The Impact of the COVID-19 "Infodemic" on Drug-Utilization Behaviors: Implications for Pharmacovigilance.

The coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an "infodemic") about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, favipiravir, and umifenovir) that could have led to inappropriate and therefore hazardous use. In this article, we analyze the rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people's behavior, and the responses of some influential regulatory authorities in an attempt to minimize the actual or potential risks arising from this behavior. Finally, we discuss the role of pharmacovigilance stakeholders in emergency management and possible strategies to deal with other similar crises in the future.

Codifying explicit and tacit practitioner knowledge in community social pediatrics organizations: Evaluation of the first step of a knowledge transfer strategy.

In this article, we the present the evaluation of the first phase of a KT initiative, the codification of the tacit and explicit knowledge of community social pediatrics (CSP) practitioners. As increasing numbers of professionals began working in the CSP field, it became necessary to capture the know-how to make it better understood. This first phase of the initiative took advantage of one of the KM stages, the codifying process that is absent from KT models. The evaluation aim to answer the question: "What is the CSPs practitioners level of familiarity with the codification document, as well as their perceptions of its utility and its contribution to the understanding of the CSP model". The results, show that most respondents had consulted the codification document and were able to describe in detail parts of it. The results also show that they considered it to be a useful and necessary tool to guide practices and helpful in understanding the model. The results of this evaluation is paving the way for the next steps of the KT initiative.

[Use of the Symptom Validation Test BEVA in Social Medical Assessment]. / Einsatz des Beschwerdenvalidierungstests BEVA in der sozialmedizinischen Begutachtung.

The present study investigates whether the BEVA is suitable to detect negative response bias by claimants with psychosomatic symptoms in the social medical assessment. 107 claimants for disability pension to a psychosomatic disorder fulfilled the BEVA, SIMS and a sociodemographic questionnaire. The social medical examiners assess the credibility of the complaints representation. A Known-Group-Design and a Bootstrapping-Design was used to estimate the validity of the BEVA. For the external criterion SFSS the following psychometric characteristics for the BEVA could be determined: specificity=0.86, sensitivity=0.42, positive predictive value=0.81, negative predictive value=0.51. The interrater reliability estimates with Cohen κ=0.253. If the expert's assessments are chosen as external criterion following psychometric characteristics were estimated: specificity=0.71, sensitivity=0.32, positive predictive value=0.38, negative predictive value=0.66. The rater agreement is Cohen κ=0.031. The results show that the BEVA has an excellent specificity in the detection of negative response bias. This is highly desirable in terms of an ethically moral discussion. Furthermore, the study shows that - in addition to the expert estimates - further screenings can improve the assessment of negative response bias.

[Quality Assurance in Sociomedical Evaluation by Peer Review: A Pilot Project of the German Statutory Pension Insurance]. / Qualitätssicherung in der Sozialmedizinischen Begutachtung durch Peer Review - ein Pilotprojekt der Deutschen Rentenversicherung.

BACKGROUND: The sociomedical evaluation by the German Pension Insurance serves the purpose of determining entitlement to disability pensions. A quality assurance concept for the sociomedical evaluation was developed, which is based on a peer Review process. Peer review is an established process of external quality assurance in health care. The review is based on a hierarchically constructed manual that was evaluated in this pilot project. METHODS: The database consists of 260 medical reports for disability pension of 12 pension insurance agencies. 771 reviews from 19 peers were included in the evaluation of the inter-rater reliability. Kendall's coefficient of concordance W for more than 2 raters is used as primary measure of inter-rater reliability. RESULTS: Reliability appeared to be heterogeneous. Kendalls W varies for the particular criteria from 0.09 to 0.88 and reached for primary criterion reproducibility a value of 0.37. CONCLUSION: The reliability of the manual seemed acceptable in the context of existing research data and is in line with existing peer review research outcomes. Nevertheless, the concordance is limited and requires optimisation. Starting points for improvement can be seen in a systematic training and regular user meetings of the peers involved.

Protocol for a process-oriented qualitative evaluation of the Waltham Forest and East London Collaborative (WELC) integrated care pioneer programme using the Researcher-in-Residence model.

INTRODUCTION: The integration of health and social care in England is widely accepted as the answer to fragmentation, financial concerns and system inefficiencies, in the context of growing and ageing populations with increasingly complex needs. Despite an expanding body of literature, there is little evidence yet to suggest that integrated care can achieve the benefits that its advocates claim for it. Researchers have often adopted rationalist and technocratic approaches to evaluation, treating integration as an intervention rather than a process. Results have usually been of limited use to practitioners responsible for health and social care integration. There is, therefore, a need to broaden the evidence base, exploring not only what works but also how integrated care can most successfully be implemented and delivered. For this reason, we are carrying out a formative evaluation of the Waltham Forest and East London Collaborative (WELC) integrated care pioneer programme. Our expectation is that this will add value to the literature by focusing on the processes by which the vision and objectives of integrated care are translated through phases of development, implementation and delivery from a central to a local perspective, and from a strategic to an operational perspective. METHODS AND ANALYSIS: The qualitative and process-oriented evaluation uses an innovative participative approach-the Researcher-in-Residence model. The evaluation is underpinned by a critical ontology, an interpretive epistemology and a critical discourse analysis methodology. Data will be generated using interviews, observations and documentary gathering. ETHICS AND DISSEMINATION: Emerging findings will be interpreted and disseminated collaboratively with stakeholders, to enable the research to influence and optimise the effective implementation of integrated care across WELC. Presentations and publications will ensure that learning is shared as widely as possible. The study has received ethical approval from University College London's Research Ethics Committee and has all appropriate NHS governance clearances.

[Can ICF core sets be helpful in preparing a social-medical expert report due to incapacity to work?--a first proposal]. / Können ICF Core Sets für die Erstellung von sozialmedizinischen Gutachten bei Anträgen auf Erwerbsminderungsrente hilfreich sein?--Ein erster Vorschlag.

INTRODUCTION: Social-medical expert reports from the German statutory pension insurance are essential for the German statutory pension regulatory authority to decide whether to grant services regarding participation as well as retirement pensions due to incapacity to work.The objective of this investigation is to determine whether the ICF Core Sets and other international approaches, such as the EUMASS Core Sets or ICF Core Set for vocational rehabilitation cover the content of the social-medical expert reports as well as to propose an approach how the ICF can be economically used by the social medicine practitioner when writing a social-medical expert report. METHOD: A retrospective quantitative study design was used to translate a total of 294 social-medical expert reports from patients with low back pain (LBP) or chronic widespread pain (CWP) into the language of the ICF (linking) by 2 independent health professionals and compare the results with the ICF Core Sets for specific health conditions and other international approaches. RESULTS: The content of social-medical expert reports was largely reflected by the condition specific brief ICF Core Sets, brief ICF Core Sets for vocational rehabilitation and EUMASS Core Sets. The weighted Kappa statistic for the agreement between the 2 health professionals who translated the expert reports were in CWP 0.69 with a bootstrapped confidence interval of 0.67-0.71 and in LBP 0.73 (0.71-0.74). DISCUSSION: The analyses show that the content of social-medical expert reports varies enormously. A combination of a condition specific brief ICF Core Set as well as vocational rehabilitation and EUMASS ICF Core Sets as well as all ICF-categories from the expert reports that were named at least in 50% of it can largely provide a basis for preparing expert reports. Within the scope of implementation the need for a specific ICF Core Set for expert reports of the German statutory pension insurance should be further analyzed and discussed.

[The Development of Quality Indicators for Management of Patients with ADHD in Social Paediatrics]. / Entwicklung von Qualitätsindikatoren für die Diagnostik und Behandlung von ADHS in der Sozialpädiatrie.

OBJECTIVE: Attention deficit/hyperactivity disorder (ADHD) with an estimated prevalence of 5% and its increased risk for comorbidities is of significant relevance for the health care system and is as well of socio-political significance. There is a lack of established methods for the evaluation of the diagnostic and therapeutic treatment of the patients. In this study, we have developed a set of evidence- and consensus-based meaningful indicators for the treatment of children with ADHD. METHODS: Following a thorough examination of the literature and published Guidelines, a first set of 90 quality indicators was created after redundancy reduction and addition of newly developed indicators. The further development of the indicator set was based on a modified version of the 2-step RAND/UCLA expert evaluation method. RESULTS: After assessment in 2 rounds of ratings, a set of 39 homogeneously positively rated indicators was established. 28 indicators apply to the quality of the diagnostic and therapeutic process, 4 to structural conditions and 3 rely on outcome. CONCLUSION: This is the first study covering the aspect of quality measurement in children with developmental disorders, especially ADHD. For the next step a pilot evaluation is necessary to complete the evaluation of the quality indicators.

[Relevance of personal contextual factors of the ICF for use in practical social medicine and rehabilitation]. / Bedeutung der personbezogenen Faktoren der ICF für die Nutzung in der praktischen Sozialmedizin und Rehabilitation.

Personal contextual factors play an essential part in the model of the International Classification of Functioning, Disability and Health (ICF). The WHO has not yet classified personal factors for global use although they impact on the functioning of persons positively or negatively. In 2010, the ICF working group of the German Society of Social Medicine and Prevention (DGSMP) presented a proposal for the classification of personal factors into 72 categories previously arranged in 6 chapters. Now a positioning paper has been added in order to stimulate a discussion about the fourth component of the ICF, to contribute towards a broader and common understanding about the nature of personal factors and to incite a dialogue among all those involved in health care as well as those people with or with-out health problems in order to gain a comprehensive perspective about a person's condition.

Sanitary conditions of abattoirs in Ibadan, Southwest Nigeria.

BACKGROUND: The environment in the abattoir is of public health concern because of its implications on the quality of meat sold in the markets. The poor sanitary states of abattoirs have been reported in the literature. Very few studies have provided a comprehensive assessment of the sanitary conditions in the abattoir premises. This study sought to assess the compliance of abattoirs in Ibadan, Southwest Nigeria with standards set by Federal Ministry of Environment. METHODOLOGY: A descriptive cross-sectional study was conducted in Ibadan using an observational checklist adapted from Policy guidelines on market and abattoir sanitation by the Federal Ministry of Environment. Twelve (12) abattoirs in Ibadan metropolis were assessed. Data obtained were analyzed using descriptive statistics. RESULTS: Concerning general inspection, only one (8.3%) of the abattoirs had adequate access route, potable water supply and functional drainage system. Many had poor solid waste management practices as heaps of refuse littered the surroundings. Internal inspection of the abattoirs revealed that two (16.7%) had adequate space and facilities. Ten (83.3%) had first aid posts even though they were not equipped with materials. Eleven (91.7%) abattoirs had toilet facilities that were either poorly kept or abandoned. CONCLUSION: This study showed that most of the abattoirs in Ibadan metropolis were operating under unhygienic and sub-standard conditions and lacked basic requirements for a good abattoir as stipulated in the Policy Guidelines on Market and Abattoir Sanitation. There is an urgent need to enforce the minimum standards as stipulated in the policy guidelines.

Embedding the 6Cs across health and social care.

The 6Cs were developed in 2012 against a backdrop of concerns about standards of nursing care in England. Over the last two years they have also been adopted by professionals and organisations outside of nursing. This article describes, and provides examples of, how the values of the 6Cs are becoming embedded across health and social care.

[The core of solidarity]. / De kern van solidariteit.

Dutch Journal of Medicine (NTVG) Lecture 2013: Organized solidarity in a welfare state is impersonal, restricted and based on enlightened self-interest. Critics of the welfare state argue that it is obsolete and we should aim for a society based on individual participation. They believe that people now prefer individualized care, that it is no longer possible to set boundaries and that too much altruism is required from those with higher incomes. In this year's NTvG lecture Margo Trappenburg contended that this criticism is unjust. Many people prefer professional care to care from the family or from volunteers and it could be possible to set boundaries again: recent developments within the medical profession are hopeful. And although the more highly educated make a greater financial contribution to the welfare state, those with a lower level of education show more, and more frequent, active solidarity. There is insufficient reason to abolish the welfare state and replace it with a society of greater individual participation.

Randomized trial of the Availability, Responsiveness and Continuity (ARC) organizational intervention for improving youth outcomes in community mental health programs.

OBJECTIVES: The primary objective of the study was to assess whether the Availability, Responsiveness and Continuity (ARC) organizational intervention improved youth outcomes in community based mental health programs. The second objective was to assess whether programs with more improved organizational social contexts following the 18-month ARC intervention had better youth outcomes than programs with less improved social contexts. METHOD: Eighteen community mental health programs that serve youth between the ages of 5 and 18 were randomly assigned to ARC or control conditions. Clinicians (n = 154) in the participating programs completed the Organizational Social Context (OSC) measure at baseline and following the 18-month ARC organizational intervention. Caregivers of 393 youth who were served by the 18 programs (9 in ARC and 9 in control) completed the Shortform Assessment for Children (SAC) once a month for six months beginning at intake. RESULTS: Hierarchical linear models (HLM) analyses indicated that youth outcomes were significantly better in the programs that completed the 18 month ARC intervention. HLM analyses also showed that youth outcomes were best in the programs with the most improved organizational social contexts following the 18 month ARC intervention. CONCLUSIONS: Youth outcomes in community mental health programs can be improved with the ARC organizational intervention and outcomes are best in programs that make the most improvements in organizational social context. The relationships linking ARC, organizational social context, and youth outcomes suggest that service improvement efforts will be more successful if those efforts include strategies to improve the organizational social contexts in which the services are embedded.

Evaluation of the project P.A.T.H.S. based on students' weekly diaries: findings from eight datasets.

This paper aims to investigate the effectiveness of the Tier 1 Program of the Project P.A.T.H.S. (positive adolescent training through holistic social programmes) based on eight datasets collected between 2005 and 2009. A total of 1,138 students who participated in the program were randomly invited (from the whole grade or in some classes) to write a piece of journal in the form of a weekly diary in order to reveal their perceptions and feelings regarding the program and the perceived benefits of the program. Based on an integration of findings from different databases, results showed that the respondents generally (1) had positive views on the program, (2) had positive views on the instructors, and (3) perceived that they had acquired competencies at the societal, school, familial, interpersonal, and personal levels after joining the program. Acknowledging the limitations of diaries, the present qualitative findings provide support for the effectiveness of the Tier 1 Program of the Project P.A.T.H.S. in Hong Kong.

Evaluation of a positive youth development program based on the repertory grid test.

The repertory grid test, based on personal construct psychology, was used to evaluate the effectiveness of Project P.A.T.H.S. (Positive Adolescent Training through Holistic Social Programmes) in Hong Kong. One hundred and four program participants (n = 104) were randomly invited to complete a repertory grid based on personal construct theory in order to provide both quantitative and qualitative data for measuring self-identity changes after joining the program. Findings generally showed that the participants perceived that they understood themselves better and had stronger resilience after joining the program. Participants also saw themselves as closer to their ideal selves and other positive role figures (but farther away from a loser) after joining the program. This study provides additional support for the effectiveness of the Tier 1 Program of Project P.A.T.H.S. in the Chinese context. This study also shows that the repertory grid test is a useful evaluation method to measure self-identity changes in participants in positive youth development programs.

Flexible rigidity: supporting HIV treatment adherence in a rapidly-changing treatment environment.

This paper examines adherence to AIDS treatment, focusing on the challenges posed by rapidly changing treatment protocols. We examine the evolving views of treatment adherence, and endorse the "concordance" approach. This emphasizes collaboration and negotiation between provider and patient to formulate and maintain a manageable treatment regimen tailored to what the patient is ready, willing, and able to tolerate. Given the extreme rapidity with which treatment guidelines are revised or even reversed, the persistent uncertainty surrounding treatment risks and benefits, and the great variability in individuals' ability to tolerate a given regimen, we propose the term "flexible rigidity" to describe the type of adherence best suited to AIDS treatment. We present an organizational approach to supporting the type of provider-patient relationships needed to improve treatment adherence that features treatment- readiness assessment and custom-tailoring of treatment for those at all stages of the treatment-readiness continuum. We note that this model could be applied as well to prevention and management of other chronic diseases.

[ICF and social medicine evaluation of capability of gainful activity: is everything clear?--a discussion article]. / ICF und sozialmedizinische Beurteilung der Leistungsfähigkeit im Erwerbsleben: Alles klar? -- Ein Diskussionsbeitrag.

The ICF (International Classification of Functioning, Disability and Health) calls attention to the complexities associated with disturbances of health. The question raised is how the various constituents and the resulting network as defined by this Classification can gain importance for medical expertise under the statutory pension insurance scheme concerning work-related capacity. Possible variations of strategy are discussed: clinical intuition, algorithmic pathways, proved medical diagnostics, particular diagnostics of activity according to ICF. A genuine "silver bullet" is not in evidence thus far. It cannot be expected that diagnostics relating to a certain sector of the ICF will basically eclipse the rest. Future standards of medical expertise should specify as clearly as possible the impact of the diverse diagnostic findings on the assessment of work-related capacity. Framing emphasis in this way cannot be performed by the ICF on its own.

[An example for a practice-oriented curriculum in social medicine under conditions of the new medical licensing regulations. Experiences with practiced-oriented teaching and possibilities for including practical issues in the teaching syllabus of medicine after the introduction of new medical licensing regulations]. / Praxisbezug in der sozialmedizinischen Lehre unter den Bedingungen der neuen ärztlichen Approbationsordnung. Erfahrungen aus der praxisbezogenen Seminararbeit und Möglichkeiten einer Weiterführung nach der neuen ärztlichen Approbationsordnung am Beispiel der Sozialmedizin.

Experience with teaching medical students the subject of Social Medicine shows that their interest can be greatly improved by including practical issues such as interviewing chronically ill patients at home, or visiting patient counselling services in the community. With the introduction of the new licensing regulations for physicians, there will be only one final examination and the medical faculties will now have to conduct the examinations themselves. In order to create legal confidence in the results, sufficient homogeneity of the teaching syllabus in Vocational and Social Medicine courses as well as in the new Health Economics courses must be assured for all students. The merger of the two medical faculties of the Free University and the Humboldt University in Berlin have increased student numbers to 400 per semester, so that 20 groups will have to be taught simultaneously. This situation makes excursions to patients or to community facilities nearly impossible. Potential alternatives to allow inclusion of practical issues in the course, even under the new circumstances, are the use of problem-based learning techniques (PBL) such as the creation of theoretical cases dealing with special problems of Social Medicine or the use of standardised patients.