Shifts in subjective well-being of different status groups: a longitudinal case-study during declining income inequality

Theory holds that as income distribution becomes more equal, the well-being of those of low socioeconomic standing increases, since their relative status is improved. In this study we measure changes in individual subjective well-being (SWB) over a three year period of declining income inequality in Iceland. Using growth mixture modelling, we identified two groups whose well-being trajectories differ. One group (n = 540) whose SWB was initially high but then declined slightly, and a second group (n = 110) whose SWB was initially low, but improved over time. This second group had lower socio-economic status and stronger materialistic values. These differing shifts in SWB coincide with diminishing income inequality and class division and the results are consistent with the status anxiety explanation of the income inequality hypothesis. Our findings suggest the need to examine separate trajectories of distinct socioeconomic groups in societies generally regarded as egalitarian, and examine the role of a materialistic value orientation further

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Introduction:In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union. Methods: We established a cohort of medicinal products with aRMMs at marketing authorisation (MA) that were centrally authorised from July 2012–December 2021 using the European Public Assessment Reports. Evaluation studies were identified from the Risk Management Plans at the time of MA. Subsequently, we retrieved protocols, final study reports, Pharmacovigilance Risk Assessment Committee (PRAC) assessment reports, and PRAC minutes. We calculated the probability of completing an effectiveness evaluation within 60 months after MA using time-to-event analyses. Besides, we compared the planned final report with the actual final report date. Results: We identified 134 medicinal products authorised with aRMMs, of which almost half (n = 63, 47.0%) had an effectiveness evaluation study. The probability of an evaluation for a medicinal product being completed within 60 months after MA was 20.7% (95% CI 6.8–32.6). Regarding study design, the probability of completing a study was higher for cross-sectional studies when compared to cohort studies (p = 0.002). Moreover, 81.0% of studies were delayed when compared to their planned final report date. Conclusion: The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed.</p

Пам'яті Миколи Чумаченка

14 жовтня на 87-ому році життя відійшов у вічність видатний учений-економіст, доктор економічних наук, академік Національної академії наук України, заслужений діяч науки і техніки України, лауреат Державної премії України в галузі науки і техніки, лауреат премій АН УРСР ім. О.Г. Шліхтера та НАН України ім. М.І. Тугана-Барановського, почесний директор Інституту економіки промисловості НАН України, ветеран Великої Вітчизняної війни, почесний громадянин міста Донецька голова редакційної колегії журналу Схід з економіки Микола Григорович Чумаченко

Antidepressants in primary care:patients' experiences, perceptions, self-efficacy beliefs, and nonadherence

PURPOSE: Patient adherence to antidepressants is poor. However, this is rather unsurprising, given the equivocal efficacy, side effects, and practical problems of antidepressants. The aim of this study was to examine a wide array of patient experiences and perceptions regarding the efficacy, side effects, and practical problems of antidepressants, as well as their associations with nonadherence, and whether patients' perceived self-efficacy moderated these associations.PATIENTS AND METHODS: Experiences and perceptions of 225 patients, recruited through community pharmacies, were efficiently assessed with the Tailored Medicine Inventory. Nonadherence was assessed through self-report and pharmacy refill data.RESULTS: Many patients were not convinced of the efficacy, thought the efficacy to be limited or did not believe antidepressants to prevent relapse, were worried about or had experienced one or more side effects, and/or had experienced one or more practical problems regarding information, intake, and packaging. Being convinced of efficacy was associated with lower intentional nonadherence (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.8-0.96). A higher number of practical problems experienced was associated with increased unintentional nonadherence (OR 1.3, 95% CI 1.1-1.7). Higher perceived self-efficacy regarding taking antidepressants was associated with lower unintentional nonadherence (OR 0.7, 95% CI 0.5-0.9). Perceived self-efficacy did not moderate associations of patient experiences and perceptions with nonadherence.CONCLUSION: Assessing a wide array of patients' experiences and perceptions regarding the efficacy, side effects, and practical problems of antidepressants contributes to better understanding of nonadherence to antidepressants. Guiding physician-patient conversations by patients' experiences and perceptions may reduce both unintentional and intentional nonadherence. Also, it may give rise to considerations of prudent discontinuation, eg, when patients are not convinced of the efficacy.</p

Long-term survival of Icelandic women following acute myocardial infarction

Publisher Copyright: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.Objective. To evaluate the impact of sex on treatment and survival after acute myocardial infarction (AMI) in Iceland. Methods. A retrospective, nationwide cohort study of patients with STEMI (2008–2018) and NSTEMI (2013–2018) and obstructive coronary artery disease. Patient and procedural information were obtained from a registry and electronic health records. Survival was estimated with Kaplan–Meier method and Cox regression analysis used to identify risk factors for long-term mortality. Excess mortality from the AMI episode was estimated by comparing the survival with age- and sex-matched population in Iceland at 30-day interval. Results. A total of 1345 STEMI-patients (24% women) and 1249 NSTEMI-patients (24% women) were evaluated. Women with STEMI (mean age: 71 ± 11 vs. 67 ± 12) and NSTEMI (mean age: 69 ± 13 vs. 62 ± 12) were older and less likely to have previous cardiovascular disease. There was neither sex difference in the extent of coronary artery disease nor treatment. Although crude one-year post-STEMI survival was lower for women (88.7% vs. 93.4%, p =.006), female sex was not an independent risk factor after adjusting for age and co-morbidities after STEMI and was protective for NSTEMI (HR 0.67, 95% CI: 0.46–0.97). There was excess 30-day mortality in both STEMI and NSTEMI for women compared with sex-, age- and inclusion year-matched Icelandic population, but thereafter the mortality rate was similar. Conclusion. Women and men with AMI in Iceland receive comparable treatment including revascularization and long-term survival appears similar. Prognosis after NSTEMI is better in women, whereas higher early mortality after STEMI may be caused by delays in presentation and diagnosis.Peer reviewe

Quality of reporting of drug exposure in pharmacoepidemiological studies

Publisher's version (útgefin grein)Purpose: Exposure definitions vary across pharmacoepidemiological studies. Therefore, transparent reporting of exposure definitions is important for interpretation of published study results. We aimed to assess the quality of reporting of exposure to identify where improvement may be needed. Method: We systematically reviewed observational pharmacoepidemiological studies that used routinely collected health data, published in 2017 in six pharmacoepidemiological journals. Reporting of exposure was scored using 11 items of the ISPE-ISPOR guideline on reporting of pharmacoepidemiological studies. Results: Of the 91 studies included, all studies reported the type of exposure (100%), while most reported the exposure risk window (85%) and the exposure assessment window (98%). Operationalization of the exposure window was described infrequently: 16% (14/90) of the studies explicitly reported the presence or absence of an induction period if applicable, 11% (5/47), and 35% (17/49) reported how stockpiling and gaps between exposure episodes were handled, respectively, and 35% (17/49) explicitly mentioned the exposure extension. Switching/add-on was reported in 62% (50/81). How switching between drugs was dealt with and specific drug codes were reported in 52 (57%) and 24 (26%) studies, respectively. Conclusion: Publications of pharmacoepidemiological studies frequently reported the type of exposure, the exposure risk window, and the exposure assessment window. However, more details on exposure assessment are needed, especially when it concerns the operationalization of the exposure risk window (eg, the presence or absence of an induction period or exposure extension, handling of stockpiling and gaps, and specific codes), to allow for correct interpretation, reproducibility, and assessment of validity.RHHG was funded by the Netherlands Organization for Scientific Research (ZonMW‐Vidi project 917.16.430) and an LUMC fellowship.Peer Reviewe

Indications related to antidepressant prescribing in the Nivel-PCD database and the SIDIAP database

Altres ajuts: Acord transformatiu CRUE-CSICAntidepressant drug consumption has increased, mainly in the elderly. This trend could be explained by the use for indications other than depression. We aimed to describe the indications related to antidepressant drug new users in two primary care settings

Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019

The quality of biopharmaceuticals is carefully monitored by manufacturers and regulators to ensure safety and efficacy throughout the entire product life cycle. Quality defects can lead to post-approval regulatory actions (RAs) to inform healthcare professionals (HCPs). The present study identified quality-related RAs for biopharmaceuticals approved in the European Union and United States between 1995 and 2019. Quality-related RAs were issued due to various quality defects and required different actions by HCPs. The quality defects were not identified due to a negative impact on efficacy and/or safety, which is reassuring. The findings reflect the capability of the stringent regulatory system and quality control to capture and counter various quality defects before the affected product and batches can harm patients

Tell me what you want, what you really really want: Estimands in observational pharmacoepidemiologic comparative effectiveness and safety studies

PURPOSE: Ideally, the objectives of a pharmacoepidemiologic comparative effectiveness or safety study should dictate its design and data analysis. This paper discusses how defining an estimand is instrumental to this process. METHODS: We applied the ICH-E9 (Statistical Principles for Clinical Trials) R1 addendum on estimands - which originally focused on randomized trials - to three examples of observational pharmacoepidemiologic comparative effectiveness and safety studies. Five key elements specify the estimand: the population, contrasted treatments, endpoint, intercurrent events, and population-level summary measure. RESULTS: Different estimands were defined for case studies representing three types of pharmacological treatments: (1) single-dose treatments using a case study about the effect of influenza vaccination versus no vaccination on mortality risk in an adult population of ≥60 years of age; (2) sustained-treatments using a case study about the effect of dipeptidyl peptidase 4 inhibitor versus glucagon-like peptide-1 agonist on hypoglycemia risk in treatment of uncontrolled diabetes; and (3) as needed treatments using a case study on the effect of nitroglycerin spray as-needed versus no nitroglycerin on syncope risk in treatment of stabile angina pectoris. CONCLUSIONS: The case studies illustrated that a seemingly clear research question can still be open to multiple interpretations. Defining an estimand ensures that the study targets a treatment effect that aligns with the treatment decision the study aims to inform. Estimand definitions further help to inform choices regarding study design and data-analysis and clarify how to interpret study findings

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019

Use of Real-World Data (RWD) has gained the interest of different stakeholders in cancer care. The aim of this study was to identify and describe the use of RWD/RWE during the pre-authorization phase of products authorized by the EMA in 2018 and 2019 (n = 111), with the focus on oncology medicines (n = 24). Information was extracted from the European Public Assessment Report (EPAR) summaries and recorded for 5 stages (11 categories) of the drug development lifecycle (discovery, early development, clinical development, registration/market launch, lifecycle management). Specific chapters of full EPAR were reviewed to substantiate the findings on RWD/RWE use in clinical trial design, efficacy, safety, and effectiveness evaluation. RWD/RWE is present in all stages of the oncology drug development; 100.0 % in discovery, 37.5 % early development, 58.3 % in clinical development, 62.5 % in registration decision and 100.0 % in post-authorization lifecycle management. Examples showed that trial design supported by RWD/RWE included use of open label/single arm studies; efficacy was about using either comparison of results to historical controls, supplying survey data obtained outside the clinical trial or utilizing expert panel advice; safety about including literature findings in evidence; and effectiveness on comparison of trial results of the given product to historical data or existing standard of care. The findings of this study provide specific insights into how RWD/RWE is used in development of cancer therapeutics, how it contributes to regulatory decision making and can guide further policy developments in this field