Outcomes important to patients with non-infectious posterior segment-involving uveitis:a qualitative study

Objective: Uveitis, a group of disorders characterised by intraocular inflammation, causes 10–15% of total blindness in the developed world. The most sight-threatening forms of non-infectious uveitis are those affecting the posterior segment of the eye, collectively known as posterior-segment involving uveitis (PSIU). Numerous different clinical outcomes have been used in trials evaluating treatments for PSIU but these may not represent patients’ and carers’ concerns. Therefore, the aims of this study were to understand the impact of PSIU on adult patients’ and carers’ lives, and to explore what outcomes of treatment are important to them.Methods: Four focus group discussions were undertaken to understand the perspectives of adult patients (n=18) and carers (n=10) with PSIU. Participants were grouped according to whether or not their uveitis was complicated by the sight-threatening condition uveitic macular oedema (UMO). Discussions were audio recorded, transcribed and analysed using the framework analytical approach. Outcomes were identified and grouped into outcome domains. Results: Eleven core domains were identified as important to patients and carers undergoing treatment for PSIU comprising: (1) visual function, (2) symptoms, (3) functional ability, (4) impact on relationships, (5) financial impact, (6) psychological morbidity and emotional well-being (7) psychosocial adjustment to uveitis, (8) doctor/patient/interprofessional relationships and access to health care, (9) treatment burden, (10) treatment side effects, (11) disease control.Conclusion: The domains identified represent patients and carers experience and perspectives and can be used to reflect on outcomes assessed in PSIU. They will directly inform the development of a core outcome set for PSIU clinical trials.Ethical approval: Ethical approval was obtained from the United Kingdom National Research Ethics Service (Reference 17-WM-0111).<br/

Anti-tumour necrosis factor biological therapies for the treatment of uveitic macular oedema (UMO) for noninfectious uveitis

BackgroundNon‐infectious uveitis describes a heterogenous group of ocular disorders characterised by intraocular inflammation in the absence of infection. Uveitis is a leading cause of visual loss, most commonly due to uveitic macular oedema (UMO). Treatment is aimed at reducing disease activity by suppression of the intraocular inflammatory response. In the case of macular oedema, the aim is to restore macular architecture as quickly as possible, in order to prevent irreversible photoreceptor damage in this area. Acute exacerbations are typically managed with corticosteroids, which may be administered topically, locally or systemically. Whilst these are often rapidly effective in achieving disease control, long‐term use is associated with significant local and systemic side effects, and 'steroid sparing agents' are typically used to achieve prolonged control in severe or recalcitrant disease. Anti‐tumour necrosis factor (TNF) drugs block a critical cytokine in the inflammatory signalling process, and have emerged as effective steroid‐sparing immunomodulatory agents in a wide range of non‐ocular conditions. There is mechanistic data to suggest that they may provide a more targeted approach to disease control in UMO than other agents, but to date, these agents have predominantly been used 'off label' as the majority are not licensed for ocular use. This review aims to summarise the available literature reporting the use of anti‐TNF therapy in UMO, thus developing the evidence‐base on which to make future treatment decisions and develop clinical guidelines in this area.ObjectivesTo assess the efficacy of anti‐TNF therapy in treatment of UMO.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 2), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; LILACS; Web of Science Conference Proceedings Citation Index‐ Science (CPCI‐S); System for Information on Grey Literature in Europe (OpenGrey); the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 29 March 2018.Selection criteriaWe planned to include all relevant randomised controlled trials assessing the use of anti‐TNF agents in treatment of UMO. No limits were applied to participant age, gender or ethnicity. The primary comparisons of this review were: anti‐TNF versus no treatment or placebo; anti‐TNF versus another pharmacological agent; comparison of different anti‐TNF drugs; comparison of different doses and routes of administration of the same anti‐TNF drug. The primary outcome measure that we assessed for this review was best‐corrected visual acuity (BCVA) in the treated eye. Secondary outcome measures were anatomical macular change, clinical estimation of vitreous haze and health‐related quality of life.Data collection and analysisTwo review authors independently screened titles and abstracts retrieved through the database searches. We retrieved full‐text reports of studies categorised as 'unsure' or 'include' after we had reviewed the abstracts. Two review authors independently reviewed each full‐text report for eligibility. We resolved discrepancies through discussion.Main resultsWe identified no completed or ongoing trial that was eligible for this Cochrane Review.Authors' conclusionsOur review did not identify any evidence from randomised controlled trials for or against the role of anti‐TNF agents in the management of UMO. Although there are a number of high‐quality randomised controlled trials that demonstrate the efficacy of anti‐TNF agents in preventing recurrence of inflammation in uveitis, the reported study outcomes do not include changes in UMO. As a result, there were insufficient data to conclude whether there was a significant treatment effect specifically for UMO. Future trials should be designed to include quantitative measures of UMO as primary study outcomes, for example by reporting the presence or absence of UMO, or by measuring central macular thickness for study participants. Furthermore, whilst UMO is an important complication of uveitis, we acknowledge that uveitis is associated with many significant structural and functional complications. It is not possible to determine treatment efficacy based on a single outcome measure. We recommend that future reviews of therapeutic interventions in uveitis should use composite measures of treatment response comprising a range of potential complications of disease.<br/

COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis

Abstract Background Uveitis, a group of disorders characterised by intraocular inflammation, causes 10–15% of total blindness in the developed world. The most sight-threatening uveitis affects the posterior segment of the eye (posterior-segment involving uveitis (PSIU)). Numerous different outcomes have been used in clinical trials evaluating alternative treatments for uveitis, limiting inter-trial comparison and aggregation of data. We aim to develop a core outcome set (COS) that would provide a standardised set of outcomes to be measured and reported in all effectiveness trials for PSIU. Methods A three-phase design will be used informed by recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Phase 1: a comprehensive list of outcomes will be identified through both a systematic review of effectiveness trials of PSIU and qualitative research with stakeholders. The qualitative study will comprise focus groups with patients and their carers in parallel with one-to-one telephone interviews with health professionals and policy-makers. In the focus groups, patients will be grouped according to whether or not their uveitis is complicated by the sight-threatening condition uveitic macular oedema (UMO) since it is hypothesised that the presence of UMO may significantly impact on patient experience of PSIU. Phase 2: Delphi methodology will be used to reduce the range of potential outcomes for the core set. Up to three Delphi rounds will be used through an online survey. Participants will be asked to rate the importance of each outcome on a 9-point Likert scale where 9 is most important. Phase 3: a consensus meeting will be held with key stakeholders to discuss the Delphi results and ratify the final outcomes to be included in the COS. Discussion The development of an agreed COS for PSIU would help ensure that outcomes which matter to key stakeholders are captured and reported in a consistent way. A COS for PSIU would allow greater comparison and aggregation of data across trials for the better evaluation of established and emerging therapies through evidence synthesis and meta-analysis to inform clinical guidelines and health policy. Trial registration COMET. http://comet-initiative.org/studies/details/640 . August 2015

A 'combined framework' approach to developing a patient decision aid: the PANDAs model

Background There is a lack of practical research frameworks to guide the development of patient decision aids [PtDAs]. This paper described how a PtDA was developed using the International Patient Decision Aids (IPDAS) guideline and UK Medical Research Council (UKMRC) frameworks to support patients when making treatment decisions in type 2 diabetes mellitus. Methods This study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format `saturation’. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process. Results The PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide. Conclusions This study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts

Socioeconomic Position and Adolescent Trajectories in Smoking, Drinking, and Psychiatric Distress

Purpose: Smoking, drinking, and psychiatric distress are inter-related and may also be associated with socioeconomic position (SEP). This paper investigates the role of SEP in adolescent development across all three of these outcomes. Methods: Data were self-reported by adolescents in the Twenty-07 Study (N = 1,515) at ages 15, 17, and 18 years. Latent class analysis was used to identify homogeneous subgroups of adolescents with distinct developmental patterns. Associations between developmental patterns and a range of socioeconomic indicators were then tested. Results: Five classes were identified. A Low Risk class had low levels for all outcomes. A High Distress class had persistently high levels of distress, but was otherwise similar to the Low Risk group. A High Drinking class drank alcohol earlier and more heavily but also had higher levels of distress than the Low Risk group. Smokers were grouped in two classes, Early Smokers and Late Smokers, and both also had raised levels of drinking and distress. Early Smokers tended to begin earlier and smoke more heavily than Late Smokers. Relative to the Low Risk class, adolescents in a disadvantaged SEP were more likely to be Early Smokers and somewhat less likely to be in the High Drinking class. SEP was not consistently associated with membership in the High Distress or Late Smokers classes. Conclusions: Associations with SEP are evident in opposing directions or absent depending on the combination and timing of outcomes, suggesting that a disadvantaged SEP is not a simple common cause for all three outcomes. © 2013 Society for Adolescent Health and Medicine. All rights reserved

Public Input to St. Lawrence River Fisheries Community Objectives

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The consequences of EU enlargement for Central and East European labour markets

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