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.
Episiotomy is still performed widely by obstetricians and midwives in some Chinese maternity units, but the reasons are unknown. This study aims to determine the knowledge, attitude and experience towards the practice of episiotomy among obstetricians and midwives in China’s public hospitals and consider strategies to reduce its practice.
A cross-sectional web survey using a self-administered questionnaire was conducted among obstetricians and midwives in 90 public hospitals in Henan Province, China.
900 (82.21%) participants completed the questionnaire. Average knowledge level (4.15, SD=1.10) on complications and overuse was identified among participants. Episiotomy was performed more frequently in secondary hospitals than in tertiary hospitals (p
In sum, episiotomy was driven by previous training, practitioners’ experience and local norms rather than the latest medical evidence. Clinicians in secondary hospitals and senior clinicians are key training targets. It is urgent to improve current clinical policies and surgical procedure guidelines for obstetricians and midwives regarding episiotomy.
This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.
Literature review and survey study.
A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.
To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.
Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.
No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.
In oncology and palliative care, patient question prompt lists (QPLs) with sample questions for patient and family increased patients’ involvement in decision-making and improved outcomes if physicians actively endorsed asking questions. Therefore, we aim to evaluate practitioners’ perceptions of acceptability and possible use of a QPL about palliative and end-of-life care in dementia.
Mixed-methods evaluation study of a QPL developed with family caregivers and experts comprising a survey and interviews with practitioners.
Two academic medical training centres for primary and long-term care in the Netherlands.
Practitioners (n=66; 73% woman; mean of 21 (SD 11) years of experience) who were mostly general practitioners and elderly care physicians.
The main survey outcome was acceptability measured with a 15–75 acceptability scale with ≥45 meaning ‘acceptable’.
The survey response rate was 21% (66 of 320 participated). The QPL was regarded as acceptable (mean 51, SD 10) but 64% felt it was too long. Thirty-five per cent would want training to be able to answer the questions. Those who felt unable to answer (31%) found the QPL less acceptable (mean 46 vs 54 for others; p=0.015). We identified three themes from nine interviews: (1) enhancing conversations through discussing difficult topics, (2) proactively engaging in end-of-life conversations and (3) possible implementation.
Acceptability of the QPL was adequate, but physicians feeling confident to be able to address questions about end-of-life care is crucial when implementing it in practice, and may require training. To facilitate discussions of advance care planning and palliative care, families and persons with dementia should also be empowered to access the QPL themselves.
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.
This study aimed to profile stress, exploring whether demographics and/or other factors uniquely contribute to stress for emergency departments nurses.
Nursing has been identified as a stressful profession with the potential to have negative impacts on nurses’ physical and mental health. Nurses working in emergency departments face unique daily stressors.
Cross‐sectional survey using a correlational design.
The survey was distributed in May 2019 to ED nurses working in New South Wales (NSW), Australia. A total of 242 nurses completed the survey, of which 190 cases were analysed. A standardised scale was used in the survey, the Expanded Nursing Stress Scale (ENSS). The sampling method for this research was non‐probability purposive sampling. STROBE checklist was used for this manuscript.
The results of this study indicated that emergency department nurses experience stress in their work settings. Stress is experienced predominantly because of problems in dealing with patients and their families, high workloads, and uncertainty concerning treatment.
The results of this study provide valuable insights into the work‐related stress experienced by emergency department nurses. This information can be used to inform the development of strategies to minimise stress for emergency nurses.
This study builds on existing, and contributes to new, knowledge about the current stressors for emergency department nurses. The results provide insights into how policies and procedures may need to be adjusted and interventions developed, that can help in reducing stress.
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.
To translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).
Cross-sectional observational study.
Forward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.
The content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p
CPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.
The aim was to use routine data available at a patient’s admission to the hospital to predict polypharmacy and drug–drug interactions (DDI) and to evaluate the prediction performance with regard to its usefulness to support the efficient management of benefits and risks of drug prescriptions.
Retrospective, longitudinal study.
We used data from a large multicentred pharmacovigilance project carried out in eight psychiatric hospitals in Hesse, Germany.
Inpatient episodes consecutively discharged between 1 October 2017 and 30 September 2018 (year 1) or 1 January 2019 and 31 December 2019 (year 2).
The proportion of rightly classified hospital episodes.
We used gradient boosting to predict respective outcomes. We tested the performance of our final models in unseen patients from another calendar year and separated the study sites used for training from the study sites used for performance testing.
A total of 53 909 episodes were included in the study. The models’ performance, as measured by the area under the receiver operating characteristic, was ‘excellent’ (0.83) and ‘acceptable’ (0.72) compared with common benchmarks for the prediction of polypharmacy and DDI, respectively. Both models were substantially better than a naive prediction based solely on basic diagnostic grouping.
This study has shown that polypharmacy and DDI can be predicted from routine data at patient admission. These predictions could support an efficient management of benefits and risks of hospital prescriptions, for instance by including pharmaceutical supervision early after admission for patients at risk before pharmacological treatment is established.
The current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.
Early Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.
Ethics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).
This study aims to compare workers’ income before and after an occupational injury, with regard to return to work and job retention, over a period of 5 years.
This study was designed as a longitudinal study.
The Panel Study of Workers’ Compensation Insurance (PSWCI) survey targeted workers involved in industrial accidents for which medical care was terminated in the year 2012.
The panel study was conducted on a final sample of 2000 workers who were selected proportionally by region (nine regions) after priority assignment by disability rating (six levels). A total of 1458 workers were finally included in this study.
This study used data from the first to fifth PSWCI. To identify the effect on income after occupational injury considering return to work and job retention, we used the generalised estimating equation.
In regard to workers’ return to work, the OR that income after an occupational injury would be higher than that before an occupational injury was 3.17 (2.41–4.17) for those who returned to original work and 2.32 (1.81–2.97) for those re-employed as compared with who did not return to work and 1.27 (1.07–1.15) for those who retained their job as compared with those who did not. The ORs were 2.91 (2.26–3.75) for those who were re-employed and retained jobs and 2.96 (2.15–4.08) for those who returned to original work and did not retain jobs as compared with those who did not return to work and did not retain jobs.
It is important for accident victims to retain their jobs to maintain their economic status.
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.
We assess whether China’s diabetes pilot hierarchical diagnosis and treatment reforms shifted patient healthcare-seeking behaviour towards primary health institutions (PHIs) and away from secondary and tertiary hospitals. From the patients’ perspective, we evaluate whether the hierarchical system saw the decline of average hospital cost, out-of-pocket (OOP) expenses and the increase of reimbursement rate in PHIs. From the health system’s perspective, we also assessed whether the share of PHIs in total costs, total visits and reimbursement rate increased and the share of secondary and tertiary hospitals decreased.
Data were collected from the health insurance bureau of 11 cities in Shandong Province, China between 2015 and 2017, which included 9 118 518 outpatient visits and 622 739 inpatient visits. For both inpatients and outpatients and the health system, we analysed health services-seeking characteristics including hospital costs, hospital visits, OOP expense and reimbursements of hospital costs. Binary logistic regression was conducted to analyse the influencing factors of seeking PHI health services.
PHIs remained the lowest hospital cost provider, but average hospital costs declined across all three healthcare levels of PHIs, secondary hospitals and tertiary hospitals from 2015 to 2017. The hierarchical system aimed to shift patients to PHIs, increasing PHIs’ share of total hospital costs. However, the PHI share of total outpatient costs declined 12.0%, while rising 15.0% in secondary hospitals, the opposite of the goal of the hierarchical medical system. Average outpatient visits rose roughly at the same rate in PHIs (5.1%) as secondary hospitals (6.8%), with no evidence of a shift in patient visits between hospital levels over 2015–2017. Average inpatient visits fell across all levels of hospitals, with no significant difference in the rate of decline between PHIs (9.4%) and secondary (7.5%) and tertiary (7.8%) hospitals. For outpatient and inpatient services, the binary logistic regression showed that over the 2015–2017 period patients with diabetes increasingly used higher level hospitals rather than PHIs (p
The implementation of the hierarchical medical system for patients with diabetes did not achieve its goal of increasing PHI utilisation and decreasing secondary and tertiary hospital utilisation. Enhancing the utilisation of PHIs for diabetes and other patients requires further health reform, including educating patients on PHI use, further reforming the health insurance schemes, improving PHI facilities and encouraging referrals to PHIs from higher level hospitals.
Mild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.
A family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.
The CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.
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.
COVID-19 is a respiratory disease caused by SARS-CoV-2 with the highest burden in the USA. Data on clinical characteristics of patients with COVID-19 in US population are limited. Thus, we aim to determine the clinical characteristics and risk factors for in-hospital mortality from COVID-19.
Retrospective observational study.
Single-network hospitals in Pennsylvania state.
Patients with confirmed SARS-CoV-2 infection who were hospitalised from 1 March to 31 May 2020.
Primary outcome was in-hospital mortality. Secondary outcomes were complications, such as acute kidney injury (AKI) and acute respiratory distress syndrome (ARDS).
Of 283 patients, 19.4% were non-survivors. The mean age of all patients was 64.1±15.9 years. 56.2% were male and 50.2% were white. Several factors were identified from our adjusted multivariate analyses to be associated with in-hospital mortality: increasing age (per 1-year increment; OR 1.07 (1.045 to 1.105)), hypoxia (oxygen saturation 10 109/µL; OR 2.732 (1.412 to 5.263)), ferritin >336 ng/mL (OR 4.016 (1.195 to 13.514)), lactate dehydrogenase >200 U/L (OR 7.752 (1.639 to 37.037)), procalcitonin >0.25 ng/mL (OR 2.404 (1.011 to 5.714)), troponin I >0.03 ng/mL (OR 2.242 (1.080 to 4.673)), need for advanced oxygen support other than simple nasal cannula (OR 4.608–13.889 (2.053 to 31.250)), intensive care unit admission/transfer (OR 13.699 (6.135 to 30.303)), renal replacement therapy (OR 21.277 (5.025 to 90.909)), need for vasopressor (OR 22.222 (9.434 to 52.632)), ARDS (OR 23.810 (10.204 to 55.556)), respiratory acidosis (OR 7.042 (2.915 to 16.949)), and AKI (OR 3.571 (1.715 to 7.407)). When critically ill patients were analysed independently, increasing Sequential Organ Failure Assessment score (OR 1.544 (1.168 to 2.039)), AKI (OR 2.128 (1.111 to 6.667)) and ARDS (OR 6.410 (2.237 to 18.182)) were predictive of in-hospital mortality.
We reported the characteristics of ethnically diverse, hospitalised patients with COVID-19 from Pennsylvania state.
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.