The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)

IntroductionThe Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI).MethodsThe development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed.ResultsThe RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the ‘intervention’) and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies.ConclusionsThe RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.<br/

Effecting change in primary care management of respiratory conditions : a global scoping exercise and literature review of educational interventions to inform the IPCRG's E-Quality initiative

This discussion paper describes a scoping exercise and literature review commissioned by the International Primary Care Respiratory Group (IPCRG) to inform their E-Quality programme which seeks to support small-scale educational projects to improve respiratory management in primary care. Our narrative review synthesises information from three sources: publications concerning the global context and health systems development; a literature search of Medline, CINAHL and Cochrane databases; and a series of eight interviews conducted with members of the IPCRG faculty. Educational interventions sit within complex healthcare, economic, and policy contexts. It is essential that any development project considers the local circumstances in terms of economic resources, political circumstances, organisation and administrative capacities, as well as the specific quality issue to be addressed. There is limited evidence (in terms of changed clinician behaviour and/or improved health outcomes) regarding the merits of different educational and quality improvement approaches. Features of educational interventions that were most likely to show some evidence of effectiveness included being carefully designed, multifaceted, engaged health professionals in their learning, provided ongoing support, were sensitive to local circumstances, and delivered in combination with other quality improvement strategies. To be effective, educational interventions must consider the complex healthcare systems within which they operate. The criteria for the IPCRG E-Quality awards thus require applicants not only to describe their proposed educational initiative but also to consider the practical and local barriers to successful implementation, and to propose a robust evaluation in terms of changed clinician behaviour or improved health outcomes.The IPCRG commissioned this work as part of the IPCRG e-Quality initiative. HP is supported by a Primary Care Research Career Award from the Chief Scientist's Office of the Scottish Government

Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited

At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK): study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations

Background: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events. Methods: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with ‘at-risk asthma’ identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients’ records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted. Discussion: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes. Trial registration: ISRCTN95472706. Registered on 5 December 2014

SERIES:eHealth in primary care. Part 4: Addressing the challenges of implementation

Background The implementation of eHealth applications in primary care remains challenging. Enhancing knowledge and awareness of implementation determinants is critical to build evidence-based implementation strategies and optimise uptake and sustainability. Objectives We consider how evidence-based implementation strategies can be built to support eHealth implementation. Discussion What implementation strategies to consider depends on (potential) barriers and facilitators to eHealth implementation in a given situation. Therefore, we first discuss key barriers and facilitators following the five domains of the Consolidated Framework for Implementation Research (CFIR). Cost is identified as a critical barrier to eHealth implementation. Privacy, security problems, and a lack of recognised standards for eHealth applications also hinder implementation. Engagement of key stakeholders in the implementation process, planning the implementation of the intervention, and the availability of training and support are important facilitators. To support care professionals and researchers, we provide a stepwise approach to develop and apply evidence-based implementation strategies for eHealth in primary care. It includes the following steps: (1) specify the eHealth application, (2) define problem, (3) specify desired implementation behaviour, and (4) choose and (5) evaluate the implementation strategy. To improve the fit of the implementation strategy with the setting, the stepwise approach considers the phase of the implementation process and the specific context. Conclusion Applying an approach, as provided here, may help to improve the implementation of eHealth applications in primary care.Prevention, Population and Disease management (PrePoD)Public Health and primary car

The impact of financial incentives on the implementation of asthma or diabetes self-management: A systematic review

Introduction: Financial incentives are utilised in healthcare systems in a number of countries to improve quality of care delivered to patients by rewarding practices or practitioners for achieving set targets. Objectives: To systematically review the evidence investigating the impact of financial incentives for implementation of supported self-management on quality of care including: organisational process outcomes, individual behavioural outcomes, and health outcomes for individuals with asthma or diabetes; both conditions with an extensive evidence base for self-management. Methods: We followed Cochrane methodology, using a PICOS search strategy to search eight databases in November 2015 (updated May 2017) including a broad range of implementation methodologies. Studies were weighted by robustness of methodology, number of participants and the quality score. We used narrative synthesis due to heterogeneity of studies. Results: We identified 2,541 articles; 12 met our inclusion criteria. The articles were from the US (n = 7), UK (n = 4) and Canada (n = 1). Measured outcomes were HbA1c tests undertaken and/or the level achieved (n = 10), written action plans for asthma (n = 1) and hospital/emergency department visits (n = 1). Three of the studies were part of a larger incentive scheme including many conditions; one focused on asthma; eight focussed on diabetes. In asthma, the proportion receiving ‘perfect care’ (including providing a written action plan) increased from 4% to 88% in one study, and there were fewer hospitalisations/emergency department visits in another study. Across the diabetes studies, quality-of-care/GP performance scores improved in three, were unchanged in six and deteriorated in one. Conclusions: Results for the impact of financial incentives for the implementation of self-management were mixed. The evidence in diabetes suggests no consistent impact on diabetic control. There was evidence from a single study of improved process and health outcomes in asthma. Further research is needed to confirm these findings and understand the process by which financial incentives may impact (or not) on care

Practice development plans to improve the primary care management of acute asthma: randomised controlled trial

Background: Our professional development plan aimed to improve the primary care management of acute asthma, which is known to be suboptimal. Methods: We invited 59 general practices in Grampian, Scotland to participate. Consenting practices were randomised to early and delayed intervention groups. Practices undertook audits of their management of all acute attacks (excluding children under 5 years) occurring in the 3 months preceding baseline, 6-months and 12-months study time-points. The educational programme [including feedback of audit results, attendance at a multidisciplinary interactive workshop, and formulation of development plan by practice teams] was delivered to the early group at baseline and to the delayed group at 6 months. Primary outcome measure was recording of peak flow compared to best/predicted at 6 months. Analyses are presented both with, and without adjustment for clustering. Results: 23 consenting practices were randomised: 11 to early intervention. Baseline practice demography was similar. Six early intervention practices withdraw before completing the baseline audit. There was no significant improvement in our primary outcome measure (the proportion with peak flow compared to best/predicted) at either the 6 or 12 month time points after adjustment for baseline and practice effects. However, the between group difference in the adjusted combined assessment score, whilst non-significant at 6 months (Early: 2.48 (SE 0.43) vs. Delayed 2.26 (SE 0.33) p = 0.69) reached significance at 12 m (Early:3.60 (SE 0.35) vs. Delayed 2.30 (SE 0.28) p = 0.02). Conclusion: We demonstrated no significant benefit at the a priori 6-month assessment point, though improvement in the objective assessment of attacks was shown after 12 months. Our practice development programme, incorporating audit, feedback and a workshop, successfully engaged the healthcare team of participating practices, though future randomised trials of educational interventions need to recognise that effecting change in primary care practices takes time. Monitoring of the assessment of acute attacks proved to be a feasible and responsive indicator of quality care

SERIES: eHealth in primary care. Part 1: Concepts, conditions and challenges.

Primary care is challenged to provide high quality, accessible and affordable care for an increasingly ageing, complex, and multimorbid population. To counter these challenges, primary care professionals need to take up new and innovative practices, including eHealth. eHealth applications hold the promise to overcome some difficulties encountered in the care of people with complex medical and social needs in primary care. However, many unanswered questions regarding (cost) effectiveness, integration with healthcare, and acceptability to patients, caregivers, and professionals remain to be elucidated. What conditions need to be met? What challenges need to be overcome? What downsides must be dealt with? This first paper in a series on eHealth in primary care introduces basic concepts and examines opportunities for the uptake of eHealth in primary care. We illustrate that although the potential of eHealth in primary care is high, several conditions need to be met to ensure that safe and high-quality eHealth is developed for and implemented in primary care. eHealth research needs to be optimized; ensuring evidence-based eHealth is available. Blended care, i.e. combining face-to-face care with remote options, personalized to the individual patient should be considered. Stakeholders need to be involved in the development and implementation of eHealth via co-creation processes, and design should be mindful of vulnerable groups and eHealth illiteracy. Furthermore, a global perspective on eHealth should be adopted, and eHealth ethics, patients' safety and privacy considered.Published versio

Can a GP be a generalist and a specialist? Stakeholders views on a respiratory General Practitioner with a special interest service in the UK

Peer reviewedPublisher PD

SERIES:eHealth in primary care. Part 2: Exploring the ethical implications of its application in primary care practice

Background: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth will affect patients' and primary care professionals' (PCPs) experiences, values, norms, and relationships.Objectives: We argue what ethical implications related to the impact of eHealth on four vital aspects of primary care could (and should) be anticipated.Discussion: (1) EHealth influences dealing with predictive and diagnostic uncertainty. Machine-learning based clinical decision support systems offer (seemingly) objective, quantified, and personalised outcomes. However, they also introduce new loci of uncertainty and subjectivity. The decision-making process becomes opaque, and algorithms can be invalid, biased, or even discriminatory. This has implications for professional responsibilities and judgments, justice, autonomy, and trust. (2) EHealth affects the roles and responsibilities of patients because it can stimulate self-management and autonomy. However, autonomy can also be compromised, e.g. in cases of persuasive technologies and eHealth can increase existing health disparities. (3) The delegation of tasks to a network of technologies and stakeholders requires attention for responsibility gaps and new responsibilities. (4) The triangulate relationship: patient-eHealth-PCP requires a reconsideration of the role of human interaction and 'humanness' in primary care as well as of shaping Shared Decision Making.Conclusion: Our analysis is an essential first step towards setting up a dedicated ethics research agenda that should be examined in parallel to the development and implementation of eHealth. The ultimate goal is to inspire the development of practice-specific ethical recommendations