This is an invited commentary on the article titled “Validation of the main diagnostic criteria of atopic dermatitis and proposing a novel diagnostic criteria in adult and elderly Chinese ...populations: a multicenter, prospective, clinical setting-based study.”
To review the current research data on long-term outcome and health-related quality of life in survivors of the acute respiratory distress syndrome (ARDS) and to compare these findings with those ...from non-ARDS patients surviving critical illness.
Between 6 months and 2 years after discharge from ICU, survivors of ARDS present with substantial impairments of the levels of body function (muscle strength, walking capacity and/or physical activity (physical SF-36 score). In contrast to non-ARDS patients from surgical ICUs, a standardized intensified physical therapy during early course of illness in ARDS patients could not show an improvement of long-term physical function performance. Furthermore, a substantial part of further ARDS patients suffer from depression (26-33%), anxiety (38-44%) or posttraumatic stress disorder (22-24%). In general, the level of functional autonomy and daily life activities was reduced, and in one study, 6 months after ICU-discharge this level was significantly lower in ARDS patients compared with non-ARDS patients. In a recent study, 44% of ARDS survivors were jobless 1 year after critical illness, whereas half of previously employed patients returned to work within 4 months after hospital discharge. General health-related quality of life was significantly reduced compared with a matched population in all studies.
Surviving ARDS is associated with a long-term substantial reduction in health-related quality of life and such a reduction does not differ from findings in patients surviving other critical illness. In further research, a special attention should be paid to prevention measures of the 'post intensive care syndrome' as well as to patient important domains, which might better explain the patient's and families' demands.
Background
The symptoms of eczema can lead to sleeplessness and fatigue and may have a substantial impact on quality of life. Use of oral H1 antihistamines (H1 AH) as adjuvant therapy alongside ...topical agents is based on the idea that combining the anti‐inflammatory effects of topical treatments with the blocking action of histamine on its receptors in the skin by H1 AH (to reduce the principal symptom of itch) might magnify or intensify the effect of treatment. Also, it would be unethical to compare oral H1 AH alone versus no treatment, as topical treatment is the standard management for this condition.
Objectives
To assess the effects of oral H1 antihistamines as 'add‐on' therapy to topical treatment in adults and children with eczema.
Search methods
We searched the following databases up to May 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database (Global Resource of EczemA Trials; from inception). We searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We also searched the s of four conference proceedings held between 2000 and 2018.
Selection criteria
We sought RCTs assessing oral H1 AH as 'add‐on' therapy to topical treatment for people with eczema compared with topical treatment plus placebo or no additional treatment as add‐on therapy.
Data collection and analysis
We used standard Cochrane methodological procedures. Primary outcome measures were 'Mean change in patient‐assessed symptoms of eczema' and 'Proportion of participants reporting adverse effects and serious adverse events'. Secondary outcomes were 'Mean change in physician‐assessed clinical signs', 'Mean change in quality of life', and 'Number of eczema flares'.
Main results
We included 25 studies (3285 randomised participants). Seventeen studies included 1344 adults, and eight studies included 1941 children. Most studies failed to report eczema severity at baseline, but they were conducted in secondary care settings, so it is likely that they recruited patients with more severe cases of eczema. Trial duration was between three days and 18 months. Researchers studied 13 different H1 AH treatments. We could not undertake pooling because of the high level of diversity across studies in terms of duration and dose of intervention, concomitant topical therapy, and outcome assessment. Risk of bias was generally unclear, but five studies had high risk of bias in one domain (attrition, selection, or reporting bias). Only one study measured quality of life, but these results were insufficient for statistical analysis.
Although this review assessed 17 comparisons, we summarise here the results of three key comparisons in this review.
Cetirizine versus placebo
One study compared cetirizine 0.5 mg/kg/d against placebo over 18 months in 795 children. Study authors did not report patient‐assessed symptoms of eczema separately for pruritus. Cetirizine is probably associated with fewer adverse events (mainly mild) (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.46 to 1.01) and the need for slightly less additional H1 AH use as an indication of eczema flare rate (P = 0.035; no further numerical data given). Physician‐assessed clinical signs (SCORing Atopic Dermatitis index (SCORAD)) were reduced in both groups, but the difference between groups was reported as non‐significant (no P value given). Evidence for this comparison was of moderate quality.
One study assessed cetirizine 10 mg/d against placebo over four weeks in 84 adults. Results show no evidence of differences between groups in patient‐assessed symptoms of eczema (pruritus measured as part of SCORAD; no numerical data given), numbers of adverse events (RR 1.11, 95% CI 0.50 to 2.45; mainly sedation, other skin‐related problems, respiratory symptoms, or headache), or physician‐assessed changes in clinical signs, amount of local rescue therapy required, or number of applications as an indicator of eczema flares (no numerical data reported). Evidence for this comparison was of low quality.
Fexofenadine versus placebo
Compared with placebo, fexofenadine 120 mg/d taken in adults over one week (one study) probably leads to a small reduction in patient‐assessed symptoms of pruritus on a scale of 0 to 8 (mean difference (MD) ‐0.25, 95% CI ‐0.43 to ‐0.07; n = 400) and a greater reduction in the ratio of physician‐assessed pruritus area to whole body surface area (P = 0.007; no further numerical data given); however, these reductions may not be clinically meaningful. Results suggest probably little or no difference in adverse events (mostly somnolence and headache) (RR 1.05, 95% CI 0.74 to 1.50; n = 411) nor in the amount of 0.1% hydrocortisone butyrate used (co‐intervention in both groups) as an indicator of eczema flare, but no numerical data were given. Evidence for this comparison was of moderate quality.
Loratadine versus placebo
A study of 28 adults compared loratadine 10 mg/d taken over 4 weeks versus placebo. Researchers found no evidence of differences between groups in patient‐assessed pruritus, measured by a 100‐point visual analogue scale (MD ‐2.30, 95% CI ‐20.27 to 15.67); reduction in physician‐assessed clinical signs (SCORAD) (MD ‐4.10, 95% CI ‐13.22 to 5.02); or adverse events. Study authors reported only one side effect (folliculitis with placebo) (RR 0.25, 95% CI 0.01 to 5.76). Evidence for this comparison was of low quality. Number of eczema flares was not measured for this comparison.
Authors' conclusions
Based on the main comparisons, we did not find consistent evidence that H1 AH treatments are effective as 'add‐on' therapy for eczema when compared to placebo; evidence for this comparison was of low and moderate quality. However, fexofenadine probably leads to a small improvement in patient‐assessed pruritus, with probably no significant difference in the amount of treatment used to prevent eczema flares. Cetirizine was no better than placebo in terms of physician‐assessed clinical signs nor patient‐assessed symptoms, and we found no evidence that loratadine was more beneficial than placebo, although all interventions seem safe.
The quality of evidence was limited because of poor study design and imprecise results. Future researchers should clearly define the condition (course and severity) and clearly report their methods, especially participant selection and randomisation; baseline characteristics; and outcomes (based on the Harmonising Outcome Measures in Eczema initiative).
Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform ...patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a “road map,” Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool.
We aimed to assess the structural validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire using item response theory/Rasch analysis and classical test theory and refine the current ...version of the DIVA if necessary.
Postmenopausal women reporting vaginal symptoms related to menopause participated in the study. Item characteristic curves were analyzed to see whether the response categories were functioning optimally. The assumptions of the Rasch model were tested for the whole DIVA as well as for each domain separately. Exploratory factor analyses were carried out and correlations of the single items with the DIVA domains were analyzed to identify the most-fitting items. Finally, validation analyses were carried out on the refined version.
We registered 185 eligible postmenopausal women. Revising the response categories of each of the four domains led to adequate looking item characteristic curves. The whole DIVA represented a multidimensional construct, however, each of the four domains fulfilled the Rasch requirements of unidimensionality, local independence, monotonicity, and an adequate model fit. Integrating item response theory/Rasch and classical test theory, two items (item 5 and item 17) showing relevant issues were identified and removed from the refined version. In the subsequent validation, the refined DIVA showed similar validation results like its original equivalent.
We created a validated refined version of the DIVA, having now three response categories instead of five. With 17 items (short-version) or rather 21 items (long-version for women with recent sexual activity), the refined DIVA is more feasible and showed several excellent measurement properties.
Female sexual dysfunction affects 41% of reproductive-age women worldwide, making it a highly prevalent medical issue. Predictors of female sexual dysfunction are multifaceted and vary from country ...to country. A synthesis of potential risk factors and protective factors may aid healthcare practitioners in identifying populations at risk, in addition to revealing modifiable factors to prevent sexual dysfunction among reproductive-age women.
Observational studies which assessed the prevalence and predictors of female sexual dysfunction in reproductive-age women were systematically sought in relevant databases (2000-2014). Significant predictors were extracted from each included publication. A qualitative analysis of predictors was performed with a focus on types of sexual regimes and level of human development.
One hundred thirty-five studies from 41 countries were included in the systematic review. The types of predictors varied according to the location of the study, the type of sexual regime and the level of gender inequality in that country/region. Consistently significant risk factors of female sexual dysfunction were: poor physical health, poor mental health, stress, abortion, genitourinary problems, female genital mutilation, relationship dissatisfaction, sexual abuse, and being religious. Consistently significant protective factors included: older age at marriage, exercising, daily affection, intimate communication, having a positive body image, and sex education. Some factors however had an unclear effect: age, education, employment, parity, being in a relationship, frequency of sexual intercourse, race, alcohol consumption, smoking and masturbation.
The sexual and reproductive lives of women are highly impacted by female sexual dysfunction, and a number of biological, psychological and social factors play a role in the prevalence of sexual dysfunction. Healthcare professionals who work with women should be aware of the many risk factors for reproductive-age women. Future prevention strategies should aim to address modifiable factors, e.g. physical activity and access to sex education; international efforts in empowering women should continue.
Sports activities can lead to exercise-related skin complaints. These include different symptoms (e.g. infections, mechanical injuries, contact dermatitis). Previous studies mostly focused only on ...skin infections and injuries in competitive athletes. The purpose of this study was to determine the frequency and characteristics of exercise-related skin complaints among sports students and to what extent these complaints influence physical fitness. We performed a self-administered online survey among 259 actively exercising sports students from two German universities. Descriptive analyses were conducted. The most common complaints were blistering (57.3%), dryness (56.7%), redness (44.7%), and chafing (34.0%). Hands and feet (78.0% each) were most frequently affected. Participants whose skin was particularly stressed (47.5%) had higher training duration (7.6 h/week, 95%-CI 6.8-8.3 h) than those without complaints (5.1 h/week, 95%-CI 5.5-6.7 h, p = 0.003). The students reported reduced intensity (34.7%) and frequency (22.7%) of training due to their skin complaints. A reduction in performance was reported by 32.0% of the students. Actively exercising sports students considered an intact skin as essential for their physical fitness. Reported impairments of the skin led to a reduced intensity and frequency of training. To enhance the awareness of exercise-related skin complaints, further research is necessary.
We aimed to further validate the German version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire.
Data were collected in the context of two intervention studies. Forty-two women ...participated in clinical trial VMP-03/2018 (NCT04222647) and 79 women in clinical trial VFCrC-01/2021 (NCT05211505). Internal consistency was calculated using Cronbach α . Correlations with other outcome measures such as a subjective assessment of symptoms and dyspareunia, the Vaginal Health Index, and the Vaginal Maturation Index were calculated regarding construct validity. A priori hypotheses were formulated for construct validity. Responsiveness was assessed after 43 (±3) and after 38 (±1) days in the two clinical trials.
Strong internal consistency in all of the DIVA domains was found ( α ≥ 0.80). Regarding construct validity (at baseline and over time), many hypotheses were confirmed. Furthermore, all of the DIVA domains were able to detect changes over time ( P ≤ 0.006). Moderate to strong effect sizes were found (≥0.460). The data supported the responsiveness of the DIVA.
Our findings from two independent intervention studies support internal consistency, construct validity, and responsiveness of the German version of the DIVA (domains).
The SARS-CoV-2 pandemic presented a challenge for caregiving relatives in the home care setting. Caregivers can transmit SARS-CoV-2 to their relatives who are often at high risk for a severe course ...of COVID-19. Regular testing of asymptomatic caregivers for SARS-CoV-2 may reduce the risk of transmission. The optimal method and frequency of regular asymptomatic testing is unknown. We conducted a prospective, randomised trial to assess the feasibility, recruitment and acceptance of different testing frequencies. This serves to inform a future definitive randomised controlled trial. We carried out a parallel three-armed feasibility trial, enrolling adult participants who provided home-based care for a relative at least twice a week. Participants were randomly assigned using sealed envelopes to either conduct saliva-based antigen self-testing at a frequency of once a week (group I), twice a week (group II), or every two days (group III). The participants completed questionnaires on a weekly basis. Main outcome measures were feasibility of recruitment, adherence to self-tests and distress caused by self-testing. We further collected data on the use of mouth-nose mask. From 25 March to 7 May 2021 we assessed 27 participants and randomised 26 in the study: 8 participants in group I, 8 in group II and 10 in group III. All participants completed the study. In group I 48/48 (100.0%; 95% CI 92.6% to 100.0%), in group II 93/96 (96.9%; 95% CI 91.2% to 98.9%) and in group III 209/210 (99.5%; 95% CI 97.4% to 99.9%) self-tests were carried out at home. Participants did not perceive regular self-testing as burdensome in any of the study arms. We did not observe any infection with SARS-CoV-2. During the study, mask adherence decreased from 35% to 19% in all groups. Conducting such a study was feasible. The participants tolerated regular self-testing well, which was reflected in a high level of test adherence. However, regular self-testing may have led to decreased protective behaviour. To demonstrate that regular asymptomatic testing reduces infection transmission, a future definitive trial should be performed at a time of a high prevalence of SARS-CoV-2 and be implemented as a multicentre study.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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