Validation of a visual analogue symptom score - the LRTI (lower respiratory tract infections)-VAS- in non-CF bronchiectasis

Bronchiectasis means irreversible, pathologic dilatation of the small and
medium-sized bronchi, resulting from a vicious cycle of inflammation and
bacterial colonization [1-3]. Although the etiology remains unclear in a large
percentage of patients (53-60%), common causes include immune defects, early
childhood infections, and aspiration [4-6]. Typically, the course of the
disease is highly variable, including nearly symptom free periods interspersed
with infective exacerbations.
A fairly large percentage of patients with bronchiectasis suffers from chronic
complaints, such as productive cough, dyspneu and fatigue [7,8]. Infective
exacerbations are characterized by worsening of symptoms and signs of pneumonia
[9].
Although the disease was considered offensive and untreatable in the
pre-antibiotic era, infections and symptoms are nowadays mostly well controlled
with antibiotics and supportive therapy [10]. However, many patients with
bronchiectasis today still experience feelings of embarrassment about their
coughing or bronchorrhoea, sometimes leading towards social isolation.

Clinical measures, such as FEV1 or oxygen saturation often correlate only
moderately with functional capacity and well-being of a patient with
bronchiectasis [11-13]. The main determinants of a patients health-related
quality of life (HRQL) appear to be the degree of dyspnoea and daily sputum
production together with the number of infective exacerbations [14,15].
Measurement of symptoms and HRQL is therefore very useful in monitoring disease
activity and assessing the impact of the disease on the patient*s daily life.
Clinical trials designed to evaluate the effect of treatment in pulmonary
diseases also frequently use HRQL or patient-reported symptoms as outcome
measures.
Nevertheless, only one specific HRQL-measure has been developed and validated
for bronchiectasis, the St George*s Respiratory Questionnaire (SGRQ) [16].

We developed a symptom scale that can be used to quantify the degree of
dyspnoea, fatigue, cough, pain and sputum colour in bronchiectatic patients.
The LRTI-VAS consists of a set of horizontal lines with two anchor points, one
at each extreme, each line representing a different symptom. The VAS (visual
analogue scale) is scored from 1 to 10, the subjects being unaware of the
numbers. Higher scores indicate more severe symptoms. Other authors showed that
a VAS-score allows reproducible measurement of breathlessness and fatigue in
both normal subjects and patients [17-19]. Furthermore it has been shown to be
sensitive to changes when measuring breathlessness [20].
The LRTI-VAS is significantly less time consuming than the SGRQ and has a low
administrative burden. Because of its simple design, it is equally suitable for
use in patients with reading difficulties or educationally subnormal patients.

To assess the validity, reliability and responsiveness of the LRTI-VAS in
non-cystic fibrosis bronchiectasis.

Part 1:
20 participants are studied on two separate days, 3 weeks apart, in a
clinically stable situation (no infective exacerbations one month before study
entry). At day 1 and day 21 each patient is asked to complete the VAS-score and
a number of other HRQL- measurements; the SF-36 Health Survey Questionnaire,
the St George Respiratory Questionnaire (SGRQ) and the Hospital Anxiety and
Depression (HAD) scale. The questionnaires are presented to the patients in a
randomized order.
On both occasions flow-volume spirometry is performed, by means of a hand-held
spirometer, operated by the researcher. Arterial oxygen saturation is measured,
using a fingertip pulse oximeter.
For each patient results of recent ( < 6 months ago) lung function testing and
a HRCT-scan are obtained. Furthermore, at day 1 each patient is asked to report
the number of infective exacerbations they have experienced over the year
before study entry and the date of the last exacerbation.

Part 2:
30 patients with bronchiectasis who present with an acute infectious
exacerbation are asked to complete the SGRQ, VAS, HADS and SF-36. The
questionnaires are completed immediately prior to commencing antibiotic
treatment and 1 week following completion of treatment. The questionnaires are
adapted to ask about symptoms in the preceding week.
On both occasions flow-volume spirometry is performed, by means of a hand-held
spirometer, operated by the researcher. Arterial oxygen saturation is measured,
using a fingertip pulse oximeter.

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