Faintly tired: a systematic review of fatigue in patients with orthostatic syncope.

BACKGROUND: Orthostatic syncope (transient loss of conscious when standing-fainting) is common and negatively impacts quality of life. Many patients with syncope report experiencing fatigue, sometimes with "brain fog", which may further impact their quality of life, but the incidence and severity of fatigue in patients with syncope remain unclear. In this systematic review, we report evidence on the associations between fatigue and conditions of orthostatic syncope. METHODS: We performed a comprehensive literature search of four academic databases to identify articles that evaluated the association between orthostatic syncope [postural orthostatic tachycardia syndrome (POTS), vasovagal syncope (VVS), orthostatic hypotension (OH)] and fatigue. Studies were independently screened using a multi-stage approach by two researchers to maintain consistency and limit bias. RESULTS: Our initial search identified 2797 articles, of which 13 met our inclusion criteria (POTS n = 10; VVS n = 1; OH n = 1; VVS and POTS n = 1). Fatigue scores were significantly higher in patients with orthostatic syncope than healthy controls, and were particularly severe in those with POTS. Fatigue associated with orthostatic syncope disorders spanned multiple domains, with each dimension contributing equally to increased fatigue. "Brain fog" was an important symptom of POTS, negatively affecting productivity and cognition. Finally, fatigue was negatively associated with mental health in patients with POTS. CONCLUSION: In conditions of orthostatic syncope, fatigue is prevalent and debilitating, especially in patients with POTS. The consideration of fatigue in patients with orthostatic disorders is essential to improve diagnosis and management of symptoms, thus improving quality of life for affected individuals.

Measuring and Demonstrating the Value of Patient Engagement Across the Medicines Lifecycle: A Patient Engagement Impact Measurement Framework.

As the pharmaceutical industry advances towards more patient-focused product development, it is well recognized that meaningful patient engagement is required for the authentic patient voice to inform research and regulatory decisions. However, for this to happen systematically and consistently across the industry, there is still a need to evaluate and communicate the value of patient engagement to all stakeholders. Evaluating engagement also informs process improvement, elevating the value further. We describe the development of a conceptual, yet practical, framework for measuring the impact of engagement to achieve this. The framework depicts how metrics can be used to capture and assess the inputs, outputs, and value of patient engagement across the medicines lifecycle. Although conceived in the context of systems and processes within one company, Novartis, the framework was co-created with patient advisors and designed to be both patient-relevant and adaptable for any pharmaceutical organization. The adoption and evolution of the framework will help to demonstrate the value-to patients, healthcare systems, and businesses-of integrating patient engagement into core activities across the medicines lifecycle. We encourage the pharmaceutical industry to apply impact measurement to build a robust evidence base, through measuring, publishing, and communicating the value of patient engagement.

Drug companies often talk to patients about making new medicines. This is called patient engagement. It helps to ensure that new medicines are right for the patients who will take them. Patient engagement is useful, but it does not always happen. Sometimes, companies make important decisions without involving patients. All drug companies need to understand why it is important to listen and learn what patients need. We made a practical way to measure this value. Our team included people from Novartis (a drug company), and patient groups. We developed a structure called the 'framework'. It measures: How we involve patients ('Inputs') What we learn from patients ('Outputs') How this benefits patients, healthcare systems, and companies ('Value') It can measure all steps from the start to the end of drug development. We invite other companies to use a similar approach and share what they measure. Doing this will show the value of patient engagement, to make it more standard practice.

Key needs, quality performance indicators and outcomes for patients with atrial fibrillation and multimorbidity: The AFFIRMO study.

BACKGROUND: Patients with atrial fibrillation (AF) often have concomitant long-term conditions that negatively impact their quality of life and the clinical management they receive. The AFFIRMO study aimed to identify the needs, quality performance indicators (QPIs), and outcomes relevant to patients, caregivers and healthcare professionals (HCPs) to improve the care of patients with AF. METHODS: An on-line survey to collect the key needs, QPIs, and outcomes relevant to patients with AF, their caregivers and HCPs, was distributed between May 2022 and January 2023 in five countries (UK, Italy, Denmark, Romania and Spain). Results from the on-line survey were discussed in a three-round Delphi process with international representatives of patients with AF, caregivers, and HCPs to determine the key needs, QPIs and outcomes for the management of patients with AF and multimorbidity. RESULTS: 659 patients (47.2% males, mean (SD) age 70.9 (10.2) years), 201 caregivers (26.9% males, mean (SD) age: 58.3 (SD 15.2) years), and 445 HCPs (57.8% males, mean (SD) age 47.4 (10.6) years) participated in the survey. An initial list of 27 needs, 9 QPIs, and 17 outcomes were identified. Eight patients, two caregivers, and 11 HCPs participated in the Delphi process. Nineteen (70%) needs, 8 (89%) QPIs, and 13 (76%) outcomes reached "consensus in", and were included in the final list. CONCLUSIONS: The final key needs, QPIs and outcomes obtained from the Delphi process will inform the AFFIRMO clinical trial, which aims to test the iABC app which incorporates an empowerment toolbox for patients and their caregivers, providing information to improve patient engagement and empowerment to help improve the clinical and self-management of patients with AF in the context of multimorbidity.

Patient engagement in multimorbidity: a systematic review of patient-reported outcome measures.

Background: People with multimorbidity are increasingly engaged, enabled, and empowered to take responsibility for managing their health status. The purpose of the study was to systematically review and appraise the psychometric properties of tools measuring patient engagement in adults with multimorbidity and their applicability for use within engagement programs. Methods: PubMed, Scopus, Web of Science, and PsycInfo were searched from inception to 1 July 2021. Gray literature was searched using EBSCO host-database "Open dissertation". The reference lists of studies meeting the inclusion criteria were searched to identify additional eligible studies. The screening of the search results and the data extraction were performed independently by two reviewers. The methodological quality of the included studies was evaluated with the COSMIN checklist. Relevant data from all included articles were extracted and summarized in evidence synthesis tables. Results: Twenty articles on eight tools were included. We included tools that measure all four dimensions of patient engagement (i.e., engagement, empowerment, activation, and participation). Their psychometric properties were analyzed separately. Most tools were developed in the last 10 years in Europe or the USA. The comparison of the estimated psychometric properties of the retrieved tools highlighted a significant lack of reliable patient engagement measures for people with multimorbidity. Available measures capture a diversity of constructs and have very limited evidence of psychometric properties that are vital for patient-reported measures, such as invariance, reliability, and responsiveness. Conclusion: This review clarifies how patient engagement, as operationalized in measures purporting to capture this concept, overlaps with, and differs from other related constructs in adults with multimorbidity. The methodological quality of psychometric tools measuring patient engagement in adults with multimorbidity could be improved. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=259968, identifier CRD42021259968.

Patient associations as stakeholders: a valuable partner for facilitating access to therapy.

One set of important objectives of patient associations is to provide education, support, and advice to those affected by cardiac arrhythmias to ensure that they have access to appropriate diagnosis and treatment. In this perspective it is essential to establish a balanced partnership between patients and clinicians in order to facilitate the work of the patient association. Such associations must work under the guidance of and in consultation with a medical advisory committee for the production of appropriate and validated educational and awareness materials. Patient association coalitions represent and promote partnerships between professionals, patients, government, organizations, and industry. The power of an alliance works in bringing pressure to bear, in lobbying on behalf of specific patient groups. This type of coalition may also act as a depository for relevant databases and contact information relating to all the members who participate in the coalition, and facilitate rapid and complete communication between all interested parties. When fully developed it may also serve to provide current information on the diagnosis, treatment, and management of cardiac arrhythmias to patients, paramedical staff, and physicians. The Arrhythmia Alliance, initially established in the UK but now developing on an international basis sources, collates, and reflects views and data collected from members, bringing beneficial perspectives to the fore to ensure that change is led by the people and for the people.

World Heart Federation Roadmap on Atrial Fibrillation - A 2020 Update.

The World Heart Federation (WHF) commenced a Roadmap initiative in 2015 to reduce the global burden of cardiovascular disease and resultant burgeoning of healthcare costs. Roadmaps provide a blueprint for implementation of priority solutions for the principal cardiovascular diseases leading to death and disability. Atrial fibrillation (AF) is one of these conditions and is an increasing problem due to ageing of the world's population and an increase in cardiovascular risk factors that predispose to AF. The goal of the AF roadmap was to provide guidance on priority interventions that are feasible in multiple countries, and to identify roadblocks and potential strategies to overcome them. Since publication of the AF Roadmap in 2017, there have been many technological advances including devices and artificial intelligence for identification and prediction of unknown AF, better methods to achieve rhythm control, and widespread uptake of smartphones and apps that could facilitate new approaches to healthcare delivery and increasing community AF awareness. In addition, the World Health Organisation added the non-vitamin K antagonist oral anticoagulants (NOACs) to the Essential Medicines List, making it possible to increase advocacy for their widespread adoption as therapy to prevent stroke. These advances motivated the WHF to commission a 2020 AF Roadmap update. Three years after the original Roadmap publication, the identified barriers and solutions were judged still relevant, and progress has been slow. This 2020 Roadmap update reviews the significant changes since 2017 and identifies priority areas for achieving the goals of reducing death and disability related to AF, particularly targeted at low-middle income countries. These include advocacy to increase appreciation of the scope of the problem; plugging gaps in guideline management and prevention through physician education, increasing patient health literacy, and novel ways to increase access to integrated healthcare including mHealth and digital transformations; and greater emphasis on achieving practical solutions to national and regional entrenched barriers. Despite the advances reviewed in this update, the task will not be easy, but the health rewards of implementing solutions that are both innovative and practical will be great.

Syncope: a patient and family perspective.

The most common form of syncope is reflex syncope (also called vasovagal syncope and reflex anoxic seizures). Reflex syncope is common, relatively simple to diagnose, and, in most cases, should not become a significant burden for patients or their families. Yet, too many patients with treatable syncope suffer dismissal of symptoms, misdiagnosis, and nondiagnosis at the hands of medical professionals. Clinicians can also focus on too narrow a range of potential causes for the symptoms. These factors can make the perspective of syncope and its care extremely burdensome, having a profoundly negative impact on patient well-being and quality of life.