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Original article
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.
To cite: Cacchio A, De
Paulis F, Maffulli N. Br J
Sports Med 2014;48:
448452.
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.
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
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
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
Discharge score
Change score
p Value
ICC(2,1)
ES
SRM
AUC
MCID
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
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.
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
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Original article
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.
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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doi: 10.1136/bjsports-2012-091552
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Data Supplement
"Supplementary Data"
http://bjsm.bmj.com/content/suppl/2013/03/07/bjsports-2012-091552.DC1.html
References
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Notes