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Original article

Development and validation of a new visa


questionnaire (VISA-H) for patients with proximal
hamstring tendinopathy
Angelo Cacchio,1 Fosco De Paulis,2 Nicola Maffulli3
Additional material is
published online only. To view
please visit the journal online
(http://dx.doi.org/10.1136/
bjsports-2012-091552).
1

Department of Life, Health


and Environmental Sciences,
School of Medicine, University
of LAquila, LAquila, Italy
2
Division of Diagnostic
Imaging, Valle Giulia Clinic,
Roma, Italy
3
Centre for Sports and Exercise
Medicine Barts and The
London School of Medicine
and Dentistry, Mile End
Hospital, London, UK
Correspondence to
Professor Angelo Cacchio,
Dipartimento di Medicina
Clinica, Sanit Pubblica,
Scienze della Vita e
dellAmbiente, Universit degli
Studi dellAquila, P.le Salvatore
Tommasi 1, LAquila 67100,
Italy; angelo.cacchio@tin.it
Accepted 13 February 2013
Published Online First
7 March 2013

ABSTRACT
Background There is a need for a patient-reported
outcome (PRO) questionnaire to evaluate patients with
proximal hamstring tendinopathy (PHT).
Objective To develop a PRO questionnaire based on
VISA questionnaire forms for patients with PHT.
Methods Item generation, item reduction, item scaling
and evaluation of the psychometric properties were used
to develop a questionnaire to assess the severity of
symptoms, function and ability to play sports in patients
with PHT and healthy subjects. The nal version, named
Victorian Institute of Sport Assessment-Proximal
Hamstring Tendons (VISA-H), consisted of eight
questions that measured the domains of pain, function
and sporting activity. The psychometric properties of a
questionnaire were estimated in a population of nonsurgical (n=20) and surgical (n=10) patients, as well as
in healthy subjects (n=30).
Results The VISA-H questionnaire displayed a high
degree of internal consistency, with a Cronbach of
0.84. (The testretest reliability was high for all groups
of participants with an intraclass correlation coefcient
ranging from 0.90 to 0.95.) The VISA-H exhibited a high
correlation with the Nirschl phase rating scale (r ranging
from 0.75 to 0.89) and a generic tendon grading
system proposed by Curwin and Stanish (r ranging from
0.70 to 0.88). Also, the responsiveness was higher
for the VISA-H questionnaire with an area under the
curve of 0.90 and a minimum clinically important
difference of 22 points.
Conclusions The VISA-H is a PRO questionnaire with
high psychometric properties for measuring pain,
function and sporting activity in patients with PHT.

Unfortunately, the success or failure of treatment


for PHT is open to interpretation, given the lack of
instruments on how to measure treatment outcome
in a standardised fashion.
The importance of monitoring the effectiveness
of treatment on the basis of the patients viewpoint
is widely recognised.10 11 Standardised patientreported outcome (PRO) questionnaires provide a
convenient method to compare different patient
populations, evaluate the outcome of treatment,
facilitate comparisons between studies, determine
the patients clinical severity, provide a guideline
for treatment and monitor treatment effects.12 13
The PRO VISA-P and VISA-A questionnaires
have been introduced to quantify athletes disability
due to patellar and Achilles tendinopathy, respectively, thereby facilitating research into these conditions.14 15 These questionnaires assess pain and the
ability to undertake physical activities and sports.
Moreover, these questionnaires have been documented as valid and reliable instruments for monitoring recovery from patellar16 17 and Achilles
tendinopathy.18 19
There is also, however, a need for an easy, valid,
and reliable PRO questionnaire to appraise the
symptoms and the ability to undertake sport, in
patients with PHT.
To our knowledge, there are no validated PRO
questionnaires for patients with PHT. Therefore,
the purpose of this study is to develop and validate
a new PRO questionnaire for patients with PHT
that requires little time to administer and is easily
readable.

MATERIALS AND METHODS


INTRODUCTION

To cite: Cacchio A, De
Paulis F, Maffulli N. Br J
Sports Med 2014;48:
448452.

Proximal hamstring tendinopathy (PHT) is an


overuse tendinopathy affecting the proximal tendon
of the hamstring muscles. PHT usually affects athletes in many sports and at all levels of participation,
but is of particular concern for elite sprinters,
hurdlers and long-distance-running athletes.13
The characteristic complaint of PHT is pain, especially while performing sports activities or when
sitting, in the area of the ischial tuberosity that
rarely radiates distally to the popliteal fossa.1 2 4
The pain typically appears and gradually increases
without being triggered by any acute event.1 2 4
Previous studies have clearly described the symptoms,16 the MRI,7 8 histopathological ndings,4
and the non-surgical1 3 and surgical treatment2 46
of this condition. A more recent study has shown
that three pain provocation tests can be used for
the clinical diagnosis of PHT in athletes.9

Cacchio A, et al. Br J Sports Med 2014;48:448452. doi:10.1136/bjsports-2012-091552

The development of this new instrument consisted


of four steps: (1) item generation and test construction, (2) item reduction, (3) item scaling and (4)
evaluation of the psychometric properties of the
nal version of the questionnaire.
The VISA-A14 and VISA-P15 questionnaires were
used as background material to develop a questionnaire specically for use in patients with PHT.

Step 1: item generation and test construction


The development of this questionnaire started with
a literature review to nd items that would be
appropriate for inclusion. In addition, other potential items used in clinical practice were gathered
while interviewing physicians, athletic trainers and
physical therapists directly involved with the management of PHT. Further, patients were informally
interviewed about symptoms that they felt were
important. Finally, an expert group of colleagues
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Original article
with several years of experience with PHT participated in two
brainstorming sessions to ensure good face validity to the 25
new items generated.

Step 2: item reduction


In this phase, a focus group consisting of the principal investigator,
a sport orthopaedic surgeon and a radiologist reviewed all the
items generated, deciding which of the 25 items should be
discarded and which should be retained. Using the frequencyimportance product (frequencymean importance) and the
Pearson productmoment correlation, six items were retained.
These six items will constitute the rst six questions (Q1Q6) of
our Victorian Institute of Sport Assessment-Proximal Hamstring
Tendons (VISA-H) questionnaire, and with the last two questions
(Q7 and Q8), similar to those of other VISA questionnaires, will
be structured in an eight-item questionnaire, covering the three
domains of pain, function and sporting activity.

Step 3: item scaling


Based on the assumptions expressed by the authors of the
VISA-A questionnaire,14 the rst six questions ( pain and function) used a 010 numerical rating scale and the nal two questions (sporting activity) used a categorical rating scale.
The worst score obtainable with the VISA-H questionnaire
was 0 points, while the best was 100 points.

Step 4: evaluation of psychometric properties of the nal


version of the VISA-H questionnaire
Participants
The nal version of the VISA-H questionnaire (see online
supplementary appendix) was administered to three groups: a
non-surgical group with 20 patients (14 men and 6 women;
mean age of 23.7 years, range 1825) with a diagnosis of PHT
and selected to receive conservative management; a surgical
group with 10 patients (8 men and 2 women; mean age of
21.4 years, range 1823) with a diagnosis of PHT and, following failure of conservative management, on the waiting list for
surgery; a healthy group with 30 individuals (20 men and 10
women; mean age of 23.1 years, range 1826) represented a
convenience sample of athletes whose age matched the patients
groups to serve as a control group. Written informed consent
was obtained from all the participants before enrolment in the
study, and the procedures followed in the study were in accordance with the ethical standards of the local ethics committee
and conformed to the Declaration of Helsinki.
For inclusion in the study, subjects in all groups had to be
older than 18 and able to give written informed consent. For
non-surgical and surgical groups, patients had to have a diagnosis of PHT made clinically and by means of MRI.1 9 A clinical
diagnosis of PHT was made when the athlete had pain in the
lower gluteal region, tenderness in the ischial tuberosity area
and positive in at least two of the following three pain provocation tests: the Puranen-Orava test, the bent-knee stretch test and
the modied bent-knee stretch test.1 9 Briey, the PuranenOrava test entails actively stretching the hamstring muscles in
the standing position with the hip exed at approximately 90,
the knee fully extended and the foot on a support. The bentknee stretch test is performed with the patient supine. The hip
and knee of the symptomatic leg are maximally exed, and the
examiner slowly straightens the knee. For the modied bentknee stretch test, the patient lies in the supine position with the
legs fully extended; the examiner grasps the symptomatic leg
behind the heel with one hand and at the knee with the other
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hand, exes the hip and knee maximally and then rapidly
straightens the knee.1 9
Exclusion criteria were: lumbar sciatic pain, piriformis syndrome, ischial tuberosity avulsion, ischiogluteal bursitis or hamstring muscle tears; pregnancy; age of <18 years; inammatory
or neoplastic disorders; any treatments administered in the last
2 months.
During the physical examination, a differential diagnosis was
made between PHT and lumbar sciatic pain, piriformis syndrome, hamstring muscle tears and knee pain. If one of the
aforesaid conditions was suspected on the basis of the clinical
ndings, additional radiographs, electroneuromyographic
studies and MRI of the lumbar spine or of the hamstring
muscles or of the knee were performed before the enrolment.

Treatments
Non-surgical management consisted of relative rest, avoiding
activities and/or exercises that would increase the severity of
symptoms, and four sessions of radial shockwave therapy, at the
rate of one session per week. At each session, 2500 shocks with
a pressure of four bars (equal to an energy ux density of
approximately 0.18 mJ/mm2) and a frequency of 10 shocks/s
were applied. The technique and methodology have been
described in detail elsewhere.1
Surgical treatment was performed in another centre according
to the procedure described by Lempainen et al.4

Procedures and questionnaires


At baseline, subjects of three groups were asked to complete the
VISA-H questionnaire, the Nirschl phase rating scale (NPRS),20
and a generic tendon grading system proposed by Curwin and
Stanish (TGSCS)21 in a comfortable room.
To assess the VISA-H testretest reliability, all three groups of
participants were asked to complete the questionnaire again
3 days later after the rst administration at baseline. To minimise
the risk of clinical changes, non-surgical and surgical groups of
patients did not receive any treatment during this 3-day interval.
The nal version of the VISA-H questionnaire consists of
eight items, covering the two domains of pain/function (questions 16) and sporting activity (questions 78). Questions 17
were scored of 10 each and question 8 was scored of 30. Scores
are summed to give a total of 100. An asymptomatic person
would score 100, while someone who is symptomatic would
score less than that.
The NPRS21 is a seven-phase (17) assessment of pain and
activity limitations caused by overuse injuries. The TGSCS22
assessed 6 of reported exercise-induced tendon pain and the
level of sports performance.
Although the psychometric properties of these tools are not
formally validated so far, TGSCS and NPRS have been used as a
standard for construct validity testing in previous VISA-A and
VISA-P validation research, respectively.14 15 2224 Moreover,
the NPRS was used as an outcome measure in a previous clinical
study on shockwave treatment for patients with chronic PHT.1
At discharge, the VISA-H, NPRS and GTRCS were administered again to the patients on completion of their non-surgical
or surgical treatment. Since the patients of the surgical group
underwent the surgical procedure in another referral centre, the
second administration of the VISA-H, NPRS and TGSCS questionnaires and a global rating of change were undertaken
between 7 and 15 days (mean: 113 days) after their discharge.
At discharge, the physician and the patient also independently
completed a 7-point global rating of change form, ranging from
1=very much worse to 7=very much improved. The
Cacchio A, et al. Br J Sports Med 2014;48:448452. doi:10.1136/bjsports-2012-091552

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Original article
physicians and the patients global rating of change scores were
averaged to give an overall change score, which was used in this
study as the criterion standard of change. This measure of
change was used as our external criterion, in the absence of a
gold standard, for the evaluation of responsiveness.25 For this
purpose, we chose global rating of change scores of 1 or 2 to
classify a worsened patient, a score of 35 to classify a stable
patient, and scores of 6 or 7 to classify an improved patient.

Data analysis
Although the Kolmogorov-Smirnov test showed that the variables were normally distributed, given the small sample size we
applied non-parametric tests. We determined that, to detect an
intraclass correlation coefcient (ICC2,1) of 0.75 and an area
under the curve (AUC) of 0.90 with a type I error of 0.05 and a
type II error of 0.20, the necessary sample size was 10 and 15
participants, respectively.
The level of statistical signicance was set at p<0.05. All analyses were conducted using MedCalc, V.11.1.1.0 for Windows
(MedCalc Software, Mariakerke, Belgium), GraphPad InStat,
V.3.05 for Windows (GraphPad Software Inc, San Diego,
California, USA) and STATA software, V.8.2 (Stata Corp, College
Station, Texas, USA).

Psychometric properties
Internal consistency
Internal consistency is the degree of inter-relatedness among the
items.26 Internal consistency of the VISA-H was assessed by
means of the Cronbach and 95% CIs, using the data from the
baseline questionnaire.27 Moreover, a principal component analysis with varimax rotation (eigenvalue >1) was applied to
analyse the factor structure of the VISA-H questionnaire.

Testretest reliability
Testretest reliability indicates the extent to which the same
results are obtained on repeated administrations of a given
instrument when no change is expected. Testretest reliability
was assessed by means of the ICC2,1.26
Changes in the VISA-H scores following both the nonsurgical and surgical treatments in comparison with the respective baselines were assessed using the Wilcoxon test.
Additionally, SE of measurement (SEM=SD(1testretest
reliability coefcient)) was calculated.27

Construct validity
Construct validity indicates the extent to which the questionnaire
scores correlate with those of other questionnaires as expected,
that is, whether the questionnaire really measures the intended
construct. Construct validity was tested by determining the relationship between the VISA-H scores and the NPRS and GTRSC
scores, both at the initial and at the discharge assessments, using
the Spearman correlation coefcients (r) and 95% CIs.
According to the original article on the VISA-A,14 construct
validity of the VISA-H was also tested, comparing by
Kruskal-Wallis test the results from the VISA-H questionnaires
for non-surgical and surgical group patients with the results of
healthy subjects. A Dunn post hoc comparison was used to
determine signicant differences between mean values when a
signicant main effect and interaction were found.

and standardised response mean (SRM) as inappropriate measures of responsiveness,26 they are accepted worldwide and used
in a large body of scientic literature and many clinicians are
familiar with them.28 Therefore, in this study, we opted to use
two distribution-based methods to assess the responsiveness of
the VISA-H questionnaire: the ES29 and the SRM,30 as well as
an anchor-based method, the receiver-operating-characteristic
(ROC) curve.25
The ROC curve was also used to provide an estimate of the
minimal minimum clinically important difference (MCID),
taken as the point on the upper left-hand corner of the ROC
curve, which most effectively discriminates between patients
who have improved and those whose condition is unchanged.31
We also computed the AUC, which can be interpreted as the
probability of correctly identifying an improved patient from
randomly selected pairs of patients who have and have not
improved.32 An AUC of 1.0 indicates perfect discrimination
between these two health states. A questionnaire that does not
discriminate more effectively than chance will have an AUC of
0.50.
Floor and ceiling effects were determined by calculating the
number of patients who obtained the best or worst scores possible at both the baseline and discharge assessments in all the
questionnaires. Floor or ceiling effects are considered to be
present if more than 15% of respondents achieved the lowest or
highest possible score, respectively.33
Floor and ceiling effects, distribution of total scores and
change scores in the overall study sample and in non-surgical
and surgical subgroups, and MCID will allow us to dene the
interpretability of our results.26 Interpretability is the degree to
which one can assign qualitative meaning to an instruments
quantitative scores or change in scores.26

RESULTS
Internal consistency
Internal consistency reached a Cronbachs of 0.84 (95% CI
0.77 to 0.89) for the eight items. When the coefcient was
calculated for the overall scale by eliminating each of the eight
items one at a time, the range was 0.750.81; no single item
was found to change the internal consistency substantially. No
items were missing from the three questionnaires at either the
baseline or discharge assessments. The principal components
analysis revealed a two-factor structure, which accounted for
73.4% of the total variance. The items loading on the rst component ( pain/function) with six questions (Q1Q6) had loadings ranging from 0.67 to 0.86, and explained 34.1% of
variance with an eigenvalue of 5.8; the second component
(sporting activity) with two questions (Q7 and Q8) had loadings
of 0.80 to 0.74, respectively, and explained 39.3% of variance
with an eigenvalue of 6.4.

Testretest reliability
The test-retest reliability yielded an ICC2,1 (table 1) of 0.92
(95% CI 0.80 to 0.97), with an SEM of 1.35 for the nonsurgical group, 0.90 (95% CI 0.63 to 0.97), with an SEM of
1.56 for the surgical group, and 0.95 (95% CI 0.90 to 0.97)
with an SEM of 0.25 for the healthy group.

Construct validity
Responsiveness and interpretability
There is no consensus on the most suitable statistical analysis to
assess responsiveness. Although the COSMIN guideline has
dened some responsiveness parameters such as effect size (ES)
Cacchio A, et al. Br J Sports Med 2014;48:448452. doi:10.1136/bjsports-2012-091552

The Spearman rank correlation coefcients describing the


extent of the correlation between the VISA-H scores and those
of the comparison questionnaires (NPRS and TGSCS) are
shown in table 2.
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Original article
Table 1 Baseline, 3-day retest, and discharge scores of the VISA-H in non-surgical (n=20), surgical (n=10) and healthy (n=8) participants, and
the magnitude of the changes after non-surgical (ES, SRM, ROC curve) and surgical (ES, SRM) patients
ROC curve

VISA-H

Group of participants

Baseline score

3-Day retest score

Discharge score

Change score

p Value

ICC(2,1)

ES

SRM

AUC

MCID

Non-surgical patients (N=16)


Surgical patients (N=9)
Healthy Subjects (N=30)

56.711.6
45.812.2
99.31.2

55.612.8
47.513.5
99.21.1

8215.7
86.917.5

25.315.8
41.118.9

<0.0001
<0.0001

0.92
0.90
0.95

2.2
3.3

1.6
2.2

0.90

22

The values are expressed as mean andSD.


AUC, area under the curve; ICC, intraclass correlation coefficient; ES, effect size; MCID, minimum clinically important difference; ROC, receiver-operating characteristic curve;
SRM, standardised response mean; VISA-H, Victorian Institute of Sport Assessment-Proximal Hamstring Tendons.

The Kruskal-Wallis test and Dunn post hoc comparison


revealed that the healthy individuals had a signicantly higher
score (99.31.2 points) compared with the patients of the nonsurgical group (56.711.6 points, p<0.001) and surgical group
(45.812.2 points p<0.001). No difference was found between
patients of the non-surgical and surgical groups ( p>0.05).

Responsiveness and interpretability


The Wilcoxon test revealed statistically signicant changes of the
VISA-H scores from baseline to discharge for both the nonsurgical (meanSD difference, 25.315.8; p<0.0001) and surgical (difference, 41.118.9; p<0.0001) groups (table 1).
There were no oor or ceiling effects for the VISA-H questionnaire from non-surgical and surgical groups at either baseline or discharge (All <15%).
The mean baseline and discharge scores, as well as the magnitude of changes expressed by the ES and SRM for the improved
patients of the non-surgical group (n=16) and surgical group
(n=9), are presented in table 1. The VISA-H had a large ES and
SRM both for the non-surgical group (ES=2.2, SRM=1.6) and
surgical group (ES=3.3, SRM=2.2).
The ROC curve analysis of the non-surgical group revealed
an AUC of 0.90 (95% CI 0.70 to 0.98; gure 1). The SE value
was 0.07. The AUC, by far, exceeded 0.5 ( p<0.0001). This
indicates that the change scores yielded by the VISA-H are signicantly better than chance at identifying an improved patient
from randomly selected pairs of improved and unimproved
patients. The MCID for the VISA-H questionnaire was of 22
points. The sensitivity and specicity associated with the MCID
of 22 were 0.91 (95% CI 0.61 to 0.98) and 0.87 (95% CI 0.48
to 0.96), respectively.

DISCUSSION
This study presents the VISA-H questionnaire constructed by
adapting questions from the VISA-P and VISA-A questionnaires,
with the overall purpose of evaluating pain/function and sporting activity of patients with PHT.

To our knowledge, the VISA-H is the rst PRO questionnaire


developed for patients with PHT.
There are many indications to be followed for the development of a questionnaire, and we have tried to follow the
COSMIN (Consensus-based Standards for the selection of
health Measurement Instruments) recommendations.26
Our psychometric evaluation proved that the VISA-H questionnaire had a high reliability, validity and responsiveness when
evaluating patients with PHT.
The Cronbach coefcient for the VISA-H was 0.84, which
indicates an excellent internal consistency. The Cronbach coefcient for the VISA-H was similar to that reported for the Swedish
version of VISA-P,34 but higher than that reported for the Dutch
version of VISA-P,35 and for the Swedish22 and German24 versions
of VISA-A. Since the internal consistency was not assessed in the
original VISA-A and VISA-P questionnaires, no comparison of
these data can be made with these studies. The high internal consistency found in the present study clearly demonstrates that the
VISA-H measures the same construct or dimension, that is, how
patients were limited by their symptoms during various physical
activities. This was conrmed by the results of factor analysis that
produced two strong factors (pain/function and sporting activity),
indicating that the VISA-H is valid for evaluating the patients
pain/function and its effect on sporting activity. These results were
similar to those of Silbernagel et al22 for the Swedish version of
the VISA-A questionnaire.
The VISA-H displayed an excellent reliability for all groups.
Our values are higher than those reported for the Dutch version
of VISA-P,35 but similar to those of the German24 and Swedish22
versions of VISA-A, and of the Swedish34 version of VISA-P. As
testretest reliability in the original VISA-A and VISA-P questionnaires was assessed using the Pearson correlation coefcient, a
direct comparison with our results is not possible.
We also analysed the SEM to dene the error associated with
a single application of the VISA-H. Using the SEM, a clinician
can be 68% condent that an initial VISA-H score of 55 points
actually falls within 1.4 points of the true score.

Table 2 Correlations between the VISA-H, NPRS and TGSCS scores at the baseline and discharge assessments
Baseline

Discharge

NPRS

VISA-H

TGSCS

NPRS

TGSCS

Groups

p Value

p Value

p Value

p Value

Non-surgical
Surgical

0.75
0.75

0.001
0.001

0.79
0.70

0.02
0.03

0.89
0.81

<0.001
0.01

0.88
0.81

0.001
0.01

The values are expressed as the Spearman correlation coefficient (r).


NPRS, Nirschl phase rating scale; TGSCS, Generic tendon grading system proposed by Curwin and Stanish; VISA-H, Victorian Institute of Sport Assessment-Proximal Hamstring Tendons.

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Original article

Figure 1 Receiver-operating-characteristic (ROC) curves illustrating the


relationship between sensitivity and complement of specicity
(1-specicity) for the Victorian Institute of Sport Assessment-Proximal
Hamstring Tendons (VISA-H) questionnaire.
The VISA-H questionnaire demonstrates good construct validity with high correlations with TGSCS and NPRS questionnaires, both at baseline and discharge. Our Spearman
correlation coefcients at baseline between VISA-H and NPRS
were lower than that reported by Visentini et al15 in the original
study on VISA-P. Our Spearman correlation coefcients at baseline between VISA-H and TGSCS questionnaires were higher
than that of the original version of the VISA-A14 and of the
Swedish22 version of VISA-A, but lower than that reported by
Loher and Nauk for the German24 version of VISA-A.
Construct validity, as tested by the Kruskal-Wallis test between
healthy participants and patients, revealed that the healthy participants marked a score to the VISA-H that was signicantly
higher than that for groups of patients.
The quality of measurement questionnaires has usually been
evaluated by considering the reliability and validity of such
questionnaires; it has, however, been suggested that responsiveness should be another criterion in the choice of a measurement
questionnaire.
To our knowledge, this is one of the rst studies that evaluated the responsiveness of the VISA form questionnaire, using
both distribution-based methods (ES and SRM) and an anchorbased method (ROC curve). Only recently, Hernandez-Sanchez
et al36 have assessed the responsiveness of the Spanish version
of VISA-P combining an anchor-based (MCS and ROC curve)
like ours and distribution-based approaches (SEM and MDC)
different from ours.
The MCID, dened as the magnitude of change that best distinguishes between patients who have improved and those
whose condition remains unchanged, was calculated using the
ROC curve analysis. Our MCID was of 22 points for the
VISA-H questionnaire in the non-surgical patients group. This
value was slightly higher than that reported by
Hernandez-Sanchez et al36 (13 points) for Spanish VISA-P. The
potential reasons for this difference could be due to the different population of patients studied and the different methodology used for calculating the MCID by ROC curve.
The VISA-H questionnaire demonstrated a high degree of
responsiveness for both the distribution-based method in both
groups of patients (ES and SRM) and the anchor-based method
(ROC curve) for the non-surgical patients group.
Cacchio A, et al. Br J Sports Med 2014;48:448452. doi:10.1136/bjsports-2012-091552

If taken together, the data obtained by both the anchor-based


and distribution-based methods demonstrate that the VISA-H
questionnaire has very high sensitivity. This allows moderate differences in clinical change to be identied when patients
undergo therapy and for there to be fewer patients necessary to
detect a signicant difference between treatment groups and
control groups in a clinical study.
Although the mean VISA-H scoring was signicantly different
between healthy individuals and patients with PHT, the score, as
previously suggested, is not considered to be a diagnostic test.14 15
Further, there was no statistically signicant difference
between mean VISA-H scores in the non-surgical and surgical
patients groups. This means that the result of the VISA-H, as
for the VISA-A and the VISA-P, does not have any role to play
in the decision as to whether or not surgery is indicated. In our
opinion, the indication for the surgical treatment in patients
with PHT remains a clinical decision that must be made between
the physician and the patient.
A limitation of our study is the small sample size of subjects.
As a consequence, we did not perform an ROC curve analysis in
the group of patients that was surgically treated. Another methodological limitation of our study is that the absence of a gold
standard for comparison makes analysis of this new questionnaire difcult.
The VISA-H questionnaire may provide clinically relevant
information to physicians and physiotherapists, and could therefore be very helpful during follow-ups when they conservatively
or surgically treat patients with PHT. However, further studies
with a large sample size across a broader age range would add
to the generalisability of our results.

CONCLUSION
In conclusion, this study provides initial evidence for VISA-H
validity, reliability and responsiveness for making judgements
about pain/function and sporting activity in patients with PHT.

What this study adds


This study provides initial evidence for validity, reliability and
responsiveness of the PRO VISA-H questionnaire which can
be used in a clinical setting for measuring the outcome,
related to pain function and sporting activity, after
non-surgical or surgical treatment in patients with PHT.

Contributors AC designed the data collection tools, monitored the data collection
for the whole trial, wrote the statistical analysis plan, cleaned and analysed the data
and drafted and revised the manuscript. She is the guarantor. NM and FDP cleaned
and analysed the data, as well as drafted and revised the paper.
Competing interests None.
Ethics approval University of LAquila.
Provenance and peer review Not commissioned; externally peer reviewed.

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Cacchio A, et al. Br J Sports Med 2014;48:448452. doi:10.1136/bjsports-2012-091552

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Development and validation of a new visa


questionnaire (VISA-H) for patients with
proximal hamstring tendinopathy
Angelo Cacchio, Fosco De Paulis and Nicola Maffulli
Br J Sports Med 2014 48: 448-452 originally published online March 7,
2013

doi: 10.1136/bjsports-2012-091552

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http://bjsm.bmj.com/content/48/6/448.full.html

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"Supplementary Data"
http://bjsm.bmj.com/content/suppl/2013/03/07/bjsports-2012-091552.DC1.html

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