R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12.

In this latest update we highlight the final results from the RCT-DUPLICATE initiative, the publication of guidance from Haute Autorité de Santé (HAS), the joint viewpoint from the Institute for Quality and Efficiency in HealthCare (IQWIG) and the Belgian HealthCare Knowledge Center, and a position from the European Organization for Research and Treatment of Cancer (EORTC). Finally, we discuss how the NICE RWE framework has been implemented to allow consideration of RWE external control arms.

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11.

In this latest update we highlight a study from the REPEAT initiative that evaluates the reproducibility of real-world data studies, the publication of the HARPER Protocol Template developed by a joint ISPE/ISPOR taskforce, and discuss recent US FDA guidance on external control arms.

Association of COVID-19 With Major Arterial and Venous Thrombotic Diseases: A Population-Wide Cohort Study of 48 Million Adults in England and Wales.

BACKGROUND: Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induces a prothrombotic state, but long-term effects of COVID-19 on incidence of vascular diseases are unclear. METHODS: We studied vascular diseases after COVID-19 diagnosis in population-wide anonymized linked English and Welsh electronic health records from January 1 to December 7, 2020. We estimated adjusted hazard ratios comparing the incidence of arterial thromboses and venous thromboembolic events (VTEs) after diagnosis of COVID-19 with the incidence in people without a COVID-19 diagnosis. We conducted subgroup analyses by COVID-19 severity, demographic characteristics, and previous history. RESULTS: Among 48 million adults, 125 985 were hospitalized and 1 319 789 were not hospitalized within 28 days of COVID-19 diagnosis. In England, there were 260 279 first arterial thromboses and 59 421 first VTEs during 41.6 million person-years of follow-up. Adjusted hazard ratios for first arterial thrombosis after COVID-19 diagnosis compared with no COVID-19 diagnosis declined from 21.7 (95% CI, 21.0-22.4) in week 1 after COVID-19 diagnosis to 1.34 (95% CI, 1.21-1.48) during weeks 27 to 49. Adjusted hazard ratios for first VTE after COVID-19 diagnosis declined from 33.2 (95% CI, 31.3-35.2) in week 1 to 1.80 (95% CI, 1.50-2.17) during weeks 27 to 49. Adjusted hazard ratios were higher, for longer after diagnosis, after hospitalized versus nonhospitalized COVID-19, among Black or Asian versus White people, and among people without versus with a previous event. The estimated whole-population increases in risk of arterial thromboses and VTEs 49 weeks after COVID-19 diagnosis were 0.5% and 0.25%, respectively, corresponding to 7200 and 3500 additional events, respectively, after 1.4 million COVID-19 diagnoses. CONCLUSIONS: High relative incidence of vascular events soon after COVID-19 diagnosis declines more rapidly for arterial thromboses than VTEs. However, incidence remains elevated up to 49 weeks after COVID-19 diagnosis. These results support policies to prevent severe COVID-19 by means of COVID-19 vaccines, early review after discharge, risk factor control, and use of secondary preventive agents in high-risk patients.

Factors Associated with Risk of Stroke-Associated Pneumonia in Patients with Dysphagia: A Systematic Review.

Dysphagia is associated with increased risk of stroke-associated pneumonia (SAP). However, it is unclear what other factors contribute to that risk or which measures may reduce it. This systematic review aimed to provide evidence on interventions and care processes associated with SAP in patients with dysphagia. Studies were screened for inclusion if they included dysphagia only patients, dysphagia and non-dysphagia patients or unselected patients that included dysphagic patients and evaluated factors associated with a recorded frequency of SAP. Electronic databases were searched from inception to February 2017. Eligible studies were critically appraised. Heterogeneity was evaluated using I2. The primary outcome was SAP. Eleven studies were included. Sample sizes ranged from 60 to 1088 patients. There was heterogeneity in study design. Measures of immunodepression are associated with SAP in dysphagic patients. There is insufficient evidence to justify screening for aerobic Gram-negative bacteria. Prophylactic antibiotics did not prevent SAP and proton pump inhibitors may increase risk. Treatment with metoclopramide may reduce SAP risk. Evidence that nasogastric tube (NGT) placement increases risk of SAP is equivocal. A multidisciplinary team approach and instrumental assessment of swallowing may reduce risk of pneumonia. Patients with impaired mobility were associated with increased risk. Findings should be interpreted with caution given the number of studies, heterogeneity and descriptive analyses. Several medical interventions and care processes, which may reduce risk of SAP in patients with dysphagia, have been identified. Further research is needed to evaluate the role of these interventions and care processes in clinical practice.

Experiences of Dysphagia after Stroke: An Interview Study of Stroke Survivors and Their Informal Caregivers.

(1) Background: Swallowing difficulties (dysphagia) after stroke are not uncommon and is a consistent risk factor for stroke-associated pneumonia. This interview study explores the perspectives of stroke survivors, who had their swallowing assessed in the first few days of admission to hospital, and their informal caregivers. (2) Methods: A participatory approach was used involving people affected by stroke in the interpretation and analysis of the interview data. Data was thematically analysed and six themes were identified. (3) Results: These themes included how past-future experiences may influence a person's emotional response to events; understanding what is happening and adjustment; the impact of dysphagia; attitudes to care; communication to patients and procedural issues. (4) Conclusion: The findings highlight the importance of effective public health messages to improve people's responsiveness to the signs of stroke, standardisation of assessment and management procedures, effective communication to patients about the consequences of dysphagia, and the impact of dysphagia on the person who had the stroke and their informal caregiver.

Variation in Dysphagia Assessment and Management in Acute Stroke: An Interview Study.

(1) Background: Patients with dysphagia are at increased risk of stroke-associated pneumonia. There is wide variation in the way patients are screened and assessed. The aim of this study is to explore staff opinions about current practice of dysphagia screening, assessment and clinical management in acute phase stroke. (2) Methods: Fifteen interviews were conducted in five English National Health Service hospitals. Hospitals were selected based on size and performance against national targets for dysphagia screening and assessment, and prevalence of stroke-associated pneumonia. Participants were purposefully recruited to reflect a range of healthcare professions. Data were analysed using a six-stage thematic process. (3) Results: Three meta themes were identified: delays in care, lack of standardisation and variability in resources. Patient, staff, and service factors that contribute to delays in dysphagia screening, assessment by a speech and language therapist, and delays in nasogastric tube feeding were identified. These included admission route, perceived lack of ownership for screening patients, prioritisation of assessments and staff resources. There was a lack of standardisation of dysphagia screening protocols and oral care. There was variability in staff competences and resources to assess patients, types of medical interventions, and care processes. (4) Conclusion: There is a lack of standardisation in the way patients are assessed for dysphagia and variation in practice relating to staff competences, resources and care processes between hospitals. A range of patient, staff and service factors have the potential to impact on stroke patients being assessed within the recommended national guidelines.

Untapping the potential of medical trainees to improve the quality of healthcare.

Doctors in training have the potential to make important contributions to improving healthcare services, at the same time as developing their own skills and knowledge about quality improvement (QI). However, meaningful improvements in healthcare quality and useful educational experiences for trainees are unlikely to occur unless employers and training organisations develop systematic approaches to involving trainees in QI. Organisations need to provide trainees with the time, resources, mentorship, educational supervision and training in QI methods required for them to carry out QI projects successfully. Focusing the efforts of trainees in tackling high value and strategically important problems, working together as teams rather than as individuals, and learning from and contributing to published QI reports will make it more likely that genuine improvements are achieved and sustained over time. Finally, career pathways should be developed to allow trainees to gain in-depth, specialist knowledge and experience of QI, and work towards becoming the improvement leaders of the future NHS.

Improving quality of care through national clinical audit.

The UK's national health services are unique in having a well established programme of national clinical audits and databases across medical, surgical and mental health conditions. The Royal College of Physicians' (RCP) Clinical Effectivess and Evaluation Unit leads many of the largest and most mature audits in partnership with specialist societies, other colleges, patient groups and academic institutions. In this paper, we shall trace the development of national audit over the last 2 decades, explore the mechanisms by which this has helped improve care and discuss how national clinical audits and databases can best support quality improvement in the NHS of the future.