FROM:
Clin Rehabil. 2012 (Feb); 26 (2): 142–151
Felix Angst,
Martin L Verra,
Susanne Lehmann,
Françoise Gysi,
Thomas Benz,
André Aeschlimann
Research Department,
Rehabilitation Clinic 'RehaClinic' Zurzach,
Bad Zurzach, Switzerland.
Clinical messages
The NASS was consistently less responsive
in function than the SF-36 and cannot be
recommended as a specific instrument to
measure pain and function more responsively
than the SF-36 in chronic whiplash
disorder.
The SF-36 seems to be a powerful, responsive
instrument in chronic pain.
|
Objective: To determine and compare the sensitivity to change of the condition-specific cervical Northern American Spine Society (NASS) and the generic Short Form 36 (SF-36).
Design: Prospective cohort study.
Subjects: One hundred and seventy five patients after whiplash injury.
Interventions: Four-week inpatient interdisciplinary pain management programme.
Main measures, analysis: Responsiveness of the NASS and the SF-36 was quantified by effect size and standardized response mean and compared within the same construct by the modified Jacknife test. Ability to detect improvement was compared using sensitivities determined from receiver operating characteristics curves.
Results: In pain, the NASS was comparable responsive to the SF-36 at the one-month follow-up (n = 175): effect sizes: 0.62 (NASS) versus 0.61 (SF-36), P = 0.914. The NASS was less responsive than the SF-36 in function: 0.23 versus 0.63, P < 0.001 and in pain+function: 0.35 versus 0.58 (P = 0.001). These relationships remained consistent using standardized response means, at the six-month follow-up (n = 103), and in the comparison of the sensitivities. Sensitivities at one month, pain: 70% (NASS) versus 62% (SF-36), P = 0.234; function: 65% versus 80%, P = 0.002; pain+function: 68% versus 78%, P = 0.035. The six-month data were similar.
Conclusions: The generic SF-36 was more responsive in function and equally responsive in pain when compared to the condition-specific NASS. The SF-36 can be recommended as a responsive instrument for measurement of pain and function in chronic whiplash syndrome.
From the FULL TEXT Article:
Introduction
Whiplash injury causes a complex paindominated
syndrome in some victims of accidents
leading to high demands on therapy management
and costs per case. [1] Whiplash-associated pain syndrome
has consequences in all aspects of biopsycho-
social health and quality of life and comprehensive
assessment is required. [2, 3] As in various
chronic pain conditions, improvements due to
treatment or in the natural course are often
small and, by that, difficult to detect and to quantify.
Condition-specific assessment instruments
are expected to be more specific and thus more
sensitive to measure small changes than generic,
comprehensively measuring ones. [4] Sensitivity to
measure change over time, synonymous responsiveness,
is a major property of an instrument and
an important part of its validity. [5] It is further a key
criteria for outcome instruments established by
the quality classification process of the Outcome
Measures in Rheumatology Clinical Trials
(OMERACT) carried out by World Health
Organization (WHO), the American College of
Rheumatology (ACR), and the European
League Against Rheumatism (EULAR). [6]
Comparative data about responsiveness are
often lacking when instruments’ properties and
qualities are rated and compared. [7] This is especially
true for instruments assessing neck pain
syndromes. [7] The most often used specific instruments
for neck pain syndromes are the Whiplash
Disability Questionnaire (WDQ), the Neck Pain
and Disability Scale (NPDS), the Oswestry
Disability Index, cervical module (ODI), the
Roland-Morris Questionnaire (RMQ), and the
cervical version of the Northern American Spine
Society questionnaire (NASS). [7]
When our interdisciplinary
rehabilitation programme started in
2003, only the NASS had been translated and
cross-culturally adapted into German: Whiplash
Disability Questionnaire: not yet translated, Neck
Pain and Disability Scale: translated in 2008, [8]
Oswestry Disability Index, cervical module translated
in 2006 [9], Roland-Morris Questionnaire:
only the low back pain version translated in
1999. [10] While there are data about reliability,
validity and effects of the NASS, [11-15] responsiveness
of the NASS has not been compared to
other instruments, especially, not by statistical
tests. [14, 15] Furthermore, responsiveness of the
NASS was not examined in the separated constructs
of pain and function up to date. [14, 15] The
need for testing the responsiveness of the NASS
in non-surgical settings has especially been
stated.7 The Short Form 36 (SF-36) is the most
widely accepted and most frequently used generic
instrument, also for comparative studies of
responsiveness.
This prospective cohort study aimed to determine
and compare the responsiveness of the
NASS and the SF-36 in patients who underwent
a specific interdisciplinary rehabilitation programme
for chronic pain syndrome after whiplash
injury. It was hypothesized that the conditionspecific
NASS was more responsive than the
generic SF-36.
Discussion
We examined the ability of the NASS and the SF-
36 self-assessment outcome instruments to sensitively
measure changes in pain and function
in chronic whiplash patients after a four-week
inpatient interdisciplinary pain management program
(n = 175) and at six-months’ follow-up
(n = 103). Both instruments were similarly responsive
in pain. In function, and by that in most comparisons
in pain+function, the SF-36 was the
significantly more responsive tool.
The results were consistent over two measurement
time points and over two analyses, the comparison
of the responsiveness measures (effect
sizes and standardized response means), and the
sensitivity analysis by receiver operating characteristics
curves. The relatively low to moderate
correlations of the score changes between the
NASS and the SF-36 confirmed the difficulties
in the ability to detect score change over time of
the two instruments. The observed score changes
were higher than so-called minimal important
differences, an estimate for an effect which
patients (on average) perceive as subjective
change (that is, by that, clinically important), on
the SF-36 but not on the NASS. In summary, the
NASS was not able to detect higher score changes
over time in clinical outcome assessment of
chronic whiplash when the SF-36 already was in
the set of instruments.
The hypothesis that a condition-specific instrument
– the NASS – is more responsive than a
generic one – the SF-36 – could not be confirmed
in this condition. One explanation for this may be
that the extensive, detailed explications of the item
level responses of the NASS may be too complicated
for certain users in contrast to the short
and simple ones of the SF-36. This may cause
uncertainties in the response and blur effects.
Secondly, overall functionality in the activities of
daily living, particularly ambulation, may be more
important than neck pain dependent tasks in
chronic whiplash in contrast to acute neck pain.
The findings of this study stay in line with those
of other studies.After three to four weeks comprehensive
rehabilitation in cervical spine disorders,
the effect size of SF-36 pain was 0.9 versus 0.54 of
NASS pain+function in 42 inpatients and 1.31
versus 0.96 in 98 outpatients. [14] Effect data of SF-
36 function scales were not reported and statistical
comparison of effect sizes between the NASS
and the SF-36 was not performed. [14, 15] The
pain+function score correlated with 0.70 to 0.80
to the SF-36 physical functioning, 0.28 to 0.65 to
SF-36 bodily pain, and 0.56 to the SF-36 physical
component summary score showingmoderate (for
pain also small) construct overlap. [12, 14, 15] A second
study about a rehabilitation programme with
physiotherapy and spa pool therapy of 92 cervical
pain patients reported effect sizes in SF-36 pain of
0.64 and SF-36 function of 0.32 while the effect size
of the NASS pain+function was 0.55. [15] In 273
chronic soft tissue and back pain patients, the
SF-36 showed similar responsiveness (bodily
pain: effect size = 0.72) when compared to the
pain numeric rating scale (effect size = 0.62) and
to the pain severity scale of the Multidimensional
Pain Inventory (MPI) (effect size = 0.85, all differences
not significant). [25] One may thus hypothesize
that the SF-36 is generally as responsive as condition-
specific tools for pain in chronic (back) pain.
Astrength of the present study is the large, prospective
cohort of subjects with consistent characteristics
treated by a standardized therapy
programme. The SF-36 and the NASS are well
known worldwide, valid, profoundly tested selfassessment
instruments and permit standardized
measurement and comparison between cohorts
of different conditions, countries, and cultures.
To our knowledge, this is the first study which
compared the effects/score changes of both instruments
in the separated constructs of pain and
function.
The following limitations have to be taken into
account. To further examine the score changes in
relation to minimal clinically important differences,
a retrospective global health rating, the
so-called transition question would have to be
applied in addition.30 A second limitation arises
from the fact that newer, more widespread instruments
as the Whiplash Disability Questionnaire,
and so on, have not been used because data collection
for the present study started before the
publication of their German versions. Further,
the high drop-out rate of 41% between the onemonth
and the six-month follow-up may be a
limitation when comparing effects between
groups but less when comparing effects within
subjects. In the outcome paper, post-hoc analysis
of the drop-outs detected low possible bias caused
by the high rate of dropped-out subjects. [16]
Finally, acute neck pain may result in different
responsiveness findings than chronic neck pain
and newer neck-specific instruments may be
more responsive than both examined tools.