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

Publikation: Bog/antologi/afhandling/rapportPh.d.-afhandlingForskning

Resumé

Baggrund

Oswestry Disability Index (ODI) er et af to anbefalede spørgeskemaer til brug ved måling af funktion hos rygpatienter. Psykometrisk testning af disse skemaer er velfunderet, men vores viden om skemaernes anvendelighed samt den mindste kliniske relevante ændring (MCID) i specifikke subgrupper af patienter med lændesmerter er begrænset. Sidst men ikke mindst, har den gængse metode til bestemmelse af MCID metodologiske svagheder. En mulig løsning kunne være at spørge rygpatienterne, hvad de mener vil være et acceptabelt resultat af behandlingen, før den igangsættes. 

Formål

Formålet med afhandlingen var at bestemme responsiviteten og MCID i specifikke subgrupper af patienter med lændesmerter. Udover belyses spørgsmålet om, hvorvidt lænderygpatienter kan bestemme, hvad et acceptabelt resultat af et behandlingsregi vil være, før dette påbegyndes. 

Metode & materiale

Studie til måling af responsivitet i undergrupper.
En omfattende oversættelse, tilpasning til det danske sprog og validering af ODI blev gennemført på lænderygpatienter set i primær- (PrS) og sekundærsektoren (SeS) i det danske sundhedsvæsen.

Studie til måling af patienters prospektive acceptable behandlingsresultat.
En metode til måling af lænderygpatienters acceptable ændring (MCIDpre) før iværksættelse af en behandling blev udviklet og sammenlignet med den gængse metode til bestemmelse af MCID (MCIDpost).

Resultater

Studie til måling af responsivitet i undergrupper.
Målefejlen på ODI blev fundet til at ligge mellem -11.5 og +13 points. Responsiviteten var sammenlignelig med de øvrige skemaer. ODI have en udpræget ``gulv-effekt'' (floor-effect) hos PrS patienter. MCID var ni points i PrS og lænderygpatienter og otte points hos SeS og bensmerte patienter. Desuden var patienternes retrospektive evaluering af behandlingseffekt mere responsiv hos PrS patienter sammenlignet med serielle målinger.

Studie til måling af patienters prospektive acceptable behandlingsresultat.
Metoden til bestemmelse af lænderygpatienters prospektive acceptable behandlingsresultat var reproducerbar. MCIDpre var større end det givne skemas målefejl og 1.5-4.5 gange større sammenlignet med MCIDpost. Hvad angår smerte, var lænderygpatienters MCIDpre næsten sammenlignelig med deres acceptable ændring bestemt efter behandlingen.

Konklusion

Den danske version af ODI er reproducerbar, valid og responsiv men grundet psykometriske forhold, er det mest hensigtsmæssigt at bruge spørgeskemaet til de mere kroniske sekundærsektor patienter. Ydermere, så er Roland Morris Disability Questionnaire (RMQ) det mest velegnede spørgeskema til patienter udelukkende med lændesmerter, mens ODI og RMQ er lige velegnede til patienter med bensmerter. Valget af smerteskala er mere vilkårligt i alle subgrupper, og smerteskalaen fra Low Back Pain Rating Scale anbefales. MCID var mere eller mindre stabil på tværs af alle subgrupperne for størstedelen af spørgeskemaerne og steg monotont med tilstandens alvorlighed ved baseline, men dette var kun gældende for PrS patienter og patienter med lænderygbesvær.

Det kliniske spørgsmål: ``hvordan har du det nu sammlignet med da du startede behandlingen'' er mest sensitivt til kliniske relevante ændringer i PrS patienter og bør inkluderes som effektmål med de gængse spørgeskemaer appliceret serielt.

Metoden til bestemmelse af lænderygpatienters prospektive acceptable behandlingsresultat er ny. Den tillader klinikeren at afstemme hvad der er acceptabelt for patienten med hvad der behandlingsmæssigt er opnåeligt. Det ser ud til, at kroniske lænderygpatienter har en fornuftig idé om, hvad der er en acceptabel ændring i smerte, men at de overvurderer ændringer i fysisk funktion og psykologiske/følelsesmæsige domæner, før behandlingen begynder.

OriginalsprogEngelsk
Udgivelses stedOdense
ForlagSyddansk Universitet
Antal sider193
StatusUdgivet - 2007

Fingeraftryk

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

Emneord

  • Lændesmerter
  • Clinimetrics
  • Outcome measures
  • Disability
  • Pain
  • Questionnaires
  • Sensitivitet og specificitet
  • Minimal clinically important difference
  • Minimal detectable change
  • Primary and secondary sector patients
  • Transition questions

Citer dette

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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",

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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. / Lauridsen, Henrik Hein.

Odense : Syddansk Universitet, 2007. 193 s.

Publikation: Bog/antologi/afhandling/rapportPh.d.-afhandlingForskning

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 -