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RMD Open May 2024To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
PERFECTRA: a pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs.
OBJECTIVE
To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a real-life treat-to-target (T2T) setting.
METHODS
Patients with biological and targeted synthetic DMARD (b/tsDMARD) naïve RA with disease duration ≤5 years without contraindications to b/tsDMARD were randomised to either TNFi or baricitinib when csDMARD failed to achieve disease control in a T2T setting. Changes in clinical and patient-reported outcome measures (PROMs) were assessed at 12-week intervals for 48 weeks. The primary endpoint was non-inferiority, with testing for superiority if non-inferiority is demonstrated, of baricitinib strategy in the number of patients achieving American College of Rheumatology 50 (ACR50) response at 12 weeks. Secondary endpoints included 28-joint count Disease Activity Score with C reactive protein (DAS28-CRP) <2.6, changes in PROMs and radiographic progression.
RESULTS
A total of 199 patients (TNFi, n=102; baricitinib, n=97) were studied. Both study groups were similar. Baricitinib was both non-inferior and superior in achieving ACR50 response at week 12 (42% vs 20%). Moreover, 75% of baricitinib patients achieved DAS28-CRP <2.6 at week 12 compared with 46% of TNFi patients. On secondary outcomes throughout the duration of the study, the baricitinib strategy demonstrated comparable or better outcomes than TNFi strategy. Although not powered for safety, no unexpected safety signals were seen in this relatively small group of patients.
CONCLUSION
Up to present, in a T2T setting, patients with RA failing csDMARDs have two main strategies to consider, Janus Kinases inhibitor versus bDMARDs (in clinical practice, predominantly TNFi). The PERFECTRA study suggested that starting with baricitinib was superior over TNFi in achieving response at 12 weeks and resulted in improved outcomes across all studied clinical measures and PROMs throughout the study duration in these patients.
Topics: Humans; Purines; Sulfonamides; Arthritis, Rheumatoid; Pyrazoles; Azetidines; Male; Female; Middle Aged; Antirheumatic Agents; Aged; Treatment Outcome; Tumor Necrosis Factor Inhibitors; Treatment Failure; Adult; Patient Reported Outcome Measures; Severity of Illness Index
PubMed: 38816210
DOI: 10.1136/rmdopen-2024-004291 -
BMJ Open May 2024This study aimed to describe the clinical characteristics of adults with suspected acute community-acquired pneumonia (CAP) on hospitalisation, evaluate their prediction...
Community-acquired pneumonia: use of clinical characteristics of acutely admitted patients for the development of a diagnostic model - a cross-sectional multicentre study.
OBJECTIVES
This study aimed to describe the clinical characteristics of adults with suspected acute community-acquired pneumonia (CAP) on hospitalisation, evaluate their prediction performance for CAP and compare the performance of the model to the initial assessment of the physician.
DESIGN
Cross-sectional, multicentre study.
SETTING
The data originated from the INfectious DisEases in Emergency Departments study and were collected prospectively from patient interviews and medical records. The study included four Danish medical emergency departments (EDs) and was conducted between 1 March 2021 and 28 February 2022.
PARTICIPANTS
A total of 954 patients admitted with suspected infection were included in the study.
PRIMARY AND SECONDARY OUTCOME
The primary outcome was CAP diagnosis assessed by an expert panel.
RESULTS
According to expert evaluation, CAP had a 28% prevalence. 13 diagnostic predictors were identified using least absolute shrinkage and selection operator regression to build the prediction model: dyspnoea, expectoration, cough, common cold, malaise, chest pain, respiratory rate (>20 breaths/min), oxygen saturation (<96%), abnormal chest auscultation, leucocytes (<3.5×10/L or >8.8×10/L) and neutrophils (>7.5×10/L). C reactive protein (<20 mg/L) and having no previous event of CAP contributed negatively to the final model. The predictors yielded good prediction performance for CAP with an area under the receiver-operator characteristic curve (AUC) of 0.85 (CI 0.77 to 0.92). However, the initial diagnosis made by the ED physician performed better, with an AUC of 0.86 (CI 84% to 89%).
CONCLUSION
Typical respiratory symptoms combined with abnormal vital signs and elevated infection biomarkers were predictors for CAP on admission to an ED. The clinical value of the prediction model is questionable in our setting as it does not outperform the clinician's assessment. Further studies that add novel diagnostic tools and use imaging or serological markers are needed to improve a model that would help diagnose CAP in an ED setting more accurately.
TRIAL REGISTRATION NUMBER
NCT04681963.
Topics: Humans; Community-Acquired Infections; Cross-Sectional Studies; Male; Female; Middle Aged; Aged; Pneumonia; Emergency Service, Hospital; Hospitalization; Denmark; Adult; ROC Curve; Prospective Studies; C-Reactive Protein
PubMed: 38816044
DOI: 10.1136/bmjopen-2023-079123 -
JMIR Mental Health May 2024Schizophrenia is a complex mental disorder characterized by significant cognitive and neurobiological alterations. Impairments in cognitive function and eye movement...
BACKGROUND
Schizophrenia is a complex mental disorder characterized by significant cognitive and neurobiological alterations. Impairments in cognitive function and eye movement have been known to be promising biomarkers for schizophrenia. However, cognitive assessment methods require specialized expertise. To date, data on simplified measurement tools for assessing both cognitive function and eye movement in patients with schizophrenia are lacking.
OBJECTIVE
This study aims to assess the efficacy of a novel tablet-based platform combining cognitive and eye movement measures for classifying schizophrenia.
METHODS
Forty-four patients with schizophrenia, 67 healthy controls, and 41 patients with other psychiatric diagnoses participated in this study from 10 sites across Japan. A free-viewing eye movement task and 2 cognitive assessment tools (Codebreaker task from the THINC-integrated tool and the CognitiveFunctionTest app) were used for conducting assessments in a 12.9-inch iPad Pro. We performed comparative group and logistic regression analyses for evaluating the diagnostic efficacy of the 3 measures of interest.
RESULTS
Cognitive and eye movement measures differed significantly between patients with schizophrenia and healthy controls (all 3 measures; P<.001). The Codebreaker task showed the highest classification effectiveness in distinguishing schizophrenia with an area under the receiver operating characteristic curve of 0.90. Combining cognitive and eye movement measures further improved accuracy with a maximum area under the receiver operating characteristic curve of 0.94. Cognitive measures were more effective in differentiating patients with schizophrenia from healthy controls, whereas eye movement measures better differentiated schizophrenia from other psychiatric conditions.
CONCLUSIONS
This multisite study demonstrates the feasibility and effectiveness of a tablet-based app for assessing cognitive functioning and eye movements in patients with schizophrenia. Our results suggest the potential of tablet-based assessments of cognitive function and eye movement as simple and accessible evaluation tools, which may be useful for future clinical implementation.
Topics: Humans; Schizophrenia; Male; Female; Adult; Computers, Handheld; Japan; Middle Aged; Eye Movements; Neuropsychological Tests; Cognitive Dysfunction; Eye Movement Measurements; Cognition
PubMed: 38815257
DOI: 10.2196/56668 -
Journal of Primary Care & Community... 2024Anxiety and depression often exacerbate multimorbidity conditions, leading to increased disability rates among affected individuals.
BACKGROUND
Anxiety and depression often exacerbate multimorbidity conditions, leading to increased disability rates among affected individuals.
OBJECTIVE
The study aimed to assess the mental health status of individuals with multimorbidity belonging to the marginalized population of Karachi, Pakistan. Specifically, the prevalence of anxiety and depression was investigated.
METHODS
A multicenter cross-sectional study was conducted between July 2022 and June 2023 in 10 primary healthcare clinics located in 4 peri-urban areas of Karachi. A total of 9331 participants were included in the study. The Patient Health Questionnaire 4 (PHQ-4), Generalized Anxiety Disorder 7 (GAD-7), and Patient Health Questionnaire 9 (PHQ-9) were used to assess symptoms of anxiety and depression. The data collected were analyzed using the statistical analysis system (SAS) version 9.4.
RESULTS
Among the study participants, 2894 (31%) were men and 5534 (59.3%) were women. The prevalence of moderate to severe anxiety was 31% among men and 59.3% among women. The age group between 41 and 60 years exhibited the highest rates of moderate to severe anxiety, 19.3% as evaluated by GAD-7 and 34.6% by PHQ-9. The Pathan ethnic group had the highest prevalence of anxiety (11%) and depression (28.3%) in the neighborhoods. Unemployed participants showed moderate to severe anxiety in 21.3% of the cases and moderate to severe depression in 25.5% of the cases.
CONCLUSION
The study revealed a significant cooccurrence of anxiety and depression among individuals with multimorbidity in the marginalized population of Karachi, Pakistan. Furthermore, the presence of anxiety symptoms in multimorbidity patients with depression indicates a more unfavorable health state. It is essential to explore the implementation of screening measures and therapeutic interventions for comorbid anxiety and depression in this population to improve clinical outcomes.
Topics: Humans; Pakistan; Male; Female; Adult; Cross-Sectional Studies; Middle Aged; Prevalence; Primary Health Care; Multimorbidity; Poverty Areas; Young Adult; Depression; Anxiety; Adolescent; Aged; Mental Disorders
PubMed: 38813988
DOI: 10.1177/21501319241258658 -
Critical Care Explorations Jun 2024To develop and validate a prediction model for 1-year mortality in patients with a hematologic malignancy acutely admitted to the ICU.
OBJECTIVES
To develop and validate a prediction model for 1-year mortality in patients with a hematologic malignancy acutely admitted to the ICU.
DESIGN
A retrospective cohort study.
SETTING
Five university hospitals in the Netherlands between 2002 and 2015.
PATIENTS
A total of 1097 consecutive patients with a hematologic malignancy were acutely admitted to the ICU for at least 24 h.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
We created a 13-variable model from 22 potential predictors. Key predictors included active disease, age, previous hematopoietic stem cell transplantation, mechanical ventilation, lowest platelet count, acute kidney injury, maximum heart rate, and type of malignancy. A bootstrap procedure reduced overfitting and improved the model's generalizability. This involved estimating the optimism in the initial model and shrinking the regression coefficients accordingly in the final model. We assessed performance using internal-external cross-validation by center and compared it with the Acute Physiology and Chronic Health Evaluation II model. Additionally, we evaluated clinical usefulness through decision curve analysis. The overall 1-year mortality rate observed in the study was 62% (95% CI, 59-65). Our 13-variable prediction model demonstrated acceptable calibration and discrimination at internal-external validation across centers (-statistic 0.70; 95% CI, 0.63-0.77), outperforming the Acute Physiology and Chronic Health Evaluation II model (-statistic 0.61; 95% CI, 0.57-0.65). Decision curve analysis indicated overall net benefit within a clinically relevant threshold probability range of 60-100% predicted 1-year mortality.
CONCLUSIONS
Our newly developed 13-variable prediction model predicts 1-year mortality in hematologic malignancy patients admitted to the ICU more accurately than the Acute Physiology and Chronic Health Evaluation II model. This model may aid in shared decision-making regarding the continuation of ICU care and end-of-life considerations.
Topics: Humans; Hematologic Neoplasms; Intensive Care Units; Male; Retrospective Studies; Middle Aged; Female; Aged; Netherlands; Adult; APACHE; Cohort Studies
PubMed: 38813435
DOI: 10.1097/CCE.0000000000001093 -
Turkish Journal of Medical Sciences 2023Adipose tissue produces several inflammatory mediators. Thus, obesity affects the disease course and the responses to the antirheumatic agents in inflammatory diseases....
BACKGROUND/AIM
Adipose tissue produces several inflammatory mediators. Thus, obesity affects the disease course and the responses to the antirheumatic agents in inflammatory diseases. The aim of the study was to determine whether the body mass index (BMI) is involved in the response to rituximab in rheumatoid arthritis (RA).
MATERIALS AND METHODS
This multicenter retrospective study included 206 RA patients who received rituximab from the Turkish Biologic (TURKBIO) registry between 2011 and the end of May 2017. Demographic and clinical data including age, sex, disease type, disease duration, and previous or current treatment with disease-modifying antirheumatic drugs (DMARDs) and biological drug durations are stored in the database. Patients with a BMI ≥30 kg/m were classified as obese, and patients with a BMI <30 kg/m were classified as nonobese. Kaplan-Meier survival analysis was performed to estimate the drug survival. The subgroups were compared using the log-rank test.
RESULTS
The mean BMI of 206 patients included in the study was 27.05 (17.2-43.4) kg/m. There were 59 (28.6%) patients in the obese group and 147 (71.4%) patients in the nonobese group. The mean age, female percentage, and baseline disease activity score 28 (DAS28) were higher in the obese group than in the nonobese group. However, the ΔDAS28 at both 6 and 12 months were not significantly different between the groups (p = 0.785 and p = 0.512, respectively). Patient pain Visual Analogue Scale (VAS), patient fatigue VAS, and patient global VAS scores were also significantly higher at baseline in the obese group (p = 0.003, p = 0.006, and p = 0.006, respectively). However, no significant difference was found in terms of changes in patient pain VAS, patient fatigue VAS, patient global VAS and physician global VAS scores at 6 and 12 months compared to those at baseline. Rituximab treatment was ongoing for 71.2% of the obese and 63.3% of the nonobese patients (p = 0.279). The median drug survival duration was 77 months in the obese group and 62 months in the nonobese group (p = 0.053). The estimated drug survival rates for rituximab were not statistically significantly different in the obese and nonobese groups. Rituximab-related side effects were also similar between the groups.
CONCLUSION
In obese and nonobese patients with RA, rituximab treatment exhibits similar side effects and similar long-term efficacy. These results suggest that obesity does not alter drug survival for rituximab and response rates, in RA and rituximab may be a favorable treatment agent in patients with RA and obesity.
Topics: Humans; Arthritis, Rheumatoid; Female; Rituximab; Male; Middle Aged; Body Mass Index; Antirheumatic Agents; Registries; Retrospective Studies; Obesity; Adult; Treatment Outcome; Aged; Turkey
PubMed: 38813042
DOI: 10.55730/1300-0144.5698 -
Turkish Journal of Medical Sciences 2023To present the incidence of recurrent lumbar disc herniation (RLDH) and to identify radiological and patient-related risk factors that lead to recurrence after lumbar...
BACKGROUND/AIM
To present the incidence of recurrent lumbar disc herniation (RLDH) and to identify radiological and patient-related risk factors that lead to recurrence after lumbar disc herniation (LDH) treatment with microdiscectomy.
MATERIALS AND METHODS
Between January 2013 and December 2021, 1214 patients who had undergone microdiscectomy for LDH were included in this retrospective study. Patients were divided into two groups, the recurrent group and the non-recurrent group, and their demographic, clinical and radiologic characteristics were recorded. The association between the variables and RLDH was assessed by univariate and multivariable logistic regression analyses.
RESULTS
Mean ages were similar in the recurrent (51.48 ± 13.63) and non-recurrent(50.38 ± 14.53) groups (p=0.232). Males represented 59.6% of the recurrent group and 49.8% of the non-recurrent group (p=0.002). Multivariable logistic regression revealed that being a male (p=0.009), diabetes mellitus (p=0.038), smoking (p<0.001), grade 4&5 disc degeneration (p<0.001), and having protruded (p=0.002), extruded LDH (p<0.001), paracentral (p=0.008) and foraminal LDH (p=0.008) were independently associated with recurrence.
CONCLUSION
To reduce RLDH frequency and need for revision surgery, modifiable risk factors should be minimized before and after the initial surgery. Also, in patients with unmodifiable risk factors, patients should be clearly informed about the risk for recurrence and possible alternative treatment methods should be considered.
Topics: Humans; Intervertebral Disc Displacement; Male; Retrospective Studies; Diskectomy; Female; Risk Factors; Middle Aged; Lumbar Vertebrae; Recurrence; Adult; Microsurgery; Aged
PubMed: 38813020
DOI: 10.55730/1300-0144.5691 -
Turkish Journal of Medical Sciences 2024Characteristics of asthma in the elderly population is not well-known. The aim of the present study was to evaluate asthma in the elderly population, to compare disease...
BACKGROUND/AIM
Characteristics of asthma in the elderly population is not well-known. The aim of the present study was to evaluate asthma in the elderly population, to compare disease characteristics between patients diagnosed <60 (aged asthma) and ≥60 (elderly asthma) years of age.
MATERIALS AND METHODS
The study was a prospective, multicenter, cross-sectional type. A questionnaire was filled out to patients 60 years of age and over, that have been followed for asthma for at least 3 months. Asthma Control Test (ACT), eight-item Morisky Medication Adherence Scale (MMAS-8) was filled out, inhaler device technique was assessed.
RESULTS
A total of 399 patients were included from 17 tertiary care centers across the country. Mean age was 67.11 years and 331 (83%) were female. The age at asthma diagnosis was ≥60 in 146 (36.6%) patients. Patients diagnosed ≥60 years were older (p < 0.001), had higher education level (p < 0.001), more commonly had first-degree relative with asthma (p = 0.038), asthma related comorbidities (p = 0.009) and accompanying rhinitis/rhinosinusitis (p = 0.005), had better asthma control (p = 0.001), were using less controller medications (p = 0.014). Inhaler technique was correct in 37% of the patients with no difference in between the groups. Treatment compliance was better in elderly asthma patients (p < 0.001). In the multivariate logistic regression analysis, having well-controlled asthma (odds ratio = 1.61, CI = 1.04-2.51), and high medication adherence rate (odds ratio = 2.43, CI = 1.48-4.0) were associated with being in the elderly asthma group.
CONCLUSION
The characteristics of asthma are different among patients aged 60 years and over which seems to be related to onset age of asthma. In our cohort, the elderly asthma patients had higher education level, and treatment adherence and asthma control was better. Patients diagnosed ≥60 years of age did not have more severe disease.
Topics: Humans; Asthma; Female; Male; Aged; Middle Aged; Cross-Sectional Studies; Prospective Studies; Medication Adherence; Age Factors; Surveys and Questionnaires; Anti-Asthmatic Agents; Aged, 80 and over
PubMed: 38812643
DOI: 10.55730/1300-0144.5792 -
Turkish Journal of Medical Sciences 2024The objective of this study is to evaluate the clinical presentations and adverse outcomes of Coronavirus Disease 2019 (COVID-19) in patients with systemic sclerosis...
BACKGROUND/AIM
The objective of this study is to evaluate the clinical presentations and adverse outcomes of Coronavirus Disease 2019 (COVID-19) in patients with systemic sclerosis (SSc) and assess the impact of SSc features on the clinical course of COVID-19.
MATERIALS AND METHODS
In this multicenter, retrospective study, SSc patients with COVID-19 were included. Clinical features of SSc, along with detailed COVID-19 data, were extracted from medical records and patient interviews.
RESULTS
The study included 112 patients (mean age 51.4 ± 12.8 years; 90.2% female). SSc-associated interstitial lung disease (ILD) was evident in 57.1% of the patients. The findings revealed hospitalization in 25.5%, respiratory support in 16.3%, intensive care unit admission in 3.6%, and a mortality rate of 2.7% among SSc patients with COVID-19. Risk factors for respiratory failure, identified through univariate analysis, included ILD (OR: 7.49, 95% CI: 1.63-34.46), ≥1 comorbidity (OR: 4.55, 95% CI: 1.39-14.88), a higher physician global assessment score at the last outpatient visit (OR 2.73, 95% CI: 1.22-6.10), and the use of mycophenolate at the time of infection (OR: 5.16, 95 %CI: 1.79-14.99). Notably, ≥1 comorbidity emerged as the sole significant predictor of the need for respiratory support in COVID-19 (OR: 5.78, 95% CI: 1.14-29.23). In the early post-COVID-19 period, 17% of patients reported the progression of the Raynaud phenomenon, and 10.6% developed new digital ulcers. Furthermore, progression or new onset of dyspnea and cough were detected in 28.3% and 11.4% of patients, respectively.
CONCLUSION
This study suggests a potential association between adverse outcomes of COVID-19 and SSc-related ILD, severe disease activity, and the use of mycophenolate. Additionally, it highlights that having comorbidities is an independent risk factor for the need for respiratory support in COVID-19 cases.
Topics: Humans; COVID-19; Scleroderma, Systemic; Female; Male; Middle Aged; Retrospective Studies; Adult; SARS-CoV-2; Risk Factors; Lung Diseases, Interstitial; Hospitalization; Comorbidity; Aged; Respiratory Insufficiency; Disease Progression
PubMed: 38812619
DOI: 10.55730/1300-0144.5768 -
Alzheimer's Research & Therapy May 2024The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people. The LipiDiDiet trial highlighted benefits of medical food in prodromal Alzheimer's disease (AD). However, the feasibility and impact of multimodal interventions combining lifestyle with medical food in prodromal AD is unclear.
METHODS
MIND-AD was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60-85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale.
RESULTS
During September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle + medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle + medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed healthy diet improvements (β = 1.11, P = 0.038; β = 1.43, P = 0.007); the lifestyle + medical food group also showed vascular risk reduction (P = 0.043) and less cognitive-functional decline (P < 0.05, exploratory analysis). There were 5 serious adverse events (control group: 1; lifestyle intervention: 3; lifestyle + medical food: 1) unrelated to interventions.
CONCLUSIONS
The multidomain lifestyle intervention, alone or combined with medical food, had good feasibility and adherence in prodromal AD. Longer-term cognitive and other health benefits should be further investigated in a larger-scale trial.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03249688.
Topics: Humans; Alzheimer Disease; Female; Male; Aged; Middle Aged; Life Style; Aged, 80 and over; Prodromal Symptoms; Combined Modality Therapy; Exercise; Cognitive Dysfunction
PubMed: 38812047
DOI: 10.1186/s13195-024-01468-x