135 research outputs found
Developing a core outcome set for the health outcomes for children and adults with congenital oesophageal atresia and/or tracheo-oesophageal fistula: OCELOT task group study protocol
No full textEnsuring young voices are heard in core outcome set development: international workshops with 70 children and young people.
No full textPlain English summary:Researchers test treatments to ensure these work and are safe. They do this by studying the effects that treatments have on patients by measuring outcomes, such as pain and quality of life. Often research teams measure different outcomes even though each team is studying the same condition. This makes it hard to compare the findings from different studies and it can reduce the accuracy of the treatment advice available to patients. Increasingly, researchers are tackling this problem by developing 'core outcome sets'. These are lists of outcomes that all researchers working on a given condition should measure in their studies. It is important that patients have a voice in the development of core outcome sets and children and young people are no exception. But their voices have rarely been heard when core outcome sets are developed. Researchers are trying to address this problem and make sure that core outcome sets are developed in ways that are suitable for children and young people. As a first step, we held two international workshops with children and young people to listen to their views. They emphasised the importance of motivating young people to participate in developing core outcome sets, making them feel valued, and making the development process more interactive, enjoyable and convenient. We hope this commentary will encourage researchers to include children and young people when developing core outcome sets and to adapt their methods so these are suitable for young participants. Future research is important to examine whether these adaptations are effective. Abstract:Background Different research teams looking at treatments for the same condition often select and measure inconsistent treatment outcomes. This makes it difficult to synthesise the results of different studies, leads to selective outcome reporting and impairs the quality of evidence about treatments. 'Core outcome sets' (COS) can help to address these problems. A COS is an agreed, minimum list of outcomes that researchers are encouraged to consistently measure and report in their studies. Including children and young people (CYP) as participants in the development of COS for paediatric conditions ensures that clinically meaningful outcomes are measured and reported. However, few published COS have included CYP as participants. COS developers have described difficulties in recruiting and retaining CYP and there is a lack of guidance on optimising COS methods for them. We aimed to explore CYP's views on the methods used to develop COS and identify ways to optimise these methods.Main body This commentary summarises discussions during two workshops with approximately 70 CYP (aged 10-18 years old) at the International Children's Advisory Network Research and Advocacy Summit, 2018. Delegates described what might motivate them to participate in a COS study, including feeling valued, understanding the need for COS and the importance of input from CYP in their development, and financial and other incentives (e.g. certificates of participation). For Delphi surveys, delegates suggested that lists of outcomes should be as brief as possible, and that scoring and feedback methods should be simplified. For consensus meetings, delegates advised preparing CYP in advance, supporting them during meetings (e.g. via mentors) and favoured arrangements whereby CYP could meet separately from parents and other stakeholders. Overall, they wanted COS methods that were convenient, enjoyable and engaging.Conclusion This commentary points to the limitations of the methods currently used to develop COS with CYP. It also points to ways to motivate CYP to participate in COS studies and to enhancements of methods to make participation more engaging for CYP. Pending much needed research on COS methods for CYP, the perspectives offered in the workshops should help teams developing COS in paediatrics and child health
Patient-reported outcome measures in core outcome sets targeted overlapping domains but through different instruments
No full textObjective: There is no comprehensive assessment of which patient-reported outcomes (PROs) are recommended in core outcome sets (COS), and how they should be measured. The aims of this study are to review COS that include patient-reported outcomes measures (PROMs), identify their target health domains, main characteristics, and their overlap within and across different disease areas. Study design and setting: We selected COS studies collected in a publicly available database that included at least one recommended PROM. We gathered information on study setting, disease area, and targeted outcome domains. Full-text of recommended instruments were obtained, and an analysis of their characteristics and content performed. We classified targeted domains according to a predefined 38-item taxonomy. Results: Overall, we identified 94 COS studies that recommended 323 unique instruments, of which: 87% were included in only one COS; 77% were disease-specific; 1.5% preference-based; and 61% corresponded to a full questionnaire. Most of the instruments covered broad health-related constructs, such as global quality of life (25%), physical functioning (22%), emotional functioning and wellbeing (7%). Conclusion: The wealth of recommended instruments observed even within disease areas does not fit with a vision of systematic, harmonized collection of PROM data in COS within and across disease areas
Improving core outcome sets development in low-and middle-income countries
No full textBackground
Standardizing outcomes and their measurement is a crucial aspect of evidence-based medicine. A core outcome set (COS) is a standardized set of outcomes that researchers should measure and report. The use of COS has the potential to reduce research waste, enhance knowledge translation, and ensure that patient-relevant outcomes are always reported. However, most COS work has been led by high-income countries (HICs), leaving a gap in low- and middle-income countries (LMICs). This thesis aims to fill this gap by exploring ways to improve the development and use of COS in LMICs, using the neonatal COS development process in Kenya as a model.
Methodology:
To understand current practice, I undertook a systematic review to describe the extent of inclusion of LMIC stakeholders in the development and use of COS (. I conducted two online surveys to explore views on including LMIC stakeholders in COS development and use. Survey 1 targeted COS developers from HICs, and Survey 2 targeted LMIC stakeholders. In survey 2, I presented three existing COS (Pre-eclampsia, COVID-19 and Palliative care) as case scenarios, and I asked respondents whether they would use the COS (with reasons).
To explore whether an existing COS, agreed predominantly by HIC stakeholders, should be adopted or adapted for the Kenyan context, I undertook key informant interviews with clinicians working in newborn units and policymakers in Kenya to understand what outcomes are important to them. I also undertook focused group discussions with caregivers/mothers who had had their neonates admitted previously to newborn units. This collaborative approach helped me understand the key outcomes from their perspective. I finally conducted a consensus meeting with key stakeholders to generate an adapted COS for use in Kenya.
Key findings
From the systematic review, only one in five (75 of 380, 20%) COS included stakeholders from LMICs, with only four COS projects originating from LMICs. In survey 1, 37 (49%) responses were received from 75 COS developers, 29 of whom had published them between 2015 and 2020. In survey 2, there were 81 respondents from LMICs; 26 had experience using a COS, and nine had been involved in COS development. Across the two surveys, personal research interests were a key driver for initiation/participation in a given COS project; LMIC stakeholders were most frequently involved in determining the ‘what to measure’ stage of COS development as opposed to the other COS development stages like scoping and how to measure. Respondents suggested that the sensitization of stakeholders on the usefulness of COS in LMICs, translation of Delphi and COS materials into local languages, and enhancement of feasibility of outcome measurements would help get more LMIC participants to be part of COS development.
The key informant interviews and Focused Group Discussions (FGD) yielded 16 outcomes (survival, length of stay in hospital, ability to feed or weight gain or growth, cognitive ability, visual impairment or retinopathy of prematurity (ROP), impact on caregivers and wider family, financial costs to the caregiver, pain, adverse events due to medicine, respiratory distress, quality of life, sepsis, future wellbeing, jaundice, necrotizing enterocolitis (NEC), ability to touch/palpate). These outcomes were subjected to a consensus-building workshop and a final set of 12 outcomes (survival, length of stay in hospital, ability to feed or weight gain or growth, cognitive ability, visual impairment or ROP, impact on caregivers and wider family, financial costs to the caregiver, pain, adverse events due to medicines, respiratory distress, quality of life, sepsis/infections) were agreed upon. Seven outcomes were similar to the HIC COS (survival, cognitive ability, visual impairment or ROP, adverse events due to medicines, respiratory distress, quality of life and sepsis/infections). In contrast, four outcomes (NEC, brain injury on imaging, hearing impairment, and general gross motor ability) were not included in this COS.
Conclusion:
Although LMIC stakeholders have been increasingly included in COS development and use over time, more work is required to test the proposed strategies for enhancing COS development and use in LMICs. This could be coupled with other methodological enhancements, such as documenting the adoption or adaptation of existing COS in an LMIC setting, which has the potential to enhance COS utility, as demonstrated in this thesis
What Predicts Optimal Telehealth Usage among Heart Failure and Chronic Obstructive Pulmonary Disease Patients?
No full text
Mechanisms of Psychological Distress following War in the Former Yugoslavia: The Role of Interpersonal Sensitivity
No full textThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.This study was funded by a grant from the European Commission, contract number INCO-CT-2004-509176. AN was supported by a Clinical Early Career Research Fellowship (113295) and a Project Grant (104288
Awareness and experiences on core outcome set development and use amongst stakeholders from low- and middle- income countries: An online survey.
No full textHarmonization of outcomes to be measured in clinical trials can reduce research waste and enhance research translation. One of the ways to standardize measurement is through development and use of core outcome sets (COS). There is limited involvement of low- and middle-income country (LMIC) stakeholders in COS development and use. This study explores the level of awareness and experiences of LMIC stakeholders in the development and use of COS. We conducted an online survey of LMIC stakeholders. Three existing COS (pre-eclampsia, COVID-19, palliative care) were presented as case scenarios, and respondents asked to state (with reason(s)) if they would or would not use the COS if they were working in that area. Quantitative data were analyzed descriptively while qualitative data were analyzed thematically. Of 81 respondents, 26 had COS experience, 9 of whom had been involved in COS development. Personal research interests and prevalence of disease are key drivers for initiation/participation in a given COS project. Most respondents would use the COS for pre-eclampsia (18/26) and COVID-19 (19/26) since the development process included key stakeholders. More than half of the respondents were not sure or would not use the palliative care COS as they felt stakeholder engagement was limited and it was developed for a different resource setting. Respondents reported that use of COS can be limited by (i) feasibility of measuring the outcomes in the COS, (ii) knowledge on the usefulness and availability of COS and (iii) lack of wide stakeholder engagement in the COS development process including having patients and carers in the development process. To ensure the development and use of COS in LMICs, collaborations are essential in awareness raising on COS utility, training, and COS development. The COS also needs to be made accessible in locally understandable languages and feasible to measure in LMICs
A non-person to the rest of the world : experiences of social isolation amongst severely impaired people with multiple sclerosis.
No full textPURPOSE: To gain insight into the experiences of, and potential solutions to, social isolation amongst severely impaired people with multiple sclerosis. METHODS: A phenomenological research approach using face-to-face, in-depth semi-structured, audio-recorded interviews. Data were transcribed and analyzed thematically. RESULTS: Sixteen severely impaired people with multiple sclerosis were interviewed (Expanded Disability Status Scale \u3e6.5); aged 38-72 years, nine female, time since diagnosis ranged 3-30 years). Four key themes were generated in line with the study objectives, each with further sub-themes. The themes were (1) Definitions of isolation (2) Causes of isolation (3) Impact of isolation, and (4) Potential eases of isolation. CONCLUSIONS: Data portrayed social isolation as complex and multi-factorial in its definitions, its causes, and its impact. Isolation is not just about being lonely or left on one\u27s own, but represents a spiral of impacts. Physical deterioration can lead to reduced choice and control regarding access to, and interaction with others and society, affecting personal identity. Sometimes this leads to further self-isolation. Personalised psychosocial support, with improved ease of access, focused on helping people with severe multiple sclerosis regain a sense of self and their place in the world may ease social isolation. Implications for rehabilitation People with severe multiple sclerosis can experience a sense of powerlessness, a lack of choice and control over daily life, leading to changes in self-identity and social isolation. Peoples\u27 experiences are very personal, and any approach to help deal with social isolation needs to be based in considering how to think positively about how life can be lived and how to make that work. Multiple sclerosis support groups should not be assumed to alleviate feelings of social isolation. Interventions should focus on personalized psychosocial input aimed at helping the person with multiple sclerosis regain a sense of self and their place in the world
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