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Hoy — Mayo 14th 2024Tus fuentes RSS

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L.
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

Effectiveness and cost-effectiveness of community-based directly observed treatment (DOT) versus health facility-based DOT of tuberculosis in Africa: protocol for a systematic review and meta-analysis

Por: Baye · T. · Kassaw · A. T. · Gebrie · D. · Girmaw · F. · Ashagrie · G.
Background

Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

Objective

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

Methods

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethics and dissemination

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42023443260.

Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study

Por: Kairies-Schwarz · N. · Mussio · I. · Bulla-Holthaus · N. · Wankmüller · E. · Wolff · G. · Gontscharuk · V. · Heinen · Y. · Perings · S. · Brockmeyer · M. · Kelm · M. · Icks · A.
Objectives

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Design

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Setting

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

Participants

A total of 74 individuals with cardiovascular diseases.

Outcomes

Risk and time preferences.

Results

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

Conclusions

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

Risk of transmission of HIV to infants during breast/chest feeding when mothers/birthing parents living with HIV are on antiretroviral therapy: a protocol for a rapid review

Por: Djiadeu · P. · Begum · H. · Archibald · C. · Ekmekjian · T. · Busa · G. · Dansoh · J. · Van Nguyen · P. · Merckx · J. · Fleurant · A.
Introduction

HIV is a major public health issue affecting millions globally. Women and girls account for 46% of new HIV infections in 2022 and approximately 1.3 million females become pregnant every year. Vertical transmission of HIV from persons living with HIV (PLHIV) to infants may occur through different modalities, such as through breast/chest feeding. Notably, 82% of PLHIV who chose to breast/chest feed are on antiretroviral therapy (ART) when feeding their infants. Precise estimates of the risk of postpartum transmission to infants during breast/chest feeding at varying viral load levels remain a significant gap in the literature.

Methods and analysis

A rapid systematic search of electronic databases will be conducted from January 2005 to the present, including Medline, Embase and Global Health. The objective of this rapid review is to explore and assess the available evidence on the effect of varying viral load levels on the risk of HIV transmission to infants during breast/chest feeding when the birthing or gestational parent living with HIV is on ART. Study characteristics will be summarised and reported to support the narrative summary of the findings. The focus will be on the absolute risk of HIV transmission from birthing parent to infant during chest/breast feeding. The findings will also be stratified by month, including the risk of HIV transmission for 6 months and greater than 6 months postpartum. We will ascertain the risk of bias using A Measurement Tool to Assess Systematic Reviews 2, Quality of Prognosis Studies and Downs and Black checklist for the appropriate study type. A summary score will not be calculated, rather the strengths and limitations of the studies will be narratively described.

Ethics and dissemination

No human subjects will be involved in the research. The findings of this rapid review will inform a future systematic review and will be disseminated through peer-reviewed publications, presentations and conferences.

PROSPERO registration number

CRD42024499393.

How effective is topical miconazole or amorolfine for mild to moderately severe onychomycosis in primary care: the Onycho Trial - a randomised double-blind placebo-controlled trial

Por: Watjer · R. M. · Bonten · T. N. · Sayed · K. · Quint · K. D. · van der Beek · M. T. · Mertens · B. J. A. · Numans · M. E. · Eekhof · J. A. H.
Objectives

To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis.

Design

Randomised, double-blind, placebo-controlled trial, with computer-generated treatment allocation at a 1:1:1 ratio.

Setting

Primary care, recruitment from February 2020 to August 2022.

Participants

193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)).

Interventions

Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution).

Main outcome measures

Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability.

Results

Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability.

Conclusions

Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis.

Trial registration number

WHO ICTRP NL8193.

Prevalence and associated factors of neurocognitive disorder among people living with HIV/AIDS in the South Gondar zone primary hospitals, North-West Ethiopia: an institution-based cross-sectional study

Por: Kelebie · M. A. · Tinsae · T. · Alemayehu · B. F. · Walelign · G. K. · Takelle · G. M.
Objective

To assess the prevalence and associated factors of neurocognitive disorder among people living with HIV/AIDS in South Gondar primary hospitals, North-West Ethiopia, 2023.

Design

Institution-based cross-sectional study design.

Setting

South Gondar primary hospitals, North-West Ethiopia.

Participants

608 participants were recruited using the systematic random sampling technique.

Measurement

Data were collected using an interviewer-administered questionnaire and medical chart reviews. The International HIV Dementia Scale was used to screen for neurocognitive disorder. The data were entered through EPI-DATA V.4.6 and exported to SPSS V.21 statistical software for analysis. In the bivariable logistic regression analyses, variables with a value of p

Results

The prevalence of neurocognitive disorder among HIV-positive participants was 39.1%. In multivariable logistic regression, lower level of education (adjusted OR (AOR)=2.94; 95% CI 1.29 to 6.82), unemployment (AOR=2.74; 95% CI 1.29 to 6.84) and comorbid medical illness (AOR=1.80; 95% CI 1.03 to 3.14) were significantly associated with neurocognitive disorder.

Conclusion

HIV-associated neurocognitive problems affected over a third of the participants. According to the current study, comorbid medical conditions, unemployment and low educational attainment are associated with an increased risk of neurocognitive disorder. Therefore, early detection and treatment are essential.

Determinants of unmet need for modern contraceptives in Ethiopia

Por: Gebrekidan · H. · Alemayehu · M. · Debelew · G. T.
Objective

To identify the determinants of the unmet need for modern contraceptives in Ethiopia.

Design

Community-based cross-sectional study.

Setting

Ethiopia.

Participants

A group of 6636 women of reproductive age (15–49 years) who were sexually active were included in the study.

Outcome

Unmet need for modern contraceptives

Method

The study used data from the 2019 Performance Monitoring for Action-Ethiopia survey, which was community-based and cross-sectional. The sample consisted of women aged 15–49 from households randomly selected to be nationally representative. Multinomial logistic regression and spatial analysis were performed to determine the factors influencing unmet needs for modern contraceptives. The descriptive analysis incorporated svy commands to account for clustering.

Results

The proportion of unmet need for modern contraceptives was 19.7% (95% CI: 18% to 21.5%). Women with supportive norms towards family planning had a lower risk of unmet need for spacing (relative risk ratio (RRR)=0.92, 95% CI: 0.86 to 0.99). Older age lowered the risk of unmet need for spacing 40–44 (RRR=0.28, 95% CI: 0.13 to 0.59) and 45–49 (RRR=0.11, 95% CI: 0.04 to 0.31). Being married increased the unmet need for spacing (RRR=1.9, 95% CI: 1.36 to 2.7) and limiting (RRR=3.7, 95% CI: 1.86 to 7.4). Increasing parity increases the risk of unmet need for spacing (RRR=1.27, 95% CI: 1.16 to 1.38) and limiting (RRR=1.26, 95% CI: 1.15 to 1.4). Contrarily, older age increased the risk of unmet need for limiting 40–44 (RRR=10.2, 95% CI: 1.29 to 79.5), 45–49 (RRR=8.4, 95% CI: 1.03 to 67.4). A clustered spatial unmet need for modern contraceptives was observed (Global Moran’s I=0.715: Z-Score=3.8496, p

Conclusions

High levels of unmet need for modern contraceptives were observed in Ethiopia, showing geographical variations. It is essential to address the key factors affecting women and work towards reducing disparities in modern contraceptive unmet needs among different regions.

Assessment of the ability of Pseudomonas aeruginosa and Staphylococcus aureus to create biofilms during wound healing in a rat model treated with carboxymethyl cellulose/carboxymethyl chitosan hydrogel containing EDTA

Abstract

The primary objective of this study was to develop a carboxymethyl cellulose (CMC) and carboxymethyl chitosan (CMCS) hydrogel containing ethylene diamine tetra acetic acid (EDTA) as the materials for wound healing. CMC and CMCS solutions were prepared with a concentration of 4% (w/v). These solutions were made using normal saline serum with a concentration of 0.5% (v/v). Additionally, EDTA with the concentrations of 0.01%, 0.05%, 0.1%, 0.5%, 1%, and 2% (w/v) was included in the prepared polymer solution. The analysis of the hydrogels revealed that they possess porous structures with interconnected pores, with average in size 88.71 ± 5.93 μm. The hydrogels exhibited a swelling capacity of up to 60% of their initial weight within 24 h, as indicated by the weight loss and swelling measurements. The antibacterial experiments showed that the formulated CMC/CMCS/EDTA 0.5% hydrogel inhibited the growth of Staphylococcus aureus and Pseudomonas aeruginosa. Moreover, the produced hydrogels were haemocompatible and biocompatible. At the last stage, the evaluation of wound healing in the animal model demonstrated that the use of the produced hydrogels significantly improved the process of wound healing. Finally, the findings substantiated the effectiveness of the formulated hydrogels as the materials for promoting wound healing and antibacterial agents.

The pivotal role of debridement in wound healing

Journal of Wound Care, Volume 33, Issue 5, Page 366-366, May 2024.
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Analysing the patient experience of COVID‐19: Exploring patients' experiences of hospitalisation and their quality of life post discharge

Abstract

Aims and Objectives

We sought to gain an understanding of the patient experience during their hospital stay for COVID-19, and the impact of COVID-19 on quality of life post discharge.

Background

Symptoms of COVID-19 include a persistent cough, dyspnoea and fatigue. Individuals with comorbidities such as cardiovascular disease have a higher risk of contracting COVID-19 and approximately 20% of those diagnosed with COVID-19 are admitted to hospital. Following discharge from hospital, 40% of patients report a worsened quality of life and up to 87% of those discharged from hospital have experienced ‘long COVID’.

Design

A qualitative design was used to understand patient experience of hospitalisation following a diagnosis of COVID-19, and their experiences following discharge from hospital.

Methods

Ten patients with a previous diagnosis of COVID-19 took part in semi-structured interviews regarding their experiences of hospitalisation and the impact on quality of life post-discharge.

Results

The results identified three key themes from the interviews: communication and the inpatient experience, symptoms following discharge and regaining independence. Patients discussed their experience of hospitalisation and how this continued to impact their emotional well-being post-discharge. However, patients appeared to push themselves physically to improve their health, despite continued COVID-19 symptoms.

Conclusion

Patients hospitalised following a diagnosis of COVID-19 experienced psychological distress during their hospital stay, as well as 3-months post-discharge. We suggest the use of psychosocial interventions to support patients post-discharge.

Relevance to Clinical Practice

The results of this study provide a greater understanding of the patient experience during their hospital stay, which can support nursing staff practice. Additionally, the study provides in depth knowledge of personal experiences of patients diagnosed with COVID-19 and the impact following hospital discharge.

Patient or Public Contribution

Patient's took part in semi-structured interviews via telephone to support the aims and objectives of this study.

Spiritual interventions: Improving the lives of colorectal cancer survivors—A systematic literature review

Abstract

Aim

To systematically review the types of spiritual interventions available for colorectal cancer survivors and determine if they improve their lives.

Design

Systematic review.

Data Source

A thorough literature search was conducted in July 2023 using PRIMO, PubMed/Medline, Cochrane, CINAHL, Scopus, and EMBASE.

Review Methods

As an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist, the Synthesis Without Meta-Analysis reporting guideline was employed. A narrative synthesis was used to analyse the data.

Results

Thirty-five articles were analysed for this study. The findings suggest that psychoeducational intervention, cognitive behavioural therapy intervention, mindfulness intervention, social intervention, and spiritual counselling improved CRC survivor's coping skills, boosted self-esteem, lessened anxiety, instilled hope, enhanced daily functioning, improved survival rates, improved neurological functional status and quality of life (QoL).

Conclusion

There is proof that spiritual interventions help CRC patients and improve their QoL. It has been discovered that spiritual intervention is helpful in the diagnosis, management, and treatment of CRC conditions.

Impact

CRC survivors may have impairments in their physical ability and daily functioning as a result of many symptoms, such as pain, bowel dysfunction, and exhaustion. Furthermore, individuals may encounter difficulties in several aspects of their psychological, emotional, social, and role functioning due to the presence of dread symptoms. Therefore, these study will help CRC survivors To implement spiritual interventions in the management of their long-term care. To cultivate problem-solving abilities, foster self-assurance, and enhance self-awareness. To alleviate symptoms, enhance everyday functioning, and improve QoL.

No Inducement

No financial incentives were used to compensate patients or members of the public for this review.

Test-retest reliability of Latin American Group for Maturity (GDLAM) protocol in older women

by Álvaro Huerta Ojeda, Emilio Jofré-Saldía, Jimena Arriagada Molina, Patricia Rojas Quinchavil, María Paz Parada Toledo, Sergio Galdames Maliqueo, María-Mercedes Yeomans-Cabrera, Carlos Jorquera-Aguilera, Frano Giakoni-Ramirez, Maximiliano Bravo

Functional autonomy (FA) is a critical factor in determining the quality of life of older adults (OA), especially in the case of older women (OW), as they face a decline in FA in their later years of life. FA should be assessed early, using valid, reliable, and low-cost tests. This study evaluated the test-retest reliability of GDLAM and GDLAM autonomy index (GI) in OW. Thirty-nine OW (71.2 ± 6.50 years) participated in the study. A repeated measures design was used to compare the interday test-retest reliability of the five GDLAM tests (seconds) and the GI (points). The five tests represent activities of daily living, such as dressing or wandering around the house, while the GI provides a weighting of the results of the five tests. The analysis consisted of the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and coefficient of variation (CV). A CV ≤ 10% and an ICC ≥ 0.80 were considered acceptable reliability, whereas a CV ≤ 5% and an ICC ≥ 0.90 were considered high reliability. The outcome of the five tests, represented by the GI, showed high interday test-retest reliability (CV = 6.00% and ICC = 0.91). The results of this study demonstrate that the five tests of the GDLAM protocol and the GI have high interday test-retest reliability and good interday reproducibility. From a practical point of view, the GDLAM protocol allows the assessment of FA of community-dwelling OW, providing background for early diagnosis and, with it, the possibility of developing an individualized physical exercise prescription.

A bilateral filtering-based image enhancement for Alzheimer disease classification using CNN

by Nicodemus Songose Awarayi, Frimpong Twum, James Ben Hayfron-Acquah, Kwabena Owusu-Agyemang

This study aims to develop an optimally performing convolutional neural network to classify Alzheimer’s disease into mild cognitive impairment, normal controls, or Alzheimer’s disease classes using a magnetic resonance imaging dataset. To achieve this, we focused the study on addressing the challenge of image noise, which impacts the performance of deep learning models. The study introduced a scheme for enhancing images to improve the quality of the datasets. Specifically, an image enhancement algorithm based on histogram equalization and bilateral filtering techniques was deployed to reduce noise and enhance the quality of the images. Subsequently, a convolutional neural network model comprising four convolutional layers and two hidden layers was devised for classifying Alzheimer’s disease into three (3) distinct categories, namely mild cognitive impairment, Alzheimer’s disease, and normal controls. The model was trained and evaluated using a 10-fold cross-validation sampling approach with a learning rate of 0.001 and 200 training epochs at each instance. The proposed model yielded notable results, such as an accuracy of 93.45% and an area under the curve value of 0.99 when trained on the three classes. The model further showed superior results on binary classification compared with existing methods. The model recorded 94.39%, 94.92%, and 95.62% accuracies for Alzheimer’s disease versus normal controls, Alzheimer’s disease versus mild cognitive impairment, and mild cognitive impairment versus normal controls classes, respectively.

Effect and outcome of equity, diversity and inclusion programs in healthcare institutions: a systematic review protocol

Por: Buh · A. · Kang · R. · Kiska · R. · Fung · S. G. · Solmi · M. · Scott · M. · Salman · M. · Lee · K. · Milone · B. · Wafy · G. · Syed · S. · Dhaliwal · S. · Gibb · M. · Akbari · A. · Brown · P. A. · Hundemer · G. L. · Sood · M. M.
Background

Equity, diversity and inclusion (EDI) in the healthcare field are crucial in meeting the healthcare needs of a progressively diverse society. In fact, a diverse healthcare workforce enables culturally sensitive care, promotes health equity and enhances the understanding of various needs and patients’ viewpoints, potentially resulting in more effective patient treatment and improved patient outcomes. Despite this, information on the effectiveness of policies or programmes promoting EDI in health institutions is scarce. The objective of this systematic review is to assess the effects and outcomes of EDI programmes in healthcare institutions.

Methods

We will conduct Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review of studies on EDI programmes and describe their effects and outcomes in healthcare institutions. We will search PubMed, Scopus, Web of Science, CINAHL and PsycINFO databases. Selected studies will include randomised control trials (RCTs), non-RCTs and cross-sectional studies published either in English or French. Quality appraisal of studies and a narrative synthesis of extracted data will be conducted as well as a meta-analysis if possible. The quality of evidence in this review will be assessed by the Grades of Recommendation, Assessment, Development and Evaluation.

Anticipated results

We anticipate that this systematic review will reveal information on the effect of EDI programmes and their outcomes in healthcare institutions. We expect this information will provide insights that will lead to improvements in designing EDI policies and programmes in healthcare institutions.

Ethics and dissemination

No ethical clearance is required for this study as no primary data will be collected. The final manuscript will be submitted to a journal for publication. In addition to this, the results of the study will also be disseminated through conference presentations to inform the research and clinical practice.

Review registration

This protocol has been registered with the International Prospective Register of Systematic Reviews; registration number CRD42024502781.

Scoping review of interventions to de-implement potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) in healthcare settings

Por: Rockwell · M. S. · Oyese · E. G. · Singh · E. · Vinson · M. · Yim · I. · Turner · J. K. · Epling · J. W.
Objectives

Potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) utilisation persists at undesirable rates worldwide. The purpose of this paper is to review the literature on interventions to de-implement potentially harmful NSAIDs in healthcare settings and to suggest directions for future research.

Design

Scoping review.

Data sources

PubMed, CINAHL, Embase, Cochrane Central and Google Scholar (1 January 2000 to 31 May 2022).

Study selection

Studies reporting on the effectiveness of interventions to systematically reduce potentially harmful NSAID utilisation in healthcare settings.

Data extraction

Using Covidence systematic review software, we extracted study and intervention characteristics, including the effectiveness of interventions in reducing NSAID utilisation.

Results

From 7818 articles initially identified, 68 were included in the review. Most studies took place in European countries (45.6%) or the USA (35.3%), with randomised controlled trial as the most common design (55.9%). Interventions were largely clinician-facing (76.2%) and delivered in primary care (60.2%) but were rarely (14.9%) guided by an implementation model, framework or theory. Academic detailing, clinical decision support or electronic medical record interventions, performance reports and pharmacist review were frequent approaches employed. NSAID use was most commonly classified as potentially harmful based on patients’ age (55.8%), history of gastrointestinal disorders (47.1%), or history of kidney disease (38.2%). Only 7.4% of interventions focused on over-the-counter (OTC) NSAIDs in addition to prescription. The majority of studies (76.2%) reported a reduction in the utilisation of potentially harmful NSAIDs. Few studies (5.9%) evaluated pain or quality of life following NSAIDs discontinuation.

Conclusion

Many varied interventions to de-implement potentially harmful NSAIDs have been applied in healthcare settings worldwide. Based on these findings and identified knowledge gaps, further efforts to comprehensively evaluate the effectiveness of interventions and the combination of intervention characteristics associated with effective de-implementation are needed. In addition, future work should be guided by de-implementation theory, focus on OTC NSAIDs and incorporate patient-focused strategies and outcomes, including the evaluation of unintended consequences of the intervention.

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L.
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

Analysis of risk factors affecting wound healing and wound infection after meningioma resection

Abstract

To analyse the risk factors affecting wound healing and infection after spinal meningioma resection surgery. The surgical incision healing of 137 patients who underwent spinal meningioma resection at our hospital from January 2021 to January 2024 was analysed. The data collected included physical examination findings, haematological and biochemical measurements, and various scales assessed upon admission and after surgery. These data were then analysed. The surgical wound healing, infection and postoperative complications were statistically analysed. Multiple logistic regression analysis method was used to conduct risk factor analysis on corresponding indicators; the odds ratio and p value of 95% confidence interval were calculated. Factors such as age and smoking history were significantly negatively correlated with wound healing after meningioma resection (odds ratio < 1.000, p < 0.05), while preoperative albumin and platelet count were significantly positively correlated with wound healing (odds ratio > 1.000, p < 0.05). Age, WHO Meningioma Grading, preoperative albumin and preoperative platelet were significantly negatively correlated with wound infection after meningioma resection (odds ratio < 1.000, p < 0.05). The history of virus infection and history of neurological disorders were significantly positively correlated with wound infection (odds ratio > 1.000, p < 0.05). The influence of each factor is different. Age, smoking history, WHO Meningioma Grading, preoperative albumin, preoperative platelets, history of virus infection and history of neurological disorders had the greatest influence on wound healing and infection after meningioma resection.

Predictive factors of clot propagation in patients with superficial venous thrombosis towards deep venous thrombosis and pulmonary embolism: a systematic review and meta-analysis

Por: van Royen · F. S.-A. · van Smeden · M. · van Doorn · S. · Rutten · F. H. · Geersing · G.-J.
Objective

A subset of patients with superficial venous thrombosis (SVT) experiences clot propagation towards deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The aim of this systematic review is to identify all clinically relevant cross-sectional and prognostic factors for predicting thrombotic complications in patients with SVT.

Design

Systematic review.

Data sources

PubMed/MEDLINE and Embase were systematically searched until 3 March 2023.

Eligibility criteria

Original research studies with patients with SVT, DVT and/or PE as the outcome and presenting cross-sectional or prognostic predictive factors.

Data extraction and synthesis of results

The CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling (CHARMS) checklist for prognostic factor studies was used for systematic extraction of study characteristics. Per identified predictive factor, relevant estimates of univariable and multivariable predictor—outcome associations were extracted, such as ORs and HRs. Estimates of association for the most frequently reported predictors were summarised in forest plots, and meta-analyses with heterogeneity were presented. The Quality in Prognosis Studies (QUIPS) tool was used for risk of bias assessment and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) for assessing the certainty of evidence.

Results

Twenty-two studies were included (n=10 111 patients). The most reported predictive factors were high age, male sex, history of venous thromboembolism (VTE), absence of varicose veins and cancer. Pooled effect estimates were heterogenous and ranged from OR 3.12 (95% CI 1.75 to 5.59) for the cross-sectional predictor cancer to OR 0.92 (95% CI 0.56 to 1.53) for the prognostic predictor high age. The level of evidence was rated very low to low. Most studies were scored high or moderate risk of bias.

Conclusions

Although the pooled estimates of the predictors high age, male sex, history of VTE, cancer and absence of varicose veins showed predictive potential in isolation, variability in study designs, lack of multivariable adjustment and high risk of bias prevent firm conclusions. High-quality, multivariable studies are necessary to be able to identify individual SVT risk profiles.

PROSPERO registration number

CRD42021262819.

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