Responsiveness of Clinical Outcome Measures: An Investigation of Low Back Pain Patients Seen in the Primary and Secondary Sectors of the Danish Health Care System

Research output: Book/anthology/thesis/reportPh.D. thesisResearch

Abstract

Background

The Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover, the most commonly used retrospective method to establish the MCID has inherent methodological flaws. Perhaps it would be more prudent to ask LBP patients what is an acceptable result of the treatment before it begins?

Objectives

The overall objective was to establish the responsiveness and MCID in specific subgroups of patients with LBP. In addition, we explored whether low back pain patients were able to determine an acceptable treatment outcome before it began.

Methods

The responsiveness in subgroups study.
An extensive cross-cultural adaptation and validation of the ODI was carried out on patients seen in the primary (PrS) and secondary sectors (SeS) of the Danish health care system.

The prospective acceptable outcome study.
A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining the MCID (MCIDpost).

Results

The responsiveness in subgroups study.
The ODI measurement error ranged between -11.5 and +13 points. Responsiveness was comparable to the external measures. A floor effect was seen in the PrS patients. The MCID was nine points in PrS and LBP only patients and eight points in SeS and leg pain patients. Moreover, patients' retrospective evaluation of treatment effect was more responsive in PrS patients compared to serial measurements.

The prospective acceptable outcome study.
The prospective acceptable outcome method was reproducible. The MCIDpre was outside instrument measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale.

Conclusion

The Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more appropriate in SeS patients. In addition, the Roland Morris Disability Questionnaire (RMQ) is the most suitable for patients with LBP only whereas the ODI and RMQ is equally suitable for patients with leg pain. The choice of pain scale is arbitrary in all subgroups and the pain subscale of the Low Back Pain Rating Scale is recommended. The MCID was more or less stable across subgroups for most instruments and increased monotonously with baseline condition severity in PrS and LBP patients only.

The clinical question: “how are you now compared to when you started the treatment” seems to be most sensitive to condition alterations in PrS patients and should be added as an outcome measure to standard questionnaires used serially.

The prospective acceptable outcome method offers a benchmark by which clinicians can balance any mismatch between what are acceptable outcomes to the patient with what is realistically obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains.

Original languageEnglish
Place of PublicationOdense
PublisherSyddansk Universitet
Number of pages193
Publication statusPublished - 2007

Fingerprint

Low Back Pain
Outcome Assessment (Health Care)
Delivery of Health Care
Leg
Health
Benchmarking
Psychometrics

Keywords

  • Low back pain
  • Klinimetri
  • Måleinstrumenter
  • Funktion
  • Smerte
  • Spørgeskemaer
  • Sensitivity and Specificity
  • Mindste kliniske vigtige ændring
  • Mindste målbare ændring
  • Primær og sekundær sektor patienter
  • Transition spørgsmål

Cite this

@phdthesis{4f4b3560e9df11dca4f8000ea68e967b,
title = "Responsiveness of Clinical Outcome Measures: An Investigation of Low Back Pain Patients Seen in the Primary and Secondary Sectors of the Danish Health Care System",
abstract = "BackgroundThe Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover, the most commonly used retrospective method to establish the MCID has inherent methodological flaws. Perhaps it would be more prudent to ask LBP patients what is an acceptable result of the treatment before it begins?ObjectivesThe overall objective was to establish the responsiveness and MCID in specific subgroups of patients with LBP. In addition, we explored whether low back pain patients were able to determine an acceptable treatment outcome before it began.MethodsThe responsiveness in subgroups study.An extensive cross-cultural adaptation and validation of the ODI was carried out on patients seen in the primary (PrS) and secondary sectors (SeS) of the Danish health care system.The prospective acceptable outcome study.A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining the MCID (MCIDpost).ResultsThe responsiveness in subgroups study.The ODI measurement error ranged between -11.5 and +13 points. Responsiveness was comparable to the external measures. A floor effect was seen in the PrS patients. The MCID was nine points in PrS and LBP only patients and eight points in SeS and leg pain patients. Moreover, patients' retrospective evaluation of treatment effect was more responsive in PrS patients compared to serial measurements.The prospective acceptable outcome study.The prospective acceptable outcome method was reproducible. The MCIDpre was outside instrument measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale.ConclusionThe Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more appropriate in SeS patients. In addition, the Roland Morris Disability Questionnaire (RMQ) is the most suitable for patients with LBP only whereas the ODI and RMQ is equally suitable for patients with leg pain. The choice of pain scale is arbitrary in all subgroups and the pain subscale of the Low Back Pain Rating Scale is recommended. The MCID was more or less stable across subgroups for most instruments and increased monotonously with baseline condition severity in PrS and LBP patients only.The clinical question: “how are you now compared to when you started the treatment” seems to be most sensitive to condition alterations in PrS patients and should be added as an outcome measure to standard questionnaires used serially.The prospective acceptable outcome method offers a benchmark by which clinicians can balance any mismatch between what are acceptable outcomes to the patient with what is realistically obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains.",
keywords = "L{\ae}ndesmerter, Clinimetrics, Outcome measures, Disability, Pain, Questionnaires, Sensitivitet og specificitet, Minimal clinically important difference, Minimal detectable change, Primary and secondary sector patients, Transition questions, Low back pain, Klinimetri, M{\aa}leinstrumenter, Funktion, Smerte, Sp{\o}rgeskemaer, Sensitivity and Specificity, Mindste kliniske vigtige {\ae}ndring, Mindste m{\aa}lbare {\ae}ndring, Prim{\ae}r og sekund{\ae}r sektor patienter, Transition sp{\o}rgsm{\aa}l",
author = "Lauridsen, {Henrik Hein}",
year = "2007",
language = "English",
publisher = "Syddansk Universitet",
address = "Denmark",

}

TY - BOOK

T1 - Responsiveness of Clinical Outcome Measures

T2 - An Investigation of Low Back Pain Patients Seen in the Primary and Secondary Sectors of the Danish Health Care System

AU - Lauridsen, Henrik Hein

PY - 2007

Y1 - 2007

N2 - BackgroundThe Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover, the most commonly used retrospective method to establish the MCID has inherent methodological flaws. Perhaps it would be more prudent to ask LBP patients what is an acceptable result of the treatment before it begins?ObjectivesThe overall objective was to establish the responsiveness and MCID in specific subgroups of patients with LBP. In addition, we explored whether low back pain patients were able to determine an acceptable treatment outcome before it began.MethodsThe responsiveness in subgroups study.An extensive cross-cultural adaptation and validation of the ODI was carried out on patients seen in the primary (PrS) and secondary sectors (SeS) of the Danish health care system.The prospective acceptable outcome study.A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining the MCID (MCIDpost).ResultsThe responsiveness in subgroups study.The ODI measurement error ranged between -11.5 and +13 points. Responsiveness was comparable to the external measures. A floor effect was seen in the PrS patients. The MCID was nine points in PrS and LBP only patients and eight points in SeS and leg pain patients. Moreover, patients' retrospective evaluation of treatment effect was more responsive in PrS patients compared to serial measurements.The prospective acceptable outcome study.The prospective acceptable outcome method was reproducible. The MCIDpre was outside instrument measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale.ConclusionThe Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more appropriate in SeS patients. In addition, the Roland Morris Disability Questionnaire (RMQ) is the most suitable for patients with LBP only whereas the ODI and RMQ is equally suitable for patients with leg pain. The choice of pain scale is arbitrary in all subgroups and the pain subscale of the Low Back Pain Rating Scale is recommended. The MCID was more or less stable across subgroups for most instruments and increased monotonously with baseline condition severity in PrS and LBP patients only.The clinical question: “how are you now compared to when you started the treatment” seems to be most sensitive to condition alterations in PrS patients and should be added as an outcome measure to standard questionnaires used serially.The prospective acceptable outcome method offers a benchmark by which clinicians can balance any mismatch between what are acceptable outcomes to the patient with what is realistically obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains.

AB - BackgroundThe Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover, the most commonly used retrospective method to establish the MCID has inherent methodological flaws. Perhaps it would be more prudent to ask LBP patients what is an acceptable result of the treatment before it begins?ObjectivesThe overall objective was to establish the responsiveness and MCID in specific subgroups of patients with LBP. In addition, we explored whether low back pain patients were able to determine an acceptable treatment outcome before it began.MethodsThe responsiveness in subgroups study.An extensive cross-cultural adaptation and validation of the ODI was carried out on patients seen in the primary (PrS) and secondary sectors (SeS) of the Danish health care system.The prospective acceptable outcome study.A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining the MCID (MCIDpost).ResultsThe responsiveness in subgroups study.The ODI measurement error ranged between -11.5 and +13 points. Responsiveness was comparable to the external measures. A floor effect was seen in the PrS patients. The MCID was nine points in PrS and LBP only patients and eight points in SeS and leg pain patients. Moreover, patients' retrospective evaluation of treatment effect was more responsive in PrS patients compared to serial measurements.The prospective acceptable outcome study.The prospective acceptable outcome method was reproducible. The MCIDpre was outside instrument measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale.ConclusionThe Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more appropriate in SeS patients. In addition, the Roland Morris Disability Questionnaire (RMQ) is the most suitable for patients with LBP only whereas the ODI and RMQ is equally suitable for patients with leg pain. The choice of pain scale is arbitrary in all subgroups and the pain subscale of the Low Back Pain Rating Scale is recommended. The MCID was more or less stable across subgroups for most instruments and increased monotonously with baseline condition severity in PrS and LBP patients only.The clinical question: “how are you now compared to when you started the treatment” seems to be most sensitive to condition alterations in PrS patients and should be added as an outcome measure to standard questionnaires used serially.The prospective acceptable outcome method offers a benchmark by which clinicians can balance any mismatch between what are acceptable outcomes to the patient with what is realistically obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains.

KW - Lændesmerter

KW - Clinimetrics

KW - Outcome measures

KW - Disability

KW - Pain

KW - Questionnaires

KW - Sensitivitet og specificitet

KW - Minimal clinically important difference

KW - Minimal detectable change

KW - Primary and secondary sector patients

KW - Transition questions

KW - Low back pain

KW - Klinimetri

KW - Måleinstrumenter

KW - Funktion

KW - Smerte

KW - Spørgeskemaer

KW - Sensitivity and Specificity

KW - Mindste kliniske vigtige ændring

KW - Mindste målbare ændring

KW - Primær og sekundær sektor patienter

KW - Transition spørgsmål

M3 - Ph.D. thesis

BT - Responsiveness of Clinical Outcome Measures

PB - Syddansk Universitet

CY - Odense

ER -