Measurement characteristics of two asthma symptom diary scales for use in clinical trials.

نویسندگان

  • N C Santanello
  • B L Barber
  • T F Reiss
  • B S Friedman
  • E F Juniper
  • J Zhang
چکیده

The measurement characteristics of two asthma symptom diary scales developed for use as health outcome measures in clinical trials of asthma therapy were investigated. A daytime diary scale was designed to capture the frequency and inconvenience of daytime asthma symptoms and their effects on activities, and a nocturnal asthma symptom diary scale was designed to capture awakenings with asthma symptoms. The internal consistency, reliability, validity and responsiveness of both asthma diary scales were assessed in 346 adult asthma patients in two placebo-controlled clinical trials of an investigational asthma therapy, a leukotriene biosynthesis inhibitor. The daytime symptom scale showed sufficient internal consistency (0.90-0.92), and the daytime and nocturnal symptom scales showed sufficient test retest reliability (0.69-0.87). Construct validity was demonstrated by generally moderate-to-strong correlations for changes in the diary scales with changes in other measures of asthma status, such as forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), and puffs of beta-agonist inhaler. Both scales demonstrated significant responsiveness to change in asthma due to therapy in one of the clinical trials. Based on these results, the daytime and nocturnal asthma symptom diary scales show measurement characteristics appropriate for use as asthma outcome measures in clinical trials of asthma therapy.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Proxy-reported questionnaires for young children with asthma: a structured review.

Which proxy-reported outcome measures have been developed for use with children aged 6 years and younger to assess asthma symptoms, asthma control, and asthma-specific health-related quality of life, and do these questionnaires' measurement properties support their use as end-points in clinical trials? A two-phase literature search was conducted: 1) studies describing relevant questionnaires we...

متن کامل

Visual analogue scale (VAS) as a monitoring tool for daily changes in asthma symptoms in adolescents: a prospective study

BACKGROUND Success in asthma management hinges on patients' competency to detect and respond to ever-changing symptom severity. Thus, it is crucial to have reliable, simple, and sustainable methods of symptom monitoring that can be readily incorporated into daily life. Although visual analogue scale (VAS) has been considered as a simple symptom assessment method, its utility as a daily symptom ...

متن کامل

Validation of an asthma quality of life diary in a clinical trial.

BACKGROUND Quality of life (QOL) is commonly measured in asthma clinical trials by a questionnaire given before and after treatment. A structured asthma QOL daily diary provides more restricted information but on a daily basis. The validity and use of such a QOL diary was examined in a clinical trial in which two asthma treatments were compared. METHODS The effects of low dose inhaled steroid...

متن کامل

Validation of an asthma symptom diary for interventional studies.

OBJECTIVE The Pediatric Asthma Diary was developed and validated to assess efficacy of interventions in children with asthma. DESIGN, PATIENTS, AND SETTING Diary validation was performed in a three week, prospective study of 106 children aged 6-14 years with asthma. Children were classified at baseline as either stable (requiring no additional asthma treatment) or new onset/worse (requiring e...

متن کامل

Symptoms and markers of symptom severity in asthma—content validity of the asthma symptom diary

BACKGROUND AND OBJECTIVES The American Thoracic Society/European Respiratory Society (ATS/ERS) Task Force acknowledged the multi-faceted nature of asthma in its recent definition of asthma control as a summary term capturing symptoms, reliever use, frequency/severity of exacerbations, lung function, and future risk and the Global Initiative for Asthma (GINA) defines the clinical manifestations ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • The European respiratory journal

دوره 10 3  شماره 

صفحات  -

تاریخ انتشار 1997