Longitudinal validity of the Hyperhidrosis Quality of Life Index (HidroQoL©) in a phase IIIb clinical trial population with hyperhidrosis: responsiveness and meaningful change.

Background: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed patient-reported outcome measure assessing the quality of life (QoL) impacts in hyperhidrosis, which has proven very good measurement properties, such as structural validity and internal consistency.

Objectives: We aimed to investigate responsiveness over time and estimate values for meaningful within-person change (MWPC) towards symptom improvement for different measurement time points (4 and 12 weeks), extending the existing validity evidence in patients with primary axillary hyperhidrosis.

Methods: Data (from a phase IIIb clinical trial) was collected at baseline, week 4, week 8, week 12, week 28, week 52, and week 72.

Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

Objective: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects.

Methods: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome.

Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

Objective: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects.

Methods: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome.

What do Hyperhidrosis Quality of Life Index (HidroQoL©) scores mean? Transferring science into practice by establishing a score banding system.

Background: The Hyperhidrosis Quality of Life Index (HidroQoL©) is a measure of quality of life (QoL) impacts in hyperhidrosis (HH).

Objectives: We aimed to establish score banding systems for the HidroQoL total score for specific contexts representing different severity/impact categories by using the Dermatology Life Quality Index (DLQI) and the Hyperhidrosis Disease Severity Scale (HDSS) as anchors, including data from 357 patients from a phase III clinical trial.

Methods: We used the HDSS, the established DLQI score bands and two single items (items 5 and 7) of the DLQI as anchors for the creation of banding systems for the HidroQoL.

Quality of patient-reported outcome measures for primary dysmenorrhea: a systematic review.

Purpose: To conduct a systematic review of the quality of patient-reported outcome measures (PROMs) for primary dysmenorrhea (PDys) using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the PROMs.

Methods: We searched PubMed and Web of Science for studies reporting on the development and/or validation of any PROMs for women with PDys. Applying the COSMIN Risk of Bias Checklist, we assessed the methodological quality of each included study.

Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial.

Background: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed and validated patient-reported outcome measure assessing the quality-of-life impacts in hyperhidrosis with 18 items. Our aim was to extend the already existing validity evidence for the HidroQoL, especially in relation to structural validity. Especially Rasch analysis has not been applied to the final 18-item HidroQoL before.

Measurement properties of quality-of-life outcome measures for children and adults with eczema: A systematic review update 2.0.

A systematic review on measurement properties of patient-reported outcome measures (PROMs) for the assessment of quality of life (QoL) in children and adults with eczema was published in 2016 and updated in 2019. We now aimed to systematically assess the measurement properties of PROMs based on recently published development and validation studies regarding quality-of-life skin- or disease-specific PROMs using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and integrate these findings with those from the 2019 update. A systematic literature search was conducted in PubMed and Embase.

Patient-reported outcome measures for uncomplicated urinary tract infections in women: a systematic review.

Purpose: To conduct a systematic review of the quality of existing patient-reported outcome measures (PROMs) for use in women with uncomplicated urinary tract infections (UTIs) applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for their use in future research.

Methods: A systematic literature search was performed in PubMed and Web of Science. Studies reporting on the development and/or validation of any PROMs for uncomplicated UTIs in women were considered eligible.

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).

Content validity of the Recap of atopic eczema (RECAP) instrument in Dutch, English and German to measure eczema control in young people with atopic eczema: a cognitive interview study.

Background: Recap of atopic eczema (RECAP) is a patient-reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self-reported and proxy-reported versions in English, Dutch and German.

'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.

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.

Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women.

Background: The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire is a validated patient-reported outcome measure (PROM) capturing the impacts of vaginal symptoms in postmenopausal women.

Aim: We aimed to psychometrically validate the German version of the DIVA questionnaire.

Methods: Data was collected online and by paper-pencil.

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.

Refinement and validation of the ItchyQoL using classical test theory and item response theory resulted in a reduction of the response categories from a 5-point to a 3-point scale.

Background: The ItchyQoL is an itch-specific patient-reported outcome measure used to assess quality of life in patients with chronic pruritus (CP).

Objectives: We aimed to assess and extend the psychometric properties of the ItchyQoL using classical test theory (CTT) and item response theory (IRT).

Methods: Item characteristic curves were analysed to investigate whether the response categories were functioning optimally.

The German RECAP questionnaire: linguistic validation and cognitive debriefing in German adults with self-reported atopic eczema and parents of affected children.

Background: Recap of atopic eczema (RECAP) is a patient-reported outcome measure (PROM) assessing eczema control. Long-term control of eczema is one of the four core outcome domains for atopic eczema trials. This instrument has been recently developed in the UK.

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema (AE) clinical trials. Previous consensus meetings have agreed on preferred instruments for clinician-reported signs (Eczema Area and Severity Index, EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure, POEM). This paper reports consensus decisions from the HOME VII meeting.

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.

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema clinical trials. Previous consensus meetings have agreed upon preferred instruments for clinician-reported signs (Eczema Area and Severity Index - EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure - POEM). This paper reports consensus decisions from the HOME VII meeting.

IDQoL, CDLQI and the 45-item CADIS received a sufficient content validity rating during the HOME VII meeting in Japan: a group discussion study.

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed that quality of life should be measured in all atopic eczema clinical trials. Various candidate instruments exist for this domain but their content validity in atopic eczema is largely unclear.

Objective: To assess the content validity of quality-of-life candidate instruments for atopic eczema in infants, children and adults in order to aid the decision on what instrument to include in the core outcome set for the quality-of-life domain.

Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial.

Background: The Hyperhidrosis Quality of Life Index (HidroQoL©) is a validated patient-reported outcome measure capturing the quality of life of people affected by hyperhidrosis.

Objectives: We aimed to extend the validity evidence to physician-confirmed diagnosis of primary axillary hyperhidrosis.

Methods: Data from a phase III randomized placebo-controlled clinical trial were used (n = 171).

Development of a validated short-form of the Childhood Atopic Dermatitis Impact Scale, the CADIS-SF15.

Background: The Childhood Atopic Dermatitis Impact Scale (CADIS) with 45 items may be burdensome to complete. We therefore aimed to develop a CADIS short-form.

Methods: Parents of 300 children completed the prototype CADIS.