Therapies for Long COVID in non-hospitalised individuals - from symptoms, patient-reported outcomes, and immunology to targeted therapies (The TLC Study): Study protocol

Introduction Individuals with COVID-19 frequently experience symptoms and impaired quality of life beyond 4-12 weeks, commonly referred to as Long COVID. Whether Long COVID is one or several distinct syndromes is unknown. Establishing the evidence base for appropriate therapies is needed. We aim to evaluate the symptom burden and underlying pathophysiology of Long COVID syndromes in non-hospitalised individuals and evaluate potential therapies. Methods and analysis A cohort of 4000 non-hospitalised individuals with a past COVID-19 diagnosis and 1000 matched controls will be selected from anonymised primary care records from the Clinical Practice Research Datalink (CPRD) and invited by their general practitioners to participate on a digital platform (Atom5TM). Individuals will report symptoms, quality of life, work capability, and patient reported outcome measures. Data will be collected monthly for one year. Statistical clustering methods will be used to identify distinct Long COVID symptom clusters. Individuals from the four most prevalent clusters and two control groups will be invited to participate in the BioWear sub-study which will further phenotype Long COVID symptom clusters by measurement of immunological parameters and actigraphy. We will review existing evidence on interventions for post-viral syndromes and Long COVID to map and prioritise interventions for each newly characterised Long COVID syndrome. Recommendations will be made using the cumulated evidence in an expert consensus workshop. A virtual supportive intervention will be coproduced with patients and health service providers for future evaluation. Individuals with lived experience of Long COVID will be involved throughout this programme through a patient and public involvement group. Ethics and dissemination Ethical approval was obtained from the Solihull Research Ethics Committee, West Midlands (21/WM/0203). The study is registered on the ISRCTN Registry (1567490). Research findings will be presented at international conferences, in peer-reviewed journals, to Long COVID patient support groups and to policymakers.

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Symptoms and Association with Health Outcomes in Relapsing-Remitting Multiple Sclerosis: Results of a US Patient Survey

Multiple Sclerosis International ◽

10.1155/2014/203183 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

Angela E. Williams ◽

Jeffrey T. Vietri ◽

Gina Isherwood ◽

Armando Flor

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Patient Reported Outcomes ◽

The United States ◽

Symptom Clusters ◽

Patient Reported ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

Background. A variety of symptoms have been reported, but the prevalence of specific symptoms in relapsing-remitting multiple sclerosis (RRMS), how they are related to one another, and their impact on patient reported outcomes is not well understood.Objective. To describe how symptoms of RRMS cooccur and their impact on patient-reported outcomes.Methods. Individuals who reported a physician diagnosis of RRMS in a large general health survey in the United States indicated the symptoms they experience because of RRMS and completed validated scales, including the work productivity and activity impairment questionnaire and either the SF-12v2 or SF-36v2. Symptom clusters were identified through hierarchical cluster analysis, and the relationship between clusters and outcomes was assessed through regression.Results. Fatigue, difficulty walking, and numbness were the most commonly reported symptoms. Seven symptom clusters were identified, and several were significantly related to patient reported outcomes. Pain, muscle spasms, and stiffness formed a cluster strongly related to physical quality of life; depression was strongly related to mental quality of life and cognitive difficulty was associated with work impairment.Conclusions. Symptoms in RRMS show a strong relationship with quality of life and should be taken into consideration in treatment decisions and evaluation of treatment success.

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Development of a New Quality of Life Measure for Duchenne Muscular Dystrophy Using Mixed Methods

Neurology ◽

10.1212/wnl.0000000000011896 ◽

2021 ◽

pp. 10.1212/WNL.0000000000011896

Author(s):

Philip A. Powell ◽

Jill Carlton ◽

Donna Rowen ◽

Fleur Chandler ◽

Michela Guglieri ◽

...

Keyword(s):

Quality Of Life ◽

Mixed Methods ◽

Duchenne Muscular Dystrophy ◽

Muscular Dystrophy ◽

Online Survey ◽

Public Involvement ◽

Face Validity ◽

Proxy Report ◽

Patient Reported

ObjectiveBased on concerns over existing patient reported outcome measures (PROMs) for assessing quality of life (QoL) in Duchenne muscular dystrophy (DMD), we describe the mixed methods development of a new QoL PROM for use in boys and men with DMD: the DMD-QoL.MethodsThe DMD-QoL was developed in 3 stages. First, draft items were generated from 18 semi-structured qualitative interviews with boys and men with DMD, analysed using framework analysis. Second, cognitive debriefing interviews with patients (n = 10), clinicians (n = 8), and patients' parents (n = 10) were undertaken and a reduced item set selected and refined. Third, psychometric data on the draft items from a cross-sectional online survey (n = 102), and stakeholder input from patients and patients' parents, was used to produce the final questionnaire. Patient and public involvement and engagement was embedded throughout the process.ResultsFrom an initial draft of 47 items, a revised set of 27 items was produced at stage 2, and this set was further refined at stage 3 to generate the DMD-QoL, a 14-item QoL PROM. The DMD-QoL is designed for use from 7 years of age by proxy report and from 10 years of age by self or proxy report. The final measure showed good psychometric properties.ConclusionsThe DMD-QoL is a new 14-item QoL PROM for boys and men with DMD, with demonstrable content and face validity.

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Children and Adults Tai Chi Study (CF-CATS2): a randomised controlled feasibility study comparing internet-delivered with face-to-face Tai Chi lessons in cystic fibrosis

ERJ Open Research ◽

10.1183/23120541.00042-2018 ◽

2018 ◽

Vol 4 (4) ◽

pp. 00042-2018 ◽

Cited By ~ 2

Author(s):

Siobhán B. Carr ◽

Patricia Ronan ◽

Ava Lorenc ◽

Awais Mian ◽

Susan L. Madge ◽

...

Keyword(s):

Quality Of Life ◽

Cystic Fibrosis ◽

Health Status ◽

Tai Chi ◽

Practice Research ◽

The Internet ◽

Night Time ◽

Face To Face ◽

Patient Reported

Virtual healthcare is fast entering medical practice. Research into the feasibility of using it to teach treatment regimens such as exercise has not been explored. Maintaining an exercise regime can be difficult in cystic fibrosis: group classes risk potential infection, yet motivation is hard to maintain when alone. Tai Chi is a low-impact exercise and involves gentle, demanding movements. This study aimed to assess the feasibility, safety and acceptability of learning Tai Chi via an internet-based approach and compared patient-reported outcomes.Children and adults with cystic fibrosis were recruited to a randomised, comparative effectiveness trial. Participants learnt eight Tai Chi movements; teaching was delivered in eight lessons over 3 months: delivered either via the internet or face-to-face. Assessments were at 3-monthly intervals over 9 months. Outcomes included health status, quality of life, sleep, mindfulness and instructor-led questions.40 adults and children completed the eight sets of Tai Chi lessons. The median age was 22.8 years (range 6.1–51.5 years); 27 patients were female. The cohort comprised 26 adults (aged >16 years), six teenagers and eight children (aged <12 years). The groups were well matched. Feasibility and safety were demonstrated. Participants showed significant improvements in self-reported sleep, cough (both daytime and night-time), stomach ache and breathing. No differences in lung function, health status, quality of life, sleep or mindfulness was shown before or after completing the lessons.Tai Chi was safe and well tolerated; it was feasible to deliver individual lessons via the internet, reducing concerns regarding cross-infection, and appeared to improve self-reported symptoms.

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Association of Physical Morbidity and Health-Related Quality of Life in a Representative Sample of Older German People

European Journal of Health Psychology ◽

10.1027/2512-8442/a000019 ◽

2018 ◽

Vol 25 (4) ◽

pp. 140-151

Author(s):

Markus A. Wirtz ◽

Matthias Morfeld ◽

Elmar Brähler ◽

Andreas Hinz ◽

Heide Glaesmer

Keyword(s):

Quality Of Life ◽

Representative Sample ◽

Short Form ◽

Physical Symptoms ◽

German Population ◽

Health Related Quality ◽

Patient Reported ◽

Related Quality ◽

Health Related

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.

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