Condensation and validation of a 4-item index of the Acne-QoL

Background: The 19-item Acne-QoL is a validated psychometric instrument designed for use in clinical trials. Objective: The purpose of this study was to develop a condensed version of the Acne-QoL as an alternative measure of psychosocial impact for use in routine clinical practice. Methods: Four condensed versions of the Acne-QoL were evaluated by regression analysis in a subset of 434 patients. The version with four items most broadly representative of acne-specific quality of life combined with a high level of correlation to Acne-QoL total score was selected for further validation in two different patient samples. Results: The patient ranked condensation, representing items from each domain of greatest patient-perceived importance and relevance was selected for further analysis (Acne-Q₄). The Acne-Q₄ explained 98.5% of the variation in total score of Acne-QoL. Validation of the Acne-Q₄ in a follow-up group and an independent subset of patients resulted in Pearson correlation coefficients of 0.967 (p<0.001). Construct validity of the Acne-Q₄ was confirmed by demonstrating a similar relationship as the Acne-QoL to acne severity. Limitations: There is less breadth and detail of QoL information in the Acne-Q₄ than in the Acne-QoL. The analysis relied on a total score for Acne-QoL, which the original developers did not validate. Conclusions: The Acne-Q₄ is accurately reflective of the parent instrument and may facilitate the psychometric evaluation of the impact of facial acne on patients in routine clinical practice by its practicality.     

Validation of the Revised 10-Item HIV Treatment Satisfaction Questionnaire Status Version and New Change Version

OBJECTIVES: Previous validation of the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs) found that nine of the 10 items performed well, but the demands item needed revision. This study investigated the psychometric properties of the revised HIVTSQs and new change version (HIVTSQc). METHODS: English-speaking Americans completed the HIVTSQs at baseline and Week 48 of a clinical trial of HIV treatments, and the HIVTSQc at Week 48. Demographic and viral load information was collected. Psychometric validation used item frequency distributions, Confirmatory Factor Analysis (CFA), item-total correlations, Cronbach's alpha, Spearman's rank correlation, Kruskal-Wallis and Mann-Whitney tests. RESULTS: At baseline, 126 of the 152 patients completed the HIVTSQs fully (100 of 106 at Week 48). The negatively skewed distribution of the revised demands item resembled that of the other nine, with comparable missing data. CFA (baseline and Week 48) supported the general satisfaction/clinical subscale (alpha 0.83; 0.85), lifestyle/ease subscale including demands (alpha 0.82; 0.85), and 10-item treatment satisfaction scale (alpha 0.89; 0.91). Subscale and scale scores differed significantly between ethnic groups. Viral load was not significantly related to subscale or scale scores. At Week 48, 97 of 106 patients completed the HIVTSQc fully. All items had negatively skewed distributions. CFA supported two subscales (general satisfaction/clinical change alpha 0.85; lifestyle/ease change alpha 0.88) and 10-item treatment satisfaction change scale (alpha 0.92). Viral load change between baseline and Week 48 correlated significantly with patients' perceptions of change in HIV control (control(c) item), but not with scale or subscale scores. CONCLUSION: The excellent psychometric properties of the HIVTSQs and HIVTSQc support their use in clinical trials.     

Evaluating health-related quality of life in patients with facial acne: development of a self-administered questionnaire for clinical trials

Although psycholosocial aspects of skin diseases are well known, disease-specific questionnaires validated for use in clinical trials are not available to assess the impact of facial acne on health-related quality of life or to evaluate therapeutic change. Development of such an instrument was undertaken and included item generation, reduction and pilottesting phases. By interviewing acne subjects and dermatologists and literature review, 168 possible items were identified. Next, 165 acne subjects identified which items affected them and rated importance on a 5-point scale. Reduction to a brief questionnaire was performed by evaluating patient-perceived importance and factor analysis; four domains were identified (self-perception, roleemotional, role-social, acne symptoms). After pilot-testing for comprehension in acne subjects, further revisions were made to improve clarity and applicability. The resulting instrument takes 10 minutes to complete, and consists of 24 questions assessing how acne affected certain aspects of patients' lives during the past week on a 7-point scale. Thus, an instrument with excellent content validity was developed to assess health-related quality of life in patients with facial acne, and is comprised of statistically meaningful items of importance to patients. Other measurement characteristics are being assessed in a recently initiated study to evaluate test-retest reliability and responsiveness to therapy.     

Effects of a phasic oral contraceptive containing desogestrel on facial seborrhea and acne

BACKGROUND: The combined oral contraceptive containing ethinylestradiol and the selective progestogen, desogestrel, in a phasic regimen (DSG-OC, Tri-merci) has been shown to reduce facial oiliness. OBJECTIVE: This study was designed to evaluate further the effects of this OC on the skin of women with facial seborrhea and mild or moderate acne. DESIGN AND METHODS: This was an open, noncomparative, bicenter study in 60 healthy Russian women, aged 18-30 years, with facial seborrhea and mild or moderate facial acne, who wished to use oral contraception. All women received the OC containing desogestrel (50/100/150 microg) and ethinylestradiol (35/30/30 microg) for three phases of 7 days followed by a 7-day pill-free interval, for six cycles. Seborrhea was assessed using the Sebutape technique, in which strips of adhesive microporous polymeric film pressed onto facial sites are used to assess sebaceous activity. Acne was assessed by counting facial lesions. Subjective evaluations of skin and hair condition, patients' feelings to them and satisfaction with the OC were made using a visual analogue scale (VAS). Assessments were made at baseline, and after one, three and six treatment cycles. RESULTS: Sebutape assessments of seborrhea were significantly improved, on the right and left cheeks, after one treatment cycle, and on the forehead after three treatment cycles. These improvements increased steadily and were much larger at the end of Cycle 6. Acne grades were significantly improved after three and six treatment cycles. VAS scores in response to questions dealing with self-esteem and self-confidence were significantly improved after three cycles and in some cases after just one cycle. The women's views of their skin and hair (greasiness) were correspondingly significantly improved. Subjective assessments indicated that after one, three and six cycles, 69%, 93% and 98%, respectively, of women were satisfied or very satisfied with the DSG-OC. CONCLUSION: In women with facial seborrhea and mild or moderate acne, the use of DSG-OC appears to improve seborrhea after just one cycle and acne grades after three cycles. These improvements are accompanied by increases in self-esteem and confidence.     

Efficacy of a combined oral contraceptive containing 0.030 mg ethinylestradiol/2 mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0.035 mg ethinylestradiol/2 mg cyproterone acetate

Background

Acne is a multifactorial disease characterized by androgenic stimulation of sebaceous glands. Therefore, combined oral contraceptives (COCs) containing anti-androgenic progestogens are suitable candidates for acne treatment. This study aimed to show that a COC containing the anti-androgen dienogest (DNG) is superior to placebo and not inferior to a COC containing the potent anti-androgen cyproterone acetate (CPA) in improving mild to moderate acne.

Study Design

Healthy women between 16 and 45 years old with mild to moderate facial acne were randomly assigned to receive ethinylestradiol (EE)/DNG (n=525), EE/CPA (n=537) or placebo (n=264) for six cycles in a multinational, multicenter, three-arm, double-blind and randomized trial. The primary efficacy variables were the percentages of change (from baseline to cycle 6) in inflammatory and total lesion count and the percentage of patients with acne improvement according to the Investigator Global Assessment.

Results

All primary analyses proved that EE/DNG was superior to placebo and non-inferior to EE/CPA (p<.05). For inflammatory lesions, the reduction (±SD) rates were −65.6±29.9% for EE/DNG, −64.6±31.2% for EE/CPA and −49.4±41.0% for placebo. For total lesions, the reduction rates were −54.7±26.3% for EE/DNG, −53.6±27.5% for EE/CPA and −39.4±33.6% for placebo. The percentages of patients with improvement of facial acne were 91.9% for EE/DNG, 90.2% for EE/CPA and 76.2% for placebo.

Conclusion

EE/DNG was superior to placebo, in spite of the prominent placebo effects, and as effective as EE/CPA in the treatment of mild to moderate acne, thus proving a valid option for the treatment of acne in women seeking oral contraception.     

A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment: a randomized trial

Objective

This study aimed to compare the effectiveness and safety of triphasic combined oral contraceptives (OCs) containing ethinyl estradiol (EE) and norgestimate (NGM) and biphasic combined OCs containing EE and desogestrel (DSG) in the treatment of mild to moderate acne.

Study design

This was an investigator-blinded, randomized, parallel group trial conducted at 3 centers in Thailand. Female subjects 18–45 years old were assigned to one or the other OCs and evaluated for efficacy and safety parameters at the baseline visit and after 1, 3 and 6 months of treatment.

Results

Among 201 randomized subjects, data from 93 subjects in the EE/NGM group and 95 subjects in the EE/DSG group were analyzed. After 6 months of treatment with EE/NGM and EE/DSG, no differences between formulations were found for the decrease in total acne lesion counts (74.4% vs. 65.1%, respectively, p=.070) or facial improvement score. More women using EE/NGM showed a decrease in severity of facial seborrhea than those using EE/DSG (p=.005). No changes in weight were noted in either group as compared to baseline.

Conclusion

Multiphasic OCs containing EE/NGM and EE/DSG provided comparable efficacy and tolerability in the treatment of acne. However, EE/NGM had a more beneficial effect on facial seborrhea reduction than EE/DSG.

Implications

EE/NGM and EE/DSG are multiphasic OCs, which were shown to be clinically equally effective for mild to moderate facial acne, and the multiphasic combined OC with NGM was more effective for women with facial seborrhea. Clinicians may apply the results of this study when considering treatment options for facial acne and seborrhea.     

Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 microg ethinylestradiol

OBJECTIVES: Poor cycle control and tolerability can be reasons for irregular pill intake. This study compared the tolerability of two low-dose oral contraceptives and their effect on cycle control. METHODS: In this open, group-comparative, randomized multicenter trial in Germany and the Netherlands, women received either 20 microg ethinylestradiol plus 150 microg desogestrel (20EE/DSG; n = 500) or 20 microg ethinylestradiol plus 100 microg levonorgestrel (20EE/LNG; n = 498) for six treatment cycles. Cycle control, dysmenorrhea and premenstrual syndrome (PMS) were assessed using diary cards. Tolerability was assessed using the self-administered questionnaires Psychological General Well-Being Index (PGWBI) and the Profile of Mood States (POMS). Acne was assessed by objective (acne counts) and subjective (no, moderate, mild, severe) acne scoring of the facial area at baseline and treatment cycles 1, 3 and 6. RESULTS: A total of 404 (78.1%) and 384 (75.3%) women in the 20EE/DSG and 20EE/LNG groups, respectively, completed the trial. The occurrence rate of irregular bleeding and spotting was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.18 vs. 0.13; p < 0.05). The mean number of bleeding-spotting days per cycle was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.63 vs. 0.48; p < 0.05). Early withdrawal bleeding was more frequent with 20EE/LNG (0.15 vs. 0.08; p < 0.005), whereas continued withdrawal bleeding was more frequent with 20EE/DSG (0.32 vs. 0.45; p < 0.001); absence of withdrawal bleeding was comparable (0.06 vs. 0.04, respectively). Thirteen subjects in the 20EE/LNG group and three in the 20EE/DSG group discontinued due to unacceptable bleeding (p < 0.05). Dysmenorrhea and PMS decreased comparably in both groups. There were no differences between groups for the mean total scores of PGWBI or POMS at all time-points. Fewer acne lesions were counted with 20EE/DSG vs. 20EE/LNG after six cycles (p < 0.05). The subjective acne scores supported this finding. CONCLUSIONS: 20EE/DSG provided better cycle control than 20EE/LNG with less treatment discontinuation due to unacceptable bleeding. There were no apparent differences between the two groups regarding tolerability and quality of life. There was less acne with 20EE/DSG.     

Stability of seasonal influenza vaccines investigated by spectroscopy and microscopy methods

The stability of different seasonal influenza vaccines was investigated by spectroscopy and microscopy methods before and after the following stress-conditions: (i) 2 and 4 weeks storage at 25 °C, (ii) 1 day storage at 37 °C and (iii) one freeze-thaw cycle. The subunit vaccine Influvac^® (Solvay Pharma) and the split vaccine Mutagrip^® (Sanofi Pasteur) were affected by all stresses. The split vaccine Fluarix^® (GlaxoSmithKline) was affected only by storage at 25 °C. The virosomal vaccine Inflexal^® V (Berna Biotech) was stable after the temperature stresses but aggregated after one freeze-thaw cycle. This study provides new insights into commercial vaccines of low antigen concentration and highlights the importance of using multiple techniques to assess vaccine stability.     

Immunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1-16 years

We assessed the immunogenicity of the paediatric dose of Epaxal^® (0.25 mL) and the degrees of seroprotection achieved with the standard dose (0.5 mL) of Epaxal^® or a dose of Havrix^® Junior, in children in an open, randomised, controlled, multi-centre, parallel-group study conducted at 2 Chilean study centres. 360 healthy children and adolescents 12 months to <17 years of age not previously vaccinated against hepatitis A were enrolled. Subjects were randomised 2:2:1 to be vaccinated with either Epaxal^® 0.25 mL [n = 146], Epaxal^® 0.5 mL [n = 142] or Havrix^® Junior [n = 72] intramuscularly on Day 1 and after 6 months (26 weeks ± 14 days). Primary end point was the proportion of subjects seroprotected (anti-HAV antibody concentration ≥10 mIU/mL) in the ATP population at Month 1. All vaccines elicited high seroprotection rates at Month 1: 95.7% with Epaxal^® 0.25 mL, 99.3% with Epaxal^® 0.5 mL and 94.0% with Havrix^® Junior. After the booster vaccination, all subjects demonstrated 100% seroprotection with all vaccines. Antibody concentrations were similarly high in all age groups. The paediatric presentation achieved antibody concentrations similar to those achieved with the 0.5 mL dose across the entire age range, and there were no differences across the range of body weights from 9.0 kg to 82.7 kg. All study vaccines were well tolerated and there were no AEs leading to discontinuation. Thus, the paediatric 0.25 mL dose of Epaxal^® fulfilled the primary objective of showing non-inferiority to the adult 0.5 mL dose and to Havrix^® Junior, in terms of seroprotection rates achieved. The results show the paediatric dose of Epaxal^® to be an attractive option when conducting childhood-vaccination programmes.     

The Marks Asthma Quality of Life Questionnaire: further validation and examination of responsiveness to change.

We performed analyses to examine the structure, validity, and responsiveness to change of the Marks Asthma Quality of Life Questionnaire (AQLQ), originally validated in Australia in a self-administered format, among 539 U.S. subjects with asthma. Subjects were interviewed twice by telephone over an 18-month period. Based on factor analyses, the subscale structure of the AQLQ was modified slightly to eliminate item overlap among subscale scores. Cross-sectionally, total AQLQ scores were significantly correlated in expected directions with baseline asthma severity scores (r = 0.58), SF-36 physical (r = -0.66) and mental (r = -0.40) health status scores, and pulmonary function (FEV1% predicted, r = -0.14). Longitudinally, changes in AQLQ total and subscale scores were significantly (P<0.01) associated with changes in asthma severity and both physical and mental status. The AQLQ, administered by telephone, appears to be useful for assessing changes in the impact of adult asthma.     

Item Reduction and Psychometric Validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS)

IntroductionDeveloped using focus groups, the Oily Skin Self Assessment Scale (OSSAS) and Oily Skin Impact Scale (OSIS) are patient-reported outcome measures of oily facial skin.ObjectiveThe aim of this study was to finalize the item-scale structure of the instruments and perform psychometric validation in adults with self-reported oily facial skin.MethodsThe OSSAS and OSIS were administered to 202 adult subjects with oily facial skin in the United States. A subgroup of 152 subjects returned, 4 to 10 days later, for test–retest reliability evaluation.ResultsOf the 202 participants, 72.8% were female; 64.4% had self-reported nonsevere acne. Item reduction resulted in a 14-item OSSAS with Sensation (five items), Tactile (four items) and Visual (four items) domains, a single blotting item, and an overall oiliness item. The OSIS was reduced to two three-item domains assessing Annoyance and Self-Image. Confirmatory factor analysis supported the construct validity of the final item-scale structures. The OSSAS and OSIS scales had acceptable item convergent validity (item-scale correlations >0.40) and floor and ceiling effects (<20%). Cronbach's alpha coefficients ranged from 0.83 to 0.89 for the OSSAS and 0.82 to 0.87 for the OSIS, demonstrating excellent internal consistency. The a priori test–retest reliability criterion (intraclass correlation [ICC] ≥0.7) was met for one of the three OSSAS domains and one of the two OSIS domains. OSSAS and OSIS domains distinguished among groups that differed in patient-reported facial oily skin severity (P < 0.0001), and bother associated with oily skin (P < 0.0001).ConclusionsThe OSSAS and OSIS versions tested in this study have been found to have strong psychometric properties in this patient sample (adults with self-reported oily facial skin), as assessments of self-reported oily facial skin severity and its emotional impact, respectively.     

PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions

ObjectiveTo evaluate the comparability and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue item bank across six chronic conditions.Study Design and SettingIndividuals (n = 1,430) with chronic obstructive pulmonary disease (n = 125), chronic heart failure (n = 60), chronic back pain (n = 218), major depressive disorder (n = 196), rheumatoid arthritis (n = 521), and cancer (n = 310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately before a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed-effects models and standardized response means were estimated to examine clinical validity and responsiveness to change.ResultsAll patient groups reported more fatigue than the general population (range = 0.2–1.29 standard deviation worse). The four clinical groups with pretreatment baseline data experienced significant improvement in fatigue at follow-up (effect size range = 0.25–0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health.ConclusionThe results support the PROMIS fatigue measures's responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research.     

Development and multi-site validation of a new condition-specific quality of life measure for eating disorders

Background

In eating disorders (EDs) treatment, outcome measurement has traditionally focused on symptom reduction rather than functioning or quality of life (QoL). Generic QoL measures lack sensitivity for some diagnoses and many not be responsive in eating disorder patients. This article describes the development and validation of a condition-specific QoL measure for adolescents and adults with eating disorders – the Eating Disorders Quality of Life Scale (EDQLS).

Methods

Multi-source and multi-stage methods were used to develop the EDQLS, with participation of patients with EDs, their family members and ED treatment providers. Sources for domain and item development included 39 articles, 12 patient and 10 treatment provider interviews, and 31 first person narratives from the internet. Four stages of validation and pre-testing involving 17 patients, 10 family members and 18 providers reduced 233 items to 40 items in 12 domains. These items were pilot tested in 41 ED patients.

Results

The final instrument was then validated in a 12 site sample of 171 individuals aged 14–60 with EDs. All items showed good dispersion. The total raw mean score was 110 out of 200 (SD 27.6) with higher scores indicating better QoL. Internal consistency was excellent (Cronbach's alpha = .96) and subscale internal consistency ranged from alpha .36 to .79 providing evidence for a strong overall construct and some multi-dimensionality. Validity was supported by significant differences in mean EDQLS according to severity levels on the EDI-2 (F = 95.3, p <.001) and the BSI (F = 86.9, p <.001). EDQLS scores were positively associated with time in treatment (F = 4.65, p = .01) suggesting responsiveness. A strong positive association was also found between EDQLS scores and stage of change (F = 15.1 p <.001). Pearson's correlations between the EDQLS and criterion instrument scores were .71 for the SF-12 mental subscale, .61 for the QoLI and .78 for the 16D, supporting construct validity. Exploratory principal components and item response theory analyses identified only a few poor fitting items.

Conclusion

The EDQLS has promising psychometric characteristics and may be useful for evaluating ED treatment effectiveness.     

Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial

BACKGROUND: A randomized, double-blind, parallel-group study to investigate the efficacy and safety of the 3 mg drospirenone (drsp)/20 mcg ethinylestradiol (EE) combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle) for the treatment of moderate acne vulgaris. STUDY DESIGN: Healthy females (aged 14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 mcg (n=266) or placebo (n=268) for six cycles of 28 days. RESULTS: Women who received the 3 mg drsp/20 mcg EE 24/4 COC had greater reductions from baseline in inflammatory, noninflammatory and total lesion counts. The odds of women in the 3 mg drsp/20 mcg EE 24/4 regimen COC group having 'clear' or 'almost clear' skin as rated by the investigators at end point was about fourfold greater than that in the placebo group (odds ratio 4.31; 95% CI: 2.11-9.60; p=.001). The 3 mg drsp/20 mcg EE 24/4 regimen COC was well tolerated and had a safety profile consistent with low-dose COC use. CONCLUSION: The 3 mg drsp/20 mcg EE 24/4 regimen COC was significantly more effective than placebo in treating moderate acne vulgaris.     

A health related quality of life measure for use in patients with urge urinary incontinence: A validation study

Objective: Urge incontinence has substantial impact on health related quality of life (HRQOL). The purpose of this research was to test the psychometric properties of the Urge-Incontinence Impact Questionnaire (U-IIQ) and Urge-Urinary Distress Inventory (U-UDI). Methods: The U-IIQ and the U-UDI were incorporated in a single arm study of an investigational once-a-day formulation of oxybutynin (Ditropan^® XL) for urge incontinence. The U-IIQ contains 7 scales scored separately: Travel, Activities, Physical activities, Feelings, Relationships, Sexual function and Nighttime bladder control. We also calculated a single index score. The U-UDI contains 9 items summarized in a single score that measures the extent to which incontinence symptoms bother patients and an urge symptoms summary score. Patients completed the questions at: start of baseline week, end of baseline week, week 4 and week 12 (final dose). Results: The questions were completed by the 257 patients enrolled in the study (91% female, mean age = 60 years). All item responses showed good variability. Internal-consistency reliability was very good (Cronbach's = 0.82–0.96). Test–retest reliability was good for all scales ([ICC] = 0.68–0.83). Discriminant validity was noted for all scales for patients with and without frequent incontinence (p 0.006 all scales). All scales demonstrated responsiveness to change over time (Guyatt's statistic = |–1.04| – |–1.71|). Conclusions: Psychometric testing indicated that the scales measured distinct and relevant domains of HRQOL for patients with urge incontinence, and that these two instruments are reliable, valid, and responsive to change in this condition.     

The EVAPIL® scale, a new tool to assess tolerance of oral contraceptives

Background

The EVAPIL® scale is a self-questionnaire aimed to assess tolerability of oral contraceptives (OC).

Methods

For initial development: a list of questions addressing the more frequent or more unpleasant minor side effects of OC was developed by a group of gynecologists and submitted to several sets of OC users. A final version with 14 questions was issued with scoring rules.For validation, the EVAPIL® scale was submitted to 3502 women who were OC users for at least 6 months to evaluate internal consistency and factorial structure. Test-retest reproducibility was studied 30 days apart in 53 other OC users.

Results

Internal consistency was good (Cronbach's alpha .71) without redundant questions. Principal components analysis with Varimax rotation was used to summarise information given by the 14 questions in a smaller number of multivariate dimensions. Dimension 1 explained 22% of the total variance, strongly correlated with all symptoms except oily skin, acne and cycle control. Dimension 2 accounted for 10% of the total variance and was correlated with oily skin and acne. Dimensions 3 and 4 were better correlated with cycle control. Reproducibility was excellent (intraclass correlation 0.88). The EVAPIL® scale was found easy to use and took no more than 5 min to complete.

Conclusion

The EVAPIL® scale demonstrated interesting psychometric properties to evaluate the tolerability of OCs in OC users. Further research is needed to address sensitivity to change and usefulness in new OC users.     

Validation of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) for patients undergoing prophylactic migraine treatment

OBJECTIVE: Health-related quality of life (HRQoL) is an important outcome measure of migraine treatments. Although a number of migraine-specific HRQoL questionnaires exist, their measurement characteristics have only been examined for patients undergoing acute treatment of migraine. The goal of the current study was to evaluate measurement properties of the widely used Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) within a group of patients undergoing prophylactic migraine treatment. METHODS: Various measurement properties of the MSQ were examined in a sample of 916 migraineurs undergoing prophylactic treatment who had scores at baseline and follow-up, as well as baseline SF-36. First, we used confirmatory factor analysis (CFA) and differential item functioning (DIF) to assure the accuracy and stability across groups of the MSQ scoring for all three subscales (Role Restrictive, Role Preventive, and Emotional Functioning). Next, item- and scale-level properties were examined, such as item-total correlations, internal consistency, and convergent and discriminant validity. RESULTS: Initial findings revealed that item 12 (measuring frustration on the Emotional Functioning subscale) performed poorly. Subsequent to its removal, the 13-item MSQ displayed excellent measurement properties, including stable latent structure at baseline and endpoint, no gender or age biases on items, appropriate item-level and scale-level reliabilities, and markedly higher convergent validity compared to discriminant validity. CONCLUSION: The 13-item MSQ appears to be an appropriate measure of migraine-specific HRQoL for patients undergoing migraine prophylaxis. Moreover, given the stability of the latent structure over time, the interpretation of scores is likely to remain quite consistent throughout a clinical trial.     

A double-blind placebo-controlled clinical trial compares the cholesterollowering effects of two different soy protein preparations in hypercholesterolemic subjects

Summary Background Soy protein is effective in lowering plasma cholesterol, LDL cholesterol and triglyceride concentrations. It has not been conclusively answered, whether and to what extent other soy constituents may also contribute to this effect. Objective To investigate the change in blood lipid levels after application of two soy-based supplements containing soy protein either without (SuproSoy^®) or with (Abacor^®) soy fiber and phospholipids in a randomized placebo-controlled triplearmed study. Methods 121 hypercholesterolemic adults (66 females, 55 males) were recruited and randomly assigned to one of three treatments. Over 8 weeks they received daily either 25 g soy protein (as a component of the supplements Abacor^® or SuproSoy^®) or 25 g milk protein (as a component of placebo). Serum lipids were measured at baseline and after 4, 6 and 8 weeks. Results After 8 weeks of supplementation total cholesterol levels were reduced by 8.0 ± 9.6% (Abacor^®) and 3.4 ± 8.3% (SuproSoy^®); LDL cholesterol levels by 9.7 ± 11.7% (Abacor^®) and 5.4 ± 11.6% (SuproSoy^®); and Apolipoprotein B levels by 6.9 ± 14.6% (Abacor^®) and 4.0 ± 12.4 % (SuproSoy^®). Serum levels of HDL cholesterol and triglycerides remained unchanged. Conclusions A preparation combining isolated soy protein with soy fibers and phospholipids showed twice the lipid-lowering effect of a preparation containing isolated soy protein alone. Therefore, such soy-based supplements can be useful in reducing the cardiovascular risk.     

Differential item functioning (DIF) in the EORTC QLQ-C30: a comparison of baseline, on-treatment and off-treatment data

Introduction Differential item functioning (DIF) analyses can be used to explore translation, cultural, gender or other differences in the performance of quality of life (QoL) instruments. These analyses are commonly performed using “baseline” or pretreatment data. We previously reported DIF analyses to examine the pattern of item responses for translations of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 QoL instrument, using only data collected prior to cancer treatment. We now compare the consistency of these results with similar analyses of on-treatment and off-treatment assessments and explore whether item relationships differ from those at baseline. Methods Logistic regression DIF analyses were used to examine the translation of each item in each multi-item scale at the three time points, after controlling for the overall scale score and other covariates. The consistency of results at the three time points was explored. Results For most EORTC QLQ-C30 subscales, the DIF results were very consistent across the three time points. Results for the Nausea and Vomiting scale varied the most across assessments. Discussion The results indicated that DIF analyses were stable across each time point and that the same DIF effects were usually found regardless of the treatment status of the respondent.     

Acute and chronic effects of four commercial herbicide formulations on Ceriodaphnia dubia

Toxicity tests with Ceriodaphnia dubia were conducted to determine acute (48 h) and chronic (7-day survival and reproduction) effects of four commonly used herbicide formulations. The 48-h LC50s in decreasing order of toxicity were 14.36 mg/L (Micro-Tech^®), 15.93 mg/L (Bicep^®), 32.99 mg/L (Extrazine^®), and 35.36 mg/L (Lexone^®). Reduced reproduction was detected at concentrations below 48-h LC50s for three of the formulations. The 7-day chronic values (ChV) based on reproduction were 17.68 mg/L (Micro-Tech^®), 8.84 mg/L (Bicep^®), 17.68 mg/L (Extrazine^®), and 8.84 mg/L (Lexone^®). The acute-to-chronic ratios (ACRs) for Micro-Tech^® (0.81), Bicep^® (1.80), Extrazine^® (1.86), and Lexone^® (4.00) indicate a relatively narrow range between acute and chronic sensitivity in daphnids. A comparison of these response data to environmental concentrations suggests these herbicides are not likely to directly impact invertebrates. Potential impacts on plants and human health should be of primary ecological and regulatory concern.