Validation of a patient-reported outcome measure for giant cell arteritis.

OBJECTIVES: GCA is systemic vasculitis manifesting as cranial, ocular or large vessel vasculitis. A prior qualitative study developed 40 candidate items to assess the impact of GCA on health-related quality of life (HRQoL). This study aimed to determine final scale structure and measurement properties of the GCA patient reported outcome (GCA-PRO) measure. METHODS: Cross-sectional study included UK patients with clinician-confirmed GCA. They completed 40 candidate items for the GCA-PRO at times 1 and 2 (3 days apart), EQ-5D-5L, ICECAP-A, CAT-PROM5 and self-report of disease activity. Rasch and exploratory factor analyses informed item reduction and established structural validity, reliability and unidimensionality of the final GCA-PRO. Evidence of validity was also established with hypothesis testing (GCA-PRO vs other PRO scores, and between participants with 'active disease' vs those 'in remission') and test-retest reliability. RESULTS: The study population consisted of 428 patients: mean (s.d.) age 74.2 (7.2), 285 (67%) female; 327 (76%) cranial GCA, 114 (26.6%) large vessel vasculitis and 142 (33.2%) ocular involvement. Rasch analysis eliminated 10 candidate GCA items and informed restructuring of response categories into four-point Likert scales. Factor analysis confirmed four domains: acute symptoms (eight items), activities of daily living (seven items), psychological (seven items) and participation (eight items). The overall scale had adequate Rasch model fit (χ2 = 25.219, degrees of freedom = 24, P = 0.394). Convergent validity with EQ5D-5L, ICECAP-A and Cat-PROM5 was confirmed through hypothesis testing. Internal consistency and test-retest reliability were excellent. CONCLUSION: The final GCA-PRO is a 30-item, four-domain scale with robust evidence of validity and reliability in measuring HRQoL in people with GCA.

Jaw claudication and jaw stiffness in giant cell arteritis: secondary analysis of a qualitative research dataset.

Objective: Jaw symptoms can be a vital clue to the diagnosis of GCA. Guidelines recommend more intensive treatment if jaw claudication is present. We sought to explore how patients with GCA described their jaw symptoms. Methods: We carried out a secondary, qualitative analysis of interview data from 36 participants from the UK (n = 25) and Australia (n = 11), originally collected in order to develop a patient-reported outcome measure for GCA. In all cases, GCA had been confirmed by biopsy/imaging. Interview transcripts were organized within QSR NVivo 12 software and analysed using template analysis. Themes were refined through discussion among the research team, including a patient partner. Results: Twenty of 36 participants reported jaw symptoms associated with GCA. The median age of these 20 participants was 76.5 years; 60% were female. Five themes were identified: physical sensations; impact on function; impact on diet; symptom response with CSs; and attribution to other causes. Physical sensations included ache, cramp, stiffness and 'lockjaw'. Functional impacts included difficulty in eating/chewing, cleaning teeth, speaking or opening the mouth. Dietary impacts included switching to softer food. Response to CSs was not always immediate. Jaw symptoms were initially mis-attributed by some participants to arthritis, age or viral illnesses; or by health-care professionals to a dental cavity, ear infection or teeth-grinding. Conclusion: Jaw symptoms in GCA are diverse and can lead to diagnostic confusion with primary temporomandibular joint disorder, potentially contributing to delay in GCA diagnosis. Further research is needed to determine the relationship of jaw stiffness to jaw claudication.

Política externa e saúde no Brasil (1995-2010): uma análise da diplomacia de saúde brasileira - da Aids ao 'Fome Zero' / Brazil's foreign policy and health (1995-2010): A policy analysis of the Brazilian health diplomacy - from AIDS to 'Zero Hunger'

RESUMO Este artigo analisa como a saúde entrou na política externa brasileira entre 1995 e 2010 e apoiou a posição internacional do País, utilizando o enfoque de análise de políticas. Essa questão raramente é examinada na literatura brasileira sobre diplomacia da saúde. A partir de revisão de literatura, análise documental e entrevistas com atores-chave, examinamos as políticas impulsionadas por complexos processos históricos de mudança no Brasil. Há importantes inter-relações entre política externa e política social, incluindo saúde. Durante os governos Lula (2003-2010), a internacionalização das políticas domésticas brasileiras, vinculadas à cooperação Sul-Sul, teve papel central. A saúde na agenda da política externa foi um importante suporte à crescente presença internacional do Brasil. Esses desenvolvimentos foram possibilitados pelo ativismo e comprometimento de diversos atores estatais e não estatais, que atuaram em dois níveis: advocacia nacional e transnacional e atividades coordenadas entre representantes do governo, incluindo diplomatas, e atores da sociedade civil. O principal argumento deste estudo é que as políticas nacionais e internacionais são interrelacionadas nesse processo, e a dinâmica doméstica e o engajamento societal são essenciais, mas não suficientes: escolhas governamentais são também determinantes. Os arranjos institucionais e políticos mudaram em diferentes conjunturas e são constantemente propensos a conflitos e mudanças.

ABSTRACT This article analyses, from a policy analysis approach, how health entered Brazilian foreign policy between 1995 and 2010 and supported the country's international position, which is rarely explored in the literature on Brazilian health diplomacy. By drawing on literature review, document analysis and key-actor interviews, we examined policies triggered by far-reaching and complex historical change processes in Brazil. We find significant interrelationships between foreign policy and social policy, including health. The internationalization of Brazilian domestic policies, and South-South cooperation, played a central role during Lula governments (2003-2010). Health found its way into the foreign policy agenda to support Brazil's growing international presence. These developments were made possible by the activism and engagement of several of State and non-State actors working on two levels: national and transnational advocacy, and coordinated activities of government representatives, including Brazilian diplomats, and civil society activists. The main argument of this study is that national and international policies are intertwined in this process and that domestic dynamics and societal engagement are essential but more is needed: governmental choices are also determinant. Institutional arrangements and policies shift in different conjunctures and are constantly prone to conflicts and change.

Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure.

OBJECTIVES: Glucocorticoids (GCs) ('steroids') are used to treat rheumatic diseases but adverse effects are common. We aimed to explore the impact of GC therapy on health-related quality of life (HRQoL), to inform the development of a treatment-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Semi-structured qualitative interviews were conducted with patients from the UK, USA and Australia, treated for a rheumatic condition with GCs in the last 2 years. Purposive sampling was used to select participants with a range of demographic and disease features. An initial conceptual framework informed interview prompts and cues. Interviews elicited GC-related physical and psychological symptoms and salient aspects of HRQoL in relation to GC therapy. Interview data were analysed inductively to develop initial individual themes and domains. Candidate questionnaire items were developed and refined. RESULTS: Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). The mean age was 58 years; 39/60 were female; and 18 rheumatic diseases were represented. Some 126 individual themes were identified and organized into six domains: physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation; impact of steroids on relationships; and benefits of steroids. Candidate questionnaire items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews and linguistic translatability assessment, informing a draft questionnaire. CONCLUSION: We describe an international qualitative study to develop candidate items for a treatment-specific PROM for patients with rheumatic diseases. A future survey will enable the validation of a final version of the PROM.

Therapists' experiences of remotely delivering cognitive-behavioural or graded-exercise interventions for fatigue: a qualitative evaluation.

Objective: Fatigue is a challenging feature of all inflammatory rheumatic diseases. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomized Trial) included remotely delivered personalized exercise programme (PEP) or cognitive-behavioural approach (CBA) interventions. The aim of this nested qualitative evaluation was to understand rheumatology health professionals' (therapists') perspectives of delivering the interventions in the LIFT trial. Methods: A subgroup of therapists who had delivered the personalized exercise programme (PEP) and cognitive-behavioural approach (CBA) interventions took part in semi-structured telephone interviews. Results: Seventeen therapists (13 women and 4 men) who delivered PEP (n = 8) or CBA (n = 9) interventions participated. Five themes were identified. In 'The benefits of informative, structured training', therapists described how they were able to practice their skills, and the convenience of having the LIFT manual for reference. When 'Getting into the swing of it', supporting patients gave therapists the confidence to tailor the content of the manual to each patient. Clinical supervision supported therapists to gain feedback and request assistance when required. In 'Delivering the intervention', therapists reported that patients valued the opportunity to talk about their fatigue and challenge their beliefs. In 'Challenges in delivering the LIFT intervention', therapists struggled to work in partnership with patients who lacked motivation or stopped engaging. Finally, in 'LIFT developing clinical skills', therapists gained confidence and professional satisfaction, seeing patients' fatigue improve over time. Conclusion: The findings support the provision of training for rheumatology health professionals to remotely deliver fatigue-management interventions. Insights from these trials can be used to better improve clinical practice and service provision.

Brazilian's Foreign Policy and Health (1995-2010): A policy analysis of the Brazilian Health Diplomacy ­ from Aids to 'Zero Hunger' / Política Externa e Saúde no Brasil (1995-2010): Uma análise da Diplomacia de Saúde brasileira - da Aids ao 'Fome Zero'

This article examines how health entered Brazilian foreign policy between 1995 and 2010 and the factors that allowed it to support the country's international presence. This issue is rarely examined in the literature on Brazilian health diplomacy. We analyze the specificities of this process within a policy analysis approach. By drawing on literature review, document analysis and key-actor interviews, we revise policies that were triggered by far-reaching and complex historical processes of change in Brazil. The article points to significant interrelationships between foreign policy and social policy, including health. Only during Lula governments (2003-2010) did health actually enter the foreign policy agenda, in significant support of Brazil's growing international presence. Brazil's internationalisation of its domestic policies connected with South-South cooperation exerted a central role. These developments were made possible by the activism and commitment of a variety of State and non-State actors who acted on at least two lines: national and transnational advocacy, and coordinated activities of Brazilian diplomats and government representatives, in collaboration with civil society activists. Institutional arrangements shifted in different conjunctures and were adjusted in a process permanently prone to conflicts and moves.

Este artigo examina como a saúde entrou na política externa brasileira entre 1995 e 2010 e os fatores que possibilitaram apoiar a sustentação da presença internacional do país. Essa questão raramente é examinada na literatura brasileira sobre diplomacia da saúde. Analisamos as especificidades desse processo por meio de uma abordagem de análise de políticas. Utilizamos revisão de literatura, de documentos e entrevistas com atores-chave para rediscutir as políticas desencadeadas por complexos e amplos processos históricos de mudança no Brasil. O artigo aponta importantes inter-relações entre política externa e política social, incluindo saúde. Somente durante os governos Lula (2003-2010) a saúde entrou de fato na agenda da política externa, em apoio significativo à crescente presença internacional do Brasil. A internacionalização das políticas domésticas brasileiras vinculadas à cooperação Sul-Sul exerceu papel central. Esses desenvolvimentos foram possibilitados pelo ativismo e comprometimento de diversos atores estatais e não estatais que atuaram em pelo menos duas linhas: advocacia nacional e transnacional e atividades coordenadas entre diplomatas brasileiros e representantes do governo, em colaboração com atores da sociedade civil. Os arranjos institucionais mudaram em diferentes conjunturas e foram ajustados em um processo propenso permanentemente a conflitos e mudanças

Remotely delivered cognitive-behavioural and personalized exercise interventions to lessen the impact of fatigue: a qualitative evaluation.

Objectives: Fatigue can be a disabling symptom of inflammatory rheumatic diseases. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomized Trial) is a randomized trial of remotely delivered cognitive-behavioural approach or personalized exercise programme interventions, compared with usual care. The aim of this nested qualitative study was to evaluate participants' experiences of taking part in the intervention, including their ideas about future service delivery. Methods: Semi-structured telephone interviews were conducted with a subgroup of LIFT participants to discuss their views and experiences of the interventions. Results: Forty-three participants (30 women) from six sites who had participated in the cognitive-behavioural approach (n = 22) or personalized exercise programme (n = 21) interventions took part. Five themes were identified in the thematic analysis. In the theme 'not a miracle cure, but a way to better manage fatigue', LIFT could not cure fatigue; however, most felt better able to manage after participating. Participants valued 'building a therapeutic relationship' with the same therapist throughout the intervention. In 'structure, self-monitoring and being accountable', participants liked the inclusion of goal-setting techniques and were motivated by reporting back to the therapist.After taking part in the interventions, participants felt 'better equipped to cope with fatigue'; more confident and empowered. Lastly, participants shared ideas for 'a tailored programme delivered remotely', including follow-up sessions, video calling, and group-based sessions for social support. Conclusion: Many participants engaged with the LIFT interventions and reported benefits of taking part. This suggests an important future role for the remote delivery of fatigue self-management.

Global Health Diplomacy (GHD) and the integration of health into foreign policy: Towards a conceptual approach.

Since the end of the Cold War, health has gone from a peripheral concern in foreign policy negotiations to a prominent place on the global political agenda. While the rise of health onto the foreign policy agenda is by now old news, the driving forces behind its expansion into new political spheres remain understudied and undertheorized. This article builds on empirical findings from a four-country study of the integration of health into foreign policy, and proposes a conceptual approach to GHD to improve understanding of the conditions under which health is successfully positioned on the foreign policy agenda. Our approach consists of three dimensions: features of institutions and the interest various actors represent in GHD; the ideational environment in which GHD operates; and issue characteristics of the specific health concern entering foreign policy. Within each dimension, we identify specific variables that, in combination, make up the explanatory power of the proposed approach. The proposed approach does not relate to, or build upon, a single social sciences, public health, or international relations (IR) theory, but can be seen as a heuristic device to identify dimensions and variables that may shape why certain health issues rise onto the foreign policy agenda.

Patient Perceptions of Physical Activity After a Diagnosis of Giant Cell Arteritis: Analysis of Multinational Qualitative Data.

OBJECTIVE: To explore patient perceptions of physical activity in giant cell arteritis (GCA). METHODS: This was a multinational qualitative study, analyzing interview data collected from participants from the UK (n = 25) and Australia (n = 11) with a definitive diagnosis of GCA from imaging or biopsy. Interview transcripts were analyzed using thematic analysis to identify themes related to physical activity. This was secondary analysis of data collected to explore health-related quality of life in people with GCA. RESULTS: A total of 108 individual codes pertaining to physical activity were identified. These were grouped into 2 overarching themes: barriers to and facilitators of physical activity, each with 4 subthemes. Barriers were categorized into physical symptoms (including visual loss, fatigue, weakness, pain, and stiffness), perceptions of personal capability (including poor stamina, confidence, and mobility), negative perceptions of physical activity, and negative consequences. Facilitators of physical activity were categorized into external facilitators (including motivation from health care professionals and support groups), access to appropriate facilities, personal strategies (including pacing and goal-setting), and personal facilitators (including internal motivation to improve symptoms, and positive reinforcement). CONCLUSION: A range of barriers and facilitators to physical activity were identified in relation to GCA. Future work could include development of an intervention to support physical activity in patients with GCA; ideally this intervention should be underpinned by an appropriate behavioral change framework and codesigned with patients.

Toxicity of boron and vanadium nanoparticles on Danio rerio embryos - Phenotypical, biochemical, and behavioral alterations.

Engineered nanoparticles (NPs) are emerging contaminants of concern and it is important to understand their environmental behavior and ecological risks to exposed organisms. Despite their ubiquitous presence in the environment, there is little information about the hazards of certain NPs, such as boron (BNPs) and vanadium (VNPs). The aim of the present research was to investigate the effects of commercial BNPs and VNPs (80 to 100 nm) to zebrafish embryos, at different levels of biological organization. A range of nominal concentrations for both NPs (0, 0.01, 0.1, 1, and 10 mg/L) was tested. Due to the presence of triton X-100 in the NPs' stock dispersions, an additional control group was included (0.001% triton X-100). Survival, hatching, and malformations of embryos were assessed for 96 hours (h) exposure. Locomotor behavior was evaluated at 120 h. Furthermore, embryos were exposed to 0, 1, and 10 mg/L of NPs to evaluate a set of biomarker responses after 96 h: cholinesterase (ChE) and glutathione S-transferase (GST) activities, total glutathione (TG) and energy budgets levels. VNPs induced malformations (10 mg/L), hyperactivity (10 mg/L), erratic swimming (0.01 mg/L), altered swimming pattern (>0.01 mg/L), delayed hatching (10 mg/L) and altered biochemical responses involved in antioxidant defense (GST and TG at >1 mg/L), neurotransmission (ChE at 10 mg/L) and energy metabolism (lipids at >1 mg/L and carbohydrates at 10 mg/L). BNPs caused malformations (10 mg/L), affected swimming pattern (>0.01 mg/L), induced erratic swimming (10 mg/L) and decreased TG content and GST activity (>1 mg/L). At the same concentrations, VNPs affected a greater number of endpoints than BNPs, demonstrating a greater toxicity to zebrafish embryos. The present study shows that BNPs and VNPs may affect aquatic organisms, albeit at relatively great non-environmentally relevant concentrations, reinforcing the importance of the risk assessment of different NPs.

Patient perceptions of health-related quality of life in giant cell arteritis: international development of a disease-specific patient-reported outcome measure.

OBJECTIVES: GCA is a large vessel vasculitis (LVV) presenting with headache, jaw claudication, musculoskeletal and visual involvement. Current treatment is glucocorticoids and anti-IL-6 tocilizumab in refractory disease. The objective of this study was to explore the impact of GCA and its treatment on people's health-related quality of life (HRQoL), to inform the development of a disease-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Participants from the UK and Australia, with biopsy- or imaging-confirmed GCA, were interviewed to identify salient aspects of HRQoL in relation to GCA and its treatment. Purposive sampling included a range of demographic and disease features (cranial, LVV-GCA and visual involvement). Inductive analysis identified individual themes of importance, then domains. Candidate questionnaire items were developed from the individual themes, refined by piloting, cognitive interviews and a linguistic translatability assessment. RESULTS: Thirty-six interviews were conducted to saturation with participants with GCA from the UK (25) and Australia (11). Mean age was 74 years, 23 (63.9%) were female, 13 (36.1%) had visual loss and 5 (13.9%) had LVV-GCA. Thirty-nine individual themes within five domains were identified: physical symptoms; activity of daily living and function; participation; psychological impact; and impact on sense of self and perception of health. Sixty-nine candidate items were developed from individual themes; piloting and refinement resulted in a 40-item draft questionnaire. CONCLUSION: This international qualitative study underpins the development of candidate items for a disease-specific PROM for GCA. The draft questionnaire is now ready for psychometric testing.

Multilateralism, world order and Covid-19: current issues and future challenges for WHO / Multilateralismo, ordem mundial e Covid-19: questões atuais e desafios futuros para a OMS

This essay discusses the work of the World Health Organization (WHO) in the light of debates about the capitalist world order and multilateralism, analyzing the confrontation of pandemics (including Covid-19) in the dynamics of the interstate system in a heterogeneous world, with asymmetries of wealth and power and led by hegemonic powers. The working hypothesis is that the changes in the credibility of the WHO, and the UN, and demands for reforms date back to the last decade of the 20th century and are closely related to issues related to global, general and sectoral, governance, which, by its turn, are linked to the transformations of multilateralism and the capitalist world order throughout the post-war and post-cold war. Through a world-system critical historical approach, supported by literature review and official WHO documents, the essay concludes that the undermining of the organization and the constant scrutiny to which it has been subjected for decades, beyond occasional failures or 'lack of capacity', result from a dual dynamic, internal and external, imposed by the transformations of the 'new liberal world order' after the cold war, associated with the advance of nationalisms and global capitalism.

Este ensaio discute a atuação da Organização Mundial de Saúde (OMS) à luz dos debates sobre a ordem mundial capitalista e o multilateralismo, analisando o enfrentamento de pandemias (incluída a Covid-19) na dinâmica do sistema interestatal em um mundo heterogêneo, com assimetrias de riqueza e poder e conduzido por potências hegemônicas. A hipótese de trabalho é que as mudanças na credibilidade da OMS, e da ONU, e as reivindicações de reformas têm antecedentes que remontam à última década do século XX e estão intimamente relacionadas às questões referentes à governança global, geral e setorial, que, por sua vez, se vinculam às transformações do multilateralismo e da ordem mundial capitalista ao longo do pós-guerra e no pós-guerra fria. Utiliza-se uma abordagem histórica crítica, na perspectiva do sistema-mundo, amparada em revisão de literatura e em documentos oficiais da OMS. Conclui-se que fragilização da organização e o constante escrutínio a que está submetida há décadas, para além de falhas pontuais ou de 'falta de capacidade', resultam de uma dupla dinâmica, interna e externa, e podem ser melhor compreendidas no contexto de desafios impostos pelas transformações da 'nova ordem mundial liberal' pós-guerra fria, associada ao avanço dos nacionalismos e do capitalismo global.

Multilateralismo, ordem mundial e Covid-19: questões atuais e desafios futuros para a OMS / Multilateralism, world order and Covid-19: current issues and future challenges for WHO

Este ensaio discute a atuação da Organização Mundial de Saúde (OMS) à luz dos debates sobre a ordem mundial capitalista e o multilateralismo, analisando o enfrentamento de pandemias (incluída a Covid-19) na dinâmica do sistema interestatal em um mundo heterogêneo, com assimetrias de riqueza e poder e conduzido por potências hegemônicas. A hipótese de trabalho é que as mudanças na credibilidade da OMS, e da ONU, e as reivindicações de reformas têm antecedentes que remontam à última década do século XX e estão intimamente relacionadas às questões referentes à governança global, geral e setorial, que, por sua vez, se vinculam às transformações do multilateralismo e da ordem mundial capitalista ao longo do pós-guerra e no pós-guerra fria. Utiliza-se uma abordagem histórica crítica, na perspectiva do sistema-mundo, amparada em revisão de literatura e em documentos oficiais da OMS. Conclui-se que fragilização da organização e o constante escrutínio a que está submetida há décadas, para além de falhas pontuais ou de 'falta de capacidade', resultam de uma dupla dinâmica, interna e externa, e podem ser melhor compreendidas no contexto de desafios impostos pelas transformações da 'nova ordem mundial liberal' pós-guerra fria, associada ao avanço dos nacionalismos e do capitalismo global.

Multilateralismo, ordem mundial e Covid-19: questões atuais e desafios futuros para a OMS / Multilateralism, world order and Covid-19: current issues and future challenges for the WHO

RESUMO Este ensaio discute a atuação da Organização Mundial da Saúde (OMS) à luz dos debates sobre a ordem mundial capitalista e o multilateralismo, analisando o enfrentamento de pandemias (incluída a Covid-19) na dinâmica de um sistema interestatal heterogêneo, com assimetrias de riqueza e poder, e conduzido por potências hegemônicas. Assume-se como hipótese de trabalho que as mudanças na credibilidade da OMS e as reivindicações de reforma têm antecedentes que remontam à última década do século XX e estão relacionadas com a governança global, geral e de saúde, que se vincula às transformações do multilateralismo e da ordem mundial capitalista ao longo do pós-guerra e do pós-guerra fria. Utiliza-se uma abordagem histórica crítica e o conceito de sistema-mundo; analisam-se dados de revisão de literatura e de documentos oficiais. Conclui-se que a fragilização da organização e o constante escrutínio a que está submetida há décadas, para além das controvérsias que lhe são inerentes, de possíveis falhas ou de 'falta de capacidade', resultam de uma dupla dinâmica, interna e externa, e podem ser mais bem compreendidas no contexto de desafios impostos tanto pelas opções políticas institucionais da Organização das Nações Unidas e da OMS quanto pelas transformações da 'nova ordem mundial liberal' associada à globalização contemporânea e ao crescimento dos nacionalismos.

ABSTRACT This essay discusses the work of the World Health Organization (WHO) in the light of debates about the capitalist world order and multilateralism, and examines how pandemics (including Covid-19) are addressed in the dynamics of a heterogeneous inter-State system with wealth and power asymmetries and led by hegemonic powers. The working hypothesis is that the WHO's changing credibility and the demands for its reform date from the late 20tn century and are related to global (general and health sector) governance, linked also to the transformations of multilateralism and the capitalist world order during the post-war and post-Cold War periods. Data from a literature review and documents were analysed on a critical approach to History and using the 'world system' concept. The undermining of the WHO and the scrutiny to which it has been subjected for decades were found to have resulted less from the controversies inherent to the organisation or any failings or 'lack of capacity' than from a dual, internal and external, dynamic. This process can be better understood in view of challenges posed both by the United Nations' and the WHO's institutional political options and by changes in the 'new liberal world order' associated with contemporary globalisation and the spread of nationalisms.

Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.

BACKGROUND: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme. DESIGN: A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. SETTING: Seven hospital rheumatology units in England and Wales. PARTICIPANTS: Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. INTERVENTIONS: RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse. MAIN OUTCOME MEASURES: Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. RESULTS: A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units; p < 0.001) and the control interventions (-0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units, p = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice. LIMITATIONS: Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. CONCLUSIONS: The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. FUTURE WORK: Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52709998. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

Rheumatoid arthritis (RA) is a lifelong inflammatory condition affecting multiple joints, with fatigue as a major consequence. Cognitive­behavioural therapy (CBT) helps patients work out links between symptoms, behaviours and thoughts driving those behaviours (e.g. why someone pushes on when exhausted), and understanding these links helps patients make changes. A CBT programme for groups of RA patients, facilitated by a psychologist, reduces fatigue impact. However, few rheumatology teams have psychologists. The study tested whether or not rheumatology nurses and occupational therapists (OTs) could facilitate the programme [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive­behavioural (CB) approaches] after brief training. The study compared the RAFT programme with usual care for RA fatigue (i.e. a short discussion of an arthritis fatigue booklet). All 333 patients received usual care, and then half of the patients were allocated (by chance) to also attend the seven-session RAFT programme. The study compared the RAFT programme with usual care for effects on fatigue, quality of life, cost and value for money. In addition, the rheumatology nurse and OT RAFT tutors were interviewed for their views on the RAFT programme. The study found that patients' fatigue impact was reduced by both the RAFT programme and usual care at 6 months and 2 years, but patients undertaking the RAFT programme improved significantly more than those receiving usual care alone. Differences were seen for improvements in fatigue impact, fatigue coping, emotional fatigue and living with fatigue. Patients were very satisfied with the RAFT programme and attended most of the sessions. The study found no significant difference between the NHS costs of the RAFT programme and usual care. Neither the RAFT programme nor usual care changed quality of life; therefore, standard value-for-money tests showed no difference between them. Tutors found that the CB questioning approach of the RAFT programme was different from their usual problem-solving style, but helped patients make life changes, and the new CB skills improved tutors' wider clinical practice. In conclusion, the trial has shown that the RAFT programme has a small to medium effect on reducing fatigue impact in patients with RA and is a potentially low-cost intervention that can be delivered by rheumatology nurses and OTs rather than a psychologist.

Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT).

OBJECTIVES: To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone. METHODS: Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0-10). Intention-to-treat regression analysis adjusted for baseline scores and centre. RESULTS: 308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect -0.59, 95% CI -1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total -3.42 (95% CI -6.44 to -0.39), Living with Fatigue -1.19 (95% CI -2.17 to -0.21), Emotional Fatigue -0.91 (95% CI -1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect -0.49 (95% CI -0.83 to -0.14), BRAF MDQ Total -2.98 (95% CI -5.39 to -0.57), Living with Fatigue -0.93 (95% CI -1.75 to -0.10), Emotional Fatigue -0.90 (95% CI -1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001). CONCLUSION: Multiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches. TRIAL REGISTRATION NUMBER: ISRCTN52709998.

Pharmaceutical Services in Mozambique: foreign aid in public provision of medicines. / Assistência Farmacêutica em Moçambique: a ajuda externa na provisão pública de medicamentos.

This article examines the activities of national and international actors in Pharmaceutical Services (PS) in Mozambique from 2007 to 2012, focusing on the public provision of HIV/Aids, malaria and tuberculosis medicines. It describes how PS functions in the country, what actors are involved in this area and the relations among them, pursuing salient issues in the modus operandi of partners in cooperation. The methodology combines literature review, document survey and analysis and interviews. The theoretical and analytical framework was given by the policy analysis approach, focusing on the role of the State and its interrelations with other actors in foreign aid in PS, and also by the networks approach. It was concluded that the interactions among the actors involved is complex and characterised by operational fragmentation and overlapping of activities between entities, centralised medicine procurement in the hands of few agents, bypassing of national structures and disregard for the strengthening needed to bolster national health system autonomy. Despite some advances in the provision and availability of medicines for these diseases, external dependence is strong, which undermines the sustainability of PS in Mozambique.

Este artigo analisa a ação de atores nacionais e internacionais na Assistência Farmacêutica (AF) em Moçambique, no período de 2007 a 2012, com foco na provisão pública de medicamentos para HIV/Aids, malária e tuberculose. Descreve-se o funcionamento da AF no país; os atores que atuam nesse âmbito e as relações entre eles; discutem-se questões relevantes sobre o modus operandi dos parceiros de cooperação. A metodologia combinou: revisão bibliográfica, levantamento e análise documental e entrevistas. O marco teórico e analítico utilizou a análise de políticas públicas com foco no papel do Estado e suas inter-relações como os demais atores na ajuda externa na área farmacêutica e a abordagem de redes. Conclui-se que a interação entre os atores envolvidos é complexa, caraterizada pela fragmentação operacional e sobreposição de atividades entre diversos entes; centralização da aquisição de medicamentos na mão de poucos agentes; by pass das estruturas nacionais e desconsideração do necessário fortalecimento do sistema nacional de saúde para a construção de sua autonomia. A despeito de alguns avanços na provisão e disponibilidade de medicamentos para essas doenças, existe forte dependência externa nesse âmbito, o que obstaculiza a sustentabilidade da AF em Moçambique.

Assistência Farmacêutica em Moçambique: a ajuda externa na provisão pública de medicamentos / Pharmaceutical Services in Mozambique: foreign aid in public provision of medicines

Resumo Este artigo analisa a ação de atores nacionais e internacionais na Assistência Farmacêutica (AF) em Moçambique, no período de 2007 a 2012, com foco na provisão pública de medicamentos para HIV/Aids, malária e tuberculose. Descreve-se o funcionamento da AF no país; os atores que atuam nesse âmbito e as relações entre eles; discutem-se questões relevantes sobre o modus operandi dos parceiros de cooperação. A metodologia combinou: revisão bibliográfica, levantamento e análise documental e entrevistas. O marco teórico e analítico utilizou a análise de políticas públicas com foco no papel do Estado e suas inter-relações como os demais atores na ajuda externa na área farmacêutica e a abordagem de redes. Conclui-se que a interação entre os atores envolvidos é complexa, caraterizada pela fragmentação operacional e sobreposição de atividades entre diversos entes; centralização da aquisição de medicamentos na mão de poucos agentes; by pass das estruturas nacionais e desconsideração do necessário fortalecimento do sistema nacional de saúde para a construção de sua autonomia. A despeito de alguns avanços na provisão e disponibilidade de medicamentos para essas doenças, existe forte dependência externa nesse âmbito, o que obstaculiza a sustentabilidade da AF em Moçambique.

Abstract This article examines the activities of national and international actors in Pharmaceutical Services (PS) in Mozambique from 2007 to 2012, focusing on the public provision of HIV/Aids, malaria and tuberculosis medicines. It describes how PS functions in the country, what actors are involved in this area and the relations among them, pursuing salient issues in the modus operandi of partners in cooperation. The methodology combines literature review, document survey and analysis and interviews. The theoretical and analytical framework was given by the policy analysis approach, focusing on the role of the State and its interrelations with other actors in foreign aid in PS, and also by the networks approach. It was concluded that the interactions among the actors involved is complex and characterised by operational fragmentation and overlapping of activities between entities, centralised medicine procurement in the hands of few agents, bypassing of national structures and disregard for the strengthening needed to bolster national health system autonomy. Despite some advances in the provision and availability of medicines for these diseases, external dependence is strong, which undermines the sustainability of PS in Mozambique.

Multinational Qualitative Research Study Exploring the Patient Experience of Raynaud's Phenomenon in Systemic Sclerosis.

OBJECTIVE: Raynaud's phenomenon (RP) is the most common manifestation of systemic sclerosis (SSc). RP is an episodic phenomenon, not easily assessed in the clinic, leading to reliance on self-report. A thorough understanding of the patient experience of SSc-RP is essential to ensuring that patient-reported outcome (PRO) instruments capture domains important to the target patient population. We report the findings of an international qualitative research study investigating the patient experience of SSc-RP. METHODS: Focus groups of SSc patients were conducted across 3 scleroderma centers in the US and UK, using a topic guide and a priori purposive sampling framework devised by qualitative researchers, SSc patients, and SSc experts. Focus groups were audio recorded, transcribed, anonymized, and analyzed using inductive thematic analysis. Focus groups were conducted until thematic saturation was achieved. RESULTS: Forty SSc patients participated in 6 focus groups conducted in Bath (UK), New Orleans (Louisiana), and Pittsburgh (Pennsylvania). Seven major themes were identified that encapsulate the patient experience of SSc-RP: physical symptoms, emotional impact, triggers and exacerbating factors, constant vigilance and self-management, impact on daily life, uncertainty, and adaptation. The interrelationship of the 7 constituent themes can be arranged within a conceptual map of SSc-RP. CONCLUSION: We have explored the patient experience of SSc-RP in a diverse and representative SSc cohort and identified a complex interplay of experiences that result in significant impact. Work to develop a novel PRO instrument for assessing the severity and impact of SSc-RP, comprising domains/items grounded in the patient experiences of SSc-RP identified in this study, is underway.

[Public-private partnerships (PPPs) in the health sector: global processes and national dynamics]. / Parcerias público-privadas (PPP) no setor saúde: processos globais e dinâmicas nacionais.

This essay addresses several dimensions that promote and consolidate the growing participation by private stakeholders in the decision-making process in health, emphasizing international and domestic factors that have facilitated and sustained the persistence of the neoliberal political and ideological perspective over the course of nearly thirty years (since the 1990s). The article emphasizes the role of intergovernmental organizations in this process, highlighting public-private interactions at the global and domestic levels, with a specific focus on so-called public-private partnerships (PPPs). The working premise is that such linkages alter the power relations in policy formulation and implementation, with a predominance of private stakeholders. The article presents an overview of the development of PPPs in Europe, Latin America, and Brazil, identifying their specific origins and the simultaneity of triggering events. The text reiterates the importance of not overlooking the power of these actors in dislodging them from this political position, whether in multilateral organizations or national health systems. The aim is to emphasize the importance of more in-depth reflection on the subject, backing debates within the sector. This entire dynamic requires rethinking strategies of resistance to preserve the rights won through centuries of struggle.

Resumo: Este ensaio se propõe a discutir algumas dimensões que impulsionam e consolidam a crescente participação de atores privados no processo de decisão na saúde, enfatizando elementos internacionais e domésticos que se potencializam e sustentam a permanência da perspectiva político-ideológica neoliberal no setor ao longo de quase trinta anos (desde os anos 1990). Enfatiza-se o papel das organizações intergovernamentais nesse processo, ressaltando-se as interações público-privadas nos âmbitos global e doméstico, sobretudo das denominadas parcerias público- privadas (PPP). Parte-se da premissa que tais articulações alteram as relações de poder na formulação e implementação de políticas, com predominância dos agentes privados. Apresenta-se um breve panorama do desenvolvimento das PPP na Europa, na América Latina e no Brasil, resgatando-se suas origens específicas e simultaneidade de eventos desencadeadores. Reitera-se a importância de não se ignorar o poder desses atores, assim como a dificuldade de deslocá-los desse lugar político, uma vez envolvidos no processo decisório, seja nas organizações multilaterais, seja nos sistemas de saúde em nível nacional. A pretensão é enfatizar a importância de aprofundamento da reflexão sobre o assunto, subsidiando os debates setoriais. Toda essa dinâmica exige repensar estratégias de resistência para preservar direitos conquistados com lutas seculares.

Resumen: Este ensayo se propone discutir algunas dimensiones que impulsan y consolidan la creciente participación de agentes privados en el proceso de toma de decisiones en el ámbito de la salud, poniendo énfasis en los elementos internacionales y nacionales que promueven y sostienen el mantenimiento de la perspectiva político-ideológica neoliberal en este sector, a lo largo de casi treinta años (desde los años 1990). Se destaca el papel de organizaciones intergubernamentales en este proceso, dando como resultado interacciones público-privadas en el ámbito global y nacional, sobre todo en las denominadas colaboraciones público-privadas (CPP). Se parte de la premisa que tales asociaciones alteran las relaciones de poder en la formulación e implementación de políticas, con un predominio de los agentes privados. Se presenta un breve panorama del desarrollo de las CPP en Europa, en Latinoamérica y en Brasil, rescatándose sus orígenes específicos y la simultaneidad de los eventos desencadenantes. Se reitera la importancia de no ignorar el poder de estos actores, así como la dificultad de desalojarlos de este espacio político, una vez involucrados en el proceso decisorio, sea en organizaciones multilaterales, sea en sistemas de salud a nivel nacional. La pretensión es resaltar la importancia de profundizar en las reflexiones sobre este asunto, apoyando los debates sectoriales. Toda esta dinámica exige repensar estrategias de resistencia para preservar los derechos conquistados a lo largo de siglos mediante luchas.