Longitudinal impact of demographic and clinical variables on Health-Related Quality of Life in Cystic Fibrosis

Objectives: The insights that people with cystic fibrosis have concerning their health are important given that aspects of health-related quality of life (HRQoL) are independent predictors of survival and a decrease in lung function is associated with a decrease in HRQoL over time. Cross-sectional data suggest that key variables, other than lung function, are also associated with HRQoL - although study results are equivocal. This work evaluates the relationship between these key demographic and clinical variables and HRQoL longitudinally. Design: Longitudinal observational study. Observations were obtained at seven time points: approximately every two years over a twelve year period. Setting: Large Adult Cystic Fibrosis Centre in the UK. Participants: 234 participants aged 14-48 years at recruitment. Outcome measure: Nine domains of HRQoL (Cystic Fibrosis Quality of Life Questionnaire) in relation to demographic (age, gender) and clinical measures (FEV1% predicted, BMI, cystic fibrosis related diabetes, B. cepacia complex, totally implantable vascular access device, nutritional and transplant status). Results: A total of 770 patient assessments were obtained for 234 patients. The results of random coefficients modelling indicated that demographic and clinical variables were identified as being significant for HRQoL over time. In addition to lung function, transplant status, age, having a totally implantable vascular access device, cystic fibrosis related diabetes, BMI and B. cepacia complex impacted on many HRQoL domains longitudinally. Gender was important for the domain of Body image. Conclusion: Demographic and changes in clinical variables were independently associated with a change in health-related quality of life over time. Compared with these longitudinal data, cross-sectional data are inadequate when evaluating the relationships between HRQoL domains and key demographic and clinical variables, as they fail to recognise the full impact of the CF disease trajectory and its treatments on quality of life

The effectiveness of rehabilitation interventions including outdoor mobility on older adults' physical activity, endurance, outdoor mobility and falls-related self-efficacy: systematic review and meta-analysis.

OBJECTIVE: To determine the effectiveness of community-based rehabilitation interventions which incorporate outdoor mobility on physical activity, endurance, outdoor mobility and falls-related self-efficacy in older adults. DESIGN: MEDLINE, Embase, CINAHL, PEDro and OpenGrey were searched systematically from inception to June 2021 for randomised controlled trials (RCTs) of community-based rehabilitation incorporating outdoor mobility on physical activity, endurance, outdoor mobility and/or falls-related self-efficacy in older adults. Duplicate screening, selection, extraction and appraisal were completed. Results were reported descriptively and with random-effects meta-analyses stratified by population (proactive [community-dwelling], reactive [illness/injury]). RESULTS: A total of 29 RCTs with 7,076 participants were identified (66% high bias for at least one domain). The outdoor mobility component was predominantly a walking programme with behaviour change. Rehabilitation for reactive populations increased physical activity (seven RCTs, 587 participants. Hedge's g 1.32, 95% CI: 0.31, 2.32), endurance (four RCTs, 392 participants. Hedges g 0.24; 95% CI: 0.04, 0.44) and outdoor mobility (two RCTs with 663 participants. Go out as much as wanted, likelihood of a journey) at intervention end versus usual care. Where reported, effects were preserved at follow-up. One RCT indicated a benefit of rehabilitation for proactive populations on moderate-to-vigorous activity and outdoor mobility. No effect was noted for falls-related self-efficacy, or other outcomes following rehabilitation for proactive populations. CONCLUSION: Reactive rehabilitation for older adults may include walking programmes with behaviour change techniques. Future research should address the potential benefit of a walking programme for proactive populations and address mobility-related anxiety as a barrier to outdoor mobility for both proactive and reactive populations

Proceedings From the Symposium on Kidney Disease in Older People: Royal Society of Medicine, London, January 19, 2017

People are living longer. On the whole, they have healthier lives and many of the problems previously seen at a younger age now appear in their later years. Kidneys, like other organs, age, and kidney disease in the aged is a prime example. In the United Kingdom, as in other developed countries, the prevalence of end stage kidney disease is highest in the 70- to 79-year-old age group. There are many older people who require renal replacement and are now considered for dialysis. While older patients with end-stage renal disease invariably aspire for a better quality of life, this needs a specialized approach and management. In January 2017, the Royal Society of Medicine held a seminar in London on “Kidney Disease in Older People” with presentations from a multidisciplinary body of experts speaking on various aspects of kidney problems in this age group and its management. The objectives were to increase awareness and improve the understanding of nephrology in the context of geriatric medicine but also geriatrics in its interface with nephrology, especially in the area of chronic kidney disease

Time to integrate global climate change and biodiversity science‐policy agendas

Funder: Research EnglandFunder: Bertarelli FoundationAbstract: There is an increasing recognition that, although the climate change and biodiversity crises are fundamentally connected, they have been primarily addressed independently and a more integrated global approach is essential to tackle these two global challenges. Nature‐based Solutions (NbS) are hailed as a pathway for promoting synergies between the climate change and biodiversity agendas. There are, however, uncertainties and difficulties associated with the implementation of NbS, while the evidence regarding their benefits for biodiversity remains limited. We identify five key research areas where incomplete or poor information hinders the development of integrated biodiversity and climate solutions. These relate to refining our understanding of how climate change mitigation and adaptation approaches benefit biodiversity conservation; enhancing our ability to track and predict ecosystems on the move and/or facing collapse; improving our capacity to predict the impacts of climate change on the effectiveness of NbS; developing solutions that match the temporal, spatial and functional scale of the challenges; and developing a comprehensive and practical framework for assessing, and mitigating against, the risks posed by the implementation of NbS. Policy implications. The Conference of the Parties (COP) for the United Nations Framework Convention on Climate Change (COP26) and the Convention on Biological Diversity (COP15) present a clear policy window for developing coherent policy frameworks that align targets across the nexus of biodiversity and climate change. This window should (a) address the substantial and chronic underfunding of global biodiversity conservation, (b) remove financial incentives that negatively impact biodiversity and/or climate change, (c) develop higher levels of integration between the biodiversity and climate change agendas, (d) agree on a monitoring framework that enables the standardised quantification and comparison of biodiversity gains associated with NbS across ecosystems and over time and (e) rethink environmental legislation to better support biodiversity conservation in times of rapid climatic change

Patients' perspectives on high-tech home care: a qualitative inquiry into the user-friendliness of four technologies

BACKGROUND: The delivery of technology-enhanced home care is growing in most industrialized countries. The objective of our study was to document, from the patient's perspective, how the level of user-friendliness of medical technology influences its integration into the private and social lives of patients. Understanding what makes a technology user-friendly should help improve the design of home care services. METHODS: Four home care interventions that are frequently used and vary in their technical and clinical features were selected: Antibiotic intravenous therapy, parenteral nutrition, peritoneal dialysis and oxygen therapy. Our qualitative study relied on the triangulation of three sources of data: 1) interviews with patients (n = 16); 2) interviews with carers (n = 6); and 3) direct observation of nursing visits of a different set of patients (n = 16). Participants of varying socioeconomic status were recruited through primary care organizations and hospitals that deliver home care within 100 km of Montreal, the largest urban area in the province of Quebec, Canada. RESULTS: The four interventions have both a negative and positive effect on patients' lives. These technologies were rarely perceived as user-friendly, and user-acceptance was closely linked to user-competence. Compared with acute I.V. patients, who tended to be passive, chronic patients seemed keener to master technical aspects. While some of the technical and human barriers were managed well in the home setting, engaging in the social world was more problematic. Most patients found it difficult to maintain a regular job because of the high frequency of treatment, while some carers found their autonomy and social lives restricted. Patients also tended to withdraw from social activities because of social stigmatization and technical barriers. CONCLUSIONS: While technology contributes to improving the patients' health, it also imposes significant constraints on their lives. Policies aimed at developing home care must clearly integrate principles and resources supporting the appropriate use of technology. Close monitoring of patients should be part of all technology-enhanced home care programs

Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA_1c≤6.5%) among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T). The objective was to inform interpretation of trial outcomes and provide recommendations for future trial delivery.</p> <p>Methods</p> <p>In-depth interviews were conducted with 45 patients and 21 health professionals recruited from 11 of 58 trial centres in the UK. Patients were broadly representative of those in the main trial in terms of treatment allocation, demographics and glycaemic control. Both physicians and research nurses were interviewed.</p> <p>Results</p> <p>Most patients were committed to taking insulin as recommended by 4-T staff. To avoid hypoglycaemia, patients occasionally altered or skipped insulin doses, normally in consultation with staff. Patients were usually unaware of the trial's glycaemic target. Positive staff feedback could lead patients to believe they had been 'successful' trial participants even when their HbA_1cexceeded 6.5%. While some staff felt that the 4-T automated insulin dose adjustment algorithm had increased their confidence to prescribe larger insulin doses than in routine clinical practice, all described situations where they had not followed its recommendations. Staff regarded the application of a 'one size fits all' glycaemic target during the trial as contradicting routine clinical practice where they would tailor treatments to individuals. Staff also expressed concerns that 'tight' glycaemic control might impose an unacceptably high risk of hypoglycaemia, thus compromising trust and safety, especially amongst older patients. To address these concerns, staff tended to adapt the trial protocol to align it with their clinical practices and experiences.</p> <p>Conclusions</p> <p>To understand trial findings, foster attainment of endpoints, and promote protocol fidelity, it may be necessary to look beyond individual patient characteristics and experiences. Specifically, the context of trial delivery, the impact of staff involvement, and the difficulties staff may encounter in balancing competing 'clinical' and 'research' roles and responsibilities may need to be considered and addressed.</p

The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011)

BACKGROUND: Evidence suggests that poor recruitment into clinical trials rests on a patient ‘deficit’ model – an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization. METHODS: The qualitative study used a ‘Framework Analysis’ that included ‘constant comparison’ in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data. RESULTS: Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment. The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding ‘informed consent’, as well as cause a sense of alienation between patients and health personnel. Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations. CONCLUSIONS: These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the ‘deficit’ model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested. TRIAL REGISTRATION: ISRCTN6112646

Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study

Due to the sensitive nature of the data generated and the possibility of identification of individuals, datasets are not generally available. The anonymised datasets used and/or analysed during the current qualitative study are available from the corresponding author on reasonable request. This study formed part of the HTA Project: 11/114/01 - PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy.Peer reviewedPublisher PD

ECFS best practice guidelines: the 2018 revision

Developments in managing CF continue to drive dramatic improvements in survival. As newborn screening rolls-out across Europe, CF centres are increasingly caring for cohorts of patients who have minimal lung disease on diagnosis. With the introduction of mutation-specific therapies and the prospect of truly personalised medicine, patients have the potential to enjoy good quality of life in adulthood with ever-increasing life expectancy. The landmark Standards of Care published in 2005 set out what high quality CF care is and how it can be delivered throughout Europe. This underwent a fundamental re-write in 2014, resulting in three documents; center framework, quality management and best practice guidelines. This document is a revision of the latter, updating standards for best practice in key aspects of CF care, in the context of a fast-moving and dynamic field. In continuing to give a broad overview of the standards expected for newborn screening, diagnosis, preventative treatment of lung disease, nutrition, complications, transplant/end of life care and psychological support, this consensus on best practice is expected to prove useful to clinical teams both in countries where CF care is developing and those with established CF centres. The document is an ECFS product and endorsed by the CF Network in ERN LUNG and CF Europe