Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.
Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.
UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.
ISRCTN registration number 73041168.
Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by the descent of the cerebellar tonsils through the foramen magnum. The management of patients with CM1 remains contentious since there are currently no UK or international guidelines for clinicians. We therefore propose a collaborative, prospective, multicentre study on the investigation, management and outcome of CM1 in the UK: the UK Chiari 1 Study (UKC1S). Our primary objective is to determine the health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months of follow-up. We also aim to: (A) determine HRQoL 12 months following surgery; (B) measure complications 12 months following surgery; (C) determine the natural history of patients with CM1 treated conservatively without surgery; (D) determine the radiological correlates of presenting symptoms, signs and outcomes; and (E) determine the scope and variation within UK practice in referral patterns, patient pathways, investigations and surgical decisions.
The UKC1S will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative model of collaborative research. Patients will be recruited after attending their first neurosurgical outpatient clinic appointment. Follow-up data will be collected from all patients at 12 months from baseline regardless of whether they are treated surgically or not. A further 12-month postoperative follow-up timepoint will be added for patients treated with decompressive surgery. The study is expected to last three years.
The UKC1S received a favourable ethical opinion from the East Midlands Leicester South Research Ethics Committee (REC reference: 20/EM/0053; IRAS 269739) and the Health Research Authority. The results of the study will be published in peer-reviewed medical journals, presented at scientific conferences, shared with collaborating sites and shared with participant patients if they so wish.
A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM.
This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus.
Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.
Clinical teaching visits (CTVs) are formative workplace-based assessments that involve a senior general practitioner (GP) observing a clinical practice session of a general practice registrar (specialist vocational GP trainee). These visits constitute a key part of Australian GP training. Despite being mandatory and resource-intensive, there is a paucity of evidence regarding the content and educational utility of CTVs. This study aims to establish the content and educational utility of CTVs across varying practice settings within Australia, as perceived by registrars and their assessors (‘CT visitors’). In addition, this study aims to establish registrar, CT visitor and practice factors associated with CTV content and perceived CTV utility ratings.
This study will collect data prospectively using online questionnaires completed soon after incident CTVs. Participants will be registrars and CT visitors of CTVs conducted from March 2020 to January 2021. The setting is three Regional Training Organisations across four Australian states and territories (encompassing 37% of Australian GP registrars).
Outcome factors will be a number of specified CTV content elements occurring during the CTV as well as participants’ perceptions of CTV utility, which will be analysed using univariate and multivariable regression.
Ethics approval has been granted by the University of Newcastle Human Research Ethics Committee, approval number H-2020-0037. Study findings are planned to be disseminated via conference presentation, peer-reviewed journals, educational practice translational workshops and the GP Synergy research subwebsite.
To identify theoretical and technical aspects regarding treatment, prevention of spread and protection of staff to inform the development of a comprehensive training curriculum on COVID-19 management.
Nine hospitals caring for patients with COVID-19 in Wuhan, China.
134 Chinese healthcare professionals (74 doctors and 60 nurses) who were deployed to Wuhan, China during the COVID-19 epidemic were included. A two-round Delphi process was initiated between March and May 2020. In the first round, the participants identified knowledge, technical and behavioural (ie, non-technical) skills that are needed to treat patients, prevent spread of the virus and protect healthcare workers. In round 2, the participants rated each item according to its importance to be included in a training curriculum on COVID-19. Consensus for inclusion in the final list was set at 80%.
Knowledge, technical and behavioural (ie, non-technical) skills that could form the basis of a training curriculum for COVID-19 management.
In the first round 1398 items were suggested by the doctors and reduced to 67 items after content analysis (treatment of patients: n=47; infection prevention and control: n=20). The nurses suggested 1193 items that were reduced to 70 items (treatment of patients: n=49; infection prevention and control: n=21). In round 2, the response rates were 82% in doctors and 93% in nurses. Fifty-eight items of knowledge, technical and behavioural skills were agreed on by the doctors to include in the final list. For the nurses, 58 items were agreed on.
This needs assessment process resulted in a comprehensive list of knowledge, technical and behavioural skills for COVID-19 management. Educators can use these to guide decisions regarding content of training curricula not only for COVID-19 management but also in preparation for future viral pandemic outbreaks.
To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.
Rapid evidence map.
MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.
We included studies in human populations susceptible to SARS-CoV-2/COVID-19, SARS-CoV-1/severe acute respiratory syndrome, Middle East respiratory syndrome coronavirus/Middle East respiratory syndrome or influenza. Interventions of interest were travel-related control measures affecting travel across national or subnational borders. Outcomes of interest included infectious disease, screening, other health, economic and social outcomes. We considered all empirical studies that quantitatively evaluate impact available in Armenian, English, French, German, Italian and Russian based on the team’s language capacities.
We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.
We included 122 studies assessing travel-related control measures. These studies were undertaken across the globe, most in the Western Pacific region (n=71). A large proportion of studies focused on COVID-19 (n=59), but a number of studies also examined SARS, MERS and influenza. We identified studies on border closures (n=3), entry/exit screening (n=31), travel-related quarantine (n=6), travel bans (n=8) and travel restrictions (n=25). Many addressed a bundle of travel-related control measures (n=49). Most studies assessed infectious disease (n=98) and/or screening-related (n=25) outcomes; we found only limited evidence on economic and social outcomes. Studies applied numerous methods, both inferential and descriptive in nature, ranging from simple observational methods to complex modelling techniques.
We identified a heterogeneous and complex evidence base on travel-related control measures. While this map is not sufficient to assess the effectiveness of different measures, it outlines aspects regarding interventions and outcomes, as well as study methodology and reporting that could inform future research and evidence synthesis.
Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.
An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.
The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.
With the acute shortage of human resources and infrastructure, mobile phones can be a critical tool for accessing health services and strengthening health systems in Bangladesh. Yet, there is a scarcity of evidence on the use of mobile phones in this context for accessing health services. In this study, we sought to explore the current use of mobile phones for accessing maternal and child healthcare and its determinants among recently delivered women in urban slums of Bangladesh.
The data were collected through interviewing 800 recently delivered women from eight slums of Dhaka city of Bangladesh during May and June 2018. The study followed a cross-sectional design and a two-stage cluster random sampling procedure was followed. A pretested structured questionnaire was employed to collect information. Chi square tests were performed for descriptive analyses and a multilevel binary logistic regression model was executed to explore the determinants of mobile phone usage for accessing maternal and childcare among the participants.
Overall, 73.8% of study participants used mobile phones for accessing maternal and child healthcare. After adjusting for potential confounders, participants’ age, husband’s occupation, sex of household head, women’s ownership of mobile phones and household wealth status were found to be significantly associated with higher odds of using mobile phones to access maternal and child healthcare.
The study highlighted the possibility of implementing large-scale mobile health (mHealth) interventions in slum settlements for accessing maternal and child healthcare and is a sustainable mitigation strategy for the acute health worker crisis in Bangladesh. The findings of this study are particularly crucial for policymakers and practitioners while they revise the health policy to incorporate mHealth interventions as highlighted in the recently initiated Digital Health Strategy of Bangladesh.
Amidst growing consensus that stakeholder decision-making during drug development should be informed by an understanding of patient preferences, the Innovative Medicines Initiative project ‘Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle’ (PREFER) is developing evidence-based recommendations about how and when patient preferences should be integrated into the drug life cycle. This protocol describes a PREFER clinical case study which compares two preference elicitation methodologies across several populations and provides information about benefit–risk trade-offs by those at risk of rheumatoid arthritis (RA) for preventive interventions.
This mixed methods study will be conducted in three countries (UK, Germany, Romania) to assess preferences of (1) first-degree relatives (FDRs) of patients with RA and (2) members of the public. Focus groups using nominal group techniques (UK) and ranking surveys (Germany and Romania) will identify and rank key treatment attributes. Focus group transcripts will be analysed thematically using the framework method and average rank orders calculated. These results will inform the treatment attributes to be assessed in a survey including a discrete choice experiment (DCE) and a probabilistic threshold technique (PTT). The survey will also include measures of sociodemographic variables, health literacy, numeracy, illness perceptions and beliefs about medicines. The survey will be administered to (1) 400 FDRs of patients with RA (UK); (2) 100 FDRs of patients with RA (Germany); and (3) 1000 members of the public in each of UK, Germany and Romania. Logit-based approaches will be used to analyse the DCE and imputation and interval regression for the PTT.
This study has been approved by the London-Hampstead Research Ethics Committee (19/LO/0407) and the Ethics Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg (92_17 B). The protocol has been approved by the PREFER expert review board. The results will be disseminated widely and will inform the PREFER recommendations.
Road trauma (RT) is a major public health problem affecting physical and mental health, and may result in prolonged absenteeism from work or study. It is important for healthcare providers to know which RT survivors are at risk of a poor outcome, and policy-makers should know the associated costs. Unfortunately, outcome after RT is poorly understood, especially for RT survivors who are treated and released from an emergency department (ED) without the need for hospital admission. Currently, there is almost no research on risk factors for a poor outcome among RT survivors. This study will use current Canadian data to address these knowledge gaps.
We will follow an inception cohort of 1500 RT survivors (16 years and older) who visited a participating ED within 24 hours of the accident. Baseline interviews determine pre-existing health and functional status, and other potential risk factors for a poor outcome. Follow-up interviews at 2, 4, 6, and 12 months (key stages of recovery) use standardised health-related quality of life tools to determine physical and mental health outcome, functional recovery, and healthcare resource use and lost productivity costs.
The Road Trauma Outcome Study is approved by our institutional Research Ethics Board. This study aims to provide healthcare providers with knowledge on how quickly RT survivors recover from their injuries and who may be more likely to have a poor outcome. We anticipate that this information will be used to improve management of all road users following RT. Healthcare resource use and lost productivity costs will be collected to provide a better cost estimate of the effects of RT. This information can be used by policy-makers to make informed decisions on RT prevention programmes.
To summarise current evidence on the use of pentoxifylline (PTX) to prevent contrast-induced nephropathy (CIN).
The PubMed, Embase and CENTRAL databases were searched for randomised controlled trials including patients with and without PTX undergoing contrast media exposure. We analysed the incidence of CIN and serum creatinine changes before and after contrast media exposure. All statistical analyses were conducted with Review Manager V.5.3.
We finally enrolled in seven randomised controlled trials with a total of 1484 patients in this analysis. All of seven included studies were performed in patients undergoing angioplasty or stenting. The overall rates of CIN were 8.8% and 10.4% in the PTX groups and control groups, respectively. However, no significant reduction in the CIN rate was observed in the patients treated with PTX compared with the control groups (OR 0.81, 95% CI 0.57 to 1.13, I2=0, p=0.21). All studies reported no hospital mortality and the new requirement for dialysis during the trials.
Perioperative administration of PTX to patients undergoing angioplasty did not significantly reduce the development of CIN but showed some weak tendency of lower serum creatinine increase. Based on the available trials, the evidence does not support the administration of PTX for the prevention of CIN. More trials with larger sample sizes are needed to evaluate the role of PTX in CIN prevention.
To identify barriers and enablers to participant retention in trials requiring questionnaire return using the theoretical domains framework (TDF).
We identified and subsequently invited participants who did not return at least one questionnaire during their participation in a clinical trial for one-to-one semi-structured telephone interviews. We used a behavioural framework (TDF) to explore whether any of the behavioural domains (eg, beliefs about consequences, emotion) affected questionnaire return. Thereafter, we generated a series of belief statements which summarised the content of participants’ main responses and coded these under separate themes.
We distributed invites to 279 eligible individuals and subsequently interviewed 9 participants who took part in the C-Gall trial. The C-Gall trial required participants to complete five postal questionnaires during their participation.
Nine participants were interviewed. We developed 7 overarching themes which were relevant for returning postal questionnaires and identified both barriers and enablers from 11 core domains: knowledge; beliefs about consequences; environmental context and resources; reinforcement; emotion; beliefs about capabilities; behavioural regulation; social professional role and identity; skills; intentions and goals. Relevant content coded under these salient domains were categorised into seven key themes: unclear expectations of trial participation, personal attributes for questionnaire return, commitment to returning questionnaires given other priorities, sources of support in returning the questionnaires, individual preferences for presentation mode and timing of the questionnaires, internal and external strategies to encourage questionnaire return and the significance of questionnaire non-return.
We demonstrate how a behavioural approach may be useful for clinical trials associated with significant participation burden (e.g. trials that require multiple questionnaire responses), acting as the essential groundwork for the development of appropriate evidence-based solutions to combat retention issues.
A subgroup of adolescent and young adult childhood cancer survivors (AYACCS) are at increased risk of psychological distress. Despite this, AYACCS experience difficulties accessing psychological support. E-mental health (e-MH) may offer a solution to reduce this treatment gap. However, research examining e-MH for AYACCS has experienced difficulties with recruitment, retention and adherence. Such difficulties may relate to: (1) help-seeking behaviour and/or (2) e-MH acceptability. The overall study aims are to: (1) examine potential associations between health service use factors, informed by Andersen’s behavioural model of health services use, and help-seeking behaviour; (2) examine attitudes towards e-MH interventions; and (3) explore perceived need for mental health support; past experience of receiving mental health support; preferences for support; and barriers and facilitators to help-seeking.
An online and paper-based cross-sectional self-report survey (98 items) and embedded qualitative interview study across Sweden, with a target sample size of n=365. Participants are aged 16–39 years, diagnosed with cancer when 0–18 years and have completed successful cancer treatment. The survey examines sociodemographic and clinical characteristics, actual help-seeking behaviour, attitudes towards e-MH, stigma of mental illness, mental health literacy, social support and current symptoms of depression, anxiety, and stress. Survey respondents with past and/or current experience of mental health difficulties are invited into the qualitative interview study to explore: (1) perceived need for mental health support; (2) past experience of receiving mental health support; (3) preferences for support; and (4) barriers and facilitators to help-seeking. Potential associations between health service use factors and help-seeking behaviour are examined using univariable and multivariable logistic regressions. Qualitative interviews are analysed using content analysis.
Ethical approval has been obtained from the Swedish Ethical Review Authority (Dnr: 2020-06271). Results will be disseminated in scientific publications and academic conference presentations.
Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth outcomes that are prevalent in low-income and middle-income settings such as the Pacific Island region. It is widely accepted that the excess burden of adverse birth outcomes is attributable to socioeconomic and environmental factors that predispose families to excess risk. Our review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island region and to identify the risk factors of adverse birth outcomes in the Pacific Island region.
This scoping review will follow the five-staged Arksey and O’Malley’s framework and consultation with Solomon Islands’ health stakeholders. A preliminary literature review was undertaken to understand the scope of the review. We will use Medical Subject Heading and keyword terms for adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest and Springer Link databases for articles published from 1 January 2000. The subsequent searches will be undertaken via Google Scholar and the internet browser to world health organisation and regional health organisations for published and unpublished reports on non-indexed studies. All articles retrieved will be managed with EndNote software. Eligible studies will be screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for final selection. In the charting phase, we will extract the data into Excel spreadsheets. The results will be presented as numerical and thematic summaries that map risk factors and prevalence to the population and cultures of the Pacific Island region.
Formal ethical approval is not required as primary or administrative data will not be collected. However, we will seek ethics approval for the stakeholder consultation from the Research Office of Curtin University and the Solomon Islands. The findings of this study will be published in peer-reviewed journals and presented in national and regional conferences and disseminated to stakeholders.
There will be no direct contact with human or patients in the case of the scoping review; therefore, no ethics will be required. However, we will seek ethical approval from the Research Ethics Office of Curtin University and the Health Research and Ethics Committee in the Solomon Islands for stakeholder consultation. Dissemination will be made through regional conferences and publication in peer-reviewed journals.
The evolution of healthcare and biomedical research into data-rich fields has raised several questions concerning data ownership. In this paper, we aimed to analyse the perspectives of Swiss experts on the topic of health data ownership and control.
In our qualitative study, we selected participants through purposive and snowball sampling. Interviews were recorded, transcribed verbatim and then analysed thematically.
Semi-structured interviews were conducted in person, via phone or online.
We interviewed 48 experts (researchers, policy makers and other stakeholders) of the Swiss health-data framework.
We identified different themes linked to data ownership. These include: (1) the data owner: data-subjects versus data-processors; (2) uncertainty about data ownership; (3) labour as a justification for data ownership and (4) the market value of data. Our results suggest that experts from Switzerland are still divided about who should be the data owner and also about what ownership would exactly mean. There is ambivalence between the willingness to acknowledge patients as the data owners and the fact that the effort made by data-processors (eg, researchers) to collect and manage the data entitles them to assert ownership claims towards the data themselves. Altogether, a tendency to speak about data in market terms also emerged.
The development of a satisfactory account of data ownership as a concept to organise the relationship between data-subjects, data-processors and data themselves is an important endeavour for Switzerland and other countries who are developing data governance in the healthcare and research domains. Setting clearer rules on who owns data and on what ownership exactly entails would be important. If this proves unfeasible, the idea that health data cannot truly belong to anyone could be promoted. However, this will not be easy, as data are seen as an asset to control and profit from.
Europe was the epicentre of the COVID-19 pandemic in March 2020, with the highest number of cases and deaths between March and April. In May, the infection numbers registered a fall followed by a second new rise, not proportionally reflected by an increase in the number of deaths. We aimed to investigate the relationship between disease prevalence and infection fatality rate (IFR), and the number of intensive care unit (ICU) and hospital admissions over time, to develop a predictive model, as well as appraising the potential contributing factors underpinning this complex relationship.
A prospective epidemiological study using data from six countries collected between 10 March and 4 September 2020. Data on the number of daily hospital and ICU admissions with COVID-19 were gathered, and the IFR and the prevalence were calculated. Trends over time were analysed. A linear regression model was used to determine the association between the fatality rates and the number of admissions.
The prediction model confirmed the linear association between the fatality rates and the numbers of ICU and hospital admissions. The exception was during the peak of the COVID-19 pandemic when the model underestimated the fatalities indicating that a substantial number of deaths occurred outside of the hospitals. The fatality rates decreased in all countries from May until September regardless of the trends in prevalence, differences in healthcare systems or strategic variations in handling the pandemic.
The observed gradual reduction in COVID-19 fatality rates over time despite varying disease prevalence and public health measures across multiple countries warrants search for a biological explanation. While our understanding of this novel virus grows, hospital and ICU admission rates remain effective predictors of patient outcomes which can be used as early warning signs for escalation of public health measures.
Haemorrhoidal disease is one of the most common anorectal disorders, which affects nearly half of the general population. Treatment of grade III haemorrhoids consists initially of conservative measures, followed by rubber band ligation and haemorrhoidectomy when unsuccessful. Given the current guidelines and numerous modalities the obvious question which needs to be answered is which treatment is the best for grade III haemorrhoids. There is a need for evaluating treatment from the patient’s point of view and transparency in surgical and non-surgical treatment outcome.
This multicentre, randomised controlled, non-inferiority trial with cost–utility analysis compares haemorrhoidectomy with rubber band ligation. Patients aged 18 years and older with symptomatic haemorrhoids grade III are recruited. Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L and in-hospital (in)direct costs and out-of-hospital postoperative costs. A key secondary outcome is recurrence at 1-year postprocedure. Secondary outcomes are complaint reduction with proctology-specific patient-reported outcome measurements (Haemorrhoid Severity Score, ProctoPROM, PROM-HISS, vaizey score), resumption of work, pain and complication rates. Data are collected at seven different time points. Standard postprocedural care is followed.
A sample size has been calculated using a one sided alpha of 0.025 and a power of 80% with an SD of 0.15 and a non-inferiority limit of 0.05. With stratification by centre and to adjust for 10% lost to follow-up the total sample size will be 360 patients in total (180 per group).
Data will be analysed according to the intention-to-treat and the per-protocol principle.
The protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centres, location AMC. Findings will be disseminated in peer-reviewed journals and presented at conferences, whether they are positive, negative or inconclusive.
Kidney transplantation remains the best treatment for end-stage kidney disease, however the requirement for indefinite immunosuppression increases the risk of cardiovascular disease, cancer and infection, leading to a reduction in long-term patient and graft survival. The gut microbiome is a critical determinant of health and modulates host immunity and metabolism through a number of recognised pathways, including through the production of immunomodulatory short-chain fatty acids (SCFA). Dietary supplementation with non-digestible fibre can augment the microbial production of SCFA and lead to favourable immune and metabolic outcomes, although this has yet to be shown in human kidney transplant recipients.
Dietary inulin for gut health in solid-organ transplantation (DIGEST) is a single-centre, unblinded, pilot parallel-arm randomised controlled trial designed to assess the feasibility and adherence of dietary inulin, a naturally occurring dietary fibre, in the early post-transplant period in kidney transplant recipients. Participants will be randomised at day 28 post-transplant to a 4-week period of dietary inulin (10–20 g/day) in addition to standard care, or standard care alone, and followed-up until week 12 post-transplant.
The primary outcomes of the study are: (i) the feasibility of participant recruitment, randomisation and retention; (ii) adherence to the intervention (inulin) and (iii) the tolerability of inulin determined by changes in gastrointestinal symptoms as scored on the Gastrointestinal Symptom Rating Scale.
Secondary outcomes include: (1) glycaemic variability determined by continuous glucose monitoring; (2) abundance of SCFA-producing microbiota, as determined by 16s rRNA sequencing of the faecal metagenome; (3) serum SCFA concentrations; (4) peripheral blood immune cell populations; (5) recipient inflammatory and metabolic profiles and (6) the incidence of biopsy-proven acute rejection and kidney function determined by estimated glomerular filtration rate.
All study visits, clinical and laboratory assessments will be integrated into usual post-transplant care, creating no additional healthcare encounters or procedures. The risks associated with this study are minor. Inulin has been shown to be well tolerated across a variety of cohorts, with the occurrence of short-term adverse gastrointestinal symptoms self-limiting. However, with gastrointestinal adverse events common following kidney transplantation, the tolerability of inulin in this cohort remains unknown. The results of DIGEST will be published in peer-reviewed journals and presented at academic conferences. This study has been approved by the Sydney Local Health District’s Ethics Committee (Royal Prince Alfred Hospital Zone).
Lifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin-like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.
This project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.
Ethical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.
At a time of unprecedented attention to the public health impact of policing, it is imperative to understand the role of occupational safety in shaping officer behaviours. We assessed the longitudinal impact of police training in a quasi-experimental hybrid type-1 trial to reduce syringe-related occupational risk, while realigning police practices with public health prevention among people who inject drugs (PWID).
Of 1806 Tijuana municipal police trainees, 771 reporting previous exposure to syringes were randomly selected for follow-up. All participants completed at least one follow-up visit; attrition at 24 months was 8%.
Between 2015 and 2016, officers received a training intervention (Safety and Health Integration in the Enforcement of Laws on Drugs, SHIELD) bundling occupational needle stick injury (NSI) prevention with health promotion among PWID.
Longitudinal analysis with generalised linear mixed models to evaluate training impact on occupational NSI risk via NSI incidence and prevalidated Syringe Threat and Injury Correlates (STIC) score. This composite indicator integrates five self-reported risky syringe-handling practices (eg, syringe confiscation, breaking) and was used as a proxy for NSI risk due to reporting bias and concerns about reliability of NSI incidence reports.
No change in self-reported NSI incidence was observed, but significant reductions in risk (16.2% decrease in STIC score) occurred at 3 months, with a sustained decrease of 17.8% through 24 months, compared with pretraining (p
SHIELD is the first intervention to be associated with significant sustained changes in police practices that pose risk for both occupational and the public’s health. Integrating occupational safety and public health education should inform other interventions to mitigate the community health detriments of policing behaviours.