Assessment of patient-reported outcome measures in pleural interventions

Abstract

Introduction: There is a lack of data evaluating the clinical effect on symptoms of pleural intervention procedures. This has led to the development of patient-reported outcome measures (PROMs) to define what constitutes patient benefit. The primary aim of this paper was to prospectively assess the effect of pleural procedures on PROMs and investigate the relationship between symptom change and clinical factors.

Methods: We prospectively collected data as part of routine clinical care from 158 patients with pleural effusion requiring interventions. Specific questionnaires included two patient-reported scores (a seven-point Likert scale and a 100 mm visual analogue scale (VAS) to assess symptoms).

Results: Excluding diagnostic aspiration, the majority of patients (108/126, 85.7%) experienced symptomatic benefit from fluid drainage (mean VAS improvement 42.6 mm, SD 24.7, 95% CI 37.9 to 47.3). There was a correlation between symptomatic benefit and volume of fluid removed post aspiration. A negative association was identified between the number of septations seen on ultrasound and improvement in dyspnoea VAS score in patients treated with intercostal chest drain.

Conclusion: The results of our study highlight the effect of pleural interventions from a patient's perspective. The outcomes defined have the potential to form the basis of a clinical useful tool to appraise the effect, compare the efficiency and identify the importance of pleural interventions to the patients.

Keywords: Pleural Disease; empyema; mesothelioma.

Conflict of interest statement

Competing interests: IP is the recipient of a REPSIRE2 European Respiratory Society Fellowship RESPIRE2-2015-7160. NMR is funded by the National Institute Health Research (NIHR) Oxford Biomedical Research Centre. RJH is funded by a Clinical Training Fellowship from the Medical Research Council (MR/L017091/1).

Figures

Figure 1

Change in visual analogue score (VAS) for dyspnoea post procedure for patients with pleural effusion. Data are presented as mean, SD. *p

Figure 2

Visual analogue scale (VAS) for pain on different procedures. Patients with ICD experience significantly more pain compared with those who had a therapeutic aspiration. Patients who had talc poudrage felt significantly more pain compared with those who had diagnostic thoracoscopy. Data are presented as mean, SD. *p

Figure 3

Correlation of volume output with difference in visual analogue scale (VAS) for dyspnoea for patients with therapeutic aspiration. Circles represent individual data points and solid line the best line that fits. (r2=0.54, p<0.0001).

Figure 4

The number of septations on ultrasound (US) is correlated with the improvement in dyspnoea after ICD insertion. Data are presented as median with IQR (p=0.08, non-parametric comparisons). VAS, visual analogue scale.