235 research outputs found

    The development and initial validation of an outcome measure for children and young people with life-limiting and life-threatening conditions

    Get PDF
    BackgroundThere is no validated outcome measure for use in children's palliative care outside of sub-Saharan Africa. Development of such a measure is required to realise the benefits of patient-centred outcome measure use that has been demonstrated in adult palliative care. Previous research into what is important to children and young people with life-limiting and life-threatening conditions has primarily focused on those with a cancer diagnosis. Much of this pre-existing research focuses on the perspectives of proxies, rather than those of the child or young person.AimTo develop an outcome measure, the children's palliative outcome scale (C-POS), for use by children and young people with life-limiting and life-threatening conditions and their families, and to establish face and content validity, comprehensiveness, comprehensibility, feasibility, and acceptability of use.MethodsA sequential mixed-methods study was conducted in three phases, following the principles of patient-reported outcome measurement design described by Rothrock and the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN).Phase 1 - gathering inputA systematic review was conducted with the aim of appraising the evidence on optimal recall period, response format and mode of administration to enable children and young people to participate in self-reporting on their health outcomes. A young person's advisory group was also consulted on the same topic.To inform face and content validity of C-POS a semi-structured qualitative interview study was conducted to seek the perspectives of children and young people, their parents/carers and siblings, health care professionals and NHS commissioners on priority symptoms, concerns, and care priorities. Participants were also asked to identify their preferences for the design of C-POS, in terms of recall period, response scale format and administration mode.Phase 2 - item generationPart 1: Parents and professionals with experience in caring for a child or young person with a life-limiting or life-threatening condition participated in a three-round modified ranking-type Delphi survey with the aim of establishing which outcomes identified in phase 1 of this thesis should be included in C-POS.Part 2: The young person’s advisory group were asked to select their priority outcomes from the items ranked in rounds 2 and 3 of the Delphi survey.Part 3: An item generation meeting was conducted with key stakeholders to develop initial C-POS versions based on the evidence collected so far.Phase 3 - item improvementCross-sectional cognitive interview study to establish acceptability, comprehensiveness, and comprehension of the initial C-POS versions within the target population.ResultsPhase 1 - gathering inputSystematic review: Findings showed that children under five years old cannot validly and reliably self-report health outcomes. Face scales demonstrated better psychometric properties than visual analogue or Likert scales. Computerised and paper scales generally show equivalent construct validity and children prefer computerised measures. Children seven years old and younger often think dichotomously so may need two response options. Those over eight years old can reliably use a three-point scale.Qualitative interview study: 106 participants were recruited: 26 children, 40 parents, 13 siblings, 15 health care professionals and 12 commissioners. Children found a short recall period and a visually appealing measure with 10 questions or fewer most acceptable. Children with life-limiting conditions were more familiar with using rating scales such as numeric and Likert than their healthy siblings and emphasised the importance of completing the measure alongside interactions with a healthcare professional. Parents assumed that electronic completion methods would be most feasible and acceptable but a small number of children preferred paper measures.Participants described many inter-related symptoms, concerns and care priorities impacting on all aspects of life. Data revealed an overarching theme of pursuing ‘normality’, described as children’s desire to undertake usual childhood activities. Parents need support with practical aspects of care to help realise this desire for normality.Phase 2 - item generationPart 1: Delphi survey (n=82). Ranking agreement between participants increased over the rounds, indicating movement towards consensus. Agreement between professional and parent ranking was poor. Professionals prioritised physical symptoms, whereas parents prioritised psychosocial and practical concerns.Part 2: 22 children and young people attended the young person's advisory group. They prioritised items related to living a ‘normal life’ such as seeing friends and attending school, in addition to items prioritised by the adult participants in the Delphi survey.Part 3: 22 participants attended the item generation meeting. Fiveage/developmental stage appropriPhase 3 - item improvementForty-eight individuals participated (36 parents; 12 children) in cognitive testing of the C-POS versions. This revealed challenges in the acceptability of some items for parents of non-verbal children and refinements were made. C-POS content and length were acceptable, and all questions were considered important. Parents reported that completing a measure that asks about what matters may be distressing but this is anticipated and acceptable.ConclusionsThis thesis demonstrates the development of the first UK patient-centred outcome measure for use with children and young people with life-limiting and life-threatening conditions and their families. By following established methodological criteria for patient-centred outcome measure development this thesis demonstrates that CPOS has robust face and content validity and is feasible and acceptable for use within the target population.</div

    Regulatory Reliance and Post-Marketing Surveillance Systems for Safe and Accelerated Introduction of New Medical Products in Low- and Middle-Income Countries

    Get PDF
    Though delayed access to medicines is still common, disease outbreaks in the past three decades has driven speedier introduction of innovative medical products. Yet, successful models for safe and accelerated introduction of new medical products in low- and middle-income countries are scarcely documented. Recent viral diseases outbreaks like Ebola, COVID-19, and Monkeypox has further highlighted the need for regulatory preparedness for health emergencies. Well-resourced countries have developed expedited regulatory pathways for such situations, while LMICs are not as prepared. They lack models for adopting best practices for implementing regulatory reliance and integrated post marketing surveillance (PMS). Experiences gained from our work strengthening regulatory systems for HIV/AIDS, Tb, and malaria may inform the development of best practices and models for accelerated introduction of future medical products. Chapter 1 of this thesis provides summary of research outputs which documents my published work on introduction of new medical products in global health. Chapter 2 is an integrative literature review of pharmaceutical access, regulatory reliance, and PMS, concluding that regulatory reliance and PMS are critical for safe and accelerated introduction of new medical products in LMICs. However, gaps and challenges exist, and they lead to delayed access which costs lives. To address those gaps, in Chapter 3 we developed Model Integrated Quality and Safety Review (IQSR) checklist, reliance-based review, and tools for integrated surveillance. Evolution in medicines regulation is typically predicated by access campaigns or mishaps. Stronger regulatory systems with well-established approaches for implementing reliance and post market surveillance have the capability to ensure safe and accelerated introduction of new medical products. To ensure that best practices are implemented, we recommended practical tools for the operationalization of reliance practices and post marketing surveillance systems. The tools identified will help regulators, industry, global health experts in advancing timely access to address unmet medical needs

    How does virtual simulation impact on nursing students’ knowledge and self-efficacy for recognising and responding to deteriorating patients? A mixed methods study.

    Get PDF
    Background: Preparing undergraduate nursing students effectively for safe clinical practice continues to present significant challenges due to the impact of the Covid-19 pandemic, global nursing shortages, greater competition for quality clinical placements, and no guarantee that nursing students will have exposure to a deteriorating patient during their clinical placements. This is a concern because early warning signs of clinical deterioration are often not detected by nurses in a timely manner, and recognition and response to deteriorating patients is recognised globally as a major safety challenge (Haddeland et al., 2018). Aim: To explore the impact of using interactive virtual simulation case studies with facilitated debriefing (Eppich and Cheng, 2015) on nursing students’ knowledge and self-efficacy for recognising and responding to early signs of clinical deterioration in patients. Design & Methods: Mixed methods study with quasi-experimental pre/post design and focus groups. A convenience sample (n=88) final year undergraduate nursing students with half the sample at each sites randomly allocated to a treatment or control group. The treatment group received a virtual simulation intervention, debriefing, and participated in a focus group. Results: The treatment group had statistically significant higher levels of clinical self-efficacy from pre to post survey scores (65.34 and 80.12) compared to the control group (62.59 and 70.73) and significantly increased levels of knowledge in recognizing and responding to the deteriorating patient scores from pre to post survey (11.30 to 13.1) in comparison to the control group (10.33 and 9.92). Conclusions: study findings demonstrated the positive impact of a the virtual simulation intervention on knowledge and confidence of undergraduate nursing students from geographically diverse areas

    A COLLABORATIVE CARE MODEL FOR PERINATAL MENTAL HEALTH CARE IN SIERRA LEONE

    Get PDF
    This study explored idioms of distress and explanatory models for perinatal psychological distress, developed a reliable and validated screening tool, and culturally adapted a problem-solving and behavioural activation intervention. Based on the proposition of the biopsychosocial vulnerability distress and outcome model, I applied mixed methods research in three phases of the study to (1) understand how pregnant women and new mothers experience and express perinatal psychological distress, their coping strategies, and their help-seeking behaviour (2) develop and validate a ten-item screening tool for perinatal psychological distress and use it to assess the prevalence of and risk factors for perinatal psychological distress, and (3) culturally adapt a problem solving and behavioural activation intervention for these pregnant women and new mothers. The ethnographic phase showed women use their hearts and (heads, minds, and brains) to express their emotions and thoughts, respectively. Thinking too much and stress were the most frequently mentioned symptoms. Their distress was related to marital or partner disharmony, gender norms, problems with in-laws, poverty, ill health, and a lack of basic amenities. They consulted religious leaders, herbalists, friends, neighbours, and family members for help for the most part. Their coping strategies included prayers, sleeping, listening to music, and sometimes alcohol to forget about their problems. During the tool development phase, we developed a ten-item tool and established a cut-off point at eight using an emic-etic approach. In the survey phase, we recruited 420 participants and measured antenatal and postnatal psychological distress prevalence of 208 (55.3%) and 212 (64.2%), respectively. Hunger, insult or rude treatment from nurses during antenatal care, ill health, and hostile in-laws were found to be independent predictors of antenatal psychological distress. Furthermore, postnatal psychological distress was independently predicted by having an unfaithful partner, inter-partner violence, ill health, and hunger. However, an income-generating activity was found to be protective for both pregnant women and new mothers. During the intervention phase, using a mixed method approach, 39 perinatal women (control = 19, intervention = 20) were randomly allocated at the community level to culturally adapted problem solving and behavioural activation interventions and a control group. The effectiveness, feasibility, and acceptability of these interventions were explored. Primary outcomes included were psychological distress and functional capacity, which were assessed at baseline, after two weeks, and at the end of the 4-week period. The results showed a reduction in symptoms with a moderate effect size (Cohen’s d = 0.40) and an increased function with regards to their daily tasks. The intervention was deemed feasible and acceptable by the laywomen in the community that delivered the intervention as well as the pregnant women and new mothers. The study identified idioms of distress and explanatory models that can be used to improve communication during clinical encounters between perinatal women and healthcare workers, which will decrease stigma and increase engagement with services. The newly developed tool can be used to screen perinatal women into services and assess their response to these services over time. The study also showed that PST is likely to be feasible, acceptable and effective. There is a need to do further studies using a fully powered randomised control trial to demonstrate effectiveness and to understand how this intervention can be integrated into the primary health care and scaled up nationwide

    The Role of General Practitioners in Disaster Health Management

    Get PDF
    Disasters are a time of excess demand for medical care overwhelming available medical services. General Practitioners (GPs) are local healthcare professionals already onsite managing the ongoing health of the majority of the community when disaster strikes. They are a medical resource, knowledgeable about the local community context, and remain to share the journey of adaptation and recovery with their local community in the days to years of aftermath. Early observations at commencement of this research demonstrated that whether GPs chose to or not, as local community health professionals they will be involved in some way in any disaster that strikes their community either during, and/or after the event. In most countries, including Australia, GPs are excluded from disaster response systems. The research aim was to identify the role of GPs in disaster health management, and to propose a system of involvement that aligns with: - the epidemiological evidence of disaster healthcare needs relevant to GPs, - the perceptions of GPs and Disaster Managers (DM) experts, and - the current All Hazards All Agencies Prevention-Preparedness-Response-Recovery (PPRR) international framework of disaster management The first study was a systematic literature review utilising PRISMA guidelines to categorise the epidemiology of physical health consequences of disasters relevant to GPs. Following this the thesis reports a series of three qualitative studies employing a constructivist grounded theory approach: two using semi-structured interviews, and one using a focus group, with disaster-experienced GPs and DMs. These studies explored barriers and facilitators to inclusion of GPs and investigated current and future roles. Research findings led to a conceptual representation for future integration of GPs, utilising the PPRR framework. Ultimately the thesis proposes a strategy for integration of GPs into existing disaster health management systems that addresses some of the barriers highlighted by the research, and elucidates the roles of GPs. The researchers sought to synthesise the emerging knowledge and facilitate implementation by key stakeholders with the intention of closing the gap between what is known and what is practiced. Findings were disseminated as per Graham's Knowledge to Action framework. Key outputs were enacted through peer-reviewed journal publications, textbook sections, guidelines for a broad range of practitioners, presentations internationally and nationally, policy revision through professional committee memberships, and advocacy for GP involvement at international, national, and local levels. To manage the challenges of disasters, countries require a resilient healthcare system that maximises capacity of all levels of local health resources, accommodates the surge in demand, and continues to sustain the local health services response in the aftermath. Comprehensive, people-focused coordination & continuity of care has the potential to improve the holistic health outcomes of disaster-affected people. Examination of the evidence from this doctorate suggests clear roles for GPs in disaster healthcare across all phases of disasters, with sustained contributions over the recovery. A knowledge of the temporal epidemiological patterns of health effects provides an opportunity for surveillance for emerging conditions over time, prevention of deterioration of existing conditions, and promotion of patient preparedness for future events, all roles within the usual realm of General Practice healthcare. An important element of GP integration is ongoing research on disaster healthcare needs presenting to GPs to continue to evaluate, justify and support ongoing GP involvement. The future challenge is to change the focus of disaster health management to person-centred healthcare integrated across all levels of usual healthcare, including evidence-based General Practice primary care contributions
    • …
    corecore