Dataset Information

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

ABSTRACT: BACKGROUND:Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application. OBJECTIVE:The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15. METHODS:This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient. RESULTS:A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively. CONCLUSIONS:We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version. TRIAL REGISTRATION:ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388.

SUBMITTER: van Kollenburg RAA

PROVIDER: S-EPMC6634948 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

van Kollenburg Rob A A RAA de Bruin Daniel Martijn DM Wijkstra Hessel H

Journal of medical Internet research 20190702 7

<h4>Background</h4>Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measur ...[more]

PMID: 31267983

Similar Datasets

Project description:IntroductionThe International Index of Erectile Function (IIEF) is the predominant patient-reported outcomes instrument for assessing male sexual function. There are obvious problems with the use of the IIEF in the assessment of an individual patient, such as for men who use injections and men who do not engage in intercourse.AimThe aim of the current study is to redesign the erectile function domain of the IIEF (IIEF6) to more accurately assess the individual patient.MethodsIn an observational study of men undergoing treatment for prostate cancer at a tertiary care institution, including 24,732 questionnaires completed by 6,780 individuals, IIEF6 scores were compared for patients using and not using erectile aids. Men not engaging in sexual intercourse were asked to describe the reason.Main outcome measureThe main outcome we were seeking was the IIEF6 scores.ResultsMean scores before erectile aids items were added was 17.7 compared with predicted scores of 18.3 vs 16.7 if patients reported their function with vs without the use of aids. No intercourse was reported for 35% of surveys. Reasons given were lack of ability or confidence in 53%, lack of willing and available partner in 28%, "other" in 17% (including respondent's or partner's health issues, low libido, preference for nonpenetrative sex or for sex with men). Doubling the sum of the 3 nonintercourse IIEF6 questions had excellent properties (difference of 0.06, limits of agreement -3.10 to 3.22).Clinical implicationsErectile function instruments must include items about erectile aids. Men who report that they have not attempted intercourse should not be assumed to have erectile dysfunction, but should be asked the reason why. For men who report lack of opportunity or preference for intercourse, the score of the 3 nonintercourse IIEF6 questions should be doubled.Strengths & limitationsThis is a large study of patients in a real-world setting. Although the study only includes radical prostatectomy patients, and although the study cohort is not fully representative of the US prostate cancer population as a whole, these issues would not affect the key findings.ConclusionThe IIEF6 can be redesigned to better assess the individual patient. Vickers AJ, Tin AL, Singh K, et al. Updating the International Index of Erectile Function: Evaluation of a Large Clinical Data Set. J Sex Med 2020;17:126-132.

Project description:BackgroundDifferent standardized questionnaires are used to assess tinnitus severity, making comparisons across studies difficult. These questionnaires are also used to measure treatment-related changes in tinnitus although they were not designed for this purpose. To solve these problems, a new questionnaire - the Tinnitus Functional Index (TFI) - has been established. The TFI is highly responsive to treatment-related change and promises to be the new gold standard in tinnitus evaluation. The aim of the current study was to validate a German version of the TFI for a German-speaking population in Switzerland.MethodsAt the ENT department of the University Hospital Zurich, 264 subjects completed an online survey including the German version for Switzerland of TFI, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and sociodemographic variables. Internal consistency of the TFI was calculated with Cronbach's alpha coefficient. Pearson correlation coefficients were used for the test-retest reliability of the TFI and to investigate convergent and discriminant validity between the THI and the BDI and BAI, respectively. Factor analysis was assessed using a principal component analysis with oblique rotation. The different factors extracted were then compared with the original questionnaire.ResultsThe German version of the TFI for Switzerland showed an excellent internal consistency (Cronbach's alpha of 0.97) and an excellent test-retest reliability of 0.91. The convergent validity with THI was high (r = 0.86). The discriminant validity with BAI and BDI showed moderate results (BAI: r = 0.60 and BDI: r = 0.65). In the factor analysis only five factors with one main factor could be extracted instead of eight factors as described in the original version. Nevertheless, relations to the original eight subscales could be demonstrated.ConclusionThe German version of the TFI for Switzerland is a suitable instrument for measuring the impact of tinnitus. The reliability and validity of this version are comparable with the original version of the TFI. Although this study showed only five factors in the factor analysis, relations to the original eight subscales were identified. Therefore, the German version of the TFI for Switzerland can deliver relevant information regarding the different tinnitus domains.Trial registrationClinical trial registration number on clinicaltrial.gov: NCT01837368 .

Project description:IntroductionFemale sexual dysfunction (FSD) is a common problem, and many self-report questionnaires are available for its evaluation. Pakistani women with sexual problems feel shy to consult with their physician. A validated self-report questionnaire, in the local language with modest expressions is required for these women.AimThe aim of this study was to translate, cross-culturally adapt, and perform a psychometric validation of an Urdu translation of the Female Sexual Function Index (FSFI).MethodsThe FSFI was translated in Urdu, and its precision was ascertained through reverse translation. It was pretested on 22 bilingual women and refined again to reach at a reliable Urdu version of the questionnaire FSFI-U. One hundred sixteen bilingual women, in a stable sexual relationship over the previous 6 months were finally asked to fill out the FSFI and FSFI-U. Their sexual function was then clinically evaluated and responses were compared with the clinical assessment as well as with each other.Main outcome measuresThe responses were analyzed through descriptive statistics for reliability, face validity, agreement between the responses to the original English version and to the FSFI-U, and also for test-retest consistency. The data were analyzed statistically using Cronbach's alpha analysis, Intraclass correlation coefficients, Pearson correlation, and Student's t-test.ResultsFSFI was found to be easily understandable and capable of adequately evaluating and measuring various aspects of female sexual function. A high degree of internal consistency was demonstrated on Cronbach's alpha analysis. Cronbach's ? coefficient for various domains was sufficiently high ranging from 0.84 to 0.97. The clinical assessment of the presence and severity of FSD also matched with the self-report questionnaire. Similarly, various domains of FSFI had high degree of correlation in the Urdu version of FSFI (P?<?0.001).ConclusionThe Urdu translation version of FSFI is valid and reliable for use in the literate population of Pakistan. Rehman KU, Asif Mahmood M, Sheikh SS, Sultan T, Khan MA. The Female Sexual Function Index (FSFI): Translation, Validation, and Cross-Cultural Adaptation of an Urdu Version "FSFI-U". Sex Med 2015;3:244-250.

Project description:PURPOSE:This study aims to objectively characterize the effect of successful nerve sparing (NS) during radical prostatectomy (RP) on postoperative urinary continence (UC) using International Index of Erectile Function (IIEF)-scores and a previously described Expanded Prostate Cancer Index Composite (EPIC) score cutoff value (COV) for UC. Several notable studies on this topic present conflicting outcomes. This is largely due to a lack of clear definitions and consensus regarding preserved erectile function (EF) and UC. METHODS:This study is comprised of all patients who underwent RP at the Kantonsspital Baden, Switzerland, between 2004 and 2013. Patients completed self-assessment questionnaires for UC (EPIC) and EF (IIEF) pre- and postoperatively (3, 6, 9, 12, 18, and 24 months; yearly thereafter). We used a previously described EPIC subscore COV, with "satisfactory continence" signified by a score >85. Statistical analysis was performed using Kaplan-Meier and Cox regression analyses for "surgeon-" and "IIEF-defined" NS definitions. RESULTS:Of 236 men with a median age of 63 years (interquartile range [IQR], 59-66 years) and median follow-up time of 48 months (IQR, 30-78 months), 176 underwent unilateral (n=33) or bilateral (n=143) NS RP. Fifty-four underwent non-NS (NNS) RP. Kaplan-Meier analyses identified the following risk factors for UC: age, prostate volume, cancer risk group, and NS status. In surgeon-defined NS RP cases, multivariate analysis for regaining continence demonstrated no significant difference (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.48-1.25; P=0.3). With successful IIEF-defined NS RPs, regression analysis demonstrated no significant difference (HR, 0.89; 95% CI, 0.59-1.35; P=0.58). Conclusions:In our population, analysis and comparison of surgeon- and IIEF-defined NS and NNS cohorts revealed that NS RP did not improve postoperative UC. The conservation of UC alone should not motivate surgeons or patients to pursue NS RP.

Project description:PurposeTo translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP).MethodsA total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875-880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521-526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211-1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month.ResultsThe floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54-0.72) with the corresponding questionnaires except for "symptom-specific well-being" (0.31-0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85-0.94) and 0.81-0.86 for the two pain scores (back and leg). The "minimum detectable change'' (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score.ConclusionThe Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China.

Dataset Information

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

Publications

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure