Acceptance of multiple micronutrient supplementations (MMS) and iron and folic acid supplement utilisation among pregnant and lactating women in the rural part of Ethiopia, 2022: a cross-sectional study

Objective
To assess the acceptance of multiple micronutrient supplements and current iron and folic acid supplement utilisation among pregnant and lactating women in rural Ethiopia.

Design
Community-based cross-sectional study using a mixed method.

Setting
This study was carried out in five regions (Oromia, Gambela, Sidama, SNNPR (Southern Nations, Nationalities and Peoples Region) and Somali) of Ethiopia, 2022. A multistage random sampling technique was employed. A structured questionnaire was used to collect data from 410 pregnant and lactating women. A purposive sampling technique was used to select participants for the five Focused Group Discussions and fifteen Key Informant Interviews. Both bivariable and multivariable logistic regression analysis was conducted with a p value

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Gennaio 2025

Practice and factors affecting informed consent among healthcare workers for major surgical procedures at Gurage zone hospitals, South Ethiopia, 2022: a facility-based cross-sectional study

Objective
This study aimed to assess the informed consent practice process and associated factors among healthcare workers for major surgical procedures at Gurage zone hospitals, in 2022.

Methods and materials
Institution-based cross-sectional study was employed.

Settings
This study was conducted in Gurage zone hospitals.

Participants
All healthcare workers who have been working in Gurage zone hospitals of surgical, operation rooms and obstetrics/gynaecology wards had exposure to patients who had undergone surgery during the study period

Outcome
The primary outcome of the study was the practice of informed consent practice among healthcare workers in Gurage zone hospitals.

Result
A total of 448 study participants were involved in this study giving a response rate of 98%. The mean (±SD) age of the study participants was 29.16 (±4.06) years. The mean score of study participants towards the surgical informed consent was 19.5, and 260 (58%, 95% CI: 53.7, 62.5) of them had good practice in the surgical informed consent. In multivariable logistic analysis model, factors like favourable attitude towards informed consent 2.4 (1.556, 3.596), work experience participants 4.9 (2.8, 8.7), adequate knowledge of informed consent 2.5 (1.6, 3.9) and communication challenge 1.6 (1.07, 2.50) were independently associated with the practice of informed consent at a p value of

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Gennaio 2025

Aetiological, seasonal and antibiotic susceptibility patterns of diarrhoeal diseases in Bhutan (2016-2022): a retrospective study of surveillance data

Objectives
This study aimed to identify the aetiological spectrum, seasonal distribution and antimicrobial resistance patterns of diarrhoeal diseases in Bhutan.

Study design and setting
The study used a cross-sectional, retrospective analysis of secondary data gathered through a passive, hospital-based sentinel surveillance for diarrhoeal disease across 12 hospitals, representing Bhutan’s demographically diverse regions.

Participants
A total of 3429 participants’ data of all age groups who presented with diarrhoea at sentinel hospitals between 1 January 1 2016 and 31 December 2022 were analysed.

Results
Diarrhoeagenic Escherichia coli (DEC), Shigella, Salmonella and Aeromonas spp. were predominant bacterial pathogens, while Rotavirus, Astrovirus and Norovirus were the leading viral pathogens. Coinfections were observed in 195 cases. Children under nine were significantly affected than the other age groups. Seasonal trends revealed that bacterial pathogen incidence peaked during the summer/monsoon season, viral pathogens were more common in winter and spring, and parasites persisted year-round. Among the antibiotics tested, gentamicin, chloramphenicol, ceftriaxone and tetracycline exhibited high efficacy, with susceptibility rates of 93.4%, 87.2%, 81.5% and 69.5%, respectively. Conversely, high resistance rates were observed for amoxicillin (80.3%), ampicillin (77.4%) and nalidixic acid (69.5%). Multidrug resistance was prevalent, with β-lactamase production contributing to resistance rates of 80.7% to penicillin and 65.4% to fluoroquinolones groups. Cephalosporin resistance was also notable, with rates of 34.4% for cephalexin, 40.0% for cefazolin and 16.9% for ceftriaxone.

Conclusions
DEC and Rotavirus were identified as the leading causes of diarrhoea, with significant resistance patterns observed in common bacterial isolates. These findings underscore the need for DEC screening in paediatric cases and emphasise the need for sustained antimicrobial resistance surveillance.

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Gennaio 2025

Which clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study.

Objectives
In the European Union, a new orphan medicinal product must demonstrate ‘significant benefit’ over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products—either directly by a head-to-head comparison within a clinical trial or indirectly as a cross-trial comparison—are necessary. In this study, we investigate the types of trial designs and statistical approaches used for demonstrating a significant benefit of a new orphan medicinal product against approved comparators used between 2012 and 2022.

Design
This is a cross-sectional study based on the European Medicines Agency’s ‘orphan maintenance’ assessment documents between 2012 and 2022. All documents were manually reviewed to extract structured data on the following outcome measures:
For every comparison between a new orphan medicinal product and a comparator used for demonstrating a significant benefit as part of an orphan maintenance procedure, we recorded the type and design of the data source and the type of statistical methodology used for the comparison.

Results
We identified 151 EMA orphan maintenance procedures with a positive decision that required the demonstration of a significant benefit. Within these 151 procedures, 418 comparisons between medicinal products were identified. Indirect comparisons are the most common approach for comparing the new orphan medicinal product to a relevant comparator (44%, 182/418), followed by qualitative comparisons (39%, 162/418) and direct comparisons (18%, 74/418). Among the indirect comparisons, naive side-by-side comparisons are most often used (71%, 129/182), whereas inferential approaches that adjust for population differences and quantify the uncertainty of the comparison are used less often (29%, 53/182). Although there is no clear time trend in the prevalence of any specific comparison type, we find that inferential indirect comparison methods approximately doubled between the first and second half of the reviewed time frame.

Conclusions
Indirect comparisons play an important role in demonstrating a significant benefit in the assessment of orphan products. Further work is needed to evaluate the appropriateness of different methodologies.

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Dicembre 2024

Thirty-six-year trends (1986-2022) in cigarette smoking and snus use in northern Sweden: a cross-sectional study

Objectives
To examine the 36-year trends in tobacco use in northern Sweden.

Design and outcome measure
Cross-sectional analysis of the eight population-based surveys that constitute the northern Sweden MONICA study (1986, 1990, 1994, 1999, 2004, 2009, 2014 and 2022). Cigarette smoking and snus use were self-reported via questionnaires, and age-adjusted percentages of cigarette smoking (including occasional use) and snus use were calculated via logit models.

Setting
General population of Norrbotten and Västerbotten (the two northernmost counties of Sweden).

Participants
6678 women and 6320 men, aged 25 to 74 years, were included for analysis. A total of 191 participants were excluded due to missing data on either cigarette smoking or snus use.

Results
Cigarette smoking decreased on a survey-to-survey basis, reaching a minimum in 2022 of 4.9% among men and 9.7% among women, corresponding to a percentage point change of 26.3 and 20.8, respectively, compared with 1986 (pwithin-group

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Dicembre 2024