BackgroundThe Clinical COPD Questionnaire (CCQ) is a simple 10-item, health-related quality of life questionnaire (HRQoL) with good psychometric properties. However, little data exists regarding the responsiveness of the CCQ to pulmonary rehabilitation (PR) or the minimal clinically important difference (MCID). The study aims were to assess the responsiveness of the CCQ to PR, to compare the responsiveness of the CCQ to other HRQoL questionnaires and to provide estimates for the MCID. Methods The CCQ, St George's Respiratory Questionnaire (SGRQ), Chronic Respiratory Questionnaire (CRQ) and COPD Assessment Test (CAT) were measured in 261 patients with COPD before and after outpatient PR. Pre to post PR changes and Cohen's effect size were calculated. Changes in CCQ were compared with changes in other HRQoL questionnaires. Using an anchor-based approach and receiver operating characteristic (ROC) curves, the CCQ change cutoffs that identified patients achieving the known MCID for other health status questionnaires with PR were identified. Results The CCQ, SGRQ, CRQ and CAT all significantly improved with PR with an effect size of −0.39, −0.33, 0.62 and −0.25, respectively. CCQ change correlated significantly with change in SGRQ, CRQ and CAT (r=0.48, 0.54, respectively; all p<0.001). ROC curves consistently identified a CCQ change cutoff of −0.4 as the best discriminating value to identify the MCID for the SGRQ, CRQ and CAT (area under curve: 0.71, 0.75 and 0.77, respectively; all p<0.001). Conclusions The CCQ is responsive to PR with an estimated clinically important improvement of −0.4 points. The CCQ is a practical alternative to more timeconsuming measures of HRQoL.

Regulatory affairs are one of the most crucial connections between the pharmaceutical company and the other stakeholder’s or regulatory agencies such as FDA, EMA, etc. Strategies in drug approval and marketing to assure the quality, safety, and efficacy of the drug follow the guidelines and laws stated under the drug and cosmetic act 1940 and rules 1945. Their primary responsibility is to keep the company in compliance with changing guidelines, which necessitates constant monitoring of the most recent industry updates. Drug regulation is a complex process as every country has its own set of documentation that must be done while regulatory submissions. From drug development and drug approval to drug commercialisation, there is a large amount of documentation that must be completed with accuracy, which can be challenging for the professional to complete, therefore, this leads to the introduction of the concept of big data that can be incorporated which will map the regulations according to 5vs model of big data. Thus, to make it more efficient, we can work big data with artificial intelligence to ease the process using natural language processing. This concept will map all the rules and guidelines together and make a cluster of similar rules together. Now, users can use the tool to locate the data of interest in a single site in a more comprised universal language that can be accessed by any professional to complete the task in the given time schedule.

Poster sessions A106Thorax 2012;67(Suppl 2):A1-A204 hypersensitivity pneumonitis (n=3), asbestosis (n=4), drug induced ILD (n=4). Pre-and post-PR data was analysed using either Paired T-Tests or Wilcoxon Tests. Results Baseline mean (standard deviation) age was 70(11) years, FVC 69 (22)% predicted and median (25 th , 75 th centiles) MRC dyspnoea score was 4 (3, 4). There was a significant improvement in ISW (95% confidence intervals 31, 69 metres), HAD-Anxiety (95% CI -0.8, -2.4) and HAD-Depression (95% CI -0.7, -2.3). There were also significant improvements in all domains of the CRQ. Conclusion The ISW and HAD scores are responsive to PR in patients with ILD.