Validated Assessment Scales for Décolleté Wrinkling and Pigmentation.

BACKGROUND: Décolleté aging includes skin dyspigmentation, laxity, and visible wrinkling. The development of globally accepted scales for the assessment of décolleté aging is essential for aesthetic research and patient evaluation. OBJECTIVE: To develop a set of grading scales for the objective assessment of décolleté aging criteria and establish the reliability and validity of these scales. MATERIALS AND METHODS: To describe age-related changes to the décolleté, 3 photonumeric grading scales were created and validated: décolleté wrinkles-at rest, décolleté wrinkles-dynamic, and décolleté pigmentation-at rest. Thirteen aesthetic experts rated photographs of the décolleté of 50 women at rest and at dynamic "hand-to-elbow" positions in 2 validation sessions. Responses were analyzed to assess interrater and intrarater reliability. RESULTS: Interrater and intrarater reliability were both "almost perfect" (≥0.81, intraclass correlation coefficient and weighted kappa) for décolleté wrinkles-dynamic, summary score for décolleté, and estimated age. Reliability was "substantial" (0.61-0.80) for all other décolleté assessments. There was high correlation between all décolleté scales, estimated age, and estimated aesthetic treatment effort. CONCLUSION: Consistent outcomes between raters and by individual raters at different time points confirm the reliability of the décolleté grading scales, indicating that they will be a valuable tool for use in clinical research and practice.

Measuring subjective complaints of attention and performance failures--development and psychometric validation in tinnitus of the self-assessment scale APSA.

BACKGROUND: There is a need for a validated self-assessment questionnaire for cognitive impairment in subjects reporting subjective tinnitus. The objective was to develop a patient-reported outcome measure. METHODS: This was a prospective, non-interventional, multicultural study. The 30-item "Attention and Performance Self-Assessment Scale" (APSA) was linguistically validated in Germany, Mexico and USA and was analyzed for content and structure. The analysis included descriptive statistics of baseline data, item characteristics, test-retest reliability (intra-class correlation coefficients, ICC), definition of internal consistency (Cronbach' s alpha), and explorative and confirmatory factor analysis to define the structure of the scale. Correlations with various tinnitus scales and subscales from the Hospital Anxiety and Depression Scale (HADS) were done to estimate convergent validity. RESULTS: The data for 211 subjects aged 30 through 60 years, (mean= 48.5 years, SD= 8.3) with mild to moderate tinnitus (mean Tinnitus Handicap Inventory-12 (THI-12) total score 11.2, SD= 5.3) were analyzed. The majority of subjects had sub-clinical scores for anxiety and depression (HADS below 11 points). Sequential principal factor analyses of the APSA resulted in a subscale which included 20 (APS20) of the original 30 items and two correlated subscales (AP-F1, AP-F2) defined by 9 items each. Both factor solutions were confirmed by confirmatory factor analysis. Test retest reliability of the APS20, AP-F1 and AP-F2 (ICC ≥ 0.87) and internal consistency (Cronbach's alpha ≥ 0.89) are high. APS20 correlated moderately high with HADS (depression: 0.54; anxiety: 0.62) and THI-12 total (0.52). In a few cases, AP-F2 correlated higher than AP-F1 with other scales (e.g. HADS-depression with AP-F1: only 0.46, but AP-F2: 0.59). CONCLUSIONS: APS20, AP-F1, and AP-F2 have good psychometrical properties. The scales will add value to the assessment of cognitive aspects of quality of life and mental health in the population with subjective tinnitus. The subscales AP-F1 and AP-F2 may be helpful for detecting specific cognitive failures and may be sensitive to different interventional effects.

Validated assessment scale for platysmal bands.

BACKGROUND: Marked platysmal bands in the neck are an unwelcome sign of aging. Botulinum neurotoxin type A has been used successfully to treat this indication, but there is a need for a validated tool for accurate assessment of dynamic platysmal bands to evaluate treatment efficacy objectively. OBJECTIVE: To develop a scale for objective assessment of dynamic platysmal bands and to validate its use in the clinical setting. METHODS: A new 5-point photonumeric assessment scale for platysmal bands was developed. Ten experts experienced in aesthetic dermatology used the scale to rate frontal and lateral neck photographs of 50 subjects in two separate validation cycles. Inter- and intrarater reliability of the scale was assessed. RESULTS: The scale comprises five ratings of platysmal band severity ranging from 0 (no relevant prominence of platysmal bands) to 4 (very severe prominence of platysmal bands). Interrater reliability was "almost perfect," with intraclass correlation coefficients of 0.81 for the first validation cycle and 0.82 for the second. Mean intrarater reliability was also high (0.89), with Pearson correlation coefficients ranging between 0.87 and 0.91. CONCLUSION: The new 5-point dynamic platysmal band photonumeric assessment scale is a valuable tool for use in the aesthetic clinical setting.

Validated composite assessment scales for the global face.

BACKGROUND: Twenty grading scales have been developed to assess age-related facial changes. Until now, the validity with regard to the patient's actual age and the clinical importance of combined measurement tools to describe facial aging was unclear. OBJECTIVE: To investigate the reliability and validity of a total face score and three global face assessment scales for estimated age, estimated aesthetic treatment effort, and signs of aging in the facial units. MATERIALS AND METHODS: Descriptive, reliability, correlation, and principal component analyses based on the assessment of 50 subjects by 12 raters using the 20 grading scales and the global face assessment scales. RESULTS: Inter- and intrarater reliability was high for the total face score and for the scales on estimated age and aesthetic treatment effort. Actual age was highly correlated with these three measures. Facial aging was indicated particularly by scales of the lower face. CONCLUSION: The aesthetic grading scales and global scales on estimated age and aesthetic treatment effort are reliable and valid instruments. The results suggest that a more-comprehensive evaluation of the human face and its age-related changes can help to identify important areas of facial aging and to define optimal aesthetic treatment strategies.

Validated assessment scales for the upper face.

BACKGROUND: Age-related upper face changes such as wrinkles, lines, volume loss, and anatomic alterations may affect quality of life and psychological well-being. The development of globally accepted tools to assess these changes objectively is an essential contribution to aesthetic research and routine clinical medicine. OBJECTIVE: To establish the reliability of several upper face scales for clinical research and practice: forehead lines, glabellar lines, crow's feet (at rest and dynamic expression), sex-specific brow positioning, and summary scores of forehead and crow's feet areas and of the entire upper face unit. METHODS AND MATERIALS: Four 5-point photonumerical rating scales were developed to assess glabellar lines and sex-specific brow positioning. Twelve experts rated identical upper face photographs of 50 subjects in two separate rating cycles using all eight scales. Responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for all upper face scales, aesthetic areas, and the upper face score except for the brow positioning scales. Intrarater reliability was high for all scales and resulting scores. CONCLUSION: Except for brow positioning, the upper face rating scales are reliable tools for valid and reproducible assessment of the aging process.

Validated assessment scales for the mid face.

BACKGROUND: The improvement of aesthetic treatment options for age-related mid face changes, such as volume loss, and the increase in patient expectations necessitates the development of more-complex and globally accepted assessment tools. OBJECTIVE: To develop three grading scales for objective assessment of the infraorbital hollow and upper and lower cheek fullness and to establish the reliability of these scales for clinical research and practice. METHODS AND MATERIALS: Three 5-point rating scales were developed to assess infraorbital hollow and upper and lower cheek fullness objectively. Twelve experts rated identical mid face photographs of 50 subjects in two separate rating cycles using the mid face scales. Test responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for the infraorbital hollow, upper cheek fullness, and lower cheek fullness scales. Intrarater reliability was high for all three scales. Both of the cheek fullness scales yielded higher reliabilities when three rather than two views were used to assess the volume changes of the cheek. CONCLUSION: The mid face scales are reliable tools for valid and reproducible assessment of age-related mid face changes.

Validated assessment scales for the lower face.

BACKGROUND: Aging in the lower face leads to lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline. Refined, easy-to-use, validated, objective standards assessing the severity of these changes are required in clinical research and practice. OBJECTIVE: To establish the reliability of eight lower face scales assessing nasolabial folds, marionette lines, upper and lower lip fullness, lip wrinkles (at rest and dynamic), the oral commissure and jawline, aesthetic areas, and the lower face unit. METHODS AND MATERIALS: Four 5-point rating scales were developed to objectively assess upper and lower lip wrinkles, oral commissures, and the jawline. Twelve experts rated identical lower face photographs of 50 subjects in two separate rating cycles using eight 5-point scales. Inter- and intrarater reliability of responses was assessed. RESULTS: Interrater reliability was substantial or almost perfect for all lower face scales, aesthetic areas, and the lower face unit. Intrarater reliability was high for all scales, areas and the lower face unit. CONCLUSION: Our rating scales are reliable tools for valid and reproducible assessment of the aging process in lower face areas.

Validated assessment scale for neck volume.

BACKGROUND: Sagging of the neck aesthetic area is an important indicator of age. The development of complex and globally accepted tools for proper assessment of the change in neck volume is an essential contribution to aesthetic research and the routine clinical setting. OBJECTIVE: To develop a grading scale for the objective assessment of the neck volume and to establish the reliability of this scale for clinical research and practice. MATERIALS AND METHODS: A 5-point rating scale was developed to assess neck volume objectively. Twelve experts rated frontal and lateral neck photographs of 50 subjects in two separate rating cycles using the neck volume scale. Responses of raters were analyzed to assess inter- and intrarater reliability. RESULTS: Interrater reliability for the neck volume scale was almost perfect, with intraclass correlation coefficients for the first and second rating cycles of 0.85 and 0.84, respectively. Intrarater reliability for the neck volume scale was high (0.90) and Pearson correlation coefficients ranged between 0.88 and 0.95 and were statistically significant. CONCLUSION: The neck volume scale demonstrates optimal reliability for clinical research and practice.

Validation of the THI-12 questionnaire for international use in assessing tinnitus: a multi-centre, prospective, observational study.

OBJECTIVE: To investigate and confirm the reliability and validity of the tinnitus handicap inventory 12 (THI-12) in various countries and languages. DESIGN: Prospective, observational study conducted in seven countries, using linguistically harmonized versions of the THI-12 in six languages. These were evaluated for test-retest reliability, internal consistency reliability, known-groups validity, and construct validity. Basic psychometric properties of supporting instruments were compared. Questionnaires were completed by the subjects at baseline and again after 12-30 days. STUDY SAMPLE: Adults with a clinical diagnosis of subjective tinnitus. RESULTS: An exploratory factor analysis of the THI-12 items for the U.S. study population at baseline revealed a single common factor of high eigenvalue. Confirmatory factor analysis supported this in the separate countries. Test-retest reliability was moderate to high, and the conclusions were supported by a known-groups analysis; correlations with other scales expected to support construct validity were moderate. CONCLUSIONS: The THI-12 total score showed acceptable psychometric properties for all countries tested. The relationships between the THI-12 and the one-month and one-week versions of the TRS and TSS were similar and convergent. The THI-12 is thus a promising diagnostic tool for assessing treatment effects in multi-cultural and multi-lingual trials on tinnitus therapy.

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus.

BACKGROUND: Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. METHODS: A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening) were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day) for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat) efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12). RESULTS: Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane), but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of < 0.05 for the 50 mg/d neramexane group associated with the functional-communicational subscores of the THI-12 and the assessments of tinnitus annoyance and tinnitus impact on life as measured on an 11-point Likert-like scale. No relevant changes were observed for puretone threshold, for tinnitus pitch and loudness match, or for minimum masking levels. The 25 mg/d neramexane group did not differ from placebo. Neramexane was generally well tolerated and had no relevant influence on laboratory values, electrocardiography and vital signs. Dizziness was the most common adverse event and showed a clear dose-dependence. CONCLUSIONS: This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT00405886.

Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time.

OBJECTIVE: To evaluate the reliability, dimensionality, predictive validity, construct validity, and sensitivity to change of the THI-12 total and sub-scales as diagnostic aids to describe and quantify tinnitus-evoked reactions and evaluate treatment efficacy. DESIGN: Explorative analysis of the German tinnitus handicap inventory (THI-12) to assess potential sensitivity to tinnitus therapy in placebo-controlled randomized studies. Correlation analysis, including Cronbach's coefficient α and explorative common factor analysis (EFA), was conducted within and between assessments to demonstrate the construct validity, dimensionality, and factorial structure of the THI-12. STUDY SAMPLE: N = 618 patients suffering from subjective tinnitus who were to be screened to participate in a randomized, placebo-controlled, 16-week, longitudinal study. RESULTS: The THI-12 can reliably diagnose tinnitus-related impairments and disabilities and assess changes over time. The test-retest coefficient for neighboured visits was r > 0.69, the internal consistency of the THI-12 total score was α ≤ 0.79 and α ≤ 0.89 at subsequent visits. Predictability of THI-12 total score and overall variance increased with successive measurements. The three-factorial structure allowed for evaluation of factors that affect aspects of patients' health-related quality of life. CONCLUSIONS: The THI-12, with its three-factorial structure, is a simple, reliable, and valid instrument for the diagnosis and assessment of tinnitus and associated impairment over time.

Amantadine sulfate reduces experimental sensitization and pain in chronic back pain patients.

We investigated if established psychophysical measures of enhanced experimental sensitization in chronic musculoskeletal pain can be reduced by adjuvant treatment with a N-methyl-d-aspartate receptor antagonist, amantadine sulfate, and whether a reduction in sensitization might be accompanied by a concurrent improvement in clinical pain. Sensitization was evaluated by an experimental tonic heat model of short-term sensitization with concurrent subjective and behavioral psychophysical scaling. Twenty-six patients with chronic back pain were included in the randomized, double-blind, placebo-controlled study and received daily dosages of either placebo or 100 mg of amantadine sulfate during a 1-wk treatment. Participants completed quantitative sensory testing of pain thresholds and experimental sensitization before and after treatment and clinical pain ratings before, during, and after treatment. Experimental sensitization and clinical pain were reduced in patients receiving verum. Initially, experimental sensitization was enhanced in patients, with early sensitization at nonpainful intensities of contact heat and enhanced sensitization at painful intensities, as shown previously. After 1 wk of treatment, experimental sensitization was reduced with amantadine sulfate but not with placebo. We conclude that adjuvant chronic pain treatment with N-methyl-d-aspartate receptor antagonists might be beneficial for chronic pain if enhanced sensitization is involved and that the quantitative sensory test of temporal summation may be used to verify this.

Assessment of low-grade hepatic encephalopathy: a critical analysis.

BACKGROUND/AIMS: The value of paper-pencil tests and West-Haven-criteria for assessment of low-grade hepatic encephalopathy under conditions of a randomized, double-blind, placebo-controlled, clinical trial was evaluated in a cohort of 217 cirrhotics. METHODS: Patients were graded at least twice clinically for severity of hepatic encephalopathy and tested concomitantly with a recommended psychometric test battery. RESULTS: Re-evaluation of the study documentation showed that at study entry 33% and during the study even 50% of the patients were wrongly allocated to minimal or overt hepatic encephalopathy. Despite the participating physicians' training, 31% of the number-connection-tests-A, 20% of the number-connection-tests-B and 28% of the line-tracing-test were in retrospect considered invalid by an independent psychologist. Neither the Portosystemic-Encephalopathy-Syndrome (PSE) test nor the Psychometric-Hepatic-Encephalopathy-Sum (PHES)-score reliably picked up clinical improvement in the individual patient. Although these test scores could statistically differentiate between patients with minimal and overt hepatic encephalopathy, the clinical classification of individual patients into one of the groups will have a high rate of error. The PHES-Score was less balanced than the score derived from the PSE-Syndrome-Test. CONCLUSIONS: Inaccuracies in conducting paper-pencil tests together with the subjectivity and incorrectness of clinical HE-grading question the usefulness of West-Haven-criteria and paper-pencil tests including related scores for quantification of low-grade HE at least in multicenter approaches.