Health status measured by the Clinical COPD Questionnaire (CCQ) improves following post-acute pulmonary rehabilitation in patients with advanced COPD: a prospective observational study.
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ABSTRACT:
SUBMITTER: van Dam van Isselt EF
PROVIDER: S-EPMC4373298 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:BackgroundPatient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM).MethodsPatients were > or = 40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1-7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis.Results210 patients were recruited, 168 completed the CCQ questionnaire on Day 42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21.ConclusionThis investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.
| S-EPMC1508149 | biostudies-literature
Project description:BackgroundAn organizational approach is proposed as an immediate solution for improving postoperative pain (POP) management. The aim was to evaluate the clinical effectiveness of a quality management system (QMS), based on procedure-specific, multimodal analgesic protocols, modified to meet the individual patients' requirements.MethodsPatients from the orthopaedic, gynaecological, visceral, and trauma surgery departments of the university hospital were involved in two prospective surveys. Survey 1 was performed at baseline and survey 2 was performed after the implementation of QMS within an interval of 1 year. The patients were asked to report pain intensity on the visual rating scale, incidence of analgesia-related side-effects, and incidence of pain interference with the items of life quality and their satisfaction with the treatment of POP.ResultsPatients from Survey 2 (n=251) reported 25-30% less pain than those from Survey 1 (n=269) (P<0.0001). Nausea was reported by 40% of the patients from Survey 1 vs 17% from Survey 2, vomiting by 25 vs 11% and fatigue by 76% in Survey 1 vs 30% in Survey 2 (P<0.0001). Life quality and patients' satisfaction improved in Survey 2 vs Survey 1 (P<0.001).ConclusionsThe implementation of QMS allowed the reduction in POP intensity with a simultaneous decrease in analgesia-related side-effects. This has led to an increased quality of life and patient satisfaction.
| S-EPMC3520148 | biostudies-literature
Project description:ObjectivesPatients discharged from the intensive care unit (ICU) often experience physical complaints and poor nutritional intake, which negatively affect their nutritional status (NS). The aim of this study was to describe the NS of patients with COVID-19 1-y post-ICU stay.MethodsThis was an observational study of adult patients with COVID-19 1-y post-ICU stay. NS assessment (nutrient balance, body composition, and physical status) was performed. We examined nutritional intake and nutrition-related complaints. Nutritional requirements were determined with indirect calorimetry and body composition with bioelectrical impedance. Fat-free mass index (FFMI) and fat mass index (FMI) were calculated. Physical status was determined using handgrip strength, the 6-min walk test, and the 1-min sit-to-stand test. Descriptive statistics and paired sample t tests were used for analysis.ResultsWe included 48 patients (73% men; median age 60 y [IQR 52;65]). Median weight loss during the ICU stay was 13%. One-y post-ICU stay, 12% of weight was regained. Median body mass index was 26 kg/m2 and 23% of the patients were obese (body mass index >30 kg/m2 and high FMI). Of the patients, 50% had high FMI and 19% had low FFMI. Median reported nutritional intake was 90% of measured resting energy expenditure. Nutrition-related complaints were seen in 16%. Percentages of normal values reached in physical tests were 92% of handgrip strength, 95% of 6-min walking distance, and 79% of 1-min sit-to-stand test.ConclusionsDespite almost fully regained weight and good physical recovery in adult patients 1-y post-ICU stay, NS remained impaired because of elevated FMI, even though reported nutritional intake was below the estimated requirements.
| S-EPMC10010062 | biostudies-literature
Project description:BackgroundPulmonary rehabilitation (PR) is recommended in people with post-acute COVID-19 syndrome (PACS), although there is a lack of studies evaluating its benefits via the most commonly used primary endpoint: the six-minute walk test (6MWT). This study evaluated the effects of PR on the dynamics of ventilation measured during the 6MWT in patients with PACS and, secondarily, evaluated the association of these findings with measures of lung function and structure.MethodsThis was an observational cross-sectional study of patients with PACS, in which 33 had undergone PR (PR-PACS group) and 32 had not undergone PR (NPR-PACS group). These patients underwent Spiropalm®-equipped 6MWT with measurement of inspiratory capacity (IC) to evaluate dynamic hyperinflation (DH). In addition, they performed spirometry, impulse oscillometry (IOS) and lung ultrasound (LUS).ResultsSpirometry was abnormal in 21.2% and 31.3% of participants in the PR-PACS and NPR-PACS groups, respectively (p = 0.36). IOS was abnormal in 28.6% and 66.7% of participants in the PR-PACS and NPR-PACS groups, respectively (p = 0.003). LUS was altered in 39.4% and 43.8% of the participants in the PR-PACS and NPR-PACS groups, respectively (p = 0.72). The 6-min walk distance (6MWD) was greater in the PR-PACS group than in the NPR-PACS group (p = 0.001]. HD was observed in 6.1% and 37.5% of participants in the PR-PACS and NPR-PACS groups, respectively, with a significant difference in ΔIC (p<0.001). The 6MWD correlated significantly with several IOS parameters and with ΔIC.ConclusionsPatients with PACS undergoing PR perform better in the 6MWT, with a higher 6MWD and less HD. In these patients, IOS is able to distinguish the effects of PR that are not differentiated by spirometry or LUS. Furthermore, the better the respiratory mechanics assessed by IOS and the less DH there was, the higher the performance in the 6MWT.
| S-EPMC10836674 | biostudies-literature
Project description:ObjectiveTo determine the feasibility and efficacy of a six-month, cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation.MethodsParticipants who completed a two-week run-in were randomly assigned to either MOBILE-Coached (n = 9) or MOBILE-Self-Monitored (n = 8). All participants met with a nurse to develop an individualized exercise plan, were issued a pedometer and exercise booklet, and instructed to continue to log their daily exercise and symptoms. MOBILE-Coached also received weekly reinforcement text messages on their cell phones; reports of worsening symptoms were automatically flagged for follow-up. Usability and satisfaction were assessed. Participants completed incremental cycle and six minute walk (6MW) tests, wore an activity monitor for 14 days, and reported their health-related quality of life (HRQL) at baseline, three, and six months.ResultsThe sample had a mean age of 68 +/-11 and forced expiratory volume in one second 18% predicted. Participants reported that logging their exercise and symptoms (FEV(1)) of 40 +/- was easy and that keeping track of their exercise helped them remain active. There were no differences between groups over time in maximal workload, 6MW distance, or HRQL (p > 0.05); however, MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months (p =0.04).ConclusionsWe showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring. The latter finding needs to be interpreted with caution since this was a purely exploratory study.Trial registrationClinicalTrials.gov (NCT00373932).
| S-EPMC2740952 | biostudies-literature
Project description:The 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.To describe the validity, responsiveness and minimum important difference of the EQ-5D-5L in COPD.Study 1: The validity of the EQ-5D-5L utility index and visual analogue scale (EQ-VAS) was compared with four established disease-specific health status questionnaires and other measures of disease severity in 616 stable outpatients with COPD. Study 2: The EQ-5D-5L utility index and EQ-VAS were measured in 324 patients with COPD before and after 8 weeks of pulmonary rehabilitation. Distribution and anchor-based approaches were used to estimate the minimum important difference.There were moderate-to-strong correlations between utility index and EQ-VAS with disease-specific questionnaires (Pearson's r=0.47-0.72). A ceiling effect was seen in 7% and 2.6% of utility index and EQ-VAS. Utility index decreased (worsening health status) with indices of worsening disease severity. With rehabilitation, mean (95% CI) changes in utility index and EQ-VAS were 0.065 (0.047 to 0.083) and 8.6 (6.5 to 10.7), respectively, with standardised response means of 0.39 and 0.44. The mean (range) anchor estimates of the minimum important difference for utility index and EQ-VAS were 0.051 (0.037 to 0.063) and 6.9 (6.5 to 8.0), respectively.The EQ-5D-5L is a valid and responsive measure of health status in COPD and may provide useful additional cost-effectiveness data in clinical trials.
| S-EPMC4893131 | biostudies-other
Project description:Coronavirus disease 2019 (COVID-19) can result in a large variety of chronic health issues such as impaired lung function, reduced exercise performance and diminished quality of life. Our study aimed to investigate the efficacy, feasibility and safety of pulmonary rehabilitation in COVID-19 patients and to compare outcomes between patients with a mild/moderate and a severe/critical course of the disease. Patients in the post-acute phase of a mild to critical course of COVID-19 admitted to a comprehensive 3-week inpatient pulmonary rehabilitation programme were included in this prospective, observational cohort study. Several measures of exercise performance (6-min walk distance (6MWD)), lung function (forced vital capacity (FVC)) and quality of life (36-question short-form health survey (SF-36)) were assessed before and after pulmonary rehabilitation. 50 patients were included in the study (24 with mild/moderate and 26 with severe/critical COVID-19). On admission, patients had a reduced 6MWD (mild: median 509 m, interquartile range (IQR) 426-539 m; severe: 344 m, 244-392 m), an impaired FVC (mild: 80%, 59-91%; severe: 75%, 60-91%) and a low SF-36 mental health score (mild: 49 points, 37-54 points; severe: 39 points, 30-53 points). Patients attended a median (IQR) 100% (94-100%) of all provided pulmonary rehabilitation sessions. At discharge, patients in both subgroups improved in 6MWD (mild/moderate: +48 m, 35-113 m; severe/critical: +124 m, 75-145 m; both p<0.001), FVC (mild/moderate: +7.7%, 1.0-17.8%, p=0.002; severe/critical: +11.3%, 1.0-16.9%, p<0.001) and SF-36 mental component (mild/moderate: +5.6 points, 1.4-9.2 points, p=0.071; severe/critical: +14.4 points, -0.6-24.5, p<0.001). No adverse event was observed. Our study shows that pulmonary rehabilitation is a feasible, safe and effective therapeutic option in COVID-19 patients independent of disease severity.
| S-EPMC7957293 | biostudies-literature
Project description:BACKGROUND:Randomized controlled trials are the gold-standard for clinical trials. However, randomization is not always feasible. In this article we propose a prospective and adaptive matched case-control trial design assuming that a control group already exists. METHODS:We propose and discuss an interim analysis step to estimate the matching rate using a resampling step followed by a sample size recalculation. The sample size recalculation is based on the observed mean resampling matching rate. We applied our approach in a simulation study and to a real data set to evaluate the characteristics of the proposed design and to compare the results to a naive approach. RESULTS:The proposed design achieves at least 10% higher matching rate than the naive approach at final analysis, thus providing a better estimation of the true matching rate. A good choice for the interim analysis seems to be a fraction of around [Formula: see text] to [Formula: see text] of the control patients. CONCLUSION:The proposed resampling step in a prospective matched case-control trial design leads to an improved estimate of the final matching rate and, thus, to a gain in power of the approach due to sensible sample size recalculation.
| S-EPMC6636117 | biostudies-literature
Project description:The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ), the COPD Assessment Test (CAT) and the St George's Respiratory Questionnaire (SGRQ) in the same pulmonary rehabilitation population using multiple approaches. In total, 451 COPD patients participated in a 3-week Pulmonary Rehabilitation (PR) programme (58 years, 65% male, 43 pack-years, GOLD stage II/III/IV 50/39/11%). Techniques used to assess the MCID were anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods standard error of measurement (SEM), 1.96SEM and half standard deviation (0.5s.d.). Patient- and criterion-referencing led to MCID estimates of 0.56 and 0.62 (CCQ); 3.12 and 2.96 (CAT); and 8.40 and 9.28 (SGRQ). Questionnaire-referencing suggested MCID ranges of 0.28-0.61 (CCQ), 1.46-3.08 (CAT) and 6.86-9.47 (SGRQ). The SEM, 1.96SEM and 0.5s.d. were 0.29, 0.56 and 0.46 (CCQ); 3.28, 6.43 and 2.80 (CAT); 5.20, 10.19 and 6.06 (SGRQ). Pooled estimates were 0.52 (CCQ), 3.29 (CAT) and 7.91 (SGRQ) for improvement. MCID estimates differed depending on the method used. Pooled estimates suggest clinically relevant improvements needing to exceed 0.40 on the CCQ, 3.00 on the CAT and 7.00 on the SGRQ for moderate to very severe COPD patients. The MCIDs of the CAT and SGRQ in the literature might be too low, leading to overestimation of treatment effects for patients with COPD.
| S-EPMC5011855 | biostudies-other
Project description:Tiotropium improves lung function and ameliorates the annual decline in forced expiratory volume in 1 s (FEV1) after bronchodilator use in patients with mild to moderate chronic obstructive pulmonary disease (COPD). However, whether these benefits persist in patients with early-stage COPD after tiotropium discontinuation is unknown. In this prospective cohort observational follow-up study, patients who had completed the Tiotropium in Early-Stage COPD (Tie-COPD) trial were followed for a maximum of 3 years, continuing or discontinuing treatment according to their willingness. The outcomes measured were spirometry parameters, COPD exacerbations, COPD Assessment Test (CAT) scores, Clinical COPD Questionnaire (CCQ) scores, modified Medical Research Council (mMRC) scores and the use of respiratory medications. Out of 376 patients, 262 (126 in the post-placebo group and 136 in the post-tiotropium group) completed the maximum 3-year follow-up after the study medication was withdrawn. After discontinuation, the decrease in FEV1 and forced vital capacity (FVC) did not differ significantly between the two groups, and neither did their annual decline. In addition, the frequency of acute COPD exacerbations and the mMRC scores were similar between the two groups after medication withdrawal. Both the mean CAT and CCQ scores were significantly lower in the post-tiotropium group than in the post-placebo group (p<0.05 for all comparisons) at the 1-year follow-up after withdrawal, but they were not different at the next follow-up. Withdrawal of tiotropium treatment in early-stage COPD resulted in difference reduction of both FEV1 and FVC, indicating that treatment should be continued.
| S-EPMC6378343 | biostudies-literature