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Patient-Reported Outcome Measures for Symptom Perception During a Cystic Fibrosis Exacerbation


Schmid-Mohler, Gabriela; Caress, Ann-Louise; Spirig, Rebecca; Benden, Christian; Yorke, Janelle (2018). Patient-Reported Outcome Measures for Symptom Perception During a Cystic Fibrosis Exacerbation. Respiratory Care, 63(3):353-366.

Abstract

BACKGROUND Symptom burden increases during pulmonary exacerbations of cystic fibrosis (CF), and patient-reported outcome measures (PROMs) are often used to evaluate symptoms as either primary or secondary outcomes. However, there is currently no guidance on the use of PROMs to assess symptom burden during pulmonary exacerbations. METHODS A systematic literature search was conducted to identify PROMs measuring symptom experience, management, or influencing factors, which were developed for CF patients and had been used at least once during pulmonary exacerbations. The PROMs included were assessed for relevance and psychometrics, according to the criteria of the United States FDA guideline and the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. RESULTS Five PROMs were identified, all measuring symptom perception. The CF Respiratory Symptom Diary (CFRSD) and the Symptom Scoring System were developed to assess symptom severity during pulmonary exacerbations. Of the other 3, which also included symptom scores of 2 quality of life measures, one assessed symptom severity exclusively, and 2 measured symptom severity in addition to other dimensions (such as symptom distress). All 5 instruments measured respiratory symptoms. Other relevant symptoms, such as energy and emotions, were covered by 4 instruments; pain and gastrointestinal symptoms were covered by 2 measures. All of the instruments demonstrated good internal consistency and sensitivity to change over a period up to 4 weeks. The symptom scores of the 2 quality of life measures with longer recall periods are not suitable for measuring assessed changes in a period of < 2 weeks. Criterion validity for gastrointestinal subscores has not been established. Discriminant validity was established in all of the instruments reviewed except for the Symptom Score System. CONCLUSIONS Of the current PROMs used during CF pulmonary exacerbations, only 2 have been developed for this purpose, and only the CFRSD fulfilled all FDA guideline criteria. To date, there is no instrument that assesses exacerbation-specific symptom distress.

Abstract

BACKGROUND Symptom burden increases during pulmonary exacerbations of cystic fibrosis (CF), and patient-reported outcome measures (PROMs) are often used to evaluate symptoms as either primary or secondary outcomes. However, there is currently no guidance on the use of PROMs to assess symptom burden during pulmonary exacerbations. METHODS A systematic literature search was conducted to identify PROMs measuring symptom experience, management, or influencing factors, which were developed for CF patients and had been used at least once during pulmonary exacerbations. The PROMs included were assessed for relevance and psychometrics, according to the criteria of the United States FDA guideline and the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. RESULTS Five PROMs were identified, all measuring symptom perception. The CF Respiratory Symptom Diary (CFRSD) and the Symptom Scoring System were developed to assess symptom severity during pulmonary exacerbations. Of the other 3, which also included symptom scores of 2 quality of life measures, one assessed symptom severity exclusively, and 2 measured symptom severity in addition to other dimensions (such as symptom distress). All 5 instruments measured respiratory symptoms. Other relevant symptoms, such as energy and emotions, were covered by 4 instruments; pain and gastrointestinal symptoms were covered by 2 measures. All of the instruments demonstrated good internal consistency and sensitivity to change over a period up to 4 weeks. The symptom scores of the 2 quality of life measures with longer recall periods are not suitable for measuring assessed changes in a period of < 2 weeks. Criterion validity for gastrointestinal subscores has not been established. Discriminant validity was established in all of the instruments reviewed except for the Symptom Score System. CONCLUSIONS Of the current PROMs used during CF pulmonary exacerbations, only 2 have been developed for this purpose, and only the CFRSD fulfilled all FDA guideline criteria. To date, there is no instrument that assesses exacerbation-specific symptom distress.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Pneumology
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Pulmonary and Respiratory Medicine
Health Sciences > Critical Care and Intensive Care Medicine
Language:English
Date:March 2018
Deposited On:03 Jan 2019 11:33
Last Modified:29 Jul 2020 08:52
Publisher:Daedalus Enterprises, Inc.
ISSN:0020-1324
OA Status:Closed
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.4187/respcare.05638
PubMed ID:29317460

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