Reducing variation in the quality of long covid care: Lessons from a national quality improvement collaborative and multi-site ethnography (preprint)

Context Long covid (post covid-19 condition) is a complex condition with diverse manifestations and uncertain prognosis. There is wide variation in how patients are investigated and managed. There have been calls for formal quality standards so as to reduce a so-called “postcode lottery” of care. We aimed to examine the nature of quality in long covid care and reduce unwarranted variation in care provided by long covid services. Methods In a mixed-method study (2021-2023), we ran a quality improvement collaborative across 10 UK sites. We also gathered data on the origins and current context of each clinic, interviewed staff and patients, and observed 12 clinics (52 consultations) and 34 multidisciplinary team (MDT) meetings (230 patient cases). Data collection and analysis were informed by relevant lenses from clinical care (e.g. evidence-based guidelines), improvement science (e.g. quality improvement cycles, reducing unwarranted variation) and philosophy of knowledge. Results The collaborative made progress towards standardizing assessment and management in some topics, but much variation remained. Clinics had different histories and path-dependencies, occupied a different place in their healthcare ecosystem and served a varied caseload including (in most clinics) a high proportion of patients with comorbidities. Dimensions of quality prioritized by patients related to the service (e.g. accessibility, ease of navigation), and human qualities of staff (e.g. attentiveness, compassion). A key route to quality long covid care was when local MDTs deliberated on unusual, complex or challenging cases for which evidence-based guidelines provided no easy answers. In such cases, collective learning occurred through idiographic reasoning, in which practitioners build lessons from the particular to the general. This contrasts with the nomothetic reasoning implicit in evidence-based guidelines, in which reasoning is assumed to go from the general (e.g. findings of clinical trials) to the particular (management of individual patients). Conclusion Not all variation in long covid services is unwarranted. Largely because long covid’s manifestations are so varied, universal ‘evidence-based’ standards are hard to define and implement. In this complex condition, quality improvement resources may be better spent supporting team-based learning locally than attempting to standardize care across widely differing services. Trial registration NCT05057260, ISRCTN15022307.

Protocol for mixed-method study by LOng COvid Multidisciplinary consortium: Optimising Treatments and servIces acrOss the NHS (LOCOMOTION) (preprint)

Introduction Long COVID, a new condition whose origins and natural history are not yet fully established, currently affects 1.5 million people in the UK. Most do not have access to specialist long COVID services. We seek to optimise long COVID care both within and outside specialist clinics, including improving access, reducing inequalities, helping patients manage their symptoms effectively at home, and providing guidance and decision support for primary care. We aim to establish a ‘gold standard’ of care by systematically analysing symptom clusters and current practices, iteratively improving pathways and systems of care, and working to disseminate better practices. Methods and analysis This mixed-method, multi-site study is informed by the principles of applied health services research, quality improvement, co-design, and learning health systems. It was developed in close partnership with patients (whose stated priorities are prompt clinical assessment; evidence-based advice and treatment; and help with returning to work and other roles) and with front-line clinicians. Workstreams and tasks to optimise assessment, treatment and monitoring are based in three contrasting settings: [1] specialist management in 10 long COVID clinics across the UK, via a quality improvement collaborative, experience-based co-design and targeted efforts to reduce inequalities of access; [2] patient self-management at home, with technology-supported monitoring; and [3] generalist management in primary care, harnessing electronic record data to study population phenotypes and develop evidence-based decision support, referral pathways and prioritisation criteria across the primary-secondary care interface, along with analysis of costs. Study governance includes an active patient advisory group. Ethics and dissemination LOCOMOTION is sponsored by the University of Leeds and approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (ref: 21/YH/0276). Dissemination plans include academic and lay publications, and partnerships with national and regional policymakers to influence service specifications and targeted funding streams. Study registration ClinicalTrials.gov NCT05057260 ; ISRCTN15022307 .

Remote Covid Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies. (preprint)

Background Accurate assessment of COVID-19 severity in the community is essential for best patient care and efficient use of services and requires a risk prediction score that is COVID-19 specific and adequately validated in a community setting. Following a qualitative phase to identify signs, symptoms and risk factors, we sought to develop and validate two COVID-19-specific risk prediction scores RECAP-GP (without peripheral oxygen saturation (SpO2)) and RECAP-O2 (with SpO2). Methods Prospective cohort study using multivariable logistic regression for model development. Data on signs and symptoms (model predictors) were collected on community-based patients with suspected COVID-19 via primary care electronic health records systems and linked with secondary data on hospital admission (primary outcome) within 28 days of symptom onset. Data sources: RECAP-GP: Oxford-Royal College of General Practitioners Research and Surveillance Centre (RSC) primary care practices (development), Northwest London (NWL) primary care practices, NHS COVID-19 Clinical Assessment Service (CCAS) (validation). RECAP-O2: Doctaly Assist platform (development, and validation in subsequent sample). Estimated sample size was 2,880 per model. Findings Data were available from 8,311 individuals. Observations, such SpO2, were mostly missing in NWL, RSC, and CCAS data; however, SpO2 was available for around 70% of Doctaly patients. In the final predictive models, RECAP-GP included sex, age, degree of breathlessness, temperature symptoms, and presence of hypertension (Area Under the Curve (AUC): 0.802, Validation Negative Predictive Value (NPV) of low risk 98.8%. RECAP-O2 included age, degree of breathlessness, fatigue, and SpO2 at rest (AUC: 0.843), Validation NPV of low risk 99.4%. Interpretation Both RECAP models are a valid tool in the assessment of COVID-19 patients in the community. RECAP-GP can be used initially, without need for observations, to identify patients who require monitoring. If the patient is monitored at home and SpO2 is available, RECAP-O2 is useful to assess the need for further treatment escalation.

Indicators for Risk of Airborne Transmission in Shared Indoor Environments and their application to COVID-19 Outbreaks (preprint)

Some infectious diseases, including COVID-19, can be transmitted via aerosols that are emitted by an infectious person and inhaled by susceptible individuals. Although physical distancing effectively reduces short-range airborne transmission, many infections have occurred when sharing room air despite maintaining distancing. We propose two simple parameters as indicators of infection risk for this situation. They combine the key factors that control airborne disease transmission indoors: virus-containing aerosol generation rate, breathing flow rate, masking and its quality, ventilation and air cleaning rates, number of occupants, and duration of exposure. COVID-19 outbreaks show a clear trend in relation to these parameters that is consistent with an airborne infection model, supporting the importance of airborne transmission for these outbreaks. The observed trends of outbreak size vs. risk parameters allow us to recommend values of the parameters to minimize COVID-19 indoor infection risk. All of the pre-pandemic spaces are in a regime where they are highly sensitive to mitigation efforts. Measles outbreaks occur at much lower risk parameter values than COVID-19, while tuberculosis outbreaks are observed at much higher risk parameter values. Since both diseases are accepted as airborne, the fact that COVID-19 is less contagious than measles does not rule out airborne transmission. It is important that future outbreak reports include ventilation information, to allow expanding our knowledge of the circumstances conducive to airborne transmission of different diseases.

Direct and indirect evidence of efficacy and safety of rapid exercise tests for exertional desaturation in Covid-19: A rapid systematic review (preprint)

Background: Even when resting pulse oximetry is normal in the patient with acute Covid-19, hypoxia can manifest on exertion. We summarise the literature on the performance of different rapid tests for exertional desaturation and draw on this evidence base to provide guidance in the context of acute COVID-19. Main research questions 1. What exercise tests have been used to assess exertional hypoxia at home or in an ambulatory setting in the context of Covid-19 and to what extent have they been validated?2. What exercise tests have been used to assess exertional hypoxia in other lung conditions, to what extent have they been validated and what is the applicability of these studies to acute Covid-19? Method: AMED, CINAHL, EMBASE MEDLINE, Cochrane and PubMed using LitCovid, Scholar and Google databases were searched to September 2020. Studies where participants had Covid-19 or another lung disease and underwent any form of exercise test which was compared to a reference standard were eligible. Risk of bias was assessed using QUADAS 2. A protocol for the review was published on the Medrxiv database. Results: Of 47 relevant papers, 15 were empirical studies, of which 11 described an attempt to validate one or more exercise desaturation tests in lung diseases other than Covid-19. In all but one of these, methodological quality was poor or impossible to fully assess. None had been designed as a formal validation study (most used simple tests of correlation). Only one validation study (comparing a 1-minute sit-to-stand test [1MSTST] with reference to the 6-minute walk test [6MWT] in 107 patients with interstitial lung disease) contained sufficient raw data for us to calculate the sensitivity (88%), specificity (81%), and positive and negative predictive value (79% and 89% respectively) of the 1MSTST. The other 4 empirical studies included two predictive studies on patients with Covid-19, and two on HIV-positive patients with suspected pneumocystis pneumonia. We found no studies on the 40-step walk test (a less demanding test that is widely used in clinical practice to assess Covid-19 patients). Heterogeneity of study design precluded meta-analysis. Discussion: Exertional desaturation tests have not yet been validated in patients with (or suspected of having) Covid-19. A stronger evidence base exists for the diagnostic accuracy of the 1MSTST in chronic long term pulmonary disease, the relative intensity of this test may raise safety concerns in remote consultations or unstable patients. The less strenuous 40-step walk test should be urgently evaluated.

Chinese Herbal Medicine (“3 Medicines and 3 Formulations”) for COVID-19: Rapid Systematic Review and Meta-Analysis (preprint)

Background: To evaluate the evidence behind claims that Chinese Herbal Medicine, specifically “three medicines and three formulations” (3M3F, comprising Jinhua Qinggan, Lianhua Qingwen, Xuebijing, Qingfei Paidu, Huashi Baidu and Xuanfei Baidu), is an effective treatment for COVID-19. Methods: We searched PubMed, MEDLINE and CNKI databases, preprint servers, clinical trial registries and supplementary sources for Chinese- or English-language randomised trials or non-randomised studies with comparator groups, which tested the constituents of 3M3F in the treatment of COVID-19 up to September 2020. Primary outcome was change in disease severity. Secondary outcomes included various symptoms. Meta-analysis (using generic inverse variance random effects model) was performed when there were two or more studies reporting on the same symptom. Results: Of 607 articles identified, thirteen primary studies (six RCTs and seven retrospective non-randomised comparative studies) with 1467 participants met our final inclusion criteria. Studies were small and had significant methodological limitations, most notably potential bias in assessment of outcomes. No study convincingly demonstrated a statistically significant impact on change in disease severity. Eight studies reported sufficiently similar secondary outcomes to be included in a meta-analysis. Some statistically significant impacts on symptoms, chest CT manifestations, laboratory variables and length of stay were demonstrated, but such findings were sparse and many remain unreplicated.Conclusions: These findings neither support nor refute the claim that 3M3F alters the severity of COVID-19 or alleviates symptoms. More rigorous studies are required to properly ascertain the potential role of Chinese Herbal Medicine in COVID-19.Systematic review registration:  This review was registered on PROSPERO (CRD42020187502) prior to data collection and analysis.

Persistent symptoms after Covid-19: qualitative study of 114 long Covid patients and draft quality criteria for services (preprint)

BackgroundApproximately 10% of patients with Covid-19 experience symptoms beyond 3-4 weeks. Patients call this "long Covid". We sought to document the lived experience of such patients, their accounts of accessing and receiving healthcare, and their ideas for improving services. MethodWe held 55 individual interviews and 8 focus groups (n = 59) with people recruited from UK-based long Covid patient support groups, social media and snowballing. We restricted some focus groups to health professionals since they had already self-organised into online communities. Participants were invited to tell their personal stories and comment on others stories. Data were audiotaped, transcribed, anonymised and coded using NVIVO. Analysis incorporated sociological theories of illness, healing, peer support, the clinical relationship, access to care, and service redesign. ResultsThe sample was 70% female, aged 27-73 years, and comprised White British (74%), Asian (11%), White Other (7%), Black (4%), and Mixed (4%). 27 were doctors and 23 other health professionals. 10% had been hospitalised. Analysis revealed a confusing illness with many, varied and often relapsing-remitting symptoms and uncertain prognosis; a heavy sense of loss and stigma; difficulty accessing and navigating services; difficulty being taken seriously and achieving a diagnosis; disjointed and siloed care (including inability to access specialist services); variation in standards (e.g. inconsistent criteria for seeing, investigating and referring patients); variable quality of the therapeutic relationship (some participants felt well supported while others felt "fobbed off"); and possible critical events (e.g. deterioration after being unable to access services). Emotional touch points in participants experiences informed ideas for improving services. ConclusionQuality principles for a long Covid service should include ensuring access to care, reducing burden of illness, taking clinical responsibility and providing continuity of care, multi-disciplinary rehabilitation, evidence-based investigation and management, and further development of the knowledge base and clinical services. Study registrationNCT04435041

Performance and impact of disposable and reusable respirators for healthcare workers during pandemic respiratory disease: a rapid evidence review. (preprint)

ObjectivesIn the context of the Covid-19 pandemic, to identify the range of filtering respirators that can be used in patient care and synthesise evidence to guide the selection and use of different respirator types. DesignComparative analysis of international standards for filtering respirators and rapid review of their performance and impact in healthcare. Data sourcesWebsites of international standards organisations, Medline and EMBASE (final search 11th May 2020), with hand-searching of references and citations. Study selectionGuided by the SPIDER tool, we included studies whose sample was healthcare workers (including students). The phenomenon of interest was respirators, including disposable and reusable types. Study designs including cross-sectional, observational cohort, simulation, interview and focus group. Evaluation approaches included test of respirator performance, test of clinician performance or adherence, self-reported comfort and impact, and perceptions of use. Research types included quantitative, qualitative and mixed methods. We excluded studies comparing the effectiveness of respirators with other forms of protective equipment. Data extraction, analysis and synthesisTwo reviewers extracted data using a template. Suitability for inclusion in the analysis was judged by two reviewers. We synthesised standards by tabulating data according to key criteria. For the empirical studies, we coded data thematically followed by narrative synthesis. ResultsWe included relevant standards from 8 authorities across Europe, North and South America, Asia and Australasia. 39 research studies met our inclusion criteria. There were no instances of comparable publications suitable for quantitative comparison. There were four main findings. First, international standards for respirators apply across workplace settings and are broadly comparable across jurisdictions. Second, effective and safe respirator use depends on proper fitting and fit-testing. Third, all respirator types carry a burden to the user of discomfort and interference with communication which may limit their safe use over long periods; studies suggest that they have little impact on specific clinical skills in the short term but there is limited evidence on the impact of prolonged wearing. Finally, some clinical activities, particularly chest compressions, reduce the performance of filtering facepiece respirators. ConclusionA wide range of respirator types and models is available for use in patient care during respiratory pandemics. Careful consideration of performance and impact of respirators is needed to maximise protection of healthcare workers and minimise disruption to the delivery of care.