ObjectiveTo identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities.MethodsWe conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups to identify domains important to people with PsA; (3) two international surveys with patients and physicians to prioritise domains; (4) an international face-to-face meeting with patients and physicians using the nominal group technique method to agree on the most important domains; and (5) presentation and votes at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016. All phases were performed in collaboration with patient research partners.ResultsWe identified 39 unique domains through the SLR (24 domains) and international focus groups (34 domains). 50 patients and 75 physicians rated domain importance. During the March 2016 consensus meeting, 12 patients and 12 physicians agreed on 10 candidate domains. Then, 49 patients and 71 physicians rated these domains' importance. Five were important to >70% of both groups: musculoskeletal disease activity, skin disease activity, structural damage, pain and physical function. Fatigue and participation were important to >70% of patients. Patient global and systemic inflammation were important to >70% of physicians. The updated PsA core domain set endorsed by 90% of OMERACT 2016 participants includes musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue and systemic inflammation.ConclusionsThe updated PsA core domain set incorporates patients' and physicians' priorities and evolving PsA research. Next steps include identifying outcome measures that adequately assess these domains.
BackgroundChildhood vaccination rates are low in Lasbela, one of the poorest districts in Pakistan's Balochistan province. This randomised cluster controlled trial tested the effect on uptake of informed discussion of vaccination costs and benefits, without relying on improved health services.MethodsFollowing a baseline survey of randomly selected representative census enumeration areas, a computer generated random number sequence assigned 18 intervention and 14 control clusters. The intervention comprised three structured discussions separately with male and female groups in each cluster. The first discussion shared findings about vaccine uptake from the baseline study; the second focussed on the costs and benefits of childhood vaccination; the third focussed on local action plans. Field teams encouraged the group participants to spread the dialogue to households in their communities. Both intervention and control clusters received a district-wide health promotion programme emphasizing household hygiene. Interviewers in the household surveys were blind of intervention status of different clusters. A follow-up survey after one year measured impact of the intervention on uptake of measles and full DPT vaccinations of children aged 12-23 months, as reported by the mother or caregiver.ResultsIn the follow-up survey, measles and DPT vaccination uptake among children aged 12-23 months (536 in intervention clusters, 422 in control clusters) was significantly higher in intervention than in control clusters, where uptake fell over the intervention period. Adjusting for baseline differences between intervention and control clusters with generalized estimating equations, the intervention doubled the odds of measles vaccination in the intervention communities (OR 2.20, 95% CI 1.24-3.88). It trebled the odds of full DPT vaccination (OR 3.36, 95% CI 2.03-5.56).ConclusionThe relatively low cost knowledge translation intervention significantly increased vaccine uptake, without relying on improved services, in a poor district with limited access to services. This could have wide relevance in increasing coverage in developing countries.Trial registrationISRCTN12421731.
Gender-based violence (GBV) is common in southern Africa. Here we use GBV to include sexual and non-sexual physical violence, emotional abuse, and forms of child sexual abuse. A sizeable literature now links GBV and HIV infection.Sexual violence can lead to HIV infection directly, as trauma increases the risk of transmission. More importantly, GBV increases HIV risk indirectly. Victims of childhood sexual abuse are more likely to be HIV positive, and to have high risk behaviours.GBV perpetrators are at risk of HIV infection, as their victims have often been victimised before and have a high risk of infection. Including perpetrators and victims, perhaps one third of the southern African population is involved in the GBV-HIV dynamic.A randomised controlled trial of income enhancement and gender training reduced GBV and HIV risk behaviours, and a trial of a learning programme reported a non-significant reduction in HIV incidence and reduction of male risk behaviours (primary prevention). Interventions among survivors of GBV can reduce their HIV risk (secondary prevention). Various strategies can reduce spread of HIV from infected GBV survivors (tertiary prevention). Dealing with GBV could have an important effect on the HIV epidemic.A policy shift is necessary. HIV prevention policy should recognise the direct and indirect implications of GBV for HIV prevention, the importance of perpetrator dynamics, and that reduction of GBV should be part of HIV prevention programmes. Effective interventions are likely to include a structural component, and a GBV awareness component.
Objectives The current psoriatic arthritis (PsA) Core Domain Set defines core domains to be measured in randomized controlled trials (RCTs) and longitudinal observational studies (LOS) and was published in 2006. At the Outcome Measures in Rheumatology (OMERACT) meeting in 2014, researchers, clinicians and patients unanimously voted for updating the PsA Core Domain Set to include the patient perspective in accordance with OMERACT Filter 2.0. Herein we report the proceedings of the PsA Workshop at the OMERACT meeting in 2016 including studies presented in the plenary, results of breakout group discussions, and final voting and endorsement of the 2016 updated PsA Core Domain Set. Methods We conducted research to develop the updated PsA Core Domain Set. At OMERACT 2016 this work was presented, discussed in breakout groups and the updated PsA core domain set was voted on and endorsed by OMERACT participants. Results The updated PsA Core Domain Set includes: musculoskeletal disease activity, skin disease activity, fatigue, pain, patient global, physical function, health related quality of life and systemic inflammation which are recommended for all RCTs and LOS). Economic cost, emotional well-being, participation and structural damage are important but not required in all RCTs and LOS. Independence, sleep, stiffness and treatment burden on the research agenda. Conclusion The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of available outcome measures for each of the core domains and development of a PsA core outcome measurement set.
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