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AnteayerBMJ Open

Physician awareness and understanding of chronic inflammatory demyelinating polyradiculoneuropathy in Japan: a web-based study

Por: Takeshita · Y. · Imajo · Y. · Oh · A. · Kikutani · M. · Okamatsu · N.
Objectives

To investigate potential knowledge gaps between neurologists and non-specialists and identify challenges in the current management of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), with a focus on ‘early diagnosis’ and ‘appropriate treatment’ for CIDP.

Design

A non-interventional, cross-sectional, web-based quantitative survey of physicians working in healthcare clinics or hospitals in Japan.

Setting

Participants were recruited from the Nikkei Business Publications panel from 18 August to 14 September 2022.

Participants

Responses from 360 physicians (120 each of internists, orthopaedists and neurologists) were collected.

Outcome measures

Responses relating to a CIDP hypothetical case and current understanding were assessed to determine awareness, collaboration preferences and diagnosis and treatment decisions.

Results

Understanding of CIDP was 90.8% among neurologists, 10.8% among orthopaedists and 13.3% among internists; >80% of orthopaedists and internists answered that neurologists are preferable for treatment. Diagnostic assessment using a hypothetical case showed 95.0% of neurologists, 74.2% of orthopaedists and 72.5% of internists suspected CIDP. Among orthopaedists and internists suspecting CIDP, >70% considered referring to neurology, while ~10% considered continuing treatment without a referral. Among neurologists, 69.4% chose intravenous immunoglobulin (IVIg) as first-line treatment and determined effectiveness to be ≤3 months.

Conclusions

Orthopaedists and internists had lower CIDP awareness compared with neurologists, which may lead to inadequate referrals to neurology. Evaluation of IVIg effectiveness for maintenance therapy occurred earlier than the guideline recommendations (6–12 months), risking premature discontinuation. Improving CIDP knowledge among orthopaedists and internists is critical for better diagnosis and collaboration with neurologists. Neurologists should consider slow and careful evaluation of IVIg maintenance therapy.

Trial registration number

UMIN000048516.

Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry

Introduction

Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.

Methods and analysis

Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.

Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.

Ethics and dissemination

Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.

Trial registration number

NCT04207892.

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

Did the COVID-19 pandemic affect levels of burnout, anxiety and depression among doctors and nurses in Bangladesh? A cross-sectional survey study

Por: Hutchings · H. A. · Rahman · M. · Carter · K. · Islam · S. · O'Neill · C. · Roberts · S. · John · A. · Fegan · G. · Dave · U. · Hawkes · N. · Ahmed · F. · Hasan · M. · Azad · A. K. · Rahman · M. M. · Kibria · M. G. · Rahman · M. M. · Mia · T. · Akhter · M. · Williams · J. G.
Introduction

COVID-19 has caused severe disruption to clinical services in Bangladesh but the extent of this, and the impact on healthcare professionals is unclear. We aimed to assess the perceived levels of anxiety, depression and burnout among doctors and nurses during COVID-19 pandemic.

Methods

We undertook an online survey using RedCap, directed at doctors and nurses across four institutions in Bangladesh (The Sheikh Russel Gastro Liver Institute & Hospital (SRNGIH), Dhaka Medical College Hospital (DMCH), Mugda Medical College Hospital (MMCH) and M Abdur Rahim Medical College (MARMC) Hospital). We collected information on demographics, awareness of well-being services, COVID-19-related workload, as well as anxiety, depression and burnout using two validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) and the Maslach Burnout Inventory (MBI).

Results

Of the 3000 participants approached, we received responses from 2705 (90.2%). There was a statistically significant difference in anxiety, depression and burnout scores across institutions (p

Conclusion

We identified a high prevalence of perceived anxiety, depression and burnout among doctors and nurses during the COVID-19 pandemic. This was worse in staff engaged in COVID-19-related activities. These findings could help healthcare organisations to plan for future similar events.

Cyberbullying and cyber-victimisation among higher secondary school adolescents in an urban city of Nepal: a cross-sectional study

Por: Kunwar · S. · Sharma · S. · Marasini · S. · Joshi · A. · Adhikari · A. · Ranjit · A. · Byanju Shrestha · I. · Shrestha · A. · Shrestha · A. K. · Karmacharya · B. M.
Objective

To assess the prevalence and factors associated with cyberbullying and cyber-victimisation among high school adolescents of Pokhara Metropolitan City, Nepal.

Design

A cross-sectional study.

Setting

Pokhara Metropolitan City, Nepal.

Participants

We used convenient sampling to enrol 450 adolescents aged 16–19 years from four distinct higher secondary schools in Pokhara Metropolitan City.

Outcome measures

We administered the Cyberbullying and an Online Aggression Survey to determine the prevalence of cyberbullying and cyber-victimisation. Univariate and multivariate logistic regression analyses were performed to estimate the ORs and 95% CIs. Data were analysed using STATA V.13.

Results

The 30-day prevalence of cyberbullying and cyber-victimisation was 14.4% and 19.8%, and the over-the-lifetime prevalence was 24.2% and 42.2%, respectively. Posting mean or hurtful comments online was the most common form of both cyberbullying and cyber-victimisation. Compared with females, males were more likely to be involved in cyberbullying (adjusted OR (AOR)=13.52; 95% CI: 6.04 to 30.25; p value

Conclusion

The study recommends the implementation of cyber-safety educational programmes, and counselling services including the rational use of internet and periodic screening for cyberbullying in educational institutions. The enforcement of strong anti-bullying policies and regulations could be helpful to combat the health-related consequences of cyberbullying.

Development and feasibility of a conceptual model for planning individualised physical exercise training (IPET) for older adults: a cross-sectional study

Por: Teljigovic · S. · Dalager · T. · Nielsen · N. O. · Holm · L. · Ejvang · M. B. · Sjogaard · G. · Sogaard · K. · Sandal · L. F.
Objective

Older adults constitute a heterogeneous group, and the focus of the individual physical exercise is often subject to the reasoning and experience of health professionals or exercise physiologists who prescribe them. Thus, this is the first effort to explicitly conceptualise the planning of individualised physical exercise training (IPET) for older adults in an outpatient setting and investigate individual exercise preferences.

Design

The concept of IPET was developed by researchers, exercise physiologists and health professionals from a real-life outpatient setting using an iterative approach. Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites form the basis of physical exercise recommendations. A cross-sectional study was conducted to assess the basis of implementing IPET.

Setting

Outpatient setting.

Participants

We included 115 older adults (70 females) from an outpatient setting with a median age of 74 years.

Outcome measures

Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites were collected and informed the concept of IPET that structures exercise programmes based on the individual citizen’s needs and physical exercise preferences. Exceeding a health indicator cut-point results in exercise content mitigating the risk associated with the health indicator.

Results

We included 115 older adults (70 females) from an outpatient setting median age of 74 years. Approximately two-thirds of participants exceeded at least one health indicator cut-point for aerobic training. One-third of the participants exceeded the cut-point for upper extremity strength, and almost all participants >99% exceeded the cut-point for lower extremity strength. Approximately two-thirds of the participants exceeded the cut-point for functional/balance training. The most prevalent site of musculoskeletal pain was the lower extremities. Eight of 20 training combinations were used, clustering the 115 participants primarily in three main training combinations.

Discussion

This study shows that older adults vary in physical functioning, indicating that exercise preferences and rehabilitation needs are individual.

Trial registration number

NCT04862481.

Impact of the design of adult mental health inpatient facilities on healthcare staff: a mixed methods systematic review

Por: Rodriguez-Labajos · L. · Kinloch · J. · Nicol · L. · Grant · S. · O'Brien · G.
Objectives

Mental health inpatient facilities are increasingly focusing on creating therapeutic, person-centred care environments. However, research shows that this focus may have unintended consequences for healthcare staff. Designs that do not pay attention to staff needs may risk contributing to stress, burnout, job dissatisfaction and mental exhaustion in the work environment. This systematic review aims to identify and synthesise current research on the design factors of adult mental health inpatient facilities that impact healthcare staff.

Design

A mixed method systematic review was conducted to search for empirical, peer-reviewed studies using the databases CINAHL, Embase, PsycINFO, PubMed and Web of Science from their inception up to 5 September 2023. The Joanna Briggs Institute’s critical appraisal checklists were used to assess the methodological quality of the eligible studies. Data were extracted and grouped based on the facility design factors.

Results

In our review, we included 29 peer-reviewed empirical studies that identified crucial design factors impacting healthcare staff in adult mental health inpatient facilities. Key factors included layouts providing optimal visibility, designated work and respite areas, and centrally located nursing stations. Notably, mixed perceptions regarding the benefits and challenges of open and glass-enclosed nursing stations suggest areas requiring further research. Facilities in geographically remote locations also emerged as a factor influencing staff dynamics. Additionally, although only supported by a limited number of studies, the significance of artwork, sensory rooms for respite, appropriate furniture and equipment, and access to alarms was acknowledged as contributory factors.

Conclusion

Through the synthesis of existing research, this review identified that the design of mental health facilities significantly impacts staff well-being, satisfaction, performance and perception of safety. Concluding that, in order to create a well-designed therapeutic environment, it is essential to account for both service users and staff user needs.

PROSPERO registration number

CRD42022368155.

Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Por: Messika · J. · Eloy · P. · Boulate · D. · Charvet · A. · Fessler · J. · Jougon · J. · Lacoste · P. · Mercier · O. · Portran · P. · Roze · H. · Sage · E. · Thes · J. · Tronc · F. · Vourc'h · M. · Montravers · P. · Castier · Y. · Mal · H. · Mordant · P. · Investigators from the ECMOToP Study
Introduction

Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis

We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination

The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number

NCT05664204.

DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study

Por: Brandt · Y. · Alers · R.-J. · Canjels · L. P. W. · Jorissen · L. M. · Jansen · G. · Janssen · E. B. N. J. · van Kuijk · S. M. · Went · T. M. · Koehn · D. · Gerretsen · S. C. · Jansen · J. F. · Backes · W. H. · Hurks · P. P. M. · van de Ven · V. · Kooi · M. E. · Spaanderman · M. E. A.
Introduction

Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.

Methods and analysis

The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.

Ethics and dissemination

This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.

Trial registration number

NCT02347540.

PERSIAN traffic safety and health cohort: a population-based precrash cohort study

Por: Golestani · M. · Razzaghi · A. · Rezaei · M. · Vahedi · L. · Pourasghar · F. · Farahbakhsh · M. · Shafiee-kandjani · A. · Meshkini · M. · Jahanjoo · F. · Yazdani · M. B. · Davtalab Esmaeili · E. · Jafari-Khounigh · A. · Ahmadi · S. · Mohammadi · R. · Ghojazadeh · M. · Sadeghi-Bazarga
Purpose

Despite to high burden of road traffic injuries (RTIs), the RTI epidemiology has received less attention with rare investments on robust population cohorts. The PERSIAN Traffic Safety and Health Cohort (PTSHC) was designed to assess the potential causal relationships between human factors and RTI mortality, injuries, severity of the injury, hospitalised injury, violation of traffic law as well as offer the strongest scientific evidence.

Participants

The precrash cohort study is carried out in four cities of Tabriz, Jolfa, Shabestar and Osku in East Azerbaijan province located in northwest Iran. The participants were people who sampled among the general population. The cluster sampling method was used to enrol the households in this study. The PTSHC encompasses a wide and comprehensive range and types of data. These include not only the common cohort data collections such as medical examination measures, previous medical history, bio assays and behavioural assessments but also includes data obtained using advanced novel technologies, for example, electronic travel monitoring, driving simulation and neuro-psycho-physiologic laboratory assessments specifically developed for traffic health field.

Findings to date

A total of 7200 participants aged 14 years and above were enrolled at baseline, nearly half of them being men. The mean age of participants was 39.2 (SD=19.9) years. The majority of participants (55.4%) belonged to the age group of 30–56 years. Currently, approximately 1 200 000 person-measurements have been collected.

Future plans

PSTHC will be used to determine the human-related risk factors by adjusting for the vehicle and land-use-related factors. Therefore, a lot of crashes can be prevented using effective interventions. Although this cohort provides valuable data, it is planned to increase its size to achieve the highest level of evidence with higher generalisability. Also, according to the national agreement this cohort is going to be extended to several geographical regions in second decade.

Mobile health biometrics to prescribe immediate remote physical activity for enhancing uptake to cardiac rehabilitation (MOTIVATE-CR+): protocol for a randomised controlled feasibility trial

Por: Crozier · A. · Cocks · M. · Hesketh · K. · Miller · G. · Mcgregor · G. · Thomas · L. · Jones · H.
Introduction

Cardiac rehabilitation (CR) can reduce cardiovascular mortality and improve health-related quality of life. In the United Kingdom, patient uptake of CR remains low (52%), falling well short of the target in the 2019 National Health Service long-term plan (85%). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and physical activity advice, enabling patients to engage in regular long-term physically active lifestyles. This randomised controlled trial (RCT) will evaluate the feasibility of mHealth technology when incorporated into a structured home-based walking intervention, in people with recent myocardial infarction.

Methods and analysis

This is a feasibility, assessor blinded, parallel group RCT. Participants will be allocated to either CR standard care (control group) or CR standard care+mHealth supported exercise counselling (mHealth intervention group). Feasibility outcomes will include the number of patients approached, screened and eligible; the percentage of patients who decline CR (including reasons for declining), agree to CR and consent to being part of the study; the percentage of patients who enrol in standard CR and reasons for drop out; and the percentage of participants who complete clinical, physical and psychosocial outcomes to identify a suitable primary outcome for a future definitive trial.

Ethics and dissemination

The trial was approved in the UK by the Northwest—Greater Manchester East Research Ethics Committee (22/NW/0301) and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings.

Trial registration numbers

NCT05774587

Non-pharmacological therapies for pain management in paediatric intensive care units: a protocol for a scoping review

Introduction

In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit.

Methods and analysis

A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenacão de Aperfeicoamento de Pessoal de Nível Superior, Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care.

Ethics and dissemination

This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children.

Trial registration number

This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT).

Kharameh cohort study (KHCS) on non-communicable diseases and preliminary findings of 3-year follow-up

Por: Rezaianzadeh · A. · Niazkar · H. R. · Rezaeianzadeh · R. · Jafari · F. · Rahimikazerooni · S. · Ghoddusi Johari · M. · Zare · M. · Hosseini · S. V.
Purpose

The Kharameh cohort study (KHCS) is one branch of the ‘Prospective Epidemiological Research Studies in Iran’, located in the south of Iran. The enrolment phase of KHCS spanned from April 2015 to March 2017, during which urban and rural residents of Kharameh were enrolled in the study. KHCS aims to investigate the incidence of non-communicable diseases (NCDs) such as hypertension, diabetes mellitus, cardiovascular diseases and cancer, and its related risk factors in a 15-year follow-up.

Participants

KHCS was designed to recruit 10 000 individuals aged 40–70 years old from both urban and rural areas of Kharameh. Thus, a total of 10 800 individuals aged 40–70 years of age were invited and, finally, 10 663 subjects were accepted to participate, with a participation rate of 98.7%.

Findings to date

Of the 10 663 participants, 5944 (55.7%) were women, and 6801 (63.7%) were rural residents. The mean age of the participants was 51.9±8.2 years. 41.8% of the participants were aged 40–49, 35.2% were aged 50–59 and the remaining 23% were 60–70 years old. Until March 2020 (first 3 years of follow-up), the total number of patients diagnosed with NCDs was 1565. Hypertension, type 2 diabetes and acute ischaemic heart disease were the most common NCDs. Furthermore, the total number of deaths during the first 3 years of follow-up was 312, with cardiovascular diseases (38.7%) as the most common cause of death, followed by cerebrovascular diseases (11.8%) and cancer (16.2%).

Future plans

The remaining 12 years of follow-up will inevitably shed light on the genetic, lifestyle/socioeconomic status, and environmental risk and protective factors of NCDs.

Comparative effectiveness of biologics in patients with rheumatoid arthritis stratified by body mass index: a cohort study in a Swiss registry

Objectives

Obesity is associated with lower treatment response in patients with rheumatoid arthritis (RA). In patients with obesity, abatacept was suggested as a preferable option to tumour necrosis factor-alpha inhibitors. We aimed to assess the comparative effectiveness of etanercept, infliximab and abatacept, compared with adalimumab, in patients with RA with obesity. Secondarily, we also investigated this in patients with overweight and normal weight for completeness.

Design

Observational cohort study.

Setting

Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry (1997–2019).

Participants

Adult patients with RA from the SCQM registry who received etanercept, infliximab, abatacept or adalimumab as their first biological or targeted synthetic disease-modifying antirheumatic drug were classified based on their body mass index (BMI) at the start of that treatment in three cohorts: obese, overweight, normal weight. They were followed for a maximum of 1 year.

Exposure

The study exposure of interest was the patients’ first biological, particularly: etanercept, infliximab and abatacept, compared with adalimumab.

Primary and secondary outcome measures

The primary study outcome was remission within 12 months, defined as 28-joint Disease Activity Score (DAS28)

Results

The study included 443 obese, 829 overweight and 1243 normal weight patients with RA. There were no statistically significant differences in the odds of DAS28-remission at ≤12 months for etanercept, infliximab and abatacept, compared with adalimumab, in any of the BMI cohorts.

Conclusions

No differences in DAS28-remission were found between the study drugs and adalimumab as first biologic in patients with RA, independently of the BMI cohort. We did not find evidence that treatment with abatacept increased the likelihood of remission compared with adalimumab among obese patients with RA.

Is reduced heart rate variability associated with functional somatic disorders? A cross-sectional population-based study; DanFunD

Por: Jorgensen · T. · Dantoft · T. M. · Petersen · M. W. · Gormsen · L. · Winter-Jensen · M. · Fink · P. · Linneberg · A. · Benros · M. E. · Eplov · L. F. · Bjerregaard · A. A. · Schovsbo · S. U. · Brinth · L. S.
Objectives

It has been hypothesised that functional somatic disorders (FSD) could be initiated by sympathetic predominance in the autonomic nervous system as measured by low heart rate variability (HRV). Earlier studies on the association between HRV and FSD are small case–control studies hampered by selection bias and do not consider the great overlap between the various FSDs. The aim of the present study is to assess any associations between HRV and various FSDs and whether chronic stress confounds such an association.

Design

A cross-sectional general population-based study.

Setting

The Danish Study of Functional Somatic Disorders conducted 2013–2015 in 10 municipalities in the western part of Greater Copenhagen, Denmark.

Participants

A total of 6891 men and women aged 18–72 years were included in the analyses after exclusion of 602 persons with missing HRV data. Various delimitations of FSD (chronic fatigue, chronic widespread pain, irritable bowel and bodily distress syndrome) were identified by validated questionnaires and diagnostic interviews. HRV parameters in time and frequency domains were calculated from successive beat-to-beat heart rate (HR) data using the ‘E-motion’ HR monitor device during 7 min of supine rest. Chronic stress was assessed by Cohen’s self-perceived stress scale.

Outcome measures

Logistic regression analyses were used to calculate possible associations between the various delimitations of FSD and HRV adjusting for chronic stress.

Results

Persons with FSD had a slightly higher mean HR and lower HRV as measured by time domain parameters, whereas associations with frequency domain parameters were not consistent. Adjusting for chronic stress attenuated associations slightly.

Conclusion

The study supports a sympathetic predominance in persons with FSD, which could not be entirely explained by chronic stress. However, it is not possible to conclude whether the association is a causal factor to or a consequence of FSD.

Perceptions of Australias e-cigarette regulations and recommendations for future reforms: a qualitative study of adolescents and adults

Por: Brierley · M.-E. E. · Yaw · S. J. L. · Jongenelis · M. I.
Objective

To assess public perceptions of the effectiveness of e-cigarette regulations in minimising use among adolescents and those who have never smoked. Specifically, we explored (1) perceived effectiveness of current regulations relating to e-cigarettes and (2) ideas for further regulations that could reduce use.

Design and participants

Focus groups (n=16) were conducted with Australian adolescents (14–17 years), young adults (18–24 years) and adults (25–39 years). Groups were stratified by age, gender and e-cigarette use status. Data were analysed using reflexive thematic analysis.

Setting

Focus groups were conducted in-person in two major Australian cities.

Results

Groups lacked a comprehensive understanding of e-cigarette regulations in Australia. When informed of these regulations, half of the groups considered the prescription model for nicotine e-cigarette products to be effective when enforced appropriately. Almost all groups considered access to non-nicotine products problematic. All groups suggested a range of demand reduction regulations, including plain packaging, health warnings, flavour restrictions and increased vape-free areas. Most groups (predominantly those who had never vaped) also recommended supply reduction regulations such as banning all e-cigarettes. The need for supply reduction measures to include addiction and mental health supports was discussed.

Conclusions

The regulations recommended by participants largely align with those that are to be introduced in Australia, indicating that these reforms are likely to be accepted by the public. Ensuring these reforms are complemented by formal supports for young people experiencing nicotine dependence and related mental health concerns is critical.

Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonisation (OPSiP trial): study protocol for a double-blind parallel group randomised placebo trial

Por: Hayes · K. · Janssen · P. · Payne · B. A. · Jevitt · C. · Johnston · W. · Johnson · P. · Butler · M.
Introduction

Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.

Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.

Methods and analysis

This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks’ gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.

Patient or public involvement

There was no patient or public involvement in the design of the study protocol.

Ethics and dissemination

This study protocol received ethics approval from the University of British Columbia’s Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.

Trial registration number

NCT03407157.

BioMEL: a translational research biobank of melanocytic lesions and melanoma

Por: Helkkula · T. · Christensen · G. · Ingvar · C. · Isaksson · K. · Harbst · K. · Persson · B. · Ingvar · A. · Hafström · A. · Carneiro · A. · Gaspar · V. · Jönsson · G. · Nielsen · K.
Introduction

Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma.

Methods and analysis

The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports.

Ethics and dissemination

The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority.

Trial registration number

NCT05446155.

Implementing adaptive e-learning for newborn care in Tanzania: an observational study of provider engagement and knowledge gains

Por: Meaney · P. A. · Hokororo · A. · Ndosi · H. · Dahlen · A. · Jacob · T. · Mwanga · J. R. · Kalabamu · F. S. · Joyce · C. L. · Mediratta · R. · Rozenfeld · B. · Berg · M. · Smith · Z. H. · Chami · N. · Mkopi · N. · Mwanga · C. · Diocles · E. · Agweyu · A.
Introduction

To improve healthcare provider knowledge of Tanzanian newborn care guidelines, we developed adaptive Essential and Sick Newborn Care (aESNC), an adaptive e-learning environment. The objectives of this study were to (1) assess implementation success with use of in-person support and nudging strategy and (2) describe baseline provider knowledge and metacognition.

Methods

6-month observational study at one zonal hospital and three health centres in Mwanza, Tanzania. To assess implementation success, we used the Reach, Efficacy, Adoption, Implementation and Maintenance framework and to describe baseline provider knowledge and metacognition we used Howell’s conscious-competence model. Additionally, we explored provider characteristics associated with initial learning completion or persistent activity.

Results

aESNC reached 85% (195/231) of providers: 75 medical, 53 nursing and 21 clinical officers; 110 (56%) were at the zonal hospital and 85 (44%) at health centres. Median clinical experience was 4 years (IQR 1–9) and 45 (23%) had previous in-service training for both newborn essential and sick newborn care. Efficacy was 42% (SD ±17%). Providers averaged 78% (SD ±31%) completion of initial learning and 7% (SD ±11%) of refresher assignments. 130 (67%) providers had ≥1 episode of inactivity >30 day, no episodes were due to lack of internet access. Baseline conscious-competence was 53% (IQR: 38%–63%), unconscious-incompetence 32% (IQR: 23%–42%), conscious-incompetence 7% (IQR: 2%–15%), and unconscious-competence 2% (IQR: 0%–3%). Higher baseline conscious-competence (OR 31.6 (95% CI 5.8 to 183.5)) and being a nursing officer (aOR: 5.6 (95% CI 1.8 to 18.1)), compared with medical officer, were associated with initial learning completion or persistent activity.

Conclusion

aESNC reach was high in a population of frontline providers across diverse levels of care in Tanzania. Use of in-person support and nudging increased reach, initial learning and refresher assignment completion, but refresher assignment completion remains low. Providers were often unaware of knowledge gaps, and lower baseline knowledge may decrease initial learning completion or activity. Further study to identify barriers to adaptive e-learning normalisation is needed.

What factors in the workplace enable success in antimicrobial stewardship in paediatric intensive care? An exploration of antimicrobial stewardship excellence through thematic analysis of appreciative inquiry interviews with healthcare staff

Por: Roche · E. · Jones · A. · Plunkett · A.
Objectives

Antimicrobial resistance (AMR) is a major global health problem. Efforts to mitigate AMR prioritise antimicrobial stewardship (AMS) interventions. These interventions typically focus on deficiencies in practice and providing negative or normative feedback. This approach may miss opportunities to learn from success. We aimed to identify factors that enable success in AMS practices in the paediatric intensive care unit (PICU) by analysing the data obtained from interviews with staff members who had achieved success in AMS.

Design

Qualitative study design using thematic analysis of appreciative inquiry interviews with healthcare staff.

Setting

31-bedded PICU in the UK between January 2017 and January 2018.

Participants

71 staff who had achieved success in AMS in the PICU.

Results

Six themes were identified: (1) cultural factors including psychological safety, leadership and positive attitude are important enablers for delivering good clinical care; (2) ergonomic design of the physical environment and ready availability of tools and resources are key elements to support good practice and decision-making; (3) expertise and support from members of the multidisciplinary team contribute to good care delivery; (4) clarity of verbal and written communication is important for sharing mental models and aims of care within the clinical team; (5) a range of intrinsic factors influences the performance of individual HCPs, including organisation skill, fear of failure, response to positive reinforcement and empathetic considerations towards peers; (6) good clinical care is underpinned by a sound domain knowledge, which can be acquired through training, mentorship and experience.

Conclusion

The insights gained in this study originate from frontline staff who were interviewed about successful work-as-done. This strengths-based approach is an understudied area of healthcare, and therefore offers authentic intelligence which may be leveraged to effect tangible improvement changes. The methodology is not limited to AMS and could be applied to a wide range of healthcare settings.

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