Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.
Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.
IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.
This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.
Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.
To make a descriptive comparison of antibodies to four major periodontal bacteria and their relation to the respiratory diseases asthma and bronchitis/emphysema, and to cancer incidence.
The serum of a random sample of men with no history of cancer incidence (n=621) was analysed by the ELISA method for antibody levels of four periodontal bacteria; the anaerobes of the so-called red complex Tannerella forsythia (TF), Porphyromonas gingivalis (PG), and Treponema denticola (TD), and the facultative anaerobe Aggregatibacter actinomycetemcomitans (AA). The antibody readings were divided into quartiles and the distribution of cases of the relevant diseases as compared with the non-cases. Comparisons of the quartile distributions were by the Pearson 2 test. Data and serum from the Oslo II study of Norwegian men from 2000 were used. The ELISA analyses were performed on thawed frozen serum. Cancer data from 17.5 years of follow-up were provided by the Norwegian Cancer Registry.
In all, 52 men had reported asthma and 23 men had bronchitis/emphysema at the health screening. Results on cancer incidence are given for all respiratory cancers, n=23, and bronchi and lung cancers separately, n=18. Stratified analyses were performed for the four endpoints showing significant association with low levels of TD antibodies for bronchitis; p=0.035. Both TF and TD were significant for low levels of antibodies among daily smokers; p=0.030 for TF and p
A low level of TD was associated with bronchitis/emphysema compared with the rest of the cohort. In the total study sample, low levels of antibodies to both TF and TD were associated with daily smoking.
Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.
We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.
This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.
Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.
REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
Global Positioning System (GPS) technology is increasingly used in health research to capture individual mobility and contextual and environmental exposures. However, the tools, techniques and decisions for using GPS data vary from study to study, making comparisons and reproducibility challenging.
The objectives of this systematic review were to (1) identify best practices for GPS data collection and processing; (2) quantify reporting of best practices in published studies; and (3) discuss examples found in reviewed manuscripts that future researchers may employ for reporting GPS data usage, processing and linkage of GPS data in health studies.
A systematic review.
Electronic databases searched (24 October 2023) were PubMed, Scopus and Web of Science (PROSPERO ID: CRD42022322166).
Included peer-reviewed studies published in English met at least one of the criteria: (1) protocols involving GPS for exposure/context and human health research purposes and containing empirical data; (2) linkage of GPS data to other data intended for research on contextual influences on health; (3) associations between GPS-measured mobility or exposures and health; (4) derived variable methods using GPS data in health research; or (5) comparison of GPS tracking with other methods (eg, travel diary).
We examined 157 manuscripts for reporting of best practices including wear time, sampling frequency, data validity, noise/signal loss and data linkage to assess risk of bias.
We found that 6% of the studies did not disclose the GPS device model used, only 12.1% reported the per cent of GPS data lost by signal loss, only 15.7% reported the per cent of GPS data considered to be noise and only 68.2% reported the inclusion criteria for their data.
Our recommendations for reporting on GPS usage, processing and linkage may be transferrable to other geospatial devices, with the hope of promoting transparency and reproducibility in this research.
CRD42022322166.
Research indicates that social networks and roles are disrupted throughout the entire trajectory of someone living with a brain tumour. Young adults aged 18–35 years are particularly vulnerable to such disruption because they are in a process of establishing themselves. Pre-existing social roles and support networks of young adults living with a primary brain tumour may change. This study aims to identify the social networks of young adults aged 18–35 years diagnosed with a primary brain tumour and to map how the diagnosis and disease course affects the social network in relation to changes in relationships and roles over time.
The study adopts a longitudinal design with a convergent mixed methods approach to describe the social network of young adults. The study utilizes a quantitative approach to social network analysis to measure network size, composition and density and a qualitative approach with interviews to gain insight into young adult’s narratives about their network. Network maps will be produced, analysed and all the findings will then be compared and integrated. Interviews and network drawing will take place at the time of the diagnoses, with follow-up interviews 6 and 12 months later. This will shed light on transformations in network compositions and network support over time.
The study has been approved by the Danish Data Protection Agency (ID P-2022-733). Written informed consent will be obtained from all patients. The results will be disseminated through a peer-reviewed journal and reported at local, national and international conferences on brain cancer.
Hearing loss is one of the leading potentially modifiable risk factors for dementia. There is growing evidence suggesting that treating hearing loss with hearing aids could be a relatively low-cost intervention in reducing cognitive decline and the risk of dementia in the long term. However, given the current constraints of the limited evidence, it is premature to draw definitive conclusions about the effect of hearing aids on cognitive functioning. More long-term randomised studies examining this effect would be recommended. Prior to embarking on large-scale lengthy randomised controlled trials (RCTs), it is imperative to determine the viability of such studies. Therefore, the purpose of the current study is to assess the feasibility of a RCT that investigates the effect of hearing aids on cognitive functioning in elderly hearing impaired individuals.
In this randomised controlled feasibility trial, 24 individuals aged 65 years or older with mild to moderate hearing loss (≥35–
This research protocol was approved by the Institutional Review Board of the University Medical Centre Utrecht (NL80594.041.22, V.3, January 2023). The trial results will be made accessible to the public in a peer-reviewed journal.
Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.
General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.
Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.
ACTRN12621001168842.
The abbreviated World Health Organisation Quality of Life tool (WHOQOL-BREF) is a short-form quality of life (QoL) assessment commonly used worldwide in both healthy and ill populations. Normative data for the Australian general population are limited. The objective of this study was to present normative data for the WHOQOL-BREF based on a general population sample. A secondary aim was to explore sociodemographic factors related to QoL.
Population-based cross-sectional study.
929 men and 830 women aged 24–94 years participating in the Geelong Osteoporosis Study.
The 26-item WHOQOL-BREF.
Means and SD for each domain are presented by age group and sex. Percentile scores were also generated. Mean scores for WHOQOL-BREF domains were 74.52 (SD=16.22) for physical health, 72.07 (SD=15.35) for psychological, 72.87 (SD=18.78) for social relationships and 79.68 (SD=12.55) for environment. We identified significant associations between sociodemographic factors and WHOQOL-BREF domains. Notably, being married or in a relationship was associated with increased odds for high QoL across all four WHOQOL-BREF domains: physical health (women OR 2.46, 95% CI 1.36 to 4.44, p=0.003), psychological (men OR 2.07, 95% CI: 1.20 to 3.55, p=0.009; women OR 2.15, 95% CI 1.21 to 3.81, p=0.009), social relationships (men OR 2.28, 95% CI 1.29 to 4.04, p=0.005; women OR 2.77, 95% CI 1.42 to 5.41, p=0.003) and environment (women OR 2.07, 95% CI 1.13 to 3.80, p=0.019).
This study provides population norms for the WHOQOL-BREF based on a representative sample of Australian adults. Our results will be useful to researchers and clinicians who can use these data as a reference point for interpreting WHOQOL-BREF scores.
Cerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP Register (GLM CPR) suggest that the majority of CP in LMICs are due to potentially preventable causes. Such data are lacking in the Latin American region. Generating comparable epidemiological data on CP from this region could enable translational research and services towards early diagnosis and early intervention. We aim to establish a Latin American multicountry network and online data repository of CP called Latin American Cerebral Palsy Register (LATAM-CPR).
The LATAM-CPR will be modelled after the GLM CPR and will support new and emerging Latin American CP registers following a harmonised protocol adapted from the GLM CPR and piloted in Argentina (ie, Argentine Register of Cerebral Palsy). Both population-based and institution-based surveillance mechanisms will be adopted for registration of children with CP aged less than 18 years to the participating CP registers. The data collection form of the LATAM-CPR will include risk factors, clinical profile, rehabilitation, socioeconomical status of children with CP. Descriptive data on the epidemiology of CP from each participating country will be reported, country-specific and regional data will be compared.
Individual CP registers have applied ethics approval from respective national human research ethics committees (HREC) and/or institutional review boards prior to the establishment and inclusion into the LATAM-CPR. Ethical approval for LATAM-CPR has already been obtained from the HREC in the two countries that started (Argentina and Mexico). Findings will be disseminated and will be made publicly available through peer-reviewed publications, conference presentations and social media communications.
Strengthening of emergency care systems, including prehospital systems, can reduce death and disability. We aimed to identify perspectives on barriers and facilitators relating to the development and implementation of a prehospital emergency care system assessment tool (PEC-SET) from prehospital providers representing several South and Southeast (SE) Asian countries.
We conducted a qualitative study using focus group discussions (FGD) informed by the Consolidated Framework for Implementation Research (CFIR). FGDs were conducted in English, audioconferencing/videoconferencing was recorded, transcribed verbatim and coded using an inductive and deductive approach. Participants suggested specific elements to be measured within three main ‘pillars’ of disease conditions proposed by the research team of the tool being developed (cardiovascular, trauma and perinatal emergencies).
We explored the perspectives of medical directors in six low-income and middle-income countries (LMICs) in South and SE Asia.
A total of 16 participants were interviewed (1 Vietnam, 4 Philippines, 4 Thailand, 5 Malaysia, 1 Indonesia and 1 Pakistan) as a part of 4 focus groups.
Themes identified within the four CFIR constructs included: (1) Intervention characteristics: importance of developing an contextually specific tool, need for generalisability, trialling in one geographical area or with one pillar before expanding; (2) Inner setting: data transfer barriers, workforce shortages; (3) Outer setting: underdevelopment of EMS nationally; need for further EMS system development prior to implementing a tool and (4) Individual characteristics: lack of buy-in by prehospital personnel. Elements proposed by participants included both process and outcome measures.
Through the CFIR framework, we identified several themes which can provide a basis for codeveloping a PEC-SET for LMICs with local stakeholders. This work may inform development of quality improvement tools in LMIC PEC systems.
Examining the perspectives of formal and informal caregivers and residents on roles, mutual expectations and needs for improvement in the care for residents with (a risk of) dehydration.
Qualitative study.
Semi-structured interviews with 16 care professionals, three residents and three informal caregivers were conducted between October and November 2021. A thematic analysis was performed on the interviews.
Three topic summaries contributed to a comprehensive view on the care for residents with (a risk of) dehydration: role content, mutual expectations and needs for improvement. Many overlapping activities were found among care professionals, informal caregivers and allied care staff. While nursing staff and informal caregivers are essential in observing changes in the health status of residents, and medical staff in diagnosing and treating dehydration, the role of residents remains limited. Conflicting expectations emerged regarding, for example, the level of involvement of the resident and communication. Barriers to multidisciplinary collaboration were highlighted, including little structural involvement of allied care staff, limited insight into each other's expertise and poor communication between formal and informal caregivers. Seven areas for improvement emerged: awareness, resident profile, knowledge and expertise, treatment, monitoring and tools, working conditions and multidisciplinary working.
In general, many formal and informal caregivers are involved in the care of residents with (a risk of) dehydration. They depend on each other's observations, information and expertise which requires an interprofessional approach with specific attention to adequate prevention. For this, educational interventions focused on hydration care should be a core element in professional development programs of nursing homes and vocational training of future care professionals.
The care for residents with (a risk of) dehydration has multiple points for improvement. To be able to adequately address dehydration, it is essential for formal and informal caregivers and residents to address these barriers in clinical practice.
In writing this manuscript, the EQUATOR guidelines (reporting method SRQR) have been adhered to.
No patient or public contribution.
Worldwide, the prevalence of degenerative diseases such as dementia and mild cognitive impairment (MCI) is increasing with population ageing and increasing life expectancy. Both conditions share modifiable risk factors. Physical inactivity is one of these modifiable risk factors, and research points to the protective effect of physical activity on the incidence of dementia and MCI. However, this association tends to change according to type, intensity, frequency, duration and volume of physical activity. Furthermore, it remains unclear which of these characteristics offers the greatest protective effect. Therefore, this study aims to evaluate the impacts of different types, intensities, frequencies, duration and volume of physical activity on dementia and cognitive decline in older adults.
The search will be carried out from October 2023, using the following databases: PubMed, Embase, Scopus, CINAHL and Web of Science. Cohort studies with a follow-up time of 1 year or longer that have investigated the incidence of dementia and/or MCI in older adults exposed to physical activity will be included. There will be no limitations on the date of publication of the studies. Studies published in English, Spanish or Portuguese will be analysed. Two researchers will independently screen the articles and extract the data. Any discrepancies will be resolved by a third reviewer. Association measures will be quantified, including OR, HR, relative risk and incidence ratio, with a 95% CI. If the data allow, a meta-analysis will be performed. To assess the methodological quality of the selected studies, the Grading of Recommendations, Assessment, Development and Evaluations instrument, and the Downs and Black instrument to assess the risk of bias, will be used.
Ethical approval is not required. The results will be submitted for publication in a peer-reviewed journal.
CRD42023400411.
The confidence of young people diagnosed with psychosis is often low. Positive self-beliefs may be few and negative self-beliefs many. A sense of defeat and failure is common. Young people often withdraw from many aspects of everyday life. Psychological well-being is lowered. Psychological techniques can improve self-confidence, but a shortage of therapists means that very few patients ever receive such help. Virtual reality (VR) offers a potential route out of this impasse. By including a virtual coach, treatment can be automated. As such, delivery of effective therapy is no longer reliant on the availability of therapists. With young people with lived experience, we have developed a staff-assisted automated VR therapy to improve positive self-beliefs (Phoenix). The treatment is based on established cognitive behavioural therapy and positive psychology techniques. A case series indicates that this approach may lead to large improvements in positive self-beliefs and psychological well-being. We now aim to conduct the first randomised controlled evaluation of Phoenix VR.
80 patients with psychosis, aged between 16 and 30 years old and with low levels of positive self-beliefs, will be recruited from National Health Service (NHS) secondary care services. They will be randomised (1:1) to the Phoenix VR self-confidence therapy added to treatment as usual or treatment as usual. Assessments will be conducted at 0, 6 (post-treatment) and 12 weeks by a researcher blind to allocation. The primary outcome is positive self-beliefs at 6 weeks rated with the Oxford Positive Self Scale. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention to treat.
The trial has received ethical approval from the NHS Health Research Authority (22/LO/0273). A key output will be a high-quality VR treatment for patients to improve self-confidence and psychological well-being.
There is an urgent need to support primary care organisations in implementing safe and high-quality virtual consultations. We have previously performed qualitative research to capture the views of 1600 primary care physicians across 20 countries on the main benefits and challenges of using virtual consultations. Subsequently, a prototype of a framework to guide the implementation of high-quality virtual primary care was developed.
To explore general practitioners’ perspectives on the appropriateness and relevance of each component of the framework’s prototype, to further refine it and optimise its practical use in primary care facilities.
Participants will be primary care physicians with active experience providing virtual care, recruited through convenience and snowball sampling. This study will use a systematic and iterative online Delphi research approach (eDelphi), with a minimum of three rounds. A pre-round will be used to circulate items for initial feedback and adjustment. In subsequent rounds, participants will be asked to rate the relevance of the framework’s components. Consensus will be defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a component. Data will be collected using structured online questionnaires. The primary outcome of the study will be a list of the essential components to be incorporated in the final version of the framework.
The study has received ethical approval conceded by the Imperial College London Science, Engineering and Technology Research Ethics Committee (SETREC) (reference no .6559176/2023). Anonymous results will be made available to the public, academic organisations and policymakers.
Drug–drug interactions (DDIs) are common and can result in patient harm. Electronic health records warn clinicians about DDIs via alerts, but the clinical decision support they provide is inadequate. Little is known about clinicians’ real-world DDI decision-making process to inform more effective alerts.
Apply cognitive task analysis techniques to determine informational cues used by clinicians to manage DDIs and identify opportunities to improve alerts.
Clinicians submitted incident forms involving DDIs, which were eligible for inclusion if there was potential for serious patient harm. For selected incidents, we met with the clinician for a 60 min interview. Each interview transcript was analysed to identify decision requirements and delineate clinicians’ decision-making process. We then performed an inductive, qualitative analysis across incidents.
Inpatient and outpatient care at a major, tertiary Veterans Affairs medical centre.
Physicians, pharmacists and nurse practitioners.
Themes to identify informational cues that clinicians used to manage DDIs.
We conducted qualitative analyses of 20 incidents. Data informed a descriptive model of clinicians’ decision-making process, consisting of four main steps: (1) detect a potential DDI; (2) DDI problem-solving, sensemaking and planning; (3) prescribing decision and (4) resolving actions. Within steps (1) and (2), we identified 19 information cues that clinicians used to manage DDIs for patients. These cues informed their subsequent decisions in steps (3) and (4). Our findings inform DDI alert recommendations to improve clinicians’ decision-making efficiency, confidence and effectiveness.
Our study provides three key contributions. Our study is the first to present an illustrative model of clinicians’ real-world decision making for managing DDIs. Second, our findings add to scientific knowledge by identifying 19 cognitive cues that clinicians rely on for DDI management in clinical practice. Third, our results provide essential, foundational knowledge to inform more robust DDI clinical decision support in the future.
Serum prokineticin-1 (s-PROK1) in the second and third trimester of pregnancy is positively correlated to preeclampsia, intrauterine growth restriction (IUGR) and preterm delivery. Women with polycystic ovary syndrome (PCOS) are prone to these adverse pregnancy outcomes. However, the contribution of PROK1 to the development of pregnancy complications and the effect of metformin and hyperandrogenism on s-PROK1 in PCOS have not been studied previously.
This work is a post hoc analysis of two prospective, randomised, placebo-controlled trials.
Pregnant women with PCOS were included from 11 study centres in Norway.
From 313 women, 264 participated in the present study after exclusions due to dropouts or insufficient serum samples.
Women with PCOS were randomly administered with metformin or placebo, from first trimester to delivery.
s-PROK1 was analysed using ELISA at gestational week 19 and related to pregnancy complications, fasting insulin levels, homoeostatic model assessment for insulin resistance (HOMA-IR), testosterone, or androstenedione levels, metformin use, PCOS phenotype and hyperandrogenism.
Maternal s-PROK1 in the second trimester did not predict pregnancy-induced hypertension, pre-eclampsia or late miscarriage/preterm delivery in women with PCOS. However, s-PROK1 was lower in women who used metformin before inclusion, both in those randomised to metformin and to placebo, compared with those who did not. s-PROK1 was also lower in those who used metformin both at conception and during pregnancy compared with those who used metformin from inclusion or did not use metformin at all. s-PROK1 was lower in hyperandrogenic compared with normo-androgenic women with PCOS.
Maternal s-PROK1 in the second trimester did not predict pregnancy complications in PCOS. Those who used metformin at conception and/or during pregnancy had lower s-PROK1. PCOS women with hyperandrogenism exhibited lower s-PROK1 compared with normo-adrogenic phenotypes.
Colorectal adenoma (CRA) is a precancerous lesion for colorectal cancer. Endoscopic resection is the first-line treatment for CRA. However, CRA recurrence rate is high. This proposed study aims to determine if Chinese herbal medicine (CHM) reduces CRA recurrence.
This project encompasses an observational, registry-based, cohort study and a nested qualitative study. The cohort study aims to include 364 postpolypectomy CRA participants at Guangdong Provincial Hospital of Chinese Medicine (GPHCM), China, with a follow-up phase of up to 1 year. In addition to routine care, these participants will receive a CHM treatment prescribed by experienced Chinese medicine (CM) clinicians. The CHM treatment encompasses CHM products and CHM formulae according to CM syndromes. The primary outcome is CRA recurrence rate at 1 year after enrolment. Secondary outcomes include characteristics of recurrent CRA, incidence of colorectal polyp (except for CRA), incidence of advanced CRA, incidence of colorectal cancer, improvement of gastrointestinal symptoms commonly seen in CRA patients, faecal occult blood test result, lipid level, fasting plasma glucose level, uric acid level, carcinoembryonic antigen, carbohydrate antigen 19-9, quality of life and safety evaluations. Logistic regression analysis will be used to explore the correlation between exposure and outcome. Qualitative interviews will be conducted among approximate 30 CRA patients from the cohort study and 10 CM practitioners in Department of Gastroenterology at GPHCM. Thematic analysis will be used to analyse qualitative data.
Ethical approval has been obtained from the Human Research Ethics Committee (HREC) of GPHCM (YF2022-320-02) and registered at Royal Melbourne Institute of Technology (RMIT) HREC. The results will be disseminated in peer-reviewed journals and international academic conferences.
ChiCTR2200065713.
Health information systems represent an opportunity to improve the care provided to people with multimorbidity. There is a pressing need to assess their impact on clinical outcomes to validate this intervention. Our study will determine whether using a digital platform (Multimorbidity Management Health Information System, METHIS) to manage multimorbidity improves health-related quality of life (HR-QoL).
A superiority, cluster randomised trial will be conducted at primary healthcare practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley (LVT) Region, Portugal, not involved in a previous pilot trial, will be eligible. At the participant level, eligible patients will be people with complex multimorbidity, aged 50 years or older, with access to an internet connection and a communication technology device. Participants who cannot sign/read/write and who do not have access to an email account will not be included in the study. The intervention combines a training programme and a customised information system (METHIS). Both are designed to help clinicians adopt a goal-oriented care model approach and to encourage patients and carers to play a more active role in autonomous healthcare. The primary outcome is HR-QoL, measured at 12 months with the physical component scale of the 12-item Short Form questionnaire (SF-12). Secondary outcomes will also be measured at 12 months and include mental health (mental component Scale SF-12, Hospital Anxiety and Depression Scale). We will also assess serious adverse events during the trial, including hospitalisation and emergency services. Finally, at 18 months, we will ask the general practitioners for any potentially missed diagnoses.
The Research and Ethics Committee (LVT Region) approved the trial protocol. Clinicians and patients will sign an informed consent. A data management officer will handle all data, and the publication of several scientific papers and presentations at relevant conferences/workshops is envisaged.
Opioid use disorder (OUD) is a major public health concern in the USA, resulting in high rates of overdose and other negative outcomes. Methadone, an OUD treatment, has been shown to be effective in reducing the risk of overdose and improving overall health and quality of life. This study analysed the distribution of methadone for the treatment of OUD across the USA over the past decade and through the COVID-19 pandemic.
Retrospective observational study using secondary data analysis of the Drug Enforcement Administration and Medicaid Databases.
USA.
Patients who were dispensed methadone at US opioid treatment programmes (OTPs).
The primary outcomes were the overall pattern in methadone distribution and the number of OTPs in the USA per year. The secondary outcome was Medicaid prescriptions for methadone.
Methadone distribution for OUD has expanded significantly over the past decade, with an average state increase of +96.96% from 2010 to 2020. There was a significant increase in overall distribution of methadone to OTP from 2010 to 2020 (+61.00%, p
There have been dynamic changes in methadone distribution for OUD. Furthermore, pronounced variation in methadone distribution among states was observed, with some states having no OTPs or Medicaid coverage. New policies are urgently needed to increase access to methadone treatment, address the opioid epidemic in the USA and reduce overdose deaths.