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.
We aimed to examine whether eHealth interventions can effectively improve anthropometric and biochemical indicators of patients with metabolic syndrome (MetS).
Systematic review and meta-analysis.
PubMed, the Web of Science, Embase, Medline, CINAHL, PsycINFO, the Cochrane Library, the Chinese National Knowledge Infrastructure, the Wanfang and Weipu databases were comprehensively searched for papers that were published from database inception to May 2019. Articles were included if the participants were metabolic syndrome (MetS) patients, the participants received eHealth interventions, the participants in the control group received usual care or were wait listed, the outcomes included anthropometric and biochemical indicators of MetS, and the study was a randomised controlled trial (RCT) or a controlled clinical trial (CCT). The Quality Assessment Tool for Quantitative Studies was used to assess the methodological quality of the included articles. The meta-analysis was conducted using Review Manager V.5.3 software.
In our review, seven RCTs and two CCTs comprising 935 MetS participants met the inclusion criteria. The results of the meta-analysis revealed that eHealth interventions resulted in significant improvements in body mass index (standardised mean difference (SMD)=–0.36, 95% CI (–0.61 to –0.10), p
The results indicated that eHealth interventions were beneficial for improving specific anthropometric outcomes, but did not affect biochemical indicators of MetS. Therefore, whether researchers adopt eHealth interventions should be based on the purpose of the study. More rigorous studies are needed to confirm these findings.
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.
The incidence of bystander cardiopulmonary resuscitation (CPR) is low in China. CPR training could improve public attitudes and willingness, but at present, the attitudes of the public after online training are unclear. This study investigated individual attitudes towards CPR, the willingness to perform it in emergencies along with the main obstacles and the overall effects of online training.
Questionnaires were distributed to investigate the public attitudes and willingness towards performing bystander CPR.
Questionnaires were accessible after the online course ‘First Aid’.
1888 students who attended ‘First Aid’ from December 2019 to 1 January 2020 and then completed the questionnaire voluntarily.
The majority understood CPR (96.7%) and displayed a willingness to learn (98.4%) and to disseminate CPR knowledge (82.0%). Characteristics associated with more positive attitudes included women, the 26–35-year olds and those in medical-related occupations (p
The overwhelming majority of respondents showed positive attitudes and willingness towards CPR. In some cases, there is still reluctance, especially towards S-CPR. Obstacles arise mainly due to lack of confidence in administering CPR, while online CPR training can markedly improve it. Therefore, we should focus on disseminating CPR knowledge, targeting those who are less willing to perform CPR and helping overcome their obstacles by online training.
Both regional analgesia and intravenous analgesia are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect of regional and intravenous analgesia has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA) as two different perioperative analgesia approaches for patients with CLI. It investigates their effects on analgesia, reperfusion and the quality of recovery perioperatively, also aims to provide clinical evidence to those non-surgical patients with non-reconstructable arteries.
This trial is a randomised, single-centre, open-label, parallel trial with target sample size of 52 in total. Eligible participants will be randomly allocated to the PCRA group (group R) or the PCIA group (group I) after admission. Participants in group R will receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine 15 mL as loading dose, 8 mL/hour as background with a patient-controlled bolus of 6 mL). Participants in group I will receive PCIA (morphine is given in boluses of 1 mg as needed, background infusion at 1 mg/hour). Data will be collected at baseline (T0), 2 hours before revascularisation treatment (T1) and 2 hours before discharge (T2). The primary outcomes include the Numerical Rating Scale pain score at T1 and T2. The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
This study received authorisation from the Institutional Review Board of Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.
Chinese Clinical Trial Registry (ChiCTR2000029298).
V.4CP.B2 (15 June 2020).
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 examine long-term trends in acute myocardial infarction (AMI) incidence and survival among Aboriginal and non-Aboriginal people.
Retrospective cohort study.
All first AMI hospital cases and deaths due to ischaemic heart disease in the Northern Territory of Australia (NT), 1992–2014.
Age standardised incidence, survival and mortality.
The upward trend in Aboriginal AMI incidence plateaued around 2007 for males and 2001 for females. AMI incidence decreased for non-Aboriginal population, consistent with the national trends. AMI incidence was higher and survival lower for males, for Aboriginal people and in older age groups. In 2014, the age standardised incidence was 881 and 579 per 100 000 for Aboriginal males and females, respectively, compared with 290 and 187 per 100 000 for non-Aboriginal counterparts. The incidence disparity between Aboriginal and non-Aboriginal population was much greater in younger than older age groups. Survival after an AMI improved over time, and more so for Aboriginal than non-Aboriginal patients, because of a decrease in prehospital deaths and improved survival of hospitalised cases.
There was an important breakpoint in increasing trends of Aboriginal AMI incidence between 2001 and 2007. The disparity in AMI survival between the NT Aboriginal and non-Aboriginal populations reduced over time as survival improved for both populations.
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.
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.
To assess the effectiveness of social support on treatment success promotion or lost to follow-up (LTFU) reduction for patients with drug-resistant tuberculosis (DR-TB).
We searched Pubmed, Web of Science, Embase, Scopus and Medline databases until 18 June 2020 for interventional or mixed-method studies which reported social support and treatment outcomes of DR-TB patients. Two independent reviewers extracted data and disagreements were resolved by consensus with a third reviewer. Random-effects meta-analysis was performed to calculate the OR and 95% CI for the effects of social support on the improvement of treatment outcomes and the heterogeneity and risk of bias were assessed.
Low-income and middle-income countries.
Treatment success is defined as the combination of the cured and treatment completion, and LTFU is measured as treatment being interrupted for two consecutive months or more.
Among 173 articles selected for full-text review, 162 were excluded through independent review (kappa=0.87) and 10 studies enrolling 1621 DR-TB patients in eight countries were included for qualitative analysis. In these studies, the most frequently introduced social support was material support (10 studies), followed by informational (eight studies), emotional (seven studies) and companionship support (four studies). Seven studies that reported treatment outcomes in both intervention arm and control arm are qualified for meta-analysis. An encouraging improvement on treatment success rate (OR: 2.58; 95% CI: 1.80 to 3.69) was found when material support was integrated into social support packages and no heterogeneity was observed (I
Material support appeared feasible and effective to improve treatment success for DR-TB patients combined with other social support interventions.
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.
Leg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.
The following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.
This systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.
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 stroke. Conventional content analysis was used to analyse 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 behaviours 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 behavioural changes in their children in response to their stroke. Support from family, friends, healthcare providers and children's school/day care was crucial to participants throughout their stroke recovery. Two major themes emerged: (a) finding a new normal; and (b) 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.
To identify determinants of family cohesion and adaptability among Chinese registered nurses.
In China, the shortage of registered nurses imposes a higher physical and emotional workload, which will aggravate their work‐family conflicts. Therefore, it is easy for nurses to ignore the importance of family, which is undeniably detrimental to healthy self‐development and providing better care to patients.
ith a cross‐sectional and observational study design (See the STROBE checklist and Supplementary File 1).
The Family Cohesion and Adaptability Scale was administered to registered nurses (N = 825) from 10 hospitals throughout China. Multiple linear regression was used to analyze the related factors for family cohesion and adaptability.
The multiple regression analysis revealed that inharmonious relationship with spouse’s parents, discordant nurse‐patient relationship, parents live in countryside, poor leadership were found to be important risk predictors of family cohesion, and inharmonious relationship with spouse’s parents, discordant nurse‐patient relationship, high education, feel overworked, poor leadership were found to be important risk predictors of family adaptability.
Hospital managers need to pay attention to the risk factors that affect nurses’ family cohesion and adaptability. To achieve this, they should employ targeted measures to enhance these aspects in time, which will help improve nurses’ family life and promote their participation and role in family decision‐making. This will not only help them create a better external environment for their healthy self‐development but also allow them to maintain a better mood and energy to take care of patients.
Family cohesion and adaptability are important for nurses, as they may affect nurses’ healthy self‐development and quality of service provided to patients. Hospital managers should pay attention to the risk factors of nurses’ family cohesion and adaptability, such as poor nurse‐patient relationship, and consider employing corresponding measures to help them.
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.