Dataset Information

Modified and simplified clinically important deterioration: multidimensional indices of short-term disease trajectory to predict future exacerbations in patients with chronic obstructive pulmonary disease.

ABSTRACT:

Background and aims

Various prediction indices based on the single time point observation have been proposed in chronic obstructive pulmonary disease (COPD), but little was known about disease trajectory as a predictor of future exacerbations. Our study explored the association between disease trajectory and future exacerbations, and validated the predictive value of the modified and simplified short-term clinically important deterioration (CID).

Methods

This study was a multicenter, prospective observational study. Patients with COPD were recruited into our study and followed up for 18?months. The modified CID (CID-C) was defined as a decrease of 100?mL in forced expiratory volume in 1 second (FEV1), or suffering exacerbations, or increase of 2?units in COPD Assessment Test (CAT) during the first 6?months follow-up. Simplified CID was defined when excluding CAT from the CID-C model.

Results

A total of 127 patients were enrolled in our final analysis. Compared with patients without exacerbations during the period of the 6th to the 18th month, patients with exacerbations were more likely to have frequent short-term exacerbations in the first 6?months (2.14 versus 0.21, p?p?p?versus 0.695, p?=?0.02).

Conclusion

Disease trajectory, including both the CID-C and the Simplified CID had significant predictive value for future exacerbations.The reviews of this paper are available via the supplemental material section.

SUBMITTER: Zhao YY

PROVIDER: S-EPMC7768878 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Publications

Modified and simplified clinically important deterioration: multidimensional indices of short-term disease trajectory to predict future exacerbations in patients with chronic obstructive pulmonary disease.

Zhao Yi-Yang YY Liu Cong C Zeng Yu-Qin YQ Zhou Ai-Yuan AY Duan Jia-Xi JX Cheng Wei W Sun Tian T Li Xin X Ma Li-Bing LB Liu Qi-Mi QM Zhu Ying-Qun YQ Chen Ming M Zhou Mei-Ling ML Chen Ping P

Therapeutic advances in respiratory disease 20200101

<h4>Background and aims</h4>Various prediction indices based on the single time point observation have been proposed in chronic obstructive pulmonary disease (COPD), but little was known about disease trajectory as a predictor of future exacerbations. Our study explored the association between disease trajectory and future exacerbations, and validated the predictive value of the modified and simplified short-term clinically important deterioration (CID).<h4>Methods</h4>This study was a multicent ...[more]

PMID: 33357117

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Project description:Background'Clinically important deterioration' (CID) is a composite endpoint measuring worsening of the key clinical features of chronic obstructive pulmonary disease (COPD), namely lung function, patient-reported outcomes, and exacerbations. ACLIFORM and AUGMENT were two 24-week, randomized, double-blind, phase III studies assessing twice-daily (BID) aclidinium bromide (AB) 400 μg/formoterol fumarate (FF) 12 μg. This pooled post-hoc analysis assessed the effects of AB/FF 400/12 μg on both first and sustained CID events versus placebo and monotherapies in patients with moderate to severe COPD.MethodsA first CID event was defined as the occurrence of a moderate/severe exacerbation or the worsening from baseline in ≥1 of the following: trough forced expiratory volume in 1 second (FEV1; ≥100 mL), Transition Dyspnea Index (TDI) focal score (≥1 unit), or St George's Respiratory Questionnaire (SGRQ) total score (≥4 units). A 'sustained' CID was defined as a worsening maintained at all subsequent visits from appearance to week 24 or a moderate/severe exacerbation at any time. CID events were assessed at three visits (weeks 4, 12, and 24); trough FEV1 was also measured at weeks 1 and 18.ResultsAB/FF 400/12 μg reduced the risk of a first CID event by 45% versus placebo (hazard ratio [HR] 0.55, p < 0.001), 18% versus FF 12 μg (HR 0.82, p < 0.01), and 15% versus AB 400 μg (HR 0.85, p < 0.05). Similarly, AB/FF 400/12 μg reduced the risk of a sustained CID event by 48% versus placebo (HR 0.52, p < 0.001) and 22% versus FF 12 μg (HR 0.78, p < 0.01). AB/FF 400/12 μg reduced the risk of a first or sustained CID event for all four components versus placebo (trough FEV1 and TDI, first and sustained CID, all p < 0.001; SGRQ first CID p < 0.001; SGRQ sustained CID, p < 0.01; exacerbations first and sustained CID, both p < 0.05) and TDI and SGRQ versus FF 12 μg (TDI, first and sustained CID both p < 0.05; SGRQ first CID p < 0.01), and SGRQ versus AB 400 μg (first CID, p < 0.05).ConclusionsAB/FF 400/12 μg BID may provide greater airway stability and fewer exacerbations or deteriorations in lung function, health status, or dyspnea compared with placebo or monotherapies.Trial registrationClinicaltrials.gov NCT01462942 (ACLIFORM); registered 26 October 2011. Clinicaltrials.gov NCT01437397 (AUGMENT); registered 19 September 2011.

Project description:Background: Motor progression varies even among those with a single diagnosis such as Parkinson's disease (PD) and little is known about the trajectory of motor signs prior to death. Understanding deterioration patterns may help clinicians counsel patients and proactively plan interdisciplinary care, including palliative care. The objective of this study was to examine and describe Unified Parkinson's Disease Rating Scale motor score (UPDRS-III) trajectories at the end of life in PD. Methods: A retrospective chart review was performed for deceased PD patients who attended the Parkinson and Movement Disorders Program at the University of Alberta for at least 5 years between 1999 and 2018. UPDRS-III scores were recorded for all visits. Trajectory patterns were visualized with Loess curves stratified by sex and age at diagnosis. Piecewise linear models were used to individually model the UPDRS-III scores, and the trajectories obtained were clustered based on their features. Results: Among the 202 charts reviewed, 84 meeting inclusion criteria were analyzed. The UPDRS-III increased over time regardless of sex and age. Distinct trajectory variations present in PD (e.g., Consistent Deterioration, Stability-Deterioration, Improvement-Deterioration, Deterioration-Improvement-Deterioration) were identified. Twenty-five percent of the patients were classified as Undetermined/Irregular trajectories. In addition, regardless of trajectory type, many patients experienced a steep increase in UPDRS-III approaching death. Those with disease diagnosis after age 65 years had a shorter survival time, compared to PD patients with a younger age of onset. Conclusion: Our study identified dominant types of motor trajectory in PD that can help clinicians understand their patients' course of illness. This information can help counsel patients regarding the variability in motor deterioration and should alert physicians to recognize a terminal decline. Age of disease onset was correlated with survival time.

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Dataset Information

Modified and simplified clinically important deterioration: multidimensional indices of short-term disease trajectory to predict future exacerbations in patients with chronic obstructive pulmonary disease.

Background and aims

Methods

Results

Conclusion

Publications

Modified and simplified clinically important deterioration: multidimensional indices of short-term disease trajectory to predict future exacerbations in patients with chronic obstructive pulmonary disease.

Similar Datasets

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