Communicating Qualitative Research Study Designs to Research Ethics Review Boards

Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers suggestions for researchers to consider in their communication of study designs to research ethics review boards. General information about the mandate of research ethics review boards is provided. In light of wide international variability with respect to research ethics regulatory environments and review board processes, specific considerations and suggestions about communicating qualitative study designs effectively are presented within a Canadian case study example

Autonomy and chronic impairment

This dissertation challenges the conception of autonomy that dominates bioethics and health care and defends a feminist relational conception of autonomy as an alternative. The work proceeds in four major steps. First, I analyze the conception of autonomy put forth by Tom Beauchamp and James Childress (B&C) that dominates bioethics and health care. While noting the value of autonomy, I show significant limitations of B&C\u27s view. Second, I explore the experience of autonomy for people with chronic impairment. I discover that any acceptable conception of autonomy will account for relational features of self-identity and self-governance. To the extent that autonomous people are independent , I discover that they have a situated-independence . That is, their independence is understood in terms of particular and extensive sorts of interconnections and interdependencies with the body, others, and the world. In this scenario, autonomy becomes a social project. Third, I present and assess Hardwig\u27s conception of autonomy as the responsible use of freedom. This view is responsive to some of the relational features of self-identity and self-governance already shown to be important. Yet I show that this view has troubling implications. Fourth, I advance a feminist conception of relational autonomy, grounded on a notion of relational selves that extends the self from human consciousness to body, others, and the structures of the world. I show that relational autonomy emerges from a cluster of knowledge, skills, personal attributes and social conditions yielding a family resemblance of conditions, at least within cultural groups, although any instance of relational autonomy will have different dynamic configurations. My procedural view remains neutral about the actual content of people\u27s desires, values, beliefs and emotional attitudes. I argue that a conception of relational autonomy requires dropping the language of respect for” autonomy in favor of promoting and sustaining relational autonomy. This view of autonomy retains the value of both B&C\u27s and Hardwig\u27s conceptions of autonomy and avoids their major problems. Despite some problems of its own that may limit its application in practice, I maintain that a conception of relational autonomy is preferable to those advanced by B&C and Hardwig

Parental response to a letter reporting child overweight measured as part of a routine national programme in England: results from interviews with parents

Background Rising rates of childhood obesity have become a pressing issue in public health, threatening both the mental and physical well-being of children. Attempts to address this problem are multifaceted, and in England include the National Child Measurement Programme (NCMP) which assesses weight status in English primary school children in reception class (aged 4–5) and in year 6 (aged 10–11), with results being sent out to parents. However the effectiveness and impact of this routine parental feedback has yet to be fully understood. This paper reports one component of a mixed methods study undertaken in North East England, examining the impact of the feedback letters on parents’ understanding and feelings about their child’s weight status and whether or not this seemed likely to lead to behaviour change. Methods One-to-one semi-structured interviews (n = 16) were conducted with a sample of parents/guardians after they had received their child’s weight results letter. Eight parents/guardians were sub-sampled from the group whose child had been indicated to be overweight or obese and eight were from the group whose child had been indicated to be of ideal weight status. Interviews were conducted until data saturation was reached for both groups. Results The reactions of parents/guardians whose children were identified as being overweight followed a sequence of behaviours ranging from shock, disgust with the programme, through denial and self-blame to acceptance, worry and intention to seek help. On the other hand, the reaction of parents/guardians whose children were identified as being ideal weight ranged from relief, pleasure and happiness through affirmation and self-congratulation to ‘othering’. Conclusions Whilst overweight and obesity is often portrayed as a medical condition, parents/guardians see it as deeply rooted in their social lives and not in health terms. Parents believe that the causes of overeating and lack of exercise relate closely to the obesogenic environment, particularly the complex social and cultural milieu and time pressures within which this sample of people live. Associating this problem in feedback letters with dangerous diseases like cancer, and advising parents to visit GPs to resolve child weight issues was perceived as inappropriate by the parents, and caused controversy and anger. Given the likelihood that the NCMP will continue as a monitoring device, it is evident that the management of the process needs to be reviewed, with particular attention being paid to the feedback process. Local health authorities will need to manage parental expectations and ensure linkage with appropriately commissioned remedial weight management interventions

Exploring the evidence base for Tier 3 specialist weight management interventions for children aged 2–18 years in the UK: a rapid systematic review

Background: The impact of specialist weight management services (Tier 3) for children with severe and complex obesity in the UK is unclear. This review aims to examine the impact of child Tier 3 services in the UK, exploring service characteristics and implications for practice. Methods: Rapid systematic review of any study examining specialist weight management interventions in any UK setting including children (2–18 years) with a body mass index >99.6th centile or >98th centile with comorbidity. Results: Twelve studies (five RCTs and seven uncontrolled) were included in a variety of settings. Study quality was moderate or low and mean baseline body mass index z-score ranged from 2.7 to 3.6 units. Study samples were small and children were predominantly older (10–14 years), female and white. Multidisciplinary team composition and eligibility criteria varied; dropout ranged from 5 to 43%. Improvements in zBMI over 1–24 months ranged from −0.13 to −0.41 units. Conclusions: Specialist weight management interventions for children with severe obesity demonstrated a reduction in zBMI, across a variety of UK settings. Studies were heterogeneous in content and thus conclusions on service design cannot be drawn. There is a paucity of evidence for Tier 3 services for children, and further research is required

A systematic review of the effect of dietary exposure that could be achieved through normal dietary intake on learning and performance of school-aged children of relevance to UK schools

The aim of the present review was to perform a systematic in-depth review of the best evidence from controlled trial studies that have investigated the effects of nutrition, diet and dietary change on learning, education and performance in school-aged children (4-18 years) from the UK and other developed countries. The twenty-nine studies identified for the review examined the effects of breakfast consumption, sugar intake, fish oil and vitamin supplementation and 'good diets'. In summary, the studies included in the present review suggest there is insufficient evidence to identify any effect of nutrition, diet and dietary change on learning, education or performance of school-aged children from the developed world. However, there is emerging evidence for the effects of certain fatty acids which appear to be a function of dose and time. Further research is required in settings of relevance to the UK and must be of high quality, representative of all populations, undertaken for longer durations and use universal validated measures of educational attainment. However, challenges in terms of interpreting the results of such studies within the context of factors such as family and community context, poverty, disease and the rate of individual maturation and neurodevelopment will remain. Whilst the importance of diet in educational attainment remains under investigation, the evidence for promotion of lower-fat, -salt and -sugar diets, high in fruits, vegetables and complex carbohydrates, as well as promotion of physical activity remains unequivocal in terms of health outcomes for all schoolchildren.</p

Improving Practice in Supported Decision-Making and Mental Capacity Assessment

Current models of evidence-based practice are predicated on the inclusion of patients / service users in decisions about their healthcare. In the United Kingdom (UK), healthcare policy and legislation requires practitioners to provide support with decision-making and, if necessary, complete mental capacity assessments to identify if service users can make informed decisions. People with communication disabilities may have difficulties understanding, thinking and talking about decisions and may require communication support. In this paper, I discuss the current challenges associated with mental capacity assessment and supported decision-making. I propose that healthcare professionals should look beyond legal and policy imperatives to consider the ethical foundations for their practice, when they face such challenges. I compare two conceptual approaches to ethical reasoning. I describe a practical solution to the clinical challenge – the development of the MCAST, a toolkit to support multidisciplinary staff to assess mental capacity and provide support to service users with communication disabilities during the decision-making proces

The need for ethical guidance for the use of patient-reported outcomes (PROs) in 2 research and clinical practice

To the Editor—Patient-reported outcomes (PROs) are increasingly being used in clinical research to provide evidence of the benefits and risk of therapy from a patient perspective. PRO data from clinical trials can inform regulatory approvals and drug labeling, clinical guideline development and health policy1. Approximately one third of clinical trials include PROs collected through the use of patient questionnaires2. Beyond trials, PRO data are also increasingly captured in observational research and routine clinical care to provide information on the burden of disease and real-world evidence of treatment safety and effectiveness3, for audit and benchmarking1, and to monitor the status of patients and provide timely care tailored to individual needs. For instance, a study demonstrated that systematic web-based collection of information on symptoms led to improved health-related quality of life, survival and quality-adjusted survival, and fewer visits to the emergency room and hospitalization, among patients receiving chemotherapy for advanced solid tumors4. Patients value PRO trial results, as they can enhance clinician–patient communication about treatment options, which helps patients to feel more empowered in shared decision-making around their care5

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort : protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context

Introduction: Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. Methods and analysis: SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500– 2000 patients from centres across the world within a period of 5 years (2013–2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once nterventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. Ethics and dissemination: The use of the cmRCT design, the development of self-guided online interventions and partnerships with patient organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc.(undefined

Validation of the Body Concealment Scale for Scleroderma (BCSS): Replication in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort

© 2016 Elsevier Ltd Body concealment is an important component of appearance distress for individuals with disfiguring conditions, including scleroderma. The objective was to replicate the validation study of the Body Concealment Scale for Scleroderma (BCSS) among 897 scleroderma patients. The factor structure of the BCSS was evaluated using confirmatory factor analysis and the Multiple-Indicator Multiple-Cause model examined differential item functioning of SWAP items for sex and age. Internal consistency reliability was assessed via Cronbach's alpha. Construct validity was assessed by comparing the BCSS with a measure of body image distress and measures of mental health and pain intensity. Results replicated the original validation study, where a bifactor model provided the best fit. The BCSS demonstrated strong internal consistency reliability and construct validity. Findings further support the BCSS as a valid measure of body concealment in scleroderma and provide new evidence that scores can be compared and combined across sexes and ages