Understanding the impact on family members is important to develop strategies to alleviate it, to ensure that novel therapeutic interventions also benefit family QOL and to support family members who may be crucial in assisting with therapy adherence.
This webinar will help uncover and measure a major hidden and ignored burden of disease. The developers of the FROM-16 will explain why the impact of disease on partners and other family members is important, and how to measure the impact with a validated generic measure, the Family Reported Outcome Measure (FROM-16). The speakers will review its global use and explain the latest successful validation of score meaning bands, that transforms the FROM-16 from being a purely research tool into a clinical measure that informs clinical decision-making. In addition, they will show how to map FROM-16 scores to EQ-5D (a questionnaire-based system that measures people’s health) utility values, allowing the use of FROM-16 to inform value-based healthcare calculations, and describe further validation studies underway.
The speakers’ research studies have revealed that nearly all family subjects state that their experiences have never previously been considered by healthcare professionals. Things that can’t be measured generally get ignored by science. The speakers therefore created the generic measure FROM-16, based on qualitative and quantitative work across 26 specialties, including Rasch analysis as part of the validation. It consists of 16 short questions across two domains, with a simple scoring system.
FROM-16 is available in more than 15 translations, with more underway, and has detailed published revalidation in Germany, Thailand and Poland. A recently completed study from the speakers, based on data from more than 4,400 patient/family member pairs, has created score meaning descriptor bands. As an example: if the score is greater than 16, this means that the family member is experiencing a major impact on their life quality because of a relative with a disease. This transforms FROM-16 into a simple usable clinical tool which has promising utility in clinical research to gain a competitive edge when comparing interventions, as well as in clinical practice. This could be of interest to both the medicine/medical devices regulatory authorities and heath technology assessment agencies. Studies are also underway to understand the impact of skin diseases on family members in comparison to the impact of other general medical conditions.
One of the strengths of a generic QOL measure is the opportunity to compare the impact of different diseases between specialties. The potential as yet untapped benefits of possible future applications of FROM-16 will be explored in this webinar.
Prof. Andrew Finlay
Professor of Dermatology, School of Medicine at Cardiff University, Developer of the FROM-16
Andrew Finlay is Professor of Dermatology in the School of Medicine at Cardiff University, UK. His main research interest has been in developing ways to understand and measure the impact that skin diseases have on people’s lives. Several of the quality of life measures that his team created are used worldwide clinically and in research, notably the DLQI that is now embedded in national guidelines and registries in more than 40 countries and has been used in more than 450 randomised controlled trials.
His current research is on measuring the huge burden from the secondary impact of disease on patients’ partners and family members, using the Family Reported Outcome Measure (FROM-16). He has published over 440 articles and is Co-Editor of “Dermatology Training – The Essentials” published this year by the British Association of Dermatologists, of which he was previously President.
Professor Finlay enjoys creating novel ideas, such as the “Finger Tip Unit” to explain how much cream to use, the “Rule of Tens” to define psoriasis severity and the “Greater Patient” to emphasise that diseases affect the partner and family as well as the patient.
Professor Finlay was appointed CBE by Queen Elizabeth in 2010 for services to medicine.
Prof. Sam Salek
Professor of Pharmacoepidemiology, School of Life and Medical Sciences, University of Hertfordshire, Developer of the FROM-16
Sam Salek is Professor of Pharmacoepidemiology in the School of Life and Medical Sciences, University of Hertfordshire, where he heads the Public Health and Patient Safety Research Group, Director of the Institute for Medicine Development and visiting Professor at the State of Hessen, Germany. Professor Salek Founded and Chaired the Patient Engagement Special Interest Group of the International Society of Quality of Life Research and is the Co-Chair of the European Hematology Association Scientific Working Group for Quality of Life and Symptoms.
His major research interests are in the development, evaluation and application of patient-reported outcome (PRO) measures. His other major research interests are in the areas of pharmacoeconomics, benefit-risk assessment of medicines and regulations, improving patient access.
Professor Salek is a Fellow of the Royal College of Physicians, the Royal Pharmaceutical Society, European Society of Clinical Pharmacy and Global Fellow in Medicines Development. He is a member of five editorial boards and has published 20 books and over 650 journal articles and abstracts. He has developed and validated 12 general and disease-specific PRO measures, whilst collaborating with the pharmaceutical industry to design PRO protocols for clinical trials. Increasingly, Professor Salek is shifting his emphasis towards the practical applications of PRO measures in clinical and policy decision-making.
Faraz Ali, PhD
Dermatologist, Member of Quality of Life team, Cardiff University
Dr. Faraz Ali graduated with a medical degree from Cardiff University in 2008 and has since completed his medical training in South Wales, UK. He has also obtained MRCP (UK) and has a PGCert in medical education. Dr. Ali is a full-time Dermatologist and a key member of the Quality of Life team based at Cardiff University where he manages various global quality of life queries and research projects. He also recently obtained a PhD on quality of life in psoriasis further cementing his expertise in the area.
Research Fellow, School of Medicine, Cardiff University
Rubina Shah, a seasoned Health Education Specialist, is a research fellow at the School of Medicine Cardiff University, undertaking validation of the Family Reported Outcome Measure (FROM-16). With a master’s degree in public health (MPH), University of Manchester and PG qualification in healthcare management, Rubina has gained rich experience within the community, public and private sectors in the UK and UAE. Before taking a research fellowship, Rubina worked as a Senior Medical Educator at Eli Lilly (Suisse) and as an expert Trainer of the Diabetes Conversation Map ToolTM. Rubina also worked in health education in the UK, delivering innovative campaigns to promote healthy living and well-being. Rubina’s achievements include ‘Educator in spotlight Eli Lilly’ Award, the Best Educator Middle East Award and a recent BMJ open publication about the impact of COVID-19 on survivors and their families, using FROM-16. Rubina has an active interest in researching patient and family quality of life, health policies and long-COVID.
Chief Scientific Officer, Vitaccess
Catherine Bottomley is a PhD Pharmacist with expertise in patient-centered outcome (PCO) research. She is currently Chief Scientific Officer at Vitaccess, a patient-focused consultancy organization offering innovative solutions to patient and carer-reported data collection in real-world settings. Catherine has overall responsibility for the pharma sponsored research studies conducted by Vitaccess including patient-reported tech-based registries, qualitative research, patient-reported outcome measure (PROM) development and implementation and observational studies. Catherine has over a decade of experience working in PCO and real-world evidence roles across a variety of pharmaceutical consultancy settings, spanning Associate Researcher through to Director.
During Catherine’s PhD at Cardiff University, she co-developed the Family Reported Outcome Measure (FROM-16), an instrument to measure the burden from the secondary impact of disease on patients’ partners and family members. Her research interests remain centered around the impact of disease on partners, families and carers.
Account Executive, Mapi Research Trust
Marie-Pierre Emery has been working in the field of clinical outcome assessments (COAs) within the non-profit Mapi Research Trust for 30 years. Leading the MRT team in her positions of Operations Director and Associate Director of Mapi Research Trust, she developed and contributed to the success of all COA information activities at Mapi Research Trust, including the creation of online databases of COA instruments (PROQOLID), of COA claims granted by health authorities in the US and Europe (PROLABELS), COA information searches and targeted literature reviews and the management and international distribution of over 670 COAs and their derivatives such as translations and electronic versions, on behalf of their authors and copyright holders.
Today, Marie-Pierre uses her 30-year experience and her privileged relationship with numerous actors in the COA field, to establish collaborative agreements with authors and copyright holders of instruments and contribute to the centralization, dissemination and exponential use of COAs in clinical research and practice worldwide, for the ultimate benefit of the patients.