Tag: pubmed

BMJ Open. 2023 Nov 2;13(11):e077037. doi: 10.1136/bmjopen-2023-077037.

ABSTRACT

INTRODUCTION: Common mental disorders, including depression, anxiety and related somatic health symptoms, are leading causes of disability worldwide. Especially in low-resource settings, psychosocial interventions delivered by non-specialist providers through task-sharing modalities proved to be valid options to expand access to mental healthcare. However, such interventions are usually eclectic multicomponent interventions consisting of different combinations of evidence-based therapeutic strategies. Which of these various components (or combinations thereof) are more efficacious (and for whom) to reduce common mental disorder symptomatology is yet to be substantiated by evidence.

METHODS AND ANALYSIS: Comprehensive search was performed in electronic databases MEDLINE, Embase, PsycINFO and the Cochrane Register of Controlled Trials-CENTRAL from database inception to 15 March 2023 to systematically identify all randomised controlled trials that compared any single component or multicomponent psychosocial intervention delivered through the task-sharing modality against any active or inactive control condition in the treatment of adults suffering from common mental disorders. From these trials, individual participant data (IPD) of all measured outcomes and covariates will be collected. We will dismantle psychosocial interventions creating a taxonomy of components and then apply the IPD component network meta-analysis (IPD-cNMA) methodology to assess the efficacy of individual components (or combinations thereof) according to participant-level prognostic factors and effect modifiers.

ETHICS AND DISSEMINATION: Ethics approval is not applicable for this study since no original data will be collected. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.

PMID:37918937 | DOI:10.1136/bmjopen-2023-077037

BMJ Open. 2023 Nov 2;13(11):e072024. doi: 10.1136/bmjopen-2023-072024.

ABSTRACT

INTRODUCTION: Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

METHODS AND ANALYSIS: The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

ETHICS AND DISSEMINATION: The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00029323).

PMID:37918930 | DOI:10.1136/bmjopen-2023-072024

BMJ Open. 2023 Nov 2;13(11):e072531. doi: 10.1136/bmjopen-2023-072531.

ABSTRACT

INTRODUCTION: One-third of children in England have special educational needs (SEN) provision recorded during their school career. The proportion of children with SEN provision varies between schools and demographic groups, which may reflect variation in need, inequitable provision and/or systemic factors. There is scant evidence on whether SEN provision improves health and education outcomes.

METHODS: The Health Outcomes of young People in Education (HOPE) research programme uses administrative data from the Education and Child Health Insights from Linked Data-ECHILD-which contains data from all state schools, and contacts with National Health Service hospitals in England, to explore variation in SEN provision and its impact on health and education outcomes. This umbrella protocol sets out analyses across four work packages (WP). WP1 defined a range of ‘health phenotypes’, that is health conditions expected to need SEN provision in primary school. Next, we describe health and education outcomes (WP1) and individual, school-level and area-level factors affecting variation in SEN provision across different phenotypes (WP2). WP3 assesses the impact of SEN provision on health and education outcomes for specific health phenotypes using a range of causal inference methods to account for confounding factors and possible selection bias. In WP4 we review local policies and synthesise findings from surveys, interviews and focus groups of service users and providers to understand factors associated with variation in and experiences of identification, assessment and provision for SEN. Triangulation of findings on outcomes, variation and impact of SEN provision for different health phenotypes in ECHILD, with experiences of SEN provision will inform interpretation of findings for policy, practice and families and methods for future evaluation.

ETHICS AND DISSEMINATION: Research ethics committees have approved the use of the ECHILD database and, separately, the survey, interviews and focus groups of young people, parents and service providers. These stakeholders will contribute to the design, interpretation and communication of findings.

PMID:37918923 | DOI:10.1136/bmjopen-2023-072531

BMJ Open. 2023 Nov 2;13(11):e071253. doi: 10.1136/bmjopen-2022-071253.

ABSTRACT

OBJECTIVES: The optimal puncture technique for neuraxial anaesthesia in different populations is unclear. We sought to obtain data from randomised controlled trials comparing the impact of ultrasound-guided technology and traditional positioning technology on the success rate of neuraxial anaesthesia.

DESIGN: Systematic review and network meta-analysis using study populations, interventions, intervention comparisons, outcome measures and study types.

DATA SOURCES: PubMed, Embase, Cochrane Library and Web of science were searched until 31 September 2022.

ELIGIBILITY CRITERIA: We included randomised controlled trials comparing three types of neuraxial anaesthesia: ultrasound-assisted, ultrasound real-time guidance and conventional positioning to describe which neuraxial anaesthesia modality is best for patients and to recommend the appropriate one for different populations.

DATA EXTRACTION AND SYNTHESIS: Five independent reviewers retrieved, screened and edited included studies using standardised methods. Assess risk of bias using the Cochrane Collaboration and Evidence Project tools. Network meta-analysis was performed using STATA V.15 statistical software.

RESULTS: Twenty-two studies containing three different interventions were included. The SUCRA values of first-pass success rates for the three neuraxial anaesthesia methods were real-time guidance (82.8%), ultrasound-assisted (67.1%) and traditional positioning (0.1%). Both ultrasound techniques improved first-pass success rates compared with traditional localization, but there was no significant difference between the two. Subgroup analysis showed that the use of real-time ultrasound guidance for neuraxial anaesthesia in pregnant and patients with obesity improved first-pass success rates. Ultrasound-assisted technology can improve first-attempt success rates in older patients with abnormal lumbar spine anatomy.

CONCLUSION: Compared with conventional positioning, ultrasound guidance technology can improve the first-pass success rate of neuraxial anaesthesia, but there is no significant difference between ultrasound-assisted and real-time guidance technology. The results of subgroup analysis tell us that the most suitable neuraxial anaesthesia method is different for different groups of people.

PROSPERO REGISTRATION NUMBER: PROSPERO number: CRD42022376041.

PMID:37918920 | DOI:10.1136/bmjopen-2022-071253

Occup Environ Med. 2023 Nov 2:oemed-2023-108875. doi: 10.1136/oemed-2023-108875. Online ahead of print.

ABSTRACT

BACKGROUND: The dose-response relationship between cancers and protracted low-dose rate exposure to ionising radiation is still uncertain. This study aims to estimate quantified relationships between low-dose radiation exposures and site-specific solid cancers among Chinese medical X-ray workers.

METHODS: This cohort study included 27 011 individuals who were employed at major hospitals in 24 provinces in China from 1950 to 1980 and had been exposed to X-ray equipment, and a control group of 25 782 physicians who were not exposed to X-ray equipment. Person-years of follow-up were calculated from the year of employment to the date of the first diagnosis of cancer or the end of follow-up, whichever occurred first. All cancers were obtained from medical records during 1950-1995. This study used Poisson regression models to estimate the excess relative risk (ERR) and excess absolute risk (EAR) for incidence of site-specific solid cancers associated with cumulative dose.

RESULTS: 1643 solid cancers were developed, the most common being lung, liver and stomach cancer. Among X-ray workers, the average cumulative colon dose was 0.084 Gy. We found a positive relationship between cumulative organ-specific dose and liver (ERR/Gy=1.48; 95% CI 0.40 to 2.83), oesophagus (ERR/Gy=18.1; 95% CI 6.25 to 39.1), thyroid (ERR/Gy=2.96; 95% CI 0.44 to 8.18) and non-melanoma skin cancers (ERR/Gy=7.96; 95% CI 2.13 to 23.12). We found no significant relationship between cumulative organ-specific doses and other cancers. Moreover, the results showed a statistically significant EAR for liver, stomach, breast cancer (female), thyroid and non-melanoma skin cancers.

CONCLUSIONS: These findings provided more useful insights into the risks of site-specific cancers from protracted low-dose rate exposure to ionising radiation.

PMID:37918914 | DOI:10.1136/oemed-2023-108875

Arch Dis Child. 2023 Nov 2:archdischild-2023-325926. doi: 10.1136/archdischild-2023-325926. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the impact of the COVID-19 pandemic experience on language development among children, we compared language development at 18 months of age, before and during the pandemic in Japan, where strict control measures continued over a long period.

METHODS: This was a repeated cross-sectional study and we included children who attended the 18-month health check-up provided by the Okayama City Public Health Center between January 2017 and December 2022 (n=33 484). We compared indicators of language development before (from January 2017 to February 2020) and during (from March 2020 to December 2022) the pandemic. Our primary outcome was the proportion of children who required follow-up for language development by the Public Health Center. The secondary outcome was the proportion of children who could not say three or more meaningful words. We estimated risk ratios (RRs) and their 95% CIs, adjusted for potential confounders.

RESULTS: The prevalence of the primary outcome was 33.5% before the pandemic and 36% during the pandemic. Compared with before the pandemic, increased RRs for the primary and secondary outcomes were observed during the pandemic, with RRs (95% CIs) of 1.09 (1.06-1.13) for the primary outcome and 1.11 (1.05-1.17) for the secondary outcome. Although the statistical interactions were not significant, the RRs were higher for children cared for at home than those in nursery schools and with ≤3 family members than those with ≥4 family members.

CONCLUSIONS: The COVID-19 pandemic was associated with an increased risk of impaired language development in children at 18 months. More extensive support is needed for higher risk families, as well as follow-up of long-term language development in children affected by the COVID-19 pandemic.

PMID:37918897 | DOI:10.1136/archdischild-2023-325926

Ann Rheum Dis. 2023 Nov 2:ard-2023-224732. doi: 10.1136/ard-2023-224732. Online ahead of print.

ABSTRACT

OBJECTIVE: Relapsing polychondritis (RP) is a systemic inflammatory disease of unknown aetiology. The objective of this study was to examine the contribution of rare genetic variations to RP.

METHODS: We performed a case-control exome-wide rare variant association analysis that included 66 unrelated European American cases with RP and 2923 healthy controls (HC). Gene-level collapsing analysis was performed using Firth’s logistics regression. Exploratory pathway analysis was performed using three different methods: Gene Set Enrichment Analysis, sequence kernel association test and higher criticism test. Plasma DCBLD2 levels were measured in patients with RP and HC using ELISA.

RESULTS: In the collapsing analysis, RP was associated with a significantly higher burden of ultra-rare damaging variants in the DCBLD2 gene (7.6% vs 0.1%, unadjusted OR=79.8, p=2.93×10^-7). Plasma DCBLD2 protein levels were significantly higher in RP than in HC (median 4.06 ng/µL vs 0.05 ng/µL, p<0.001). The pathway analysis revealed a statistically significant enrichment of genes in the tumour necrosis factor signalling pathway driven by rare damaging variants in RELB, RELA and REL using higher criticism test weighted by eigenvector centrality.

CONCLUSIONS: This study identified specific rare variants in the DCBLD2 gene as a putative genetic risk factor for RP. These findings should be validated in additional patients with RP and supported by future functional experiments.

PMID:37918895 | DOI:10.1136/ard-2023-224732

Ann Rheum Dis. 2023 Nov 2:ard-2023-224623. doi: 10.1136/ard-2023-224623. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the long-term efficacy and safety of azathioprine (AZA), 18-month fixed-schedule rituximab (RTX), 18-month tailored RTX and 36-month RTX in preventing relapses in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis who achieved a complete remission after induction therapy. Patients treated with 36-month RTX received either a fixed or a tailored regimen for the first 18 months and a fixed regimen for the last 18 months (36-month fixed/fixed RTX and 36-month tailored/fixed RTX, respectively).

METHODS: The Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trials sequentially compared: 18-month fixed-schedule RTX versus AZA (MAINRITSAN); 18-month fixed-schedule RTX versus 18-month tailored-RTX (MAINRITSAN2); and extended therapy to 36 months with four additional RTX infusions after MAINRITSAN2 versus placebo (MAINRITSAN3). Patients were then followed prospectively through month 84 and their data were pooled to analyse relapses and adverse events. The primary endpoint was relapse-free survival at month 84.

RESULTS: 277 patients were enrolled and divided in 5 groups: AZA (n=58), 18-month fixed-schedule RTX (n=97), 18-month tailored-RTX (n=40), 36-month tailored/fixed RTX (n=42), 36-month fixed/fixed RTX (n=41). After adjustment for prognostic factors, 18-month fixed-schedule RTX was superior to AZA in preventing major relapses at month 84 (HR 0.38, 95% CI 0.20 to 0.71). The 18-month tailored-RTX regimen was associated with an increased risk of major relapse compared with fixed-schedule regimen (HR 2.92, 95% CI 1.43 to 5.96). The risk of major relapse was similar between 36-month fixed/fixed and 18-month fixed-RTX (HR 0.69, 95% CI 0.38 to 1.25).

CONCLUSIONS: According to these results, it appears that the 84-month remission rate is higher with an 18-month fixed RTX regimen compared with AZA and 18-month tailored RTX. Also, extending RTX to 36 months does not appear to reduce the long-term relapse rate compared with the 18-month fixed RTX regimen. However, as this study was underpowered to make this comparison, further prospective studies are needed to determine the potential long-term benefits of extending treatment in these patients.

PMID:37918894 | DOI:10.1136/ard-2023-224623

Ann Rheum Dis. 2023 Nov 2:ard-2023-224501. doi: 10.1136/ard-2023-224501. Online ahead of print.

ABSTRACT

OBJECTIVES: Investigating the association between different definitions of axial involvement and syndesmophytes development over 2 years in patients with psoriatic arthritis (PsA).

METHODS: Patients from a prospective multicentre cohort (Belgian Epidemiological Psoriatic Arthritis Study) involving 17 Belgian rheumatology practices were recruited between December 2012 and July 2014 and included when fulfilling the Classification Criteria for Psoriatic Arthritis. Axial involvement included six clinical and two radiographic oriented definitions.Two calibrated central readers evaluated radiographic damage by assessing the modified Stoke Ankylosing Spondylitis Spinal Score and modified New York criteria. New syndesmophytes after 2 years were described conditional on axial involvement at baseline. Logistic regression analyses were used to investigate the association between syndesmophyte development and axial involvement. All definitions of axial involvement were evaluated separately.

RESULTS: From 150 patients, a 2-year follow-up of spinal radiographs was obtained. There are 11 patients with new syndesmophytes after 2 years. For the clinical definitions of axial involvement ‘global assessment’, ‘detailed assessment’, ‘back pain (BP)’ and ‘inflammatory BP (IBP)’ the probabilities of developing syndesmophytes ranged between 0.06 and 0.08 and were similar for the presence or absence of the definition. When including elevated C reactive protein (CRP) to the definitions the probability of developing syndesmophytes over 2 years increased two times for CBP and seven times for IBP.With radiographic axial involvement a similar trend was seen; radiographic sacroiliitis as definition showed a probability three times higher. When combined with elevated CRP there would be a 14 times higher chance to develop syndesmophytes in 2 years. The ORs varied from 0.83 to 13.80, though none of them were statistically significant.

CONCLUSIONS: The likelihood of syndesmophyte formation in PsA is low. The probability of developing syndesmophytes is much higher when axial involvement is determined radiographically rather than clinically, particularly in the context of high CRP.

PMID:37918893 | DOI:10.1136/ard-2023-224501

Z Geburtshilfe Neonatol. 2023 Nov 2. doi: 10.1055/a-2180-7302. Online ahead of print.

ABSTRACT

INTRODUCTION: Pregnant women and their offspring represented a vulnerable patient collective during the Covid-19 pandemic. Beyond the direct effect of SARS-CoV-2 via vertical transmission, an indirect impact on the fetus can occur through placental lesions deteriorating placental villous function. We performed a histopathological analysis of placentas of parturients with SARS-CoV-2 compared to healthy controls.

METHODS AND MATERIALS: Between February 2022 and July 2022 we conducted a prospective case-control study analyzing placental specimens of parturients with SARS-CoV-2 infection compared to specimens of placentas of healthy controls. Patient history, Covid-19-specific symptoms, and obstetric outcomes were recorded. Statistical analysis was performed.

RESULTS: During the observation period 71 patients were included with a gestational age 37 1/7-41 5/7 weeks. Thirty-six patients presented with SARS-CoV-2 infection. The control group consisted of 35 patients and showed no placental abnormalities. Among SARS-CoV-2-positive parturients, 66.7% of placentas of the case group showed histopathological abnormalities classified as vascular or inflammatory abnormalities. 22.2% of placentas showed acute ischemic infarction areas. 8.3% of placentas showed subchorionic layered thrombi. There was one case of severe acute subchorionitis. SARS-CoV-2 increased the risk of placental lesions significantly (OR 3.000, CI 1.890-4.762, p=0.0001). Placental lesions had no significant impact on perinatal acidosis (OR 0.455, CI 0.044-4.667, p=0.498) or number of cesarean sections (OR 2.314, CI 0.717-7.473, p=0.156).

CONCLUSION: SARS-CoV-2 infection during labor and delivery increased the risk of adverse outcomes. Histopathological analysis indicated that the placenta as a maternal-fetal interface was affected by SARS-CoV-2, leading to systemic vasculopathy and inflammation.

PMID:37918832 | DOI:10.1055/a-2180-7302