High-risk prescribing and preventable drug-related complications are common in primary care. We evaluated whether the rates of high-risk prescribing by primary care clinicians and the related ...clinical outcomes would be reduced by a complex intervention.
In this cluster-randomized, stepped-wedge trial conducted in Tayside, Scotland, we randomly assigned participating primary care practices to various start dates for a 48-week intervention comprising professional education, informatics to facilitate review, and financial incentives for practices to review patients' charts to assess appropriateness. The primary outcome was patient-level exposure to any of nine measures of high-risk prescribing of nonsteroidal antiinflammatory drugs (NSAIDs) or selected antiplatelet agents (e.g., NSAID prescription in a patient with chronic kidney disease or coprescription of an NSAID and an oral anticoagulant without gastroprotection). Prespecified secondary outcomes included the incidence of related hospital admissions. Analyses were performed according to the intention-to-treat principle, with the use of mixed-effect models to account for clustering in the data.
A total of 34 practices underwent randomization, 33 of which completed the study. Data were analyzed for 33,334 patients at risk at one or more points in the preintervention period and for 33,060 at risk at one or more points in the intervention period. Targeted high-risk prescribing was significantly reduced, from a rate of 3.7% (1102 of 29,537 patients at risk) immediately before the intervention to 2.2% (674 of 30,187) at the end of the intervention (adjusted odds ratio, 0.63; 95% confidence interval CI, 0.57 to 0.68; P<0.001). The rate of hospital admissions for gastrointestinal ulcer or bleeding was significantly reduced from the preintervention period to the intervention period (from 55.7 to 37.0 admissions per 10,000 person-years; rate ratio, 0.66; 95% CI, 0.51 to 0.86; P=0.002), as was the rate of admissions for heart failure (from 707.7 to 513.5 admissions per 10,000 person-years; rate ratio, 0.73; 95% CI, 0.56 to 0.95; P=0.02), but admissions for acute kidney injury were not (101.9 and 86.0 admissions per 10,000 person-years, respectively; rate ratio, 0.84; 95% CI, 0.68 to 1.09; P=0.19).
A complex intervention combining professional education, informatics, and financial incentives reduced the rate of high-risk prescribing of antiplatelet medications and NSAIDs and may have improved clinical outcomes. (Funded by the Scottish Government Chief Scientist Office; ClinicalTrials.gov number, NCT01425502.).
Long COVID is a devastating, long-term, debilitating illness which disproportionately affects healthcare workers, due to the nature of their work. There is currently limited evidence specific to ...healthcare workers about the experience of living with Long COVID, or its prevalence, pattern of recovery or impact on healthcare.
Our objective was to assess the effects of Long COVID among healthcare workers and its impact on health status, working lives, personal circumstances, and use of health service resources.
We conducted a systematic rapid review according to current methodological standards and reported it in adherence to the PRISMA 2020 and ENTREQ statements.
We searched relevant electronic databases and identified 3770 articles of which two studies providing qualitative evidence and 28 survey studies providing quantitative evidence were eligible. Thematic analysis of the two qualitative studies identified five themes: uncertainty about symptoms, difficulty accessing services, importance of being listened to and supported, patient versus professional identity and suggestions to improve communication and services for people with Long COVID. Common long-term symptoms in the survey studies included fatigue, headache, loss of taste and/or smell, breathlessness, dyspnoea, difficulty concentrating, depression and anxiety.
Healthcare workers struggled with their dual identity (patient/doctor) and felt dismissed or not taken seriously by their doctors. Our findings are in line with those in the literature showing that there are barriers to healthcare professionals accessing healthcare and highlighting the challenges of receiving care due to their professional role. A more representative approach in Long COVID research is needed to reflect the diverse nature of healthcare staff and their occupations. This rapid review was conducted using robust methods with the codicil that the pace of research into Long COVID may mean relevant evidence was not identified.
Childbirth is a major risk factor for urinary incontinence (UI). As a result, pelvic floor muscle training (PFMT) is commonly recommended during and after pregnancy to prevent the onset of UI. PFMT ...is often classed as a physical activity (PA) behaviour, hence PA guidelines for postnatal women encourage PFMT alongside aerobic activities. However, postnatal lifestyle interventions tend to overlook PFMT which can be detrimental to women's health and future health risks, including urinary incontinence. This study aimed to explore perceptions and acceptability of a postnatal physical activity and PFMT intervention with postnatal women in Scotland.
We recruited women who had given birth within the last 5 years by displaying posters in health centres and community centres in Stirling and through Facebook. Data was gathered via online and face-to-face focus groups, that were audio recorded and transcribed verbatim. Analytic themes were initially organised under related concepts derived from the topic guide and thematic analysis conducted. Subsequent analysis was by the Framework technique.
A total of seven online and face-to-face focus group discussions with 31 women identified there was a clear intention behaviour gap for engagement in PA, with both psychological and logistical barriers identified such as motivation and childcare. This was distinct from PFMT where there was a feeling of helplessness around not knowing how to perform a correct PFMT contraction subsequently resulting in women not adhering to PFMT guidance. Women felt there was no accessible PFMT advice available through the NHS. Some participants had received PFMT advice after childbirth and spoke of the Squeezee app being useful in adhering to a PFMT regimen but they did require additional teaching on how to do correct contractions. There was need for clarity and practical support for PFMT in the postnatal period with an approved intervention incorporating an accessible app being suggested by participants.
Women would like to be trained on postnatal PFMT but face barriers to accessing adequate information and education on how to do a PFMT contraction. An intervention combining PFMT training and an app would be the most useful for their needs and circumstances.
Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions ...work or fail, and whether they can be transferred to other settings and populations. However, historically, context has not been sufficiently explored and reported resulting in the poor uptake of trial results. Therefore, suitable methodologies are needed to guide the investigation of context. Case study is one appropriate methodology, but there is little guidance about what case study design can offer the study of context in trials. We address this gap in the literature by presenting a number of important considerations for process evaluation using a case study design.
In this paper, we define context, the relationship between complex interventions and context, and describe case study design methodology. A well-designed process evaluation using case study should consider the following core components: the purpose; definition of the intervention; the trial design, the case, the theories or logic models underpinning the intervention, the sampling approach and the conceptual or theoretical framework. We describe each of these in detail and highlight with examples from recently published process evaluations.
There are a number of approaches to process evaluation design in the literature; however, there is a paucity of research on what case study design can offer process evaluations. We argue that case study is one of the best research designs to underpin process evaluations, to capture the dynamic and complex relationship between intervention and context during implementation. We provide a comprehensive overview of the issues for process evaluation design to consider when using a case study design.
DQIP - ClinicalTrials.gov number, NCT01425502 - OPAL - ISRCTN57746448.
Objectives (A) To measure the extent to which different candidate outcome measures identified high-risk prescribing that is potentially changeable by the data-driven quality improvement in primary ...care (DQIP) intervention.(B) To explore the value of reviewing identified high-risk prescribing to clinicians.(C) To optimise the components of the DQIP intervention. Design Mixed method study. Setting General practices in two Scottish Health boards. Participants 4 purposively sampled general practices of varying size and socioeconomic deprivation. Outcome measures Prescribing measures targeting (1) high-risk use of the non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelets; (2) ‘Asthma control’ and (3) ‘Antithrombotics in atrial fibrillation (AF)’. Intervention The prescribing measures were used to identify patients for review by general practices. The ability of the measures to identify potentially changeable high-risk prescribing was measured as the proportion of patients reviewed where practices identified a need for action. Field notes were recorded from meetings between researchers and staff and key staff participated in semistructured interviews exploring their experience of the piloted intervention processes. Results Practices identified a need for action in 68%, 25% and 18% of patients reviewed for prescribing measures (1), (2) and (3), respectively. General practitioners valued being prompted to review patients, and perceived that (1) ‘NSAID and antiplatelet’ and (2) ‘antithrombotics in AF’ were the most important to act on. Barriers to initial and ongoing engagement and to sustaining improvements in prescribing were identified. Conclusions ‘NSAIDs and antiplatelets’ measures were selected as the most suitable outcome measures for the DQIP trial, based on evidence of this prescribing being more easily changeable. In response to the barriers identified, the intervention was designed to include a financial incentive, additional ongoing feedback on progress and reprompting review of patients, whose high-risk prescribing was restarted after a decision to stop. Trial registration number Clinicaltrials.gov NCT01425502.
Emotional labour or emotion management describes regulation of feelings to fulfil specific job roles, discussed extensively around commercial and caring professions and more recently qualitative ...researchers. During the COVID-19 pandemic, this was heightened due to changes in the socio-political context affecting individual circumstances and research practice, yet accounts pertaining to qualitative researchers are lacking.
This paper presents a collaborative autoethnographic account of the emotional labour experiences of researchers working on a longitudinal, mixed methods study on the lived experiences of healthcare workers with Long COVID in Scotland during the pandemic. The types, intensity and impacts of the emotional labour was unforeseen at the outset, rooted in a culmination of unique factors that transpired over time: circumstances pertaining to the socio-political context; the novelty, unpredictability and devastating nature and impacts of Long COVID illness; the levels of participant distress and their unfulfilled support needs. In response, researchers engaged in a range of types of emotion management - Strategic emotion work; Emotional reflexivity; Emotion work to cope with emotive dissonance and Managing relationships. This was additionally challenging given the already difficult homeworking and lockdown climate balancing workplace and personal responsibilities, and by the necessary use of remote methods for both data-gathering and interacting with colleagues, which impeded our ability to provide and receive support. Critically, emotional labour needs to be recognised, acknowledged and formal plans put in place to support researchers across individual, research team and institutional levels, with consideration of socio-political influences at the time of study.
•Researchers emotional labour was heightened during the Covid-19 pandemic.•Socio-political context was key in shaping researchers emotional labour experiences.•Emotional labour needs to be recognised, routinely planned for and supported across multi-levels.
Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is ...good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors.
This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention.
We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.
High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. ...The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable.
We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters) that agree to take part will receive the data-driven quality improvement in primary care (DQIP) intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR) up front and a small payment of 15 GBP (24 USD; 17 EUR) for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will additionally be a process and economic evaluation alongside the main trial.
The DQIP intervention is an example of a potentially sustainable safety improvement intervention that builds on the existing National Health Service IT-infrastructure to facilitate systematic management of high-risk prescribing by existing practice staff. Although the focus in this trial is on Non-steroidal anti-inflammatory drugs and antiplatelets, we anticipate that the tested intervention would be generalisable to other types of prescribing if shown to be effective.
ClinicalTrials.gov, dossier number: NCT01425502.
Process evaluations are recommended to open the 'black box' of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current ...literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.
We reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.
The developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.
There is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.
Clinicaltrials.gov NCT01425502.
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