Persistent cough with sputum production is an important clinical trait in chronic obstructive pulmonary disease (COPD). We defined “frequent productive cough” based on 2 questions from the St ...George's Respiratory Questionnaire (SGRQ) and sought to determine its occurrence and associated outcomes in patients with physician-assigned asthma and/or COPD from the NOVELTY study.
Frequent productive cough was defined as cough and sputum production most or several days/week for the past 3 months (scoring ≥3 for both SGRQ questions). Relationships with baseline disease characteristics and exacerbations over 12 months’ follow-up were examined using logistic regression.
Baseline SGRQ data were available for 7125 patients, of whom 31.3% had frequent productive cough. It was more common in asthma+COPD (38.8%) and COPD (38.1%) than asthma (25.0%), increasing with physician-assessed severity, and in current versus former and never smokers. Patient-reported symptomatic worsening was more common in patients with versus without frequent productive cough. Reduced post-bronchodilator FEV1 (odds ratio OR per 10% decrement 1.14 95% confidence interval 1.11–1.16) and history of pollutant exposure at home/work (OR 1.50 1.33–1.69) were associated with frequent productive cough in all diagnoses. Patients with baseline frequent productive cough were more likely to have ≥1 exacerbation over the subsequent 12 months (OR 1.71 1.52–1.93), including exacerbations requiring hospital admission and those treated with oral corticosteroids.
Frequent productive cough represents an important indicator of adverse clinical outcomes across asthma and/or COPD. Research into the underlying pathologic mechanisms is required to support targeted therapy development.
NCT02760329.
•Frequent productive cough was present across physician-assigned asthma and/or COPD.•Prevalence of this clinical trait increased with higher physician-assessed severity.•The trait was associated with reduced FEV1 and pollutant exposure in all diagnoses.•Frequent productive cough was associated with higher risk of greater disease burden.
Abstract Background Brain bioenergetic anomalies and redox dysregulation have been implicated in the pathophysiology of psychotic disorders. The present study examined brain energy-related ...metabolites and the balance between nicotinamide adenine dinucleotide metabolites (oxidized NAD + and reduced NADH) using31 P-magnetic resonance spectroscopy (31 P-MRS) in unaffected siblings, compared to first episode psychosis (FEP) patients and healthy controls. Methods 21 unaffected siblings, 32 FEP patients (including schizophrenia spectrum and affective psychoses), and 21 controls underwent31 P-MRS in the frontal lobe (6 × 6 × 4 cm3 ) on a 4T MR scanner, using custom-designed dual-tuned surface coil with outer volume suppression. Brain parenchymal pH and steady-state metabolite ratios of high energy phosphate compounds were measured. NAD + and NADH levels were determined using a31 P-MRS fitting algorithm. 13 unaffected sibling-patient pairs were related; other patients and siblings were unrelated. ANCOVA analyses were used to examine31 P-MRS measures, with age and gender as covariates. Results The phosphocreatine/adenosine triphosphate ratio was significantly reduced in both unaffected siblings and FEP patients, compared to controls. NAD +/NADH ratio was significantly reduced in patients compared to siblings and controls, with siblings showing a reduction in NAD +/NADH compared to controls that was not statistically significant. Compared to patients and controls, siblings showed significantly reduced levels of NAD +. Siblings did not differ from patients or controls on brain pH. Discussion Our results indicate that unaffected siblings show some, but not all the same abnormalities in brain energy metabolites and redox state as FEP patients. Thus,31 P-MRS studies may identify factors related both to risk and expression of psychosis.
After 30 years of clinical research into drug-induced movement disorder (DIMD), we are still facing unresolved issues regarding the interrelations between psychiatric symptoms and DIMD. Recently, I ...proposed a new classification of DIMD that includes abnormal movements previously labelled extrapyramidal symptoms. DIMD caused by psychotropic drugs is still confused with psychiatric symptoms treated by the same drugs. The results from 2 international multicentre trials, the InterSePT and the Ris-Consta Studies, conducted in the era of both typical and atypical antipsychotic agents, which included over 3,000 patients with schizophrenia and schizoaffective disorder worldwide, still showed a high, but decreasing, incidence of pretreatment DIMD, which varied from 57.5% (1998-1999) to 47.4% (1999-2000), and a decreasing incidence of tardive dyskinesia, which varied from 12% (1998-1999) to 10.2% (1999-2000), reflecting the greater use of atypical antipsychotic drugs. Furthermore, in both studies, psychiatric symptoms as measured by the Positive and Negative Symptom Scale (PANSS) were significantly correlated with DIMD and DIMD subtypes, thus suggesting the need for additional measurement instruments in schizophrenia and related psychoses.
Patients with mild asthma represent a substantial proportion of the population with asthma, yet there are limited data on their true burden of disease. We aimed to describe the clinical and ...healthcare resource utilisation (HCRU) burden of physician-assessed mild asthma.
Patients with mild asthma were included from the NOVEL observational longiTudinal studY (NOVELTY; NCT02760329), a global, 3-year, real-world prospective study of patients with asthma and/or chronic obstructive pulmonary disease from community practice (specialised and primary care). Diagnosis and severity were based on physician discretion. Clinical burden included physician-reported exacerbations and patient-reported measures. HCRU included inpatient and outpatient visits.
Overall, 2004 patients with mild asthma were included; 22.8% experienced ≥1 exacerbation in the previous 12 months, of whom 72.3% experienced ≥1 severe exacerbation. Of 625 exacerbations reported, 48.0% lasted >1 week, 27.7% were preceded by symptomatic worsening lasting >3 days, and 50.1% required oral corticosteroid treatment. Health status was moderately impacted (St George's Respiratory Questionnaire score: 23.5 standard deviation ± 17.9). At baseline, 29.7% of patients had asthma symptoms that were not well controlled or very poorly controlled (Asthma Control Test score <20), increasing to 55.6% for those with ≥2 exacerbations in the previous year. In terms of HCRU, at least one unscheduled ambulatory visit for exacerbations was required by 9.5% of patients, including 9.2% requiring ≥1 emergency department visit and 1.1% requiring ≥1 hospital admission.
In this global sample representing community practice, a significant proportion of patients with physician-assessed mild asthma had considerable clinical burden and HCRU.
•Patients with physician-assessed mild asthma still have significant disease burden.•Over 20% of patients experienced any exacerbation in the previous 12 months.•Almost 10% of patients had one or more hospital or clinic visit for an exacerbation.•Nearly 30% of patients had not well or very poorly controlled asthma symptoms.•Many patients were prescribed medication consistent with more severe disease.
No short patient-reported outcome (PRO) instruments assess overall health status across different obstructive lung diseases. Thus, the wording of the introduction to the Chronic Obstructive Pulmonary ...Disease (COPD) Assessment Test (CAT) was modified to permit use in asthma and/or COPD. This tool is called the Chronic Airways Assessment Test (CAAT).
The psychometric properties of the CAAT were evaluated using baseline data from the NOVELTY study (NCT02760329) in patients with physician-assigned asthma, asthma + COPD or COPD. Analyses included exploratory/confirmatory factor analyses, differential item functioning and analysis of construct validity. Responses to the CAAT and CAT were compared in patients with asthma + COPD and those with COPD.
CAAT items were internally consistent (Cronbach's alpha: > 0.7) within each diagnostic group (n = 510). Models for structural and measurement invariance were strong. Tests of differential item functioning showed small differences between asthma and COPD in individual items, but these were not consistent in direction and had minimal overall impact on the total score. The CAAT and CAT were highly consistent when assessed in all NOVELTY patients who completed both (N = 277, Pearson's correlation coefficient: 0.90). Like the CAT itself, CAAT scores correlated moderately (0.4-0.7) to strongly (> 0.7) with other PRO measures and weakly (< 0.4) with spirometry measures.
CAAT scores appear to reflect the same health impairment across asthma and COPD, making the CAAT an appropriate PRO instrument for patients with asthma and/or COPD. Its brevity makes it suitable for use in clinical studies and routine clinical practice.
NCT02760329.
In two double-blind trials conducted in North America, 513 patients with chronic schizophrenia received risperidone, haloperidol, or placebo. In the present study, combined data from the two trials ...were analyzed.
Patients were randomly assigned to receive placebo, fixed doses of risperidone (2, 6, 10, and 16 mg/day) or 20 mg/day of haloperidol for 8 weeks. Factor analysis of scores on the Positive and Negative Syndrome Scale (PANSS) produced five dimensions (negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression), similar to the five dimensions of previous factor-analytic studies of PANSS data.
Mean changes (symptom reductions) in PANSS factor scores from baseline to treatment Weeks 6 and 8 were significantly greater in patients receiving 6-16 mg/day of risperidone than in patients receiving placebo or haloperidol. The advantages of risperidone were greatest for negative symptoms, uncontrolled hostility/excitement, and anxiety/depression. Even at the lowest dose, 2 mg/day, risperidone was significantly (p < or = .05) superior to haloperidol in reducing negative symptoms. The differences in outcomes between risperidone and haloperidol on PANSS scores were not related to extrapyramidal symptoms.
Risperidone produced significantly (p < or = .05) greater improvements than haloperidol on all five dimensions. The large between-group differences on negative symptoms, hostility/excitement, and anxiety/depression suggest that risperidone and other serotonin/dopamine antagonists have qualitatively different effects from those of conventional antipsychotic agents.
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