To the Editor The ECOSPOR III trial compared an investigational microbiome therapy (SER-109) with placebo for the treatment of recurrent Clostridioides difficile infection, with results on recurrence through 24 weeks published recently in JAMA. Although it is encouraging to see a new agent for treatment of recurrent C difficile infection, we have some questions about this study. First, the inclusion criteria mandated more than 3 episodes of C difficile infection within the last year, the most recent of which could be treated with a maximum of 10 to 21 days of therapy with either vancomycin or fidaxomicin. Yet the 2017 and 2021 Infectious Diseases Society of America (IDSA) guidelines suggested that when vancomycin is used to treat such patients, it should be tapered and/or pulsed or followed with additional therapy (eg, rifaximin). Therefore, for the 73% of participants who received vancomycin, the length of therapy may have been inappropriately short, which may have contributed to the 47.3% treatment failure and recurrence rate observed.
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Extended Follow-up of Microbiome Therapeutic SER-109 for Recurrent Clostridioides difficile Infection—Reply
In Reply Dr Hamilton and colleagues question why taper/pulse regimens of vancomycin were not used in the ECOSPOR III trial for patients with recurrent C difficile infection. Vancomycin has excellent bactericidal activity against C difficile bacteria with no detectable toxin concentrations by day 4, but has no activity against C difficile spores, which germinate in a disrupted microbiome, leading to C difficile infection. The rationale for taper/pulse regimens is to allow microbiome diversification with decreasing antibiotic exposure.
Efficacia limitata dei farmaci analgesici per la lombalgia acuta
Thirty-year follow-up of the NICHD Study of Early Child Care and Youth Development (SECCYD): the challenges and triumphs of conducting in-person research at a distance
Purpose
The purpose of the current study, The National Institute of Child Health and Human Development (NICHD) Study of Health in Early and Adult Life (SHINE), was to build on the landmark Study of Early Child Care and Youth Development (SECCYD), a longitudinal birth cohort initiated in 1991, by conducting a health-focused follow-up of the now adult participants. This effort has produced an invaluable resource for the pursuit of life course research examining links between early life risk and resilience factors and adulthood health and disease risk.
Participants
Of the 927 NICHD SECCYD participants available for recruitment in the current study, 705 (76.1%) participated in the study. Participants were between 26 and 31 years and living in diverse geographic locations throughout the USA.
Findings to date
In descriptive analyses, the sample exhibited risk on health status indicators, especially related to obesity, hypertension and diabetes. Of particular concern, the prevalence of hypertension (29.4%) and diabetes (25.8%) exceeded national estimates in similar-age individuals. Health behaviour indicators generally tracked with the parameters of poor health status, showing a pattern of poor diet, low activity and disrupted sleep. The juxtaposition of the sample’s relatively young age (mean=28.6 years) and high educational status (55.6% college educated or greater) with its poor health status is noteworthy, suggesting a dissociation between health and factors that are typically health protective. This is consistent with observed population health trends, which show a worsening of cardiometabolic health status in younger generations of Americans.
Future plans
The current study, SHINE, lays the groundwork for future analyses in which the uniquely robust measures collected as a part of the original NICHD SECCYD will be leveraged to pinpoint specific early life risk and resilience factors as well as the correlates and potential mechanisms accounting for variability in health and disease risk indicators in young adulthood.
Understanding Patterns of Missingness in Acute Ischemic Stroke Trials: A Secondary Analysis of Pooled Participant-Level Follow-Up Data
Stroke, Ahead of Print.
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation
New England Journal of Medicine, Ahead of Print.
Al via la Campagna Step Up contro il tumore al colon, un'app per raggiungere 10mila passi al giorno
Persiani, camminare e mangiare sano fondamentali per la prevenzione
Analisi RCT – quali sono i farmaci migliori per la lombalgia acuta?
School readiness of children at high risk of cerebral palsy randomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials
Introduction
School readiness includes cognitive, socio-emotional, language and physical growth and development domains which share strong associations with life-course opportunities. Children with cerebral palsy (CP) are at increased risk of poor school readiness compared with their typically developing peers. Recently, earlier diagnosis of CP has allowed interventions to commence sooner, harnessing neuroplasticity. First, we hypothesise that early referral to intervention for children at-risk of CP will lead to improved school readiness at 4–6 years relative to placebo or care as usual. Second, we hypothesise that receipt of early diagnosis and early intervention will lead to cost-savings in the form of reduced healthcare utilisation.
Methods and analysis
Infants identified as at-risk of CP ≤6 months corrected age (n=425) recruited to four randomised trials of neuroprotectants (n=1), early neurorehabilitation (n=2) or early parenting support (n=1) will be re-recruited to one overarching follow-up study at age 4–6 years 3 months. A comprehensive battery of standardised assessments and questionnaires will be administered to assess all domains of school readiness and associated risk factors. Participants will be compared with a historical control group of children (n=245) who were diagnosed with CP in their second year of life. Mixed-effects regression models will be used to compare school readiness outcomes between those referred for early intervention versus placebo/care-as-usual. We will also compare health-resource use associated with early diagnosis and intervention versus later diagnosis and intervention.
Ethics and dissemination
The Children’s Health Queensland Hospital and Health Service, The University of Queensland, University of Sydney, Monash University and Curtin University Human Research Ethics Committees have approved this study. Informed consent will be sought from the parent or legal guardian of every child invited to participate. Results will be disseminated in peer-reviewed journals, scientific conferences and professional organisations, and to people with lived experience of CP and their families.
Trial registration number
ACTRN12621001253897.
Risk Prediction of New Intracranial Aneurysms at Follow-Up Screening in People With a Positive Family History
Stroke, Ahead of Print. Background:In first-degree relatives of patients with aneurysmal subarachnoid hemorrhage (aSAH), the risk of an intracranial aneurysm can be predicted at initial screening but not at follow-up screening. We aimed to develop a model for predicting the probability of a new intracranial aneurysm after initial screening in people with a positive family history of aSAH.Methods:In a prospective study, we obtained data from follow-up screening for aneurysms of 499 subjects with ≥2 affected first-degree relatives. Screening took place at the University Medical Center Utrecht, the Netherlands, and the University Hospital of Nantes, France. We studied associations between potential predictors and the presence of aneurysms using Cox regression analysis and the predictive performance at 5, 10, and 15 years after initial screening using C statistics and calibration plots, while correcting for overfitting.Results:In 5050 person-years of follow-up, intracranial aneurysms were found in 52 subjects. The risk of aneurysm at 5 years was 2% to 12%, at 10 years, 4% to 28%, and at 15 years, 7% to 40%. Predictors were female sex, history of intracranial aneurysms/aneurysmal subarachnoid hemorrhage, and older age. The sex, previous history of intracranial aneurysm/aSAH, older age score had a C statistic of 0.70 (95% CI, 0.61–0.78) at 5 years, 0.71 (95% CI, 0.64–0.78) at 10 years, and 0.70 (95% CI, 0.63–0.76) at 15 years and showed good calibration.Conclusions:The sex, previous history of intracranial aneurysm/aSAH, older age score provides risk estimates for finding new intracranial aneurysms at 5, 10, and 15 years after initial screening, based on 3 easily retrievable predictors; this can help to define a personalized screening strategy after initial screening in people with a positive family history for aSAH.
New Report on Mpox Cases Leading Up to 2022 Global Outbreak
From January 1, 2022, through January 27, 2023, more than 85 000 confirmed human mpox (monkeypox) cases in 110 countries and 86 deaths were reported to the World Health Organization.
Assessing the impact of COVID-19 pandemic on the health of residents and the healthcare system in Alberta, Canada: an observational study–The Alberta POST-COVID Follow-up Study
Introduction
Very little is known about how the COVID-19 pandemic has affected the health of residents and the healthcare system in Alberta, Canada. The purpose of this study is to establish an observational study to characterise the health of residents in Alberta, Canada, over time, covering a population that tested negative or positive for COVID-19 during the pandemic. The primary outcome is to characterise ‘long COVID-19’ and the health status of residents during the COVID-19 pandemic. Secondary outcomes include the estimation of the risk of and risk factors associated with adverse health outcomes and healthcare utilisation and burdens.
Methods and analysis
This is a population-level provincial observational study which will follow-up with Alberta residents who underwent testing for COVID-19 and completed surveys adapted from the ISARIC COVID-19 long-term follow-up survey. The survey data will be linked with medical records. Statistical analyses will be carried out to characterise ‘long COVID-19’ and the health status of residents during the pandemic. The outcomes of this study will inform strategies for primary care and rehabilitation services to prevent chronic consequences; contribute to healthcare management, interventional studies, rehabilitation and health management to reduce overall morbidity and improve long-term outcomes of COVID-19 and the COVID-19 pandemic and potentially guide a self-evaluation of a remote monitoring system to manage individuals’ health.
Ethics and dissemination
This study was reviewed and approved by the University of Alberta ethics committee (Study ID: Pro00112053 & Pro00113039) on 13 August 2021 and adheres to the Alberta Health Services research information management policy. Study results will be used to manage clinical care, published in peer-reviewed journals and presented at local, national and international conferences.
Protocol version
6 June 2022
EuroQol ID
161 015.
Opticare protocol: a randomised control trial to evaluate the impact of a mobile antenatal care clinic in isolated rural areas on prenatal follow-up
Introduction
Rural residence appears to be a factor of vulnerability among pregnant women with poor clinical antenatal care. Our principal objective is to assess the impact of an infrastructure for a mobile antenatal care clinic on the completion of antenatal care for women identified as geographically vulnerable in a perinatal network.
Methods and analysis
Controlled cluster-randomised study in two parallel arms comparing an intervention group with an open-label control group. This study will concern the population of pregnant women who must live in one of the municipalities covered by the perinatal network and considered to be an area of geographic vulnerability. The cluster randomisation will take place according to the municipality of residence. The intervention will be the implementation of pregnancy monitoring by a mobile antenatal care clinic. The completion of antenatal care between the intervention and control groups will be a binary criterion: 1 will be attributed to each antenatal care that includes all visits and supplementary examinations. Sample size has been estimated to be 330 at least with an 80% participation rate.
The univariate analyses will compare the follow-up rates (with Fisher’s exact test), and all individual characteristics collected (Fisher’s exact test, Student’s t-test) between the two groups. The multivariate analysis will use a mixed linear model analysis and consider the cluster effect as random; the initial model will include known confounders from the literature, confounders identified in univariate analyses, and the clinically relevant prognostic factors. All of these factors will be taken into account in the model as a fixed effect.
Ethics and dissemination
The Patient Protection Committee North-West II approved this study on 4 February 2021 (IRB 2020-A02247-32). The results will be the subject of scientific communications and publications.
Trial registration number
NCT04823104.
Scaling-up high-impact micronutrient supplementation interventions to improve adolescents nutrition and health in Burkina Faso and Tanzania: protocol for a cluster-randomised controlled trial
Introduction
Adolescence is a critical time for growth and development, but this age group is often neglected in research and development of nutrition interventions. Despite recommendations from the WHO to provide nutrient supplements to adolescents, evidence remains scarce on the most effective supplementation strategy. This study aims to compare weekly iron and folic acid (IFA) supplementation with daily multiple micronutrient supplements (MMSs) in prevention of anaemia and improvement of school outcomes among adolescents in Burkina Faso and Tanzania.
Methods and analysis
A three-arm cluster-randomised, school-based supplementation trial will be conducted among 84 schools (42 schools per site) and roughly 4500 students aged 10–17. Schools will be matched on three characteristics: number of students, school ranking profile, distance to main road (Tanzania) or distance to city council (Burkina Faso). Each school will be randomised to receive either weekly IFA, daily MMSs or serve as a control. Supplements will be delivered to students by teachers, who will provide monitoring data to the study team. Baseline and endline surveys will be conducted prior to and after each supplementation cycle (12 weeks in Burkina Faso; 1 year in Tanzania) to assess haemoglobin, anthropometry and sociodemographic variables. The primary outcome of haemoglobin will be analysed continuously using linear regression, and anaemia status will be analysed using logistic or multinomial regression, depending on categorisation level of the outcome. Secondary analyses of school performance indicators will also be conducted with either logistic or linear regression.
Ethics and dissemination
This protocol has been approved by the Institutional Review Board of the Harvard TH Chan School of Public Health (IRB20-1108) and the Research Ethics Committees for the Ministries of Health in Tanzania (Zanzibar) and Burkina Faso. Results will be disseminated during meetings with the Ministries of Health and the participating communities as well as through peer-reviewed publications.
Trial registration number
NCT04657640; NCT05104554
Treatment outcomes and its associated factors among pneumonia patients admitted to public hospitals in Harar, eastern Ethiopia: a retrospective follow-up study
Objective
Although there is a high risk of drug resistance, empiric treatment is a common approach for pneumonia management. In this respect, it is relevant to know treatment outcomes of patients with pneumonia. This study aimed to assess treatment outcomes and its associated factors among pneumonia patients treated at two public hospitals in Harar, eastern Ethiopia.
Design
Retrospective follow-up study.
Setting
Jugal General Hospital and Hiwot Fana Specialised University Hospital in Harar, eastern Ethiopia.
Participants
Patients admitted and treated for pneumonia in the two public hospitals in eastern Ethiopia between April 2020 and April 2021.
Primary outcome
The primary outcome was unfavourable treatment outcome (died or transferred to intensive care unit) for pneumonia patients.
Results
A total of 693 patients with pneumonia were included in the study. 88 (12.7%) of these patients had an unfavourable treatment outcome, which included 14 (2%) transfers to the intensive care unit and 74 (10.7%) deaths. Patients with comorbidity (adjusted OR, AOR=2.96; 95% CI: 1.47 to 5.97) and with clinical features including abnormal body temperature (AOR=4.03; 95% CI: 2.14 to 7.58), tachycardia (AOR=2.57; 95% CI: 1.45 to 4.55), bradypnoea or tachypnoea (AOR=3.92; 95% CI:1.94 to 7.92), oxygen saturation below 90% (AOR=2.52; 95% CI:1.37 to 4.64) and leucocytosis (AOR=2.78, 95%, CI:1.38 to 5.58) had a significantly increased unfavourable treatment outcome.
Conclusion
We found that nearly one out of eight patients with pneumonia had unfavourable treatment outcomes. It was considerably high among patients with comorbidities and apparent abnormal clinical conditions. Therefore, taking into account regionally adaptable intervention and paying close attention to pneumonia patients admitted with comorbidity and other superimposed abnormal conditions might help improve the treatment outcomes of these populations.
Oral function and cumulative long-term care costs among older Japanese adults: a prospective 6-year follow-up study of long care receipt data
Objectives
This study evaluated the relationship between status of oral function and related long-term care service costs.
Design
This was a prospective 6-year follow-up study of previous survey data.
Setting
The data were obtained from the Japan Gerontological Evaluation Study conducted between 2010 and 2011.
Participants
The participants were functionally independent older adults in 12 municipalities across Japan.
Interventions
Care service benefit costs were tracked over 6 years using publicly available claims records (n=46 616) to monitor respondents’ cumulative care costs.
Primary and secondary outcome measures
The primary outcome variable was the cumulative cost of long-term care insurance services during the follow-up period. We adjusted for the presence or absence of oral function problems, age, sex, physical function and socioeconomic and lifestyle background at the time of the baseline survey.
Results
Tobit analysis revealed that, compared with those with no oral function problems, cumulative long-term care service benefit costs for those with one, two or three oral function problems were approximately US$4020, US$4775 and US$82 92, respectively, over 6 years. Compared with those with maintained oral function, there was a maximum difference of approximately US$8292 in long-term care service costs for those with oral function problems. With increase in number of oral function problems, there was a concomitant elevation in the cost of long-term care.
Conclusions
Oral function in older people was associated with cumulative long-term care insurance costs. The oral function of older people should be maintained to reduce future accumulated long-term care insurance costs. Compared with those with maintained oral function, there was a maximum difference of approximately US$8292 in long-term care service costs for those with oral function problems. The cost of long-term care was amplified as oral problems increased.