Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.
The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.
We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.
The study findings will provide the evidence base to inform future colorectal diagnostic services.
The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.
Although low-density lipoprotein cholesterol (LDL-C) is established as the primary cardiovascular disease (CVD) risk factor, some individuals with LDL-C within desirable limits still develop coronary artery disease (CAD). Lipoprotein(a) (Lp(a)) has emerged as a genetically determined independent risk factor for CVD. This study aims to investigate Lp(a) by determining its association with coronary artery stenosis severity, identifying its ethnic-specific genetic determinants and assessing its relationship with an energy-dense dietary pattern.
The PUTRA-CV study is a 3-year, multicentre, case-control observational study involving adult patients who have undergone coronary angiography. The primary outcome is the association between Lp(a) levels and the severity of angiographic CAD (assessed by Gensini or Syntax score). Secondary outcomes include the frequencies of Lp(a)-associated single nucleotide polymorphisms (SNPs) (rs10455872 and rs3798220) and the association between dietary patterns and Lp(a) levels. Lp(a) will be measured using a particle-enhanced immunoturbidimetric method, and SNPs will be genotyped using high-resolution melting. Dietary intake will be assessed using a validated semiquantitative food frequency questionnaire. Data will be analysed using SPSS. Descriptive statistics will be used to summarise population characteristics. Bivariate analyses will use chi-square (2), independent t-tests or Mann-Whitney U tests as appropriate. The independent association between Lp(a) and coronary artery stenosis severity will be determined using multivariable logistic regression, adjusting for confounders. Empirically driven dietary patterns will be derived using reduced rank regression, and their association with Lp(a) will be assessed. For genetic analysis, allele frequencies of the LPA SNPs rs10455872 and rs3798220 will be calculated and compared between cases and controls.
Ethical approval has been obtained from the ethics committees of the Ministry of Health Malaysia (NMRR ID-24-00877-2ID-IIR), Universiti Putra Malaysia (JKEUPM-2024–246), Universiti Teknologi MARA (REC/07/2024-OT/FB/2) and Universiti Malaya Medical Centre (MREC ID NO: 2 02 453–13692). The findings will be disseminated via peer-reviewed journals and conferences.
Traditional peoples and communities (TPCs), such as indigenous peoples and quilombolas (communities descended from escaped African slaves), face challenges related to food security and the impact of the food environment on their health. Changes in food systems, urbanisation and loss of territorial rights have contributed to less healthy eating patterns, with increased consumption of ultra-processed foods and a higher prevalence of chronic non-communicable diseases. Despite this, there are gaps in knowledge about how the food environments of these communities are investigated, especially in relation to the physical, economic, political and sociocultural dimensions.
This scoping review will be conducted following the methodological framework developed by the Joanna Briggs Institute for scoping reviews, and its reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews checklist. A systematic search will be carried out in the following databases: PubMed, SciELO, Web of Science, Embase and EBSCO, using terms related to traditional populations and food environments. The studies to be included will be selected according to the inclusion and exclusion criteria defined based on the population, concept and context technique. The study population will include TPCs, such as indigenous peoples and quilombolas; the concept will address the food environment in its physical, economic, political and sociocultural dimensions; and the context will encompass studies conducted at a global level, without any restrictions on geographic location. The study type will include original articles and grey literature. The screening of studies will involve independent reviewers and predefined inclusion and exclusion criteria. Data synthesis will be presented in tables, including information on focus, geographic scope and methodology of the selected studies. The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies of Exposure tool.
As the study does not involve the collection of primary data or human participants, it does not require ethical approval. The results will be submitted to peer-reviewed journals and presented at public health and nutrition conferences, contributing to the advancement of knowledge on food environments of TPCs.
This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.
A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.
Data were sourced from the published literature and input from international stakeholders.
pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.
A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.
We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.
The use of natural environments and nature activities as elements in the treatment and rehabilitation of mental health challenges is gaining international attention. The objective of the present review was to summarise the knowledge on the effects of nature-based health interventions (NBHIs) targeting individuals diagnosed with anxiety, depression and/or experiencing stress.
Systematic review and meta-analyses. The quality and certainty of evidence were assessed using the SIGN and GRADE.
Searches were performed in Embase, MEDLINE, PsycINFO, CINAHL, Cochrane and Web of Science.
(1) NBHIs, (2) Individuals with a diagnosis of mild to moderate anxiety, depression and/or experiencing stress, (3) Age of participating individuals: 18–84 years, (4) Study designs: randomised controlled trials, cohort studies, case-control studies and case-series studies and (5) Publication date: 2000–2024.
Screening, quality appraisal and certainty of evidence, assessed using SIGN and GRADE, were performed by two independent reviewers, except title screening. Meta-analyses were performed using random-effect models.
Nineteen articles were included, of which 14 were included in the meta-analyses. The articles showed substantial variation in design, interventions, settings and risk of bias, limiting the certainty of evidence according to GRADE. Participating in NBHIs led to a small to large effect in mental health with standardised mean changes of –0.80 (95% CI= (–1.56; –0.04)), –0.87 (95% CI= (–1.18; –0.56)), –0.32 (95% CI= (–0.74; 0.09)) and 0.58 (95% CI= (0.39; 0.77)) for anxiety, depression and stress scores and overall mental health scores, respectively.
This is the first systematic review examining the effect of NBHIs exclusively on individuals diagnosed with anxiety, depression and/or experiencing stress. Our findings suggest small to large improvements after participating in NBHIs. However, methodological limitations to the included articles necessitate cautious interpretation.
CRD42024516270.
COVID-19 in children is generally of short duration, but some may take longer to recover. This study investigated the time to symptom resolution following SARS-CoV-2 infection among children in a community setting on the outskirts of an urban centre in Brazil.
Prospective cohort study.
This is a community-based cohort of children living in Manguinhos, a favela in Rio de Janeiro. The cohort was followed through home visits and telephone monitoring of symptoms. The analysis focused on symptomatic children from this cohort with confirmed SARS-CoV-2 infection. Recovery time was defined as the interval between the first date with symptoms and the first date without symptoms following a positive SARS-CoV-2 test.
A total of 1276 children (boys and girls aged 2–
COVID-19 recovery time, assessed based on change points on the symptom persistence probability curve (Kaplan-Meier).
Among children who tested positive, 148 (60%) were symptomatic. The median recovery time was 11 days (IQR: 7–16). Two inflection points were identified on the Kaplan-Meier curve: days 16 and 34. Children who were ill during the Omicron wave took longer to recover. More boys became asymptomatic within the first 15 days; about 93% of girls recovered by day 33, and boys were more common among those who recovered in ≥34 days. Children aged 6–
Among children from a vulnerable area in Rio de Janeiro, recovery time was longer than that reported in other countries, with 9.5% of children experiencing persistent symptoms for more than 33 days. These findings are crucial for understanding the implications of COVID-19 in specific socioeconomic contexts and the dynamics of paediatric recovery in community settings.
Nearly 40% of adults receiving life-saving dialysis for kidney failure report depressive symptoms. With more than 40 000 Canadians on dialysis, this is a significant health burden. Cognitive behavioural therapy (CBT) has been shown to be effective for treating depressive symptoms; however, it is rarely considered or used for people receiving dialysis. The aim of this realist study is to evaluate and explain how, why, for whom and in what circumstances therapist-guided and remotely delivered CBT works in order to provide equitable mental healthcare to individuals with depressive symptoms receiving dialysis.
The project will include a realist synthesis, a quantitative cohort study and a realist evaluation. Realist methodology is a theory-driven approach that seeks to explain how generative mechanisms are shaped by contextual features, giving rise to outcome patterns. We will begin by developing an initial programme theory (IPT) from the literature and interviews with CBT therapists to understand how CBT is intended to work and for whom. We will use data from the quantitative cohort study to identify contexts that may shape outcome patterns in CBT for people receiving dialysis. This includes previously collected survey data and data from a longitudinal cohort study, both sourced from people across Canada undergoing dialysis. We will test and refine the IPT using data from a realist evaluation and existing literature. The realist evaluation will involve participants from the quantitative cohort study who received therapist-guided, remotely delivered CBT.
Ethical approvals have been granted. We have planned a wide range of dissemination strategies: journal manuscripts and conference presentations, executive memos for administrators of renal programmes in Canada, an online inventory of resources for depressive symptoms and presentations of findings together with patient partners at all participating sites.
CRD42023476184.
Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.
The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.
The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.
Malaria hotspots have been the focus of public health managers during the last two decades because of the potential elimination gains that can be obtained by targeting them. Advances in spatial technologies in the 20th century such as geographic information systems, remotely sensed satellite data on climate and ecology, and statistical methods for spatial cluster detection have enhanced our ability to map fine-scale patterns of malaria transmission. This led to the diversification of analytical approaches and a lack of consensus on methods and standardised indicators for malaria hotspot detection, raising challenges for comparing and synthesising findings across different studies. This review aims to fill this gap by identifying and summarising all publicly available peer-reviewed articles on spatial and spatio-temporal analytical approaches used to detect malaria hotspots while highlighting research gaps.
This scoping review will follow the Joanna Briggs Institute Framework. A comprehensive search will be conducted in PubMed, Medline, Web of Science, Scopus and Embase using keywords related to malaria, hotspots and detection. Retrieved articles published between 1 January 2000 and 31 December 2024 in English or French will be uploaded to Covidence for screening. Empirical studies that apply spatial or spatio-temporal analytical methods to detect malaria hotspots will be included. Studies will be excluded if they rely solely on geographical visualisation without formal spatial analysis. Data extraction will be performed by two independent reviewers, with disagreements resolved by discussion. Data will be summarised using descriptive statistics and thematic analysis.
This scoping review will involve the secondary analysis of published literature on malaria hotspot analysis; therefore, ethics approval is not required. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist will be used to ensure transparency and methodological rigour in reporting. The findings will be disseminated through publication in a peer-reviewed journal and presented at scientific conferences via abstracts, oral or poster presentations.
This review has been registered on the Open Science Framework under the DOI: https://doi.org/10.17605/OSF.IO/C8KUN.