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Patients undergoing primary knee arthroplasty, before and six months postoperative, tested the final version in Spanish. Psychometric properties of feasibility, reliability, validity and sensitivity to change were assessed. Feasibility: a high number of missing items in questions 3, 4 and 5 were observed. The number of patients with a missing item was Sensitivity to change: statistically significant differences were found between the mean scores of the first visit compared to the postoperative.

However, some changes at the completion instructions are recommended. Measurement of outcomes has been widely used in orthopedic surgery. During the past decade there has been an increasing number of instruments developed and validated according to the answers offered by patients, whereas previously there were only results based on clinical data provided by the surgeon.

Questionnaires are essential tools to measure the impact of a specific surgical technique such as primary knee arthroplasty.

The vast majority of questionnaires have been developed in English. In order to apply them at countries these must be translated and later validated.

The process of translation has been previously standardized and it is denominated transcultural adaptation [ 1 - 4 ]. Later on, translated version must be validated in the population of the country of application, showing a reliability, feasibility, validity and sensitivity to change similar to the questionnaire in the original language. It consists of 7 items, in which 3 have 4 sub-items, which makes a total of 16 questions with Likert-type answers ranging between 5 or 7 multiple-choices.

The questionnaire has been applied previously in order to measure functional recovery of patients who had undergone primary hip or knee arthroplasty [ 6 ]. We present the analysis of its psychometric properties; feasibility, reliability, validity and sensitivity to change. The cultural adaptation of the questionnaire was carried out at an early stage, developing 1. The analysis of psychometric properties was performed prospectively with version 1.

With this aim, patients filled out versions 1. These last two were administered for the convergent validity. All patients participating in it were informed and signed an informed consent prior to their inclusion in the study. The process of cultural adaptation of questionnaires for evaluating results in health follows a methodology that can be summarized as follows:.

Double translation from the original questionnaire English to Spanish. The translation was performed by two translators, an expert in questionnaires as well as an English philologist. Retro-translation of the first intermediate version in Spanish to the original language English. A back-translation to English was performed by an independent expertise in questionnaires. Comparison of the retro-translation with the original version and composition of the second intermediate version Spanish.

A committee of experts checked version 1. During this phase the aim was to evaluate appropriateness, according to its relationship with knee disease and comprehensibility of the items, as well as to assess the final 1.

Once we had version 1. Inclusion criteria for the present study were 1 Patients undergoing primary total knee arthroplasty, 2 Signed informed consent had been obtained from the patient, 3 The patient was at least eighteen years old on the day of signing the informed consent and 4 The patient was cognitively intact, fluent in Spanish, and sufficiently literate to complete the self-administered questionnaire. Exclusion criteria were patients who the investigator believed that might fail to comply with the protocol.

Next we described scorings registered from the patients during visits 1 and 2, comparing these scorings from the studied questionnaire to figure out if there were significant differences between the moments of measurement and to analyze the sensitivity to change from the questionnaires used in the present study. The statistical analysis was performed at both evaluation-times before and after surgery. The analyzed properties in each case were the following:.

Feasibility: this was evaluated according to the percentage of no-answer in every item missing items and to the percentage of patients that did not answer some item, as well as to the completion time of the studied questionnaires.

Moreover, ceiling effect was studied percentage of patients with maximum score, indicating a better clinical situation , together with floor effect percentage of patients with minimum score, indicating a worse clinical outcome , for every item and for global scoring of every instrument used.

Values lower than 0. Regarding EFA, the following were obtained:. Kaiser-Meyer-Olkin: measures the sampling adequacy, which should be greater than 0. It is larger when the partial correlations among variables are small [ 8 ]. If we try to get together variables from a questionnaire as factors, there must be certain relationship between the variables. Sensitivity to change: analysis of the differences within the mean scores between before and after surgery t -test for related samples and Wilcoxon signed-ranked test.

This item 1 had low comprehensibility 1. The panel of experts later confirmed this fact, which made it advisable to change the composition of the item, especially taking into account that 4 out of 10 interviewed patients did not answer. Several options were discussed in order to change the composition Tense, Rigid, Numb, Feeling of rigidness, Painful.

The final version of the questionnaire was version 1. Once obtained the Spanish version 1. The amount of missing items at the SF questionnaire was very low, between 6 1.

Percentage of patients with missing items: patients On the other hand, the SF presented only 31 patients 9. Ceiling and floor effects: both effects were almost invaluable for the Hip and Knee Questionnaire, and very low for WOMAC pain, stiffness and physical function.

As for SF health questionnaire, the ceiling and floor effects were null for the two summary scores, as these were standardized with the mean of the Spanish general population. The item-rest correlation advises the removal of item 6 Which of the following statements best describes your ability to get around most of the time during the past week?

All coefficients were significant at level 0. When comparing Hip and Knee with SF, correlation coefficients are also moderate, however, these are more proximal to 0. In conclusion, there seems to be a significant improvement after undergoing joint replacement. Sensitivity to change of the questionnaires: mean differences between scorings at visits 1 and 2. The only effect small in magnitude was for the mental component of SF Instead, within the rest of scales, this effect was high, which contributes with more evidence of the correct validation of the scale that we are studying in this case, in terms of sensitivity to change.

The vast majority of these instruments have been designed in English. Therefore, it was necessary to establish requisites for the translation process, and these were applied in the present study [ 4 ].

However, the term cross-cultural adaptation refers to a wider process that includes not only translation but also the cultural adaptation to the new country of application. Different habits of life within different cultures can alter the results of a questionnaire. This questionnaire was developed originally outside Spain. The result of the cultural adaptation was version 1. This item 1 had a low comprehensibility, and an appropriateness slightly lower than 3, probably because the question was not understandable.

The panel of experts confirmed this fact, especially since this question was not answered by 4 out of 10 patients and advised changing the composition of the item.

Several alternative options were proposed, and the final composition was that exposed in version 1. This makes a large group of patients from different hospital centers around Spain, avoiding geographic bias. This evaluation test was implemented not only for the mentioned questionnaire, but for two validated scale; a specific one WOMAC and a generic SF , widely used in our country.

The SF Health Questionnaire, [ 13 , 14 ] measures health-related quality of life, applicable to any group of population. Its Spanish version has already been validated [ 15 - 17 ]. The WOMAC questionnaire [ 18 ] is a specific instrument developed to evaluate the impact in quality of life of osteoarthritis. The questionnaire has been previously translated and validated in Spain [ 19 ]. Regarding the feasibility of the scales, the Hip and Knee questionnaire presented, during both visits, a high percentage of missing items at questions 3, 4 and 5.

These questions refer to multiple-choice answers for every joint at study, and a possible cause of failure could be the instructions not being clear enough: the patient has to mark and answer for every line a, b, c, d , and not exclusively mark the line that refers to the operated joint in each case.

They understood that they were asking only for the affected knee joint when in fact asked about the status of both knees and hips. We believe that the questionnaire is still appropiate for the following reasons: first, the patients answered the question correctly on their affected joint; secondly, despite some missing items the questionnaire responses have shown its feasibility, internal validity, reliability and sensitivity to change.

In this sense, it would be recommended having the doctor revising its correct complementation. These difficulties were reflected in the high percentage of patients with at least one missing item in the Hip and Knee within both visits The analysis of the ceiling and floor effect reflected scorings almost insignificant. Except for item 6 Which of the following statements best describes your ability to get around most of the time during the past week? Results from this item at the preoperative phase would advise its removal.

However, at the postoperative visit, the results from this item were satisfactory. Regarding the convergent validity , a significant association with the specific instrument WOMAC was found moderate-high , supporting the correct validation of the questionnaire.

In the same line, when compared to the generic scale SF, the associations were found to be significant, in a higher intensity when compared to the functional dimensions of SF rather than to Role Emotional or Social, just as we expected. Finally, with regards to the sensitivity to change of the tests, we found, in all cases, statistically significant differences between mean scores at visit 1 compared to visit 2.

We observed, in all cases, an improvement after the surgical procedure, reinforcing once more, the correct validation of the questionnaires to find changes in quality of life of patients following a knee procedure.

Several limitations should be taken into consideration when reviewing the present manuscript. Firstly, no patients with severe hip dysfunction were included.

Second, test-retest reliability, and thus, correlation coefficient, were not provided, even though it has been already described in previous translations. We recommend having the doctor revising its correct complementation. Moreover, its limited extension makes it possible to be included in the regular clinical practice of medical doctors.

Each author certifies that he or she has no commercial associations e. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. OA participated in drafting the article, carried out the statistical analysis and designed the manuscript. PS participated in revision of the manuscript and interpretation of results. All authors read and approved the final version of the manuscript.


Transcultural adaptation and validation of the “Hip and Knee” questionnaire into Spanish

Patients undergoing primary knee arthroplasty, before and six months postoperative, tested the final version in Spanish. Psychometric properties of feasibility, reliability, validity and sensitivity to change were assessed. Feasibility: a high number of missing items in questions 3, 4 and 5 were observed. The number of patients with a missing item was Sensitivity to change: statistically significant differences were found between the mean scores of the first visit compared to the postoperative.


The Western Ontario and McMaster Universities Osteoarthritis Index WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip , including pain, stiffness, and physical functioning of the joints. The WOMAC has also been used to assess back pain, rheumatoid arthritis , juvenile rheumatoid arthritis , systemic lupus erythematosus , and fibromyalgia. The WOMAC measures five items for pain score range 0—20 , two for stiffness score range 0—8 , and 17 for functional limitation score range 0— A WOMAC test takes about 12 minutes, but is also available in a short form, although this has not been as extensively tested as the full version. It has been translated into more than 65 languages. The ACR says the pain subscale "has been variable across studies but generally meets the minimum standard.

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