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J Occup Rehabil ; 2022 Oct 29.
Article in English | MEDLINE | ID: covidwho-2320815


Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2-3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted.

Clin Chem Lab Med ; 61(4): 599-607, 2023 03 28.
Article in English | MEDLINE | ID: covidwho-2197305


This article discusses principles and concepts for ideal regulatory frameworks for diagnostics, and the expression of those principles in the EU IVDR. The authors present the benefits of regulatory frameworks and implementation approaches for diagnostics that are risk-based, globally convergent, connected, nimble and efficient, under the IVDR and with a future outlook. While many expressions of these principles can already be found in the EU IVDR text, and in its implementation approaches, their further embrace is needed in future EU diagnostic regulation. In the long term outlook, risk-based approaches can be extended to comprise entity-based excellence appraisals. Globally convergent approaches can be more explicit in e.g. qualification and classification of products. This will also help further reliance models. Better connections and cooperation between regulators across the healthcare spectrum including pharmaceuticals should be fostered. Nimble approaches such as Emergency Use Authorisations for pandemics are essential in highly regulated schemes like the IVDR and beyond. Finally, regulatory efficiency as in timely availability of IT infrastructure and oversight mechanisms is a distinguishing attribute of globally competitive diagnostic regulatory schemes. All the above needs consideration in the long term efforts to modernize the EU regulatory system, so that diagnostics can play their important role in clinical research as well as along the entire care continuum in the EU.

Government Regulation , Humans , Pharmaceutical Preparations , Legislation, Drug , Diagnosis , Health Care Sector/legislation & jurisprudence , European Union
Aust J Prim Health ; 28(4): 303-314, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1751826


OBJECTIVE: There is an increasing demand for tertiary pain services, with long waiting times compounded by limited reach to regional and remote areas. Community-based pain programs are a feasible evidence-based model of care to improve access to multidisciplinary care. Australian primary health networks (PHNs) are well placed to commission pain programs to reduce the growing burden of chronic pain. The aim of this study was to support PHN decision-making by: (1) describing current PHN community-based pain programs; (2) assessing their alignment to key elements and implementation enablers of pain programs identified by an expert consensus process; and (3) describing PHN pain program adaptations during the COVID-19 pandemic. METHODS: PHN program managers of community-based pain programs (n = 9) were invited to participate in an online survey and follow-up email consultation about their pain program. Six PHN program managers (representing South Eastern NSW PHN, Nepean Blue Mountains PHN, North Western Melbourne PHN, Gold Coast PHN, Adelaide PHN and the WA Primary Health Alliance) participated in the study with three PHNs commissioning two different types of pain programs. RESULTS: PHN community-based pain programs are multidisciplinary programs underpinned by a biopsychosocial model of pain, and focus on self-management (e.g. exercise, psychological strategies) and pain education. Most PHN pain programs are group-based programs that target adults with chronic non-cancer pain, provide individual allied health referrals as required and are evaluated as part of the electronic Persistent Pain Outcomes Collaboration. Gaps include pain programs for Aboriginal and Torres Strait Islander people, and people from culturally and linguistically diverse backgrounds, with one notable exception of a PHN pain program for people from culturally and linguistically diverse and refugee backgrounds co-designed with consumers and relevant services. Programs targeting subacute pain to prevent progression to chronic pain are, with one exception, another gap area. PHN pain programs demonstrated a high level of alignment with expert-agreed key elements and implementation enablers. The COVID-19 pandemic precipitated the rapid adaptation of PHN pain programs using available methods for the delivery of digitally enabled care. CONCLUSIONS: The findings provide a greater understanding for researchers and PHN decision-makers of the key features of PHN community-based pain programs, their alignment with expert-agreed key elements and implementation enablers, the target-population gaps, and the types of program adaptations during the COVID-19 pandemic. The findings also illustrate the potential for using digitally enabled delivery methods to increase accessibility to pain programs with further research warranted.

COVID-19 , Chronic Pain , Health Services, Indigenous , Adult , Analgesics, Opioid , Australia , Chronic Pain/therapy , Humans , Native Hawaiian or Other Pacific Islander , Pandemics , Referral and Consultation