Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain

Lars Christian Haugli Bråten; Lars Grøvle; Monica Wigemyr; Maja Wilhelmsen; Elisabeth Gjefsen; Ansgar Espeland; Anne Julsrud Haugen; Jan Sture Skouen; Jens Ivar Brox; John Anker Zwart; Kjersti Storheim; Raymond WJG Ostelo; Margreth Grotle

doi:10.1016/j.jclinepi.2022.07.012

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain

Lars Christian Haugli Bråten^*, Lars Grøvle, Monica Wigemyr, Maja Wilhelmsen, Elisabeth Gjefsen, Ansgar Espeland, Anne Julsrud Haugen, Jan Sture Skouen, Jens Ivar Brox, John Anker Zwart, Kjersti Storheim, Raymond WJG Ostelo, Margreth Grotle

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. Study Design and Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. Results: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15–40% reduction, depending on including “slightly improved” in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. Conclusion: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

Original language	English
Pages (from-to)	75-87
Number of pages	13
Journal	Journal of clinical epidemiology
Volume	151
DOIs	https://doi.org/10.1016/j.jclinepi.2022.07.012
Publication status	Published - Nov 2022

Bibliographical note

Funding Information:
We thank Helse Sør-Øst (grant no: 2015090 ) and Helse Vest (grant no: 911938 and 911891 ) for funding the AIM-study, KLINBEFORSK (grant no: 2017201 ) and all patients participating in the study.

Funding Information:
The AIM-study group: University Hospital North Norway, Tromsø (four patients): Terese Fors, Guro Kjos, Ida Beate Østhus (Department of Rehabilitation). Trondheim University Hospital, Trondheim (21 patients): Gunn Hege Marchand, Britt Elin Lurud, Fredrik Granvigen (Department of Physical Medicine and Rehabilitation), Hege Andersen (National Advisory Unit of Spinal Surgery), Øystein Petter Nygaard, Vidar Rao (Department of Neurosurgery). Haukeland University Hospital, Bergen (37 patients): Thomas Istvan Kadar (Department of Physical Medicine and Rehabilitation), Siv Krüger Claussen, Erling Andersen (Department of Clinical Engineering), Per Kristoffersen and Nils Vetti (Department of Radiology), Jörg Aβmus (Center for Clinical Research). Vestre Viken Hospital, Drammen (38 patients): Sigrun Randen (Department of Physical Medicine and Rehabilitation), Hilde Presberg (Department of Neurology). Oslo University Hospital, Oslo (50 patients): Linda Margareth Pedersen, Bendik Slagsvold Winsvold (FORMI), Karianne Wiger Gammelsrud (Department of microbiology), Maria Dehli Vigeland, Benedicte Alexandra Lie, Siri Tennebø Flåm, Magnus Dehli Vigeland (Department of Medical Genetics). Østfold Hospital Trust (30 patients): Marianne Thorsø, Knut Morten Huneide, (Department of Physical Medicine and Rehabilitation), Veronica Sørensen (Department of Rheumatology). Thor Einar Holmgard (patient representative). We thank Helse Sør-Øst (grant no: 2015090) and Helse Vest (grant no: 911938 and 911891) for funding the AIM-study, KLINBEFORSK (grant no: 2017201) and all patients participating in the study. Author contributions: Lars Christian Haugli Bråten: Conceptualization, Formal analysis, Writing - original draft Lars Grøvle: Investigation, Methodology, Writing - review & editing Monica Wigemyr: Data Curation, Resources, Writing - review & editing Maja Wilhelmsen: Investigation, Writing - review & editing Elisabeth Gjefsen: Writing - review & editing, Visualization Ansgar Espeland: Methodology, Writing - review & editing Anne Julsrud Haugen: Investigation, Writing - review & editing Jan Sture Skouen: Investigation, Writing - review & editing Jens Ivar Brox: Methodology, Supervision, Writing - review & editing John-Anker Zwart: Project administration, Funding acquisition, Writing - review & editing Kjersti Storheim: Project administration, Funding acquisition, Writing - review & editing Raymond WJG Ostelo: Supervision, Methodology, Conceptualization, Writing - review & editing Margreth Grotle: Supervision, Methodology, Conceptualization, Writing - review & editing. Declaration of interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Publisher Copyright:
© 2022 The Author(s)

Keywords

EuroQol's health related quality of life
Low back pain
Minimal important change
Oswestry disability index
Pain intensity numerical rating scale
Patient reported outcome measure
Predictive modeling
Responsiveness
Roland-Morris disability questannaire

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jclinepi.2022.07.012

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Cite this

Bråten, L. C. H., Grøvle, L., Wigemyr, M., Wilhelmsen, M., Gjefsen, E., Espeland, A., Haugen, A. J., Skouen, J. S., Brox, J. I., Zwart, J. A., Storheim, K., Ostelo, R. WJG., & Grotle, M. (2022). Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain. Journal of clinical epidemiology, 151, 75-87. https://doi.org/10.1016/j.jclinepi.2022.07.012

@article{bc56576626ca45ecb034338527d8737e,

title = "Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain",

abstract = "Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. Study Design and Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. Results: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15–40% reduction, depending on including “slightly improved” in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. Conclusion: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.",

keywords = "EuroQol's health related quality of life, Low back pain, Minimal important change, Oswestry disability index, Pain intensity numerical rating scale, Patient reported outcome measure, Predictive modeling, Responsiveness, Roland-Morris disability questannaire",

author = "Br{\aa}ten, {Lars Christian Haugli} and Lars Gr{\o}vle and Monica Wigemyr and Maja Wilhelmsen and Elisabeth Gjefsen and Ansgar Espeland and Haugen, {Anne Julsrud} and Skouen, {Jan Sture} and Brox, {Jens Ivar} and Zwart, {John Anker} and Kjersti Storheim and Ostelo, {Raymond WJG} and Margreth Grotle",

note = "Funding Information: We thank Helse S{\o}r-{\O}st (grant no: 2015090 ) and Helse Vest (grant no: 911938 and 911891 ) for funding the AIM-study, KLINBEFORSK (grant no: 2017201 ) and all patients participating in the study. Funding Information: The AIM-study group: University Hospital North Norway, Troms{\o} (four patients): Terese Fors, Guro Kjos, Ida Beate {\O}sthus (Department of Rehabilitation). Trondheim University Hospital, Trondheim (21 patients): Gunn Hege Marchand, Britt Elin Lurud, Fredrik Granvigen (Department of Physical Medicine and Rehabilitation), Hege Andersen (National Advisory Unit of Spinal Surgery), {\O}ystein Petter Nygaard, Vidar Rao (Department of Neurosurgery). Haukeland University Hospital, Bergen (37 patients): Thomas Istvan Kadar (Department of Physical Medicine and Rehabilitation), Siv Kr{\"u}ger Claussen, Erling Andersen (Department of Clinical Engineering), Per Kristoffersen and Nils Vetti (Department of Radiology), J{\"o}rg Aβmus (Center for Clinical Research). Vestre Viken Hospital, Drammen (38 patients): Sigrun Randen (Department of Physical Medicine and Rehabilitation), Hilde Presberg (Department of Neurology). Oslo University Hospital, Oslo (50 patients): Linda Margareth Pedersen, Bendik Slagsvold Winsvold (FORMI), Karianne Wiger Gammelsrud (Department of microbiology), Maria Dehli Vigeland, Benedicte Alexandra Lie, Siri Tenneb{\o} Fl{\aa}m, Magnus Dehli Vigeland (Department of Medical Genetics). {\O}stfold Hospital Trust (30 patients): Marianne Thors{\o}, Knut Morten Huneide, (Department of Physical Medicine and Rehabilitation), Veronica S{\o}rensen (Department of Rheumatology). Thor Einar Holmgard (patient representative). We thank Helse S{\o}r-{\O}st (grant no: 2015090) and Helse Vest (grant no: 911938 and 911891) for funding the AIM-study, KLINBEFORSK (grant no: 2017201) and all patients participating in the study. Author contributions: Lars Christian Haugli Br{\aa}ten: Conceptualization, Formal analysis, Writing - original draft Lars Gr{\o}vle: Investigation, Methodology, Writing - review & editing Monica Wigemyr: Data Curation, Resources, Writing - review & editing Maja Wilhelmsen: Investigation, Writing - review & editing Elisabeth Gjefsen: Writing - review & editing, Visualization Ansgar Espeland: Methodology, Writing - review & editing Anne Julsrud Haugen: Investigation, Writing - review & editing Jan Sture Skouen: Investigation, Writing - review & editing Jens Ivar Brox: Methodology, Supervision, Writing - review & editing John-Anker Zwart: Project administration, Funding acquisition, Writing - review & editing Kjersti Storheim: Project administration, Funding acquisition, Writing - review & editing Raymond WJG Ostelo: Supervision, Methodology, Conceptualization, Writing - review & editing Margreth Grotle: Supervision, Methodology, Conceptualization, Writing - review & editing. Declaration of interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Publisher Copyright: {\textcopyright} 2022 The Author(s)",

year = "2022",

month = nov,

doi = "10.1016/j.jclinepi.2022.07.012",

language = "English",

volume = "151",

pages = "75--87",

journal = "Journal of clinical epidemiology",

issn = "0895-4356",

publisher = "Elsevier USA",

}

Bråten, LCH, Grøvle, L, Wigemyr, M, Wilhelmsen, M, Gjefsen, E, Espeland, A, Haugen, AJ, Skouen, JS, Brox, JI, Zwart, JA, Storheim, K, Ostelo, RWJG & Grotle, M 2022, 'Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain', Journal of clinical epidemiology, vol. 151, pp. 75-87. https://doi.org/10.1016/j.jclinepi.2022.07.012

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain. / Bråten, Lars Christian Haugli; Grøvle, Lars; Wigemyr, Monica et al.
In: Journal of clinical epidemiology, Vol. 151, 11.2022, p. 75-87.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain

AU - Bråten, Lars Christian Haugli

AU - Grøvle, Lars

AU - Wigemyr, Monica

AU - Wilhelmsen, Maja

AU - Gjefsen, Elisabeth

AU - Espeland, Ansgar

AU - Haugen, Anne Julsrud

AU - Skouen, Jan Sture

AU - Brox, Jens Ivar

AU - Zwart, John Anker

AU - Storheim, Kjersti

AU - Ostelo, Raymond WJG

AU - Grotle, Margreth

N1 - Funding Information: We thank Helse Sør-Øst (grant no: 2015090 ) and Helse Vest (grant no: 911938 and 911891 ) for funding the AIM-study, KLINBEFORSK (grant no: 2017201 ) and all patients participating in the study. Funding Information: The AIM-study group: University Hospital North Norway, Tromsø (four patients): Terese Fors, Guro Kjos, Ida Beate Østhus (Department of Rehabilitation). Trondheim University Hospital, Trondheim (21 patients): Gunn Hege Marchand, Britt Elin Lurud, Fredrik Granvigen (Department of Physical Medicine and Rehabilitation), Hege Andersen (National Advisory Unit of Spinal Surgery), Øystein Petter Nygaard, Vidar Rao (Department of Neurosurgery). Haukeland University Hospital, Bergen (37 patients): Thomas Istvan Kadar (Department of Physical Medicine and Rehabilitation), Siv Krüger Claussen, Erling Andersen (Department of Clinical Engineering), Per Kristoffersen and Nils Vetti (Department of Radiology), Jörg Aβmus (Center for Clinical Research). Vestre Viken Hospital, Drammen (38 patients): Sigrun Randen (Department of Physical Medicine and Rehabilitation), Hilde Presberg (Department of Neurology). Oslo University Hospital, Oslo (50 patients): Linda Margareth Pedersen, Bendik Slagsvold Winsvold (FORMI), Karianne Wiger Gammelsrud (Department of microbiology), Maria Dehli Vigeland, Benedicte Alexandra Lie, Siri Tennebø Flåm, Magnus Dehli Vigeland (Department of Medical Genetics). Østfold Hospital Trust (30 patients): Marianne Thorsø, Knut Morten Huneide, (Department of Physical Medicine and Rehabilitation), Veronica Sørensen (Department of Rheumatology). Thor Einar Holmgard (patient representative). We thank Helse Sør-Øst (grant no: 2015090) and Helse Vest (grant no: 911938 and 911891) for funding the AIM-study, KLINBEFORSK (grant no: 2017201) and all patients participating in the study. Author contributions: Lars Christian Haugli Bråten: Conceptualization, Formal analysis, Writing - original draft Lars Grøvle: Investigation, Methodology, Writing - review & editing Monica Wigemyr: Data Curation, Resources, Writing - review & editing Maja Wilhelmsen: Investigation, Writing - review & editing Elisabeth Gjefsen: Writing - review & editing, Visualization Ansgar Espeland: Methodology, Writing - review & editing Anne Julsrud Haugen: Investigation, Writing - review & editing Jan Sture Skouen: Investigation, Writing - review & editing Jens Ivar Brox: Methodology, Supervision, Writing - review & editing John-Anker Zwart: Project administration, Funding acquisition, Writing - review & editing Kjersti Storheim: Project administration, Funding acquisition, Writing - review & editing Raymond WJG Ostelo: Supervision, Methodology, Conceptualization, Writing - review & editing Margreth Grotle: Supervision, Methodology, Conceptualization, Writing - review & editing. Declaration of interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Publisher Copyright: © 2022 The Author(s)

PY - 2022/11

Y1 - 2022/11

N2 - Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. Study Design and Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. Results: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15–40% reduction, depending on including “slightly improved” in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. Conclusion: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

AB - Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. Study Design and Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. Results: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15–40% reduction, depending on including “slightly improved” in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. Conclusion: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

KW - EuroQol's health related quality of life

KW - Low back pain

KW - Minimal important change

KW - Oswestry disability index

KW - Pain intensity numerical rating scale

KW - Patient reported outcome measure

KW - Predictive modeling

KW - Responsiveness

KW - Roland-Morris disability questannaire

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UR - http://www.scopus.com/inward/citedby.url?scp=85137020360&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2022.07.012

DO - 10.1016/j.jclinepi.2022.07.012

M3 - Article

C2 - 35926821

AN - SCOPUS:85137020360

SN - 0895-4356

VL - 151

SP - 75

EP - 87

JO - Journal of clinical epidemiology

JF - Journal of clinical epidemiology

ER -

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain

Abstract

Bibliographical note

Keywords

UN SDGs

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