Showing papers by "Judy Wright published in 2016"

Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes.

Abstract: Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

Abstract: Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

OP09 For whom and in what circumstances does the use of patient reported outcome measures (PROMs) improve patient care? A realist synthesis

Abstract: Background It is suggested that the use of patient reported outcome measure (PROMs) can enhance patients’ consultations with clinicians and improve clinical management. However, existing systematic reviews have found it difficult to reach firm conclusions about the impact of PROMs feedback on the process and outcomes of patient care, largely due to the heterogeneity and complexity of the intervention itself and the wide range of indicators used to assess its impact. This suggests a lack of consensus or even clarity about how this interventions is expected to work. Methods We conducted a realist synthesis to explore the contexts in which and processes through which PROMs enable patients to share concerns with clinicians and change clinicians’ communication practices within the consultation. We identified the ideas and assumptions (program theories) underlying how PROMs use was intended to work and developed an overall model to act as a framework for the review. Electronic databases were searched and backwards and forward citation tracking were carried out on key systematic reviews. We selected papers relevant to testing our theories and 36 papers were included. Results PROMs completion prompts patients to engage in self-reflection and identify then prioritise issues of importance to them. Whether PROMs supported or constrained patients in sharing issues with clinicians depended on the structure of the PROM and existing clinician-patient relationship. Patients valued PROMs but preferred to share information with clinicians when they had established a trusting relationship with them. Clinicians preferred to develop rapport through their verbal interactions with patients. Clinicians perceived standardised PROMs constrained their relationship with patients and were difficult to incorporate into the flow of consultations. Clinicians avoided using them or adapted the PROM, which may compromise their validity. Individualised PROMs supported consultations by allowing patients to ‘tell their story’ but were less useful as an outcome measure to measure change over time. Discussion It is the process of PROMs completion which helps patients to reflect on their health and raise issues with clinicians. The structure of the PROM was a key determinant of the extent to which the use of PROMs supported or constrained the clinician-patient relationship. PROMs may support the care of individual patients through acting as a ‘conversation opener’ rather than as a standardised, quantified summary of patients’ problems.

Optimizing informed consent for percutaneous coronary intervention: a mixed methods study

Abstract: University of Huddersfield Calderdale and Huddersfield NHS Trust, Huddersfield, United Kingdom