The rise of electronic nicotine delivery systems (ENDS) has introduced new challenges to tobacco control and regulation, particularly among young adults, raising questions about their safety. This umbrella review aimed to synthesise existing systematic reviews with or without meta-analyses to evaluate the health impacts of ENDS.
We conducted a systematic literature search via the PICO strategy across multiple databases, focusing on e-cigarettes, ENDS and e-liquids, while excluding non-nicotine e-cigarette and nicotine replacement therapies (NRTs). Health outcomes include a range of clinical diseases and physiological changes. Quality assessment was performed via assessing the methodoligcal quality of systematic reviews 2 (AMSTAR-2), and the findings were synthesised narratively and in tables, prioritising the highest-rated reviews. The meta-analyses used R software (V.4.3) random effects models, and evidence quality was assessed via the Grading of Recommendations, Assessment, Development and Evaluation criteria.
Of the 5055 records, 69 systematic reviews were included. Systematic reviews have indicated increased risks of cardiovascular and respiratory diseases, mental health issues and substance abuse with ENDS use, especially among adolescents. Cardiovascular risk factors included increased heart rate (mean difference (MD) 1.41, 95% CI 0.81 to 2.01, I2=91%) from 25 studies; increased blood pressure (MD for systolic blood pressure=0.51 mm Hg, 95% CI 0.26 to 0.75, I2=89%; MD for diastolic blood pressure=0.59 mm Hg, 95% CI 0.35 to 0.83, I2=82%) from 23 studies; endothelial dysfunction and increased platelet activity. Respiratory risk factors included reduced lung function and a higher incidence of asthma in nine studies (OR 1.30, 95% CI 1.1 to 1.55; I2=43%) and chronic obstructive pulmonary disease. Mental health concerns, such as depression and suicidality, were also prevalent among adolescent ENDS users. Nine studies reported a negative effect of ENDS on periodontal health. Evidence of carcinogens has been found in the urinary examinations of ENDS users in some studies. The adverse events reported in seven randomised controlled trials with 2611 participants were similar between ENDS and NRT (RR 1.13, 95% CI 0.83 to 1.54, I2=12%).
Exposure to ENDS is harmful to various organ systems, especially cardiovascular and respiratory systems. Comprehensive regulatory measures and public health strategies are necessary to curb the use of ENDS, particularly among young people.
Body image dissatisfaction (BID) is relatively common in Chinese female undergraduates. This study aims to explore the reasons for BID among female undergraduates to develop effective early intervention strategies.
A qualitative research approach was used through semi-structured interviews, allowing for an in-depth understanding of the experiences of participants.
The study was conducted from April 2024 to November 2024 at Yibin University in Sichuan province, China.
The study involved 25 female undergraduates with an average age of 19.8±1.3 years. These participants were selected to provide rich qualitative data about their experiences and views regarding BID.
The participants showed a high level of BID, and the thematic analysis revealed five overarching themes regarding the causes of BID among female undergraduates: (1) individual factors; (2) media factors; (3) family factors; (4) peer factors; and (5) overall societal impact.
The thematic analysis revealed that dissatisfaction with body image among female undergraduates is a multidimensional issue influenced by various factors, including individual and sociocultural elements. The conclusion emphasises the necessity of strengthening comprehensive intervention measures to address these influencing factors.
by Rahil Mahmoudi, Maral Nabaee, Akram Kooshki, Saba Shourideh Yazdi, Mahboubeh Neamatshahi, Elaheh Foroumandi
BackgroundWith the high prevalence of diabetes worldwide and the known benefits of functional foods in controlling diabetes, this study aimed to explore the connection between prebiotic food intake and biochemical indices in diabetic patients.
MethodsThis cross-sectional study was conducted on 504 participants with type 2 diabetes who were part of the Sabzevar Persian Cohort study that was initiated in February 2018. A 148-items food frequency questionnaire was utilized to assess the daily amount of prebiotic food consumption. Blood serum samples were collected from participants to measure fasting blood sugar levels, lipid profile, and kidney function indicators. Additionally, anthropometric measurements were taken following standard protocols. Statistical analyses were performed using SPSS version 20, with correlation tests adjusted for confounders, and significance set at p Results
This study involved 44.9% male and 55.1% female participants, with an average age of 54.81 ± 7.65 years. A significant correlation was observed between soybean consumption and serum low density lipoprotein (LDL) status (R = −0.110, P = 0.014). Moreover, a higher intake of banana was linked to lower blood urea nitrogen (BUN) levels (R = −0.109, P = 0.015). Furthermore, the consumption of honey exhibited a negative association with both systolic blood pressure (BP) (R = −0.106, P = 0.018) and diastolic BP (R = −0.132, P = 0.003). Green peas intake was also inversely associated with DBP (R = −0.092, P = 0.039).
ConclusionThis study found a positive correlation between the regular intake of prebiotic foods and improved management of BUN, LDL, and BP in individuals with type 2 diabetes. However, further mechanistic studies are necessary to better understand the potential causal effects of prebiotic foods on metabolic health in this population.
Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.
This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.
The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.
ClinicalTrials.gov ID: NCT06090552.
Advarra Pro 00070994.
23-38948.
Protocol Date: 24 October 2024. Protocol Version: 4.
To describe the outcomes of an e(electronic)-Delphi survey used to achieve consensus on the essential elements that should be included in a multidisciplinary, nurse-led service for patients with chronic heart failure (CHF).
The study design was based on a three-round e-Delphi survey.
A series of three survey rounds were used to gather expert opinions and achieve consensus on the key elements that should be included in a CHF disease management program from a sample of healthcare professionals and organizational leaders with expertise in existing CHF services. Consensus for each item was defined as at least 90% agreement.
There were 20 participants (18 healthcare professionals and 2 organizational leaders) in round-1, 22 (20 healthcare professionals and 2 organizational leaders) in round-2, and 17 (15 healthcare professionals and 2 organizational leaders) in round-3. Fifteen participants attended a final online meeting (13 healthcare professionals and 2 organizational leaders). Consensus was obtained on five essential components: (i) consumer education, (ii) treatment optimization using a multidisciplinary approach, (iii) discharge planning, (iv) provision of supportive community care and (v) mechanisms to respond to early symptoms of decompensated CHF.
Participants focused on mechanisms to improve treatment effectiveness, patient and family knowledge, communication between healthcare providers and supportive care in the community. The proposed model of care may be useful to other health service providers who are designing or adapting CHF models of care for the South-East Asian environment.
This research provides a solid basis for using a Delphi method to resolve the challenges and issues of transferring global model-based recommendations in CHF knowledge. The Delphi method proved successful as an important step in developing a culturally acceptable model of chronic care that meets the goals of local healthcare providers.
To explore how urinary (UI) and anal incontinence (AI) affect various aspects of quality of life (QoL) and the risk of depression 6 months postpartum, using patient-reported outcome measures (PROMs).
Prospective cohort study.
Women who gave birth between 2020 and 2022 within a local obstetric collaborative network in the Netherlands, including 13 midwifery practices, 5 maternity care organisations at the primary care level, and 1 secondary teaching hospital.
Prospectively collecting data by using the questionnaires of the International Consortium for Health Outcome Measures Pregnancy and Childbirth set at five moments during pregnancy and postpartum.
Associations between UI, AI, QoL and likelihood of depression based on PROMs collected from questionnaire 6 months postpartum.
Of the 663 women who completed the 6-month postpartum questionnaire, 79 women had severe UI, 71 had severe AI and 45 experienced both. These women reported significantly lower QoL as measured by PROMIS-10: 34 (IQR 30.5–38.5), 34 (IQR 30–39.5), and 32 (IQR 27–35), respectively, compared with a score of 37 (IQR 33–42) for the total population. Additionally, the positive rate for depression screening was notably higher among these groups, with rates of 6%, 10% and 18%, respectively, compared with 3% for the overall group.
In this observational cohort study, we found that severe UI and/or AI 6 months postpartum significantly impact QoL and increase the likelihood of depression, as indicated by PROMs. Our findings emphasise the importance of screening, evaluation and treatment of UI and/or AI to improve the QoL and reduce the risk of depressive disorders for postpartum women.
Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.
Observational study using general practice electronic health record data linked to specialist claims data.
272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.
Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).
The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.
Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).
Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.
Alcohol dependence (AD) is highly prevalent and has severe consequences on health and quality of life. However, the efficacy of approved pharmacotherapies such as naltrexone (NTX) remains limited, highlighting the need for novel pharmacotherapeutic approaches. Cannabidiol (CBD) is a promising candidate, which has shown potential to reduce craving and alcohol use by modulating brain circuits involved in craving and addiction. Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.
This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. A total of 150 patients with AD will be randomised (1:1:1) to receive either 800 mg or 1200 mg CBD plus 50 mg oral NTX or placebo plus 50 mg oral NTX for 14 days. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale (OCDS-G) where the primary endpoint is the change from baseline to the end of treatment. Secondary outcomes include craving during the entire study, quality of life, depressive symptoms, anxiety, patient-reported outcomes, neural brain activation, CBD plasma levels, time to relapse, alcohol use and treatment safety. For the comparison of each experimental group to the control group, a strata-adjusted (centre and baseline OCDS-G) van Elteren test is applied with adjustment for multiple testing by Bonferroni-Holm.
The trial has been approved by the Ethics Committee and the competent authority (ID: B_03510). All participants will provide written informed consent. An independent Data and Safety Monitoring Board will monitor safety. This trial complies with national and international regulations.
NCT06845124; EU Trial Number: 2024-518164-12-00.
To examine the impact of the COVID-19 pandemic on the substitution of surgical procedures in benign gynaecology in the Netherlands.
Quantitative longitudinal study evaluating the effects of the COVID-19 pandemic.
Nationwide healthcare delivery was analysed across six benign gynaecological pathways from 2016 to 2022 using Vektis and Dutch Hospital Data (DHD), accessed via Statistics Netherlands (Centraal Bureau voor de Statistiek).
The study focused on six benign gynaecological pathways classified using Dutch Diagnosis Treatment Combinations (DTCs): heavy menstrual blood loss (G11), uterine fibroids (G15), endometriosis (G17), prolapse (G25), infertility treatment (F11) and first trimester pregnancy complications (Z12). All patients receiving care within these pathways between 1 January 2016 and 31 December 2022 were included. Exclusions applied to all patients under 18 years old and, only within the menstrual disorder pathway, patients over 51 years old to exclude most postmenopausal blood loss cases where no alternative treatment applies.
Cohorts from the initial pandemic year (2020) were compared with four prepandemic cohorts (2016–2019) and late-pandemic (2021) and postpandemic (2022) cohorts.
The primary outcome was the trend in the total number of patients in surgical and non-surgical procedure groups across cohort periods. Secondary outcomes included trends within individual pathways.
The analysis identified a significant reduction in benign gynaecological care during 2020, with an 18.3% (p
The COVID-19 pandemic significantly disrupted both surgical and non-surgical procedures within benign gynaecological pathways. Reduced care uptake during the pandemic waves was not recovered but instead forgone. The reduction in surgical procedures did not correspond with increased use of non-surgical alternatives. Future research should prioritise evaluating the long-term impacts of this disruption on patients and society.
Evaluating skin reactions is crucial in topical product development. Turmeric/epigallocatechin-3-gallate (EGCG) emulgel demonstrates therapeutic potential for cutaneous diseases, warranting further investigation in human studies. The Human Repeat Insult Patch Test (HRIPT) of skin irritation and sensitisation potential caused by the turmeric/EGCG emulgel is designed to evaluate the safety of the investigational product in healthy volunteers prior to conducting the efficacy study in patients with dermatological diseases.
60 healthy Thai volunteers will be enrolled in this single-centre, double-blind HRIPT pilot clinical trial to evaluate skin irritation and sensitisation potential caused by turmeric/EGCG emulgel. Primary endpoints include the number and proportion of participants exhibiting skin irritation and sensitisation, while secondary endpoints focus on the frequency and severity of adverse events. The study will comprise a screening period, a 3-week induction phase, a 2-week rest phase and a 1-week challenge phase. Fully occlusive adhesive patches containing study products will be applied to participants’ backs 10 times. Skin irritation will be assessed using the Draize dermal irritation scoring system, and skin sensitisation will be evaluated using the International Contact Dermatitis Research Group scoring system.
The Research Ethics Committee of the Faculty of Medicine, Chiang Mai University, approved this study protocol and related documents on 6 March 2025 (Ref. No. 108/2025).
TCTR20250317007.
Our objectives were (1) to characterise the age-sex-standardised prevalence of comorbidities among people living with HIV (PLWH) and people not living with HIV (PnLWH) between 2001 and 2019 and (2) to examine the effect of comorbidities on direct healthcare costs among PLWH and PnLWH.
This was a retrospective, matched cohort study conducted with the Comparative Outcomes and Service Utilisation Trends (COAST) cohort, which contained all known PLWH in British Columbia (BC), Canada and a general population sample.
BC, Canada.
A total of 9554 PLWH and 47 770 PnLWH from the COAST cohort were followed between 2001 and 2019. Participants were at least 19 years old and 82% male in both groups.
The primary outcomes were the age-sex-standardised prevalence of 16 comorbidities, calculated annually, among PLWH and PnLWH. Secondary outcomes included direct healthcare costs associated with each comorbidity among PLWH and PnLWH. Outcomes were ascertained from administrative health databases.
PLWH exhibited a higher age-sex-standardised prevalence of most comorbidities compared with PnLWH over the study period. Relative disparities in liver and kidney diseases markedly decreased since 2008. Disparities in the prevalence of mental health disorders and substance use disorder (SUD) were consistently large throughout the study period. Comorbidities were associated with high healthcare costs, especially among PLWH.
This study underscores the persistent and evolving burden of non-AIDS-defining comorbidities among PLWH, even in the context of improved HIV management. The high prevalence of mental health disorders and SUD, coupled with the substantial healthcare costs associated with these conditions, emphasises the need for holistic and integrated care models that address the full spectrum of health challenges faced by PLWH.
Extended reality (XR) interventions have the potential to benefit patients undergoing elective cardiac surgical and interventional procedures. However, there are no systematic reviews with meta-analyses to guide clinical care.
To critically evaluate the evidence on the effectiveness of XR interventions on patient anxiety and pain and other associated outcomes.
Systematic review and meta-analysis following the PRISMA 2020 statement.
A systematic search of five databases (CENTRAL, CINAHL, MEDLINE, PsycInfo, Scopus) from inception to July 2023.
Screening and data extraction was conducted independently by multiple reviewers. Stata (Version 17) was used to conduct meta-analyses for patient anxiety and pain. Secondary patient outcomes were summarised in a synthesis. The Cochrane Risk of Bias (Version 2) tool was applied to trials and the NHLBI Study Quality Assessment tools to all other study designs.
Of the 3372 records identified, 22 were included, 10 of which were eligible for inclusion in the meta-analyses. Fifty-seven percent of randomised trials were rated as high risk of bias. Virtual reality (VR) was the only XR technology evaluated. VR significantly reduced pre-procedural anxiety (standardised mean difference: −1.29; 95% confidence interval − 1.96, −0.62, p < 0.001), and peri-procedural anxiety (standardised mean difference: −0.50; 95% confidence interval − 0.83, −0.18, p < 0.003) but did not reduce pain levels, compared with usual care. VR increased pre-procedural knowledge and postsurgical physical and pulmonary function. VR interventions may also improve emotional wellbeing, care delivery and physiological outcomes, but evidence was inconsistent.
XR potentially benefits cardiac patients undergoing elective invasive procedures and surgery by reducing pre- and peri-procedural anxiety and increasing procedural knowledge and physical function.
Cardiac nurses' role can be supported by VR interventions to improve the patient experience and several aspects of patient care.
Not applicable as this is a systematic review.
To explore the cognitive representations and emotional responses to living with chronic heart failure of people receiving limited community disease management.
Individuals living with heart failure face self-care and emotional challenges due to the overwhelming nature of adapting to lifestyle changes, particularly in subtropical areas.
Qualitative descriptive. We applied Leventhal's Common Sense Model of Self-Regulation as the framework for interviews and analyses.
Twenty patients with chronic heart failure were interviewed during a hospital admission for exacerbation of their condition in a tertiary hospital in Thailand.
Analysis of the components of Leventhal's model of cognitive representations of illness revealed two themes relating to Illness Identity: (1) lack of knowledge of the diagnosis and how to recognise symptoms of the disease, and (2) recognition of symptoms of an exacerbation of CHF was based on past experience rather than education. These resulted in delays responding to cardiac instability and confusion about the intent of treatment. Participants recognised the chronicity of their disease but experienced it as an unrelenting cycle of relative stability and hospitalisations. Perceived Controllability was low. Two themes were: (1) Low perceived trust in the efficacy of medical treatment and lifestyle changes, and (2) Low perceived trust in their ability to comply with recommended lifestyle changes. The Consequences were significant emotional distress and high burden of disease. The two themes of emotional responses were (1) Frustration and hopelessness with the uncertainty and unpredictability of the disease, and (2) Sense of loss of independence, functional capacity and participation in life's activities.
Chronically ill patients need support to understand their illness and make better treatment and lifestyle decisions. Improving patients' self-efficacy to manage treatment and symptom fluctuations has the potential to improve their mental well-being and minimise the impact of their condition on suffering and participation in employment and community.
Leventhal's Common Sense Model of Self-Regulation can be used to examine cognitive and emotional elements of illness perceptions, which link to individuals' ability to make informed decisions about disease management and influence health behaviours. Understanding illness perceptions underpins strategies for enhancing and sustaining self-management behaviours.
The study findings accentuate the need to establish long-term condition support programs in low-middle income countries where the burden of heart failure is increasing exponentially.
The Consolidated Criteria for Reporting Qualitative Research (COREQ) guideline was used to explicitly and comprehensively report our qualitative research.
Patients contributed to the conduct of the study by participating in the data collection via face-to-face interviews.
by Yusuf Ari Mashuri, Vitri Widyaningsih, Alimah Premanawasti, Jaap Koot, Zinzi Pardoel, Jeanet Landsman-Dijkstra, Maarten Postma, Ari Probandari
BackgroundA high prevalence of hypertension is found in Low- and Middle-income Countries (LMICs) including in Indonesia. However, hypertension awareness, treatment, and control are relativity poor. A community-based program to screen and educate people on non-communicable disease prevention (POSBINDU) was launched by the Indonesian government. However, the association between participation in the POSBINDU program with increasing knowledge, attitude, and practice of hypertension has not been widely assessed. In this study, we compared the knowledge, attitudes, and practices among people who accessed the POSBINDU and those who did not access the POSBINDU program. Subsequently, factors associated with the knowledge, attitudes, and practices among people who accessed the POSBINDU and those who did not access the POSBINDU were explored.
MethodsThis was an observational study with a cross-sectional design measuring the knowledge, attitudes, and practices for hypertension control in four districts in Indonesia from October 2019 to January 2020. A total of 1,988 respondents were included in this study. A questionnaire was used to assess the knowledge, attitudes, and practices of hypertension. Simple logistic regression was used to investigate the correlation between the characteristics of respondents and knowledge, attitudes, and practice status. Multiple logistic regression tests were conducted to investigate factors associated with knowledge, attitudes, and practice status.
ResultsWe found that people who accessed POSBINDU had higher odds of having better knowledge (aOR:1.4; 95%CI:1.2–1.8), however, accessed to POSBINDU was associated with lower attitudes (aOR:0.6; 85%CI: 0.5–0.7) and had no association with hypertension-related practice.
ConclusionPeople who accessed POSBINDU have an association with good knowledge, but the association with good attitude and practice was less clear. Therefore, an improvement in the POSBINDU program is needed to increase the attitudes and practices of hypertension.