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Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department

Por: Lynaes · C. · Ravn · S. L. · Skou · S. T. · Mogensen · C. B. · Arvig · M. D. · Christensen · S. W. M. · Sterling · M. · Andersen · T. E.
Introduction

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

Methods and analysis

This prospective cohort study will include 100 participants (18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

Ethics and dissemination

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

Trial registration number

NCT06176209.

'Small Steps towards improving 24-hour time-use behaviours to decrease the risk of dementia: protocol for a personalised, web-based randomised controlled trial in community-dwelling older adults

Por: Mellow · M. L. · Blake · H. T. · Ferguson · T. · Robins · B. · Dumuid · D. · Olds · T. · Stanford · T. E. · Laver · K. · Keage · H. · Coates · A. · Wade · A. T. · Rogers · M. · Davis · A. · Di Venuto · L. · Tregoweth · E. · Yandell · C. · Tainsh · B. · Smith · A. E.
Introduction

Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.

Methods and analysis

Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.

Ethics and dissemination

Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.

Trial registration number

NCT06291909).

Prevalence, determinants and consequences of delayed treatment intensification among type 2 diabetes mellitus patients at the University of Gondar Comprehensive Specialised Hospital, Northwest Ethiopia, 2024: a mixed-methods study

Por: Mussie · D. A. · Zerihun · T. E. · Kassaw · A. T. · Muche · E. A.
Objective

To ascertain the clinical impact, prevalence and associated determinants of delayed treatment intensification, defined as delaying the escalation of treatment plans for individuals with type 2 diabetes mellitus who fail to attain ideal glycaemic control, at the University of Gondar Comprehensive Specialised Hospital in Northwest Ethiopia.

Design

A mixed-methods study.

Setting

University of Gondar Comprehensive Specialised Hospital.

Participants

420 patients with type 2 diabetes mellitus with poor glycaemic control after the index date were included in this study. A simple random sampling technique was employed to select the required sample size. Data were collected retrospectively and entered into EpiData V.4.6 and exported to Stata V.14.2 for analysis.

Method

Multivariable logistic regression was used to identify factors associated with delayed treatment intensification. A p value of 0.05 in the multivariable analysis was considered statistically significant. Qualitative data were collected through in-depth interviews with eight selected healthcare providers, and thematic analysis was undertaken to identify the underlying barriers to timely treatment intensification.

Primary outcome

Delayed treatment intensification.

Results

The prevalence of delayed treatment intensification was 51.4% (95% CI 46.6% to 56.2%), with a median delay of 14 months (IQR: 7.5–42 months) from the index date. Among those experiencing delayed treatment intensification, 43.1% developed new chronic diabetic complications, including retinopathy (18.1%), neuropathy (14.4%) and nephropathy (6.0%). Other complications (hypertension, stroke, heart failure and diabetic foot ulcer) accounted for 4.64% of the cases. Significant predictors of delayed treatment intensification included longer duration of diabetes (adjusted ORs (AOR) 1.68; 95% CI 1.13 to 2.5), presence of comorbidities (AOR 1.83; 95% CI 1.04 to 3.2) and use of cardioprotective medications (AOR 1.59; 95% CI: 1.04 to 2.43). The qualitative findings revealed additional barriers contributing to delayed treatment intensification, including financial limitations, insufficient patient awareness and non-adherence among patients. Additionally, healthcare provider-related factors, including professional fatigue and knowledge gaps, as well as health institution-related factors such as inadequate healthcare infrastructure.

Conclusions

This study found a high prevalence of delayed treatment intensification (51.4%), associated with comorbidities, longer disease duration, low patient awareness, cardioprotective drug use and barriers related to the system and providers. To address these gaps, priorities should include strengthening patient education, scheduling regular reviews for high-risk patients and improving clinical decision support tools for timely treatment intensification. Enhancing healthcare infrastructure, such as medication supply and diagnostic services, and offering refresher training to reduce provider fatigue, are also crucial for improving the delivery of diabetes care.

Structural equation analysis on the inter-relationships between optimal antenatal care, health facility delivery and early postnatal care among women in Ethiopia: EDHS 2016

Por: Feleke · S. F. · Tesfa · N. A. · Geto · A. K. · Habtie · T. E. · Ahmed · S. S. · Ashagrie · G. · Kassa · M. A. · Yayeh · B. M. · Emagneneh · T.
Objective

This study employs structural equation modelling to explore the inter-relationships among optimal antenatal care (ANC), health facility delivery and early postnatal care (EPNC) in Ethiopia. By identifying both direct and indirect influencing factors, the study offers valuable insights to support integrated maternal health strategies and guide informed decision-making by policymakers and women alike.

Design

The secondary analysis of the Ethiopian Demographic and Health Survey 2016 was performed to investigate inter-relationships between optimal ANC, health facility delivery and postnatal care (PNC) among women in Ethiopia. Data were analysed with R software V.4.3.2. The study used binary logistic regression to examine differences in optimal ANC, health facility delivery and EPNC, focusing on variables with a p value of 0.1 or less. Selected variables were incorporated into a generalised structural equation model (GSEM) using the LAVAAN package to explore both direct and indirect effects. The GSEM method assessed the impact of exogenous variables on endogenous variables, all binary, using a logistic link and binomial family. Missing data were handled with the multiple imputation by chained equations package, and sampling weights were applied to ensure national and regional representativeness.

Setting and participant

The source population comprised all women of reproductive age (15–49 years) who gave birth in the 5 years preceding the survey. From 16 650 interviewed households (98% response rate), we identified 7590 eligible women with recent births. Finally, we included 2415 women who had attended four or more ANC visits.

Result

Media exposure significantly boosts the likelihood of using ANC (OR=1.8, 95% CI (1.04 to 3.23), p=0.04), health facility delivery (OR=1.7, 95% CI (1.23 to 2.45), p=0.05) and PNC (OR=2.0, 95% CI (1.6 to 4.01), p=0.01). Urban residence and secondary education also enhance ANC (OR=1.2, 95% CI (1.01 to 2.88), p=0.022; OR=1.3, 95% CI (1.20 to 3.01), p=0.018), health facility delivery (OR=1.1, 95% CI (1.01 to 3.24), p=0.035; OR=1.5, 95% CI (1.22 to 3.45), p=0.03) and PNC (OR=1.6, 95% CI (1.01 to 4.32), p=0.03). ANC directly affects health facility delivery (OR=1.4, 95% CI (1.28 to 3.09), p=0.01) and PNC (OR=1.6, 95% CI (1.01 to 3.80), p=0.03). Additionally, women aged 20–34 years and those from male-headed households positively impact health facility delivery (OR=1.5, 95% CI (1.20 to 4.80), p=0.01; OR=1.3, 95% CI (1.07 to 3.45), p=0.014) and PNC (OR=1.4, 95% CI (1.10 to 2.90), p=0.01; OR=1.2, 95% CI (1.07 to 3.08), p=0.025).

Conclusions

Optimal ANC is vital for encouraging health facility delivery and EPNC. To enhance maternal and neonatal health, policies should integrate these services. Key predictors include being aged 20–34, having secondary and higher education, media exposure, male-headed households and living in urban areas. Improving education and media exposure can boost maternal healthcare service use.

Self-directed arm-crank exercise to improve volitional control of the trunk in patients with subacute spinal cord injury: a multicentre, parallel-group, randomised controlled trial protocol

Por: Hidalgo Mas · M. d. R. · Kearney · J. · Middleton · V. · Chiu · C.-Y. · Duda · J. L. · Nightingale · T. E. · Martinez-Valdes · E. · Ahmed · Z. · Chiou · S.-Y.
Introduction

A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET’s impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET’s effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.

Methods and analysis

This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (

Ethics and dissemination

This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.

Trial registration number

ISRCTN17247972

Incidence, progression and predictors of chronic kidney disease among adult HIV/AIDS patients on antiretroviral treatment in comprehensive specialised hospitals in the Amhara Region, Ethiopia, 2022: a multi-centre retrospective follow-up study

Por: Abate · M. D. · Kassa · M. A. · Yilak · G. · Habtie · T. E. · Temesgen · D. · Mulu · B. · Feleke · S. F. · Baylie · A. · Bizuayehu · M. A.
Objective

To assess the incidence, progression and predictors of chronic kidney disease among adult patients living with HIV/AIDS who are receiving antiretroviral therapy.

Design

An institution-based, multicentre retrospective follow-up study was conducted among a randomly selected sample of 535 adult patients. Data were entered into Epi Data version 4.6.0 and analysed using STATA version 14.0. A Cox proportional hazards regression model was fitted to identify independent predictors of chronic kidney disease incidence. Variables with p

Setting and participants

The study was conducted at comprehensive specialised hospitals in the Amhara Region of Ethiopia. Adult patients with HIV/AIDS receiving follow-up antiretroviral therapy between 1 April 2012 and 31 September 2022 were the cohort participants.

Results

Of the 528 adult patients included in the final analysis, 15 (2.84%) developed chronic kidney disease during the follow-up period, resulting in an overall incidence rate of 4.1 per 1000 person-years of observation. Significant predictors of chronic kidney disease included baseline age (adjusted HR (AHR)=1.053; 95% CI, 1.001 to 1.108), serum creatinine (AHR=1.698; 95% CI, 1.302 to 2.215), blood urea nitrogen (AHR=1.031; 95% CI, 1.001 to 1.061) and baseline viral load ≥1000 copies/mL (AHR=3.464; 95% CI, 1.104 to 10.871).

Conclusion

The incidence of chronic kidney disease among adult patients with HIV was clinically significant. Older age, baseline viral load ≥1000 and high blood urea nitrogen and creatinine levels were significant predictors of higher risk. Proactive measures, such as closer kidney monitoring, targeted care for older patients and ensuring optimal viral suppression with effective antiretroviral therapy, can delay or prevent the development of chronic kidney disease.

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