Responsiveness of the PROMIS® measures to changes in disease status among pediatric nephrotic syndrome patients: a Midwest pediatric nephrology consortium study

Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study...

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Veröffentlicht in:	Health and quality of life outcomes Jg. 15; H. 1; S. 166
Hauptverfasser:	Selewski, David T., Troost, Jonathan P., Cummings, Danyelle, Massengill, Susan F., Gbadegesin, Rasheed A., Greenbaum, Larry A., Shatat, Ibrahim F., Cai, Yi, Kapur, Gaurav, Hebert, Diane, Somers, Michael J., Trachtman, Howard, Pais, Priya, Seifert, Michael E., Goebel, Jens, Sethna, Christine B., Mahan, John D., Gross, Heather E., Herreshoff, Emily, Liu, Yang, Carlozzi, Noelle E., Reeve, Bryce B., DeWalt, Darren A., Gipson, Debbie S.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	London BioMed Central 23.08.2017 BioMed Central Ltd Springer Nature B.V
Schlagworte:	Adolescent Age Anchoring Anxiety Anxiety - psychology Assessment centers Care and treatment Child Children Chronic illnesses Consortia Correlation analysis Depression - psychology Edema Evaluation Family medical history Fatigue Fatigue - psychology Female Health Status Humans Information systems Interference Interpersonal Relations Kidney diseases Male Measurement Medicine Medicine & Public Health Mental depression Mobility Nephrology Nephrotic syndrome Nephrotic Syndrome - psychology Pain Pain - psychology Patient Reported Outcome Measures Patients Pediatric diseases Pediatrics Peer relationships Population Prospective Studies Proteins Proteinuria Quality of Life Quality of Life Research Remission Self Report - standards Urine Pediatrics Nephrotic syndrome Patient-reported outcomes Children Quality of life
ISSN:	1477-7525, 1477-7525
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Abstract	Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. Methods One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Results Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time ( p < 0.001). When the PROMIS measures were compared to the patients’ global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. Conclusion This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure.
AbstractList	Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. Methods One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Results Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time ( p < 0.001). When the PROMIS measures were compared to the patients’ global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. Conclusion This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure. Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure. Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure. Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. Methods One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Results Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. Conclusion This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure. Keywords: Patient-reported outcomes, Quality of life, Nephrotic syndrome, Pediatrics, Children Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome.BACKGROUNDNephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome.One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items.METHODSOne hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items.Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores.RESULTSDisease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores.This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure.CONCLUSIONThis study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure. Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. Methods One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Results Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients’ global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. Conclusion This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure.
ArticleNumber	166
Audience	Academic
Author	Massengill, Susan F. Greenbaum, Larry A. Troost, Jonathan P. Mahan, John D. Reeve, Bryce B. Gross, Heather E. Cummings, Danyelle Selewski, David T. Carlozzi, Noelle E. Hebert, Diane Liu, Yang Cai, Yi Kapur, Gaurav Somers, Michael J. Gipson, Debbie S. Shatat, Ibrahim F. Goebel, Jens Pais, Priya Gbadegesin, Rasheed A. DeWalt, Darren A. Seifert, Michael E. Sethna, Christine B. Herreshoff, Emily Trachtman, Howard
Author_xml	– sequence: 1 givenname: David T. surname: Selewski fullname: Selewski, David T. email: dselewsk@med.umich.edu organization: Division of Nephrology, Department of Pediatrics & Communicable Diseases, C.S. Mott Children’s Hospital, University of Michigan – sequence: 2 givenname: Jonathan P. surname: Troost fullname: Troost, Jonathan P. organization: Division of Nephrology, Department of Pediatrics & Communicable Diseases, C.S. Mott Children’s Hospital, University of Michigan – sequence: 3 givenname: Danyelle surname: Cummings fullname: Cummings, Danyelle organization: Division of Nephrology, Department of Pediatrics & Communicable Diseases, C.S. Mott Children’s Hospital, University of Michigan – sequence: 4 givenname: Susan F. surname: Massengill fullname: Massengill, Susan F. organization: Division of Pediatric Nephrology, Levine Children’s Hospital – sequence: 5 givenname: Rasheed A. surname: Gbadegesin fullname: Gbadegesin, Rasheed A. organization: Department of Pediatrics, Division of Nephrology, Duke University Medical Center – sequence: 6 givenname: Larry A. surname: Greenbaum fullname: Greenbaum, Larry A. organization: Department of Pediatrics, Emory University and Children’s Healthcare of Atlanta – sequence: 7 givenname: Ibrahim F. surname: Shatat fullname: Shatat, Ibrahim F. organization: Pediatric Nephrology and Hypertension, Sidra Medical and Research Center – sequence: 8 givenname: Yi surname: Cai fullname: Cai, Yi organization: DeVos Children’s Hospital – sequence: 9 givenname: Gaurav surname: Kapur fullname: Kapur, Gaurav organization: Pediatric Nephrology and Hypertension Division, Children’s Hospital of Michigan – sequence: 10 givenname: Diane surname: Hebert fullname: Hebert, Diane organization: Division of Nephrology, The Hospital for Sick Children – sequence: 11 givenname: Michael J. surname: Somers fullname: Somers, Michael J. organization: Division of Nephrology, Boston Children’s Hospital, Harvard Medical School – sequence: 12 givenname: Howard surname: Trachtman fullname: Trachtman, Howard organization: Department of Pediatrics, Division of Nephrology, New York University Langone Medical Center – sequence: 13 givenname: Priya surname: Pais fullname: Pais, Priya organization: Pediatric Nephrology and Hypertension, Medical College of Wisconsin – sequence: 14 givenname: Michael E. surname: Seifert fullname: Seifert, Michael E. organization: Division of Pediatric Nephrology, Department of Pediatrics, University of Alabama Birmingham – sequence: 15 givenname: Jens surname: Goebel fullname: Goebel, Jens organization: Division of Nephrology and Hypertension, Cincinnati Children’s Hospital – sequence: 16 givenname: Christine B. surname: Sethna fullname: Sethna, Christine B. organization: Division of Pediatric Nephrology, Cohen Children’s Medical Center of New York – sequence: 17 givenname: John D. surname: Mahan fullname: Mahan, John D. organization: Nationwide Children’s Hospital, The Ohio State University, College of Medicine – sequence: 18 givenname: Heather E. surname: Gross fullname: Gross, Heather E. organization: University of North Carolina – sequence: 19 givenname: Emily surname: Herreshoff fullname: Herreshoff, Emily organization: Division of Nephrology, Department of Pediatrics & Communicable Diseases, C.S. Mott Children’s Hospital, University of Michigan – sequence: 20 givenname: Yang surname: Liu fullname: Liu, Yang organization: Department of Psychology, University of North Carolina – sequence: 21 givenname: Noelle E. surname: Carlozzi fullname: Carlozzi, Noelle E. organization: Department of Physical Medicine and Rehabilitation, University of Michigan – sequence: 22 givenname: Bryce B. surname: Reeve fullname: Reeve, Bryce B. organization: University of North Carolina – sequence: 23 givenname: Darren A. surname: DeWalt fullname: DeWalt, Darren A. organization: University of North Carolina – sequence: 24 givenname: Debbie S. surname: Gipson fullname: Gipson, Debbie S. organization: Division of Nephrology, Department of Pediatrics & Communicable Diseases, C.S. Mott Children’s Hospital, University of Michigan
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Snippet	Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of... Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The... Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of...
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