Development and validation of a new visaquestionnaire (VISA-H) for patients with proximalhamstring tendinopathyAngelo Cacchio,1 Fosco De Paulis,2 Nicola Maffulli3

Additional material ispublished online only. To viewplease visit the journal online(http://dx.doi.org/10.1136/bjsports-2012-091552).1Department of Life, Healthand Environmental Sciences,School of Medicine, Universityof LAquila, LAquila, Italy2Division of DiagnosticImaging, Valle Giulia Clinic,Roma, Italy3Centre for Sports and ExerciseMedicine Barts and TheLondon School of Medicineand Dentistry, Mile EndHospital, London, UK

Correspondence toProfessor Angelo Cacchio,Dipartimento di MedicinaClinica, Sanit Pubblica,Scienze della Vita edellAmbiente, Universit degliStudi dellAquila, P.le SalvatoreTommasi 1, LAquila 67100,Italy; angelo.cacchio@tin.it

Accepted 13 February 2013Published Online First7 March 2013

To cite: Cacchio A, DePaulis F, Maffulli N. Br JSports Med 2014;48:448452.

ABSTRACTBackground There is a need for a patient-reportedoutcome (PRO) questionnaire to evaluate patients withproximal hamstring tendinopathy (PHT).Objective To develop a PRO questionnaire based onVISA questionnaire forms for patients with PHT.Methods Item generation, item reduction, item scalingand evaluation of the psychometric properties were usedto develop a questionnaire to assess the severity ofsymptoms, function and ability to play sports in patientswith PHT and healthy subjects. The nal version, namedVictorian Institute of Sport Assessment-ProximalHamstring Tendons (VISA-H), consisted of eightquestions that measured the domains of pain, functionand sporting activity. The psychometric properties of aquestionnaire were estimated in a population of non-surgical (n=20) and surgical (n=10) patients, as well asin healthy subjects (n=30).Results The VISA-H questionnaire displayed a highdegree of internal consistency, with a Cronbach of0.84. (The testretest reliability was high for all groupsof participants with an intraclass correlation coefcientranging from 0.90 to 0.95.) The VISA-H exhibited a highcorrelation with the Nirschl phase rating scale (r rangingfrom 0.75 to 0.89) and a generic tendon gradingsystem proposed by Curwin and Stanish (r ranging from0.70 to 0.88). Also, the responsiveness was higherfor the VISA-H questionnaire with an area under thecurve of 0.90 and a minimum clinically importantdifference of 22 points.Conclusions The VISA-H is a PRO questionnaire withhigh psychometric properties for measuring pain,function and sporting activity in patients with PHT.

INTRODUCTIONProximal hamstring tendinopathy (PHT) is anoveruse tendinopathy affecting the proximal tendonof the hamstring muscles. PHT usually affects ath-letes 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, espe-cially while performing sports activities or whensitting, in the area of the ischial tuberosity thatrarely radiates distally to the popliteal fossa.1 2 4

The pain typically appears and gradually increaseswithout being triggered by any acute event.1 2 4

Previous studies have clearly described the symp-toms,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 shownthat three pain provocation tests can be used forthe clinical diagnosis of PHT in athletes.9

Unfortunately, the success or failure of treatmentfor PHT is open to interpretation, given the lack ofinstruments on how to measure treatment outcomein a standardised fashion.The importance of monitoring the effectiveness

of treatment on the basis of the patients viewpointis widely recognised.10 11 Standardised patient-reported outcome (PRO) questionnaires provide aconvenient method to compare different patientpopulations, evaluate the outcome of treatment,facilitate comparisons between studies, determinethe patients clinical severity, provide a guidelinefor treatment and monitor treatment effects.12 13

The PRO VISA-P and VISA-A questionnaireshave been introduced to quantify athletes disabilitydue to patellar and Achilles tendinopathy, respect-ively, thereby facilitating research into these condi-tions.14 15 These questionnaires assess pain and theability to undertake physical activities and sports.Moreover, these questionnaires have been docu-mented as valid and reliable instruments for moni-toring recovery from patellar16 17 and Achillestendinopathy.18 19

There is also, however, a need for an easy, valid,and reliable PRO questionnaire to appraise thesymptoms and the ability to undertake sport, inpatients 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 validatea new PRO questionnaire for patients with PHTthat requires little time to administer and is easilyreadable.

MATERIALS AND METHODSThe development of this new instrument consistedof four steps: (1) item generation and test construc-tion, (2) item reduction, (3) item scaling and (4)evaluation of the psychometric properties of thenal version of the questionnaire.The VISA-A14 and VISA-P15 questionnaires were

used as background material to develop a question-naire specically for use in patients with PHT.

Step 1: item generation and test constructionThe development of this questionnaire started witha literature review to nd items that would beappropriate for inclusion. In addition, other poten-tial items used in clinical practice were gatheredwhile interviewing physicians, athletic trainers andphysical therapists directly involved with the man-agement of PHT. Further, patients were informallyinterviewed about symptoms that they felt wereimportant. Finally, an expert group of colleagues

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with several years of experience with PHT participated in twobrainstorming sessions to ensure good face validity to the 25new items generated.

Step 2: item reductionIn this phase, a focus group consisting of the principal investigator,a sport orthopaedic surgeon and a radiologist reviewed all theitems generated, deciding which of the 25 items should bediscarded and which should be retained. Using the frequency-importance product (frequencymean importance) and thePearson productmoment correlation, six items were retained.These six items will constitute the rst six questions (Q1Q6) ofour Victorian Institute of Sport Assessment-Proximal HamstringTendons (VISA-H) questionnaire, and with the last two questions(Q7 and Q8), similar to those of other VISA questionnaires, willbe structured in an eight-item questionnaire, covering the threedomains of pain, function and sporting activity.

Step 3: item scalingBased on the assumptions expressed by the authors of theVISA-A questionnaire,14 the rst six questions (pain and func-tion) used a 010 numerical rating scale and the nal two ques-tions (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 nalversion of the VISA-H questionnaireParticipantsThe nal version of the VISA-H questionnaire (see onlinesupplementary appendix) was administered to three groups: anon-surgical group with 20 patients (14 men and 6 women;mean age of 23.7 years, range 1825) with a diagnosis of PHTand selected to receive conservative management; a surgicalgroup with 10 patients (8 men and 2 women; mean age of21.4 years, range 1823) with a diagnosis of PHT and, follow-ing failure of conservative management, on the waiting list forsurgery; a healthy group with 30 individuals (20 men and 10women; mean age of 23.1 years, range 1826) represented aconvenience sample of athletes whose age matched the patientsgroups to serve as a control group. Written informed consentwas obtained from all the participants before enrolment in thestudy, and the procedures followed in the study were in accord-ance with the ethical standards of the local ethics committeeand 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. Fornon-surgical and surgical groups, patients had to have a diagno-sis of PHT made clinically and by means of MRI.1 9 A clinicaldiagnosis of PHT was made when the athlete had pain in thelower gluteal region, tenderness in the ischial tuberosity areaand positive in at least two of the following three pain provoca-tion tests: the Puranen-Orava test, the bent-knee stretch test andthe modied bent-knee stretch test.1 9 Briey, the Puranen-Orava test entails actively stretching the hamstring muscles inthe standing position with the hip exed at approximately 90,the knee fully extended and the foot on a support. The bent-knee stretch test is performed with the patient supine. The hipand knee of the symptomatic leg are maximally exed, and theexaminer slowly straightens the knee. For the modied bent-knee stretch test, the patient lies in the supine position with thelegs fully extended; the examiner grasps the symptomatic legbehind the heel with one hand and at the knee with the other

hand, exes the hip and knee maximally and then rapidlystraightens the knee.1 9

Exclusion criteria were: lumbar sciatic pain, piriformis syn-drome, ischial tuberosity avulsion, ischiogluteal bursitis or ham-string muscle tears; pregnancy; age of

physicians and the patients global rating of change scores wereaveraged to give an overall change score, which was used in thisstudy as the criterion standard of change. This measure ofchange was used as our external criterion, in the absence of agold standard, for the evaluation of responsiveness.25 For thispurpose, we chose global rating of change scores of 1 or 2 toclassify a worsened patient, a score of 35 to classify a stablepatient, and scores of 6 or 7 to classify an improved patient.

Data analysisAlthough the Kolmogorov-Smirnov test showed that the vari-ables were normally distributed, given the small sample size weapplied non-parametric tests. We determined that, to detect anintraclass correlation coefcient (ICC2,1) of 0.75 and an areaunder the curve (AUC) of 0.90 with a type I error of 0.05 and atype II error of 0.20, the necessary sample size was 10 and 15participants, respectively.The level of statistical signicance was set at p1) was applied toanalyse the factor structure of the VISA-H questionnaire.

Testretest reliabilityTestretest reliability indicates the extent to which the sameresults are obtained on repeated administrations of a giveninstrument when no change is expected. Testretest reliabilitywas assessed by means of the ICC2,1.

26

Changes in the VISA-H scores following both the non-surgical and surgical treatments in comparison with the respect-ive baselines were assessed using the Wilcoxon test.Additionally, SE of measurement (SEM=SD(1testretest

reliability coefcient)) was calculated.27

Construct validityConstruct validity indicates the extent to which the questionnairescores correlate with those of other questionnaires as expected,that is, whether the questionnaire really measures the intendedconstruct. Construct validity was tested by determining the rela-tionship between the VISA-H scores and the NPRS and GTRSCscores, both at the initial and at the discharge assessments, usingthe 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 byKruskal-Wallis test the results from the VISA-H questionnairesfor non-surgical and surgical group patients with the results ofhealthy subjects. A Dunn post hoc comparison was used todetermine signicant differences between mean values when asignicant main effect and interaction were found.

Responsiveness and interpretabilityThere is no consensus on the most suitable statistical analysis toassess responsiveness. Although the COSMIN guideline hasdened some responsiveness parameters such as effect size (ES)

and standardised response mean (SRM) as inappropriate mea-sures of responsiveness,26 they are accepted worldwide and usedin a large body of scientic literature and many clinicians arefamiliar with them.28 Therefore, in this study, we opted to usetwo distribution-based methods to assess the responsiveness ofthe VISA-H questionnaire: the ES29 and the SRM,30 as well asan anchor-based method, the receiver-operating-characteristic(ROC) curve.25

The ROC curve was also used to provide an estimate of theminimal minimum clinically important difference (MCID),taken as the point on the upper left-hand corner of the ROCcurve, which most effectively discriminates between patientswho have improved and those whose condition is unchanged.31

We also computed the AUC, which can be interpreted as theprobability of correctly identifying an improved patient fromrandomly selected pairs of patients who have and have notimproved.32 An AUC of 1.0 indicates perfect discriminationbetween these two health states. A questionnaire that does notdiscriminate more effectively than chance will have an AUC of0.50.Floor and ceiling effects were determined by calculating the

number of patients who obtained the best or worst scores pos-sible at both the baseline and discharge assessments in all thequestionnaires. Floor or ceiling effects are considered to bepresent if more than 15% of respondents achieved the lowest orhighest possible score, respectively.33

Floor and ceiling effects, distribution of total scores andchange scores in the overall study sample and in non-surgicaland surgical subgroups, and MCID will allow us to dene theinterpretability of our results.26 Interpretability is the degree towhich one can assign qualitative meaning to an instrumentsquantitative scores or change in scores.26

RESULTSInternal consistencyInternal consistency reached a Cronbachs of 0.84 (95% CI0.77 to 0.89) for the eight items. When the coefcient wascalculated for the overall scale by eliminating each of the eightitems one at a time, the range was 0.750.81; no single itemwas found to change the internal consistency substantially. Noitems were missing from the three questionnaires at either thebaseline or discharge assessments. The principal componentsanalysis revealed a two-factor structure, which accounted for73.4% of the total variance. The items loading on the rst com-ponent (pain/function) with six questions (Q1Q6) had load-ings ranging from 0.67 to 0.86, and explained 34.1% ofvariance with an eigenvalue of 5.8; the second component(sporting activity) with two questions (Q7 and Q8) had loadingsof 0.80 to 0.74, respectively, and explained 39.3% of variancewith an eigenvalue of 6.4.

Testretest reliabilityThe 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 non-surgical group, 0.90 (95% CI 0.63 to 0.97), with an SEM of1.56 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 validityThe Spearman rank correlation coefcients describing theextent of the correlation between the VISA-H scores and thoseof the comparison questionnaires (NPRS and TGSCS) areshown in table 2.

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The Kruskal-Wallis test and Dunn post hoc comparisonrevealed that the healthy individuals had a signicantly higherscore (99.31.2 points) compared with the patients of the non-surgical group (56.711.6 points, p

The VISA-H questionnaire demonstrates good construct val-idity with high correlations with TGSCS and NPRS question-naires, both at baseline and discharge. Our Spearmancorrelation coefcients at baseline between VISA-H and NPRSwere lower than that reported by Visentini et al15 in the originalstudy on VISA-P. Our Spearman correlation coefcients at base-line between VISA-H and TGSCS questionnaires were higherthan that of the original version of the VISA-A14 and of theSwedish22 version of VISA-A, but lower than that reported byLoher 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 parti-cipants marked a score to the VISA-H that was signicantlyhigher than that for groups of patients.The quality of measurement questionnaires has usually been

evaluated by considering the reliability and validity of suchquestionnaires; it has, however, been suggested that responsive-ness should be another criterion in the choice of a measurementquestionnaire.To our knowledge, this is one of the rst studies that evalu-

ated the responsiveness of the VISA form questionnaire, usingboth distribution-based methods (ES and SRM) and an anchor-based method (ROC curve). Only recently, Hernandez-Sanchezet al36 have assessed the responsiveness of the Spanish versionof 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 dis-

tinguishes between patients who have improved and thosewhose condition remains unchanged, was calculated using theROC curve analysis. Our MCID was of 22 points for theVISA-H questionnaire in the non-surgical patients group. Thisvalue was slightly higher than that reported byHernandez-Sanchez et al36 (13 points) for Spanish VISA-P. Thepotential reasons for this difference could be due to the differ-ent population of patients studied and the different method-ology 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 bothgroups of patients (ES and SRM) and the anchor-based method(ROC curve) for the non-surgical patients group.

If taken together, the data obtained by both the anchor-basedand distribution-based methods demonstrate that the VISA-Hquestionnaire has very high sensitivity. This allows moderate dif-ferences in clinical change to be identied when patientsundergo therapy and for there to be fewer patients necessary todetect a signicant difference between treatment groups andcontrol groups in a clinical study.Although the mean VISA-H scoring was signicantly different

between healthy individuals and patients with PHT, the score, aspreviously suggested, is not considered to be a diagnostic test.14 15

Further, there was no statistically signicant differencebetween mean VISA-H scores in the non-surgical and surgicalpatients groups. This means that the result of the VISA-H, asfor the VISA-A and the VISA-P, does not have any role to playin the decision as to whether or not surgery is indicated. In ouropinion, the indication for the surgical treatment in patientswith PHTremains a clinical decision that must be made betweenthe 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 inthe group of patients that was surgically treated. Another meth-odological limitation of our study is that the absence of a goldstandard for comparison makes analysis of this new question-naire difcult.The VISA-H questionnaire may provide clinically relevant

information to physicians and physiotherapists, and could there-fore be very helpful during follow-ups when they conservativelyor surgically treat patients with PHT. However, further studieswith a large sample size across a broader age range would addto the generalisability of our results.

CONCLUSIONIn conclusion, this study provides initial evidence for VISA-Hvalidity, reliability and responsiveness for making judgementsabout pain/function and sporting activity in patients with PHT.

What this study adds

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

Contributors AC designed the data collection tools, monitored the data collectionfor the whole trial, wrote the statistical analysis plan, cleaned and analysed the dataand drafted and revised the manuscript. She is the guarantor. NM and FDP cleanedand 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-2012-0915522013

2014 48: 448-452 originally published online March 7,Br J Sports Med

Angelo Cacchio, Fosco De Paulis and Nicola Maffulli

proximal hamstring tendinopathyquestionnaire (VISA-H) for patients with Development and validation of a new visa

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