Can we collect health-related quality of life information from anticoagulated atrial fibrillation participants who have recently experienced a bleed? An observational feasibility study in primary and secondary care in Wales and through a UK online forum.

OBJECTIVE: To evaluate the feasibility of recruiting participants diagnosed with atrial fibrillation (AF) taking oral anticoagulation therapies (OATs) and recently experiencing a bleed to collect health-related quality of life (HRQoL) information. DESIGN: Observational feasibility study. The study aimed to determine the feasibility of recruiting participants with minor and major bleeds, the most appropriate route for recruitment and the appropriateness of the patient-reported outcome measures (PROMs) selected for collecting HRQoL information in AF patients, and the preferred format of the surveys. SETTING: Primary care, secondary care and via an online patient forum. PARTICIPANTS: The study population was adult patients (≥18) with AF taking OATs who had experienced a recent major or minor bleed within the last 4 weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes - PROMs: EuroQol 5 Dimensions-5 Levels, Perception of Anticoagulant Treatment Questionnaire, part 2 only (part 2), atrial fibrillation effect on quality of life. Secondary outcomes - Location of bleed, bleed severity, current treatment, patient perceptions of HRQoL in relation to bleeding events. RESULTS: We received initial expressions of interest from 103 participants. We subsequently recruited 32 participants to the study-14 from primary care and 18 through the AF forum. No participants were recruited through secondary care. Despite 32 participants consenting, only 26 initial surveys were completed. We received follow-up surveys from 11 participants (8 primary care and 3 AF forum). COVID-19 had a major impact on the study. CONCLUSIONS: Primary care was the most successful route for recruitment. Most participants recruited to the study experienced a minor bleed. Further ways to recruit in secondary care should be explored, especially to capture more serious bleeds. TRIAL REGISTRATION NUMBER: The study is registered in the Clinicaltrials.gov database, NCT04921176.

Investigating the feasibility of recruitment to an observational, quality-of-life study of patients diagnosed with atrial fibrillation (AF) who have experienced a bleed while anticoagulated: EQUAL-AF feasibility study protocol.

BACKGROUND: Oral anticoagulation therapies (OATs) are often prescribed in conjunction with medications to restore normal heart rate rhythm which can limit the risk of an atrial fibrillation (AF) related stroke and systemic thromboembolism. However, they are associated with the serious side effect of bleeding. Both clinically relevant nonmajor bleeding (CRNMB) and major bleeding while anticoagulated are believed to have a significant impact on patient quality of life (QoL). There is currently limited research into the effect bleeding has on QoL. The aim of this study is to evaluate the feasibility of identifying and recruiting patients diagnosed with AF, who are taking OATs and have recently experienced a bleed and collecting information on their QoL. METHODS: We will recruit a minimum of 50 patients to this cross-sectional, observational study. We will recruit from general practices, secondary care, and through an online AF forum. We will ask participants to complete three validated patient-reported outcome measures (PROMs), EQ5D, AFEQT, and PACT-Q, approximately 4 weeks following a bleed and again 3 months later. We will randomly select a subset of 10 participants (of those who agree to be interviewed) to undergo a structured interview with a member of the research team to explore the impact of bleeding on their QoL and to gain feedback on the three PROMs used. We will undertake a descriptive analysis of the PROMs and demographic data. We will analyse the qualitative interviews thematically to identify key themes. DISCUSSION: We aim to establish if it is possible to recruit patients and use PROMs to collect information regarding how patient QoL is affected when they experience either a clinically relevant non-major bleed (CRNMB) or major bleed while taking OATs for the management of AF. We will also explore the appropriateness, or otherwise, of the three identified PROMs for assessing quality of life following a bleed. PROMS: Three PROMs were selected following a literature review of similar QoL studies and using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for comparison. A review of the current literature produced no suitable validated PROM to record QoL experiences in patients who have been diagnosed with AF and have experienced a bleed while anticoagulated. As such, the EQ5D, AFEQT, and PACT-Q (part 2) were deemed most appropriate for use in this feasibility study. TRIAL REGISTRATION: The trial has been adopted onto the NIHR Portfolio (ID no. 47771) and registered with www. CLINICALTRIALS: gov (no. NCT04921176) retrospectively registered in June 2021.

The Challenges of Outcomes-Based Contract Implementation for Medicines in Europe.

OBJECTIVES: The aim was to outline the challenges of implementing outcomes-based contracts (OBCs) in Europe. METHODS: A scoping review was conducted, building on the searches of a previous systematic review and updating them for December 2017 until May 2021. The combined results were screened, based on inclusion and exclusion criteria. All identified studies published in the English language that described specific OBC schemes for medicines in European countries were included. Insights into the challenges of OBCs were extracted and analysed to develop a conceptual framework. RESULTS: Ten articles from the previous systematic review matched our inclusion criteria, along with 14 articles from electronic searches. Analysis of these 24 articles and classification of the challenges revealed that there are multiple barriers that must be overcome if OBCs that benefit all stakeholders are going to be adopted widely across Europe. These challenges were grouped according to five key themes: negotiation framework; outcomes; data; administration and implementation; and laws and regulation. CONCLUSIONS: If the promise of OBCs is to be fully realised in Europe, there remain major challenges that need to be overcome by all stakeholders working in partnership. The overlapping and interconnected nature of these challenges highlights the complexity of OBC arrangements.

Data linkage can reduce the burden and increase the opportunities in the implementation of Value-Based Health Care policy: a study in patients with ulcerative colitis (PROUD-UC Study).

Introduction: Healthcare systems face rising demand and unsustainable cost pressures. In response, health policymakers are adopting Value-Based Health Care (VBHC), targeting available resources to achieve the best possible patient outcomes at the lowest possible cost and actively disinvesting in care of low-value. This requires the evaluation of longitudinal clinical and patient reported outcome measures (PROMs) at an individual-level and population-scale, which can create significant data challenges. Achieving this through routinely collected electronic health record (EHR) data-linkage could facilitate the implementation of VBHC without an unacceptable data burden on patients or health systems and release time for higher-value activities. Objectives: Our study tested the ability to report an international, patient-centred outcome dataset (ICHOM-IBD) using only anonymised individual-level population-scale linked electronic health record (EHR) data sources, including clinical and patient-reported outcomes, in a cohort of patients with moderate-to-severe ulcerative colitis (UC), receiving biopharmaceutical therapies ("biologics") in a single, publicly funded, healthcare system. Results: We identified a cohort of 17,632 patients with UC in Wales and a cohort from two Health Boards of 447 patients with UC receiving biologics. 112 of these patients had completed 866 condition-specific PROMs during their biologics treatment. 44 out of 59 (74.6%) items in the ICHOM-IBD could be derived from routinely collected data of which a primary care source was essential for eight items and desirable for 21. Conclusions: We demonstrated that it is possible to report most but not all the ICHOM-IBD outcomes using routinely collected data from multiple sources without additional system burden, potentially supporting Value-Based Health Care implementation with population data science. As digital collection of PROMs and use of condition-specific registries grow, greater utility of this approach can be anticipated. We have identified that the availability of longitudinal primary and secondary care data linked with PROMs is essential for this to be possible.

The effects of a new Tendo-Achilles Pathway (TAP) on an orthopaedic department- A quality improvement study.

BACKGROUND: Achilles tendinopathy is a common pathology that is considered difficult to treat. At a time of austerity in the NHS it is essential to have carefully designed pathways that are monitored in terms of cost and effectiveness. However, a paucity of evidence exists for what the "best value" dedicated "joined up" pathway of care is for this difficult condition. OBJECTIVES: Design, implement and evaluate the impact of a new therapist lead pathway for Tendon- Achilles Pain (TAP).  METHODS: Process mapping, driver diagrams, stakeholder analysis and a series of Plan-Do-Study-Act cycles were used to design and implement TAP. To assess the impact of TAP, data was compared on whole system measures for 46 patients treated with referral to the traditional service (without TAP) and 46 patients managed according to the newly designed pathway (with TAP). A cost analysis was also conducted. RESULTS: A quality improvement approach led to the successful design and implementation of a therapist lead TAP. The impact of TAP included positive effects on patient satisfaction, a decrease in duplication of treatments, investigations and inappropriate reviews with consultants. No safety concerns were found. TAP was also £44,000 cheaper per annum than the previous service. CONCLUSION: Collaboration between orthopaedic and therapy services has resulted in a standardised pathway of care for patients with an Achilles tendinopathy.  It has removed unwanted variation, provided an opportunity to monitor the outcomes of treatments and resulted in decreased cost for the health board.

Long-term outcomes of microsurgical nasal replantation: review of the literature and illustrated 10-year follow-up of a pediatric case with full sensory recovery.

We present a case of successful artery only total nose replantation in an 18-month-old child, with 10 years of follow-up and full sensory recovery despite no nerve repair. The common absence of veins for anastomosis does not prevent successful replant, as demonstrated with the use of Hirudo medicinalis use in this unique case. We comprehensively review the literature of this rare and complex injury and advocate microsurgical replantation where possible over other methods of nasal reconstruction.

Congenital circumferential constriction band of the abdomen: a case report.

We report a case of congenital constriction band of abdomen associated with limb pseudarthrosis. The constriction band around the abdomen, though may cause initial difficulty with ventilation and parental distress, does not interfere with feeding, bowel movements, and growth. It heals spontaneously with supportive treatment though surgery may be needed in some cases.