in primary care. Methods Four phases were completed: (1) context analysis, (2) collaboration protocol development, (3) digitalization, and (4) process evaluation. Two community pharmacies and seven general practices participated. In phase 1, two focus groups were conducted, of which one with healthcare providers (HCP, N = 5) and one with patients (N = 11). In phase 4, four semi-structured interviews and one focus group (N = 6) were conducted with healthcare providers. The goal of these focus groups and interviews was to obtain insights into current care to support medication adherence (phase 1), opportunities for collaboration (phase 2) and process evaluation (phase 4). Data were analyzed in Atlas.ti using thematic analyses. Results Both T2DM patients and HCPs considered medication adherence vital. Suboptimal collaboration between HCPs and unreliable ways to monitor medication non-adherence appeared important barriers for adequate care to support medication adherence (phase 1). The nurse practitioner (NP) was chosen as the interventionist with supportive roles for other HCPs (phase 2). All components of the intervention were digitalized (phase 3). The implementation of the digitalized intervention was reported to be suboptimal (phase 4). Main reasons were that pharmacy refill data were unreliable, NPs experienced difficulties addressing medication non-adherence adequately and collaboration between HCPs was suboptimal. Conclusions The medication adherence enhancing intervention was successfully digitalized, but implementation of the digitalized intervention appeared not feasible as of yet.

Abstract Background Patients with diabetes mellitus type 2 (DM2) and/or coronary heart disease (CHD) are at high risk to develop major depression. Preventing incident major depression may be an important tool in reducing the personal and societal burden of depression. The aim of the current study was to assess the cost-effectiveness of a stepped care program to prevent major depression (Step-Dep) in diabetes mellitus type 2 and/or coronary heart disease patients with subthreshold depression in comparison with usual care. Methods An economic evaluation with 12 months follow-up was conducted alongside a pragmatic cluster-randomized controlled trial from a societal perspective. Participants received care as usual (n = 140) or Step-Dep (n = 96) which consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to a general practitioner. Primary outcomes were quality-adjusted life years (QALYs) and cumulative incidence of major depression. Costs were measured every 3 months. Missing data was imputed using multiple imputation. Uncertainty around cost-effectiveness outcomes was estimated using bootstrapping and presented in cost-effectiveness planes and acceptability curves. Results There were no significant differences in QALYs or depression incidence between treatment groups. Secondary care costs (mean difference €1644, 95% CI €344; €3370) and informal care costs (mean difference €1930, 95% CI €528; €4089) were significantly higher in the Step-Dep group than in the usual care group. The difference in total societal costs (€1001, 95% CI €-3975; €6409) was not statistically significant. The probability of the Step-Dep intervention being cost-effective was low, with a maximum of 0.41 at a ceiling ratio of €30,000 per QALY gained and 0.32 at a ceiling ratio of €0 per prevented case of major depression. Conclusions The Step-Dep intervention is not cost-effective compared to usual care in a population of patients with DM2/CHD and subthreshold depression. Therefore, widespread implementation cannot be recommended. Trial registration The trial was registered in the Netherlands Trial Register ( NTR3715 ).

BackgroundThere is still limited evidence on the effectiveness and implementation of smoking cessation interventions for people with severe mental illness (SMI) in Dutch outpatient psychiatric settings. The present study aimed to establish expert consensus on the core components and strategies to optimise practical implementation of a smoking cessation intervention for people treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands.DesignA modified Delphi method was applied to reach consensus on three core components (behavioural counselling, pharmacological treatment and peer support) of the intervention. The Delphi panel comprised five experts with different professional backgrounds. We proposed a first intervention concept. The panel critically examined the evolving concept in three iterative rounds of 90 min each. Responses were recorded, transcribed verbatim and thematically analysed.ResultsOverall, results yielded that behavioural counselling should focus on preparation for smoking cessation, guidance, relapse prevention and normalisation. Pharmacological treatment consisting of nicotine replacement therapy (NRT), Varenicline or Bupropion, under supervision of a psychiatrist, was recommended. The panel agreed on integrating peer support as a regular part of the intervention, thus fostering emotional and practical support among patients. Treatment of a co-morbid cannabis use disorder needs to be integrated into the intervention if indicated. Regarding implementation, staff's motivation to support smoking cessation was considered essential. For each ambulatory team, two mental health care professionals will have a central role in delivering the intervention.ConclusionsThis study provides insight into expert consensus on the core components of a smoking cessation intervention for people with SMI. The results of this study were used for the development of a comprehensive smoking cessation program.

BackgroundSocial distancing has been implemented by many countries to curb the COVID-19 pandemic. Understanding public support for this policy calls for effective and efficient methods of monitoring public opinion on social distancing. Twitter analysis has been suggested as a cheaper and faster-responding alternative to traditional survey methods. The current empirical evidence is mixed in terms of the correspondence between the two methods.ObjectiveWe aim to compare the two methods in the context of monitoring the Dutch public's opinion on social distancing. For this comparison, we quantified the temporal and spatial variations in public opinion and their sensitivities to critical events using data from both Dutch Twitter users and respondents from a longitudinal survey.MethodsA longitudinal survey on a representative Dutch sample (n = 1,200) was conducted between July and November 2020 to measure opinions on social distancing weekly. From the same period, near 100,000 Dutch tweets were categorized as supporting or rejecting social distancing based on a model trained with annotated data. Average stances for the 12 Dutch provinces and over the 20 weeks were computed from the two data sources and were compared through visualizations and statistical analyses.ResultsBoth data sources suggested strong support for social distancing, but public opinion was much more varied among tweets than survey responses. Both data sources showed an increase in public support for social distancing over time, and a strong temporal correspondence between them was found for most of the provinces. In addition, the survey but not Twitter data revealed structured differences among the 12 provinces, while the two data sources did not correspond much spatially. Finally, stances estimated from tweets were more sensitive to critical events happened during the study period.ConclusionsOur findings indicate consistencies between Twitter data analysis and survey methods in describing the overall stance on social distancing and temporal trends. The lack of spatial correspondence may imply limitations in the data collections and calls for surveys with larger regional samples. For public health management, Twitter analysis can be used to complement survey methods, especially for capturing public's reactivities to critical events amid the current pandemic.

Toxoplasma gondii is considered a disease risk for many native Australian species. Feral cats are the key definitive host of T. gondii in Australia and therefore, investigating the epidemiology of T. gondii in cat populations is essential to understanding the risk posed to wildlife. Test sensitivity and specificity are poorly defined for diagnostic tests targeting T. gondii in cats and there is a need for validated techniques. This study focused on the feral cat population on Phillip Island, Victoria, Australia. We compared a novel real-time PCR (qPCR) protocol to the modified agglutination test (MAT) and used a Bayesian latent class modelling approach to assess the diagnostic parameters of each assay and estimate the true prevalence of T. gondii in feral cats. In addition, we performed multivariable logistic regression to determine risk factors associated with T. gondii infection in cats. Overall T. gondii prevalence by qPCR and MAT was 79.5% (95% confidence interval 72.6–85.0) and 91.8% (84.6–95.8), respectively. Bayesian modelling estimated the sensitivity and specificity of the MAT as 96.2% (95% credible interval 91.8–98.8) and 82.1% (64.9–93.6), and qPCR as 90.1% (83.6–95.5) and 96.0% (82.1–99.8), respectively. True prevalence of T. gondii infection in feral cats on Phillip Island was estimated as 90.3% (83.2–95.1). Multivariable logistic regression analysis indicated that T. gondii infection was positively associated with weight and this effect was modified by season. Cats trapped in winter had a high probability of infection, regardless of weight. The present study suggests qPCR applied to tissue is a highly sensitive, specific and logistically feasible tool for T. gondii testing in feral cat populations. Additionally, T. gondii infection is highly prevalent in feral cats on Phillip Island, which may have significant impacts on endemic and introduced marsupial populations.

Abstract Background Pediatric burn injuries are a major cause of death and injury, occurring mainly in resource poor environments. Recovery from burns is widely reported to be constrained by physical, psychological, relationship and reintegration challenges. These challenges have been widely described, but not the enablers of psychosocial recovery. This is especially true in pediatric burn research, with few multi- perspective studies on the recovery process. Methods This qualitative study involved 8 focus group discussions (four with 15 children post-burn injury, four with 15 caregivers) and 12 individual interviews with staff working in pediatric burns that explored the psychosocial needs of children after a burn and the enablers of their recovery. Purposive sampling was utilized and recruitment of all three categories of participants was done primarily through the only hospital burns unit in the Western Cape, South Africa. The interviews focused on factors that supported the child’s recovery and were sequentially facilitated from the child and the family’s experiences during hospitalization, to the return home to family and friends, followed by re-entry into school. Thematic analysis was used to analyze verbatim interview transcripts. Results The recovery enablers that emerged included: (i) Presence and reassurance; indicating the comfort and practical help provided by family and close friends in the hospital and throughout the recovery process; (ii) Normalizing interactions and acceptance; where children were treated the same as before the injury to promote the acceptance of self and by others especially once the child returned home; and (iii) Sensitization of others and protection; signifying how persons around the child had assisted the children to deal with issues in the reintegration process including the re-entry to school. Conclusions This study indicates that the psychosocial recovery process of children hospitalized for burns is enabled by the supportive relationships from family members, close friends and burn staff, present during hospitalization, the return home, and school re-entry. Support included comfort and physical presence of trusted others and emotional support; affirmation of the child’s identity and belonging despite appearance changes; and the advocacy and protection for the re-entry back into the school, and more generally the community.

Objective This was to elucidate the experiences and perceptions of people with severe mental illness (SMI) and their health care professionals with the SMILE (Severe Mental Illness Lifestyle Evaluation) group-based lifestyle intervention. SMILE focuses primarily on promoting healthy diet, physical activity and weight loss. Method A qualitative study with semi-structured interviews was conducted using purposive sampling. Interviews were conducted with 15 clients and 13 health care professionals (HCPs). Data were analysed according to a thematic analysis. Results Four overall themes were identified: interest in a lifestyle programme; group-based setting; changes in lifestyle behaviour; and preconditions for changing health behaviour. The results showed that clients valued the programme and were interested in the subject of lifestyle. The group-based setting was seen as a positive and important aspect of the intervention. Making lifestyle changes was acknowledged as difficult, especially in combination with the presence of psychiatric symptoms. Clients acquired an improved awareness of different aspects related to lifestyle behaviour. Irrespective of weight loss achieved, clients found their efforts successful with relatively ‘small’ changes. Some needed more support during the intervention than others. The practical activities in group sessions were regarded as most useful. HCPs were enthusiastic about the programme and their interactions with lifestyle improvements. Conclusions The results of this study shed light on different aspects that were considered important when delivering a lifestyle intervention to people with SMI. We recommend considering these aspects when implementing a lifestyle intervention in a mental health care setting for clients with SMI.

Abstract Flupyradifurone is a novel butenolide insecticide, first approved as an active substance for use in plant protection products by Commission Implementing Regulation (EU) 2015/2084. Following concerns that this substance may pose high risks to humans and the environment, the French authorities, in November 2020, asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. In addition, in June 2020, the Dutch Authorities notified the Commission, under Article 56 of Regulation (EC) No 1107/2009, of new information on flupyradifurone on the wild bee species Megachile rotundata. This notification is also referred to in the French notification on flupyradifurone. Consequently, the EFSA PPR Panel was mandated to quantify the likelihood of this body of evidence constituting proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments. A stepwise methodology was designed, including: (i) the initial screening; (ii) data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) weight of evidence, including consideration of the previous EU assessments; (iv) uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For the human health, only one study was considered relevant for the genotoxic potential of flupyradifurone in vitro. These data did not provide sufficient information to overrule the EU assessment, as in vivo studies already addressed the genotoxic potential of flupyradifurone. Environment: All available data investigated hazards in bee species. For honey bees, the likelihood of the new data indicating higher hazards than the previous EU assessment was considered low or moderate, with some uncertainties. However, among solitary bee species – which were not addressed in the previous EU assessment – there was evidence that Megachile rotundata may be disproportionately sensitive to flupyradifurone. This sensitivity, which may partially be explained by the low bodyweight of this species, was mechanistically linked to inadequate bodily metabolisation processes.

Abstract Acetamiprid is a pesticide active substance with insecticidal action currently under the third renewal (AIR3) of the Commission implementing regulation (EU) No 844/2012. Following concerns that this substance may pose high risks to humans and the environment, the French authorities asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. Consequently, the EFSA PPR Panel was mandated to advise on the likelihood that body of evidence would constitute proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments.A stepwise methodology was designed, including: (i) the initial screening; (ii) the data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) the weight of evidence, including consideration of the previous EU assessments; (iv) the uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For human health, no conclusive evidence of higher hazards compared to previous assessment was found for genotoxicity, developmental toxicity, neurotoxicity including developmental neurotoxicity and immunotoxicity. However, due to the lack of adequate assessment of the current data set, the PPR Panel recommends conducting an assessment of endocrine disrupting properties for acetamiprid in line with EFSA/ECHA guidance document for the identification of endocrine disruptors. For environment, no conclusive, robust evidence of higher hazards compared to the previous assessment was found for birds, aquatic organisms, bees and soil organisms. However, the potential of high inter‐species sensitivity of birds and bees towards acetamiprid requires further consideration.

ImportanceAmyloid-β positron emission tomography (PET) imaging allows in vivo detection of fibrillar plaques, a core neuropathological feature of Alzheimer disease (AD). Its diagnostic utility is still unclear because amyloid plaques also occur in patients with non-AD dementia.ObjectiveTo use individual participant data meta-analysis to estimate the prevalence of amyloid positivity on PET in a wide variety of dementia syndromes.Data sourcesThe MEDLINE and Web of Science databases were searched from January 2004 to April 2015 for amyloid PET studies.Study selectionCase reports and studies on neurological or psychiatric diseases other than dementia were excluded. Corresponding authors of eligible cohorts were invited to provide individual participant data.Data extraction and synthesisData were provided for 1359 participants with clinically diagnosed AD and 538 participants with non-AD dementia. The reference groups were 1849 healthy control participants (based on amyloid PET) and an independent sample of 1369 AD participants (based on autopsy).Main outcomes and measuresEstimated prevalence of positive amyloid PET scans according to diagnosis, age, and apolipoprotein E (APOE) ε4 status, using the generalized estimating equations method.ResultsThe likelihood of amyloid positivity was associated with age and APOE ε4 status. In AD dementia, the prevalence of amyloid positivity decreased from age 50 to 90 years in APOE ε4 noncarriers (86% [95% CI, 73%-94%] at 50 years to 68% [95% CI, 57%-77%] at 90 years; n = 377) and to a lesser degree in APOE ε4 carriers (97% [95% CI, 92%-99%] at 50 years to 90% [95% CI, 83%-94%] at 90 years; n = 593; P

Abstract EFSA asked the Panel on Plant Protection Products and their residues to deliver a Scientific Opinion on testing and interpretation of comparative in vitro metabolism studies for both new active substances and existing ones. The main aim of comparative in vitro metabolism studies of pesticide active substances is to evaluate whether all significant metabolites formed in the human in vitro test system, as a surrogate of the in vivo situation, are also present at comparable level in animal species tested in toxicological studies and, therefore, if their potential toxicity has been appropriately covered by animal studies. The studies may also help to decide which animal model, with regard to a particular compound, is the most relevant for humans. In the experimental strategy, primary hepatocytes in suspension or culture are recommended since hepatocytes are considered the most representative in vitro system for prediction of in vivo metabolites. The experimental design of 3 × 3 × 3 (concentrations, time points, technical replicates, on pooled hepatocytes) will maximise the chance to identify unique (UHM) and disproportionate (DHM) human metabolites. When DHM and UHM are being assessed, test item‐related radioactivity recovery and metabolite profile are the most important parameters. Subsequently, structural characterisation of the assigned metabolites is performed with appropriate analytical techniques. In toxicological assessment of metabolites, the uncertainty factor approach is the first alternative to testing option, followed by new approach methodologies (QSAR, read‐across, in vitro methods), and only if these fail, in vivo animal toxicity studies may be performed. Knowledge of in vitro metabolites in human and animal hepatocytes would enable toxicological evaluation of all metabolites of concern, and, furthermore, add useful pieces of information for detection and evaluation of metabolites in different matrices (crops, livestock, environment), improve biomonitoring efforts via better toxicokinetic understanding, and ultimately, develop regulatory schemes employing physiologically based or physiology‐mimicking in silico and/or in vitro test systems to anticipate the exposure of humans to potentially hazardous substances in plant protection products.

Nudges, such as defaults, are generally found to be effective in guiding immediate behavioural decisions. However, little is known about whether the effect of a nudge can be lasting, meaning that it spills over to subsequent similar choices without the presence of a nudge. In three experiments, we explored the temporal spillover effects of a default nudge. The results of Experiments 1 (N = 1,077) and 2 (N = 1,036) suggest that nudging participants into completing a longer questionnaire affected their decision for the same behaviour a day later without the presence of a nudge. However, nudging participants into a healthier food choice in Experiment 3 (N = 969) did not result in such a temporal spillover effect. The results indicated that participants' change in attitude towards the nudged behaviour may partly explain the temporal spillover effects. These findings suggest that for some, but not all behaviours, default nudges may have the potential to yield temporal spillover effects and warrant a further investigation of boundary conditions and facilitators of the spillover effects of nudges.

Abstract Background Cardiovascular disease is the leading cause of the estimated 11–25 years reduced life expectancy for persons with serious mental illness (SMI). This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidaemia. Obesity is associated with a sedentary lifestyle, limited physical activity and an unhealthy diet. Lifestyle interventions for persons with SMI seem promising in reducing weight and cardiovascular risk. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a lifestyle intervention among persons with SMI in an outpatient treatment setting. Methods The Serious Mental Illness Lifestyle Evaluation (SMILE) study is a cluster-randomized controlled trial including an economic evaluation in approximately 18 Flexible Assertive Community Treatment (FACT) teams in the Netherlands. The intervention aims at a healthy diet and increased physical activity. Randomisation takes place at the level of participating FACT-teams. We aim to include 260 outpatients with SMI and a body mass index of 27 or higher who will either receive the lifestyle intervention or usual care. The intervention will last 12 months and consists of weekly 2-h group meetings delivered over the first 6 months. The next 6 months will include monthly group meetings, supplemented with regular individual contacts. Primary outcome is weight loss. Secondary outcomes are metabolic parameters (waist circumference, lipids, blood pressure, glucose), quality of life and health related self-efficacy. Costs will be measured from a societal perspective and include costs of the lifestyle program, health care utilization, medication and lost productivity. Measurements will be performed at baseline and 3, 6 and 12 months. Discussion The SMILE intervention for persons with SMI will provide important information on the effectiveness, cost-effectiveness, feasibility and delivery of a group-based lifestyle intervention in a Dutch outpatient treatment setting. Trial registration Dutch Trial Registration NL6660, registration date: 16 November 2017.

Abstract The EFSA Panel on Plant Protection Products and their Residues (PPR) has developed, as a self‐task mandate (EFSA‐Q‐2019‐00100), two adverse outcome pathway (AOP)‐informed integrated approach to testing and assessment (IATA) case studies to answer a developmental neurotoxicity (DNT) hazard identification and characterisation problem formulation that could support the regulatory decisions for the pesticide active substances deltamethrin and flufenacet. The IATA were developed to assess the applicability of the DNT in vitro testing battery (IVB), designed to explore fundamental neurodevelopmental processes, in the regulatory risk assessment of pesticides. For this purpose, an evidence‐based‐approach methodology was applied: 1) systematic literature review and critical appraisal of all the evidence i.e. human observational studies, in vivo data from rodent models and new approach methodologies (NAMs, i.e. in vitro studies including high‐throughput testing from IVB and zebrafish studies from the literature) for both case studies; 2) a quantitative uncertainty analysis of all the evidence using expert knowledge elicitation (EKE) and a probabilistic approach; 3) integration of all the evidence using the AOP conceptual framework. This stepwise approach resulted in the postulation of an evidence‐based AOP network for one of the case studies. A probabilistic quantification of the weight of evidence (WoE) using Bayesian network analysis allowed the assessment and the quantification of the uncertainty in the postulated AOP. The approach taken allowed conclusions to be drawn with an acceptable level of certainty in DNT hazard identification and characterisation of deltamethrin and that flufenacet is not a developmental neurotoxicant, supporting the relevance of the mechanistic understanding. The case studies show the applicability of the DNT‐IVB for hazard identification and characterisation and illustrate the usefulness of an AOP‐informed IATA for regulatory decision making. The overall activity led to improved interpretation of human data by providing a plausible mechanistic link to adverse outcomes, which would support their contextualisation in the risk assessment process. This Scientific Opinion allows the PPR Panel to draft several recommendations for the implementation of the AOP‐informed IATA methodology and of the DNT‐IVB in the regulatory risk assessment of pesticides.

Abstract The European Commission asked the European Food Safety Authority (EFSA) to prepare a statement on a framework for the environmental risk assessment (ERA) of transition metals (e.g. iron and copper) used as active substances in plant protection products (PPPs). Non‐degradability, essentiality and specific conditions affecting fate and behaviour as well as their toxicity are distinctive characteristics possibly not covered in current guidance for PPPs. The proposed risk assessment framework starts with a preliminary phase, in which monitoring data on transition metals in relevant environmental compartments are provided. They deliver the metal natural background and anthropogenic residue levels to be considered in the exposure calculations. A first assessment step is then performed assuming fully bioavailable residues. Should the first step fail, refined ERA can, in principle, consider bioavailability issues; however, non‐equilibrium conditions need to be taken into account. Simple models that are fit for purpose should be employed in order to avoid unnecessary complexity. Exposure models and scenarios would need to be adapted to address environmental processes and parameters relevant to the fate and behaviour of transition metals in water, sediment and soils (e.g. speciation). All developments should follow current EFSA guidance documents. If refined approaches have been used in the risk assessment of PPPs containing metals, post‐registration monitoring and controlled long‐term studies should be conducted and assessed. Utilisation of the same transition metal in other PPPs or for other uses will lead to accumulation in environmental compartments acting as sinks. In general, it has to be considered that the prospective risk assessment of metal‐containing PPPs can only cover a defined period as there are limitations in the long‐term hazard assessment due to issues of non‐degradability. It is therefore recommended to consider these aspects in any risk management decisions and to align the ERA with the goals of other overarching legislative frameworks.

Doel: Het doel van het huidige onderzoek is zicht te krijgen op het verloop van de klankontwikkeling bij de huidige generatie Nederlandse kinderen met gehoorverlies en te onderzoeken welke factoren van invloed zijn op de klankontwikkeling bij deze groep kinderen. Methode: De klankontwikkeling van een groep van 28 kinderen met licht tot zeer ernstig perceptief gehoorverlies en van 31 kinderen zonder gehoorverlies is gevolgd over een periode van 12 maanden (leeftijd van 6 tot 18 maanden). Hiervoor werd elke 3 maanden de Infant Monitor of Vocal Production (IMP) afgenomen bij ouders. Daarnaast gaven ouders elke 3 maanden informatie over de hoorontwikkeling van hun kind (LittlEARS) en de draagduur van de hoortoestellen (aanpassing van de Amplification in Daily Life Questionnaire). Ook zijn datalogging gegevens van de hoortoestellen verzameld bij de audiologische centra. Resultaten: Uit dit onderzoek bleek dat kinderen met gehoorverlies op de leeftijd van 9 maanden een achterstand in de klankontwikkeling lieten zien ten opzichte van hun horende leeftijdsgenoten. Tevens lieten de resultaten zien dat een hogere mate van gehoorverlies leidt tot een minder goede hoorontwikkeling en daarmee een minder goede klankontwikkeling. Kinderen die hun hoortoestel meer droegen hadden een betere hoorontwikkeling. Conclusie: Op groepsniveau laten kinderen met gehoorverlies in het eerste levensjaar al een achterstand zien in de klankontwikkeling ten opzichte van kinderen zonder gehoorverlies. Er zijn, onder andere als gevolg van de mate van gehoorverlies, echter grote individuele verschillen in het verloop van de klankontwikkeling binnen de groep kinderen met gehoorverlies. Meer onderzoek is nodig om verder vast te stellen welke kinderen met gehoorverlies een groter risico lopen op een achterblijvende klankontwikkeling.

Nudges have repeatedly been found to be effective, however they are claimed to harm autonomy, and it has been found that laypeople expect this too. To test whether these expectations translate to actual harm to experienced autonomy, three online studies were conducted. The paradigm used in all studies was that participants were asked to voluntarily participate in a longer version of the questionnaire. This was either done in a hypothetical setting, where participants imagined they were asked this question, but did not answer it, and reported their expectations for autonomy; Or in an actual choice setting where participants answered the question and then reported their actual autonomy. The first study utilized the hypothetical setting and tried to replicate that laypeople expect nudges to harm autonomy with the current paradigm. A total of 451 participants were randomly assigned to either a control, a default nudge, or a social norm nudge condition. In the default nudge condition, the affirmative answer was pre-selected, and in the social norm nudge condition it was stated that most people answered affirmative. The results showed a trend for lower expected autonomy in nudge conditions, but did not find significant evidence. In Study 2, with a sample size of 454, the same design was used in an actual choice setting. Only the default nudge was found to be effective, and no difference in autonomy was found. In Study 3, Studies 1 and 2 were replicated. Explanation of the nudge was added as an independent variable and the social norm nudge condition was dropped, resulting in six conditions and 1322 participants. The results showed that participants indeed expected default nudges to harm their autonomy, but only if the nudge was explained. When actually nudged, no effect on autonomy was found, independent of the presence of an explanation.