Perception of patient-centred care and its relationship with management outcomes and complications among patients with DM in Malawi

Background
Patient-centred care (PCC) is associated with better experiences for chronic care encounters and better outcomes. However, its assessment and resultant management outcomes have not been well documented in Malawi. As Malawi strives to institutionalise PCC in its quality-of-care initiatives, documenting its correlates and outcomes is a good starting point in the implementation and advocacy of PCC among chronic care patients, particularly those living with diabetes mellitus (DM).

Aim
We sought to assess the level of diabetic patients’ perception of PCC and its relationship to self-efficacy, adherence and glycaemic control among patients with DM.

Study setting
This study was done in DM clinics of two district and two central hospitals in southern Malawi.

Research design and methods
This was a cross-sectional analytical study. We studied 607 subsequent consenting adult patients with DM. We assessed the level of perception of using a locally generated and validated tool and its correlation with self-efficacy, adherence and long-term glycaemic control after a medical encounter. We used K-means clustering, linear and logistic regression, and path analysis in the analysis.

Outcomes
The study’s outcome measures included adherence, self-efficacy, long-term glycaemic control. Adherence included aspects related to medication, diet, lifestyle and appointment keeping and was assessed using the Hill-Bone tool. Self-efficacy was assessed using a Stanford self-efficacy tool while long-term glycaemic control was determined through haemoglobin A1c (HbA1c) point-of-care testing.

Results
Overall, the mean score for PCC was 62.86 (SD 14.78). The study highlighted two groups of patients with statistically distinct mean scores of 51.6 (7.8) vs 77.1 (7.2) out of a possible 92 (p

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[Articles] Intravascular lithotripsy for the treatment of calcified coronary lesions in individuals of advanced age: a post-hoc analysis of the multicentre, prospective BENELUX-IVL study

In patients of advanced age, IVL for calcified coronary lesions demonstrates a favorable safety and efficacy profile, with high technical success and low rates of device-related adverse events. Nonetheless, larger studies with extended follow-up are warranted to confirm these findings and establish long-term outcomes.

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Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial

Introduction
Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

Methods and analysis
We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

Ethics and dissemination
The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

Trial registration number
NCT06188793.

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AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers – comparing facial versus intranasal administration via pharmacometric modelling

Introduction
Pain accounts for approximately 80% of emergency department admissions. While intravenous morphine titration is commonly used for severe pain, non-invasive alternatives that bypass intravenous access are needed. Nebulised fentanyl, combined with pupillometry for objective monitoring of opioid impregnation, may offer a rapid and safe alternative for pain management.

Methods and analysis
This phase I, open-label, randomised, exploratory, crossover, single-centre prospective controlled trial will employ pharmacokinetic–pharmacodynamic (PK–PD) modelling to assess the variability in bioavailability of nebulised fentanyl administered via intranasal route versus facial aerosol. 20 healthy volunteers will receive three repeated administrations of fentanyl over two visits. At each visit, blood samples (n=11) will be collected for fentanyl quantification by liquid chromatography–tandem mass spectrometry, and pupillary unrest in ambient light (PUAL) measurements (n=9) will be recorded. The resulting data will be analysed using Monolix 2024R1 to model PK–PD relationships, perform Monte Carlo simulations and determine the optimal dosing and timing required to achieve a reduction of more than 30% in PUAL, while also evaluating safety, comfort and tolerance.

Ethics and dissemination
The study has been approved by the Ethic Committee Île-de-France VII (approval reference number: 000216, February 2024) and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, conference presentations and appropriate data-sharing platforms to support further research and clinical application.

Trial registration number
This trial is registered at ClinicalTrials.gov (Identifier: NCT06281951).

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Men matter: a cross-sectional exploration of the forgotten fathers of children born to adolescent mothers in South Africa

Background
Fathers are intricately bound to the experience of adolescent mothers and their children. Yet, fathers of children born to adolescent mothers, particularly within the context of HIV, remain neglected in the literature. These exploratory analyses provide insight into the characteristics of fathers of children born to adolescent mothers affected by HIV in South Africa.

Setting
Eastern Cape Province, South Africa.

Design
Cross-sectional data from a prospective cohort study.

Participants
Young mothers (10–24 years of age) and their children (0–68 months). All mothers completed detailed study questionnaires, including standardised and study-specific measures, relating to their self, their children and the fathers of their children. Summary statistics are presented based on maternal self-report of father characteristics. 2 tests and t-tests (Fisher’s exact/Kruskal-Wallis tests, where appropriate) were additionally used to explore sample characteristics (including father characteristics, maternal experience and child characteristics) according to paternal age and father involvement in childcare (defined by responses to four maternal self-report questions). Father characteristics were also explored according to maternal HIV status and maternal mental health status.

Results
40% of fathers were adolescents (10–19 years) at the birth of their children. Overall, father involvement was low (19.5%). Compared with noninvolved fathers, involved fathers were more likely to be older when their child was born (21 years vs 20 years, t=4.30, p=0.04), to be in a relationship with the mothers of their children (74.8% vs 47.2%, 2=40.8, p≤0.0001), to reside with their children and their mothers (14.7% vs 3.7%, 2=49.3, p≤0.0001) and to attend the first antenatal appointment (4.3% vs 1.5%, 2=5.21, p=0.02). A quarter (25.4%; 227/894) of the adolescent mothers in the sample were living with HIV. The prevalence of maternal HIV was found to be higher among adolescent mothers of children born to older fathers compared with adolescent fathers (31.7% vs 15.9%, 2=28.3, p≤0.001). Likewise, depressive symptoms were more prevalent among adolescent mothers of children born to older fathers compared with adolescent fathers (9.9% vs 5.3%, 2=6.08, p=0.01). Adolescent mothers reporting poor mental health were less likely to be in a relationship with the fathers of their children (41.8% vs 54.1%, 2=7.32, p=0.03) and more likely to experience domestic violence perpetrated by the fathers of their children (8.2% vs 3.3%, 2=6.07, p=0.01) and to engage in arguments about finances with the fathers of their children (30.0% vs 17.0%, 2=10.8, p=0.001). While some differences in individual subscales were identified, overall composite scores of child cognitive development did not differ according to father age or father involvement.

Conclusions
Analyses provide the first preliminary description of the fathers of children born to adolescent mothers affected by HIV in South Africa. Fathers are inherently tied to the experiences of adolescent mothers and their children. Father involvement with their children was low. Further research is required to explore the potential barriers to father involvement and pathways to overcome these. Efforts to bolster father engagement, such as the inclusion of fathers within maternal and child service provision, may have benefits for fathers, adolescent mothers and their children. There was a high prevalence of adolescent fatherhood in the study. Adolescent fathers may have specific needs requiring tailored intervention for adolescent parent families. The need for the inclusion of fathers within policy, programming and research remains.

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[Articles] Antibiotic use for common illnesses in children living with disability: a multi-country study across 42 low- and middle-income countries

Children with disabilities are at a higher risk of developing common illnesses but are not necessarily more or less likely to use antibiotics for these conditions compared to children without disabilities. However, gender, country and impairment type disparities persist. Targeted efforts are needed to address these health inequities and ensure equitable access to care.

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[Articles] The impact of biological interventions on health-related quality of life in adults with Crohn's disease: a systematic review with meta-analysis

Methodological issues in HRQoL measurement, including the need for larger sample sizes, standardized reporting, and uniform participant characteristics, contribute to the low methodological quality of current evidence on the impact of biological agents on HRQoL in CD. There is a large unmet need to investigate the association between clinical outcomes and HRQoL outcomes more thoroughly.

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Clinical presentation of adults with persistently low alkaline phosphatase activity: a retrospective multicentre, cross-sectional study in Germany

Objective
Persistently low serum alkaline phosphatase (ALP) activity is the hallmark of hypophosphatasia (HPP). However, low ALP values are not commonly recognised in routine clinical practice, often leading to delayed HPP diagnosis. Determining symptoms associated with persistently low ALP activity may facilitate a timelier diagnosis and improved treatment of patients with HPP. This study aimed to evaluate the signs and symptoms associated with low ALP.

Design
Retrospective, multicentre, cross-sectional study.

Setting
Medical records of adults with low ALP activity collected in 18 German clinics and large medical centres with medical specialty in endocrinology, diabetology, rheumatology and osteology were assessed. Serum ALP activity, medical history, previous diagnoses, laboratory values and symptoms were analysed.

Participants
Records were screened to identify patients≥18 years with ALP activity below the lower limit of the normal range within the last 5 years. Exclusion criteria were oncological or haematological disorders, intensive care at the time of low ALP measurement and having more than one ALP measurement in the normal range or above. Data from 849 patients with ≥1 low ALP value (median age: 44.0, min 18.0, max 90.0), including a subset of 32 patients with documented HPP diagnosis, were analysed.

Results
The study cohort presented with a spectrum of clinical manifestations and diagnostic profiles. Patients with HPP displayed typical symptoms, in particular musculoskeletal pain and fractures, more often than patients without HPP diagnosis (n=817). Among patients without HPP, 26.6% were diagnosed with hypothyroidism. 35 patients displayed 4+ clinical and biochemical signs typical for HPP that were attributed to differential diagnoses, such as rheumatic diseases, fibromyalgia and osteoporosis/osteopenia, suggesting the possibility of underlying HPP in some cases.

Conclusion
Most patients in this study had hypophosphatasemia without further evaluation, highlighting the need for greater awareness of low ALP levels in clinical practice. Recognising low ALP levels, especially when accompanied by symptoms like pain, musculoskeletal and dental abnormalities, is crucial for timely diagnosis and improved patient care.

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Rationale and protocol for a longitudinal cohort study of children with cerebral palsy in China assessing functional developmental trends, genetic aetiology and imaging

Introduction
Cerebral palsy (CP), the most common physical disability in children, imposes substantial economic and psychological burdens on families and society. The clinical management of CP remains challenging due to the limited efficacy of current treatments and the heterogeneity of its aetiologies and clinical presentations. This study aims to investigate the functional changes and identify influencing factors in Chinese children with CP. Through analysis of neuroimaging and genetic data, this study seeks to inform the development of preventive and therapeutic strategies and guide healthcare decision-making for this population.

Methods and analysis
This prospective cohort study aims to recruit 2051 children with CP across China. Baseline data will include demographic and clinical characteristics. Participants will undergo comprehensive assessments, including motor, cognitive, language, social, behavioural, nutritional, pain, sleep and quality-of-life domains, with regular follow-up evaluations. Trio whole-exome sequencing and detailed neuroimaging and musculoskeletal imaging will also be performed. This study will also assess caregivers’ quality of life and emotional burden. Mendelian randomisation will be adopted to evaluate genetic contributions to functional outcomes and their causal relationship with health metrics. Analytical methods will include correlation analysis, logistic regression (binary and multivariate), linear and non-linear mixed-effects models and structural equation modelling.

Ethics and dissemination
Ethics approval was granted by the Research Ethics Committee of Guangzhou Women and Children’s Medical Center (No.2023-346A01). All study procedures will adhere to the approved protocol. Study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
ChiCTR2300079017.

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Cross-sectional study of the association between diet and physical inactivity with obesity, diabetes and hypertension among older adults in Sierra Leone

Objective
To examine the association between behavioural risk factors and their physiological sequelae among adults aged 40 and above in Bo District, Sierra Leone.

Design
Cross-sectional study.

Setting
Household survey in Bo District, Sierra Leone.

Participants
The study included 1978 randomly sampled adults aged 40 and above (44.4% male and 55.6% female). The majority of participants were aged 40–49 years (34.5%). Data were collected using a household survey based on the validated WHO STEPs questionnaire.

Methods
Multivariable logistic regression analysis was performed to determine associations between behavioural risk factors (diet, physical activity and salt intake) and the presence of hypertension, diabetes and/or obesity, adjusting for sociodemographic variables.

Primary outcome measure
The primary outcomes were the presence of hypertension, diabetes or overweight/obesity. Hypertension was defined as systolic blood pressure of ≥140 mm Hg and/or diastolic blood pressure of ≥90 (measured); diabetes as fasting glucose of ≥7.0 mmol/L, random plasma glucose level of ≥11.1 mmol/L or the use of antidiabetic medications (self-reported) and overweight/obesity as having a body mass index of ≥25 kg/m² (measured).

Results
At least one physiological risk factor for cardiovascular diseases, that is, hypertension, obesity or diabetes, was present in 43.5% of participants. Hypertension was associated with urban living (OR=1.46, 95% CI (1.41 to 1.51)), older age (OR for 80+=3.98, 95% CI (3.70 to 4.28)), insufficient fruit and vegetable intake (OR=1.52, 95% CI (1.46 to 1.60)) and low physical activity (OR=1.35, 95% CI (1.27 to 1.43)). Diabetes was associated with urban residence (OR=1.84, 95% CI (1.66 to 2.05)), older age (OR for 70–79=3.82, 95% CI (3.28 to 4.45)), low fruit and vegetable consumption (OR=1.61, 95% CI (1.36 to 1.90)), high salt intake (OR=1.34, 95% CI (1.21 to 1.49)) and low physical activity (OR=1.47, 95% CI (1.26 to 1.71)). Obesity was associated with urban living (OR=1.66, 95% CI (1.59 to 1.72)), high salt intake from two or more sources (OR=1.21, 95% CI (1.17 to 1.25)) and low physical activity (OR=1.30, 95% CI (1.22 to 1.39)). Male sex (OR=0.37, 95% CI (0.36 to 0.38)) and older age (OR for 80+=0.39, 95% CI (0.35 to 0.43)) were protective factors.

Conclusions
In Bo District, nearly half of adults over 40 face hypertension, diabetes or obesity, especially urban dwellers, older age groups and those eating too few fruits and vegetables, consuming excess salt and getting little exercise. Public health efforts should focus on urban-targeted nutrition education, salt-reduction strategies, community exercise programmes and routine blood pressure and glucose screening, working with local leaders to ensure sustainable lifestyle changes and early disease detection.

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Association of multiple symptoms with sleep quality and duration: a cross-sectional population-based study of older men in Sweden

Objective
To evaluate any association of the presence and severity of nine major symptoms (pain, tiredness, drowsiness, nausea, appetite, breathlessness, depression, anxiety, and perceived well-being) with sleep quality and duration in elderly men.

Design and setting
Cross-sectional analysis within the population-based VAScular and Chronic Obstructive Lung disease study (VASCOL) conducted in southern Sweden in 2019.

Participants
A total of 838 older men aged 73 years.

Measures
Severity of the symptoms was self-reported between 0 and 10 on a numerical rating scale. Breathlessness was also assessed using the Multidimensional Dyspnoea Profile and Dyspnoea-12. Sleep quality was reported on a 5-point Likert scale from ‘very well’ to ‘very bad’and sleep duration on a 7-point scale from ‘less than 4 hours’ to ‘more than 10 hours’. Associations of each symptom score with having worse sleep quality (‘bad’ or ‘very bad’) and/or shorter sleep duration (

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Methods of assessment of diabetic retinopathy in low- and middle-income countries: a protocol for scoping review

Introduction
Globally, over a hundred million people are estimated to suffer from diabetic retinopathy (DR), which is a major complication of diabetes mellitus (DM). The prevalence of DM is projected to increase from the current 537 million by almost 50%, to 783 million by 2045. As a result, DR is one of the fastest rising causes of preventable blindness. Three out of four people suffering from DM live in low- and middle-income countries (LMICs), where resources for both diagnosis and treatment are lacking. There has been a reduction in the rate of blindness from DR in high-income countries, while an opposite trend has been noted in LMICs, contributing to this massive morbidity burden. This scoping review aims to ascertain the methods used to assess DR in LMICs.

Methods and analysis
The scoping review will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Review (PRISMA-ScR) guidelines and the Arksey and O’Malley (2005) methodology framework. A systematic search of peer-reviewed literature will be carried out for all papers up to 15 May 2025 by identifying studies from electronic databases, including Embase, Medline and CENTRAL (Cochrane Library). A hand search of the associated reference lists of included studies and grey literature will also be conducted. The identified studies will be screened based on agreed eligibility (inclusion/exclusion) criteria by two independent reviewers, with any disagreements resolved via arbitration from a third reviewer. The data will be thematically summarised according to different aspects of DR assessment methods, and key findings will be elicited. The key findings will provide a comprehensive and clear understanding of the assessment methods used to identify DR in LMICs.

Ethics and dissemination
Ethical approval was not sought for this work as only publicly available information is used. The results will be disseminated through a peer-reviewed publication, conference presentations and meetings with stakeholders.

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Achieving impactful treatment for paediatric endocrine disorders in low- to middle-income countries (LMICs): a scoping review

Objectives
Endocrine disorders, such as hypo/hyperthyroidism and diabetes, affect over 5% of the world’s population, with an additional 5% of cases remaining undiagnosed. Despite the increasing prevalence of endocrine disorders, especially in low- to middle-income countries (LMICs), limited research offers comprehensive guidance on treating this complex medical field. This scoping review aims to provide evidence-based recommendations for efficient, effective and accessible treatment of paediatric thyroid conditions and diabetes in LMICs.

Design
Scoping review guidelines outlined by the Preferred Reporting Items for Systematic and Meta-Analysis Extension for Scoping Reviews, using the Joanna Briggs Institute (JBI) methodology to analyse healthcare administration approaches in LMICs.

Data sources
PubMed, Google Scholar, MEDLINE, EconLit, Science Direct and Scopus were searched using a set of search terms from 19 December 2023 to 16 January 2024. An additional high-level search was performed in May 2025.

Eligibility criteria
Selection of a variety of peer-reviewed publications with a setting in LMICs. Articles were included if they described an intervention strategy related to select paediatric chronic diseases, endocrine conditions or non-communicable diseases. The treatment strategies in question were government initiatives, mobile health, specialised programmes and primary care.

Data extraction and synthesis
One reviewer manually reviewed articles and documented findings on Microsoft Excel. In accordance with JBI methodological guidelines, no risk of bias assessment or quality appraisal of included studies was conducted.

Results
After reviewing primary care, specialised care, government intervention programmes and mobile care initiatives within developing countries, primary care with an emphasis on task shifting emerged as the best approach for treating paediatric endocrine disorders.

Conclusion
Despite recommendations favouring specialised care or government interventions, primary care proves to be the optimal method for treating endocrine conditions. Given limited healthcare funding in LMICs, implementing primary care initiatives can achieve significant health outcomes while maximising resources.

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Treatment and exercise strategies and their associations with pain and disability: a prospective cohort study of patients with long-lasting low back pain

Objectives
To describe self-reported treatment and exercise strategies among patients with long-lasting low back pain (LBP) 1 month after consultation at a specialised hospital-based Medical Spine Clinic and evaluate their associations with changes in pain and disability 1 and 3 months after consultation.

Design
Prospective cohort study using questionnaire data before consultation (baseline) and 1 and 3 months after consultation.

Setting
Specialised hospital-based Medical Spine Clinic, Denmark.

Participants
1686 patients with long-lasting LBP completed the baseline questionnaire; 908 patients responded at 1 month, of them 623 responded at 3 month.

Interventions
Patients were categorised by treatment (physiotherapy, chiropractic treatment, physiotherapy+chiropractic treatment and no recommended treatment) and exercise strategy (exercise continued, exercise ceased, exercise initiated and not exercising).

Primary and secondary outcome measures
Pain was assessed by the numeric rating scale (NRS: 0–10), and disability was assessed by the Oswestry disability index (ODI: 0–100).

Results
1-month postconsultation, half of the patients received no recommended treatment; most others received physiotherapy (42%). Nearly half of the patients continued exercise, 28% continued to be inactive, and 22% initiated exercise. For the population as a whole, pain changed by –0.74 (95% CI –0.90; –0.58) and –1.02 (95% CI –1.22; –0.83) points on the NRS at 1- and 3-month follow-up, respectively, and disability by –2.65 (95% CI –3.51; –1.78) and –4.48 (95% CI –5.59; –3.38) points on the ODI. Differences between treatment strategies were small. However, the two groups not exercising improved less compared with those who continued exercise when adjusted for age, sex and baseline level (order of magnitude from 0.07 to 1.18 points on the NRS and from 4.01 to 9.08 points on the ODI). For pain, these group differences were statistically significant at 1 month (p

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[Articles] Development of a World Health Organization indicator and corresponding questions to measure effective coverage of rehabilitation

We propose a global tracer indicator for measuring effective coverage of rehabilitation at the population level that is captured through population-based surveys. This global indicator uses chronic primary low back pain as the tracer health condition and World Health Organization Disability Assessment Schedule 2.0 12-item to assess whether quality interventions have been provided that produce the desired health gain.

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