Tag: statistics

Psychiatry Clin Neurosci. 2023 May 11. doi: 10.1111/pcn.13565. Online ahead of print.

ABSTRACT

AIM: The main aim of this study was to investigate the additional effects of L-theanine, an amino acid in tea and an analog of glutamate with neuroprotective and anti-depressant properties, on obsessive-compulsive disorder (OCD) symptoms in combination with fluvoxamine.

METHODS: Patients from either sex aged between 18-60 years diagnosed with OCD, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), who had a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of more than 21 were enrolled in a double-blinded, parallel-group, placebo-controlled, clinical trial of 10 weeks to receive either L-theanine (100 mg twice daily) and fluvoxamine (100 mg daily initially followed by 200 mg daily after week 5) or placebo and fluvoxamine. The primary outcome of interest in this study was the Y-BOCS total score decrease from baseline.

RESULTS: From a total of 95 evaluated patients, 50 completed our study; 30 were randomly assigned to each group. Multivariate analysis (ANOVA) showed a significant effect of time × treatment for L-theanine in obsession subscale (F = 5.51, p-value = 0.008) of the Y-BOCS score but not in the total and compulsion scores. Our results showed significantly more improvement in obsession subscale scores in L-theanine compared to placebo group (p = 0.007, Cohen’s d = 0.82). Also, total Y-BOCS scores were lower in L-theanine compared to placebo group at week 5 (p = 0.039, Cohen’s d = 0.60) and 10 (p = 0.008, Cohen’s d = 0.80). However, there was no significant between-group differences in compulsion subscale scores. Complete response was also more frequent in the L-theanine group (p = 0.0001).

CONCLUSION: Findings in this study suggest L-theanine as a relatively safe and effective adjuvant therapy for moderate to severe OCD. This article is protected by copyright. All rights reserved.

PMID:37169515 | DOI:10.1111/pcn.13565

BMJ Open. 2023 May 11;13(5):e065538. doi: 10.1136/bmjopen-2022-065538.

ABSTRACT

INTRODUCTION: Low dietary calcium intake is a risk factor for pre-eclampsia, a major contributor to maternal and perinatal mortality and morbidity worldwide. Calcium supplementation can prevent pre-eclampsia in women with low dietary calcium. However, the optimal dose and timing of calcium supplementation are not known. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to determine the effects of various calcium supplementation regimens in preventing pre-eclampsia and its complications and rank these by effectiveness. We also aim to evaluate the cost-effectiveness of calcium supplementation to prevent pre-eclampsia.

METHODS AND ANALYSIS: We will identify randomised trials on calcium supplementation before and during pregnancy by searching major electronic databases including Embase, CINAHL, MEDLINE, CENTRAL, PubMed, Scopus, AMED, LILACS, POPLINE, AIM, IMSEAR, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform, without language restrictions, from inception to February 2022. Primary researchers of the identified trials will be invited to join the International Calcium in Pregnancy Collaborative Network and share their IPD. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. We will perform a series of one-stage and two-stage IPD random-effect meta-analyses to obtain the summary intervention effects on pre-eclampsia with 95% CIs and summary treatment-covariate interactions (maternal risk status, dietary intake, timing of intervention, daily dose of calcium prescribed and total intake of calcium). Heterogeneity will be summarised using tau², I² and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Minor study effects (potential publication bias) will be investigated using funnel plots. A decision analytical model for use in low-income and middle-income countries will assess the cost-effectiveness of calcium supplementation to prevent pre-eclampsia.

ETHICS AND DISSEMINATION: No ethical approvals are required. We will store the data in a secure repository in an anonymised format. The results will be published in peer-reviewed journals.

PROSPERO REGISTRATION NUMBER: CRD42021231276.

PMID:37169508 | DOI:10.1136/bmjopen-2022-065538

BMJ Open. 2023 May 11;13(5):e068969. doi: 10.1136/bmjopen-2022-068969.

ABSTRACT

OBJECTIVE: The purpose of this systematic review and meta-analysis was to investigate whether glucocorticoid might be beneficial after hepatectomy.

DESIGN: Systematic review and meta-analysis.

DATA SOURCES: PubMed, Embase, Cochrane Library and Web of Science.

ELIGIBILITY CRITERIA: We included studies assessing the efficacy of perioperative glucocorticoid administration in patients undergoing liver surgery.

DATA EXTRACTION AND SYNTHESIS: Four data bases were retrieved for all randomised controlled trials. We considered postoperative complications, hospital stay and postoperative chemistry evaluations as outcomes. Pooled effects of dichotomic variables were expressed as relative risk (RR) with a 95% CI. The mean difference was used for continuous variables and an inverse variance statistical method was adopted.

RESULTS: Fourteen studies with 1205 patients were included. Lower risk of overall complications was associated with glucocorticoid (RR, 0.77; 95% CI 0.64 to 0.92), while no difference was found in hospital stay (RR, 0.02; 95% CI -0.47 to 0.51). There were also improvements in postoperative chemistry evaluations including interleukin 6 on day 1 and 3, C reactive protein on day 1, 2 and 3, international normalised ratio on day 2, total bilirubin on day 1, 2, 3 and 5, albumin on day 1.

CONCLUSION: Current evidence indicated that perioperative glucocorticoid administration for patients undergoing hepatectomy reduced the risk of overall complications with inhibited postoperative inflammatory response and improved postoperative liver function.

PROSPERO REGISTRATION NUMBER: CRD42022307533.

PMID:37169506 | DOI:10.1136/bmjopen-2022-068969

BMJ Open. 2023 May 11;13(5):e070837. doi: 10.1136/bmjopen-2022-070837.

ABSTRACT

INTRODUCTION: Despite the availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), 21 793 people were newly diagnosed with HIV in Europe in 2019. The Concerted action on seroconversion to AIDS and death in Europe study aims to understand current drivers of the HIV epidemic; factors associated with access to, and uptake of prevention methods and ART initiation; and the experiences, needs and outcomes of people with recently acquired HIV.

METHODS AND ANALYSIS: This longitudinal observational study is recruiting participants aged ≥16 years with documented laboratory evidence of HIV seroconversion from clinics in Canada and six European countries. We will analyse data from medical records, self-administered questionnaires, semistructured interviews and participatory photography. We will assess temporal trends in transmitted drug resistance and viral subtype and examine outcomes following early ART initiation. We will investigate patient-reported outcomes, well-being, and experiences of, knowledge of, and attitudes to HIV preventions, including PrEP. We will analyse qualitative data thematically and triangulate quantitative and qualitative findings. As patient public involvement is central to this work, we have convened a community advisory board (CAB) comprising people living with HIV.

ETHICS AND DISSEMINATION: All respective research ethics committees have approval for data to contribute to international collaborations. Written informed consent is required to take part. A dissemination strategy will be developed in collaboration with CAB and the scientific committee. It will include peer-reviewed publications, conference presentations and accessible summaries of findings on the study’s website, social media and via community organisations.

PMID:37169505 | DOI:10.1136/bmjopen-2022-070837

BMJ Open. 2023 May 11;13(5):e068600. doi: 10.1136/bmjopen-2022-068600.

ABSTRACT

INTRODUCTION: The chronic inflammatory state in rheumatoid arthritis (RA) augments the risk of cardiovascular disease (CVD), with pro-inflammatory cytokines tumour necrosis factor (TNF) and interleukin 6 (IL-6) playing a vital role. Consequently, biological disease-modifying antirheumatic drugs (bDMARDs) may attenuate that risk. IL-6 is also a myokine, secreted from exercising skeletal muscles, where IL-6 exhibits anti-inflammatory effects that may ameliorate the risk of CVD. In healthy humans treated with IL-6 signalling inhibitors (IL-6i), exercise induced loss of visceral fat mass and cardiac adaptations were abolished. We hypothesise that IL-6 signalling inhibition will impair the cardiac and metabolic adaptions to exercise training compared with TNF inhibition in RA patients.

METHODS AND ANALYSIS: 80 RA patients treated with IL-6i (n=40) or TNF inhibitors (n=40) are included in a 12-week randomised investigator-blinded 4×4 min high-intensity interval training (HIIT) study. Patients are stratified for medical treatment and sex and allocated 1:1 to an exercise or a no exercise control group (four groups). The supervised exercise intervention comprises 3 weekly HIIT sessions on an ergometer bicycle. The primary outcome is the change in left ventricular mass (LVM), and key secondary outcome is change in visceral fat mass. Both outcomes are measured by MRI. Primary statistical analysis will evaluate LVM at follow-up in a regression model. Intention-to-treat and per protocol analyses will be conducted. The latter necessitates a minimum attendance rate of 80%, adherence to bDMARDs treatment of ≥80% and minimum 8 min (50%) of maximal heart rate above 85% per session.

ETHICS AND DISSEMINATION: The study has been approved by the Capital Region Ethics Committee (H-21010559 amendments 86424, 87463 and 88044) and the Danish Medicines Agency (2021-b005287-21). The trial will follow ICH-GCP guidelines. Regardless of outcome, results will be published in relevant peer-reviewed journals.

TRIAL REGISTRATION NUMBERS: Eudra-CT: 2021-b005287-21 and NCT05215509.

PMID:37169504 | DOI:10.1136/bmjopen-2022-068600

Open Heart. 2023 May;10(1):e002275. doi: 10.1136/openhrt-2023-002275.

ABSTRACT

OBJECTIVE: There is a substantial incidence of stroke in patients with atrial fibrillation (AF) not receiving anticoagulation. The reasons for not receiving anticoagulation are generally attributed to clinician’s choice, however, a proportion of AF patients refuse anticoagulation. The aim of our study was to investigate factors associated with patient refusal of anticoagulation and the clinical outcomes in these patients.

METHODS: Our study population comprised patients in the Global Anticoagulant Registry in the FIELD (GARFIELD-AF) registry with CHA₂DS₂-VASc≥2. A logistic regression was developed with predictors of patient anticoagulation refusal identified by least absolute shrinkage and selection operator methodology. Patient demographics, medical and cardiovascular history, lifestyle factors, vital signs (body mass index, pulse, systolic and diastolic blood pressure), type of AF and care setting at diagnosis were considered as potential predictors. We also investigated 2-year outcomes of non-haemorrhagic stroke/systemic embolism (SE), major bleeding and all-cause mortality in patients who refused versus patients who received and patients who did not receive anticoagulation for other reasons.

RESULTS: Out of 43 154 AF patients, who were at high risk of stroke, 13 283 (30.8%) did not receive anticoagulation at baseline. The reason for not receiving anticoagulation was unavailable for 38.7% (5146/13 283); of the patients with a known reason for not receiving anticoagulation, 12.5% (1014/8137) refused anticoagulation. Diagnosis in primary care/general practitioner, Asian ethnicity and presence of vascular disease were strongly associated with a higher risk of patient refusal of anticoagulation. Patient refusal of anticoagulation was associated with a higher risk of non-haemorrhagic stroke/SE (adjusted HR (aHR) 1.16 (95% CI 0.77 to 1.76)) but lower all-cause mortality (aHR 0.59 (95% CI 0.43 to 0.80)) compared with patients who received anticoagulation. The GARFIELD-AF mortality score corroborated this result.

CONCLUSION: The data suggest patient refusal of anticoagulation is a missed opportunity to prevent AF-related stroke. Further research is required to understand the patient profile and mortality outcome of patients who refuse anticoagulation.

PMID:37169491 | DOI:10.1136/openhrt-2023-002275

Open Heart. 2023 May;10(1):e002197. doi: 10.1136/openhrt-2022-002197.

ABSTRACT

OBJECTIVE: Postmarketing observational studies report that a substantial percentage of patients with atrial fibrillation (AF) receive a reduced non-vitamin K antagonist oral anticoagulant (NOAC) dose without a clear indication. Recently, increasing evidence has become available to explore the clinical consequences of such off-label reduced dosing (OLRD). This study aims to systematically review and meta-analyse observational studies that report clinical outcomes associated with OLRD of NOACs compared with on-label non-reduced dosing (OLNRD) of NOACs in patients with AF.

METHODS AND ANALYSIS: We performed a systematic literature review and meta-analysis of observational studies reporting clinical outcomes in AF patients with OLRD of an NOAC compared with AF patients with OLNRD of an NOAC. Using random effects meta-analyses, we estimated the risk of stroke/thromboembolism, bleeding and all-cause mortality.

RESULTS: We included 19 studies with a total of 170 394 NOAC users. In these studies, the percentage of OLRD among patients with an indication for an on-label non-reduced NOAC dose ranged between 9% and 53%. 7 of these 19 studies met the predefined criteria for meta-analysis (n=80 725 patients). The pooled HR associated with OLRD of NOACs was 1.04 (95% CI 0.83 to 1.29; 95% prediction interval (PI) 0.60 to 1.79) for stroke/thromboembolism, 1.10 (95% CI 0.95 to 1.29; 95% PI 0.81 to 1.50) for bleeding and 1.22 (95% CI 0.81 to 1.84; 95% PI 0.55 to 2.70) for all-cause mortality.

CONCLUSION: This meta-analysis shows no statistically significant increased risk of stroke/thromboembolism, nor a decreased bleeding risk, nor a difference in risk of all-cause mortality in patients with OLRD of NOACs. Future research may focus on differences between NOACs.

PMID:37169490 | DOI:10.1136/openhrt-2022-002197

Neurologia (Engl Ed). 2023 May;38(4):278-283. doi: 10.1016/j.nrleng.2021.10.006.

ABSTRACT

INTRODUCTION: Stroke is highly prevalent in Latin America and one of the leading causes of morbidity and mortality in the world. Educating children about stroke has been established as an effective method to detect symptoms early, reduce hospital visits, and raise awareness among adults.

OBJECTIVE: To analyze the effectiveness of a mobile application to improve knowledge and understanding of stroke among children.

METHOD: We conducted a focus group session including 12 children in order to analyze the behavior of 6 questions previously validated by expert neurologists. Subsequently, 105 primary school students between the ages of 7 and 12 completed a questionnaire on stroke symptoms and how to contact the emergency services before and after using an application on stroke symptoms. Qualitative analyses and the Student t test were used to verify the existence of differences between pre- and post-intervention test results.

RESULTS: After a single 40-min working session with the application, between 50% and 67% of the children were able to identify the signs of stroke, and 96.2% knew the national emergency services telephone number. Statistical analysis revealed statistically significant differences before and after the intervention with the digital application (t=19.54; p<0.001) and intragroup differences in the post-intervention test results (t=40.71; p<0.001).

CONCLUSION: Primary school children who used our digital application increased their knowledge, understanding, and learning of stroke symptoms.

PMID:37169470 | DOI:10.1016/j.nrleng.2021.10.006

Can J Surg. 2023 May 11;66(3):E269-E273. doi: 10.1503/cjs.012322. Print 2023 May-Jun.

ABSTRACT

BACKGROUND: Patients with knee osteoarthritis (OA) in northwestern Ontario are referred by their primary care provider (PCP) to a centralized assessment clinic for evaluation by an advanced practice physiotherapist (APP) to determine if they will require surgical management. However, many patients are found to not require surgical management, resulting in delays for patients who do. A decision-support tool was developed to address this issue and to guide treatment options by determining the need for surgical or nonsurgical approaches.

METHODS: We used a proof-of-concept method to assess the use of the decision-support tool in northwestern Ontario. Data from 100 consecutive patients assessed for knee OA management were collected from the Thunder Bay centralized assessment clinic. Two levels of agreement analyses (calculated using Cohen κ statistic) were performed, between the APP assessment decision (surgical or non-surgical) and the decision-support tool recommendation, and between the surgeon’s decision (surgical or non-surgical) and the decision-support tool recommendation.

RESULTS: We found a near-perfect agreement (κ = 0.870, n = 65) between the APP decision and the decision-support tool recommendation, when controlled for patient preference. There was a substantial level of agreement (κ = 0.618, n = 72) between the decision-support tool recommendation and the surgeon’s decision.

CONCLUSION: The decision-support tool recommendation showed considerable agreement with the decisions of the APP and surgeon indicating that it could be a valuable tool to guide PCPs caring for patients with knee OA. The applicability of a decision-support tool in northwestern Ontario displayed promising results, but further research is needed to examine the feasibility in a primary care setting.

PMID:37169385 | DOI:10.1503/cjs.012322

Braz J Psychiatry. 2023 May 11;45(2):127-131. doi: 10.47626/1516-4446-2022-2811.

ABSTRACT

OBJECTIVE: Childhood maltreatment (CM) is a significant risk factor for the development and severity of bipolar disorder (BD) with increased risk of suicide attempts (SA). This study evaluated whether a machine learning algorithm could be trained to predict if a patient with BD has a history of CM or previous SA based on brain metabolism measured by positron emission tomography.

METHODS: Thirty-six euthymic patients diagnosed with BD type I, with and without a history of CM were assessed using the Childhood Trauma Questionnaire. Suicide attempts were assessed through the Mini International Neuropsychiatric Interview (MINI-Plus) and a semi-structured interview. Resting-state positron emission tomography with 18F-fluorodeoxyglucose was conducted, electing only grey matter voxels through the Statistical Parametric Mapping toolbox. Imaging analysis was performed using a supervised machine learning approach following Gaussian Process Classification.

RESULTS: Patients were divided into 18 participants with a history of CM and 18 participants without it, along with 18 individuals with previous SA and 18 individuals without such history. The predictions for CM and SA were not significant (accuracy = 41.67%; p = 0.879).

CONCLUSION: Further investigation is needed to improve the accuracy of machine learning, as its predictive qualities could potentially be highly useful in determining histories and possible outcomes of high-risk psychiatric patients.

PMID:37169366 | DOI:10.47626/1516-4446-2022-2811