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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.

Multivariate analysis of the impact of weather and air pollution on emergency department visits for night-time headaches among children: retrospective, clinical observational study

Por: Yamaguchi · H. · Nozu · K. · Ishiko · S. · Nagase · H. · Ninchoji · T. · Nagano · C. · Takeda · H. · Unzaki · A. · Ishibashi · K. · Morioka · I. · Iijima · K. · Ishida · A.
Objectives

To examine the association between the number of visits to the emergency department (ED) by children for night-time headaches and exposure to multifaceted factors, such as meteorological conditions and air pollution.

Design

We conducted a clinical observational time-series analysis study.

Setting

We reviewed consecutive patients younger than 16 years of age at the primary ED centre in Kobe city, Japan, during the night shift (19:30–7:00 hours) between 1 January 2011 and 31 December 2019.

Participants

In total, 265 191 children visited the ED; 822 presented with headache during the study period.

Primary outcome measures

We investigated the effects of meteorological factors and air pollutants by multivariate analysis of Poisson regression estimates. A subanalysis included the relationship between the number of patients with night-time headaches and the above factors by sex. Furthermore, the effect of typhoon landing on patient visits for headache was also analysed. Headache was not classified because examinations were performed by general paediatricians (non-specialists).

Results

The number of patients with night-time headaches displayed distinct seasonal changes, with peaks during the summer. Multivariate analysis of Poisson regression estimates revealed a significant positive relationship between the number of patients for headache and mean temperature. Subanalysis by sex indicated a positive relationship between the number of patients with headache and mean temperature in both sexes; however, it was significant only for females. No relationship was found between the number of patients with headache and air pollution. There was no change in the number of patients for night-time headaches 3 days before and after typhoon landing.

Conclusions

High temperature is the main factor for visiting ED for night-time headaches among children in Kobe city. Our results suggest that preventive measures against night-time headaches may be possible by reducing time spent outside during summer.

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.

Development of the Prevent for Work questionnaire (P4Wq) for assessment of musculoskeletal risk in the workplace: part 1--literature review and domains selection

Por: Langella · F. · Christensen · S. W. M. · Palsson · T. S. · Hogh · M. · Gagni · N. · Bellosta-Lopez · P. · Christiansen · D. H. · Delle Chiaie · M. · Domenech-Garcia · V. · Johnston · V. · Szeto · G. P. Y. · Villafane · J. H. · Herrero · P. · Berjano · P.
Objective

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.

Design

Literature review and survey study.

Setting and participants

A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.

Interventions and outcome

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.

Results

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.

Conclusions

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.

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.

<i>In vivo</i> assessment of a delayed release formulation of larazotide acetate indicated for celiac disease using a porcine model

by Hiroko Enomoto, James Yeatts, Liliana Carbajal, B. Radha Krishnan, Jay P. Madan, Sandeep Laumas, Anthony T. Blikslager, Kristen M. Messenger

There is no FDA approved therapy for the treatment of celiac disease (CeD), aside from avoidance of dietary gluten. Larazotide acetate (LA) is a first in class oral peptide developed as a tight junction regulator, which is a lead candidate for management of CeD. A delayed release formulation was tested in vitro and predicted release in the mid duodenum and jejunum, the target site of CeD. The aim of this study was to follow the concentration versus time profile of orally administered LA in the small intestine using a porcine model. A sensitive liquid chromatography/tandem mass spectrometry method was developed to quantify LA concentrations in porcine intestinal fluid samples. Oral dosing of LA (1 mg total) in overnight fasted pigs resulted in time dependent appearance of LA in the distal duodenum and proximal jejunum. Peak LA concentrations (0.32–1.76 μM) occurred at 1 hour in the duodenum and in proximal jejunum following oral dosing, with the continued presence of LA (0.02–0.47 μM) in the distal duodenum and in proximal jejunum (0.00–0.43 μM) from 2 to 4 hours following oral dosing. The data shows that LA is available in detectable concentrations at the site of CeD.

The effects of a psycho‐educational intervention to improve pain management after day surgery: A randomised clinical trial

Abstract

Aims and objectives

To evaluate the effectiveness of a psycho‐educational intervention for shoulder and breast day surgery patients in decreasing pain intensity and pain interference with function and strengthening adherence with the analgesic regimen; and further to identify factors that influence average pain intensity and pain interference with function.

Background

Pain is one of the most prevalent symptoms after day surgery. However, pain management is left to the patients and family, and interventions to help patients are needed.

Design

Randomised clinical trial with an intervention (n = 101) and a usual care group (n = 119) using multiple measurements during 6 months postoperatively. The CONSORT checklist is used.

Methods

Patients in the intervention group received a booklet about pain and pain management and coaching by research nurses on postoperative days 2, 3 and 7. Differences between groups were identified using the chi‐squared analysis and t tests. Changes with time were identified using a linear mixed model with repeated measures.

Results

After controlling for covariates, group differences at any time in average pain intensity and pain interference with function were not statistically significant. Changes over time within any one group in average pain intensity and pain interference with function were statistically significant and decreased with time. Higher levels of average pain intensity and pain interference over time were associated with shoulder surgery, female, younger, pain expectation, preoperative pain and poorer adherence.

Conclusions

No group differences related to the intervention were revealed, and preoperative teaching together with a pain management booklet and coaching may help to strengthen the intervention's effects. Further research on interventions directed towards pain management is needed.

Relevance to clinical practice

Day surgery patients’ postoperative pain and pain management is not satisfactorily handled. To encourage and educate patients to use the prescribed analgesics in the immediate postoperative days may be necessary to enhance pain management.

Clinical trial registration

ClinicalTrials.gov (NCT01595035).

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).

Investigating correlates of athletic identity and sport-related injury outcomes: a scoping review

Por: Renton · T. · Petersen · B. · Kennedy · S.
Objectives

To conduct a scoping review that (1) describes what is known about the relationship between athletic identity and sport-related injury outcomes and (2) describes the relationship that an injury (as an exposure) has on athletic identity (as an outcome) in athletes.

Design

Scoping review.

Participants

A total of n=1852 athletes from various sport backgrounds and levels of competition.

Primary and secondary outcome measures

The primary measure used within the studies identified was the Athletic Identity Measurement Scale. Secondary outcome measures assessed demographic, psychosocial, behavioural, physical function and pain-related constructs.

Results

Twenty-two studies were identified for inclusion. Samples were dominated by male, Caucasian athletes. The majority of studies captured musculoskeletal injuries, while only three studies included sport-related concussion. Athletic identity was significantly and positively associated with depressive symptom severity, sport performance traits (eg, ego-orientation and mastery-orientation), social network size, physical self-worth, motivation, rehabilitation overadherence, mental toughness and playing through pain, as well as injury severity and functional recovery outcomes. Findings pertaining to the association that an injury (as an exposure) had on athletic identity (as an outcome) were inconsistent and limited.

Conclusions

Athletic identity was most frequently associated with psychosocial, behavioural and injury-specific outcomes. Future research should seek to include diverse athlete samples (eg, women, athletes of different races, para-athletes) and should continue to reference theoretical injury models to inform study methodologies and to specify variables of interest for further exploration.

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

Could social prescribing contribute to type 2 diabetes prevention in people at high risk? Protocol for a realist, multilevel, mixed methods review and evaluation

Por: Calderon Larranaga · S. · Clinch · M. · Greenhalgh · T. · Finer · S.
Introduction

Social prescribing is an innovation being widely adopted within the UK National Health Service policy as a way of improving the management of people with long-term conditions, such as type 2 diabetes (T2D). It generally involves linking patients in primary care with non-medical community-based interventions. Despite widespread national support, evidence for the effectiveness of social prescribing is both insufficient and contested. In this study, we will investigate whether social prescribing can contribute to T2D prevention and, if so, when, how and in what circumstances it might best be introduced.

Methods and analysis

We will draw on realist evaluation to investigate the complex interpersonal, organisational, social and policy contexts in which social prescribing relevant to T2D prevention is implemented. We will set up a stakeholder group to advise us throughout the study, which will be conducted over three interconnected stages. In stage 1, we will undertake a realist review to synthesise the current evidence base for social prescribing. In stage 2, we will investigate how social prescribing relevant to people at high risk of T2D ‘works’ in a multiethnic, socioeconomically diverse community and any interactions with existing T2D prevention services using qualitative, quantitative and realist methods. In stage 3 and building on previous stages, we will synthesise a ‘transferable framework’ that will guide implementation and evaluation of social prescribing relevant to T2D prevention at scale.

Ethics and dissemination

National Health Service ethics approval has been granted (reference 20/LO/0713). This project will potentially inform the adaptation of social prescribing services to better meet the needs of people at high risk of T2D in socioeconomically deprived areas. Findings may also be transferable to other long-term conditions. Dissemination will be undertaken as a continuous process, supported by the stakeholder group. Tailored outputs will target the following audiences: (1) service providers and commissioners; (2) people at high risk of T2D and community stakeholders; and (3) policy and strategic decision makers.

PROSPERO registration number

CRD42020196259.

Are medical record front page data suitable for risk adjustment in hospital performance measurement? Development and validation of a risk model of in-hospital mortality after acute myocardial infarction

Por: Wu · C. · Zhang · D. · Bai · X. · Zhou · T. · Wang · Y. · Lin · Z. · He · G. · Li · X. · for the China PEACE Collaborative Group · Weng · Xie · Wu · Chen · Li · Wang · Yu · Li · Li · Hao · Zhang · Wu · Zhang · Liu · Wang · Jia · Bate · Qiqige · Jin · Cai · Liu · Xu · He · Yang · Yuan · Wang · Gu
Objectives

To develop a model of in-hospital mortality using medical record front page (MRFP) data and assess its validity in case-mix standardisation by comparison with a model developed using the complete medical record data.

Design

A nationally representative retrospective study.

Setting

Representative hospitals in China, covering 161 hospitals in modelling cohort and 156 hospitals in validation cohort.

Participants

Representative patients admitted for acute myocardial infarction. 8370 patients in modelling cohort and 9704 patients in validation cohort.

Primary outcome measures

In-hospital mortality, which was defined explicitly as death that occurred during hospitalisation, and the hospital-level risk standardised mortality rate (RSMR).

Results

A total of 14 variables were included in the model predicting in-hospital mortality based on MRFP data, with the area under receiver operating characteristic curve of 0.78 among modelling cohort and 0.79 among validation cohort. The median of absolute difference between the hospital RSMR predicted by hierarchical generalised linear models established based on MRFP data and complete medical record data, which was built as ‘reference model’, was 0.08% (10th and 90th percentiles: –1.8% and 1.6%). In the regression model comparing the RSMR between two models, the slope and intercept of the regression equation is 0.90 and 0.007 in modelling cohort, while 0.85 and 0.010 in validation cohort, which indicated that the evaluation capability from two models were very similar.

Conclusions

The models based on MRFP data showed good discrimination and calibration capability, as well as similar risk prediction effect in comparison with the model based on complete medical record data, which proved that MRFP data could be suitable for risk adjustment in hospital performance measurement.

Relationship between workers return to work, job retention and income in industrial accidents in Korea: a longitudinal study

Por: Bae · S. W. · Jeong · I. · Yoon · J.-H. · Lee · S. W. · Kim · T. H. · Won · J.-U.
Objective

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.

Design

This study was designed as a longitudinal study.

Setting

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.

Participants

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.

Methods

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.

Results

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.

Conclusions

It is important for accident victims to retain their jobs to maintain their economic status.

Web-based early intervention for children with motor difficulties aged 3-8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

Por: Camden · C. · Zwicker · J. G. · Morin · M. · Schuster · T. · Couture · M. · Poder · T. G. · Maltais · D. B. · Battista · M.-C. · Baillargeon · J.-P. · Goyette · M. · Pratte · G. · Hurtubise · K. · Phoenix · M. · Nguyen · T. · Berbari · J. · Tousignant · M. · WECARE TEAM
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT04254302.

'Its not something you can take in your hands'. Swiss experts perspectives on health data ownership: an interview-based study

Por: Martani · A. · Genevieve · L. D. · Elger · B. · Wangmo · T.
Objectives

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.

Design

In our qualitative study, we selected participants through purposive and snowball sampling. Interviews were recorded, transcribed verbatim and then analysed thematically.

Setting

Semi-structured interviews were conducted in person, via phone or online.

Participants

We interviewed 48 experts (researchers, policy makers and other stakeholders) of the Swiss health-data framework.

Results

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.

Conclusions

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.

Knowledge, attitude and psychological status of patients living with hepatitis C in five provinces in China: a cross-sectional survey

Por: Zhao · T.-S. · Jin · C. · Wang · Y. · Cui · F.
Objective

This study investigated the knowledge, attitudes and psychological status of hepatitis C virus (HCV)-positive patients through a cross-sectional survey to provide scientific strategies for improving their treatment compliance and quality of life.

Setting

The research was conducted in nine hospitals in five provincial administrative regions in China, namely Inner Mongolia, Jilin, Beijing, Hebei and Sichuan.

Participants

A total of 457 patients were recruited for this study and 409 patients were included in the final analysis. The participants were 215 men and 194 women, with an average age of 59 years.

Primary and secondary outcome measures

The primary outcomes were scores on scales assessing knowledge, attitudes and psychological status. The secondary outcomes were transmission of HCV, preference regarding the mode in which information about HCV was provided and factors affecting treatment.

Results

Blood transfusion was the most common route of HCV transmission (42.7%), followed by surgery (15.9%) and blood donation/sale (8.7%). The misunderstanding of HCV and negative attitudes towards other HCV-positive patients were relatively common among HCV-positive patients and were more pronounced among rural and ethnic minority populations. HCV-positive patients were generally categorised as possibly having symptoms of depression. Patients with negative attitudes were more likely to have symptoms of depression (OR=0.6, 95% CI 0.4 to 0.8).

Conclusions

HCV-positive patients had a poor understanding of HCV and a negative attitude towards other HCV-positive patients. It is very important to develop effective health education strategies to improve the knowledge, attitudes and mental health of HCV-positive patients and enhance treatment compliance.

Protocol for a pilot single-centre, parallel-arm, randomised controlled trial of dietary inulin to improve gut health in solid organ transplantation: the DIGEST study

Por: Singer · J. · Li · Y. J. · Ying · T. · Aouad · L. J. · Gracey · D. M. · Wyburn · K. · Macia · L. · Wu · H. · Chadban · S. J.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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).

Trial registration number

ACTRN12620000623998.

Use of psychotropic drugs and drugs with anticholinergic properties among residents with dementia in intermediate care facilities for older adults in Japan: a cohort study

Por: Hamada · S. · Kojima · T. · Hattori · Y. · Maruoka · H. · Ishii · S. · Okochi · J. · Akishita · M.
Objectives

To evaluate the prescription and discontinuation of psychotropic drugs (PD) and drugs with anticholinergic properties (DAP) in residents with dementia admitted to Roken, a major type of long-term care facility in Japan.

Design

Cohort study.

Setting

A nationwide questionnaire survey across 3598 Roken in Japan in 2015 (up to five randomly selected residents per facility).

Participants

This study included 1201 residents from 343 Roken (response rate: 10%). We determined the presence and severity of dementia using a nationally standardised measure.

Primary and secondary outcome measures

Prescriptions of PD and DAP at admission and 2 months after admission were evaluated. Multivariable logistic regression was used to evaluate the associations of residents’ baseline characteristics with prescriptions or discontinuation.

Results

Prescription rates decreased for antidementia drugs (19.4% to 13.0%), hypnotics (25.1% to 22.6%) and anxiolytics (12.3% to 10.7%), whereas those for other PD, such as antipsychotics (13.2% to 13.6%), antidepressants (7.4% to 6.7%), antiepileptic drugs (7.1% to 7.8%) and DAP (35.2% to 36.6%) did not statistically significantly decrease. Some factors were associated with the prescriptions, for example, for antipsychotics, older age (≥85 years) (adjusted OR (aOR), 0.60; 95% CI 0.43 to 0.85) and being bedridden (aOR 0.67; 95% CI 0.47 to 0.97) were associated with a lower use of antipsychotics, whereas severe dementia was associated with a higher use of antipsychotics (aOR 3.26; 95% CI 2.26 to 4.70). At an individual level, a quarter of residents prescribed PD or DAP at admission had discontinued at least one PD or DAP, respectively, 2 months after admission. Antidementia drug use in severe dementia (aOR 1.86; 95% CI 1.04 to 3.31) and PD use in older age (aOR 1.61; 95% CI 1.00 to 2.60; in residents with disabling dementia) were associated with discontinuation.

Conclusions

There is possible scope for deprescribing PD and DAP in Roken residents with dementia to mitigate the risks of adverse events.

Reducing police occupational needle stick injury risk following an interactive training: the SHIELD cohort study in Mexico

Por: Beletsky · L. · Abramovitz · D. · Baker · P. · Arredondo · J. · Rangel · G. · Artamonova · I. · Marotta · P. · Mittal · M. L. · Rocha-Jimenez · T. · Morales · M. · Clairgue · E. · Kang · S. · Banuelos · A. · Cepeda · J. · Patterson · T. A. · Strathdee · S. A.
Objective

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).

Setting

Tijuana, Mexico.

Participants

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%.

Intervention

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.

Outcome measures

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.

Results

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

Conclusions

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.

Trial registration number

NCT02444403.

Study protocol of a systematic review and qualitative evidence synthesis using two different approaches: Healthcare related needs and desires of older people with post-stroke aphasia

Introduction

Stroke is a frequent disease in the older population of Western Europe with aphasia as a common consequence. Aphasia is known to impede targeting treatment to individual patients’ needs and therefore may reduce treatment success. In Germany, the postacute care of patients who had stroke is provided by different healthcare institutions of different sectors (rehabilitation, nursing and primary care) with substantial difficulties to coordinate services. We will conduct two qualitative evidence syntheses (QESs) aiming at exploring distinct healthcare needs and desires of older people living with poststroke aphasia. We thereby hope to support the development of integrated care models based on needs of patients who are very restricted to communicate them. Since various methods of QESs exist, the aim of the study embedding the two QESs was to determine if findings differ according to the approach used.

Methods and analysis

We will conduct two QESs by using metaethnography (ME) and thematic synthesis (ThS) independently to synthesise the findings of primary qualitative studies. The main differences between these two methods are the underlying epistemologies (idealism (ME) vs realism (ThS)) and the type of research question (emerging (ME) vs fixed (ThS)).

We will search seven bibliographical databases. Inclusion criteria comprise: patients with poststroke aphasia, aged 65 years and older, studies in German/English, all types of qualitative studies concerning needs and desires related to healthcare or the healthcare system. The protocol was registered in the International Prospective Register of Systematic Reviews, follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and includes three items from the Enhancing Transparency in Reporting the synthesis of Qualitative Research checklist.

Ethics and dissemination

Ethical approval is not required. Findings will be published in a peer-reviewed journal and presented on national conferences.

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