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Objective. The original english version of Oral Health Impact Profile (IOHIP) was translated in Italian language, and then validated among a consecutive sample of patients attending in the dental ward at the Dental Institute of the “Sapienza” University of Rome, Italy. Research design. The original english version of IOHIP-14 was translated into the Italian language by a professional translator and subsequently back-translated into English by an independent person and then validated. Participants: 852 person, 342 males (40.1%) and 510 females (59.9%) participated to this survey. Results. The Cronbach’s alpha of the scale was 0.90. No correlation was negative and the correlation coefficients extended form 0.27 (the correlation between “pain“ “irritable”) to 0.69 (the correlation between “totally unable to function” and “difficult to do jobs”). The coefficients ranged from 0.42 to 0.74 with no value above the drop-out value of 0.20 recommended for included an item in a 15 points scale. A highly significant relationship between the IOHIP scores and the perceived oral health status was observed. The subjects who perceived their oral health status to be poor had a higher IOHIP score than those thought their oral health status was good or fair. Similarly there was a significant relationship between the IOHIP scores and the perceived need for dental care.
Conclusions. The translated Italian version of IOHIP-14 demonstrates an acceptable method to assess the impact of oral health on the quality of life, with evidence of reliability and validity, making it a promising instrument for assessing IOHIP in an adult population.
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Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14)
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                                                                                                                 Original article



                   Validation of the Italian version of the Oral Health
                   Impact Profile-14 (IOHIP-14)




                                                                                                                                  li
                                                                                  na
                   Denise Corridore, DDS, PhD1                            IOHIP-14 demonstrates an acceptable method to
                   Guglielmo Campus, DDS, PhD2                            assess the impact of oral health on the quality of




                                                                                io
                   Fabrizio Guerra, DDS, PhD1                             life, with evidence of reliability and validity, mak-
                   Francesca Ripari, DDS, PhD1                            ing it a promising instrument for assessing IOHIP
                   Silvana Sale, DDS, PhD2                                in an adult population.
                   Livia Ottolenghi, DDS, PhD1




                                                                             az
                                                                          Key words: oral health, quality of life, IOHIP-14.

                   1 Department of Oral and Maxillo-facial Sciences,
                     “Sapienza” University of Rome                        Introduction




                                                                          rn
                   2 Dental School, University of Sassari

                                                                          Very few valid tools existed to assess functional and
                                                                          psychological outcomes of oral disorders until recently.
                   Corresponding author:




                                                                       te
                                                                          The impact of health on an individual’s quality of life
                   Silvana Sale                                           has been defined as ‘health-related quality of life’ (1).
                   Dental School, University of Sassari                   Oral health-related quality of life (OHRQoL) come out
                   Viale San Pietro, 43/C I                               of the development of socio-dental indicators, in order
                   07100 Sassari, Italy
                   E-mail: si.sale@tiscali.it
                                                                    In    to find out non-clinical aspects of oral health, broaden-
                                                                          ing the focus of oral epidemiological research (2).
                                                                          Self-reported health measures have been demon-
                                                                          strated to reflect a pervasive mood disposition of neg-
                   Summary                                                ative affectivity (3). OHRQoL measures should also
                                                             ni
                                                                          correspond to decision-making criteria (like treatment
                   Objective. The original english version of Oral        needs, timing etc).
                   Health Impact Profile (IOHIP) was translated in
                                                                          The original 49-item IOHIP (Oral Health Impact Pro-
                   Italian language, and then validated among a con-
                                              o

                                                                          file) was developed by Locker and Slade (2-4) and
                   secutive sample of patients attending in the den-
                                                                          based on Locker’s conceptual model of oral health
                   tal ward at the Dental Institute of the “Sapienza”
                                          izi


                                                                          (5). It includes seven domains namely: functional limi-
                   University of Rome, Italy.
                                                                          tation, physical pain, psychological discomfort, physi-
                   Research design. The original english version of
                                                                          cal disability, psychological disability, social disability
                   IOHIP-14 was translated into the Italian language
                                                                          and handicap. The validity and reliability of a short
                   by a professional translator and subsequently
                           Ed




                                                                          version of the questionnaire, the IOHIP-14, has been
                   back-translated into English by an independent
                                                                          documented in several different clinical conditions
                   person and then validated. Participants: 852 per-
                                                                          like oral surgery, elderly, etc (6-7).
                   son, 342 males (40.1%) and 510 females (59.9%)
                                                                          Three different scoring methods of the IOHIP-14 have
                   participated to this survey.
                   Results. The Cronbach’s alpha of the scale was         been reported: 1- a simple summary of the recorded
                   0.90. No correlation was negative and the correla-     score (which is expressed as the sum of the seven
               C




                   tion coefficients extended form 0.27 (the correla-     raw sub-scale scores on a scale from 0 to 4 where a
                   tion between “pain“ “irritable”) to 0.69 (the corre-   high score signifies worse OHRQoL); 2- a weighted
                                                                          and standardized summary score (where weights are
    CI




                   lation between “totally unable to function” and
                   “difficult to do jobs”). The coefficients ranged       attributed to every question within the domain); 3- the
                   from 0.42 to 0.74 with no value above the drop-out     total number of problems reported (i.e. occasionally,
                   value of 0.20 recommended for included an item         often, or very often with a possible range of 0–14
                   in a 15 points scale. A highly significant relation-   problems) (8-10). The IOHIP scale originally devel-
                   ship between the IOHIP scores and the perceived        oped in English has been recently translated into dif-
©




                   oral health status was observed. The subjects          ferent languages (10-12) and the various versions of
                   who perceived their oral health status to be poor      this scale have shown to be valid and reliable instru-
                   had a higher IOHIP score than those thought their      ments to assess oral health-related quality of life in
                   oral health status was good or fair. Similarly there   the different populations.
                   was a significant relationship between the IOHIP       The aims of the study were to assess the validity and
                   scores and the perceived need for dental care.         reliability of the Italian version of the Oral Health Im-
                   Conclusions. The translated Italian version of         pact Profile-14 (IOHIP-14).

                   Annali di Stomatologia 2013; IV (3-4): 239-243                                                                239
3_Sale_Riv Annali 3-4 2013 13/02/14 10:39 Pagina 240




                   D. Corridore et al.


                   Materials and methods                                       5-point Likert type scale: 0=never, 1=hardly ever, 2=oc-
                                                                               casionally, 3=fairly often and 4=very often.
                   The study protocol received en ethical approval from
                   the Ethics Committee of the “Sapienza” University of
                   Rome n° 507/ 2007.                                          Data analysis




                                                                                                                                          li
                                                                               The unweighted Italian IOHIP-14 score was calculat-




                                                                                    na
                   Study design                                                ed by summing the scores of the responses to the 14
                                                                               items while the unweighted IOHIP subscale scores
                   In 2005 a small pilot study (13) was carried out, in        were calculated by summing the scores of the re-
                   which the original 49-IOHIP was translated and then         sponses to items corresponding to the subscales. Ac-




                                                                                  io
                   pre-validated. The results of this pilot study showed       cordingly the IOHIP score could therefore range from
                   good reliability of the index, however an excessively       0 to 14 for an individual. Instrument reliability was
                   time-consuming was noted. Since the IOHIP-49 is a           measured by assessing internal consistency and
                                                                               test–retest reliability. Internal consistency was as-




                                                                               az
                   long questionnaire and time-consuming to administer,
                   the same research group decided to translate and vali-      sessed using Cronbach’s α (which measures the cor-
                   date the shorter and self-administrate IOHIP-14 scale       relation between items, i.e. questions), for each of the
                   in a larger sample population.                              seven health domains, and for all 14 items. To as-
                                                                               sess test–retest reliability, the intraclass correlation




                                                                            rn
                                                                               coefficient (ICC) was calculated based on the repeat-
                   Translation procedure                                       ed subministration of the questionnaire to 25% of the
                                                                               sample after 60 days. Cronbach’s α values and test–




                                                                         te
                   In order to ensure a correct procedure for cross-cultur-    retest ICCs above 0.5-0.7 (14-16) are generally con-
                   al adaptation and linguistic validation, the Authors fol-   sidered to indicate sufficient reliability for an instru-
                   lowed a translation/back-translation procedure. The         ment or scale to be used to make group compar-
                   IOHIP-14 scale was forward translated into Italian by       isons; instruments or scales with coefficients above
                                                                      In
                   two translators who are native Italian, are fluent in       0.85 are considered reliable enough for individual pa-
                                                                               tient comparisons. With regard to internal consisten-
                   English and have experience of the issue; then a con-
                   sensus version was identified and subsequently back-        cy, inter-item and corrected item- total correlation co-
                   translated into English by an independent person who        efficients for the different IOHIP scale items were al-
                   was not involved in the study to guarantee accuracy         so calculated (Paerson’s coefficient). The homogene-
                                                        ni
                   and comparability of the translation.                       ity of the scale was evaluated on the basis of the cor-
                                                                               rected item-total correlation coefficients computing
                                                                               the correlation between each individual item in the
                   Selection of the sample                                     scale and the rest of the scale with the item of inter-
                                             o

                                                                               est eliminated. Construct validity of the scale was as-
                   A consecutive sample of patients attending the Den-         sessed examining the association between perceived
                                         izi


                   tal Department of the “Sapienza” University of Rome,        oral health status, perceived need for treatment, type
                   Italy was invited to take part in this cross-sectional      of visit (first examination or recall visit) and the IOHIP
                   study during the first three weeks of the month of          scores using Kruskal Wallis test. The acceptability of
                   June 2007. All the subjects were recruited by the clin-     the instrument was evaluated by calculating the num-
                          Ed




                   ical staff, trained in the study protocol and procedures    ber of missing items (non-responses). All data entry
                   by the investigator team. The clinical staff explained      and analyses were conducted with the STATA SE 9.0
                   the aim of the research and the procedures involved         statistical analysis software from STATA Inc. (USA).
                   and asking the participation and to sign a consent          Unless stated otherwise, the criterion for statistical
                   form. Participants completed the questionnaire in the       significance was set at α=0.05.
                   waiting room.
               C




                   Cognitive disparity and communication problems
                   among the participants may hamper the use of an in-         Results
    CI




                   strument and seriously affect the results of scoring sys-
                   tems, so subjects with more than 5 missing answers          Of the 852 individuals included in the survey, more
                   were excluded from further analysis.                        than a quarter of the sample (30.99%) was aged
                   During the study period 1045 person attended to the         more than 50 years and more than half of them
                   Dental Department of the “Sapienza” University of           (69.01%) were between 20-49 years (Tab. 1). Table 2
                   Rome. All of them were asked to participated, 878 (ac-      displays the correlation matrix for the 14 items of the
©




                   ceptance rate 84.0%) accepted but the questionnaire         IOHIP-14 scale. No correlation was negative and the
                   was completed by 852 person, 342 males (40.1%) and          correlation coefficients extended form 0.27 (the corre-
                   510 females (59.9%) that were enrolled for this survey.     lation between “pain“ “irritable”) to 0.69 (the correla-
                   The IOHIP-14 scale consists of 14 questions or items        tion between “totally unable to function” and “difficult
                   about impacts that could arise as a result of problems      to do jobs”). The reliability was evaluated on the ba-
                   in teeth, mouth or dentures and are grouped into seven      sis of the corrected item-total correlation coefficients
                   dimensions or domains. The responses are made on a          (Tab. 3). The coefficients ranged from 0.42 (difficult

                   240                                                                         Annali di Stomatologia 2013; IV (3-4): 239-243
3_Sale_Riv Annali 3-4 2013 13/02/14 10:39 Pagina 241




                   Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14)


                   to relax) to 0.74 (interrupted meals) with no value                      Discussion
                   above the drop-out value of 0.20 recommended to in-
                   clude an item in a 15 points scale. The Cronbach’s al-                   The measurement of the oral health-related quality of
                   pha of the scale was 0.90. The results of the assess-                    life is, ideally, a culturally sensitive instrument, but this
                   ment of construct validity are shown in Table 4. A                       procedure is a costly and time-consuming work; an al-




                                                                                                                                                      li
                   highly significant relationship between the IOHIP                        ternative method would be to translate an existing in-
                   scores and the perceived oral health status was ob-                      strument and adapt it in an other language i.e. Italian.




                                                                                              na
                   served. The subjects who perceived their oral health                     The present study therefore attempted at validating an
                   status to be poor had a higher IOHIP score than                          Italian translation of the IOHIP-14 and to adapt the orig-
                   those who thought their oral health status to be good                    inal English IOHIP version to the Italian cultural envi-
                   or fair. Similarly there was a significant relationship                  ronment and to investigate its psychometric properties.




                                                                                            io
                   between the IOHIP scores and the perceived need                          The topic of the cross-cultural adaption of health-relat-
                   for dental care. These results support the construct                     ed self-reported measure have been debated in several
                   validity of the translated IOHIP-14 scale.                               reports (4, 17). The adopted instruments must be cul-
                   Intraclass correlation coefficients for patients be-




                                                                                         az
                                                                                            turally and socially appropriate and reliable for the local
                   tween baseline and second administration of the                          population demonstrating also good psychometric prop-
                   questionnaire (n= 219 subjects 25.70% of the total                       erties. Therefore a rigorous translation and validation
                   sample examined) were 0.74, and 0.72 using the total                     process is fundamental before an instrument build up
                   IOHIP-14, weighted and number of problems scoring




                                                                                      rn
                                                                                            for one culture could be used in another population
                   methods, respectively (data not in table).                               group with a different culture.
                   All subjects answered to all 14 items of the IOHIP                       The results of this study were considered sufficient for
                   questionnaire and there were no missing values. 7                        the instrument’s use to discriminate subjects with differ-




                                                                                   te
                   items (8, 9, 18, 26, 30, 39, 44) lead to impact on less                  ent levels of perceived oral health and to evaluate
                   than 5% of the participants. At a closer examination,                    changes in the OHRQoL in a typical target population
                   these items showed a connection to severe oral                           of the questionnaire survey. The reliability of the instru-
                   health related impacts such as eating/digestion im-                      ment, assessed using Cronbach’s alpha, was higher
                   pairment and the use of prostheses, which can be ex-
                   pected to be rather infrequent among young people.
                                                                                In          the standard criteria deemed (18); furthermore the val-
                                                                                            ue achieved in our paper was higher than those report-
                                                                                            ed in the original English version (19). Since its devel-
                                                                                            opment, the IOHIP-14 has been preferred to the IOHIP-
                                                                                            49 by a number of researchers due to its practicality
                   Table 1. Gender and age distribution of the sample.
                                                               ni
                                                                                            (10, 19). A considerable scientific evidence now exists
                                                                                            on the validity and reliability of the IOHIP-14 (20).
                   Age in years        Males            Females             Total
                                                                                            The main reason for using the short form was to make
                   18-29               52               76                  128             available an efficient way of data collection based on
                                              o

                   30-39               70               134                 204             the premise that a long questionnaire cannot be used in
                   40-49               94               162                 256             some research settings and clinical practices even
                                          izi


                   50-59               48               62                  110             though it provides more comprehensive data. A mea-
                   60-69               38               42                  80              sure that takes a long time to be filled in may be not
                   >69                 40               34                  74              useful in a clinical setting (like a Dental Clinic) due to
                   Total               342              510                 852
                                                                                            the burden placed on patients and clinicians (4, 20).
                            Ed




                   Table 2. Internal consistency: IOHIP inter-item correlation, correlation coefficients.

                   IOHIP                                  1.        2.     3.       4.     5.     6.     7.     8.     9.    10.   11.   12.   13. 14.
               C




                   1.    Difficult pronounce words       —
                   2.    Worsened taste                0.53      —
                   3.    Pain                          0.38    0.41        —
    CI




                   4.    Uncomfortable to eat          0.42    0.45      0.58     —
                   5.    Self-conscious                0.48    0.49      0.58   0.65       —
                   6.    Feel tensed                   0.45    0.45      0.53   0.54     0.62     —
                   7.    Diet unsatisfactory           0.43    0.44      0.35   0.52     0.48   0.49     —
                   8.    Interrupted meals             0.47    0.50      0.48   0.54     0.56   0.52   0.58     —
©




                   9.    Difficult to relax            0.40    0.47      0.52   0.49     0.55   0.64   0.44   0.61     —
                   10.   Embarrassed                           0.39      0.43   0.42     0.49   0.63   0.58   0.47   0.55   0.56   —
                   11.   Irritable                     0.39    0.38      0.27   0.33     0.39   0.39   0.42   0.43   0.38   0.47   —
                   12.   Difficult to do jobs          0.41    0.39      0.36   0.35     0.39   0.40   0.49   0.52   0.53   0.43 0.49   —
                   13.   Life less satisfying          0.45    0.46      0.38   0.45     0.50   0.51   0.50   0.54   0.55   0.50 0.50 0.61   —
                   14.   Totally unable to function    0.43    0.44      0.37   0.43     0.42   0.44   0.48   0.58   0.51   0.42 0.45 0.69 0.68     —
                   Pearson coefficient

                   Annali di Stomatologia 2013; IV (3-4): 239-243                                                                                    241
3_Sale_Riv Annali 3-4 2013 13/02/14 10:39 Pagina 242




                   D. Corridore et al.


                   Table 3. Reliability analysis: corrected item-total correlation and Cronbach’s alpha.

                   IOHIP                                          Item-total                       Average total-item                     alpha
                                                                 correlation                          covariance
                   1.    Difficult pronounce words                  0.58                                   0.65                           0.90




                                                                                                                                                   li
                   2.    Worsened taste                             0.60                                   0.65                           0.90
                   3.    Pain                                       0.59                                   0.64                           0.90




                                                                                         na
                   4.    Uncomfortable to eat                       0.66                                   0.62                           0.90
                   5.    Self-conscious                             0.72                                   0.61                           0.89
                   6.    Feel tensed                                0.69                                   0.62                           0.89
                   7.    Diet unsatisfactory                        0.64                                   0.64                           0.90




                                                                                       io
                   8.    Interrupted meals                          0.74                                   0.62                           0.89
                   9.    Difficult to relax                         0.42                                   0.61                           0.92
                   10.   Embarrassed                                0.67                                   0.63                           0.90
                   11.   Irritable                                  0.55                                   0.66                           0.90




                                                                                    az
                   12.   Difficult to do jobs                       0.64                                   0.64                           0.90
                   13.   Life less satisfying                       0.70                                   0.63                           0.89
                   14.   Totally unable to function                 0.67                                   0.64                           0.90




                                                                                 rn
                   Table 4. Association between type of visit, perceived oral health status, perceived need for dental care and IOHIP-14 scores.




                                                                              te
                   Variable IOHIP-14 scores                Self perceived oral health             Self perceived oral health
                                                           status on first examination            status on recall examination
                                                           n (%)           In                     n (%)
                   Poor                                    190 (50.2)                             251 (53.2)
                   Fair                                    132 (35.2)                             172 (36.4)
                   Good                                    55 (14.6)                              52 (10.4)
                                                                                                                                          P=0.02
                   Variable IOHIP-14 scores                Self perceived need for dental         Self perceived need for dental
                                                           ni
                                                           care on first examination              care on recall examination
                                                           n (%)                                  n (%)
                   Yes                                     211 (55.8)                             189 (39.9)
                                              o

                   No                                      133 (35.2)                             243 (51.3)
                   Don’t know                              34 (9.0)                               42 (8.9)
                                                                                                                                          P=0.001
                                          izi



                   Kruskal-Wallis test was used to test the differences between groups.
                            Ed




                   The high alpha value (0.90) indicates that the 14                    study, but the response rate was high and the results
                   items of translated IOHIP scale measures the same                    permitted to draw conclusions about the validity of the
                   construct. The fit of a specific item to the scale was               Italian version of IOHIP-14 in a wider general practice
                   considered deleting the item and examining the                       population of patients.
                   change in the alpha value of the scale. It was evident               No general consensus exists about which method
                   from the results that the omission of any of the 14                  should be used to assess reliability, validity and re-
               C




                   items did not raise the Cronbach’s alpha score of the                sponsiveness (10, 21). However, the α coefficients and
                   scale. If an item is well fitted to its scale, the value of          test-restest coefficients observed seemed indicate the
    CI




                   alpha would decrease when the particular item is                     Italian IOHIP-14 as a reliable method.
                   deleted from the scale. This provides further evidence               However, a limitation in this study is that only subjective
                   for the very satisfactory internal consistency of the                outcomes were used. Clinical data could reduce per-
                   translated scale.                                                    sonal beliefs’ influences on answers in a quality of life-
                   The significant associations between the IOHIP-14 and                related questionnaire.
                   subscales scores and the self-rated oral health status               Therefore, further studies of the properties of the Ital-
©




                   and subject’s perceived treatment need supported the                 ian IOHIP-14 should be carried out including clinical
                   construct validity of the Italian version of IOHIP. All              assessment and testing of the questionnaire in popu-
                   these results were able to suggest that the Italian ver-             lations with a higher disease burden/disease variation
                   sion of IOHIP demonstrated good validity and reliability.            i.e. diabetic patients or older groups. Other aspects of
                   The inclusion in this sample of irregular attenders – i.e.           the questionnaire should be checked as the respon-
                   patients who only register when attending for an imme-               siveness of Italian IOHIP-14 to changes in oral health
                   diate problem may be considered a limitation of the                  conditions.


                   242                                                                                  Annali di Stomatologia 2013; IV (3-4): 239-243
3_Sale_Riv Annali 3-4 2013 13/02/14 10:39 Pagina 243




                   Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14)


                   Conclusions                                                                 in Sri Lanka. J Oral Rehabil 2004; 31:831-836.
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                   IOHIP and then it could be considered a valuable in-




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                                           izi
                           Ed
               C
    CI
©




                   Annali di Stomatologia 2013; IV (3-4): 239-243                                                                                        243
