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REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data

Por: Dasgupta · T. · De Allegri · M. · Brenner · S. · Kaminjolo-Kambala · C. · Lohmann · J.
Objectives

This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC).

Design

A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System.

Setting

Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi.

Participants

Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services.

Interventions

The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding.

Outcome measures

Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months.

Results

No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (–0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (–10.84 childbirths/facility and –20.66 consultations/facility, respectively), and in trends of utilisation over time (–0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country.

Conclusions

Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

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.

Understanding the use and outcomes of high-flow nasal cannula among infants admitted to Canadian hospitals with bronchiolitis (CanFLO): a protocol for a multicentre, retrospective cohort study

Por: DAlessandro · M. · Fricano · C. · Abdulsatar · F. · Bechard · N. · Brar · J. S. · Drouin · O. · Foulds · J. L. · Giglia · L. · Gill · P. J. · Gupta · R. · Li · P. · McConnery · J. · Metcalf · J. · Sakran · M. · Seaton · C. · Sehgal · A. · Sirizzotti · N. · Mbuagbaw · L. · Wahi · G. · On beha
Introduction

Bronchiolitis is the most common viral lower respiratory tract infection in children under 2 years of age. Respiratory support with high-flow nasal cannula (HFNC) is increasingly used in this patient population with limited understanding of the patients most likely to benefit and considerable practice variability of use. This study aims to understand the factors associated with failure of HFNC support among patients with bronchiolitis and to describe the current practice variations of HFNC use in patients with bronchiolitis in Canadian hospitals including fluid management and parameters to initiate, escalate and discontinue HFNC support.

Methods and analysis

This is a multicentre retrospective cohort study including hospitalised patients aged 0–24 months with bronchiolitis requiring support with HFNC between January 2017 and December 2021. Clinical data will be collected from patient medical records from Canadian hospitals (n=12), including academic and community centres. HFNC failure will be defined as the need for escalation to non-invasive or invasive mechanical ventilation. Factors associated with HFNC failure will be analysed using logistic regression. Descriptive statistics will be used to describe practice variations of HFNC utilisation and management.

Ethics and dissemination

Approval from the Research Ethics Boards (REBs) has been obtained for each participating study site prior to onset of data collection including Clinical Trials Ontario for all Ontario hospital sites and REBs from British Columbia Children’s Hospital, Stollery Children’s Hospital, Montreal Children’s Hospital and CHU Sainte-Justine. Study results will be disseminated through presentation at national/international conferences and publication in high-impact, peer-reviewed journals.

Organisation and delivery of a dedicated multidisciplinary prone ventilation team in the intensive care unit: Strategies and lessons from COVID-19

by Luke Bracegirdle, Matthew Stubbs, Rezaur Rahman, Alexander I. R. Jackson, Helmi C. Burton-Papp, Robert Chambers, Sanjay Gupta, Michael P. W. Grocott, Ahilanandan Dushianthan

Background

COVID-19 placed immense strain on healthcare systems, necessitating innovative responses to the surge of critically ill patients, particularly those requiring mechanical ventilation. In this report, we detail the establishment of a dedicated critical care prone positioning team at University Hospital Southampton in response to escalating demand for prone positioning during the initial wave of the pandemic.

Methods

The formation of a prone positioning team involved meticulous planning and collaboration across disciplines to ensure safe and efficient manoeuvrers. A comprehensive training strategy, aligned with national guidelines, was implemented for approximately 550 staff members from a diverse background. We surveyed team members to gain insight to the lived experience.

Results

A total of 78 full-time team members were recruited and successfully executed over 1200 manoeuvres over an eight-week period. Our survey suggests the majority felt valued and expressed pride and willingness to participate again should the need arise.

Conclusion

The rapid establishment and deployment of a dedicated prone positioning team may have contributed to both patient care and staff well-being. We provide insight and lessons that may be of value for future respiratory pandemics. Future work should explore objective clinical outcomes and long-term sustainability of such services.

Defining anthropometric thresholds (mid-arm circumference and calf circumference) in older adults residing in the community: a cross-sectional analysis using data from the population representative Longitudinal Aging Study in India (LASI DAD)

Por: Bhagwasia · M. · Rao · A. R. · Banerjee · J. · Bajpai · S. · Khobragade · P. Y. · Raman · A. V. · Talukdar · A. · Jain · A. · Rajguru · C. · Sankhe · L. · Goswami · D. · Shanthi · G. S. · Kumar · G. · Varghese · M. · Dhar · M. · Gupta · M. · Koul · P. A. · Mohanty · R. R. · Chakrabarti · S.
Objectives

To identify factors associated with malnutrition (undernutrition and overnutrition) and determine appropriate cut-off values for mid-arm circumference (MAC) and calf circumference (CC) among community-dwelling Indian older adults.

Design

Data from the first wave of harmonised diagnostic assessment of dementia for Longitudinal Ageing Study in India (LASI-DAD) were used. Various sociodemographic factors, comorbidities, geriatric syndromes, childhood financial and health status were included. Anthropometric measurements included body mass index (BMI), MAC and CC.

Setting

Nationally representative cohort study including 36 Indian states and union territories.

Participants

4096 older adults aged >60 years from LASI DAD.

Outcome measures

The outcome variable was BMI, categorised as low (2), normal (18.5–22.9 kg/m2) and high (>23 kg/m2). The cut-off values of MAC and CC were derived using ROC curve with BMI as the gold standard.

Results

902 (weighted percentage 20.55%) had low BMI, 1742 (44.25%) had high BMI. Undernutrition was associated with age, wealth-quintile and impaired cognition, while overnutrition was associated with higher education, urban living and comorbidities such as hypertension, diabetes and chronic heart disease. For CC, the optimal lower and upper cut-offs for males were 28.1 cm and >31.5 cm, respectively, while for females, the corresponding values were 26 cm and >29 cm. Similarly, the optimal lower and upper cut-offs for MAC in males were 23.9 cm and >26.9 cm, and for females, they were 22.5 cm and >25 cm.

Conclusion

Our study identifies a high BMI prevalence, especially among females, individuals with higher education, urban residents and those with comorbidities. We establish gender-specific MAC and CC cut-off values with significant implications for healthcare, policy and research. Tailored interventions can address undernutrition and overnutrition in older adults, enhancing standardised nutritional assessment and well-being.

Abdominal fat depots and their association with insulin resistance in patients with type 2 diabetes

by Umesh Kumar Garg, Nitish Mathur, Rahul Sahlot, Pradeep Tiwari, Balram Sharma, Aditya Saxena, Raj Kamal Jainaw, Laxman Agarwal, Shalu Gupta, Sandeep Kumar Mathur

Background

Asian-Indians show thin fat phenotype, characterized by predominantly central deposition of excess fat. The roles of abdominal subcutaneous fat (SAT), intra-peritoneal adipose tissue, and fat depots surrounding the vital organs (IPAT-SV) and liver fat in insulin resistance (IR), type-2 diabetes (T2D) and metabolic syndrome (MetS) in this population are sparsely investigated.

Aims and objectives

Assessment of liver fat, SAT and IPAT-SV by MRI in subjects with T2D and MetS; and to investigate its correlation with IR, specifically according to different quartiles of HOMA-IR.

Methods

Eighty T2D and the equal number of age sex-matched normal glucose tolerant controls participated in this study. Abdominal SAT, IPAT-SV and liver fat were measured using MRI. IR was estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

Results

T2D and MetS subjects have higher quantity liver fat and IPAT-SV fat than controls (P = 9 x 10−4 and 4 x 10−4 for T2D and 10−4 and 9 x 10−3 for MetS subjects respectively). MetS subjects also have higher SAT fat mass (P = 0.012), but not the BMI adjusted SAT fat mass (P = 0.48). Higher quartiles of HOMA-IR were associated with higher BMI, W:H ratio, waist circumference, and higher liver fat mass (ANOVA Test P = 0.020, 0.030, 2 x 10−6 and 3 x 10−3 respectively with F-values 3.35, 3.04, 8.82, 4.47 respectively). In T2D and MetS subjects, HOMA-IR showed a moderately strong correlation with liver fat (r = 0.467, P −5 and r = 0.493, P −7), but not with SAT fat and IPAT-SV. However, in MetS subjects IPAT-SV fat mass showed borderline correlation with IR (r = 0.241, P r = 0.13, P = 0.26). In non-T2D and non-MetS subjects, no such correlation was seen. On analyzing the correlation between the three abdominal adipose compartment fat masses and IR according to its severity, the correlation with liver fat mass becomes stronger with increasing quartiles of HOMA-IR, and the strongest correlation is seen in the highest quartile (r = 0.59, P −3). On the other hand, SAT fat mass tended to show an inverse relation with IR with borderline negative correlation in the highest quartile (r = -0.284, P P = 0.07).

Conclusion

In individuals suffering from T2D and MetS, IR shows a trend towards positive and borderline negative correlation with liver fat and SAT fat masses respectively. The positive trend with liver fat tends to become stronger with increasing quartile of IR. Therefore, these findings support the theory that possibly exhaustion of protective compartment’s capacity to store excess fat results in its pathological deposition in liver as ectopic fat.

What works for and what hinders deimplementation of low-value care in emergency medicine practice? A scoping review

Por: Gangathimmaiah · V. · Drever · N. · Evans · R. · Moodley · N. · Sen Gupta · T. · Cardona · M. · Carlisle · K.
Objectives

Low-value care can harm patients and healthcare systems. Despite a decade of global endeavours, low value care has persisted. Identification of barriers and enablers is essential for effective deimplementation of low-value care. This scoping review is an evidence summary of barriers, enablers and features of effective interventions for deimplementation of low-value care in emergency medicine practice worldwide.

Design

A mixed-methods scoping review was conducted using the Arksey and O’Malley framework.

Data sources

Medline, CINAHL, Embase, EMCare, Scopus and grey literature were searched from inception to 5 December 2022.

Eligibility criteria

Primary studies which employed qualitative, quantitative or mixed-methods approaches to explore deimplementation of low-value care in an EM setting and reported barriers, enablers or interventions were included. Reviews, protocols, perspectives, comments, opinions, editorials, letters to editors, news articles, books, chapters, policies, guidelines and animal studies were excluded. No language limits were applied.

Data extraction and synthesis

Study selection, data collection and quality assessment were performed by two independent reviewers. Barriers, enablers and interventions were mapped to the domains of the Theoretical Domains Framework. The Mixed Methods Appraisal Tool was used for quality assessment.

Results

The search yielded 167 studies. A majority were quantitative studies (90%, 150/167) that evaluated interventions (86%, 143/167). Limited provider abilities, diagnostic uncertainty, lack of provider insight, time constraints, fear of litigation, and patient expectations were the key barriers. Enablers included leadership commitment, provider engagement, provider training, performance feedback to providers and shared decision-making with patients. Interventions included one or more of the following facets: education, stakeholder engagement, audit and feedback, clinical decision support, nudge, clinical champions and training. Multifaceted interventions were more likely to be effective than single-faceted interventions. Effectiveness of multifaceted interventions was influenced by fidelity of the intervention facets. Use of behavioural change theories such as the Theoretical Domains Framework in the published studies appeared to enhance the effectiveness of interventions to deimplement low-value care.

Conclusion

High-fidelity, multifaceted interventions that incorporated education, stakeholder engagement, audit/feedback and clinical decision support, were administered daily and lasted longer than 1 year were most effective in achieving deimplementation of low-value care in emergency departments. This review contributes the best available evidence to date, but further rigorous, theory-informed, qualitative and mixed-methods studies are needed to supplement the growing body of evidence to effectively deimplement low-value care in emergency medicine practice.

Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study

Por: Knutson · K. L. · Pershing · M. L. · Abbott · S. · Alexandria · S. J. · Chiluka · S. · Chirinos · D. · Giachello · A. · Gupta · N. · Harrington · K. · Rittner · S. S. · Sorond · F. · Wong · M. · Vu · T.-H. T. · Zee · P. C. · Carnethon · M. R.
Introduction

Cognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or Hispanic/Latinx. Poor sleep is strongly associated with the development of vascular and metabolic diseases, which correlate with cognitive dysfunction. Therefore, sleep may contribute to observed disparities in cognitive disorders. The Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO) is a longitudinal, observational cohort study that focuses on gathering data to better understand racial/ethnic sleep disparities and illuminate the relationship among sleep, race and ethnicity and changes in cognitive function. This investigation may help inform targeted interventions to minimise disparities in cognitive health among ageing adults.

Methods and analysis

The DISCO study will examine up to 495 individuals aged 55 and older at two time points over 24 months. An equal number of black, white and Hispanic/Latinx individuals will be recruited using methods aimed for adults traditionally under-represented in research. Study procedures at each time point will include cognitive tests, gait speed measurement, wrist actigraphy, a type 2 home polysomnography and a clinical examination. Participants will also complete self-identified assessments and questionnaires on cognitive ability, sleep, medication use, quality of life, sociodemographic characteristics, diet, substance use, and psychological and social health.

Ethics and dissemination

This study was approved by the Northwestern University Feinberg School of Medicine Institutional Review Board. Deidentified datasets will be shared via the BioLINCC repository following the completion of the project. Biospecimen samples from the study that are not being analysed can be made available to qualified investigators on review and approval by study investigators. Requests that do not lead to participant burden or that conflict with the primary aims of the study will be reviewed by the study investigators.

Violence and aggression against nurses during the COVID‐19 pandemic in Latin America. From the emerging leaders program of the Interamerican Society of Cardiology (SIAC)

Abstract

Introduction

During the Coronavirus (COVID-19) pandemic, healthcare providers have overcome difficult experiences such as workplace violence. Nurses are particularly vulnerable to workplace violence. The objective of this study was to characterize violence and aggression against nurses during the COVID-19 pandemic in Latin America.

Methods

An electronic cross-sectional survey was conducted in 19 Latin American countries to characterize the frequency and type of violent actions against front-line healthcare providers.

Results

Of the original 3544 respondents, 16% were nurses (n = 567). The mean age was 39.7 ± 9.0 years and 79.6% (n = 2821) were women. In total, 69.8% (n = 2474) worked in public hospitals and 81.1% (n = 2874) reported working regularly with COVID-19 patients. Overall, about 68.6% (n = 2431) of nurses experienced at least one episode of workplace aggression during the pandemic. Nurses experienced weekly aggressions more frequently than other healthcare providers (45.5% versus 38.1%, p < .007). Nurses showed a trend of lower reporting rates against the acts of aggression suffered (p = .076). In addition, nurses were more likely to experience negative cognitive symptoms after aggressive acts (33.4% versus 27.8%, p = .028). However, nurses reported considering changing their work tasks less frequently compared to other healthcare providers after an assault event (p = .005).

Conclusion

Workplace violence has been a frequent problem for all healthcare providers during COVID-19 pandemic in Latin America. Nurses were a particularly vulnerable subgroup, with higher rates of aggressions and cognitive symptoms and lower rate of complaints than other healthcare providers who suffered from workplace violence. It is imperative to develop strategies to protect this vulnerable group from aggressions during their tasks.

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