Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations.
This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders.
This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.
To investigate psychological and behavioural responses to COVID-19 among the Chinese general population.
We conducted a population-based mobile phone survey between 1 February and 10 February 2020 via random digit dialling. A total of 1011 adult residents in Wuhan (n=510), the epicentre and quarantined city, and Shanghai (n=501) were interviewed. Proportional quota sampling and poststratification weighting were used. Multivariable logistic regression models were used to investigate perception factors associated with the public responses.
We measured anxiety levels using the 7-item Generalised Anxiety Disorder Scale (GAD-7) and asked respondents to report their precautionary behaviours before and during the outbreak.
The prevalence of moderate or severe anxiety was significantly higher (p
Prevalence of moderate or severe anxiety and strict personal precautionary behaviours was generally high, regardless of the quarantine status. Our results support efforts for handwashing education programmes with a focus on hygiene procedures in China and timely dissemination of reliable information.
Graft versus host disease (GVHD) is a major cause of morbidity and mortality following allogenic haematopoietic stem cell transplantation. It is an immunological reaction, involving many organs, leading to a wide range of clinical manifestations. Cutaneous manifestations are the most common sign of GVHD, as well as pain, vulnerability to infection and impaired quality of life.
Despite the burdens that cutaneous GVHD presents for patients, their carers and the healthcare system, limited evidence is available to guide day to day supportive skin care and wound management. Our objective is to conduct a scoping review to map the evidence for skin and wound management and identify evidence-practice gaps for individuals with acute or chronic cutaneous GVHD.
Our review will follow the scoping review methodological framework developed by Arksey and O’Malley and further refined by the Joanna Briggs Institute Scoping Review Methods Manual. Databases to be searched include; PubMed, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Web of Science and MEDLINE from 1970 to February 2020. Database searches will be supplemented with searches from relevant reference lists and grey literature. Descriptive statistical analyses will be performed.
This scoping review does not require ethical approval. Findings will be disseminated through a peer-reviewed publication and conference presentation.
To assess the delirium severity (DS), its risk factors and association with adverse patient outcomes in chronically critically ill (CCI) patients.
A prospective cohort study.
A tertiary care hospital with postacute intensive care units (ICUs) in Germany.
N=267 CCI patients with critical illness polyneuropathy and/or critical illness myopathy, aged 18–75 years, who had undergone elective tracheotomy for weaning failure.
Primary outcomes: DS was assessed using the Confusion Assessment Method for the Intensive Care Unit-7 delirium severity score, within 4 weeks (t1) after the transfer to a tertiary care hospital. In post hoc analyses, univariate linear regressions were employed, examining the relationship of DS with clinical, sociodemographic and psychological variables. Secondary outcomes: additionally, correlations of DS with fatigue (using the Multidimensional Fatigue Inventory-20), quality of life (using the Euro-Quality of Life) and institutionalisation/mortality at 3 (t2) and 6 (t3) months follow-up were computed.
Of the N=267 patients analysed, 9.4% showed severe or most severe delirium symptoms. 4.1% had a full-syndromal delirium. DS was significantly associated with the severity of illness (p=0.016, 95% CI –0.1 to –0.3), number of medical comorbidities (p
Illness severity is positively associated with DS during postacute care in CCI patients. An adequate management of delirium is essential in order to mitigate functional and cognitive long-term sequelae following ICU.
The motivation and retention of community health workers (CHWs) is a challenge and inadequately addressed in research and policy. We sought to identify factors influencing the retention of CHWs in Ethiopia and ways to avert their exit.
A qualitative study was undertaken using in-depth interviews with the study participants. Interviews were audio-recorded, and then simultaneously translated into English and transcribed for analysis. Data were analysed in NVivo 12 using an iterative inductive-deductive approach.
The study was conducted in two districts each in the Tigray and Southern Nations, Nationalities and People’s Republic (SNNPR) regions in Ethiopia. Respondents were located in a mix of rural and urban settings.
Leavers of health extension worker (HEW) positions (n=20), active HEWs (n=16) and key informants (n=11) in the form of policymakers were interviewed.
We identified several extrinsic and intrinsic motivational factors affecting the retention and labour market choices of HEWs. While financial incentives in the form of salaries and material incentives in the form of improvements to health facility infrastructure, provision of childcare were reported to be important, non-material factors like HEWs’ self-image, acceptance and validation by the community and their supervisors were found to be critical. A reduction or loss of these non-material factors proved to be the catalyst for many HEWs to leave their jobs.
Our study contributes new empirical evidence to the global debate on factors influencing the motivation and retention of CHWs, by being the first to include job leavers in the analysis. Our findings suggest that policy interventions that appeal to the social needs of CHWs can prove to be more acceptable and potentially cost-effective in improving their retention in the long run. This is important for government policymakers in resource constrained settings like Ethiopia that rely heavily on lay workers for primary healthcare delivery.
We aimed to compare the incidence, subtypes and aetiology of stroke, and in-hospital death due to stroke, between Aboriginal and non-Aboriginal people in Central Australia, a remote region of Australia where a high proportion Aboriginal people reside (40% of the population). We hypothesised that the rates of stroke, particularly in younger adults, would be greater in the Aboriginal population, compared with the non-Aboriginal population; we aimed to elucidate causes for any identified disparities.
A retrospective population-based study of patients hospitalised with stroke within a defined region from 1 January 2011 to 31 December 2014.
Alice Springs Hospital, the only neuroimaging-capable acute hospital in Central Australia, serving a network of 50 healthcare facilities covering 672 000 km2.
161 residents (63.4% Aboriginal) of the catchment area admitted to hospital with stroke.
Rates of first-ever stroke, overall (all events) stroke and in-hospital death.
Of 121 residents with first-ever stroke, 61% identified as Aboriginal. Median onset-age (54 years) was 17 years younger in Aboriginal patients (p
Stroke incidence (both subtypes) and in-hospital deaths for remote Aboriginal Australians are dramatically greater than in non-Aboriginal people, especially in patients aged
To explore how the self-management of comorbid long-term conditions is experienced and negotiated by people with dementia and their carers.
Secondary thematic analysis of 82 semi-structured interviews.
Community settings across the United Kingdom.
11 people with dementia, 22 family carers, 19 health professionals and 30 homecare staff.
We identified three overarching themes: (1) The process of substituting self-management: stakeholders balanced the wishes of people with dementia to retain autonomy with the risks of lower adherence to medical treatments. The task of helping a person with dementia to take medication was perceived as intermediate between a personal care and a medical activity; rules about which professionals could perform this activity sometimes caused conflict. (2) Communication in the care network: family carers often communicated with services and made decisions about how to implement medical advice. In situations where family carers or homecare workers were not substituting self-management, it could be challenging for general practitioners to identify changes in self-management and decide when to intervene. (3) Impact of physical health on and from dementia: healthcare professionals acknowledged the inter-relatedness of physical health and cognition to adapt care accordingly. Some treatments prescribed for long-term conditions were perceived as unhelpful when not adapted to the context of dementia. Healthcare professionals and homecare workers sometimes felt that family carers were unable to accept that available treatments may not be helpful to people with dementia and that this sometimes led to the continuation of treatments of questionable benefit.
The process of substituting self-management evolves with advancement of dementia symptoms and relies on communication in the care network, while considering the impact on and from dementia to achieve holistic physical health management. Care decisions must consider people with dementia as a whole, and be based on realistic outcomes and best interests.
Contingency management (CM) is a treatment for substance misuse that involves the provision of incentives. This review examines the hypothesis that adding another formal psychotherapy, such as cognitive–behavioural therapy (CBT) or motivational enhancement therapy (MET), to CM improves substance use outcomes at both treatment end and at post-treatment follow-up compared with CM only.
Searches were performed in December 2017 and July 2019 of seven electronic bibliographic databases (MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, CINAHL, PsycEXTRA), as well as online trial registries and EThoS, and were followed by reference list screening.
Included studies were randomised controlled trials of adults (18–65) who were using illicit substances, alcohol or tobacco. Studies featured an experimental arm delivering CM combined with a structured evidence-based psychotherapeutic intervention and a CM-only arm. Studies published up to July 2019 were included.
The primary outcome was biometrically verified point prevalent abstinence (PPA) at treatment end. Secondary outcomes included biometrically verified PPA at post-treatment follow-up and self-reported days of use at treatment end and post-treatment follow-up. Pooled risk ratios for PPA outcomes and standardised mean differences for days of use were calculated using random effects models. Risk of bias was assessed using the Grading of Recommendations Assessment, Development and Evaluation.
12 studies (n=1654) were included. The primary analysis found no evidence of a synergistic effect in PPA at treatment end (relative risk (RR) 0.97, 95% CI 0.85 to 1.09; p=0.57). Sensitivity analysis of studies featuring CBT/MET also found no evidence of an effect (RR 0.92; 95% CI 0.79 to 1.08; p=0.32). None of the secondary outcomes showed any evidence of benefit.
The results of the meta-analyses found no evidence that combining CM with another intervention improves the short-term or long-term effects of CM treatment.
Fast diagnostic algorithms using high-sensitivity troponin (hsTn) in suspected acute coronary syndrome (ACS) are regarded as beneficial to expedite diagnosis and safe discharge of patients in crowded emergency departments (ED). This study investigates the effects of crowding on process times related to the diagnostic protocol itself or other time delays, and outcomes.
Prospective single-centre observational study.
Final study population of 2525 consecutive patients with suspected ACS within 12 months, after exclusion of patients with ST-elevation myocardial infarction, missing blood samples, referral from other hospitals or repeated visits.
Use of fast algorithms as per 2015 European Society of Cardiology guidelines.
Crowding was defined as mismatch between patient numbers and monitoring capacities, or mean physician time per case, categorised as normal, high and very high crowding. Outcome measures were length of ED stay, direct discharge from ED, laboratory turn around times (TAT), utilisation of fast algorithms, absolute and relative non-laboratory time, as well as mortality.
Crowding was associated with increased length of ED stay (3.75–4.89 hours, p
Process times, and particularly non-laboratory times, are prolonged in a crowded ED diminishing some positive effects of fast diagnostic algorithms in suspected ACS. Higher crowding levels were not significantly associated with higher all-cause mortality rates.
Automated haematology analysers measure various parameters of relevance to clinical research along with routine complete blood count (CBC)-related components. We aimed to establish ethnicity-specific and sex-specific reference intervals for 26 research-specific parameters as well as 18 routinely reported components using a large cohort of healthy Korean adults. The necessity of requiring separate sex-specific reference intervals for each parameter was also examined.
A retrospective database review.
Single tertiary-care hospital of approximately 375 physicians and 530 nurses.
This study included 1383 reference individuals (840 men and 543 women).
Following the Clinical and Laboratory Standards Institute guidelines for establishing reference intervals, routine CBCs as well as research parameters were measured using an ADVIA 2120i instrument.
All the routine components except for mean platelet volume and per cent lymphocytes differed significantly between men and women. Most research parameters also differed between the sexes; the exceptions were large platelets, platelet dry mass distribution width, per cent basophil saturation, per cent peroxidase saturation and per cent abnormal peroxidase absorption. Despite these differences, separate reference intervals for men and women were required only for two research-specific parameters: ‘percentage high cellular haemoglobin’ and ‘percentage of hyperchromic red blood cells (RBCs)’.
Even though most parameters showed significant differences between men and women, none of the evaluated parameters except two RBC-related factors required separate reference intervals for each sex.
Large disparities in colorectal cancer (CRC) management and survival have been observed across Europe. Despite recent increases, the survival deficit of Estonian patients with CRC persists, particularly for rectal cancer. The aim of this study was to examine diagnostic, staging and treatment patterns of CRC in Estonia, comparing clinical data from 1997 and 2011.
Nationwide population-based retrospective study.
All incident cases of colon and rectal cancer diagnosed in 1997 and 2011 identified from the Estonian Cancer Registry. Clinical data gathered from medical records.
Differences in diagnostic, staging and treatment patterns; 5-year relative survival ratios.
The number of colon cancer cases was 337 in 1997 and 498 in 2011; for rectal cancer, the respective numbers were 209 and 349. From 1997 to 2011, large increases were seen in the use of colonoscopy and lung and liver imaging. Radical resection rate increased from 48% to 59%, but emergency surgeries showed a rise from 18% to 26% in colon and from 7% to 14% in rectal cancer. The proportion of radically operated patients with ≥12 lymph nodes examined pathologically increased from 2% to 58% in colon cancer and from 2% to 50% in rectal cancer. The use of neoadjuvant radiotherapy increased from 6% to 39% among stage II and from 20% to 50% among patients with stage III rectal cancer. The use of adjuvant chemotherapy in stage III colon cancer increased from 42% to 63%. The 5-year RSR increased from 50% to 58% in colon cancer and from 37% to 64% in patients with rectal cancer.
Major improvements were seen in the diagnostics, staging and treatment of CRC in Estonia contributing to better outcomes. Increase in emergency surgeries highlights possible shortcomings in timely diagnosis and treatment.
To evaluate the impact of new National Drug Pricing Policy (NDPP) 2018 on access to medicines in terms of prices, availability and affordability.
Two cross-sectional surveys were undertaken before and after the launch of NDPP 2018, using a modified WHO/Health Action International (WHO/HAI) methodology.
Four districts of Lahore division, Pakistan.
16 public sector hospitals and 16 private sector retail pharmacies.
The pre and post survey data on prices and availability of lowest price generics (LPGs) and originator brands (OBs) of 50 medicines were obtained by visiting the same public and private sector health facilities (n=32). Out of 50, 46 surveyed medicines were from the National Essential Medicines List. Inflation-adjusted median unit prices (MUPs) and median price ratios (MPRs) from 2019 were used for price comparison. Affordability was calculated in terms of number of days’ wages required to get a standard treatment by the lowest paid unskilled government worker.
The overall mean percent availabilities remained poor in both years, that is, far less than 80%. In the public sector, the mean percent availability of OBs improved from 6.8% to 33.1%, whereas, in the case of LPGs, it was reduced from 35.1% to 9%. In the private sector, the mean percent availability of both OBs and LPGs demonstrated slight improvements in 2019, that is, 55.0%–58.3% and 20.3%–32.3%. The adjusted MUPs and MPRs of OBs significantly increased by a median of 4.29% (Wilcoxon test p=0.001, p=0.0001), whereas the adjusted MUPs and MPRs of LPGs increased by a median of 15.7% (p=0.002, p=0.0002). Overall, the affordability of many medicines for common ailments was reduced significantly in 2019.
The availability of medicines slightly improved, except in the case of LPGs, which was reduced in the public sector. The implementation of NDPP 2018 led to increase in drug prices, making the standard treatment for some of the most prevalent ailments unaffordable. So verily, the drug pricing policy must be reviewed to ensure access to essential medicines.
Continuous antiretroviral therapy (ART) suppresses HIV plasma viral load (pVL) to very low levels, which allows for some immune recovery. Discontinuation of ART leads to pVL rebound from reservoirs of persistence and latency, and progressive immunodeficiency. One promising but controversial strategy targeting CD4+ T lymphocytes with a monoclonal antibody (mAb) against α4β7 integrin has shown promise through sustained virological remission of pVL (SVR) in SIV239-infected rhesus macaques. We propose to assess the safety and tolerability of vedolizumab, a licensed humanised mAb against human α4β7 integrin, in healthy HIV-infected adults on ART. This study will also assess, by analytical treatment interruption (ATI), whether vedolizumab treatment can induce SVR beyond ART and vedolizumab treatment.
The HIV-ART-vedolizumab-ATI (HAVARTI) trial is a single-arm, dose-ranging pilot trial in healthy HIV-positive adult volunteers receiving ART. Twelve consenting persons will be enrolled in sequential groups of 4 to each serial dosing vedolizumab regimen (300 mg, 150 mg, 75 mg). The primary outcomes are: (1) to assess the safety and tolerability of seven serial infusions of vedolizumab at each of three doses; (2) to identify the immunovirological measures, including pVL and T-cell kinetics, that characterise HIV/ART cases before, during, after vedolizumab treatment and ATI; and (3) to seek SVR of pVL after ATI. Secondary outcomes will include immune reconstitution and pVL suppression as well as immune reconstitution and long-term safety following re-initiation of ART in the absence of SVR.
The study protocol was approved by the Ottawa Health Science Network-REB and by the Health Canada Therapeutic Products Directorate. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open access journal within a year of study completion.
Trauma registries are an integral part of a well-organised trauma system. Tanzania, like many low and middle-income countries, does not have a trauma registry. We describe the development, structure, implementation and impact of a context appropriate standardised trauma form based on the adaptation of the WHO Data Set for Injury (DSI), for clinical documentation and use in a national trauma registry.
Our study was conducted in emergency units of five regional referral hospitals in Tanzania.
Mixed methods participatory action research was employed. After an assessment of baseline trauma documentation, we conducted semi-structured interviews with a purposefully selected sample of 33 healthcare providers from all participating hospitals to understand, develop, pilot and implement a standardised trauma form. We compared the number and types of variables captured before and after the form was implemented.
Change in proportion of variables of DSI captured after implementation of a standardised trauma documentation form.
Piloting and feedback informed the development of a context appropriate standardised trauma documentation paper form with carbonless copy that could be used as both the clinical chart and data capture. Among 721 patients (seen by 21 clinicians) during the initial 30-day pilot, overall variable capture was 86.4% of required variables. After modifications of the form and training of healthcare providers, the form was implemented for 7 months, during which the capture improved to 96.3% among 6302 patients (seen by 31 clinicians). The providers reported the form was user-friendly, resulted in less time documenting, and served as a guide to managing trauma patients.
The development and implementation of a contextually appropriate, standardised trauma form were successful, yielding increased capture rates of injury variables. This system will facilitate expansion of the trauma registry across the country and inform similar initiatives in Sub-Saharan Africa.
Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.
Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.
To explore the experience of parenting for younger stroke survivors (aged 18 to 64 years at the time of the stroke).
Stroke among younger adults increased 43% between 2000 and 2010. The social, emotional, and physical functioning of younger adults affects multiple aspects of their lives including parenting. There is limited research on the experience of parenting after stroke.
This is a qualitative descriptive study.
We conducted individual semi‐structured interviews with 10 younger adults who were actively parenting children under the age of 18 years at the time of the stroke. Conventional content analysis was used to analyze the data. We report the methods and results using the COREQ checklist.
Impairments from stroke disrupted participants’ identity, relationships, and roles as a parent. The degree to which parenting abilities and behaviors were affected by stroke was contingent upon the type and severity of impairments as well as the children's age. Participants also observed emotional and behavioral changes in their children in response to their stroke. Support from family, friends, healthcare providers, and children's school/daycare was crucial to participants throughout their stroke recovery. Two major themes emerged: 1) finding a new normal and 2) support for parenting post‐stroke.
Findings enable a deeper understanding of the distinct parenting challenges younger stroke survivors face and can inform future research on this population.
Study findings highlight the need for continual and tailored follow‐up by nurses and other allied healthcare professionals to decrease the difficulty stroke survivors experience when trying to resume their role as parents.
The aim was to explore how nurses experience compassionate care for patients with cancer and family caregivers in different phases of the palliative pathway.
Compassion is fundamental to palliative care and viewed as a cornerstone of high‐quality care provision. Healthcare authorities emphasize that patients should have the opportunity to stay at home for as long as possible. There are, however, care deficiencies in the palliative pathway.
This study employed a qualitative design using focus groups and a hermeneutic approach.
Four focus groups with three to seven female nurses in each group were conducted in Mid‐Norway in 2018. Nurses’ ages ranged from 28‐60 years (mean age =45 years), and they were recruited through purposive sampling (N = 21). Compassionate care was chosen as the theoretical framework. Reporting followed the COREQ guidelines.
Three themes expressing compassionate care related to different phases of the pathway were identified: (a) information and dialogue, (b) the creation of a space for dying, and (c) family caregivers’ acceptance of death.
This study showed that it was crucial to create a space for dying, characterized by trust, collaboration, good relationships, empathy, attention, silence, caution, slowness, symptom relief, and the absence of noise and conflict.
The quality of compassion possessed by individual practitioners, as well as the overall design of the healthcare system, must be considered when creating compassionate care for patients and their family caregivers. Nursing educators and health authorities should pay attention to the development of compassion in education and practice. Further research should highlight patients’ and family caregivers’ experiences of compassionate care and determine how healthcare systems can support compassionate care.
What does this paper contribute to the wider global clinical community? It provides insight into nurses’ role in compassionate care in different phases of the palliative pathway. It highlights the importance of early engagement with family caregivers, as a key element of compassionate care. Nurses play a crucial role in creating a space for dying, which is important for patients’ and their family members’ preparation for death.
Epidemiological research on the association between diesel exhaust exposure and lung cancer risk has some methodological challenges that give rise to different conclusions and intense debates. This raises the question about the role of selective citation and of citation bias in particular. Our aim was to investigate the occurrence and prevalence of selective citation in this field.
Web of Science Core Collection.
We identified 96 publications in this network, with 4317 potential citations. For each publication, we extracted characteristics such as study conclusion and funding source. Some of these characteristics are related to the study content: study design, sample size, method of diesel exposure assessment, type of diesel technology under investigation, and whether smoking had been adjusted for.
Whether a citation occurs or not, measured and analysed according to the preregistered protocol. Exploratively we analysed the association between funding source and study conclusion.
Methodological content of a study was clearly related to citation, studies using more sophisticated methods were more likely to be cited. There was some evidence for citation bias: supportive publications had a higher chance of being cited than non-supportive ones, but after adjustment for study quality, this effect decreased substantially (adjusted OR 1.3, 95% CI 1.0 to 1.7). Explorative analyses indicated that three quarters of non-profit funded publications had a supportive study conclusion against only one quarter of the industry-funded publications.
There is evidence for selective citation within this field, but the evidence for citation bias was weak. It seems that factors related to the methodology had more impact on citation than the conclusion of a study. Interestingly, publications that were funded by industry were more skeptical about a causal relationship between diesel exhaust and lung cancer compared to non-profit-funded publications.
Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes.
A cohort of 145 children and young people with CF aged 6–16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.
This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes.
Ethical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment.
To define the epidemiological curve of COVID-19 in Qatar and determine factors associated with severe or critical illness.
Case series of first 5685 COVID-19 cases in Qatar.
All confirmed COVID-19 cases in the State of Qatar between 28 February and 18 April 2020.
Number of total and daily new COVID-19 infections; demographic characteristics and comorbidity burden and severity of infection; factors associated with severe or critical illness.
Between 28 February and 18 April 2020, 5685 cases of COVID-19 were identified. Median age was 34 (IQR 28–43) years, 88.9% were male and 8.7% were Qatari nationals. Overall, 83.6% had no concomitant comorbidity, and 3.0% had three or more comorbidities. The overwhelming majority (90.9%) were asymptomatic or with minimal symptoms, with 2.0% having severe or critical illness. Seven deaths were observed during the time interval studied. Presence of hypertension or diabetes was associated with a higher risk of severe or critical illness, but age was not. The epidemiological curve indicated two distinct patterns of infection, a larger cluster among expatriate craft and manual workers and a smaller one among Qatari nationals returning from abroad during the epidemic.
COVID-19 infections in Qatar started in two distinct clusters, but then became more widespread in the population through community transmission. Infections were mostly asymptomatic or with minimal symptoms and associated with very low mortality. Severe/critical illness was associated with presence of hypertension or diabetes but not with increasing age.