Sensitivity, specificity, reliability, and clinical validity of provider-reported symptoms: A comparison with self-reported symptoms

Amy C. Justice, Linda Rabeneck, Ron D. Hays, Albert W. Wu, Samuel A. Bozzette

Research output: Contribution to journalArticlepeer-review

Abstract

Background: If symptoms are to be recognized and effectively addressed in clinical research, they must be collected using sensitive, specific, reliable, and clinically meaningful methods. Objective: To perform a comparison of self-administered symptom survey data with data from conventional provider-reports. Design/Methods: Secondary data analysis of AIDS Clinical Trials Group Study 081 (ACTG 081), a randomized trial taking place in 33 sites comparing three approaches to prophylaxis for Pneumocystis carinii-related pneumonia that found no difference among treatment arms. The study was performed on 842 subjects with advanced HIV infection. No intervention was undertaken as a result of this study. ACTG 081 included data on functional status, global quality of life and survival, and two methods of symptom measurement: an open-ended, provider-reported symptom assessment (provider-report) and a self-administered symptom survey (self-report). Agreement was measured using kappa scores. Sensitivity and specificity were calculated using self-report as the standard. Reliability was measured by intersite variation and test-retest reliability (8 weeks later). Clinical validity was evaluated by testing expected associations with functional status, global quality of life, and survival. Results: Symptom data were available for 808 patients (96%). Patient and provider agreement was poor (mean κ, 0.14; range, 0.07-0.25). Compared with self-report, providers underreported the presence and severity of symptoms (mean symptom count, 5.2 versus 1.3; mean severity score, 1.3 versus 0.74). provider-report demonstrated greater variability by site (R2 associated with site, 0.02 versus 0.16) and poorer test-retest reliability (mean κ, 0.34 versus 0.25). Provider-report severity scores were less strongly associated than were self- report with functional status (χ2, 252 versus 80), global quality of life (R2 for model, 0.57 versus 0.15), and survival (χ2, 38 versus 24). Self- reported symptom severity was strongly correlated to patient-reported global quality of life (p, 0.75; p < .0001). Conclusions: Provider-reported symptoms as currently collected within the ACTG are less sensitive and reproducible than a self-administered symptom survey. Provider-reported severity scores are also more weakly associated with functional status, global quality of life, and survival. A self-reported symptom survey may provide a better method of symptom measurement for HIV research.

Original languageEnglish (US)
Pages (from-to)126-133
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume21
Issue number2
StatePublished - Jun 1 1999

Keywords

  • Adverse drug reactions
  • Functional status
  • Global quality of life
  • HIV infection
  • Reliability
  • Survival
  • Symptoms
  • Validity

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Virology

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