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Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)

Por: Thapar · A. · Lawton · R. · Burgess · L. · Shalhoub · J. · Bradbury · A. · Cullum · N. · Epstein · D. · Gohel · M. · Horne · R. · Hunt · B. J. · Norrie · J. · Davies · A. H.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN registration number 73041168.

UK Chiari 1 Study: protocol for a prospective, observational, multicentre study

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Validation of breast cancer risk assessment tools on a French-Canadian population-based cohort

Por: Jantzen · R. · Payette · Y. · de Malliard · T. · Labbe · C. · Noisel · N. · Broët · P.
Objectives

Evaluate the accuracy of the Breast Cancer Risk Assessment Tool (BCRAT), International Breast Cancer Intervention Study risk evaluation tool (IBIS), Polygenic Risk Scores (PRS) and combined scores (BCRAT+PRS and IBIS +PRS) to predict the occurrence of invasive breast cancers at 5 years in a French-Canadian population.

Design

Population-based cohort study.

Setting

We used the population-based cohort CARTaGENE, composed of 43 037 Quebec residents aged between 40 and 69 years and broadly representative of the population recorded on the Quebec administrative health insurance registries.

Participants

10 200 women recruited in 2009–2010 were included for validating BCRAT and IBIS and 4555 with genetic information for validating the PRS and combined scores.

Outcome measures

We computed the absolute risks of breast cancer at 5 years using BCRAT, IBIS, four published PRS and combined models. We reported the overall calibration performance, goodness-of-fit test and discriminatory accuracy.

Results

131 (1.28%) women developed a breast cancer at 5 years for validating BCRAT and IBIS and 58 (1.27%) for validating PRS and combined scores. Median follow-up was 5 years. BCRAT and IBIS had an overall expected-to-observed ratio of 1.01 (0.85–1.19) and 1.02 (0.86–1.21) but with significant differences when partitioning by risk groups (p

Conclusions

In this French-Canadian population-based cohort, BCRAT and IBIS have good mean calibration that could be improved for risk subgroups, and modest discriminatory accuracy. Despite this modest discriminatory power, these tools can be of interest for primary care physicians for delivering a personalised message to their high-risk patients, regarding screening and lifestyle counselling.

Practitioners perceptions of acceptability of a question prompt list about palliative care for advance care planning with people living with dementia and their family caregivers: a mixed-methods evaluation study

Por: van der Steen · J. T. · Heck · S. · Juffermans · C. C. · Garvelink · M. M. · Achterberg · W. P. · Clayton · J. · Thompson · G. · Koopmans · R. T. · van der Linden · Y. M.
Objectives

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.

Design

Mixed-methods evaluation study of a QPL developed with family caregivers and experts comprising a survey and interviews with practitioners.

Setting

Two academic medical training centres for primary and long-term care in the Netherlands.

Participants

Practitioners (n=66; 73% woman; mean of 21 (SD 11) years of experience) who were mostly general practitioners and elderly care physicians.

Outcomes

The main survey outcome was acceptability measured with a 15–75 acceptability scale with ≥45 meaning ‘acceptable’.

Results

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.

Conclusion

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.

Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey

Por: Hermelijn · S. · Kersten · C. · Mullassery · D. · Muthialu · N. · Cobanoglu · N. · Gartner · S. · Bagolan · P. · Mesas Burgos · C. · Sgro · A. · Heyman · S. · Till · H. · Suominen · J. · Schurink · M. · Desender · L. · Losty · P. · Ertresvag · K. · Tiddens · H. A. W. M. · Wijnen · R. M. H
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Expert consensus on moving towards a value-based healthcare system in the Netherlands: a Delphi study

Por: Steinmann · G. · Delnoij · D. · van de Bovenkamp · H. · Groote · R. · Ahaus · K.
Objectives

While the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC.

Design

The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.

Setting and participants

A Dutch expert panel consisting of nine members participated in a two-round survey.

Primary and secondary outcome measures

We developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel.

Results

After two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking.

Conclusion

This paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC’s widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea.

Study protocol: content and perceived educational utility of different modalities of clinical teaching visit (CTV) workplace-based assessments within Australian general practice vocational training: a cross-sectional study

Por: Fielding · A. · Mundy · B. E. · Tapley · A. · Klein · L. · Gani · S. · Bentley · M. · Boland · R. · Zbaidi · L. · van Driel · M. L. · Holliday · E. · Magin · P.
Introduction

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.

Methods and analysis

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 and dissemination

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.

Improving the patient-centred care of children with life-altering skin conditions using feedback from electronic patient-reported outcome measures: protocol for a hybrid effectiveness-implementation study (PEDS-ePROM)

Por: Tyack · Z. · Simons · M. · McPhail · S. M. · Harvey · G. · Zappala · T. · Ware · R. S. · Kimble · R. M.
Introduction

Using patient-reported outcome measures (PROMs) with children have been described as ‘giving a voice to the child’. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.

Methods and analysis

A hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children’s hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.

Ethics and dissemination

Ethical approval was obtained from Children’s Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12620000174987).

Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial

Por: Pondofe · K. · Fregonezi · G. A. F. · Brito · O. · Dourado Junior · M. E. · Torres-Castro · R. · Resqueti · V. R.
Introduction

This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).

Methods and analysis

This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV1) and FEV1/FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05.

Ethics and dissemination

The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease’s rapid progression is a limitation for performing a long-term clinical study.

Trial registration number

RBR-3z23ts; Pre-results.

Travel-related control measures to contain the COVID-19 pandemic: an evidence map

Por: Movsisyan · A. · Burns · J. · Biallas · R. · Coenen · M. · Geffert · K. · Horstick · O. · Klerings · I. · Pfadenhauer · L. M. · von Philipsborn · P. · Sell · K. · Strahwald · B. · Stratil · J. M. · Voss · S. · Rehfuess · E.
Objectives

To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.

Design

Rapid evidence map.

Data sources

MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.

Eligibility criteria

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.

Data extraction and synthesis

We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.

Results

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.

Conclusions

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.

CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial

Por: Norgaard · S. K. · Mathiesen · E. R. · Norgaard · K. · Clausen · T. D. · Damm · P. · Ringholm · L.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT03770767

Impact of COVID-19 pandemic on mental health among general Bangladeshi population: a cross-sectional study

Por: Das · R. · Hasan · M. R. · Daria · S. · Islam · M. R.
Objectives

Mental health problems significantly increased worldwide during the coronavirus (COVID-19) pandemic. At the early stage of the outbreak, the government of Bangladesh imposed lockdown and quarantine approaches to prevent the spread of the virus, which impacted people’s daily life and health. The COVID-19 pandemic has also affected people’s economic status, healthcare facilities and other lifestyle factors in Bangladesh. We aimed to assess the impact of the COVID-19 pandemic on mental health among the Bangladeshi population.

Methods

We conducted an online cross-sectional survey among 672 Bangladeshi people aged between 15 and 65 years all over the country from 15 April to 10 May 2020. After obtaining electronic consent, we conducted a survey assessing people’s sociodemographic profiles and psychometric measures. We used The University of California, Los Angeles (UCLA) Loneliness Scale-8, Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-Item Scale and Pittsburgh Sleep Quality Index to assess loneliness, depression, anxiety and sleep disturbance, respectively.

Results

The prevalence of loneliness, depression, anxiety and sleep disturbance was estimated at 71% (mild: 32%, moderate: 29%, severe: 10%), 38% (mild: 24%, moderate: 11%, severe: 3%), 64% (mild: 30%, moderate: 17%, severe: 17%) and 73% (mild: 50%, moderate: 18%, severe: 5%), respectively. In Bangladesh, the key factors associated with poor mental health during COVID-19 were female sex, unemployment, being a student, obesity and living without a family. The present study also identified statistically significant interrelationships among the measured mental health issues.

Conclusions

A large portion of respondents reported mental health problems during the COVID-19 pandemic in Bangladesh. The present study suggests longitudinal assessments of mental health among Bangladeshi people to determine the gravity of this issue during and after the pandemic. Appropriate supportive programmes and interventional approaches would address mental health problems in Bangladesh during the COVID-19 pandemic.

Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

Por: Elliott · C. · Alexander · C. · Salt · A. · Spittle · A. J. · Boyd · R. N. · Badawi · N. · Morgan · C. · Silva · D. · Geelhoed · E. · Ware · R. S. · Ali · A. · McKenzie · A. · Bloom · D. · Sharp · M. · Ward · R. · Bora · S. · Prescott · S. · Woolfenden · S. · Le · V. · Davidson · S.-A. · Thorn
Introduction

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.

Method and analysis

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 and dissemination

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).

Trial registration number

ACTRN12619001422112.

Treatment preferences for preventive interventions for rheumatoid arthritis: protocol of a mixed methods case study for the Innovative Medicines Initiative PREFER project

Por: Falahee · M. · Simons · G. · DiSantostefano · R. L. · Valor Mendez · L. · Radawski · C. · Englbrecht · M. · Schölin Bywall · K. · Tcherny-Lessenot · S. · Kihlbom · U. · Hauber · B. · Veldwijk · J. · Raza · K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Predictors of poor health and functional recovery following road trauma: protocol of a British Columbian inception cohort study

Por: Shum · L. K. · Chan · H. · Erdelyi · S. · Pei · L. X. · Brubacher · J. R.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Addressing HIV care, mental health and substance use among youth and young adults in the Bay Area: description of an intervention to improve information, motivation and behavioural skills

Por: McCuistian · C. · Wootton · A. R. · Legnitto-Packard · D. · Gruber · V. A. · Dawson-Rose · C. · Johnson · M. O. · Saberi · P.
Objective

Youth represent a population disparately impacted by the HIV epidemic. With most new HIV diagnoses occurring among adolescents and young adults, novel approaches to address this disparity are necessary. The objective of the current study was to describe the Youth to Telehealth and Text to Improve Engagement in Care (Y2TEC) intervention, which aims to fill this gap. The Y2TEC intervention (trial registration NCT03681145) offers an innovative approach to improve HIV treatment engagement among youth living with HIV by focusing on treatment barriers related to mental health and substance use. This allows for a holistic approach to providing culturally informed intervention strategies for this population.

Participants and setting

The Y2TEC intervention was developed for youth with HIV in the large metropolitan area of the San Francisco Bay Area. The Y2TEC intervention was developed based on formative interdisciplinary research and is grounded in the information–motivation–behavioural skills model.

Results

The intervention includes 12 sessions each lasting 20–30 minutes, which are delivered through videoconferencing and accompanying bidirectional text messaging. The intervention sessions are individualised, with session dosage in each major content area determined by participant’s level of acuity.

Conclusions

The Y2TEC intervention is well positioned to help decrease HIV-related disparities in youth living with HIV through its innovative use of video-counselling technologies and an integrated focus on HIV, mental health and substance use.

Evaluation of the alignment of policies and practices for state-sponsored educational initiatives for sustainable health workforce solutions in selected Southern African countries: a protocol, multimethods study

Por: Mabunda · S. · Angell · B. · Joshi · R. · Durbach · A.
Introduction

Health systems across the world are facing challenges with shortages and maldistribution of skilled health professionals. Return-of-service (ROS) initiatives are government-funded strategies used to educate health professionals by contracting beneficiaries to undertake government work on a year-for-year basis after their qualification. It is envisaged that once they have served their contract, they will be attracted to serve in the same area or government establishment beyond the duration of their obligatory period. Little is known about the processes that led to the development and implementation of ROS policies. Furthermore, there is no systematic evaluation of the strategies that demonstrate their utility. This research aims to evaluate the ROS initiatives, explore their efficacy and sustainability in five Southern African countries.

Methods and analysis

This study will be conducted in South Africa, Eswatini, Lesotho, Botswana and Namibia in a phased approach through a multimethods approach of policy reviews, quantitative and qualitative research. First, a review will be conducted to explore current ROS schemes. Second, a quantitative retrospective cohort study of ROS scheme recipients for the period 2000–2010 will be undertaken. Information will be sourced from multiple provincial or national information systems and/or databases. Third, we will conduct semistructured group or individual interviews with senior health, education, ROS managing agency managers (where appropriate) and finance managers and/policy makers in each country to determine managers’ perceptions, challenges and the costs and benefits of these schemes. Fourth, we will interview or conduct group discussions with health professional regulatory bodies to assess their willingness to collaborate with ROS initiative funders.

Ethics and dissemination

Ethics approval for this study was obtained through the Human Research Ethics Committees of the University of New South Wales (HC200519), Australia; South Africa and Lesotho (065/2020); Eswatini (SHR302/2020); Namibia (SK001); and Botswana (HPDME 13/18/1). Relevant findings will be shared through presentations to participating governments, publications in peer-reviewed journals and presentations at relevant conferences.

Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial: a qualitative study based on the theoretical domains framework

Por: Lawrie · L. · Duncan · E. M. · Dunsmore · J. · Newlands · R. · Gillies · K.
Objectives

To identify barriers and enablers to participant retention in trials requiring questionnaire return using the theoretical domains framework (TDF).

Study design and setting

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.

Participants

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.

Results

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.

Conclusion

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.

Trial registration number

55215960; Pre-results.

Self-reported health and smoking status, and body mass index: a case-control comparison based on GEN SCRIP (GENetics of SChizophRenia In Pakistan) data

Por: Ayub · M. · Arsalan · A. · Khan · S.-u.-D. A. · Bajwa · S. · Hussain · F. · Umar · M. · Khizar · B. · Sibtain · M. · Butt · A. · Mukhtar-Ul-Haq · M. · Dogar · I. A. · Ansari · M. A. · Shafiq · S. · Tariq · M. · Hussain · M. I. · Nasar · A. · Mustafa · A. B. · Taj · R. · Rehman · R. U. · Rajp
Introduction

Individuals with schizophrenia are at a high risk of physical health comorbidities and premature mortality. Cardiovascular and metabolic causes are an important contributor. There are gaps in monitoring, documenting and managing these physical health comorbidities. Because of their condition, patients themselves may not be aware of these comorbidities and may not be able to follow a lifestyle that prevents and manages the complications. In many low-income and middle-income countries including Pakistan, the bulk of the burden of care for those struggling with schizophrenia falls on the families.

Objectives

To determine the rate of self-reported physical health disorders and risk factors, like body mass index (BMI) and smoking, associated with cardiovascular and metabolic disorders in cases of schizophrenia compared with a group of mentally healthy controls.

Design

A case-controlled, cross-sectional multicentre study of patients with schizophrenia in Pakistan.

Settings

Multiple data collection sites across the country for patients, that is, public and private psychiatric OPDs (out patient departments), specialised psychiatric care facilities, and psychiatric wards of teaching and district level hospitals. Healthy controls were enrolled from the community.

Participants

We report a total of 6838 participants’ data with (N 3411 (49.9%)) cases of schizophrenia compared with a group of healthy controls (N 3427 (50.1%)).

Results

BMI (OR 0.98 (CI 0.97 to 0.99), p=0.0025), and the rate of smoking is higher in patients with schizophrenia than in controls. Problems with vision (OR 0.13 (0.08 to 0.2), joint pain (OR 0.18 (0.07 to 0.44)) and high cholesterol (OR 0.13 (0.05 to 0.35)) have higher reported prevalence in controls. The cases describe more physical health disorders in the category ‘other’ (OR 4.65 (3.01 to 7.18)). This captures residual disorders not listed in the questionnaire.

Conclusions

Participants with schizophrenia in comparison with controls report more disorders. The access in the ‘other’ category may be a reflection of undiagnosed disorders.

How COVID-19 has affected general practice consultations and income: general practitioner cross-sectional population survey evidence from Ireland

Por: Homeniuk · R. · Collins · C.
Objectives

How general practice is delivered in many countries has drastically changed due to the COVID-19 pandemic. This study aimed to answer the question of how general practice has changed in Ireland in response to COVID-19.

Design

The Irish College of General Practitioners surveyed its membership before and after the global pandemic hit Ireland using a cross-sectional online survey instrument.

Setting

This study focuses on primary care, specifically general practice, in Ireland.

Participants

In February 2020 before the global pandemic, 526 general practices across Ireland submitted responses to the survey; 538 general practices responded to the second survey during the pandemic in June 2020. This covers 32% and 33% of practices in Ireland, respectively.

Main outcome measures

The type of consultations by general practitioners (GPs) and practice nurses in both surveys is the main outcome measure reported in this paper. Other changes such as the perceived change in attendance by certain patient groups and practice income are also reported.

Results

Face-to-face consultations significantly (p

Conclusions

It is likely that the way general practice is delivered will not return to as it was before the COVID-19 pandemic and increased telemedicine can be expected. However, it is necessary to assess the impact of this shift on patient health and to assess healthcare provider and patient experience to ensure continued high-quality care and patient safety.

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