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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.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Por: Moreno · M. · Barry · A. · Gmeiner · M. · Yaro · J. B. · Serme · S. S. · Byrne · I. · Ramjith · J. · Ouedraogo · A. · Soulama · I. · Grignard · L. · Soremekun · S. · Koele · S. · ter Heine · R. · Ouedraogo · A. Z. · Sawadogo · J. · Sanogo · E. · Ouedraogo · I. N. · Hien · D. · Sirima · S. B
Introduction

Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis

We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination

The London School of Hygiene & Tropical Medicine’s Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number

NCT05878366.

The incidence, characteristics, impact and risk factors of post-COVID chronic pain in Thailand: A single-center cross-sectional study

by Suratsawadee Wangnamthip, Nantthasorn Zinboonyahgoon, Pranee Rushatamukayanunt, Patcha Papaisarn, Burapa Pajina, Thanawut Jitsinthunun, Panuwat Promsin, Rujipas Sirijatuphat, César Fernández-de-las-Peñas, Lars Arendt-Nielsen, Daniel Ciampi de Andrade

The COVID-19 pandemic has affected millions of individuals worldwide. Pain has emerged as a significant post-COVID-19 symptom. This study investigated the incidence, characteristics, and risk factors of post-COVID chronic pain (PCCP) in Thailand. A cross-sectional study was conducted in participants who had been infected, including those hospitalized and monitored at home by SARS-CoV-2 from August to September 2021. Data were collected for screening from medical records, and phone interviews were done between 3 to 6 months post-infection. Participants were classified into 1) no-pain, 2) PCCP, 3) chronic pain that has been aggravated by COVID-19, or 4) chronic pain that has not been aggravated by COVID-19. Pain interference and quality of life were evaluated with the Brief Pain Inventory and EuroQol Five Dimensions Five Levels Questionnaire. From 1,019 participants, 90% of the participants had mild infection, assessed by WHO progression scale. The overall incidence of PCCP was 3.2% (95% CI 2.3–4.5), with 2.8% (95% CI 2.0–4.1) in mild infection, 5.2% (95% CI 1.2–14.1) in moderate infection and 8.5% (95% CI 3.4–19.9) in severe infection. Most participants (83.3%) reported pain in the back and lower extremities and were classified as musculoskeletal pain and headache (8.3%). Risk factors associated with PCCP, included female sex (relative risk [RR] 2.2, 95% CI 1.0–4.9) and greater COVID-19 severity (RR 3.5, 95% CI 1.1–11.7). Participants with COVID-19-related exacerbated chronic pain displayed higher pain interferences and lower utility scores than other groups. In conclusion, this study highlights the incidence, features, and risk factors of post-COVID chronic pain (PCCP) in Thailand. It emphasizes the need to monitor and address PCCP, especially in severe cases, among females, and individuals with a history of chronic pain to improve their quality of life in the context of the ongoing COVID-19 pandemic.

Assessment of antimalarial activity of crude extract of Chan-Ta-Lee-La and Pra-Sa-Chan-Dang formulations and their plant ingredients for new drug candidates of malaria treatment: <i>In vitro</i> and <i>in vivo</i> experiments

by Prapaporn Chaniad, Arisara Phuwajaroanpong, Walaiporn Plirat, Atthaphon Konyanee, Abdi Wira Septama, Chuchard Punsawad

The emergence and spread of antimalarial drug resistance have become a significant problem worldwide. The search for natural products to develop novel antimalarial drugs is challenging. Therefore, this study aimed to assess the antimalarial and toxicological effects of Chan-Ta-Lee-La (CTLL) and Pra-Sa-Chan-Dang (PSCD) formulations and their plant ingredients. The crude extracts of CTLL and PSCD formulations and their plant ingredients were evaluated for in vitro antimalarial activity using Plasmodium lactate dehydrogenase enzyme and toxicity to Vero and HepG2 cells using the tetrazolium salt method. An extract from the CTLL and PSCD formulations exhibiting the highest selectivity index value was selected for further investigation using Peter’s 4-day suppressive test, curative test, prophylactic test, and acute oral toxicity in mice. The phytochemical constituents were characterized using gas chromatography-mass spectrometry (GC-MS). Results showed that ethanolic extracts of CTLL and PSCD formulations possessed high antimalarial activity (half maximal inhibitory concentration = 4.88, and 4.19 g/mL, respectively) with low cytotoxicity. Ethanolic extracts of the CTLL and PSCD formulations demonstrated a significant dose-dependent decrease in parasitemia in mice. The ethanolic CTLL extract showed the greatest suppressive effect after 4 days of suppressive (89.80%) and curative (35.94%) testing at a dose of 600 mg/kg. Moreover, ethanolic PSCD extract showed the highest suppressive effect in the prophylactic test (65.82%) at a dose of 600 mg/kg. There was no acute toxicity in mice treated with ethanolic CTLL and PSCD extracts at 2,000 mg/kg bodyweight. GC-MS analysis revealed that the most abundant compounds in the ethanolic CTLL extract were linderol, isoborneol, eudesmol, linoleic acid, and oleic acid, whereas ethyl 4-methoxycinnamate was the most commonly found compound in the ethanolic PSCD extract, followed by 3-hydroxy-2-(4-hydroxy-3-methoxyphenyl)-4H-chromen-4-one, flamenol, oleic acid amide, linoleic acid, and oleic acid. In conclusions, ethanolic CTLL and PSCD extracts exhibited high antimalarial efficacy in vitro. The ethanolic CTLL extract at a dose of 600 mg/kg exhibited the highest antimalarial activity in the 4-day suppressive and curative tests, whereas the ethanolic PSCD extract at a dose of 600 mg/kg showed the highest antimalarial activity in the prophylactic test.

Relationship between body mass index and mortality of burns patients: A systematic review and meta‐analysis

Abstract

This systematic review and meta-analysis aimed to evaluate the relationship between body mass index (BMI) and mortality of burn patients. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex, and Scientific Information Database (SID) using keywords extracted from Medical Subject Headings such as “Body mass index”, “Burns” and “Mortality” from the earliest to the April 1, 2023. The quality of the studies included in this systematic review was evaluated using the appraisal tool for cross-sectional studies (AXIS tool). Finally, six articles were included in this systematic review and meta-analysis. A total of 16 154 burn patients participated in six studies. Their mean age was 46.32 (SD = 1.99). Of the participants, 71.7% were males. The mean length of hospitalization was 18.80 (SD = 8.08) days, and the average TBSA in burn patients was 38.32 (SD = 2.79) %. Also, the average BMI in burn patients was 27.10 (SD = 1.75). Results found mortality in patients with abnormal BMI (overweight to morbidity BMI) was 0.19 more than normal BMI (ES: 1.19, 95%CI: 0.76–1.87, Z = 0.75, I 2: 71.8%, p = 0.45). Results of linear dose–response showed each 5 kg/m2 increase in BMI was associated with a 5% increase in mortality that was marginally significant (ES: 1.05, 95%CI: 1.00–1.11, Z = 1.99, I 2: 22.2%, p = 0.047). There was a non-linear relationship between levels of BMI and mortality (Prob > χ 2 = 0.02). There was an increase in mortality from percentile 10 to 50, although it was not significant (Correlational coefficient: 0.01, p = 0.85). Also, there was an increase in mortality rate from percentile 50 to 90 that was statistically significant (correlational coefficient: 0.06, p = 0.047). Finally, the results of the study indicated BMI can increase the chance of mortality by 0.19, although it was not significant. As a result, more studies are needed to better judge the relationship between BMI and mortality in burn victims.

The influence of supportive work environment on work‐related stress and conflict management style among emergency care nurses: A descriptive correlational study

Abstract

Background

Stress and conflict in emergency departments are inevitable but can be managed. A supportive work environment is key to helping emergency care providers, especially nurses, constructively manage work-related stress and conflict.

Aim

The aim of this study was to assess the influence of supportive work environments on work-related stress and conflict management style among emergency care nurses.

Methods

A descriptive correlational research design was utilized. Data were collected from 221 staff nurses recruited from two university hospital emergency departments in Alexandria, Egypt. Three instruments were used: (1) perceived organizational support scale, (2) nurses' occupational stressors scale, and (3) conflict management style inventory.

Results

There was a highly significant correlation between supportive work environments and work-related stress (p = .000) and a significant correlation between supportive work environments and conflict management style (p = .026). Supportive work environments had a significant inverse negative relationship with work-related stress experienced by nurses (p = .001) and accounted for 51% of variance in work-related stress. Meanwhile, supportive work environments had a significant positive relationship with conflict management styles of nurses (p = .026). Work-related stress had a significant relationship with nurses' conflict management style (p = .000) and accounted for 45% of the variance in conflict management style.

Linking Evidence to Action

The style of conflict management modeled by staff within emergency departments can positively or negatively influence the work environment and level of work-related stress. There is a necessity to cultivate a supportive culture for nurses in emergency departments to develop skills for constructive conflict management styles to reduce work-related stress.

Stress appraisal in the workplace and its associations with productivity and mood: Insights from a multimodal machine learning analysis

by Mohamad Awada, Burcin Becerik Gerber, Gale M. Lucas, Shawn C. Roll

Previous studies have primarily focused on predicting stress arousal, encompassing physiological, behavioral, and psychological responses to stressors, while neglecting the examination of stress appraisal. Stress appraisal involves the cognitive evaluation of a situation as stressful or non-stressful, and as a threat/pressure or a challenge/opportunity. In this study, we investigated several research questions related to the association between states of stress appraisal (i.e., boredom, eustress, coexisting eustress-distress, distress) and various factors such as stress levels, mood, productivity, physiological and behavioral responses, as well as the most effective ML algorithms and data signals for predicting stress appraisal. The results support the Yerkes-Dodson law, showing that a moderate stress level is associated with increased productivity and positive mood, while low and high levels of stress are related to decreased productivity and negative mood, with distress overpowering eustress when they coexist. Changes in stress appraisal relative to physiological and behavioral features were examined through the lenses of stress arousal, activity engagement, and performance. An XGBOOST model achieved the best prediction accuracies of stress appraisal, reaching 82.78% when combining physiological and behavioral features and 79.55% using only the physiological dataset. The small accuracy difference of 3% indicates that physiological data alone may be adequate to accurately predict stress appraisal, and the feature importance results identified electrodermal activity, skin temperature, and blood volume pulse as the most useful physiologic features. Implementing these models within work environments can serve as a foundation for designing workplace policies, practices, and stress management strategies that prioritize the promotion of eustress while reducing distress and boredom. Such efforts can foster a supportive work environment to enhance employee well-being and productivity.

Effect of screw angulation and multiple insertions on load-to-failure of polyaxial locking system

by Jakub Glowacki, Tomasz Bartkowiak, Piotr Paczos, Patryk Mietlinski, Pawel Zawadzki, Lukasz Lapaj

Purpose

Polyaxial locking plates rely on the alignment between the thread-to-thread connections of the screw head and the plate hole. These implants have provided substantial support for surgeons. In particular, extended screw positioning have proven to be beneficial in the fixation of challenging fractures. This study aimed to investigate the mechanical properties of ChM 5.0 ChLP polyaxial screws inserted in off-axis trajectories, including multiple insertions and to correlate these parameters with the screw head and the plate hole thread-to-thread engagement.

Methods

Polyaxial locking screws were inserted into the plates at various angles (0°,10°,15°, -15° off-axis). Multiple time inserted screws were placed firstly at 15°, then 0° and finally -15° off-axis in the same plate hole. A microCT scan of the plate-hole and screw-head interface was conducted before destructive tests. Representative screws from each group were also examined by Scanning Electron Microscope.

Results

The standard insertion at 0° sustained the greatest maximum bending strength without relocation in the screw hole. Screws inserted at 10° and 15° (one time) showed a significant reduction in load-to-failure of up to 36% and 55%, (p = 0.001) (p = 0.001) respectively. Screws inserted at -15° after a maximum of three multiple insertions with angle shift, showed a total reduction in force of up to 70% (p = 0.001). A microCT analysis of thread engagement showed significant correlations. However, the results obtained for multiple insertions were highly variable.

Conclusions

ChM 5.0 ChLP polyaxial locking system has valuable properties that foster fracture fixation, providing various surgical options. Nevertheless, the freedom of off-axis placement and multiple insertions of the screws comes at the price of reduced force. When possible surgeons should minimize the angles of insertions.

Association between oral condition and subjective psychological well-being among older adults attending a university hospital dental clinic: A cross-sectional study

by Noriko Takeuchi, Nanami Sawada, Daisuke Ekuni, Manabu Morita

Positive psychological well-being has a favorable impact on survival rates in both healthy and unhealthy populations. Oral health is also associated with psychological well-being, is multidimensional in nature, and includes physical, psychological, emotional, and social domains that are integral to overall health and well-being. This study aimed to identify the associations between individual and environmental characteristics, oral condition and nutritional status in relation to subjective well-being among older adults using the Wilson and Cleary conceptual model. The participants were older adults (age ≥ 60 years) attending a university hospital. Subjective well-being was assessed using the World Health Organization-5 Well-Being Index, oral condition was assessed based on the number of bacteria in the tongue coating, oral wettability, tongue pressure, occlusal force, oral diadochokinesis, and masticatory ability, and subjective swallowing function was assessed using the Eating Assessment Tool, number of remaining teeth, and number of functional teeth. In addition, factors related to well-being, including social networks, life–space mobility, nutritional status, smoking history, drinking history, and medical history were assessed. In the analysis, structural equation modeling was used to investigate the association between oral condition and subjective well-being. Confirmatory factor analysis revealed oral condition as a latent variable, including tongue pressure, oral diadochokinesis /pa/, /ta/, /ka/, occlusal force, masticatory ability, subjective swallowing function, and number of functional teeth. Structural Equation Modeling revealed that oral condition was positively correlated with nutritional status, and nutritional status was positively correlated with the World Health Organization-5 Well-Being Index. These findings suggest that oral condition may influence subjective well-being via nutritional status or social environmental factors.
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