Health Status In COPD Research Articles

Predictors and risk factors of pulmonary embolism after total hip arthroplasty: an NSQIP study.

Pulmonary embolism (PE) is a well-known contributor to morbidity after total hip arthroplasty (THA). Considerable efforts have been invested in reducing PE occurrence through pharmacological and perioperative interventions. Nonetheless, the effectiveness of these strategies in reducing the incidence and overall mortality associated with pulmonary embolism events remains a matter of debate. Therefore, identifying risky patients has been gaining importance. We utilised data from the National Surgical Quality Improvement Program (NSQIP) participant usage file (PUF) database spanning the years 2016 to 2021. All preoperative parameters were analysed with chi-square afterwards, meaningful ones were run with logistic regression test. A study examined factors influencing pulmonary embolism (PE) prevalence in 235,393 total hip arthroplasty patients. Univariate analysis identified significant associations between PE and female gender, diabetes, smoking, dyspnea, CHF, COPD, hypertension (HT), bleeding disorders, disseminated cancer, steroid use, and functional health status. Multivariate analysis revealed male gender as protective, while COPD, hypertension, and disseminated cancer increased PE risk. Notably, smoking appeared protective. PE patients had higher return-to-operation rates (41.7% vs. 2.2%) but similar 30-day mortality (0.2% vs. 0.04%), though mortality's odds ratio was not significant. Our findings suggest that certain patient characteristics, such as COPD and metastatic malignancy, significantly influence the likelihood of PE development.

The Effect of Sleep Impairment, as Assessed by the CASIS Questionnaire, in Patients with Chronic Obstructive Pulmonary Disease on Disease Severity and Physical and Mental Health: A Cross-Sectional Study in Primary Care.

The aim of our study was to assess the prevalence of sleep impairment among primary care patients with COPD and explore its impact on disease severity and overall health status. This cross-sectional study included 251 participants > 40 years old from the prospective COCARE COPD study. Data on sociodemographic characteristics, medical history, disease-specific quality of life [COPD Assessment Test (CAT)], COPD severity [Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 categorization based on CAT score and exacerbations], fatigue [Fatigue Severity Scale (FSS)], psychological parameters [Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7)], and sleep complaints [COPD and Asthma Sleep Impact Scale (CASIS) and Epworth Sleepiness Scale (ESS)] were collected. Multiple logistic regression analysis was conducted to test for associations of sleep impairment with COPD and overall health status, adjusting for confounders. Sleep impairment, indicated by a CASIS score ≥ 30, increased the risk of worse COPD health status (CAT ≥ 10 OR: 9.7, 95% CI: 5-19, p < 0.001), COPD severity (GOLD B OR: 8.9, 95% CI: 4.5-17.6, p < 0.001 and GOLD E OR: 17.4, 95% CI: 5.1-59.4, p < 0.001), excessive daytime sleepiness (ESS > 10, OR: 3.2, 95% CI: 1.3-8.1, p = 0.012), depressive symptoms (PHQ-9 ≥ 10, OR: 6.4, 95% CI: 2.1-19.1, p = 0.001), anxiety symptoms (GAD-7 ≥ 10, OR: 3.9, 95% CI: 1.6-9.2, p = 0.002), and fatigue (FSS ≥ 36, OR: 5.3, 95% CI: 2.8-9.8, p < 0.001). In conclusion, our findings suggest that sleep impairment, based on the CASIS questionnaire, is associated with worse physical and mental health in patients with COPD. Therefore, through consistent evaluation of sleep and targeted management strategies, healthcare providers could improve the quality of life for these patients.

Sleep quality in COPD patients: correlation with disease severity and health status.

ABSTRACTObjective:To evaluate clinical predictors of poor sleep quality in COPD patients with and without obstructive sleep apnea (OSA). Methods:Consecutive stable patients with COPD were evaluated for OSA by means of overnight polysomnography; for sleep quality by means of the Pittsburgh Sleep Quality Index (PSQI); and for disease impact by means of the COPD Assessment Test. COPD severity was graded in accordance with the 2020 GOLD guidelines. Predictors of poor sleep quality were evaluated by multivariate logistic regression analysis. Results:We studied 51 patients with COPD alone and 51 patients with COPD and OSA. Both groups had similar age (66.2 ± 9.2 years vs. 69.6 ± 10.7, p = 0.09) and airflow limitation (p = 0.37). Poor sleep quality was present in 74.8% of the study participants, with no significant difference between COPD patients with and without OSA regarding PSQI scores (p = 0.73). Polysomnography showed increased stage 1 non-rapid eye movement sleep and arousal index, as well as reduced sleep efficiency and stage 3 non-rapid eye movement sleep, in the group of patients with COPD and OSA (p < 0.05). Independent predictors of poor sleep quality were GOLD grade C/D COPD (OR = 6.4; 95% CI, 1.79-23.3; p < 0.01), a COPD Assessment Test score ≥ 10 (OR = 12.3; 95% CI, 4.1-36.5; p < 0.01), and lowest SaO2 < 80% (p < 0.0001). Conclusions:Poor sleep quality is quite common in patients with COPD and is associated with severe COPD and poor health status, having a negative impact on overall quality of life. Despite changes in polysomnography, OSA appears to have no impact on subjective sleep quality in COPD patients.

Associations with Post-Consultation Health-Status in Primary Care Managed Acute Exacerbation of COPD.

BackgroundIt has been demonstrated that antibiotic prescribing for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) can be safely reduced in primary care when general practitioners have access to C-reactive protein (CRP) rapid testing.AimTo investigate the factors associated with post-consultation COPD health status in patients presenting with AECOPD in this setting.Design and SettingA cohort study of patients enrolled in a randomised controlled trial. Patients aged 40+ years with a clinical diagnosis of COPD who presented in primary care across England and Wales with an AECOPD were included.MethodsParticipants were contacted for follow-up at one- and two-weeks by phone and attended the practice four weeks after the index consultation. The outcome of interest was the Clinical COPD Questionnaire (CCQ) score. Multivariable multilevel linear regression models fitted to examine the factors associated with COPD health status in the four-weeks following consultation for an AECOPD.ResultsA total of 649 patients were included, with 1947 CCQ total scores analysed. Post-consultation CCQ total scores were significantly higher (worse) in participants with diabetes (adjusted mean difference [AMD]=0.26; 95% confidence interval (CI) 0.08–0.45), obese patients compared to those with normal body mass index (AMD = 0.25, 95% CI 0.07–0.43), and those who were prescribed oral antibiotics in the prior 12 months (AMD = 0.26; 95% CI 0.11–0.41), but only the two latter associations remained after adjusting for other sociodemographic variables.ConclusionCOPD health status was worse in the four weeks following primary care consultation for AECOPD in patients with obesity and those prescribed oral antibiotics in the preceding year.

Association of mild cognitive impairment and characteristic of COPD and overall health status in a cohort study

ABSTRACT Introduction: We evaluated risk factors and demographic characteristics of associated with mild cognitive impairment (MCI) in patients with COPD. Methods: 220 individuals with COPD enrolled in a cohort study designed to evaluate anxiety conducted at 16 clinical centers. Cognitive impairment was assessed with the Montreal Cognitive Assessment (MoCA), a cutoff score of <26 defined as MCI. Data were collected including spirometry, 6-minute walk test, symptom burden by COPD Assessment Test and dyspnea by Modified Medical Research Council, anxiety measured by Anxiety Inventory of Respiratory Disease, Generalized Anxiety Disorder-7 and Hospital Anxiety Depression Scale, depression by Patient Health Questionnaire-9 and health status by Patient Reported Outcomes Measurement Information System and sleep quality by the Pittsburg Sleep Quality Index. Results: The median age was 65 years and 54% of participants were male. 119(54%) of participants had MCI as classified by MoCA. In multivariable logistic regression, higher odds ratios (OR) (95% confidence interval) for MCI (MoCA) <26 were associated with increased years of age, 1.06 (1.02 -1-09, p<0.003); African-American race, 3.68(1.67-8.11, p<0.001); persistent phlegm, 2 (1.12-3.57, p<0.01) and sleep disturbance, 1.04(1.01-1.08, p<0.01). Conclusions: COPD patients commonly screen positive for MCI. Characteristics associated with MCI included age, African-American race, sleep disturbance and persistent phlegm.

Associations of sense of coherence and self-efficacy with health status and disease severity in COPD

Sense of coherence and self-efficacy has been found to affect health-related quality of life in chronic diseases. However, research on respiratory diseases is limited. Here we report findings on quality of life (QoL) of COPD patients and the associations with coherence and self-efficacy. This study consists of the Greek national branch of the UNLOCK study, with a sample of 257 COPD patients. Coherence and self-efficacy are positively inter-correlated (Pearson rho = 0.590, p < 0.001). They are negatively correlated with the quality of life (CAT) [Pearson rho: coherence = −0.29, p < 0.001; self-efficacy = −0.29, p < 0.001) and mMRC (coherence = −0.37, p < 0.001; self-efficacy rho = −0.32, p < 0.001)]. Coherence is inversely associated with (Global Initiative for Chronic Obstructive Lung Disease) GOLD 2018—CAT and GOLD 2018—mMRC classification and “having at least one exacerbation in the past year”. Findings are stressing the need for their incorporation in primary health care and COPD guidance as it maybe that enhancing coherence and self-efficacy will improve QoL.

Development and Validation of the Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease (mCOPD-PRO).

PurposeThe present study aimed to develop and validate the modified patient-reported outcome scale for chronic obstructive pulmonary disease (mCOPD-PRO) for measuring the health status in COPD using both classical test theory and item response theory.MethodsA working group was initially established. The conceptual framework of COPD-PRO was modified. Subsequently, items related to COPD were gathered and selected through expert consultation, patient cognitive interviewing, classical test theory methods, as well as the item response theory method. Finally, the formed mCOPD-PRO was evaluated in terms of reliability, content validity, construct validity, criterion validity, known groups validity, and feasibility.ResultsA total of 155 items were gathered in the item bank, and two rounds of expert consultation, interviews with patients and field survey were conducted. The mCOPD-PRO included 27 items in the physiological, psychological, and environmental domains. The Cronbach’s alpha of the instrument was 0.954. The correlation coefficients between the scores of each item and its domain scores ranged from 0.429 to 0.902. Confirmatory factor analysis showed that the comparative fit index, incremental fit index, non-normed fit index, standardized root-mean-square residual, and root-mean-square error of approximate were 0.91, 0.91, 0.90, 0.11, and 0.16, respectively. The correlation coefficient between mCOPD-PRO total scores and COPD assessment test scores and the modified Medical Research Council dyspnea scale scores was 0.771 and 0.651, respectively. The differences in mCOPD-PRO total scores and domain scores between the mild/moderate group and severe/extremely severe group of patients with COPD were both statistically significant (P<0.01). The acceptance and completion rates of mCOPD-PRO were both 99.5%, and the median completion time was 5 min (IQR, 4–11 min).ConclusionThe 27-item mCOPD-PRO is well developed and has good reliability, validity, and feasibility. It may provide a scientific and effective instrument for the clinical evaluation of COPD.

Thresholds for clinically important deterioration versus improvement in COPD health status: results from a randomised controlled trial in pulmonary rehabilitation and an observational study during routine clinical practice.

ObjectivesChronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires.Design and settingData were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2).ParticipantsPatients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis.Primary outcomesThe COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George’s Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds.ResultsIn total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from −3.78 to −1.53 (CAT), from −0.50 to −0.19 (CCQ), and from −9.20 to −2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from −5.02 to −3.29 vs 3.89 to 8.14 (CAT), from −0.90 to −0.72 vs 0.42 to 1.23 (CCQ), and from −15.85 to −13.63 vs 7.46 to 9.30 (SGRQ).ConclusionsMCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings.Trial registration numberRoutine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.

Influence of comorbid heart disease on dyspnea and health status in patients with COPD - a cohort study.

PurposeThe aim of this study was to examine the changing influence over time of comorbid heart disease on symptoms and health status in patients with COPD.Patients and methodsThis is a prospective cohort study of 495 COPD patients with a baseline in 2005 and follow-up in 2012. The study population was divided into three groups: patients without heart disease (no-HD), those diagnosed with heart disease during the study period (new-HD) and those with heart disease at baseline (HD). Symptoms were measured using the mMRC. Health status was measured using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT; only available in 2012). Logistic regression with mMRC ≥2 and linear regression with CCQ and CAT scores in 2012 as dependent variables were performed unadjusted, adjusted for potential confounders, and additionally adjusted for baseline mMRC, respectively, CCQ scores.ResultsMean mMRC worsened from 2005 to 2012 as follows: for the no-HD group from 1.8 (±1.3) to 2.0 (±1.4), (P=0.003), for new-HD from 2.2 (±1.3) to 2.4 (±1.4), (P=0.16), and for HD from 2.2 (±1.3) to 2.5 (±1.4), (P=0.03). In logistic regression adjusted for potential confounding factors, HD (OR 1.71; 95% CI: 1.03–2.86) was associated with mMRC ≥2. Health status worsened from mean CCQ as follows: for no-HD from 1.9 (±1.2) to 2.1 (±1.3) with (P=0.01), for new-HD from 2.3 (±1.5) to 2.6 (±1.6) with (P=0.07), and for HD from 2.4 (±1.1) to 2.5 (±1.2) with (P=0.57). In linear regression adjusted for potential confounders, HD (regression coefficient 0.12; 95% CI: 0.04–5.91) and new-HD (0.15; 0.89–5.92) were associated with higher CAT scores. In CCQ functional state domain, new-HD (0.14; 0.18–1.16) and HD (0.12; 0.04–0.92) were associated with higher scores. After additional correction for baseline mMRC and CCQ, no statistically significant associations were found.ConclusionHeart disease contributes to lower health status and higher symptom burden in COPD but does not accelerate the worsening over time.

Specific Factors Predict the Risk for Urgent and Emergent Colectomy in Patients Undergoing Surgery for Diverticulitis

The aim of this study was to identify preoperative characteristics that may determine the need for emergency surgery for diverticulitis and assess postoperative outcomes for these patients when compared with elective surgery. All patients included in the ACS-NSQIP-targeted colectomy database from 2012 to 2013 who underwent colectomy with an underlying diagnosis of diverticulitis were included. Preoperative characteristics and 30-day postoperative outcomes were evaluated for patients who underwent elective versus emergent/urgent surgery using univariable and multivariable analyses. Of 8708 patients with diverticular disease, 28.1 per cent underwent emergent/urgent colectomy. Patients who underwent emergent/urgent colectomy had greater preoperative steroid use, diabetes mellitus, disseminated cancer, chronic renal failure, hypertension, chronic heart failure, chronic liver disease, COPD, and dependent functional health status (P < 0001). There were more patients with age >65 years (P < 0001), smoking history (P < 0.05), and BMI < 18.5 kg/m² (P < 0001) in the emergent/urgent colectomy group. After performing multivariable analysis, preoperative steroid use, weight loss >10 per cent, BMI < 18 kg/m², smoking, age > 65, and comorbid conditions were associated with a higher rate of emergent/urgent surgery. Mortality (5.2% vs 0.2%) and infectious and noninfectious complications were higher after nonelective colectomy. Emergent/urgent colectomy was also associated with longer hospital stay and reoperation. Emergency and urgent colectomy for diverticulitis is associated with significantly worse outcomes than after elective surgery, and patients with comorbid conditions who develop attacks of diverticulitis may in fact be the population that might best benefit from a lower threshold for an elective colectomy.

Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of copd health status tools

BackgroundThe Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George’s Respiratory Questionnaire (SGRQ).MethodsModerate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency.ResultsIn total 451 patients were included (57.9 ± 6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2 ± 7.3 (CAT), 2.9 ± 1.2 (CCQ) and 50.7 ± 17.3 (SGRQ). MCID estimates for improvement ranged − 3.1 to − 1.4 for CAT, − 0.6 to − 0.3 for CCQ, and − 10.3 to − 7.6 for SGRQ. Absolute higher – though not significant – MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference − 1.4: CI -2.3 to − 0.5) and CCQ (difference − 0.2: CI -0.3 to −0.1) using a five-point GRC.ConclusionsThe recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ.Trial registrationRIMTCORE trial #DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).

General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial

BackgroundMost patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. C-reactive protein (CRP) is an acute-phase biomarker that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. It is not clear whether the addition of a CRP point-of-care test (POCT) to clinical assessment leads to a reduction in antibiotic consumption without having a negative impact on COPD health status.Methods/designThis is a multicentre, individually randomised controlled trial (RCT) aiming to include 650 participants with a diagnosis of AECOPD in primary care. Participants will be randomised to be managed according to usual care (control) or with the addition of a CRP POCT to guide antibiotic prescribing. Antibiotic consumption for AECOPD within 4 weeks post randomisation and COPD health status (total score) measured by the Clinical COPD Questionnaire (CCQ) at 2 weeks post randomisation will be co-primary outcomes. Primary analysis (by intention-to-treat) will determine differences in antibiotic consumption for superiority and COPD health status for non-inferiority. Secondary outcomes include: COPD health status, CCQ domain scores, use of other COPD treatments (weeks 1, 2 and 4), EQ-5D utility scores (weeks 1, 2 and 4 and month 6), disease-specific, health-related quality of life (HRQoL) at 6 months, all-cause antibiotic consumption (antibiotic use for any condition) during first 4 weeks post randomisation, total antibiotic consumption (number of days during first 4 weeks of antibiotic consumed for AECOPD/any reason), antibiotic prescribing at the index consultation and during following 4 weeks, adverse effects over the first 4 weeks, incidence of pneumonia (weeks 4 and 6 months), health care resource use and cost comparison over the 6 months following randomisation. Prevalence and resistance profiles of bacteria will be assessed using throat and sputum samples collected at baseline and 4-week follow-up. A health economic evaluation and qualitative process evaluation will be carried out.DiscussionIf shown to be effective (i.e. leads to a reduction in antibiotic use with no worse COPD health status), the use of the CRP POCT could lead to better outcomes for patients with AECOPD and help reduce selective pressures driving the development of antimicrobial resistance. PACE will be one of the first studies to evaluate the cost-effectiveness of a POCT biomarker to guide clinical decision-making in primary care on patient-reported outcomes, antibiotic prescribing and antibiotic resistance for AECOPD.Trial registrationISRCTN registry, ID: ISRCTN24346473. Registered on 20 August 2014.

Morning and night symptoms in primary care COPD patients: a cross-sectional and longitudinal study. An UNLOCK study from the IPCRG.

COPD symptoms show a diurnal variability. However, morning and night variability has generally not been taken into consideration in disease management plans. The aims of this study were to cross-sectionally assess morning and night symptom prevalence and correlation with health status and disease severity in COPD, and to determine to what extent they could predict longitudinal outcomes, exacerbations and health status. A further aim is to explore whether the CCQ is able to depict this morning/night symptomatology. We included 2,269 primary care COPD patients (58% male, 49% current smokers, with a mean age of 65±11 years) from a Dutch Asthma/COPD service. Spirometry, patient history, the Clinical COPD Questionnaire(CCQ) and the Asthma Control Questionnaire(ACQ) were assessed; we used the latter to evaluate morning (question 2) and night symptoms (question 1). A total of 1159 (51.9%) patients reported morning symptoms (ACQ question 2>0) and 879 (39.4%) had night complaints (ACQ question 1>0). Patients with morning/night symptoms were mostly smokers and had on average poorer lung function, higher CCQ scores and used more rescue inhalers (P<0.0001). Patients using long-acting muscarinic antagonists (LAMAs) had less night symptoms, showing a possible favourable effect. Only a small proportion of stable or slightly unstable patients (CCQ total scores <2) had severe morning symptoms (ACQ 2⩾4: n=19, 1.1%) or severe night symptoms (ACQ 1⩾4: n=11, 0.7%). Night symptoms seemed to predict future exacerbations; however, baseline exacerbations were the strongest predictors (n=346, OR:4.13, CI: 2.45−6.95, P<0.000). Morning symptoms increased the odds of poor health status at follow-up (n=346, OR:12.22, CI:4.76−31.39, P<0.000). Morning and night symptoms in COPD patients are common, and they are associated with poor health status and predicted future exacerbations. Our study showed that patients with morning/night symptoms have higher scores in CCQ, and therefore we do not really miss patients with high morning/night symptomatology when we only measure CCQ. Severe morning symptoms predicted worsening of COPD health status.

Health literacy and health outcomes in chronic obstructive pulmonary disease

BackgroundThere is little information worldwide about the impact of health literacy (HL) on clinical outcomes of COPD. Our aim was to quantify inadequate HL in Spain, as measured by the Short Assessment of Health Literacy for Spanish Adults questionnaire, and to examine the associations between HL and both COPD outcomes and health status. Methods296 COPD patients of 68(SD = 9) years and a FEV1%predicted of 53%(SD = 18%) were enrolled and followed-up for one year. 59% showed “inadequate” HL. ResultsIndividuals with inadequate HL were older (70[SD = 9] vs 65[SD = 8] years; p < 0.001) and had less knowledge of their disease, as measured by the low HL-COPD questionnaire, (6.9[SD = 2.3] vs 7.5[SD = 1.9]; p < 0.001). While their lung function was no different, they reported significant differences in mMRC (1.6[SD = 1] vs 1.4[SD = 1]; p < 0.001), CAT (19.2[SD = 8.1] vs 18.3[SD = 7.5]; p = 0.049), and EQ-5 (3.1[SD = 2.2] vs 2.3[SD = 1.9]; p < 0.00). Those with inadequate HL had also higher risk of having ≥2 comorbidities (OR = 1.87; 95%CI = 1.14–3.08), need of assistance (OR = 2.5; 95%CI = 1.5–4.2), anxiety/depression (OR = 1.9; 95%CI = 1.2–3.0), admissions or visits to the emergency department (OR = 1.70; 95%CI = 1.1–2.7), and all-cause deaths in the following year (3.8% (SE = 1.1%) vs 0%; p = 0.051). ConclusionsInadequate HL is prevalent among COPD patients and it is related to health status and relevant clinical outcomes of the disease. HL needs to be considered when planning the care for COPD patients.

The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference

BackgroundThe EQ-5D, a generic health status questionnaire that is widely used in health economic evaluation, was recently expanded to the EQ-5D-5L to address criticisms of unresponsiveness and ceiling effect.AimsTo describe...

Evaluation of the Persian Transcript of the COPD Assessment Test in the Measurement of COPD Health Status in Iranian COPD Patients

Aim:Chronic obstructive pulmonary disease is a completely irreversible obstructive airway disease. The COPD assessment test (CAT) is one of the standard methods for the clinical assessment of the disease, which is translated into Persian. This study investigated the reliability of the test and its relationship with the severity of the disease.Methods:In this cross-sectional study, 120 patients filled out the Persian transcript of the test. After two weeks, the patients filled out the CAT test again. Obstruction severity was determined for all the patients using spirometry, and the patients were categorized into four groups according to the Global Initiative for Chronic Obstructive Lung Disease criteria. The relationship between the test scores and the disease severity wan validated.Results:The mean age of the patients was 51.5 years. The Cronbach’s alpha coefficient of the Persian transcript of the test was 0.872 in the first time, and 0.885 in the second time. Intragroup reliability, test re-test and intragroup correlations were significant for all the questions (<0.001). The relationship between the test mean score and obstruction severity was significant, and the correlation between disease categorization in accordance with obstruction severity and categorization according to the test score was significant as well.Conclusion:The Persian transcript of the assessment test for COPD was reliable and is directly related to the disease severity according to airflow limitation.

Glycopyrronium Improves Health Status, Lung Function in COPD

Glycopyrronium Improves Health Status, Lung Function in COPD

Measurement of C-reactive protein, procalcitonin and neutrophil elastase in saliva of COPD patients and healthy controls: correlation to self-reported wellbeing parameters.

BackgroundSaliva is increasingly promoted as an alternative diagnostic bio-sample to blood; however its role in respiratory disease requires elucidation. Our aim was to investigate whether C-reactive protein (CRP), procalcitonin (PCT) and neutrophil elastase (NE) could be measured in unstimulated whole saliva, and to explore differences between COPD patients and controls with normal lung function. We also determined the relationship between these salivary biomarkers and self-reported COPD-relevant metrics.MethodsSalivary CRP, PCT and NE levels were measured at each of 3 visits over a 14-day period alongside spirometry and a daily self-assessment dairy in 143 subjects: 20 never-smokers and 25 smokers with normal spirometry; 98 COPD patients [GOLD Stage I, 16; Stage II, 32; Stage III, 39; Stage IV, 11]. Twenty-two randomly selected subjects provided simultaneous blood samples.ResultsLevels of each salivary biomarker could distinguish between the above cohorts. Significant differences remained for salivary CRP and NE (p < 0.05) following adjustment for age, gender, sampling time, gum disease and total co-morbidities; but not for BMI except for salivary NE, which remained higher in smokers compared to non-smokers and stable COPD subjects (p < 0.001). Patients with acute COPD exacerbations had a median increase in all 3 salivary biomarkers (p < 0.001); CRP: median 5.74 ng/ml, [interquartile range (IQR) 2.86–12.25], PCT 0.38 ng/ml, [IQR 0.22–0.94], and NE 539 ng/ml, [IQR 112.25–1264]. In COPD patients, only salivary CRP and PCT levels correlated with breathing scores (r = 0.14, p < 0.02; r = 0.13, p < 0.03 respectively) and sputum features but not with activities of daily living. Salivary CRP and PCT concentrations strongly correlated with serum counterparts [r = 0.82, (95 % CI: 0.72–0.87), p < 0.001 by Spearman’s; and r = 0.53, (95 % CI: 0.33–0.69), p < 0.006 respectively]; salivary NE did not.ConclusionsCRP, PCT and NE were reliably and reproducibly measured in saliva, providing clinically-relevant information on health status in COPD; additionally NE distinguished smoking status. All 3 salivary biomarkers increased during COPD exacerbations, with CRP and PCT correlating well with patient-derived clinical metrics. These results provide the conceptual basis for further development of saliva as a viable bio-sample in COPD monitoring and exacerbation management.Electronic supplementary materialThe online version of this article (doi:10.1186/s12931-015-0219-1) contains supplementary material, which is available to authorized users.

One-year change in health status and subsequent outcomes in COPD

BackgroundPoor health status has been associated with morbidity and mortality in patients with COPD. To date, the impact of changes in health status on these outcomes remains unknown.AimsTo explore the...

Once-daily fluticasone furoate/vilanterol 100/25 mcg versus twice daily combination therapies in COPD - mixed treatment comparisons of clinical efficacy.

BackgroundFluticasone furoate (FF)/vilanterol (VI) 100/25 mcg is a once-daily inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) treatment approved in the United States, Canada and Europe for the long-term maintenance therapy of COPD. We report data from mixed treatment comparisons (MTC) of once-daily FF/VI against established twice-daily ICS/LABA combination therapies on clinical efficacy outcomes.MethodsData from 33 parallel-group randomised controlled trials (RCTs) of ICS/LABAs, of ≥8 weeks’ duration in patients ≥12 years of age with COPD, identified by systematic review, were analysed using covariate-adjusted Bayesian hierarchical models for three efficacy outcomes. Lung function, assessed by change from baseline in forced expiratory volume in one second (FEV1), was the outcome of primary interest (n = 28 studies). Secondary objectives were assessment of annual rate of moderate/severe exacerbations (n = 15) and patient-reported health status, measured by change from baseline in St George’s Respiratory Questionnaire (SGRQ) Total score (n = 20). Overall, 25 different treatments were included in the MTC; we report findings, including probabilities of non-inferiority, for comparisons of once-daily FF/VI 100/25 mcg with twice-daily fluticasone propionate (FP)/salmeterol (SAL) 500/50 mcg and budesonide (BUD)/formoterol (FORM) 400/12 mcg.ResultsFor FEV1, FF/VI 100/25 mcg demonstrated >99% probability of non-inferiority to FP/SAL 500/50 mcg and BUD/FORM 400/12 mcg using a 50 mL margin. For annual rate of moderate/severe exacerbations, FF/VI 100/25 mcg demonstrated 73% and 77% probability of non-inferiority to FP/SAL 500/50 mcg and BUD/FORM 400/12 mcg, respectively, using a 10% rate ratio margin. For SGRQ Total score, the corresponding probabilities of non-inferiority were 99% and 98%, respectively, on a 2-unit margin. Significant covariate effects were identified: increased age was associated with deterioration in FEV1 and reduced exacerbation frequency; shorter study duration was associated with reduced exacerbation frequency.ConclusionsFF/VI 100/25 mcg was comparable with corresponding doses of FP/SAL and BUD/FORM on lung function and health status outcomes. Non-inferiority on moderate/severe exacerbation rate was not demonstrated to the same degree of confidence, though observed rates were similar. Model limitations include a weak treatment network for the exacerbation analysis and variability across the included studies. Our data support previous RCT findings suggesting that the efficacy of FF/VI 100/25 mcg on lung function and health status in COPD is comparable with twice-daily ICS/LABAs.Electronic supplementary materialThe online version of this article (doi:10.1186/s12931-015-0184-8) contains supplementary material, which is available to authorized users.