Chest
Volume 122, Issue 3, September 2002, Pages 920-929
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Clinical Investigations
Pneumonia
The Community-Acquired Pneumonia Symptom Questionnaire: A New, Patient-Based Outcome Measure To Evaluate Symptoms in Patients With Community-Acquired Pneumonia

https://doi.org/10.1378/chest.122.3.920Get rights and content

Study objectives

To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP).

Design

A psychometric study within an international, prospective, randomized, double-blind study. The CAP-symptom questionnaire (CAP-Sym) is a new, 18-item, patient-reported outcome measure that evaluates the bothersomeness of CAP-related symptoms during the past 24 h using a 6-point Likert scale. We used “gold standard” psychometric methods to comprehensively evaluate the acceptability, reliability, validity, and responsiveness of the CAP-Sym.

Setting

Sixty-four centers in 13 countries (France, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom).

Patients

Five hundred fifty-six patients with CAP, recruited from outpatient clinics, general practice, and hospital centers.

Interventions

Randomization 1:1 to moxifloxacin (400 mg once daily), oral or standard oral treatment (amoxicillin, 1 g tid, or clarithromycin, 500 mg bid), alone or in combination, for up to 14 days.

Results

Standard psychometric tests confirmed the acceptability (item nonresponse, item-endorsement frequencies, item/scale floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations, test-retest reliability), validity (content, construct, convergent, discriminant, known groups), and responsiveness of the CAP-Sym.

Conclusions

The CAP-Sym is a practical and scientifically sound patient-based outcome measure of CAP-related symptoms that has been developed using “gold standard” methods. As the only fully validated measure of symptoms in patients with CAP, which is quick and easy to administer and is more responsive than the generic Medical Outcomes Study 36-Item Short-Form Health Survey, the CAP-Sym provides a practical and rigorous method for improving the evaluation of outcomes in clinical trials and audit.

Section snippets

Questionnaire Development

We interviewed 33 patients with CAP in the United States and France to identify content domains and questions for the CAP-Sym. The interview sample included patients at different stages of the condition: from onset to up to 7 days after onset (5 US patients, 2 French patients), 8 to 21 days after onset (10 US patients, 7 French patients), and at the end of oral antimicrobial treatment (at least 28 days after onset; 5 US patients, 4 French patients). The patients’ mean age was 52 years, and 58%

Respondent Characteristics

As shown in Table 2, a total of 556 patients from 13 countries completed the baseline assessment. The sample included 321 men (58%) and 235 women (42%), who ranged in age from 17 to 97 years (mean, 50.41 years).

Item Reduction

The unrotated principal component factor analysis confirmed that items were measuring a single construct. One item (coughing up blood) that did not load on the first unrotated factor > 0.30 was sufficiently near to this criterion (0.27) to support this assumption. There was a low

Discussion

The CAP-Sym is a practical and scientifically sound patient-based outcome measure of CAP-related symptoms that has been developed using “gold standard” methods. As the only fully validated measure of symptoms in CAP, which is quick and easy to administer and is more responsive than the generic SF-36, the CAP-Sym provides a rigorous method for improving the evaluation of treatment outcomes in CAP. A short questionnaire that takes < 2 min to complete, it can be easily incorporated into clinical

APPENDIX

Acknowledgment

We thank the study investigators in each of the clinical sites.

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    This work was funded by Bayer plc. Drs. Lamping and Schroter have received research funding and support for attending con- ferences from Bayer. MAPI Values (Dr. Marquis and Ms. Marrel) has received funding from Bayer for consulting, questionnaire development, and linguistic validation.

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