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The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness.

ABSTRACT: A standardized tampon insertion and removal test, the Tampon Test provides an alternative to sexual intercourse pain as an outcome measure for vulvodynia research. We report upon the reliability, validity, and responsiveness to change of the Tampon Test as an outcome measure for vulvodynia clinical trials.Outcome measures were assessed in women enrolled in the Vulvar Vestibulitis Clinical Trial, a randomized clinical trial of oral desipramine and topical lidocaine effectiveness. Reliability estimates of the Tampon Test using the Kappa statistic evaluated week-to-week measures at baseline. Tampon Test construct and discriminant validity were assessed through correlation with other outcome measures. Patients' ability to regularly perform the Tampon Test was compared with regularity of reporting intercourse pain.During the 2-week baseline phase, women with vulvodynia reported stable mean Tampon Test scores 4.6+/-2.6 (week -2); 4.6+/-2.7 (week -1); and 4.7+/-2.8 (week 0) with moderate week-to-week reliability (weighted Kappa 0.52). Over an 8-week phase of trial intervention, change in the Tampon Test measure significantly correlated to a number of outcome measures, including daily pain (r=0.42), intercourse pain (r=0.35), cotton swab vestibular pain (r=0.38), and the Brief Pain Inventory (r=0.49). Women with vulvodynia study participants performed the Tampon Test 96.3% of the requested time, which was twofold higher adherence than intercourse pain measurement (49.7%).The Tampon Test reflects a real life experience that is reliable, with good construct validity as shown by the breadth of correlated outcome measures. The Tampon Test is an appropriate outcome measure for vulvodynia research that can be considered for use as the primary efficacy endpoint in clinical trials of treatments for vulvodynia.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068II.

SUBMITTER: Foster DC

PROVIDER: S-EPMC2756618 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness.

Foster David C DC Beth Kotok Merrill M Huang Li-Shan LS Watts Arthur A Oakes David D Howard Fred M FM Stodgell Chris J CJ Dworkin Robert H RH

Obstetrics and gynecology 20090401 4

<h4>Objective</h4>A standardized tampon insertion and removal test, the Tampon Test provides an alternative to sexual intercourse pain as an outcome measure for vulvodynia research. We report upon the reliability, validity, and responsiveness to change of the Tampon Test as an outcome measure for vulvodynia clinical trials.<h4>Methods</h4>Outcome measures were assessed in women enrolled in the Vulvar Vestibulitis Clinical Trial, a randomized clinical trial of oral desipramine and topical lidocai ...[more]

PMID: 19305326

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Project description:BackgroundCurrently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the 'Patient Enablement Instrument', we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test-retest reliability, measurement error, responsiveness and floor and ceiling effects.MethodsThe PEI-BP consists of 6 items that are rated on a 0-10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test-retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire-physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain.ResultsThe PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test-retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population.ConclusionsThe PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended.Trial registrationNot applicable.

Project description:ObjectivesThe aim of the present study was to investigate the construct validity, responsiveness and reliability of the Feline Grimace Scale (FGS) in kittens.MethodsA total of 36 healthy female kittens (aged 10 weeks to 6 months) were included in a prospective, randomized, blinded study. Video recordings of all kittens were made before and 1 and 2 h after ovariohysterectomy using an opioid-free injectable anesthetic protocol with or without multimodal analgesia. Additional recordings were taken before and 1 h after administration of rescue analgesia (buprenorphine 0.02 mg/kg IM) to painful kittens. Screenshots of facial images were collected from the video recordings for FGS scoring. Four observers blinded to treatment groups and time points scored 111 randomized images twice with a 5-week interval using the FGS. Five action units (AUs) were scored (ear position, orbital tightening, muzzle tension, whiskers position and head position; 0-2 each). Construct validity, responsiveness, and inter- and intra-rater reliability were evaluated using linear models with Benjamini-Hochberg correction, Wilcoxon signed-rank test and single intraclass correlation coefficients (ICCsingle), respectively (P <0.05).ResultsFGS total ratio scores were higher at 1 and 2 h after ovariohysterectomy (median [interquartile range, IQR]: 0.30 [0.20-0.40] and 0.30 [0.20-0.40], respectively) than at baseline (median [IQR]: 0.10 [0.00-0.30]) (P <0.001). FGS total ratio scores were lower after the administration of rescue analgesia (median [IQR] before and after rescue analgesia) 0.40 [0.20-0.50] and 0.20 [0.10-0.38], respectively (P <0.001). Inter-rater ICCsingle was 0.68 for the FGS total ratio scores and 0.35-0.70 for all AUs considered individually. Intra-rater ICCsingle was 0.77-0.91 for the FGS total ratio scores and 0.55-1.00 for all AUs considered individually.Conclusions and relevanceThe FGS is a valid and responsive acute pain-scoring instrument with moderate inter-rater reliability and good to excellent intra-rater reliability in kittens.

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The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness.

Publications

The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness.

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