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Colchicine has been shown to reduce cardiovascular events and may improve outcomes in arteriovenous fistulas used for haemodialysis due to antiproliferative effects. However, it is often avoided in patients receiving dialysis. Therefore, a large trial assessing the potential benefits of colchicine in dialysis patients cannot begin without further data on feasibility. The primary objective of this study is to assess the feasibility of carrying out future trials of colchicine in dialysis patients.
This is an open-label, single centre, single arm study with 100 participants. The primary outcome is feasibility and the decision to progress to a full-scale trial. This will be based on the consent rate and the colchicine discontinuation rate. Secondary objectives are testing the feasibility of data collection procedures relating to quality-of-life measures, vascular access interventions and safety. Other secondary objectives are to assess the utility of the electronic health record for collecting trial data and to explore patients’ and healthcare providers’ experiences and attitudes towards colchicine and a feasibility study.
The study has Research Ethics Committee approval (Wales REC 6; 24/WA/0277). It is intended that the results of the study will be reported in peer-reviewed scientific journals.
To evaluate the criterion validity and test–retest reliability of the Chinese version International Physical Activity Questionnaire-Short Form (cIPAQ-SF) for assessing sedentary behaviour and physical activity (PA) in overweight and obese Chinese adults, using activPAL as the reference.
A cross-sectional study was conducted at a Clinical Nutrition Clinic in China. Participants completed the cIPAQ-SF before and after wearing an activPAL for 7 consecutive days. Criterion validity was assessed using Pearson’s/Spearman’s correlation coefficients and Bland-Altman plots for sitting time (hours/day), moderate, vigorous and moderate-to-vigorous PA (MVPA) (min/week). Sensitivity and specificity evaluated the IPAQ-SF’s accuracy in identifying those not engaging in any PA and those not meeting the PA recommendation (MVPA ≥150 min/week). Test–retest reliability was assessed using intraclass correlation (ICC).
Among 80 participants (age 33.9±7.3 years; body mass index 29.1±4.5 kg/m²), the IPAQ-SF demonstrated moderate criterion validity for sitting time (r=0.577 on weekdays, r=0.444 on weekends) and MVPA (=0.451) compared with activPAL. It underestimated sitting time by 3.5 hours/day on weekdays and 2.9 hours/day on weekends. The cIPAQ-SF showed moderate-to-high sensitivity for correctly identifying individuals who were not engaging in any PA (53.6%–85.7%) or not meeting PA recommendations (93.8%), but its specificity was low to moderate (47.8%–73.7%) for PA engagement and meeting guidelines (55.2%). Test–retest reliability was moderate for sitting time (ICC=0.549–0.614) and poor to moderate for PA levels (ICC=0.453–0.592).
The IPAQ-SF demonstrates moderate validity and reliability in assessing sedentary behaviour and insufficient PA among overweight and obese Chinese adults. It can be used to identify physically inactive individuals for targeted interventions and monitor changes in sedentary behaviour.
The real-world evidence on the association between vitamin D supplementation and cognitive outcomes has been scant and controversial. We aimed to investigate the longitudinal association between vitamin D supplement use and subsequent cognitive functioning among US older adults.
Prospective cohort study.
A nationally representative ageing cohort in USA: the Health and Retirement Study (HRS).
Participants were drawn from the HRS wave 12 and included respondents who had complete data on dietary supplement use and cognitive assessment. A total of 5065 participants (mean age: 67.5±10.2 years, 61.6% female, 76.6% White ethnicity) were included, of whom 2004 (39.6%) participants were vitamin D supplement users.
Change in cognitive function scores over 6 years of follow-up (from HRS waves 12–15), estimated by linear mixed model adjusted for multiple covariates.
Compared with non-users, vitamin D users had an accelerated decline in global cognitive function (difference in the rate of change: –0.052 points/year; 95% CI –0.092 to –0.013, p=0.010) and in executive function score (difference: –0.021 points/year; 95% CI –0.037 to –0.005, p=0.010). Sensitivity analysis suggested that accelerated cognitive decline was only observed among supplement users with normal baseline serum 25(OH)D level (p=0.004), but not the group with insufficient/deficient levels (p=0.826).
Our findings do not support vitamin D supplementation as a means of preventing or slowing cognitive decline in older people with adequate vitamin D status. While healthcare providers should encourage adequate vitamin D intake from dietary sources and moderate sun exposure, caution should be taken when recommending such supplements to older adults without a clear indication for it.
Infertility is a significant reproductive health issue that affects couples physically, emotionally and socially. This qualitative study aims to explore the psycho-social experiences and coping strategies of infertile couples attending infertility clinics at Saint Paul’s Hospital, Addis Ababa, Ethiopia.
This study employed a descriptive phenomenological research design. In-depth interviews were conducted with 12 purposively selected couples experiencing infertility. The study used thematic analysis to capture the emotional, social and psychological impacts of infertility on individuals and their relationships.
Key themes identified include emotional distress, social stigma, marital strain and a sense of isolation. Participants reported experiencing feelings of shame, depression and anxiety, often exacerbated by societal expectations and pressure to conceive. Coping strategies varied across individuals and included seeking medical intervention, social support, religious faith and, in some cases, withdrawal from social interactions.
The study highlights the need for comprehensive psychological support and counselling services in infertility care to address the mental health and social challenges faced by infertile couples. Promoting awareness to reduce stigma and enhancing social support systems may improve the overall well-being of affected individuals.
The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.
This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.
The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.
A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.
Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.
The study was registered on clinicaltrials.gov (NCT06192862).
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