INTRODUCTION: The COVID-19 pandemic can cause emotional distress, which can in turn lead to the development of mental and physical symptoms. AIM: We examined the association of the COVID-19 outbreak and the mental, physical and sexual health of the female Polish population. METHODS: Data were collected in an online survey distributed on social media from April 22, 2020 through to May 7, 2020. The data collection began one month after the start of lockdown in Poland. MAIN OUTCOME MEASURE: Women were asked to complete the Beck Depression Inventory (BDI) and the Female Sexual Function Index (FSFI) questionnaires. RESULTS: Overall, 1644 women (median age 23 years) took part in the survey. They reported a lower frequency of sexual activity (P < .001) and a lower libido level (P < .001) during the pandemic then before it. 57.5% of the study group (n = 944) strongly agreed or agreed that fear of the health condition of loved ones was a source of stress and depressed mood. The average BDI-II total score was 11 (range 0-51; IQR 5-18), which corresponds to minimal depression. The average FSFI total score was 27.01 ± 7.61 (range 2-36). The FSFI and BDI scores were significantly correlated (P < .001). The FSFI score was significantly correlated with the presence of any comorbid chronic disease, the intensity of the fear of infection and fear of health conditions, perceived loneliness, and the being up to date with media news. The BDI score was significantly correlated with age, the intensity of the fear of infection and fear of health conditions, perceived loneliness, being up to date with media news, and the more frequent use of stimulants. CONCLUSIONS: The COVID-19 lockdown setting was associated with a high occurrence of depressive symptoms and increased risk of sexual dysfunction with decreased libido and lower sexual frequency the most commonly reported issues. Szuster E, Kostrzewska P, Pawlikowska A, et al. Mental and Sexual Health of Polish Women of Reproductive Age During the COVID-19 Pandemic - An Online Survey. Sex Med 2021;XX:XXXXXX.

Summary The burden of visible skin diseases (VSDs) includes not only physical symptoms but also psychosocial consequences such as depression, anxiety, impaired quality of life and low self-esteem. Stigmatisation was shown to play a major role in people with skin diseases The aim of the study was to review the evidence for the components, drivers, and impacts of (self-) stigma, and to organise the data into a series of conceptual models. A targeted literature search was conducted to identify studies on (self-) stigma in relation to VSD. Conceptual models of stigma in VSDs were developed from existing generic conceptual models for VSD and of generic conceptual models of stigma and were refined after discussion with a board of experts, patient advocacy groups, clinicians and researchers. A total of 580 references were identified, of which 56 references were analysed and summarised. Two conceptual models of stigma were identified: one with external stigma and self-stigma dimensions, the other for self-stigma in mental health. These models were adapted to allow a complete description of stigma in VSDs. For this, a distinction was made between ‘discrimination’ and ‘impact’. Finally, five models were developed: Macro-overview; Stigma, Impact and Socio-demographics; Stigma, Impact and Disease Characteristics; Stigma, Impact and Quality of Life; and Stigma, Impact and Coping. Gaps were identified in available quantitative evidence. To our knowledge, this is the first conceptual model of stigma in VSDs. The model will help to standardise evaluation of stigma and to enhance empirical evaluation of anti-stigma interventions in VSDs. Further research should be conducted to develop a more complete model in stigma due to significant gaps in existing evidence, particularly including the stigma in others (external stigma) and also to cover a broader range of VSDs as their impact on particular dimensions of stigma differs.

Coronavirus 2019 (COVID-19) has caused significant disruption to the cell and gene therapy (CGT) industry, which has historically faced substantial complexities in supply of materials, and manufacturing and logistics processes. As decision-makers shifted their priorities to COVID-19-related issues, the challenges in market authorisation, and price and reimbursement of CGTs were amplified. Nevertheless, it is encouraging to see that some CGT developers are adapting their efforts toward the development of promising COVID-19-related therapeutics and vaccines. Manufacturing resilience, digitalisation, telemedicine, value-based pricing, and innovative payment mechanisms will be increasingly harnessed to ensure that market access of CGTs is not severely disrupted.

OBJECTIVES: Cervical cancer is a leading cause of cancer-related mortality in women in China. This analysis is a quantitative evidence synthesis pooling information about each cervical cancer risk factor. METHODS: A meta-model was developed to estimate the risk of cervical cancer for a woman aged 18-85 years in Mainland China based on her risk profile at the time of assessment. The meta-model was built using findings of a systematic literature review that identified 21 case-control studies reporting data on 105 groups of cervical cancer risk factors in Chinese women. Extracted risk factors were ranked, and 17 were selected by Chinese clinical experts for inclusion in the meta-model. Risk equations were developed for each selected study. Predicted risks for each study were dependent on the risk profile under consideration and study-specific risks were pooled to an overall risk estimate using a random-effects meta-analysis. Sensitivity analysis was conducted using 100 artificial patient profiles (in the absence of patient data). RESULTS: Predicted risks for the 100 profiles suggested that the model had good face validity and could differentiate between high and non-high cervical cancer risk profiles. CONCLUSION: This innovative meta-model approach assesses cervical cancer risk in Chinese women from a holistic perspective and could be adapted for other diseases and settings.

Objectives: While several authors have suggested using a multi-criteria approach for orphan drug assessment and proposed lists of determinants of orphan drug value, studies on social preferences regarding these determinants remain limited. The current study aimed to identify preferences of the French general population regarding attributes characterizing the value of orphan drugs in a discrete choice experiment.Methods: The list of attributes was formed based on a literature search and was refined through expert interviews, a focus group, and a pilot study. The final list included nine attributes: disease-associated disability, disease-associated mortality, number of patients, availability of alternative treatments, treatment impact on disease disability, treatment impact on mortality, treatment safety, uncertainty around therapeutic effect, and annual treatment cost per patient. Members of the General Public were presented with 12 choice sets containing two drug profiles described according to the attributes and an option to fund neither of these treatments. The questionnaire was disseminated online. A conditional logit model with random effects was used to estimate the weight of each attribute.Results: A total of 958 persons participated in the study (48.7% male, mean age: 47.5 years). All attributes except for disease-associated disability had a statistically significant influence on the choices made by participants. The attribute with the highest weight was treatment impact on mortality (p < 0.0001), followed by uncertainty around therapeutic effect (p < 0.0001). The direction of results was generally consistent with intuition: patients preferred a drug with a larger impact on mortality, a larger impact on disability, with mild or no adverse events, with less uncertainty. Although patients appeared to prefer drugs with a lower budget impact, the relationship between patient preferences and costs was more complex.Conclusions: Preferences of the general public between orphan drugs are mostly driven by the impact on mortality and the degree of certainty regarding the available evidence.

Health state utility values (HSUVs) identified from utility elicitation studies are widely used in pharmacoeconomic evaluations for chronic hepatitis C (CHC) and are particularly instrumental in health technology assessment (HTA) evaluations such as those from the National Institute for Health and Care Excellence (NICE).

BACKGROUND: In recent years there is a growing interest in public beliefs about mental disorders. Numerous representative population-based studies have been conducted around the globe, also in European countries bordering on the Mediterranean Sea. However, relatively little is known about public beliefs in countries in Northern Africa. OBJECTIVE: To fill this gap by comparing public beliefs about mental disorders in Tunisia and Germany, focusing on causal beliefs, help-seeking recommendations and treatment preferences. METHODS: Representative national population-based surveys have been conducted in Tunisia in 2012 (N = 811) and in Germany in 2011 (N = 1852), using the same interview mode and the same fully structured interview starting with a vignette depicting a person suffering from either schizophrenia or depression. RESULTS: In Tunisia, the public was more likely to adopt psychosocial and to reject biogenetic explanations than in Germany. Correspondingly, psychological treatments were more frequently recommended and biological ones more frequently advised against. There was also a strong inclination to share religious beliefs and to recommend seeking religious advice. Tunisians tended much more than Germans to hold moralistic views and to blame the afflicted person for his or her illness. In Tunisia, the public tended less to differentiate between schizophrenia and depression than in Germany. CONCLUSION: Marked differences between Tunisia and Germany exist in public beliefs about the causes of mental disorders and their treatment, which correspond to differences in cultural orientations prevailing in these countries. Mental health professionals need to be sensitive to the particular cultural context in which they operate, in order to be able to reach those they intend to care for.

Real-world evidence (RWE) provides external validity, supplementing and enhancing the randomized controlled trial (RCT) data with valuable information on patient behaviours and outcomes, turning efficacy and safety results into real-world effectiveness and risks, but the use of RWE is associated with challenges.The objectives of this communication were to (1) summarise all guidance on how to conduct an RWE meta-analysis (MA) and how to develop an RWE cost-effectiveness model, (2) to describe our experience, challenges faced and solutions identified, (3) to provide recommendations on how to conduct such analyses.No formal guidelines on how to conduct an RWE MA or to develop an RWE cost-effectiveness model were identified. Using the context of non-vitamin K antagonist oral anticoagulants (NOACs) in stroke prevention in atrial fibrillation, we conducted an RWE MA, after having identified sources of uncertainty. We then implemented the results in an RWE cost-effectiveness model, defined as a model where all inputs come from RWE, including all parameters related to treatment effect. Based on challenges faced, our first recommendation relates to the necessity of conducting sensitivity analyses, either based on clinical or methodological considerations. Our second recommendation is the need for extensive collaboration with a wide range of experts, during the development of the analyses protocols, the implementation of the analyses and the interpretation of the results.RWE may address a number of gaps related to the treatment effect, and RWE economic evaluations for the treatment effect can provide extremely valuable insights into real-world economic value of interventions. As the increased recognition of the value of RWE could influence health technology assessment decision, and current practices, this communication supports the urgent need of more formal guidelines.