Quality of locally designed surveys in a quality improvement collaborative: review of survey validity and identification of common errors.

OBJECTIVE: Surveys are a commonly used tool in quality improvement (QI) projects, but little is known about the standards to which they are designed and applied. We aimed to investigate the quality of surveys used within a QI collaborative, and to characterise the common errors made in survey design. METHODS: Five reviewers (two research methodology and QI, three clinical and QI experts) independently assessed 20 surveys, comprising 250 survey items, that were developed in a North American cystic fibrosis lung transplant transition collaborative. Content Validity Index (CVI) scores were calculated for each survey. Reviewer consensus discussions decided an overall quality assessment for each survey and survey item (analysed using descriptive statistics) and explored the rationale for scoring (using qualitative thematic analysis). RESULTS: 3/20 surveys scored as high quality (CVI >80%). 19% (n=47) of survey items were recommended by the reviewers, with 35% (n=87) requiring improvements, and 46% (n=116) not recommended. Quality assessment criteria were agreed upon. Types of common errors identified included the ethics and appropriateness of questions and survey format; usefulness of survey items to inform learning or lead to action, and methodological issues with survey questions, survey response options; and overall survey design. CONCLUSION: Survey development is a task that requires careful consideration, time and expertise. QI teams should consider whether a survey is the most appropriate form for capturing information during the improvement process. There is a need to educate and support QI teams to adhere to good practice and avoid common errors, thereby increasing the value of surveys for evaluation and QI. The methodology, quality assessment criteria and common errors described in this paper can provide a useful resource for this purpose.

How do healthcare providers use national audit data for improvement?

BACKGROUND: Substantial resources are invested by Health Departments worldwide in introducing National Clinical Audits (NCAs). Yet, there is variable evidence on the NCAs' effectiveness and little is known on factors underlying the successful use of NCAs to improve local practice. This study will focus on a single NCA (the National Audit of Inpatient Falls -NAIF 2017) to explore: (i) participants' perspectives on the NCA reports, local feedback characteristics and actions undertaken following the feedback underpinning the effective use of the NCA feedback to improve local practice; (ii) reported changes in local practice following the NCA feedback in England and Wales. METHODS: Front-line staff perspectives were gathered through interviews. An inductive qualitative approach was used. Eighteen participants were purposefully sampled from 7 of the 85 participating hospitals in England and Wales. Analysis was guided by constant comparative techniques. RESULTS: Regarding the NAIF annual report, interviewees valued performance benchmarking with other hospitals, the use of visual representations and the inclusion of case studies and recommendations. Participants stated that feedback should target front-line healthcare professionals, be straightforward and focused, and be delivered through an encouraging and honest discussion. Interviewees highlighted the value of using other relevant data sources alongside NAIF feedback and the importance of continuous data monitoring. Participants reported that engagement of front-line staff in the NAIF and following improvement activities was critical. Leadership, ownership, management support and communication at different organisational levels were perceived as enablers, while staffing level and turnover, and poor quality improvement (QI) skills, were perceived as barriers to improvement. Reported changes in practice included increased awareness and attention to patient safety issues and greater involvement of patients and staff in falls prevention activities. CONCLUSIONS: There is scope to improve the use of NCAs by front-line staff. NCAs should not be seen as isolated interventions but should be fully embedded and integrated into the QI strategic and operational plans of NHS trusts. The use of NCAs could be optimised, but knowledge of them is poor and distributed unevenly across different disciplines. More research is needed to provide guidance on key elements to consider throughout the whole improvement process at different organisational levels.

Challenges to implementing artificial intelligence in healthcare: a qualitative interview study with healthcare leaders in Sweden.

BACKGROUND: Artificial intelligence (AI) for healthcare presents potential solutions to some of the challenges faced by health systems around the world. However, it is well established in implementation and innovation research that novel technologies are often resisted by healthcare leaders, which contributes to their slow and variable uptake. Although research on various stakeholders' perspectives on AI implementation has been undertaken, very few studies have investigated leaders' perspectives on the issue of AI implementation in healthcare. It is essential to understand the perspectives of healthcare leaders, because they have a key role in the implementation process of new technologies in healthcare. The aim of this study was to explore challenges perceived by leaders in a regional Swedish healthcare setting concerning the implementation of AI in healthcare. METHODS: The study takes an explorative qualitative approach. Individual, semi-structured interviews were conducted from October 2020 to May 2021 with 26 healthcare leaders. The analysis was performed using qualitative content analysis, with an inductive approach. RESULTS: The analysis yielded three categories, representing three types of challenge perceived to be linked with the implementation of AI in healthcare: 1) Conditions external to the healthcare system; 2) Capacity for strategic change management; 3) Transformation of healthcare professions and healthcare practice. CONCLUSIONS: In conclusion, healthcare leaders highlighted several implementation challenges in relation to AI within and beyond the healthcare system in general and their organisations in particular. The challenges comprised conditions external to the healthcare system, internal capacity for strategic change management, along with transformation of healthcare professions and healthcare practice. The results point to the need to develop implementation strategies across healthcare organisations to address challenges to AI-specific capacity building. Laws and policies are needed to regulate the design and execution of effective AI implementation strategies. There is a need to invest time and resources in implementation processes, with collaboration across healthcare, county councils, and industry partnerships.

Conceptualising interventions to enhance spread in complex systems: a multisite comprehensive medication review case study.

BACKGROUND: Advancing the description and conceptualisation of interventions in complex systems is necessary to support spread, evaluation, attribution and reproducibility. Improvement teams can provide unique insight into how interventions are operationalised in practice. Capturing this 'insider knowledge' has the potential to enhance intervention descriptions. OBJECTIVES: This exploratory study investigated the spread of a comprehensive medication review (CMR) intervention to (1) describe the work required from the improvement team perspective, (2) identify what stays the same and what changes between the different sites and why, and (3) critically appraise the 'hard core' and 'soft periphery' (HC/SP) construct as a way of conceptualising interventions. DESIGN: A prospective case study of a CMR initiative across five sites. Data collection included: observations, document analysis and semistructured interviews. A facilitated workshop triangulated findings and measured perceived effort invested in activities. A qualitative database was developed to conduct thematic analysis. RESULTS: Sites identified 16 intervention components. All were considered essential due to their interdependency. The function of components remained the same, but adaptations were made between and within sites. Components were categorised under four 'spheres of operation': Accessibility of evidence base; Process of enactment; Dependent processes and Dependent sociocultural issues. Participants reported most effort was invested on 'dependent sociocultural issues'. None of the existing HC/SP definitions fit well with the empirical data, with inconsistent classifications of components as HC or SP. CONCLUSIONS: This study advances the conceptualisation of interventions by explicitly considering how evidence-based practices are operationalised in complex systems. We propose a new conceptualisation of 'interventions-in-systems' which describes intervention components in relation to their: proximity to the evidence base; component interdependence; component function; component adaptation and effort.

How to design, implement and evaluate organizational interventions for maximum impact: the Sigtuna Principles.

Research on organizational interventions needs to meet the objectives of both researchers and participating organizations. This duality means that real-world impact has to be considered throughout the research process, simultaneously addressing both scientific rigour and practical relevance. This discussion paper aims to offer a set of principles, grounded in knowledge from various disciplines that can guide researchers in designing, implementing, and evaluating organizational interventions. Inspired by Mode 2 knowledge production, the principles were developed through a transdisciplinary, participatory and iterative process where practitioners and academics were invited to develop, refine and validate the principles. The process resulted in 10 principles: 1) Ensure active engagement and participation among key stakeholders; 2) Understand the situation (starting points and objectives); 3) Align the intervention with existing organizational objectives; 4) Explicate the program logic; 5) Prioritize intervention activities based on effort-gain balance; 6) Work with existing practices, processes, and mindsets; 7) Iteratively observe, reflect, and adapt; 8) Develop organizational learning capabilities; 9) Evaluate the interaction between intervention, process, and context; and 10) Transfer knowledge beyond the specific organization. The principles suggest how the design, implementation, and evaluation of organizational interventions can be researched in a way that maximizes both practical and scientific impact.

Working together to co-produce better health: The experience of the Collaboration for Leadership in Applied Health Research and Care for Northwest London.

OBJECTIVES: To improve the provision of health care, academics can be asked to collaborate with clinicians, and clinicians with patients. Generating good evidence on health care practice depends on these collaborations working well. Yet such relationships are not the norm. We examine how social science research and health care improvement practice were linked through a programme designed to broker collaborations between clinicians, academics, and patients to improve health care - the UK National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Northwest London. We discuss the successes and challenges of the collaboration and make suggestions on how to develop synergistic relationships that facilitate co-production of social science knowledge and its translation into practice. METHODS: A qualitative approach was used, including ethnographic elements and critical, reflexive dialogue between members of the two collaborating teams. RESULTS: Key challenges and remedies were connected with the risks associated with new ways of working. These risks included differing ideas between collaborators about the purpose, value, and expectations of research, and institutional opposition. Dialogue between collaborators did not mean absence of tensions or clashes. Risk-taking was unpopular - institutions, funders, and partners did not always support it, despite simultaneously demanding 'innovation' in producing research that influenced practice. CONCLUSIONS: Our path was made smoother because we had funding to support the creation of a 'potential space' to experiment with different ways of working. Other factors that can enhance collaboration include a shared commitment to dialogical practice, a recognition of the legitimacy of different partners' knowledge, a long timeframe to identify and resolve problems, the maintenance of an enabling environment for collaboration, a willingness to work iteratively and reflexively, and a shared end goal.

Evolving quality improvement support strategies to improve Plan-Do-Study-Act cycle fidelity: a retrospective mixed-methods study.

BACKGROUND: Although widely recommended as an effective approach to quality improvement (QI), the Plan-Do-Study-Act (PDSA) cycle method can be challenging to use, and low fidelity of published accounts of the method has been reported. There is little evidence on the fidelity of PDSA cycles used by front-line teams, nor how to support and improve the method's use. Data collected from 39 front-line improvement teams provided an opportunity to retrospectively investigate PDSA cycle use and how strategies were modified to help improve this over time. METHODS: The fidelity of 421 PDSA cycles was reviewed using a predefined framework and statistical analysis examined whether fidelity changed over three annual rounds of projects. The experiences of project teams and QI support staff were investigated through document analysis and interviews. RESULTS: Although modest, statistically significant improvements in PDSA fidelity occurred; however, overall fidelity remained low. Challenges to achieving greater fidelity reflected problems with understanding the PDSA methodology, intention to use and application in practice. These problems were exacerbated by assumptions made in the original QI training and support strategies: that PDSA was easy to understand; that teams would be motivated and willing to use PDSA; and that PDSA is easy to apply. QI strategies that evolved to overcome these challenges included project selection process, redesign of training, increased hands-on support and investment in training QI support staff. CONCLUSION: This study identifies support strategies that may help improve PDSA cycle fidelity. It provides an approach to assess minimum standards of fidelity which can be replicated elsewhere. The findings suggest achieving high PDSA fidelity requires a gradual and negotiated process to explore different perspectives and encourage new ways of working.

Translating evidence in complex systems: a comparative review of implementation and improvement frameworks.

PURPOSE: An increasing number of implementation and improvement frameworks seek to describe and explain how change is made in healthcare. This paper aims to explore how existing frameworks conceptualize the influence of complexity in translating evidence into practice in healthcare. DATA SOURCES: A database was interrogated using a search strategy to identify publications that present frameworks and models for implementation and improvement. STUDY SELECTION: Ten popular implementation and improvement frameworks were purposively selected. DATA EXTRACTION: Comparative analysis was conducted using an analytical framework derived from SHIFT-Evidence, a framework that conceptualizes complexity in implementation and improvement initiatives. RESULTS: Collectively the frameworks accounted for key concepts of translating evidence in complex systems: understanding the uniqueness of each setting; the interdependency of practices/processes and the need to respond to unpredictable events and emergent learning. The analysis highlighted heterogeneity of the frameworks in their focus on different aspects of complexity. Differences include the extent to which problems and solutions are investigated or assumed; whether endpoints are defined as the uptake of interventions or achievement of goals; and emphasis placed on fixed-term interventions versus continual improvement. None of the individual frameworks reviewed incorporated all the implications of complexity, as described by SHIFT-Evidence. CONCLUSION: This research identifies the differences in how implementation and improvement frameworks consider complexity, suggesting that SHIFT-Evidence offers a more comprehensive overview compared with the other frameworks. The similarity of concepts across the frameworks suggests growing consensus in the literature, with SHIFT-Evidence providing a conceptual bridge between the implementation and improvement fields.

Successful Healthcare Improvements From Translating Evidence in complex systems (SHIFT-Evidence): simple rules to guide practice and research.

BACKGROUND: Evidence translation and improvement research indicate that healthcare contexts are complex systems, characterized by uncertainty and surprise, which often defy orchestrated intervention attempts. This article reflects on the implications of complexity on attempts to translate evidence, and on a newly published framework for Successful Healthcare Improvements From Translating Evidence in complex systems (SHIFT-Evidence). DISCUSSION: SHIFT-Evidence positions the challenge of evidence translation within the complex and evolving context of healthcare, and recognizes the wider issues practitioners routinely face. It is empirically grounded, and designed to be comprehensive, practically relevant and actionable. SHIFT-evidence is summarized by three principles designed to be intuitive and memorable: 'act scientifically and pragmatically'; 'embrace complexity'; and 'engage and empower'. Common challenges and strategies to overcome them are summarized in 12 'simple rules' that provide actionable guidance. CONCLUSION: SHIFT-Evidence provides a practical tool to guide practice and research of evidence translation and improvement within complex dynamic healthcare settings. Implications are that improvement initiatives and research study designs need to take into account the unique initial conditions in each local setting; conduct needs to respond to unpredictable effects and address dependent problems; and evaluation needs to be sensitive to evolving priorities and the emergent range of activities required to achieve improvement.

A new typology for understanding context: qualitative exploration of the model for understanding success in quality (MUSIQ).

BACKGROUND: The importance of contextual factors in influencing quality improvement and implementation (QI&I) initiatives is broadly acknowledged. Existing treatments of context have primarily viewed it as static and distinct from interventions themselves. The objective of this study was to advance understanding of the complex and dynamic interaction between context, intervention, and implementation strategies. Using the Model for Understanding Success in Quality (MUSIQ), we aimed to better understand the roles of, and inter-relationships between, contextual factors within QI&I initiatives. METHODS: Secondary analysis was performed on qualitative data collected as part of two studies: (1) an evaluation of a state-wide obstetrical quality improvement (QI) initiative, and (2) a study of the use of Plan-Do-Study-Act cycle method in QI projects. Electronic coding databases from each study were reviewed jointly. Data analysis was initiated deductively using MUSIQ as a template. Codes were added in an inductive manner. RESULTS: All original factors in MUSIQ were observed to be important in the QI initiatives studied and new factors were identified. Three distinct types of context were identified; the setting(s) of care in which QI&I takes place (Type 1); the context of the team conducting a specific project (Type 2); and the wider context supporting general QI&I (Type 3). The picture of context emerging from this study is a dynamic one with multiple, closely-linked factors operating at different levels in a system that is constantly changing in response to QI&I initiatives. To capture this complexity, a revised model (MUSIQ v2.0) was created positioning use of structured QI&I approaches as the focal point and demonstrating how context influenced effective use of these approaches, and in turn, how these approaches supported teams in navigating context by adapting interventions to fit local settings. CONCLUSIONS: MUSIQ is a useful tool to explore the roles of, and inter-relationships between, contextual factors within QI&I initiatives. The revised model may help address some existing controversies about how context influences QI&I success and help ensure that future research efforts consider context not as static background, but as a complex system that is constantly changing, tightly-linked, and governed by feedback loops.

Simple rules for evidence translation in complex systems: A qualitative study.

BACKGROUND: Ensuring patients benefit from the latest medical and technical advances remains a major challenge, with rational-linear and reductionist approaches to translating evidence into practice proving inefficient and ineffective. Complexity thinking, which emphasises interconnectedness and unpredictability, offers insights to inform evidence translation theories and strategies. Drawing on detailed insights into complex micro-systems, this research aimed to advance empirical and theoretical understanding of the reality of making and sustaining improvements in complex healthcare systems. METHODS: Using analytical auto-ethnography, including documentary analysis and literature review, we assimilated learning from 5 years of observation of 22 evidence translation projects (UK). We used a grounded theory approach to develop substantive theory and a conceptual framework. Results were interpreted using complexity theory and 'simple rules' were identified reflecting the practical strategies that enhanced project progress. RESULTS: The framework for Successful Healthcare Improvement From Translating Evidence in complex systems (SHIFT-Evidence) positions the challenge of evidence translation within the dynamic context of the health system. SHIFT-Evidence is summarised by three strategic principles, namely (1) 'act scientifically and pragmatically' - knowledge of existing evidence needs to be combined with knowledge of the unique initial conditions of a system, and interventions need to adapt as the complex system responds and learning emerges about unpredictable effects; (2) 'embrace complexity' - evidence-based interventions only work if related practices and processes of care within the complex system are functional, and evidence-translation efforts need to identify and address any problems with usual care, recognising that this typically includes a range of interdependent parts of the system; and (3) 'engage and empower' - evidence translation and system navigation requires commitment and insights from staff and patients with experience of the local system, and changes need to align with their motivations and concerns. Twelve associated 'simple rules' are presented to provide actionable guidance to support evidence translation and improvement in complex systems. CONCLUSION: By recognising how agency, interconnectedness and unpredictability influences evidence translation in complex systems, SHIFT-Evidence provides a tool to guide practice and research. The 'simple rules' have potential to provide a common platform for academics, practitioners, patients and policymakers to collaborate when intervening to achieve improvements in healthcare.

The use of process mapping in healthcare quality improvement projects.

Introduction Process mapping provides insight into systems and processes in which improvement interventions are introduced and is seen as useful in healthcare quality improvement projects. There is little empirical evidence on the use of process mapping in healthcare practice. This study advances understanding of the benefits and success factors of process mapping within quality improvement projects. Methods Eight quality improvement projects were purposively selected from different healthcare settings within the UK's National Health Service. Data were gathered from multiple data-sources, including interviews exploring participants' experience of using process mapping in their projects and perceptions of benefits and challenges related to its use. These were analysed using inductive analysis. Results Eight key benefits related to process mapping use were reported by participants (gathering a shared understanding of the reality; identifying improvement opportunities; engaging stakeholders in the project; defining project's objectives; monitoring project progress; learning; increased empathy; simplicity of the method) and five factors related to successful process mapping exercises (simple and appropriate visual representation, information gathered from multiple stakeholders, facilitator's experience and soft skills, basic training, iterative use of process mapping throughout the project). Conclusions Findings highlight benefits and versatility of process mapping and provide practical suggestions to improve its use in practice.

Criteria for evaluating programme theory diagrams in quality improvement initiatives: a structured method for appraisal.

BACKGROUND: Despite criticisms that many quality improvement (QI) initiatives fail due to incomplete programme theory, there is no defined way to evaluate how programme theory has been articulated. The objective of this research was to develop, and assess the usability and reliability of scoring criteria to evaluate programme theory diagrams. METHODS: Criteria development was informed by published literature and QI experts. Inter-rater reliability was tested between two evaluators. About 63 programme theory diagrams (42 driver diagrams and 21 action-effect diagrams) were reviewed to establish whether the criteria could support comparative analysis of different approaches to constructing diagrams. RESULTS: Components of the scoring criteria include: assessment of overall aim, logical overview, clarity of components, cause-effect relationships, evidence and measurement. Independent reviewers had 78% inter-rater reliability. Scoring enabled direct comparison of different approaches to developing programme theory; action-effect diagrams were found to have had a statistically significant but moderate improvement in programme theory quality over driver diagrams; no significant differences were observed based on the setting in which driver diagrams were developed. CONCLUSIONS: The scoring criteria summarise the necessary components of programme theory that are thought to contribute to successful QI projects. The viability of the scoring criteria for practical application was demonstrated. Future uses include assessment of individual programme theory diagrams and comparison of different approaches (e.g. methodological, teaching or other QI support) to produce programme theory. The criteria can be used as a tool to guide the production of better programme theory diagrams, and also highlights where additional support for QI teams could be needed.

Improving patient safety for older people in acute admissions: implementation of the Frailsafe checklist in 12 hospitals across the UK.

Background: checklists are increasingly proposed as a means to enhance safety and quality of care. However, their use has been met with variable levels of success. The Frailsafe project focused on introducing a checklist with the aim to increase completion of key clinical assessments and to facilitate communication for the care of older patients in acute admissions. Objectives: to examine the use of the Frailsafe checklist, including potential to contribute to improved safety, quality and reliability of care. Methods: 110 qualitative interviews and group discussions with healthcare professionals and other specialties, 172 h of ethnographic observation in 12 UK hospitals and reporting of high-level process data (completion of checklist and relevant frailty assessments). Qualitative analysis followed a thematic and theory-driven approach. Results: through use of the checklist, hospital teams identified limitations in their existing assessments (e.g. absence of delirium protocols) and practices (e.g. unnecessary catheter use). This contributed to hospitals reporting just 24.0% of sampled patients as having received all clinical assessments across key domains for this population for the duration of the project (1,687/7,021 checklists as fully completed). Staff perceptions and experiences of using the checklist varied significantly, primarily driven by the extent to which the aims of this quality improvement project aligned with local service priorities and pre-existing team communications styles. Conclusions: the Frailsafe checklist highlighted limitations with frailty assessment in acute care and motivated teams to review routine practices. Further work is needed to understand whether and how checklists can be embedded in complex, multidisciplinary care.

What makes a sustainability tool valuable, practical and useful in real-world healthcare practice? A mixed-methods study on the development of the Long Term Success Tool in Northwest London.

OBJECTIVES: Although improvement initiatives show benefits to patient care, they often fail to sustain. Models and frameworks exist to address this challenge, but issues with design, clarity and usability have been barriers to use in healthcare settings. This work aimed to collaborate with stakeholders to develop a sustainability tool relevant to people in healthcare settings and practical for use in improvement initiatives. DESIGN: Tool development was conducted in six stages. A scoping literature review, group discussions and a stakeholder engagement event explored literature findings and their resonance with stakeholders in healthcare settings. Interviews, small-scale trialling and piloting explored the design and tested the practicality of the tool in improvement initiatives. SETTING: National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Northwest London (CLAHRC NWL). PARTICIPANTS: CLAHRC NWL improvement initiative teams and staff. RESULTS: The iterative design process and engagement of stakeholders informed the articulation of the sustainability factors identified from the literature and guided tool design for practical application. Key iterations of factors and tool design are discussed. From the development process, the Long Term Success Tool (LTST) has been designed. The Tool supports those implementing improvements to reflect on 12 sustainability factors to identify risks to increase chances of achieving sustainability over time. The Tool is designed to provide a platform for improvement teams to share their own views on sustainability as well as learn about the different views held within their team to prompt discussion and actions. CONCLUSION: The development of the LTST has reinforced the importance of working with stakeholders to design strategies which respond to their needs and preferences and can practically be implemented in real-world settings. Further research is required to study the use and effectiveness of the tool in practice and assess engagement with the method over time.

The foundations of quality improvement science.

As an alternative to 'big bang' initiatives, plan-do-study-act (PDSA) cycles are an increasingly popular approach to conducting tests of change to support quality improvement in healthcare. Using PDSA cycles can help clinicians deliver improvements in patient care through a structured experimental approach to learning and tests of change. The PDSA approach facilitates individual, team and organisational learning, making it an essential tool for the future hospital. This paper provides an example of the benefits of using PDSA in practice to test and develop a change idea to ensure it is fit for purpose. As with any new skill or competency, learning to use PDSA cycles takes time and practice and is necessary to ensure that the method is being used to its full effect. This paper explores some of the challenges encountered by clinicians in learning to use PDSA cycles well, and provides advice on how they can be overcome to help practitioners get more out of using the method.

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

BACKGROUND: Although 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. METHODS: Sequential 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. RESULTS: In 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. CONCLUSIONS: Patient 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.

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

BACKGROUND: The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. OBJECTIVES: To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. METHODS: A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. RESULTS: The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. CONCLUSIONS: A large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms.