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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.

Policy changes and the screening, diagnosis and treatment of drug-resistant tuberculosis patients from 2015 to 2018 in Zhejiang Province, China: a retrospective cohort study

Por: Jiang · W. · Peng · Y. · Wang · X. · Elbers · C. · Tang · S. · Huang · F. · Chen · B. · Cobelens · F.
Objectives

To examine changes in the screening, diagnosis, treatment and management of drug-resistant tuberculosis (DRTB) patients, and investigate the impacts of DRTB-related policies on patients of different demographic and socioeconomic characteristics.

Design

A retrospective cohort study using registry data, plus a survey on DRTB-related policies.

Setting

All prefecture-level Centres for Disease Control in Zhejiang Province, China.

Main outcome measures

Alongside the care cascade, we examined: (1) reported number of presumptive DRTB patients; (2) percentage of presumptive patients with drug susceptibility testing (DST) records; (3) percentage of DRTB/rifampicin-resistant (RR) patients registered; (4) percentage of RR/multidrug-resistant TB (MDRTB) patients that received anti-DRTB treatment; and (5) percentage of RR/MDRTB patients cured/completed treatment among those treated. Multivariate logistic regressions were conducted to explore the impacts of DRTB policies after adjusting for other factors.

Results

The number of reported presumptive DRTB patients and the percentage with DST records largely increased during 2015–2018, and the percentage of registered patients who received anti-DRTB treatment also increased from 59.0% to 86.5%. Patients under the policies of equipping GeneXpert plus expanded criteria for DST had a higher likelihood of being registered compared with no GeneXpert (adjusted OR (aOR)=2.57, 95% CI: 1.20 to 5.51), while for treatment initiation the association was only significant when further expanding the registration criteria (aOR=2.38, 95% CI: 1.19 to 4.79). Patients with registered residence inside Zhejiang were more likely to be registered (aOR=1.96, 95% CI: 1.52 to 2.52), treated (aOR=3.83, 95% CI: 2.78 to 5.28) and complete treatment (aOR=1.92, 95% CI: 1.03 to 3.59) compared with those outside.

Conclusion

The policy changes on DST and registration have effectively improved DRTB case finding and care. Nevertheless, challenges remain in servicing vulnerable groups such as migrants and improving equity in the access to TB care. Future policies should provide comprehensive support for migrants to complete treatment at their current place of residence.

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.

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.

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).

Magnitude and associated factors of unmet need for family planning among rural women in Ethiopia: a multilevel cross-sectional analysis

Por: Alem · A. Z. · Agegnehu · C. D.
Objective

This study was aimed to assess the magnitude and associated factors of unmet need for family planning among rural women in Ethiopia.

Design

Cross-sectional study.

Setting

Ethiopia.

Participants

Reproductive age group women.

Primary outcome

Unmet need for family planning.

Methods

This study drew data from Ethiopian Demographic and Health Survey, which was conducted from 18 January to 27 June 2016. A total of 8327 rural reproductive-aged (15–49 years) women were included. A two-level multivariable logistic regression model was carried out to identify individual and community-level factors associated with unmet need for family planning. Adjusted OR (AOR) with a 95% CI was used to assess the strength of association between independent and dependent variables.

Results

The overall unmet need for family planning among rural women was 24.08% (95% CI 23.17 to 25.01), of which 14.79% was for spacing and 9.29% for limiting. Number of children (AOR=1.15; 95% CI 1.07 to 1.24) and working status of women (AOR=1.18; 95% CI 1.02 to 1.37) were significantly associated with a higher odds of unmet need for family planning. However, women with primary education (AOR=0.87; 95% CI 0.74 to 0.94), women married at age 18 or later (AOR=0.82; 95% CI 0.70 to 0.96), women from households with high wealth index (AOR=0.77; 95% CI 0.64 to 0.94), women who deem distance to a health facility as not a big problem (AOR=0.85; 95% CI 0.73 to 0.99), women from communities with a high percentage of educated women (AOR=0.73; 95% CI 0.59 to 0.89) and women who live in communities with high media exposure (AOR=0.81, 95% CI 0.68 to 0.98) were significantly associated with a lower odds of unmet needs for family planning.

Conclusion

Unmet need for family planning among reproductive-aged women in rural Ethiopia was high. Number of children, working status of women, women’s education, age at first marriage, household wealth, distance to a health facility, community women’s education and community media exposure were significantly associated with unmet needs for family planning. Therefore, to reduce unmet need for family planning, public health policymakers should consider both individual and community-level factors when designing FP programmes and emphasis should be given to high-risk populations.

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.

Predicting the risk of drug-drug interactions in psychiatric hospitals: a retrospective longitudinal pharmacovigilance study

Por: Wolff · J. · Hefner · G. · Normann · C. · Kaier · K. · Binder · H. · Domschke · K. · Hiemke · C. · Marschollek · M. · Klimke · A.
Objectives

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.

Design

Retrospective, longitudinal study.

Setting

We used data from a large multicentred pharmacovigilance project carried out in eight psychiatric hospitals in Hesse, Germany.

Participants

Inpatient episodes consecutively discharged between 1 October 2017 and 30 September 2018 (year 1) or 1 January 2019 and 31 December 2019 (year 2).

Outcome measures

The proportion of rightly classified hospital episodes.

Methods

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.

Results

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.

Conclusion

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.

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.

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.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial

Por: Sprange · K. · Mountain · G. · Craig · C.
Objectives

Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions.

Design

We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention.

Intervention

The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions.

Results

The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics.

Conclusions

The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions.

Trial registration number

ISRCTN67209155.

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.

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.

Urinary placental growth factor as a predictor of complications in hypertensive disorders in pregnancy: a protocol for systematic review and meta-analysis

Por: Francoeur · C. · Moreau · J. · Lemaire-Paquette · S. · Battista · M.-C. · Roy-Lacroix · M.-E. · Cote · A.-M.
Introduction

Preeclampsia is an important cause of maternal and fetal morbidity and mortality. Although the diagnostic and prognostic values of circulating placental growth factor (PlGF) have been extensively studied, urinary PlGF represents an excellent alternative to facilitate sample collection in the follow-up of pregnant women. The aim of this study is to determine whether urinary PlGF levels throughout pregnancy can predict severe maternal, fetal/placental and neonatal complications in women with hypertensive disorders in pregnancy.

Methods and analysis

Studies that evaluated pregnant women with hypertensive disorders and at least one measurement of urinary PlGF will be included. Studies that measure urinary PlGF after the occurrence of the complications will be excluded. The main outcome will consist of severe maternal complications in women with hypertensive disorders in pregnancy. Secondary outcomes will consist of severe fetal/placental and neonatal complications as defined by the International Collaboration to Harmonize Outcomes for Pre-eclampsia. Prospective cohort studies and case–controls studies reporting original data will be included. Studies will be identified by searching MEDLINE and SCOPUS databases. The first literature search was conducted on 2 March 2020, and another search will be performed before analyses. All eligible studies will be assessed for risk of bias with a standardised 10-items study quality assessment tool adapted from the Study Quality Assessment tools developed by the National Institutes of Health (NIH). Summary of ORs and 95% CIs will be reported to evaluate the association between urinary PlGF levels and hypertensive disorders in pregnancy and its complications. A random-effect meta-analysis will also be performed.

Ethics and dissemination

Review by an ethics committee will not be required for this systematic review. This study will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and will be submitted for publication in a peer-reviewed journal as well as for presentation at conferences targeting different stakeholders, including researchers, physicians and patients.

PROSPERO registration number

CRD42020186313.

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.

Contexts and mechanisms that promote access to healthcare for populations experiencing homelessness: a realist review

Por: Siersbaek · R. · Ford · J. A. · Burke · S. · Ni Cheallaigh · C. · Thomas · S.
Objective

The objective of this study was to identify and understand the health system contexts and mechanisms that allow for homeless populations to access appropriate healthcare when needed.

Design

A realist review.

Data sources

Ovid MEDLINE, embase.com, CINAHL, ASSIA and grey literature until April 2019.

Eligibility criteria for selecting studies

The purpose of the review was to identify health system patterns which enable access to healthcare for people who experience homelessness. Peer-reviewed articles were identified through a systematic search, grey literature search, citation tracking and expert recommendations. Studies meeting the inclusion criteria were assessed for rigour and relevance and coded to identify data relating to contexts, mechanisms and/or outcomes.

Analysis

Inductive and deductive coding was used to generate context–mechanism–outcome configurations, which were refined and then used to build several iterations of the overarching programme theory.

Results

Systematic searching identified 330 review articles, of which 24 were included. An additional 11 grey literature and primary sources were identified through citation tracking and expert recommendation. Additional purposive searching of grey literature yielded 50 records, of which 12 were included, for a total of 47 included sources. The analysis found that healthcare access for populations experiencing homelessness is improved when services are coordinated and delivered in a way that is organised around the person with a high degree of flexibility and a culture that rejects stigma, generating trusting relationships between patients and staff/practitioners. Health systems should provide long-term, dependable funding for services to ensure sustainability and staff retention.

Conclusions

With homelessness on the rise internationally, healthcare systems should focus on high-level factors such as funding stability, building inclusive cultures and setting goals which encourage and support staff to provide flexible, timely and connected services to improve access.

Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

Por: Haigh · L. · McPherson · S. · Mathers · J. C. · Anstee · Q. M.
Introduction

Lifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin-like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.

Methods and analysis

This project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.

Ethics and dissemination

Ethical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.

Trial registration number

ISRCTN93410321.

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