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Coeliac disease in the Trondelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients

Por: Lukina · P. · Andersen · I. L. · Eggen · P. T. · Mjones · P. G. · Ronne · E. · Bolstad · N. · Klaasen · R. A. · Warren · D. J. · Iversen · R. · Hveem · K. · Bernklev · T. · Jelsness-Jorgensen · L. P. · Pedersen · L. · Jonkers · I. · Lagergren · P. · Sollid · L. M. · Lundin · K. · Ness-Je
Purpose

Coeliac disease (CD) is a common disorder and affects about 1% of the population worldwide. CD in the Trøndelag Health Study (HUNT) is a population-based cohort study which was established to provide new knowledge about CD that can improve the diagnostics and management, prevent the onset or progression and expand the knowledge about the role of genetics of the disease.

Participants

The cohort is based on the fourth wave of the population-based HUNT study (HUNT4), Norway, performed during 2017–2019, also including linkage to hospital records and the Norwegian Patient Registry (NPR). A total of 54 541 HUNT4 participants with available sera were screened for CD by serology. All seropositive participants were invited to a clinical assessment, including endoscopy with duodenal biopsies, during 2019–2023.

Findings to date

A total of 1107 HUNT4 participants (2%) were seropositive for CD and 1048 were eligible for clinical assessment, including biopsy. Of these, 724 participants attended the clinical assessment and 482 were identified with CD. In addition, 371 participants with CD were identified through the hospital records and NPR. In total, 853 participants in HUNT4 with biopsy-verified CD diagnosis were identified.

Future plans

All participants in the study will be invited to a follow-up assessment after at least 1 year, including repeated standard serological testing, endoscopy and tissue sampling. The collected data and material will be used to establish the true population-based prevalence of CD. The consequences of CD, including symptoms, deficiencies and comorbidity, will be investigated and possible triggers and predictors, will be studied. With access to serum samples from the previous HUNT surveys in HUNT Biobank, serological signs of CD in prediagnostic samples of seropositive individuals will be used. Genetic studies will identify new CD markers, assess genotype–phenotype links and explore gene–environment correlations.

Registration

clinicaltrials.gov identifier: NCT04041622.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Optimising HIV care using information obtained from PROMs: protocol for an observational study

Por: Moody · K. · Nieuwkerk · P. T. · Bedert · M. · Nellen · J. F. · Weijsenfeld · A. · Sigaloff · K. C. E. · Laan · L. · Bruins · C. · van Oers · H. · Haverman · L. · Geerlings · S. E. · Van der Valk · M.
Introduction

Successful antiviral therapy has transformed HIV infection into a chronic condition, where optimising quality of life (QoL) has become essential for successful lifelong treatment. Patient-reported outcome measures (PROMs) can signal potential physical and mental health problems related to QoL. This study aims to determine whether PROMs in routine clinical care improve quality of care as experienced by people with HIV (PWH).

Methods and analysis

We report the protocol of a multicentre longitudinal cohort studying PWH at Amsterdam University Medical Centres in the Netherlands. PROMs are offered annually to patients via the patient portal of the electronic health record. Domains include anxiety, depression, fatigue, sleep disturbances, social isolation, physical functioning, stigma, post-traumatic stress disorder, adherence, drug and alcohol use and screening questions for sexual health and issues related to finances, housing and migration status. Our intervention comprises (1) patients’ completion of PROMs, (2) discussion of PROMs scores during annual consultations and (3) documentation of follow-up actions in an individualised care plan, if indicated. The primary endpoint will be patient-experienced quality of care, measured by the Patient Assessment of Chronic Illness Care, Short Form (PACIC-S). Patients will provide measurements at baseline, year 1 and year 2. We will explore change over time in PACIC-S and PROMs scores and examine the sociodemographical and HIV-specific characteristics of subgroups of patients who participated in all or only part of the intervention to ascertain whether benefit has been achieved from our intervention in all subgroups.

Ethics and dissemination

Patients provide consent for the analysis of data collected as part of routine clinical care to the AIDS Therapy Evaluation in the Netherlands study (ATHENA) cohort through mechanisms described in Boender et al. Additional ethical approval for the analysis of these data is not required under the ATHENA cohort protocol. The results will be presented at national and international academic meetings and submitted to peer-reviewed journals for publication.

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