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 L’Aquila, L’Aquila, 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, Sanità Pubblica,Scienze della Vita edell’Ambiente, Università degliStudi dell’Aquila, P.le SalvatoreTommasi 1, L’Aquila 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;48:448–452.

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 final 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 α of0.84. (The test–retest reliability was high for all groupsof participants with an intraclass correlation coefficientranging 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 from−0.70 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.1–3

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,1–6 the MRI,7 8 histopathological findings,4

and the non-surgical1 3 and surgical treatment2 4–6

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 patient’s 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 patient’s 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 thefinal version of the questionnaire.The VISA-A14 and VISA-P15 questionnaires were

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

Step 1: item generation and test constructionThe development of this questionnaire started witha literature review to find 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 (frequency×mean importance) and thePearson product–moment correlation, six items were retained.These six items will constitute the first six questions (Q1–Q6) 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 first six questions (pain and func-tion) used a 0–10 numerical rating scale and the final two ques-tions (sporting activity) used a categorical rating scale.

The worst score obtainable with the VISA-H questionnairewas 0 points, while the best was 100 points.

Step 4: evaluation of psychometric properties of the finalversion of the VISA-H questionnaireParticipantsThe final 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 18–25) 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 18–23) 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 18–26) represented aconvenience sample of athletes whose age matched the patients’groups 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 beolder 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 modified bent-knee stretch test.1 9 Briefly, the Puranen-Orava test entails actively stretching the hamstring muscles inthe standing position with the hip flexed 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 flexed, and theexaminer slowly straightens the knee. For the modified 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, flexes 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 <18 years; inflammatoryor neoplastic disorders; any treatments administered in the last2 months.

During the physical examination, a differential diagnosis wasmade between PHT and lumbar sciatic pain, piriformis syn-drome, hamstring muscle tears and knee pain. If one of theaforesaid conditions was suspected on the basis of the clinicalfindings, additional radiographs, electroneuromyographicstudies and MRI of the lumbar spine or of the hamstringmuscles or of the knee were performed before the enrolment.

TreatmentsNon-surgical management consisted of relative rest, avoidingactivities and/or exercises that would increase the severity ofsymptoms, and four sessions of radial shockwave therapy, at therate of one session per week. At each session, 2500 shocks witha pressure of four bars (equal to an energy flux density ofapproximately 0.18 mJ/mm2) and a frequency of 10 shocks/swere applied. The technique and methodology have beendescribed in detail elsewhere.1

Surgical treatment was performed in another centre accordingto the procedure described by Lempainen et al.4

Procedures and questionnairesAt baseline, subjects of three groups were asked to complete theVISA-H questionnaire, the Nirschl phase rating scale (NPRS),20

and a generic tendon grading system proposed by Curwin andStanish (TGSCS)21 in a comfortable room.

To assess the VISA-H test–retest reliability, all three groups ofparticipants were asked to complete the questionnaire again3 days later after the first administration at baseline. To minimisethe risk of clinical changes, non-surgical and surgical groups ofpatients did not receive any treatment during this 3-day interval.

The final version of the VISA-H questionnaire consists ofeight items, covering the two domains of pain/function (ques-tions 1–6) and sporting activity (questions 7–8). Questions 1–7were scored of 10 each and question 8 was scored of 30. Scoresare summed to give a total of 100. An asymptomatic personwould score 100, while someone who is symptomatic wouldscore less than that.

The NPRS21 is a seven-phase (1–7) assessment of pain andactivity limitations caused by overuse injuries. The TGSCS22

assessed 6° of reported exercise-induced tendon pain and thelevel of sports performance.

Although the psychometric properties of these tools are notformally validated so far, TGSCS and NPRS have been used as astandard for construct validity testing in previous VISA-A andVISA-P validation research, respectively.14 15 22–24 Moreover,the NPRS was used as an outcome measure in a previous clinicalstudy on shockwave treatment for patients with chronic PHT.1

At discharge, the VISA-H, NPRS and GTRCS were adminis-tered again to the patients on completion of their non-surgicalor surgical treatment. Since the patients of the surgical groupunderwent the surgical procedure in another referral centre, thesecond administration of the VISA-H, NPRS and TGSCS ques-tionnaires and a global rating of change were undertakenbetween 7 and 15 days (mean: 11±3 days) after their discharge.

At discharge, the physician and the patient also independentlycompleted a 7-point global rating of change form, ranging from1=‘very much worse’ to 7=‘very much improved’. The

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physician’s and the patient’s 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 a‘gold 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 3–5 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 coefficient (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 significance was set at p<0.05. All ana-lyses 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, CollegeStation, Texas, USA).

Psychometric propertiesInternal consistencyInternal consistency is the degree of inter-relatedness among theitems.26 Internal consistency of the VISA-H was assessed bymeans of the Cronbach α and 95% CIs, using the data from thebaseline questionnaire.27 Moreover, a principal component ana-lysis with varimax rotation (eigenvalue >1) was applied toanalyse the factor structure of the VISA-H questionnaire.

Test–retest reliabilityTest–retest reliability indicates the extent to which the sameresults are obtained on repeated administrations of a giveninstrument when no change is expected. Test–retest 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×√(1−test–retestreliability coefficient)) 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 coefficients (r) and 95% CIs.

According to the original article on the VISA-A,14 constructvalidity 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 significant differences between mean values when asignificant main effect and interaction were found.

Responsiveness and interpretabilityThere is no consensus on the most suitable statistical analysis toassess responsiveness. Although the COSMIN guideline hasdefined 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 scientific 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 thenumber 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 define theinterpretability of our results.26 Interpretability is the degree towhich one can assign qualitative meaning to an instrument’squantitative scores or change in scores.26

RESULTSInternal consistencyInternal consistency reached a Cronbach’s α of 0.84 (95% CI0.77 to 0.89) for the eight items. When the α coefficient wascalculated for the overall scale by eliminating each of the eightitems one at a time, the range was 0.75–0.81; 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 first com-ponent (pain/function) with six questions (Q1–Q6) 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.

Test–retest 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 coefficients 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 significantly higherscore (99.3±1.2 points) compared with the patients of the non-surgical group (56.7±11.6 points, p<0.001) and surgical group(45.8±12.2 points p<0.001). No difference was found betweenpatients of the non-surgical and surgical groups (p>0.05).

Responsiveness and interpretabilityThe Wilcoxon test revealed statistically significant changes of theVISA-H scores from baseline to discharge for both the non-surgical (mean±SD difference, 25.3±15.8; p<0.0001) and sur-gical (difference, 41.1±18.9; p<0.0001) groups (table 1).

There were no floor or ceiling effects for the VISA-H ques-tionnaire from non-surgical and surgical groups at either base-line or discharge (All <15%).

The mean baseline and discharge scores, as well as the magni-tude of changes expressed by the ES and SRM for the improvedpatients of the non-surgical group (n=16) and surgical group(n=9), are presented in table 1. The VISA-H had a large ES andSRM both for the non-surgical group (ES=2.2, SRM=1.6) andsurgical group (ES=3.3, SRM=2.2).

The ROC curve analysis of the non-surgical group revealedan AUC of 0.90 (95% CI 0.70 to 0.98; figure 1). The SE valuewas 0.07. The AUC, by far, exceeded 0.5 (p<0.0001). Thisindicates that the change scores yielded by the VISA-H are sig-nificantly better than chance at identifying an improved patientfrom randomly selected pairs of improved and unimprovedpatients. The MCID for the VISA-H questionnaire was of 22points. The sensitivity and specificity associated with the MCIDof 22 were 0.91 (95% CI 0.61 to 0.98) and 0.87 (95% CI 0.48to 0.96), respectively.

DISCUSSIONThis study presents the VISA-H questionnaire constructed byadapting questions from the VISA-P and VISA-A questionnaires,with the overall purpose of evaluating pain/function and sport-ing activity of patients with PHT.

To our knowledge, the VISA-H is the first PRO questionnairedeveloped for patients with PHT.

There are many indications to be followed for the develop-ment of a questionnaire, and we have tried to follow theCOSMIN (Consensus-based Standards for the selection ofhealth Measurement Instruments) recommendations.26

Our psychometric evaluation proved that the VISA-H ques-tionnaire had a high reliability, validity and responsiveness whenevaluating patients with PHT.

The Cronbach α coefficient for the VISA-H was 0.84, whichindicates an excellent internal consistency. The Cronbach α coeffi-cient for the VISA-H was similar to that reported for the Swedishversion of VISA-P,34 but higher than that reported for the Dutchversion of VISA-P,35 and for the Swedish22 and German24 versionsof VISA-A. Since the internal consistency was not assessed in theoriginal VISA-A and VISA-P questionnaires, no comparison ofthese data can be made with these studies. The high internal con-sistency found in the present study clearly demonstrates that theVISA-H measures the same construct or dimension, that is, howpatients were limited by their symptoms during various physicalactivities. This was confirmed by the results of factor analysis thatproduced two strong factors (pain/function and sporting activity),indicating that the VISA-H is valid for evaluating the patient’spain/function and its effect on sporting activity. These results weresimilar to those of Silbernagel et al22 for the Swedish version ofthe VISA-A questionnaire.

The VISA-H displayed an excellent reliability for all groups.Our values are higher than those reported for the Dutch versionof VISA-P,35 but similar to those of the German24 and Swedish22

versions of VISA-A, and of the Swedish34 version of VISA-P. Astest–retest reliability in the original VISA-A and VISA-P question-naires was assessed using the Pearson correlation coefficient, adirect comparison with our results is not possible.

We also analysed the SEM to define the error associated witha single application of the VISA-H. Using the SEM, a cliniciancan be 68% confident that an initial VISA-H score of 55 pointsactually falls within ±1.4 points of the true score.

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, andthe magnitude of the changes after non-surgical (ES, SRM, ROC curve) and surgical (ES, SRM) patients

Group of participants Baseline score 3-Day retest score Discharge score Change score p Value ICC(2,1) ES SRM

ROC curve

AUC MCID

VISA-H Non-surgical patients (N=16) 56.7±11.6 55.6±12.8 82±15.7 25.3±15.8 <0.0001 0.92 2.2 1.6 0.90 22Surgical patients (N=9) 45.8±12.2 47.5±13.5 86.9±17.5 41.1±18.9 <0.0001 0.90 3.3 2.2Healthy Subjects (N=30) 99.3±1.2 99.2±1.1 0.95

The values are expressed as mean and±SD.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.

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

Baseline Discharge

NPRS TGSCS NPRS TGSCS

Groups p p Value r p Value r p Value r p Value

VISA-H Non-surgical –0.75 0.001 –0.79 0.02 –0.89 <0.001 –0.88 0.001Surgical –0.75 0.001 –0.70 0.03 –0.81 0.01 –0.81 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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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 coefficients at baseline between VISA-H and NPRSwere lower than that reported by Visentini et al15 in the originalstudy on VISA-P. Our Spearman correlation coefficients 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 betweenhealthy participants and patients, revealed that the healthy parti-cipants marked a score to the VISA-H that was significantlyhigher than that for groups of patients.

The quality of measurement questionnaires has usually beenevaluated 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 first 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, defined 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 ofresponsiveness 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 identified when patientsundergo therapy and for there to be fewer patients necessary todetect a significant difference between treatment groups andcontrol groups in a clinical study.

Although the mean VISA-H scoring was significantly differentbetween 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 significant 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 difficult.

The VISA-H questionnaire may provide clinically relevantinformation 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 L’Aquila.

Provenance and peer review Not commissioned; externally peer reviewed.

REFERENCES1 Cacchio A, Rompe JD, Furia JP, et al. Shockwave therapy for the treatment of

chronic proximal hamstring tendinopathy in professional athletes. Am J Sports Med2011;39:146–53.

2 Puranen J, Orava S. The hamstring syndrome. A new diagnosis of gluteal sciaticpain. Am J Sports Med 1988;16:517–21.

3 Fredericson M, Moore W, Guillet M, et al. High hamstring tendinopathy in runners:meeting the challenges of diagnosis, treatment, and rehabilitation. Phys Sportsmed2005;33:32–43.

Figure 1 Receiver-operating-characteristic (ROC) curves illustrating therelationship between sensitivity and complement of specificity(1-specificity) for the Victorian Institute of Sport Assessment-ProximalHamstring Tendons (VISA-H) questionnaire.

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4 Lempainen L, Sarimo J, Mattila K, et al. Proximal hamstring tendinopathy: results ofsurgical management and histopathologic fi ndings. Am J Sports Med 2009;37:727–34.

5 McGregor C, Ghosh S, Young DA, et al. Traumatic and overuse injuries of theischial origin of the hamstrings. Disabil Rehabi 2008;30:1597–601.

6 Young IJ, Van Riet RP, Bell SN. Surgical release for proximal hamstring syndrome.Am J Sports Med 2008;36:2372–8.

7 De Paulis F, Cacchio A, Michelini O, et al. Sports injuries in the pelvis and hip:diagnostic imaging. Eur J Radiol 1998;27:S49–59.

8 Koulouris G, Connell D. Hamstring muscle complex: an imaging review.Radiographics 2005;25:571–86.

9 Cacchio A, Borra F, Severini G, et al. Reliability and validity of three painprovocation tests used for the diagnosis of chronic proximal hamstringtendinopathy. Br J Sports Med 2012;46:883–7.

10 Kirkley A, Griffin S, McLintock H, et al. The development and evaluation of adisease-specific quality of life measurement tool for shoulder instability. The WesternOntario Shoulder Instability Index (WOSI). Am J Sports Med 1998;26:764–72.

11 Thomeé P, Währborg P, Börjesson M, et al. A new instrument for measuringself-efficacy in patients with an anterior cruciate ligament injury. Scand J Med SciSports 2006;16:181–7.

12 Delitto A. Are measures of function and disability important in low back care? PhysTher 1994;74:452–62.

13 Suk M, Hanson B, Norvell D, et al. AO handbook, musculoskeletal outcomesmeasures and instruments. Stuttgart: Thieme, 2005.

14 Robinson JM, Cook JL, Purdam C, et al. for Victorian Institute of Sport TendonStudy Group. The VISA-A questionnaire: a valid and reliable index of the clinicalseverity of Achilles tendinopathy. Br J Sports Med 2001;35:335–41.

15 Visentini PJ, Khan KM, Cook JL, et al. for Victorian Institute of Sport Tendon StudyGroup. The VISA score: an index of severity of symptoms in patients with jumper’sknee (patellar tendinosis). J Sci Med Sport 1998;1:22–8.

16 Khan KM, Maffulli N, Coleman BD, et al. Patellar tendinopathy: some aspects ofbasic science and clinical management. Br J Sports Med 1998;32:346–55.

17 Khan KM, Visentini PJ, Kiss ZS, et al. Correlation of ultrasound and magneticresonance imaging with clinical outcome after patellar tenotomy: prospective andretrospective studies. Victorian Institute of Sport Tendon Study Group. Clin J SportMed 1999;9:129–37.

18 Rompe JD, Furia J, Maffulli N. Eccentric loading versus eccentric loading plusshock-wave treatment for midportion Achilles tendinopathy: a randomized controlledtrial. Am J Sports Med 2008;37:463–70.

19 Silbernagel KG, Thomee R, Eriksson BI, et al. Continued sports activity, using apain-monitoring model, during rehabilitation in patients with Achilles tendinopathy:a randomized controlled study. Am J Sports Med 2007;35:897–906.

20 Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med 1992;11:851–70.

21 Curwin S, Stanish WD. Tendinitis: its etiology and treatment Lexington. Lexington,MA: Collamore Press, 1984.

22 Silbernagel KG, Thomee R, Karlsson J. Cross-cultural adaptation of the VISA-Aquestionnaire, an index of clinical severity for patients with Achilles tendinopathy,with reliability, validity and structure evaluations. BMC Musculoskelet Disord2005;6:12.

23 Maffulli N, Longo UG, Testa V, et al. Italian translation of the VISA-A score fortendinopathy of the main body of the Achilles tendon. Disabil Rehabil2008;30:1635–9.

24 Lohrer H, Nauck T. Cross-cultural adaptation and validation of the VISA-Aquestionnaire for German-speaking Achilles tendinopathy patients. BMCMusculoskeletal Disord 2009;10:134.

25 Stratford PW, Binkley FM, Riddle DL. Health status measures: strategies and analyticmethods for assessing change scores. Phys Ther 1996;76:1109–23.

26 Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating themethodological quality of studies on measurement properties: A clarification of itscontent. BMC Med Res Methodol 2010;10:22.

27 Streiner DL, Norman GR. Health measurement scales: a practical guide to theirdevelopment and use. New York, NY: Oxford University Press, 2003.

28 Angst F. The new COSMIN guidelines confront traditional concepts ofresponsiveness. BMC Med Res Methodol 2011;11:152.

29 Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in healthstatus. Med Care 1989;27:S178–89.

30 Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments fororthopedic evaluation. Med Care 1990;28:632–42.

31 Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically importantdifference (MCID): a literature review and directions for future research. Curr OpinRheumatol 2002;14:109–14.

32 Hosmer DW, Lemeshow S. Applied logistic regression. 2nd edn. New York:John Wiley & Sons, Inc, 2000.

33 McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: areavailable health status surveys adequate? Qual Life Res 1995;4:293–307.

34 Frohm A, Saartok T, Edman G, et al. Psychometric properties of a Swedishtranslation of the VISA-P outcome score for patellar tendinopathy. BMCMusculoskelet Disord 2004;5:49.

35 Zwerver J, Kramer T, Van den Akker-Scheek I. Validity and reliability of the Dutchtranslation of the VISA-P questionnaire for patellar tendinopathy. BMCMusculoskelet Disord 2009;10:102.

36 Hernandez-Sanchez S, Hidalgo MD, Gomez A. Responsiveness of theVISA-P scale for patellar tendinopathy in athletes. Br J Sports Med.2014;48:453–7.

6 of 6 Cacchio A, et al. Br J Sports Med 2014;48:448–452. doi:10.1136/bjsports-2012-091552

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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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