Evaluating the implementation of a quality improvement process in General Practice using a realist evaluation framework

© 2018 John Wiley & Sons, Ltd. Rationale, aims, and objectives: Underuse of anticoagulants in atrial fibrillation is known to increase the risk of stroke and is an international problem. The National Institute for Health Care and Excellence guidance CG180 seeks to reduce atrial fibrillation related strokes through prescriptions of Non-vitamin K antagonist Oral Anticoagulants. A quality improvement programme was established by the West of England Academic Health Science Network (West of England AHSN) to implement this guidance into General Practice. A realist evaluation identified whether the quality improvement programme worked, determining how and in what circumstances. Methods: Six General Practices in 1 region, became the case study sites. Quality improvement team, doctor, and pharmacist meetings within each of the General Practices were recorded at 3 stages: initial planning, review, and final. Additionally, 15 interviews conducted with the practice leads explored experiences of the quality improvement process. Observation and interview data were analysed and compared against the initial programme theory. Results: The quality improvement resources available were used variably, with the training being valued by all. The initial programme theories were refined. In particular, local workload pressures and individual General Practitioner experiences and pre-conceived ideas were acknowledged. Where key motivators were in place, such as prior experience, the programme achieved optimal outcomes and secured a lasting quality improvement legacy. Conclusion: The employment of a quality improvement programme can deliver practice change and improvement legacy outcomes when particular mechanisms are employed and in contexts where there is a commitment to improve service

Children's consent and the zone of parental discretion

This paper briefly reviews highlights from decades of debates in medicine, law, bioethics, psychology and social research about children’s and parents’ views and consent to medical treatment and research. There appears to have been a rise and later a fall in respect for children’s views, illustrated among many examples by a recent book on the zone of parental discretion, which is reviewed. A return to greater respect for children’s views and consent is advocated

Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

Background: The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16). Methods: In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results: The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001). Conclusions: The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose

The pharmaceutical industry and the nation's industry

SIGLELD:84/00161(Pharmaceutical) / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Annual review

Available from British Library Document Supply Centre-DSC:1519.9252(1995) / BLDSC - British Library Document Supply CentreSIGLEGBUnited Kingdo