 The VISA-A Questionnaire: A valid and reliable index of the clinical severity of achilles tendinopathyClick to read the .pdf version CLINICAL SEVERITY OF ACHILLES
TENDINOPATHY Paul
Jƒ Craig PurdamƒJennifer M Robinson*, Jill L Cook Visentinig, Judy Ross#,
Nicola Maffulli#, Jack E Taunton*, Karim M Khan* for the Victorian Institute of
Sport Tendon Study Group * Department of Family Practice (Allan
McGavin Sports Medicine Centre) and Department
of Physiotherapy, LaTrobe University, Bundoora, Australiaƒ & Victorian
Institute of Sport Tendon Study Group, g Alphington Sports Medicine Clinic and
School of Physiotherapy, University of Melbourne, Australia and Victorian
Institute of Sport Tendon Study Group, Melbourne, Australia # Department of Orthopaedic Surgery, Address for correspondence: Dr. Karim Khan, James Mather Building ,
5084 Fairview Avenue , Vancouver , V6T 1Z3 3055 Wesbrook Mall, Vancouver , B.C. Tel: (604) 822-1891 Fax: (604) 822-6950 E-Mail: kkhan@interchange.ubc.ca ABSTRACT Objective—There is no
disease-specific, reliable and valid clinical measure of Achilles tendinopathy.
We aimed to develop and test a questionnaire-based instrument that would serve
as an index of severity of Achilles tendinopathy. Methods—We used item generation, item
reduction, item scaling and pretesting to develop a questionnaire to assess the severity of
Achilles tendinopathy. The final version consisted of 8 questions that measured
the domains of pain, function in daily living and sporting activity. Results
range from 0100 where 100 represents the perfect score. We then tested its
validity and reliability in a population of non-surgical patients with Achilles
tendinopathy (n=45), pre-surgical patients with Achilles tendinopathy (n=14) and
in two normal control populations (total n=87) Results— The VISA-A questionnaire had
good test-retest (r=0.93), intra-rater (3 tests, r=0.90) and interrater (r=0.90)
reliability as well as good stability when compared one week apart (r=0.81). The
mean (95% CI) VISA-A score in the non-surgical patients was 64 (59-69), in
pre-surgical patients 44 (28-60) and in control subjects it exceeded 96 (94-99).
Thus, the VISA-A score was higher in non-surgical than in pre-surgical patients
and higher in control subjects than in both patient populations (p<0.00). Conclusions—The VISA-A questionnaire
is reliable and displayed construct validity when means were compared in
patients with a range of severity of Achilles tendinopathy and control subjects.
The continuous numerical result of the
VISA-A questionnaire has the potential to provide utility in both the clinic
setting and research. The test is not designed to be diagnostic. Further studies
are needed to determine whether VISA-A score predicts
prognosis. Key Terms: Achilles; tendinopathy;
tendinitis; outcome; questionnaire INTRODUCTION Achilles tendinopathy is a major cause
of prolonged pain and disability in sportspeople and those who undertake an
active lifestyle such as hiking and walking1-3. It may cause between 2% and 16%
of people to abandon playing 1 2 4 5. In some settings, 20-30% of patients who
present with this condition require surgical treatment 6-8. Furthermore, as
physical inactivity is a risk factor for many multi-system diseases 9, Achilles
tendinopathy can lead to suboptimal overall health, not just sporting
inconvenience. There have been many studies published
on the subject of Achilles tendinopathy, but there remain very few prospective
studies of treatment outcome 4 10-13. One factor limiting efficacy studies in
Achilles tendon research is the lack of a standardised outcome measure by which
to evaluate treatment of Achilles tendinopathy 14. Several quantitative tests of ankle
function 15 have been used to measure outcome in Achilles tendinopathy 4 and
there are tests to evaluate Achilles tendon function after complete rupture 16.
However, condition-specific numerical scales generally have greater sensitivity
and specificity than do general-purpose scales17-20. The inventor of the
muchused Lysholm scale for knee instability emphasised the need for ‘different
or modified scoring systems for the follow-up of patients with different
diagnoses 18. A specific scale for patients with patellar tendinopathy 19 has
proven useful in numerous peer-reviewed studies 21-23. Therefore, the aim of
this study was to develop and test a questionnairebased instrument to measure
the severity of Achilles tendinopathy. METHODS To develop the questionnaire we
performed item generation, item reduction, item scaling and pretesting as
outlined below. We then tested its validity and reliability in clinical and
control populations. Ethics approval was obtained from the University of British
Columbia Ethics Committee . Item generation The Victorian Institute of Sport tendon
study group ( Melbourne , Australia ) first developed an index of severity for
patellar tendinopathy, 19. We used this as a template from which to develop a
questionnaire specifically for use in Achilles tendinopathy. A literature review
was done to find items that would be appropriate for inclusion. In addition,
colleagues were consulted to find unpublished items used in clinical practice.
The second step involved interviewing colleagues with expertise in the area of
Achilles tendinopathy. Finally, patients were informally interviewed regarding
symptoms they felt important. Item reduction A focus group consisting of the
principal questionnaire developer, a primary care sports medicine physician and
two physiotherapists reviewed the items generated. They decided that three
domains - pain, functional status and activity were necessary and they allocated
three questions to each domain (Table 1) 24-27 Item scaling A visual analog scale (VAS) is more
accurate and sensitive than categorical verbal scales 25 28-32 . The first 6
questions utilise a VAS so that to the patient may report magnitude of a
continuum of subjective symptoms. Activity is best measured using a categorical rating system based on an incremental
range of values 33. Thus, the final two questions used a categorical rating
scale. Pretesting Prior to being shown the working version
of the questionnaire, a group of fifteen clinicians expert in the field of
tendon injuries were asked to identify questions they felt were important in
assessing the severity of Achilles tendon disorders. The group comprised 8
physiotherapists, 4 primary care physicians, one orthopaedic surgeon and one
rehabilitation specialist. The same 15 participants were then shown the VISA-A
score and asked to evaluate the questionnaire. They were specifically asked if
there were any questions they would add, delete, or modify. Fourteen of the
participants had no questions to add, none wanted any deleted or modified. Weighting The questionnaire tests the three
significant domains of dysfunction with three questions for each (question 8 is
effectively 2 questions, one relating to pain with activity and the other to
duration of activity). By removing redundancies and eliminating items of less
importance weighting of the remaining items may be the same (each question is
scored out of 10) without affecting the value of the questionnaire 20. The final
version of the questionnaire was called the Victorian Institute of Sport
Assessment-Achilles questionnaire (VISA-A) (Table 1). Reliability and validity testing We administered the VISA-A questionnaire
to four populations. Group 1—non-surgical patients (n=45), were those who
attended a primary care sports medicine clinic. Group 2—surgical patients
(n=13), were those who had been referred to a sports orthopaedist for tendon
surgery. Group 3—university students (n=63), represented a convenience sample
of young normally active people to serve as a control group and Group 4— members of a running club (n=24),
represented active, but non-injured individuals whose age matched the patient
groups. As imaging does not provide a gold standard for tendon disorders,
diagnosis was by assessment of 2 expert clinicians as has been justified in
other tendon studies 34-36. For inclusion into the study, subjects in all groups
had to be adults older than 18 who were able to give written informed consent.
For groups 1 and 2 subjects had to have a diagnosis of
Achilles tendinosis, paratendinitis or partial rupture with or without a
retrocalcaneal or Achilles bursitis. For groups 3 and 4 subjects had to belong
to the two groups as defined. Women who were pregnant or nursing were excluded,
as were patients with a total rupture of the Achilles tendon. Subjects with
previous or current Achilles tendon symptoms, but who were not currently
undergoing treatment for the condition, were not excluded from the control
groups as these groups were designed to reflect the populations. We tested construct validity in two
ways. First, the 45 non-surgical patients in Group 1 completed the VISA-A test
and two other generic tendon grading systems 37 38 at one visit. Second, we
tested the VISA-A scale in both surgical patients (Group 2) who are generally
considered to have the most significant degree of disease, and two control
populations (Groups 3 and 4). All patients in Group 1 attended our
research centre on two occasions one week apart and completed the VISA-A
questionnaire 3 times to test its reliability. At either the first or second
visit, patients completed the questionnaire twice with a 60-minute interval to
measure test-retest reliability. Short-term reliability was measured by
comparing VISA-A scores at one-week follow-up with the baseline measure. To test
inter-tester reliability, the chief investigator (JR) and one of two other
trained researchers administered the VISA-A questionnaire in a subset of 16
subjects. We also tested inter-tester and test-retest reliability studies in a
control group (Group 4). We did not test reliability in the surgical patients as
they travelled to a tertiary referral centre and were not available for the
one-week followup (short-term stability) measure. Statistical methods All data were entered on a personal
computer and results analysed using SPSS Version 7.0. Descriptive data are
reported as mean, standard deviation and 95% confidence interval (95% CI).
Correlation of VISA-A scores in Group 1 patients with the other scoring scales
was by Spearman's rank correlation coefficient for nonparametric data, as the
data were not normally distributed. Reliability data were analysed by
Pearson’s r as these data were normally distributed. VISA-A score in the
various study groups were compared using single factor analysis of variance
(ANOVA) with Tukey’s post-hoc test. RESULTS Subjects Descriptive data concerning study
participants are shown in Table 2. Twelve Group 1 non-surgical patients (24
tendons) had bilateral symptoms and 33 patients had unilateral symptoms, giving
a total of 57 symptomatic tendons and 33 asymptomatic tendons. As the presence
of Achilles tendon pain was not an exclusion from any group in the study 2
university students and 3 running club subjects reported pain in the Achilles
tendon. Questionnaire The final version of the VISA-A
questionnaire contained eight questions that covered the three domains of pain
(questions 1- 3), function (questions 4-6) and activity (questions 7 & 8.)
Questions one to seven are scored out of 10 and question 8 carries a maximum of
30. Scores are summed to give a total out of 100. An asymptomatic person would
score 100 (Table 1). When a participant answers question 8 he or she must answer
only part A, B or C. If the participant has pain when undertaking sport it means
that he or she automatically loses at least 10, and possibly 20 points. Reliability Reliability of the VISA-A questionnaire
is summarised in Table 3. There was no difference in scores whether the
test-retest questionnaires were done at the first visit or at the second visit.
(p=0.58). Validity The construct validation is illustrated
(Figures 1 and 2). The VISA-A score was significantly correlated to both Percy
and Conochie's grade of severity (Spearman’s rho=0.58; p<0.01) and to that
of Curwin and Stanish (Spearman’s rho=-0.57; p<0.001). The second part of construct validity
testing compared scores in various patient and control groups. Comparing the
VISA-A scores of all 4 groups revealed that the Achilles tendinopathy patient
groups’ (both Group 1 and 2) mean VISA-A scores were significantly lower
(p=0.00) than those of the control groups (both Group 3 and 4) (Figure 3).
Furthermore, patients with Achilles tendinopathy in Group 1 (non-surgical
patients) had a significantly higher mean VISA score than patients in Group 2 (presurgical
patients) (Figure 3). DISCUSSION To be in a position to practice
evidence-based medicine, the sports-medicine community must conduct studies with
objective outcome measures. To date there is no tool designed for this purpose
in patients with Achilles tendinopathy. The present study suggests that the
VISA-A questionnaire may fill this void, as it is valid, reliable and
user-friendly. Strengths of the VISA-A questionnaire The VISA-A questionnaire displayed
construct validity when used in 2 populations of patients with Achilles
tendinopathy and control subjects. The questionnaire avoids the redundant
components of non-specific scoring systems such as that developed for hind foot
problems by the American Orthopaedic Society 17 27, and those devised for
Achilles tendon rupture 39 40. The VISA-A questionnaire also compares favourably
with two generic tendon-grading systems 37 38 that use a categorical rating
scale. There are no published validation or reliability data for either of these
scales and categorical scales have been criticised for being insensitive to
subtle changes in a clinical condition 41 42. . We believe that the questionnaire’s
excellent reliability reflects the uncomplicated nature of the questions and the
use of a visual analogue scale that has proven reliable in questionnaires 43.
Because the questionnaire can be self-administered with a minimum of
investigator assistance it avoids some potential for observer bias that can
diminish interobserver reliability. As well as being valid and reliable, the
VISA-A questionnaire is easy to use. It generally takes less than 5 minutes to
administer, even in patients with chronic and severe symptoms. Also, we found
that a medical student and a sports medicine physician obtained virtually
identical results so specialised training is not required to administer the
test. In clinical practice, we have found that patients who have had the
questionnaire administered once by an investigator or clinician can easily
complete the questionnaire alone on future occasions. Although this aspect of
questionnaire use was not tested formally in the present study, we believe the
instrument has the potential to be selfadministered after the baseline test. The continuous numerical result of the
VISA-A questionnaire is ideal for comparing patient’s progress in the clinical
setting. As tendinopathy takes some time to resolve, weeks can elapse between
physician visits. The VISA-A score could be used to monitor patients’
progress. However, until the VISA-A scale is tested in longitudinal studies we
can only suggest it has potential for use in this way. In the research setting, this index of
severity of Achilles tendinopathy could prove very useful in descriptive studies
as well as providing an outcome measure in intervention studies. However, we
consider that any such studies would be greatly strengthened if they were
carried out in homogenous groups of athletes (e.g., runners only, volleyball
players only) as the VISA-A score has not yet been shown to respond equally to
change in Achilles tendon function in different sports. Nevertheless, our data
show it is suitable for patients being managed both conservatively and
surgically. Because the test requires no equipment and is not subject to
observer bias it may prove suitable for as part of the data collected in
multi-centre studies. Clinically-relevant methodological
issues when administering the VISA-A (new subhead) We note in question 8 that
participants answer only part A, B or C. However, we found that after we
explained this concept to participants they had no trouble understanding it
subsequently. The question is scored in this way to differentiate patients who
have a certain functional level without pain, and those who perform to a similar
level of function despite pain. Clearly the latter is not as close to perfect as
the former, and the VISA-A score reflects that because of the three stems of
question 8. As a corollary of this point, the recreational person who has
Achilles tendinopathy, or for example, an archer, could only score a maximum of
70 on the VISA-A score as outlined. In this clinical setting, once the patient
reached 70, both the patient and the doctor would realise that represented that
the patient was cured. In randomised controlled trials where the VISA-A is used
as an outcome measure, researchers could standardised the score as a percentage,
or, as is most usual, report change, either in absolute units or as a percentage
of baseline. Thus, just as knee extension strength (a measurement) is sometimes
used as a raw score (in kg), adjusted for height in the data (in kg/cm), or
corrected for in regression, so the VISA score has the potential to be used in a
variety of ways depending on the setting. Although there was a statistically
significant difference between population mean VISA-A scores in the non-surgical
and surgical patient groups, this does not mean that the VISAA score has any
role to play in the decision as to whether or not surgery is indicated. The only
indication for surgery in Achilles tendinopathy is failure of conservative
management and this remains a clinical decision to be made between doctor and
patient. Limitations of the VISA-A questionnaire We emphasise that the VISA-A
questionnaire is an index of the severity of a clinically diagnosed condition -
it is not a diagnostic tool. Thus, other conditions that influence lower limb
function (such as ankle sprain) will reduce a patient’s VISA-A score.
Furthermore, limitation of function (such as severe sciatica) limits the
subject’s ability to score well in question 8, even though the Achilles tendon
may be uninjured. This has not proven a problem in the patellar tendon research
21-23 that used the similarly designed VISA questionnaire for that condition
(VISA-P). A limitation of the present study is that we do not have longitudinal
change data - so cannot comment on the sensitivity of the VISA-A to detect
change with intervention. This aspect of the instrument will be evaluated in a
future study. Further studies should also test the reliability and the
short-term stability of the VISA score in the setting of a surgical population.
Nevertheless, we have no reason to suspect that it would be inferior to the
reliability data reported here. We conclude that the VISA-A
questionnaire provides a valid, reliable, and user-friendly index of the
severity of Achilles tendinopathy. Although the limited time for consultation in
routine clinical practice means that the main role of this tool is likely to be
as an outcome measure in treatment studies, the VISA-A scale can be easily
administered in clinical practice. Further studies are needed to determine
whether VISA-A score predicts prognosis.
Take home message: There is a need for a
quantitative index of pain and function in patients with Achilles tendinopathy.
The VISA-A questionnaire is a valid, reliable and easy-to-administer measure of
the severity of Achilles tendinopathy and appears suitable for both clinical
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