Julie E Reed

Systematic review of the application of the plan–do–study–act method to improve quality in healthcare

Background Plan–do–study–act (PDSA) cycles provide a structure for iterative testing of changes to improve quality of systems. The method is widely accepted in healthcare improvement; however there is little overarching evaluation of how the method is applied. This paper proposes a theoretical framework for assessing the quality of application of PDSA cycles and explores the consistency with which the method has been applied in peer-reviewed literature against this framework. Methods NHS Evidence and Cochrane databases were searched by three independent reviewers. Empirical studies were included that reported application of the PDSA method in healthcare. Application of PDSA cycles was assessed against key features of the method, including documentation characteristics, use of iterative cycles, prediction-based testing of change, initial small-scale testing and use of data over time. Results 73 of 409 individual articles identified met the inclusion criteria. Of the 73 articles, 47 documented PDSA cycles in sufficient detail for full analysis against the whole framework. Many of these studies reported application of the PDSA method that failed to accord with primary features of the method. Less than 20% (14/73) fully documented the application of a sequence of iterative cycles. Furthermore, a lack of adherence to the notion of small-scale change is apparent and only 15% (7/47) reported the use of quantitative data at monthly or more frequent data intervals to inform progression of cycles. Discussion To progress the development of the science of improvement, a greater understanding of the use of improvement methods, including PDSA, is essential to draw reliable conclusions about their effectiveness. This would be supported by the development of systematic and rigorous standards for the application and reporting of PDSAs.

TRAP–LIG, a modified telomere repeat amplification protocol assay to quantitate telomerase inhibition by small molecules

The telomerase enzyme is implicated in a large proportion of human cancers. Its major function is to maintain the length of telomeric DNA by synthesizing telomeric DNA repeats, and its enzymatic activity is assayed by means of the telomere repeat amplification protocol (TRAP) assay. We show here that this assay is unable to reliably determine the ability of small molecules to inhibit the enzyme because they interfere with the PCR step of the assay, resulting in a major overestimation of their activity. We report a modified TRAP assay that incorporates the addition of an intermediate step, enabling ligand to be removed from the final PCR process using a commercially available oligonucleotide purification kit, so that more reliable estimates of telomerase inhibition can be made.

Stabilisation of human telomeric quadruplex DNA and inhibition of telomerase by a platinum–phenanthroline complex

Two new mono-substituted phenanthroline ligands and their platinum(II) square planar complexes have been prepared; one of the complexes has been shown to induce a high degree of quadruplex DNA stabilisation and to inhibit telomerase.

The problem with Plan-Do-Study-Act cycles

Quality improvement (QI) methods have been introduced to healthcare to support the delivery of care that is safe, timely, effective, efficient, equitable and cost effective. Of the many QI tools and methods, the Plan-Do-Study-Act (PDSA) cycle is one of the few that focuses on the crux of change, the translation of ideas and intentions into action. As such, the PDSA cycle and the concept of iterative tests of change are central to many QI approaches, including the model for improvement,1 lean,2 six sigma3 and total quality management.4 PDSA provides a structured experimental learning approach to testing changes. Previously, concerns have been raised regarding the fidelity of application of PDSA method, which may undermine learning efforts,5 the complexity of its use in practice5 ,6 and as to the appropriateness of the PDSA method to address the significant challenges of healthcare improvement.7 This article presents our reflections on the full potential of using PDSA in healthcare, but in doing so we explore the inherent complexity and multiple challenges of executing PDSA well. Ultimately, we argue that the problem with PDSA is the oversimplification of the method as it has been translated into healthcare and the failure to invest in a rigorous and tailored application of the approach. The purpose of the PDSA method lies in learning as quickly as possible whether an intervention works in a particular setting and to making adjustments accordingly to increase the chances of delivering and sustaining the desired improvement. In contrast to controlled trials, PDSAs allow new learning to be built in to this experimental process. If problems are identified with the original plan, then the theory can be revised to build on this learning and a subsequent experiment conducted to see if it has resolved the problem, and …

Designing quality improvement initiatives: the action effect method, a structured approach to identifying and articulating programme theory

Background The identification and articulation of programme theory can support effective design, execution and evaluation of quality improvement (QI) initiatives. Programme theory includes an agreed aim, potential interventions to achieve this aim, anticipated cause/effect relationships between the interventions and the aim and measures to monitor improvement. This paper outlines the approach used in a research and improvement programme to support QI initiatives in identifying and articulating programme theory: the action effect method. Background to method development Building on a previously used QI method, the driver diagram, the action effect method was developed using co-design and iteration over four annual rounds of improvement initiatives. This resulted in a specification of the elements required to fully articulate the programme theory of a QI initiative. The action effect method The action effect method is a systematic and structured process to identify and articulate a QI initiatives programme theory. The method connects potential interventions and implementation activities with an overall improvement aim through a diagrammatic representation of hypothesised and evidenced cause/effect relationships. Measure concepts, in terms of service delivery and patient and system outcomes, are identified to support evaluation. Discussion and conclusions The action effect method provides a framework to guide the execution and evaluation of a QI initiative, a focal point for other QI methods and a communication tool to engage stakeholders. A clear definition of what constitutes a well-articulated programme theory is provided to guide the use of the method and assessment of the fidelity of its application.

Patient and Public Views on Electronic Health Records and Their Uses in the United Kingdom: Cross-Sectional Survey

Background The development and implementation of electronic health records (EHRs) remains an international challenge. Better understanding of patient and public attitudes and the factors that influence overall levels of support toward EHRs is needed to inform policy. Objective To explore patient and public attitudes toward integrated EHRs used simultaneously for health care provision, planning and policy, and health research. Methods Cross-sectional questionnaire survey administered to patients and members of the public who were recruited from a stratified cluster random sample of 8 outpatient clinics of a major teaching hospital and 8 general practices in London (United Kingdom). Results 5331 patients and members of the public responded to the survey, with 2857 providing complete data for the analysis presented here. There were moderately high levels of support for integrated EHRs used simultaneously for health care provision, planning and policy, and health research (1785/2857, 62.47%), while 27.93% (798/2857) of participants reported being undecided about whether or not they would support EHR use. There were higher levels of support for specific uses of EHRs. Most participants were in favor of EHRs for personal health care provision (2563/2857, 89.71%), with 66.75% (1907/2857) stating that they would prefer their complete, rather than limited, medical history to be included. Of those “undecided” about integrated EHRs, 87.2% (696/798) were nevertheless in favor of sharing their full (373/798, 46.7%) or limited (323/798, 40.5%) records for health provision purposes. There were similar high levels of support for use of EHRs in health services policy and planning (2274/2857, 79.59%) and research (2325/2857, 81.38%), although 59.75% (1707/2857) and 67.10% (1917/2857) of respondents respectively would prefer their personal identifiers to be removed. Multivariable analysis showed levels of overall support for EHRs decreasing with age. Respondents self-identifying as Black British were more likely to report being undecided or unsupportive of national EHRs. Frequent health services users were more likely to report being supportive than undecided. Conclusions Despite previous difficulties with National Health Service (NHS) technology projects, patients and the public generally support the development of integrated EHRs for health care provision, planning and policy, and health research. This support, however, varies between social groups and is not unqualified; relevant safeguards must be in place and patients should be guided in their decision-making process, including increased awareness about the benefits of EHRs for secondary uses.

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

Highlights • Most participants would prefer to opt-in before their identifiable records are used.• Half of participants would share their de-identified records under implicit consent.• A low awareness of EHRs persists among participants.• Participants who were aware of EHRs were more willing to share de-identified data.• Awareness and consent expectations vary by socio-demographic characteristics.

Patient and public views about the security and privacy of Electronic Health Records (EHRs) in the UK: results from a mixed methods study

BackgroundAlthough policy discourses frame integrated Electronic Health Records (EHRs) as essential for contemporary healthcare systems, increased information sharing often raises concerns among patients and the public. This paper examines patient and public views about the security and privacy of EHRs used for health provision, research and policy in the UK.MethodsSequential mixed methods study with a cross-sectional survey (in 2011) followed by focus group discussions (in 2012-2013). Survey participants (N = 5331) were recruited from primary and secondary care settings in West London (UK). Complete data for 2761 (51.8 %) participants were included in the final analysis for this paper. The survey results were discussed in 13 focus groups with people living with a range of different health conditions, and in 4 mixed focus groups with patients, health professionals and researchers (total N = 120). Qualitative data were analysed thematically.ResultsIn the survey, 79 % of participants reported that they would worry about the security of their record if this was part of a national EHR system and 71 % thought the National Health Service (NHS) was unable to guarantee EHR safety at the time this work was carried out. Almost half (47 %) responded that EHRs would be less secure compared with the way their health record was held at the time of the survey. Of those who reported being worried about EHR security, many would nevertheless support their development (55 %), while 12 % would not support national EHRs and a sizeable proportion (33 %) were undecided. There were also variations by age, ethnicity and education. In focus group discussions participants weighed up perceived benefits against potential security and privacy threats from wider sharing of information, as well as discussing other perceived risks: commercial exploitation, lack of accountability, data inaccuracies, prejudice and inequalities in health provision.ConclusionsPatient and public worries about the security risks associated with integrated EHRs highlight the need for intensive public awareness and engagement initiatives, together with the establishment of trustworthy security and privacy mechanisms for health information sharing.

Survey of patient and public perceptions of electronic health records for healthcare, policy and research: Study protocol

BackgroundImmediate access to patients’ complete health records via electronic databases could improve healthcare and facilitate health research. However, the possible benefits of a national electronic health records (EHR) system must be balanced against public concerns about data security and personal privacy. Successful development of EHR requires better understanding of the views of the public and those most affected by EHR: users of the National Health Service. This study aims to explore the correlation between personal healthcare experience (including number of healthcare contacts and number and type of longer term conditions) and views relating to development of EHR for healthcare, health services planning and policy and health research.Methods/designA multi-site cross-sectional self-complete questionnaire designed and piloted for use in waiting rooms was administered to patients from randomly selected outpatients’ clinics at a university teaching hospital (431 beds) and general practice surgeries from the four primary care trusts within the catchment area of the hospital. All patients entering the selected outpatients clinics and general practice surgeries were invited to take part in the survey during August-September 2011. Statistical analyses will be conducted using descriptive techniques to present respondents’ overall views about electronic health records and logistic regression to explore associations between these views and participants’ personal circumstances, experiences, sociodemographics and more specific views about electronic health records.DiscussionThe study design and implementation were successful, resulting in unusually high response rates and overall recruitment (85.5%, 5336 responses). Rates for face-to-face recruitment in previous work are variable, but typically lower (mean 76.7%, SD 20). We discuss details of how we collected the data to provide insight into how we obtained this unusually high response rate.

Understanding what matters to patients – identifying key patients' perceptions of quality

Objectives To demonstrate a statistical method to enable the identification of key drivers of quality from a patient perspective that can be used by service providers to help drive improvement. Design Cross-tabulation, Chi-square analysis and Cramers V calculation using SPSS software of NHS Inpatient Surveys 2006 and 2007. Setting The NHS Inpatient Survey is a standardized survey designed by the Picker Institute conducted on a sample of patients across all acute care hospital trusts in England. Participants The surveys (available from the UK Data Archive) provide anonymized patient data for over 77,000 patients in 2006 and 72,000 patients in 2007. Main outcome measures Cramers V score testing associations between patient ratings on multiple components of care and ratings on the overall quality of care. Results Of the 58 questions analysed, some questions correlate more strongly with overall satisfaction of care than others and there is strong agreement of results over the two years. Of the top 20 rated components, communication (both between professionals and between professionals and patients) and trust engendered by that communication is a recurring theme. Conclusions Hospital trusts are required to develop quality indicators and collate detailed feedback from patients in addition to the annual inpatient survey to measure these. To make best use of resources, additional data collection should focus on those aspects of care of most importance to patients locally. This analysis demonstrates a statistical technique that can help to identify such priority areas by showing those aspects of care most strongly associated with the overall rating of care. The analysis uses national level data to demonstrate how this can be achieved. This shows the importance to patients of being treated with dignity and respect, and good communication between staff and between staff and patients.