Two Minimal Clinically Important Difference (2MCID) : A New Twist on an Old Concept

This work is open access licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, https://creativecommons.org/licenses/by-nc/4.0/Peer reviewe

Meaning of Family Reported Outcome Measure (FROM-16) severity score bands: a cross-sectional online study in the UK

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/Objective: To assign clinical meanings to the Family Reported Outcome Measure (FROM-16) scores through the development of score bands using the anchor-based approach. Design and setting: A cross-sectional online study recruited participants through UK-based patient support groups, research support platforms (HealthWise Wales, Autism Research Centre-Cambridge University database, Join Dementia Research) and through social service departments in Wales. Participants: Family members/partners (aged ≥18 years) of patients with different health conditions. Intervention: Family members/partners of patients completed the FROM-16 questionnaire and a Global Question (GQ). Main outcome measure: Various FROM-16 band sets were devised as a result of mapping of mean, median and mode of the GQ scores to FROM-16 total score, and receiver operating characteristic-area under the curve cut-off values. The band set with the best agreement with GQ based on weighted kappa was selected. Results: A total of 4413 family members/partners (male=1533, 34.7%; female=2858, 64.8%; Prefer not to say=16, 0.4%; other=6, 0.14%) of people with a health condition (male=1994, 45.2%; female=2400, 54.4%; Prefer not to say=12, 0.3%; other=7, 0.16%) completed the online survey: mean FROM-16 score=15.02 (range 0–32, SD=8.08), mean GQ score=2.32 (range 0–4, SD=1.08). The proposed FROM-16 score bandings are: 0–1=no effect on the quality of life of family member; 2–8=small effect on family member; 9–16=moderate effect on family member; 17–25=very large effect on family member; 26–32=extremely large effect on family member (weighted kappa=0.60). Conclusion: The FROM-16 score descriptor bands provide new information to clinicians about interpreting scores and score changes, allowing better-informed treatment decisions for patients and their families. The score banding of FROM-16, along with a short administration time, demonstrates its potential to support holistic clinical practice.Peer reviewe

Comparative analysis of UWB balance Antipodal Vivaldi Antenna for array configuration

In this paper, an Ultra-wideband Balance Antipodal Vivaldi Antenna in planar and h-plane array configuration is presented. The comparison of four elements of BAVA array in both planes has been observed. Each element of an antenna printed on the glass-reinforced epoxy laminate material (FR4) with a thickness of 1.5mm and relative permittivity of 4.3. The dimension of every single element is 60.75mm x 66mm approximately. The array elements of both planes almost cover the whole UWB frequency range with the reflection coefficient of -10dB. Based on the simulation results, the array elements in planar configuration showing good reflection and works well at 3.2GHz frequency while the configuration in h-plane the array elements works well at 7GHz of frequency. In planar configuration, the operating frequency of antenna elements is shifting as a result of the distance between inter elements which intensification in wavelength. The array elements in h-plane produce more gain up to 10.2 dB with good radiation patterns as compared to the planar plane. The antenna design and optimization development are verified using CST simulation software

UWB antenna based time-domain approach for through the walls gap estimation

This paper has introduced a novel experimental system adopted a time domain approach for estimating through wall distance and recognizes buried objects behind the wall. The designed and fabricated balanced antipodal Vivaldi antenna (BAVA) has been used for the development of UWB system. The working mechanism of an intended detection system based on time domain reflectometry (TDR) and ground-penetrating radar (GPR). A miniature pulse in the UWB range is generated by the vector network analyzer (VNA) to irradiate a barrier made of two walls separated by airgap between them. The signal radiations reflect partially from the front wall while remaining goes through for getting reflected from the rear wall. The VNA is used for measuring the time interval passed between the instant when an incident signal irradiates the first wall and the instant when the incident signal gets reflected from the rear wall. The investigational process of a system is carried out by UWB antenna probe. The detected information is attained using the values of reflection coefficient (S 11 ) represented in time domain measurements. Experimental results have been proved the ability to detect wall gap as well as the width estimation between two walls with high accuracy. The maximum percentage error has been found to not exceeding 4.5% in the worst condition

Mapping of the DLQI scores to EQ-5D utility values using ordinal logistic regression

Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.Purpose: The Dermatology Life Quality Index (DLQI) and the European Quality of Life-5 Dimension (EQ-5D) are separate measures that may be used to gather health-related quality of life (HRQoL) information from patients. The EQ-5D is a generic measure from which health utility estimates can be derived, whereas the DLQI is a specialty-specific measure to assess HRQoL. To reduce the burden of multiple measures being administered and to enable a more disease-specific calculation of health utility estimates, we explored an established mathematical technique known as ordinal logistic regression (OLR) to develop an appropriate model to map DLQI data to EQ-5D-based health utility estimates. Methods: Retrospective data from 4010 patients were randomly divided five times into two groups for the derivation and testing of the mapping model. Split-half cross-validation was utilized resulting in a total of ten ordinal logistic regression models for each of the five EQ-5D dimensions against age, sex, and all ten items of the DLQI. Using Monte Carlo simulation, predicted health utility estimates were derived and compared against those observed. This method was repeated for both OLR and a previously tested mapping methodology based on linear regression. Results: The model was shown to be highly predictive and its repeated fitting demonstrated a stable model using OLR as well as linear regression. The mean differences between OLR-predicted health utility estimates and observed health utility estimates ranged from 0.0024 to 0.0239 across the ten modeling exercises, with an average overall difference of 0.0120 (a 1.6% underestimate, not of clinical importance). Conclusions: This modeling framework developed in this study will enable researchers to calculate EQ-5D health utility estimates from a specialty-specific study population, reducing patient and economic burden.Peer reviewedFinal Published versio

A systematic review of 457 randomised controlled trials using the Dermatology Life Quality Index: experience in 68 diseases and 42 countries

Background Over 29 years of clinical application, the Dermatology Life Quality Index (DLQI) has remained the most used PRO in dermatology due to its robustness, simplicity and ease of use. Objectives This systematic review aimed to generate further evidence of its utility in randomised controlled trials and is the first to cover all diseases and interventions. Methods The methodology followed PRISMA guidelines and included seven bibliographic databases, searching articles published from January 1 1994 until November 16, 2021. Articles were reviewed independently by two assessors, and an adjudicator resolved any opinion differences. Results Of 3220 screened publications, 457 articles meeting eligibility criteria for inclusion, describing research on 198,587 patients, were analysed. DLQI scores were primary endpoints in 24 (5.3%) of studies. Most studies were of psoriasis (53.2%), although 68 different diseases were studied. Most study drugs were systemic (84.3%), with biologics 55.9% of all pharmacological interventions. Topical treatments comprised 17.1% of total pharmacological interventions. Non-pharmacological interventions were 13.8% of the total interventions, mainly laser therapy and UV treatment. 63.6% of studies were multicentre, with trials conducted in at least 42 different countries, and 41.7% were conducted in multiple countries. Minimal importance difference (MID) was reported in analysis of 15.1% of studies, but only 1.3% considered full score meaning banding of DLQI. 61 (13.4%) of studies investigated statistical correlation of DLQI with clinical severity assessment or other PRO/QoL tools. 62% to 86% of studies had within group scores differences greater than the MID in “active treatment arms”. The JADAD risk of bias scale showed that bias was generally low, as 91.4% of studies had JADAD scores of ≥3; only 0.44% of studies showed high risk from randomisation, 13.8% high risk from blinding and 10.4% high risk from unknown outcome of all participants in the studies. 18.3% of studies declared that they followed an intention-to treat (ITT) protocol, and imputation for missing DLQI data was used in 34.1% of studies. Conclusions This systematic review provides a wealth of evidence for use of the DLQI in clinical trials to inform researchers’ and clinicians’ decision for its further use. Recommendations are also made for improving the reporting of data from future RCT trials using DLQI