An Organizational-Level Program of Intervention for AKI: A Pragmatic Stepped Wedge Cluster Randomized Trial

Background Variable standards of care may contribute to poor outcomes associated with AKI. We evaluatedwhether a multifaceted intervention (AKI e-alerts, an AKI care bundle, and an education program)would improve delivery of care and patient outcomes at an organizational level.Methods A multicenter, pragmatic, stepped-wedge cluster randomized trial was performed in five UK hospitals,involving patients with AKI aged$18 years. The intervention was introduced sequentially across fixed three-monthperiods according to a randomly determined schedule until all hospitals were exposed. The primary outcome was30-day mortality,withpre-specifiedsecondaryendpointsandanestedevaluationof careprocessdelivery.Thenatureof the intervention precluded blinding, but data collection and analysiswere independent of project delivery teams.Results We studied 24,059 AKI episodes, finding an overall 30-day mortality of 24.5%, with no differencebetween control and intervention periods. Hospital length of stay was reduced with the intervention(decreases of 0.7, 1.1, and 1.3 days at the 0.5, 0.6, and 0.7 quantiles, respectively). AKI incidence increasedand was mirrored by an increase in the proportion of patients with a coded diagnosis of AKI. Our assessmentof process measures in 1048 patients showed improvements in several metrics including AKI recognition,medication optimization, and fluid assessment.Conclusions A complex, hospital-wide intervention to reduce harm associated with AKI did not reduce30-day AKImortality but did result in reductions in hospital length of stay, accompanied by improvementsin in quality of care. An increase in AKI incidence likely reflected improved recognitio

Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. MAIN TEXT: We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. CONCLUSION: Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate

Stakeholders and diabetes managed clinical networks in Scotland : Capturing the complexities of patient and professional involvement

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Reflections on applying for NHS ethical approval and governance in a climate of rapid change: prioritising process over principles

Ethical review and governance of health services research in the UK have undergone significant changes in recent years. Tracing this incremental development helps to understand the rationale for introducing a more standardised process. Reflecting on our experience of approval for a national, multi‐centred, qualitative study provides useful insights into both the advantages and disadvantages of this new approach. Advantages include promoting awareness of ethical issues and timely review of proposals. However, excessive bureaucracy and inconsistency in obtaining local governance approvals can lead to unacceptable delays. There is also a danger that the current focus on the process of applying for ethical approval may overshadow debate about the principles of ethical research practice. Over‐reliance on a checklist approach may perpetuate an erroneous notion of ethical approval being a ‘hurdle’ to negotiate instead of an ongoing consideration. Unanticipated theoretical and methodological implications for future health services research are critically examined. Given the continued globalisation of health services research, this discussion may help inform debates and decisions about restructuring ethical review processes in other countries

Perspectives on epilepsy in people with intellectual disabilities: comparison of family carer, staff carer and clinician score profiles on the Glasgow Epilepsy Outcome Scale (GEOS)

PURPOSE: Clinical practice with people with intellectual disability relies heavily upon caregiver report. Crucially, the carer's perspective may depend upon his or her relationship to the patient. We investigated similarities and differences within and between family and paid carers in their reports on the Glasgow Epilepsy Outcome Scale (GEOS), an instrument that quantifies concerns about epilepsy in this population [Epilepsia 42 (2001) 1043]. METHODS: GEOS forms were available on 186 patients (108 males; mean age 39 years) across 384 primary respondents (141 staff, 83 family, 160 clinicians) and independently completed secondary respondents (67 staff, 36 family). Data were analysed to consider levels of concern as rated bv staff carers, family members and clinicians, and also to consider inter-rater agreement on the concerns raised. RESULTS: There were significant differences in the magnitude of concern on each sub-scale [concerns about seizures, treatment, caring and social impact; range of F(2,171)=9.5-64.7; all P<0.0001]. Post hoc testing revealed that family members scored all sub-scales more highly than staff carers or clinicians, and that staff carers scored more highly than clinicians on all but one sub-scale. Inter-rater agreement between family members was considerably higher (range of r=0.69-0.91) than between staff carers (r=0.30-0.47) across the GEOS sub-scales. Association between staff and family ratings was also modest (r< or = 0.39). CONCLUSIONS: It is preferable for the same staff member to complete each administration of the GEOS because of inter-staff variability in reporting of concerns. Families provide a consistent, but more extreme, picture and clinicians generally underestimate the concerns of direct caregivers. However, content of concerns varies relatively little across respondents