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Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Volume 178, Issue 2, Page JC20, February 2025.
Annals of Internal Medicine, Volume 178, Issue 2, February 2025.
This Viewpoint discusses the public health benefits that could be gained if the US Food and Drug Administration (FDA) were to mandate very low-nicotine-content cigarettes (VLNCs).
Introduction
As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.
Methods and analysis
The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.
POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.
Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.
The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).
Ethics and dissemination
Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.
Trial registration number
ISRCTN12834598; ACTRN12623001166662.
Introduction
The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.
Methods and analysis
This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. It aims to recruit 692 participants in Dutch primary care. Entry criteria include age 50–75 years, low SES and/or migration background, one or more dementia risk factors (hypertension, dyslipidaemia, diabetes mellitus, physical inactivity, smoking, depression and overweight) or manifest cardiovascular disease and possession of a smartphone. Participants are randomised to a coach-supported, interactive app facilitating self-management of dementia risk factors or to a control app with static health information. The primary effectiveness outcome is a composite score of systolic blood pressure, non-high-density lipoprotein cholesterol and body mass index. Implementation outcomes include coverage, adoption, acceptability, appropriateness, feasibility, fidelity, costs and sustainability of the intervention. Secondary outcomes include the Cardiovascular Risk Factors, Ageing and Dementia risk score and its individual risk factors, and disability, physical activity, depressive symptoms, cognitive functioning and daily distance moved.
Ethics and dissemination
The MIND-PRO trial is funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10510032120004) and approved by the Ethics Committee of Amsterdam UMC (reference: METC 2023.0770). Results are expected in 2026 and will be submitted for publication in a peer-reviewed journal, and presented at scientific conferences.
Trial registration number
ISRCTN92928122.
This randomized clinical trial compares the effectiveness of an integrated pain team vs pharmacist collaborative management on pain and opioid dosage.
This case report describes a man in his 60s with hypertension, deep vein thrombosis, and a recent diagnosis of HIV presented with low CD4 cell count after starting antiretroviral therapy with tenofovir alafenamide-emtricitabine-bictegravir.
This randomized clinical trial evaluates the effectiveness of pain coping skills training, a cognitive behavioral intervention, on pain interference among people receiving maintenance hemodialysis.
Design
Prospective feasibility study.
Objectives
To inform the design and conduct of a large-scale clinical cohort study investigating adolescents with moderate-to-severe spinal pain.
Setting
Chiropractic care in Sydney, Australia.
Participants
Adolescents aged 12–17 years with spinal pain (≥4/10 pain intensity score).
Methods
Adolescents and chiropractors completed baseline and week-12 follow-up questionnaires, with adolescents reporting pain intensity and recovery weekly via text messages during weeks 1–11. Questionnaire measures included spinal pain, pain coping, quality of life, physical activity, clinical assessment findings and care delivered. Chiropractors provided usual clinical care. We conducted a descriptive feasibility analysis.
Primary outcomes
(1) Recruitment rate, (2) response rate to each data collection instrument and (3) retention rate.
Results
From May 2021 to February 2023, 20 chiropractors from 10 clinics were enrolled (invited n=85). 10 chiropractors recruited 45 adolescents (15.4±1.4 years, 43% female) over 13.5 months, excluding an 8-month pause due to COVID-19 disruptions. The average recruitment rate was 0.6 adolescents/recruiting chiropractor/month. We achieved a 100% response to chiropractor baseline and follow-up questionnaires, 98% to adolescent baseline, 94% average response to combined weekly text messages and 93% retention of adolescents at study completion.
Conclusions
Our high response and retention rates demonstrate feasible data collection methods in this population. Addressing low recruitment by expanding the number and type of clinicians is necessary for a successful larger study.
Introduction
Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.
Methods and analysis
This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (
Introduction
Infant mortality in low or middle-income countries (LoMICs) is still triple that of high-income countries (HICs), and the high mortality burden regions are also weighed down by a triple or quadruple burden of disease such as HIV and tuberculosis; chronic illness; mental health; injury and violence; and maternal, neonatal and child mortality. Emerging data suggest that the sudden unexpected death in infancy (SUDI) burden in LoMICs is at least 10-fold that in HICs. While ending preventable deaths in the neonatal period has received some global attention, the postnatal period where SUDIs occur is a poorly understood and data-poor area in LoMICs. We propose conducting a systematic review to evaluate the burden and trends of SUDIs in LoMICs since 2004.
Methods and analysis
We will systematically search PubMed, Web of Science, Scopus, African Index Medicus, EBSCOHost, Google Scholar, WHOIS and WHO database to identify studies published from July 2004 until October 2024. Two reviewers will screen titles and abstracts and select full-text articles independently for review. We will use the tool developed by the South African Medical Research Council—Burden of Disease Review Manager (BODRevMan)—to assess the risk of bias for each included study. Risk of bias will be assessed for each included study. Information on the prevalence and/or incidence of SUDI and its subcategories and case definitions will be extracted from each article. Where possible, data on prevalence, incidence and subcategories will be pooled using a random effects meta-analysis to account for variability between estimates. The I2 statistic will establish the level of heterogeneity due to variation in estimates rather than chance. Results will be presented in tables and graphs. The systematic review will be reported according to the PRISMA 2020 checklist.
Ethics and dissemination
Ethical approval is not required as this is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.
PROSPERO registration number
CRD42023466162.
