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BackgroundSelf-management plays an important role in maintaining good control of diabetes mellitus, and mobile phone interventions have been shown to improve such self-management. The Health Promotion Board of Singapore has created a caloric-monitoring mobile health app, the “interactive Diet and Activity Tracker” (iDAT). ObjectiveThe objective was to identify and describe short-term (8-week) trajectories of use of the iDAT app among patients with type 2 diabetes mellitus in a primary care setting in Singapore, and identify patient characteristics associated with each trajectory. MethodsA total of 84 patients with type 2 diabetes mellitus from a public primary care clinic in Singapore who had not previously used the iDAT app were enrolled. The app was demonstrated and patients’ weekly use of the app was monitored over 8 weeks. Weekly use was defined as any record in terms of food entry or exercise workout entry in that week. Information on demographics, diet and exercise motivation, diabetes self-efficacy (Diabetes Empowerment Scale-Short Form), and clinical variables (body mass index, blood pressure, and glycosylated hemoglobin/HbA1c) were collected at baseline. iDAT app use trajectories were delineated using latent-class growth modeling (LCGM). Association of patient characteristics with the trajectories was ascertained using logistic regression analysis. ResultsThree iDAT app use trajectories were observed: Minimal Users (66 out of 84 patients, 78.6%, with either no iDAT use at all or use only in the first 2 weeks), Intermittent-Waning Users (10 out of 84 patients, 11.9%, with occasional weekly use mainly in the first 4 weeks), and Consistent Users (8 out of 84 patients, 9.5%, with weekly use throughout all or most of the 8 weeks). The adjusted odds ratio of being a Consistent User, relative to a Minimal User, was significantly higher for females (OR 19.55, 95% CI 1.78-215.42) and for those with higher exercise motivation scores at baseline (OR 4.89, 95% CI 1.80-13.28). The adjusted odds ratio of being an Intermittent-Waning User relative to a Minimal User was also significantly higher for those with higher exercise motivation scores at baseline (OR 1.82, 95% CI 1.00-3.32). ConclusionsThis study provides insight into the nature and extent of usage of a caloric-monitoring app among patients with type 2 diabetes and managed in primary care. The application of LCGM provides a useful framework for evaluating future app use in other patient populations.

IntroductionHuman papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicéntrico de TAMizaje y triaje de cáncer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC.Methods and analysisWomen aged 30-64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50 000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNCT01881659.

Abstract Background Irritable bowel syndrome (IBS) is a common gastrointestinal disorder. The prevalence of IBS in Asian countries varies from 2.9% to 15.6%. IBS does not result in increased mortality, but is associated with psychological distress and disruption of work and sleep. Consequently, the evaluation of health-related quality of life (HRQoL) is an important outcome measure for patients with IBS since it provides a holistic assessment of the patient's emotional, social and physical function. However, some HRQoL tools can be time-consuming to apply. EQ-5D is a brief HRQoL tool which has been validated in the Western IBS population but has thus far not been used in Asia. This study was conducted to determine whether persons with self-reported symptoms that met the Rome III criteria for IBS had a poorer quality of life than those without these symptoms. We also aimed to determine which specific aspects of quality of life were most affected and whether any risk factors distinguished those with and without IBS. Methods Self-administered questionnaires which included the Rome III diagnostic questionnaire modules for IBS and the EQ-5D questionnaire were obtained from participants of a health symposium in Singapore on 31th October 2010. IBS was diagnosed based on the Rome III Criteria. The main outcome measure was the EQ-5D index score. The relationship between the presence of IBS and the EQ-5D index score, individual dimensions of EQ-5D and demographic risk factors were examined. Results 449 completed questionnaires were analyzed. The mean EQ-5D index score for IBS was 0.739 which was a significant reduction compared to non-IBS participants [−0.11 (95% CI: -0.15 to −0.07), p Conclusion IBS sufferers have significantly poorer quality of life. Assessment of HRQoL in IBS using the EQ-5D should be considered in further studies and routine clinical practice.

Background: Regional variations in gastric cancer incidence are not explained by prevalence of Helicobacter pylori, the main cause of the disease, with several areas presenting high H. pylori prevalence but low gastric cancer incidence. The IARC worldwide H. pylori prevalence surveys (ENIGMA) aim at systematically describing age and sex-specific prevalence of H. pylori infection around the world and generating hypotheses to explain regional variations in gastric cancer risk. Methods: We selected age- and sex-stratified population samples in two areas with different gastric cancer incidence and mortality in Chile: Antofagasta (lower rate) and Valdivia (higher rate). Participants were 1–69 years old and provided interviews and blood for anti-H. pylori antibodies (IgG, VacA, CagA, others) and atrophy biomarkers (pepsinogens). Results: H. pylori seroprevalence (Age-standardized to world population) and antibodies against CagA and VacA were similar in both sites. H. pylori seroprevalence was 20% among children <10 years old, 40% among 10–19 year olds, 60% in the 20–29 year olds and close to or above 80% in those 30+ years. The comparison of the prevalence of known and potential H. pylori cofactors in gastric carcinogenesis between the high and the low risk area showed that consumption of chili products was significantly higher in Valdivia and daily non-green vegetable consumption was more common in Antofagasta. Pepsinogen levels suggestive of gastric atrophy were significantly more common and occurred at earlier ages in Valdivia, the higher risk area. In a multivariate model combining both study sites, age, chili consumption and CagA were the main risk factors for gastric atrophy. Conclusions: The prevalence of H. pylori infection and its virulence factors was similar in the high and the low risk area, but atrophy was more common and occurred at younger ages in the higher risk area. Dietary factors could partly explain higher rates of atrophy and gastric cancer in Valdivia. Impact: The ENIGMA study in Chile contributes to better understanding regional variations in gastric cancer incidence and provides essential information for public health interventions. [ABSTRACT FROM AUTHOR]

Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore. Methods:We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419) or control (n = 421). Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge. Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001). Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting. Trial Registration: Clinicaltrials.gov, no NCT02325752 [ABSTRACT FROM AUTHOR]

Introduction and aim: Head injuries are a common complaint among children presenting to the emergency department (ED). This study is part of an ongoing prospective surveillance of head injured children presenting to a paediatric ED. We aim to derive predictors for moderate to severe head injury in our population. Materials and methods: We performed an unmatched case-control study. Cases were defined as those who presented to the ED with moderate to severe head injury, during the period from 2006 to 2014. Controls were obtained from the prospective surveillance head injury database and were children who presented to the ED with head injury but who remained well on follow up. We compared variables from demographics, mechanism of injury, history, and physical examination. Results: There were 39 cases and 1173 controls. In the prospective database, our event rate was 0.5% and our computed tomography (CT) rate was 1%. Among those with moderate to severe head injury, they were more likely to be involved in road traffic accidents, have a history of difficult arousal, confusion or disorientation and a history of seizure. On physical examination, cases were more likely to have the presence of altered mental status, base of skull fracture, scalp hematoma and anisocoria. On multivariable analysis, the following 4 predictors remained statistically significant: Involvement in road traffic accident (p < 0.001), difficult arousal (p < 0.001), vomiting (p = 0.003) and signs of base of skull fracture (p < 0.001). Using these 4 variables, the Area under Curve was 0.97 {Sensitivity 92.3% (79.1-98.4%), Specificity 93.0% (91.4-94.4%), positive predictive value 30.5% (22-40%), negative predictive value 99.7% (99.2-99.9%)}. Conclusion: Involvement in road traffic accident, difficult arousal, base of skull fracture and vomiting are independent predictors for moderate to severe head injury in our paediatric population. [ABSTRACT FROM AUTHOR]

INTRODUCTION Patients with functional gastrointestinal disorders (FGIDs) have a decreased quality of life (QoL). Psychological illnesses are strongly associated with FGIDs. This study examined the effect of a comprehensive psychological intervention programme designed for refractory FGID patients. METHODS Refractory FGID patients at a tertiary gastroenterology unit were encouraged to participate in a psychological intervention programme, which included screening for anxiety and depression in patients, educating patients and physicians on FGIDs, and providing early access to psychiatric consultation for patients with significant psychological illnesses. The duration of follow-up was six months. Outcomes were measured using the Irritable Bowel Syndrome-QoL (IBS-QoL) instrument and the EuroQol five dimensions (EQ-5D) questionnaire. RESULTS A total of 1,189 patients (68% female, 80% Chinese, mean age 48.6 years) participated in the programme. Among these participants, 51% had a significant psychological disorder (Hospital Anxiety and Depression Scale [HADS] anxiety or depression score > 7). These participants had a significantly poorer QoL (IBS-QoL and EQ-5D, both p < 0.0001), and were more likely to be single or English-speaking, as compared to the participants without psychological disorders. Participants who completed ≥ 3 months of follow-up (n = 906) showed significant and durable improvement. High baseline HADS anxiety score predicted improvement (p < 0.001), with participant IBS-QoL and EQ-5D scores decreasing over time. CONCLUSION The intervention programme was associated with a clinically meaningful improvement in the QoL of patients with refractory FGIDs. High baseline anxiety was predictive of improvement. [ABSTRACT FROM AUTHOR]

Background: Pediatric traumatic brain injury (TBI) constitutes a significant burden and diagnostic challenge in the emergency department (ED). While large North American research networks have derived clinical prediction rules for the head injured child, these may not be generalizable to practices in countries with traditionally low rates of computed tomography (CT). We aim to study predictors for moderate to severe TBI in our ED population aged < 16 years. Methods: This was a retrospective case-control study based on data from a prospective surveillance head injury database. Cases were included if patients presented from 2006 to 2014, with moderate to severe TBI. Controls were age-matched head injured children from the registry, obtained in a 4 control: 1 case ratio. These children remained well on diagnosis and follow up. Demographics, history, and physical examination findings were analyzed and patients followed up for the clinical course and outcome measures of death and neurosurgical intervention. To predict moderate to severe TBI, we built a machine learning (ML) model and a multivariable logistic regression model and compared their performances by means of Receiver Operating Characteristic (ROC) analysis. Results: There were 39 cases and 156 age-matched controls. The following 4 predictors remained statistically significant after multivariable analysis: Involvement in road traffic accident, a history of loss of consciousness, vomiting and signs of base of skull fracture. The logistic regression model was created with these 4 variables while the ML model was built with 3 extra variables, namely the presence of seizure, confusion and clinical signs of skull fracture. At the optimal cutoff scores, the ML method improved upon the logistic regression method with respect to the area under the ROC curve (0.98 vs 0.93), sensitivity (94.9% vs 82.1%), specificity (97.4% vs 92.3%), PPV (90.2% vs 72.7%), and NPV (98.7% vs 95.4%). Conclusions: In this study, we demonstrated the feasibility of using machine learning as a tool to predict moderate to severe TBI. If validated on a large scale, the ML method has the potential not only to guide discretionary use of CT, but also a more careful selection of head injured children who warrant closer monitoring in the hospital. [ABSTRACT FROM AUTHOR]

Background: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder. The prevalence of IBS in Asian countries varies from 2.9% to 15.6%. IBS does not result in increased mortality, but is associated with psychological distress and disruption of work and sleep. Consequently, the evaluation of health-related quality of life (HRQoL) is an important outcome measure for patients with IBS since it provides a holistic assessment of the patient's emotional, social and physical function. However, some HRQoL tools can be time-consuming to apply. EQ-5D is a brief HRQoL tool which has been validated in the Western IBS population but has thus far not been used in Asia. This study was conducted to determine whether persons with self-reported symptoms that met the Rome III criteria for IBS had a poorer quality of life than those without these symptoms. We also aimed to determine which specific aspects of quality of life were most affected and whether any risk factors distinguished those with and without IBS. Methods: Self-administered questionnaires which included the Rome III diagnostic questionnaire modules for IBS and the EQ-5D questionnaire were obtained from participants of a health symposium in Singapore on 31th October 2010. IBS was diagnosed based on the Rome III Criteria. The main outcome measure was the EQ-5D index score. The relationship between the presence of IBS and the EQ-5D index score, individual dimensions of EQ-5D and demographic risk factors were examined. Results: 449 completed questionnaires were analyzed. The mean EQ-5D index score for IBS was 0.739 which was a significant reduction compared to non-IBS participants [?0.11 (95% CI: -0.15 to ?0.07), p < 0.001]. Multivariate analysis showed that IBS was significantly associated with younger age and higher education level. Of the five EQ-5D dimensions, IBS sufferers were significantly affected in mobility, anxiety or depression, usual activity and pain. There was a "dose related" increase in likelihood of having IBS with increased severity of pain and anxiety or depression. Conclusion: IBS sufferers have significantly poorer quality of life. Assessment of HRQoL in IBS using the EQ-5D should be considered in further studies and routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Viral load (VL) is recommended for monitoring the response to highly active antiretroviral therapy (HAART) but is not routinely available in most low- and middle-income countries. The purpose of the study was to determine whether a CD4-based monitoring and switching strategy would provide a similar clinical outcome compared to the standard VL-based strategy in Thailand. Methods and Findings: The Programs for HIV Prevention and Treatment (PHPT-3) non-inferiority randomized clinical trial compared a treatment switching strategy based on CD4-only (CD4) monitoring versus viral-load (VL). Consenting participants were antiretroviral-naïve HIV-infected adults (CD4 count 50–250/mm3) initiating non-nucleotide reverse transcriptase inhibitor (NNRTI)-based therapy. Randomization, stratified by site (21 public hospitals), was performed centrally after enrollment. Clinicians were unaware of the VL values of patients randomized to the CD4 arm. Participants switched to second-line combination with confirmed CD4 decline >30% from peak (within 200 cells from baseline) in the CD4 arm, or confirmed VL >400 copies/ml in the VL arm. Primary endpoint was clinical failure at 3 years, defined as death, new AIDS-defining event, or CD4 <50 cells/mm3. The 3-year Kaplan-Meier cumulative risks of clinical failure were compared for non-inferiority with a margin of 7.4%. In the intent to treat analysis, data were censored at the date of death or at last visit. The secondary endpoints were difference in future-drug-option (FDO) score, a measure of resistance profiles, virologic and immunologic responses, and the safety and tolerance of HAART. 716 participants were randomized, 356 to VL monitoring and 360 to CD4 monitoring. At 3 years, 319 participants (90%) in VL and 326 (91%) in CD4 were alive and on follow-up. The cumulative risk of clinical failure was 8.0% (95% CI 5.6–11.4) in VL versus 7.4% (5.1–10.7) in CD4, and the upper-limit of the one-sided 95% CI of the difference was 3.4%, meeting the pre-determined non-inferiority criterion. Probability of switch for study criteria was 5.2% (3.2–8.4) in VL versus 7.5% (5.0–11.1) in CD4 (p = 0.097). Median time from treatment initiation to switch was 11.7 months (7.7–19.4) in VL and 24.7 months (15.9–35.0) in CD4 (p = 0.001). The median duration of viremia >400 copies/ml at switch was 7.2 months (5.8–8.0) in VL versus 15.8 months (8.5–20.4) in CD4 (p = 0.002). FDO scores were not significantly different at time of switch. No adverse events related to the monitoring strategy were reported. Conclusions: The 3-year rates of clinical failure and loss of treatment options did not differ between strategies although the longer-term consequences of CD4 monitoring would need to be investigated. These results provide reassurance to treatment programs currently based on CD4 monitoring as VL measurement becomes more affordable and feasible in resource-limited settings. Trial registration ClinicalTrials.gov NCT00162682 Please see later in the article for the Editors' Summary

Background/Aims The International Agency for Research on Cancer (IARC), as the specialized cancer agency of the World Health Organization, recognizes that gastric cancer (GC) is a disease of high global importance and the burden will continue to rise unless effective control measures are implemented. The Working Group convened by IARC recommended that all countries consider including GC in their national cancer control programs. Methods IARC has launched three major GC research programs for epidemiology, prevention and implementation of preventive strategies, namely ENIGMA, a series of international prevalence surveys to investigate age-specific prevalence of Helicobacter pylori in areas of low and high GC risk using standardized methods, HELPER, a unique large randomized controlled clinical trial to investigate the effect of H. pylori eradication on GC development in Korea in collaboration with the Korean National Cancer Center, and GISTAR, another large clinical trial to investigate if H. pylori screening followed by treatment of participants tested positive and endoscopic follow-up of those with serological evidence of atrophic gastritis can reduce GC mortality in East Europe in collaboration with University of Latvia. Results The first ENIGMA was completed in Chile (Antofagasta and Valdivia) and is underway in Iran (Shiraz and Ardabil). ENIGMA will start shortly in Uganda and Costa Rica with plans to include more countries. HELPER is set to complete its recruitment target by 2019. The GISTAR Pilot was completed in 2015 involving 3,455 Latvians. Recruitment for GISTAR continues with more than 8,000 participants included so far. The design and progress/preliminary results from each study will be presented. Conclusions Through international collaborations, IARC puts forward major efforts to understand worldwide epidemiology of H. pylori infection and GC and to identify markers for risk stratification and relevant preventive measures for implementation to reduce its global burden which will remain substantial for the next decades. [ABSTRACT FROM AUTHOR]

Background: Hemophilia-associated bleeding and resultant joint pain and mobility restrictions can predispose patients to poor health-related quality of life (HRQoL). Therefore, efficacy of a treatment needs to address more than just annualized bleed rates., Objectives: Describe the evolution of HRQoL, pain, and activity in patients with hemophilia A, treated with efmoroctocog alfa prophylaxis., Design: A post hoc analysis from Kids A-LONG (NCT01458106), A-LONG (NCT01181128), and long-term extension study ASPIRE (NCT01454739) assessed change in pain and activity-related patient-reported outcomes (PROs)., Methods: Physical health, pain, and HRQoL were assessed by PROs for a cumulative treatment duration of up to ~6 years. The primary endpoint was change from baseline in EuroQoL (EQ)-5D and Haemophilia Quality of Life Questionnaire (Haem-A-QoL)., Results: 118 adult/adolescents and 71 pediatric patients were included. The proportion of adults and adolescents reporting no problem in the EQ-5D analysis of ' pain/discomfort ' significantly increased from A-LONG baseline (35.04%; 41/117) to ASPIRE month 30 (44.68%; 21/47; p  = 0.024). Mean (standard deviation) Haem-A-QoL subdomain scores for ' feeling ' and ' physical health ' at A-LONG baseline improved by -3.24 (15.13; p  = 0.018) and -3.85 (23.07; p  = 0.047), respectively, at study end. Proportion of pediatric patients reporting no problem on the EQ-5D analysis of ' pain/discomfort ', significantly increased from A-LONG baseline (75.0%; 42/56) to ASPIRE baseline (95.56%; 43/45; p  = 0.046). Satisfaction levels for pediatric patients were high at A-LONG baseline and maintained until study end., Conclusion: Long-term efmoroctocog alfa prophylaxis reduces pain and improves HRQoL in adult and adolescent patients with hemophilia A. In pediatric patients, it reduces perceived pain and maintains satisfaction levels., Trial Registration: NCT01458106, NCT01181128, NCT01454739., Competing Interests: PR has received travel support to attend conferences from CSL Behring and Takeda; speaker and/or consultancy honoraria from Pfizer, Sobi, and Idogen. NK, LB, and DE are employees of SOBI AB. SL has received honoraria for speaking and reimbursement for attending symposia or congresses from Roche, Sobi, Novo Nordisk, CSL Behring, Takeda, and Sanofi. KA, SB, and MM have no conflicts to disclose., (© The Author(s), 2024.)

Introduction: Patients with functional gastrointestinal disorders (FGIDs) have a decreased quality of life (QoL). Psychological illnesses are strongly associated with FGIDs. This study examined the effect of a comprehensive psychological intervention programme designed for refractory FGID patients., Methods: Refractory FGID patients at a tertiary gastroenterology unit were encouraged to participate in a psychological intervention programme, which included screening for anxiety and depression in patients, educating patients and physicians on FGIDs, and providing early access to psychiatric consultation for patients with significant psychological illnesses. The duration of follow-up was six months. Outcomes were measured using the Irritable Bowel Syndrome-QoL (IBS-QoL) instrument and the EuroQol five dimensions (EQ-5D) questionnaire., Results: A total of 1,189 patients (68% female, 80% Chinese, mean age 48.6 years) participated in the programme. Among these participants, 51% had a significant psychological disorder (Hospital Anxiety and Depression Scale [HADS] anxiety or depression score > 7). These participants had a significantly poorer QoL (IBS-QoL and EQ-5D, both p < 0.0001), and were more likely to be single or English-speaking, as compared to the participants without psychological disorders. Participants who completed ≥ 3 months of follow-up (n = 906) showed significant and durable improvement. High baseline HADS anxiety score predicted improvement (p < 0.001), with participant IBS-QoL and EQ-5D scores decreasing over time., Conclusion: The intervention programme was associated with a clinically meaningful improvement in the QoL of patients with refractory FGIDs. High baseline anxiety was predictive of improvement.