Frequency of atopic dermatitis and psoriasis in the elderly - Cross-sectional findings from the German AugUR study.

Introduction Atopic Dermatitis (AD) and psoriasis appear to affect 2-3% (lifetime prevalence) people worldwide. However, there is little epidemiological data on the prevalence of those two chronic inflammatory skin diseases in the elderly. The aim of this study was to provide frequency estimates of AD and psoriasis obtained from an elderly population in Germany. Methods We examined baseline data from the AugUR study, a cohort study focusing on an aging population within the vicinity of Regensburg, Germany (comprising 1,133 participants with a median age of 76.7 years, 45% being female). We estimated raw frequencies of physician-diagnosed AD and psoriasis from participants' self-reports in personal interviews. These frequencies were adjusted to reflect the demographic distribution of the Bavarian population, considering both gender and age groupings spanning five or ten years. Results Data from 1,133 participants aged 70-95 (45.1% women) were available for analysis. Physician-diagnosed AD was reported by 3.3 % of participants (2.4% from men, 4.3% from women) and 5.6% (95%-CI: 4.3-7.1%) reported physician-diagnosed psoriasis (6.6% in men, 4.3% in women). Age- and gender-standardized frequency estimates for AD were 3.4% (95%-CI: 2.4-4.6, 2.6% in men, 4.3% in women) and 5.3% for psoriasis (95%-CI: 4.1-6.8, 6.3% in men and 4.1% in women). Conclusion This study indicates a lower than previously reported lifetime-prevalence of AD (3.4% vs. 8-10%) and a higher one regarding psoriasis (5.3% vs. 2-4%) in highly aged individuals. More epidemiological research in elderly populations using validated physician diagnoses are desirable.

Determining the optimal frequency of SARS-CoV-2 regular asymptomatic testing: A randomized feasibility trial in a home care setting.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: The trial is registered with the German Clinical Trials Register, DRKS00026234.

Cross-sectional study on exercise-related skin complaints among sports students at two German universities.

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.

Validation of the Recap of Atopic Eczema (RECAP) Measurement Instrument for Eczema Control in Adult Patients in an Asian Clinical Setting.

Recap of atopic eczema (RECAP) is a self-reported 7-item questionnaire recommended by the Harmonising Outcome Measures in Eczema initiative to measure eczema control. As RECAP has not been validated in a real-world clinical population in Asia, RECAP was investigated as a measure of eczema control in Singapore. Patients with atopic eczema at the National Skin Centre from July 2019 to January 2020 were included for analysis. Both patient- and physician-reported outcome measures were available for correlation analyses. Correlation analysis was also performed to investigate construct validity, and floor or ceiling effects of RECAP. A total of 260 atopic eczema patients aged between 15 and 87 years were recruited. There were minimal floor and ceiling effects for RECAP scores. There were strong, significant correlations of RECAP with POEM (r = 0.84, p < 0.001) and DLQI (r = 0.81, p < 0.001). Correlation with SCORAD was moderate (r = 0.60, p < 0.001). Correlations remained similar after age, gender, and ethnicity adjustments. Discriminative validity was demonstrated by a significant linear trend of increasing RECAP scores with increasing eczema severity. RECAP demonstrates good discriminative and construct validity evidenced by strong correlations with symptoms and quality of life and moderate correlations with eczema signs. RECAP is useful to measure eczema control in Singapore.

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial.

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

An evidence map of systematic reviews on models of outpatient care for patients with chronic heart diseases.

BACKGROUND: Chronic heart disease affects millions of people worldwide and the prevalence is increasing. By now, there is an extensive literature on outpatient care of people with chronic heart disease. We aimed to systematically identify and map models of outpatient care for people with chronic heart disease in terms of the interventions included and the outcomes measured and reported to determine areas in need of further research. METHODS: We created an evidence map of published systematic reviews. PubMed, Cochrane Library (Wiley), Web of Science, and Scopus were searched to identify all relevant articles from January 2000 to June 2021 published in English or German language. From each included systematic review, we abstracted search dates, number and type of included studies, objectives, populations, interventions, and outcomes. Models of care were categorised into six approaches: cardiac rehabilitation, chronic disease management, home-based care, outpatient clinic, telemedicine, and transitional care. Intervention categories were developed inductively. Outcomes were mapped onto the taxonomy developed by the COMET initiative. RESULTS: The systematic literature search identified 8043 potentially relevant publications on models of outpatient care for patients with chronic heart diseases. Finally, 47 systematic reviews met the inclusion criteria, covering 1206 primary studies (including double counting). We identified six different models of care and described which interventions were used and what outcomes were included to measure their effectiveness. Education-related and telemedicine interventions were described in more than 50% of the models of outpatient care. The most frequently used outcome domains were death and life impact. CONCLUSION: Evidence on outpatient care for people with chronic heart diseases is broad. However, comparability is limited due to differences in interventions and outcome measures. Outpatient care for people with coronary heart disease and atrial fibrillation is a less well-studied area compared to heart failure. Our evidence mapping demonstrates the need for a core outcome set and further studies to examine the effects of models of outpatient care or different interventions with adjusted outcome parameters. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42020166330).

Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies.

OBJECTIVE: We aimed to further validate the German version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. METHODS: 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. RESULTS: 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. CONCLUSIONS: Our findings from two independent intervention studies support internal consistency, construct validity, and responsiveness of the German version of the DIVA (domains).

Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey.

BACKGROUND: Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a 'Long List' of all domains that might be important to measure. OBJECTIVES: To compile a 'Long List' of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts. METHODS: First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains. RESULTS: Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains 'signs', 'symptoms' and 'HE-related quality of life'. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested 'itch' and 'ability to work' as core sub-domains. Further outcomes from the domains 'HE control over time', 'patient-reported treatment experience' and 'skin barrier function' were mentioned. CONCLUSION: 'Itch' was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a 'Long List' of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.

The HOME Core outcome set for clinical trials of atopic dermatitis.

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.

Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review.

PURPOSE: To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. METHODS: We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. RESULTS: Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. CONCLUSION: Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020170247.

'As long as I have a restroom somewhere [ ], I am fine': a qualitative study on the perspectives of peri- and postmenopausal women on the impact of the urinary component of the genitourinary syndrome of menopause (GSM).

BACKGROUND: Our aim was to gain insight into the experiences of women suffering from the urinary component of the Genitourinary Syndrome of Menopause (GSM) and to understand the impact of urinary complaints as part of GSM on the lives of affected women. DESIGN: Qualitative study. SETTING: Online, primary care. PARTICIPANTS AND METHODS: Postmenopausal women aged from 46 to 85 years reporting vaginal and urinary complaints were recruited to participate in either online or face-to-face focus groups to share their experiences with urinary complaints as part of GSM. Transcripts of sessions were analysed using qualitative content analysis. RESULTS: One online focus group, one face-to-face focus group and one online-interview were conducted, involving 11 women. Five a priori assumed main themes related to the impact of urogenital symptoms were identified: daily life, emotional well-being, sexual functioning, self-concept and body image, and interpersonal relations and communication. Additionally, two further themes associated with GMS as a clinical condition were inductively found: unmet healthcare needs, including expectations of affected women regarding menopausal symptoms and a lack of adequate health education, and aspects on the personal dealing with the complaints, including personal coping strategies and medical treatment. CONCLUSIONS: This study showed that urinary complaints as part of GSM have, similar to vaginal complaints, negative impacts on the daily life, the emotional well-being, the sexual functioning, the self-concept and body impact as well as interpersonal relations and communication of affected women. We further identified several unmet healthcare needs that should trigger improvements in healthcare.

Measurement properties of patient-reported outcome measures (PROMs) in patients with hyperhidrosis: protocol for a systematic review.

BACKGROUND: Hyperhidrosis is a chronic skin condition that impairs the patient's quality of life (QoL). There are several patient-reported outcome measures (PROMs) for patients affected by hyperhidrosis available; however an evidence-based assessment of their quality has not been undertaken so far. OBJECTIVE: In our systematic review, we aim to identify all existing PROMs that were developed and/or validated for measuring patient-reported outcomes in patients with hyperhidrosis and assess their measurement properties in a transparent and structured way to give a recommendation for future clinical research. METHODS/DESIGN: Our systematic review aims to contain all PROMs developed and/or validated for patients with hyperhidrosis. We will perform a highly sensitive, systematic literature search including the databases MEDLINE (Ovid), EMBASE (Ovid), and Science Citation Index Expanded and Social Sciences Citation Index (Web of Science). Especially studies which evaluate, describe, or compare measurement properties of PROMs for patients with hyperhidrosis will be considered as eligible. Two independent reviewers will judge the eligibility of the studies found in the literature search. The study and PROM characteristics will be summarized in evidence tables. The methodological quality of each study will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. We will apply predefined and consensus-based quality criteria for good measurement properties. Subsequently, the quality of the evidence will be graded. Furthermore, aspects on interpretability and feasibility will be described. A final recommendation will be given. DISCUSSION: In our systematic review, we aim to provide a comprehensive description of the quality of all existing PROMs for patients with hyperhidrosis. The assessment of measurement properties, interpretability, and feasibility will serve as a guidance regarding the selection of PROMs for future clinical hyperhidrosis trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020170247.

Frequency of hand eczema in the elderly: Cross-sectional findings from the German AugUR study.

BACKGROUND: Hand eczema (HE) is a chronic inflammatory skin disease caused by a genetic predisposition and environmental exposures. There is a lack of population-based studies on skin diseases in the elderly. OBJECTIVES: Our aim was to estimate the frequency of HE in the elderly to determine its burden of disease in this particular population. METHODS: We analyzed data from the research platform AugUR, a study on chronic diseases in the elderly (n = 1133, ages 70-95 years, mean age 77.6, 45.1% women). Raw frequencies were estimated using self-reports on physician-diagnosed HE from a standardized personal interview. Frequencies were standardized to the Bavarian population weighted by gender and 5-year age-groups. RESULTS: In our sample 2.7% (95% confidence interval [CI] 1.6-4.3) of the paticipants reported to ever have been diagnosed with HE. Among those 57% were male. After standardization, the frequency was estimated at 2.8% (95% CI 1.9-3.9). There were no differences between male and female participants. CONCLUSIONS: Compared to other studies on lifetime frequency of HE, our estimates seem to be remarkably lower. More in-depth studies with validated diagnoses are warranted to precisely estimate the burden of HE in the elderly.

Adherence to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist in articles published in EAACI Journals: A bibliographic study.

Research data derived from observational studies are accumulating quickly in the field of allergy and immunology and a large amount of observational studies are published every year. The aim of the present study was to evaluate the adherence to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist by papers published in the three European Academy of Allergy and Clinical Immunology journals, during the period 2009-2018. To this end, we conducted a bibliographic study of up to eight randomly selected papers per year per Journal. Our literature search resulted in 223 papers. Amongst those, 80, 80 and 63 records were from Paediatric Allergy and Immunology, Allergy and Clinical and Translational Allergy, respectively; the latter was published only from 2011 on. Prospective, case control and cross-sectional designs were described in 88, 43 and 92 papers, respectively. Full reporting of all STROBE items was present in 47.4%, 45.6% and 41.2% for the cohort, cross-sectional and case-control studies, respectively. Generally, no time trend in adherence of reporting STROBE items was observed, apart from reporting funding, which increased from 60% in 2009/2010 to more than 90% in 2018. We identified a cluster of STROBE items with low proportions of full reporting constituted by the items on reporting study design in the title and methods, variables types along with their measurement/assessment, bias and confounding, study size, and grouping of variables. It appears that the STROBE checklist is a suitable tool in observational allergy epidemiology. However, adherence to the STROBE checklist appeared suboptimal.

Refinement of the German Day-to-Day Impact of Vaginal Aging questionnaire in perimenopausal and postmenopausal women using item response theory and classical test theory.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Measurement properties of patient-reported outcome measures (PROMs) for women with genitourinary syndrome of menopause: a systematic review.

OBJECTIVE: Genitourinary syndrome of menopause affects up to 50% of postmenopausal women and has negative impacts on the women's quality of life. In this systematic review, we aimed to identify and assess the measurement properties of all existing patient-reported outcome measures (PROMs) specific for genitourinary symptoms that were developed and/or validated for measuring patient-reported outcomes in postmenopausal women. METHODS: Studies which evaluated, described, or compared measurement properties of PROMs were considered as eligible. We performed a systematic literature search in MEDLINE, EMBASE, and Web of Science. The methodological quality of each study was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. Furthermore, predefined quality criteria for good measurement properties were applied and the quality of the evidence was graded. RESULTS: Nine articles reporting on four PROMs were included. Two instruments, the Vulvovaginal Symptoms Questionnaire and the Day-to-Day Impact of Vaginal Aging Questionnaire, can be further recommended for use. Both showed moderate to high quality of evidence for sufficient structural validity, internal consistency, and construct validity. The two other instruments, urogenital atrophy quality of life (UGAQoL) and the Urogenital Symptom Scale, cannot be recommended for use, whereby the UGAQoL still has the opportunity to be recommended if the authors gave access to the instrument and further validation studies were conducted. CONCLUSIONS: Both Vulvovaginal Symptoms Questionnaire and Day-to-Day Impact of Vaginal Aging Questionnaire can be recommended for use and results obtained with these two instruments can be seen as trustworthy. Future validation studies should focus on those two instruments.

Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review.

Assessment of the effectiveness of teledermatology has been hampered by the variety of outcome measures used, limiting the possibility for meta-analysis. This systematic mapping review classified the outcome measurement instruments used in randomized controlled trials of teledermatology conducted between 2008 and 2018 using the Core Outcome Measures in Effectiveness Trials taxonomy. Sixteen articles describing 12 studies were identified. Each trial used a mean of 3.7 outcome measurements (range 2-7) , with a total of 55 different instruments employed. Most instruments mapped on the "skin and subcutaneous tissue outcomes" domain. The most frequently used instrument (Dermatology Life Quality Index) was used in only 3 studies. Over 60% of the instruments used did not cite any evidence of validation. This mapping review provides a list of outcome measurement instruments that can be used as a resource when designing teledermatology trials in the future and provides the foundation for the development of a core outcome set.