QALYs ARE NOT VALID FOR HEALTH DECISION-MAKING – RESULTS FROM THE EUROPEAN ECHOUTCOME PROJECT
Jan 25th 2013

Treatment decisions based on QALYs are seriously flawed and must not be used in Europe, say researchers

European project shows QALY approach to funding medical treatment should be abandoned

Patients denied access to life-saving treatments due to flawed reasoning

The Quality Adjusted Life Years approach to deciding what medical treatments are available on health services – used by the UK, Canada and Australia and generating much interest across Europe – is dangerously flawed and should be abandoned, according a European Commission funded research project.

The results of the project, announced today (25th January) at a Brussels conference on health outcomes in Europe, highlights huge failings in the way some Health Technology Assessment (HTA) agencies notably the UK s National Institute for Health and Clinical Excellence (NICE), recommend which treatments be made available on health services, and warns against this system being adopted across Europe.

HTA agencies are charged with recommending whether new treatments should be publicly funded. NICE, perhaps Europe s most well known HTA agencies, uses Quality Adjusted Life Years (QALY). QALY is an economic theory which mathematically weighs the number of life years and the improvement to quality of life provided by different treatments. On the basis of this calculation, recommendations are made about whether treatments are offered by the UK s National Health Service (NHS). In the UK, if the incremental cost per QALY (cost of one additional year in perfect health) is below £30,000 then the treatment is usually recommended to be accessible to patients. Whilst Germany has explicitly rejected it, many European countries are currently considering replicating the NICE model.

he QALY method is based on four key assumptions about how patients rate additional life and different health states. ECHOUTCOME, a three year, €1m, European Commission-funded project, brought together six universities and research agencies to investigate these four assumptions, finding them all to be invalid.

The research surveyed 1,300 respondents in Belgium, France, Italy and the UK, and is the largest investigation into QALYs ever undertaken. It used a questionnaire designed by medical and economics experts and carried out by trained interviewers to test the assumptions.

The responses varied hugely across the population showing that the way people rate different medical outcomes is personal, and cannot be summed up by a neat formula. The project concludes that QALY is therefore an invalid way to make medical decisions and should be replaced by a more flexible, case by case approach.

The four assumptions invalidated by the research are:

Assumption 1: Time and quality of life can be measured in consistent intervals. This is true for life years, as two years is twice as long as one year. But quality of life is personal and different people rank different conditions as having a greater or worse impact. The QALY system which grades different conditions and assigns them a number cannot be said to reflect how real people view these conditions.

Assumption 2: Life years and quality of life are linked. This assumes that someone who prefers 10 years of healthy life to five years, will also prefer 10 years in a wheelchair to five years. The results showed that this does not reflect how real people feel.

Assumption 3: People are neutral about risk. The results showed most people are either risk averse or willing to take risk. It was very rare to find someone was neutral. The assumption that people are neutral can lead to decisions which completely distort the desires of patients.

Assumption 4: Willingness to sacrifice life years is constant over time. This assumption suggests an individual willing to trade off five years in a remaining 25 years (20% of life) for better health, will also give up two years in 10. The research showed that willingness to sacrifice time for life quality over different periods of time varied enormously.

Gerard Duru, Emeritus Research Director in Mathematics at the French National Centre of Scientific research (CNRS) said: “The underlying assumptions of the QALY outcome are very theoretical and are not verified in a real population. The QALY indicator is not a valid scientific scale. It is impossible to know what we are measuring, and therefore impossible to base a formula upon it. To be able to trust this formula, all four of these assumptions must be validated. If they aren t we don t have the right to use it.”

The researchers point to examples where NICE has made negative appraisals of innovative medicines based on this flawed assessment method. NICE had assessed that some biologic drugs could be used for the management of rheumatoid arthritis, but not a new one – abatacept. This was based on one QALY assessment that said it was over the threshold, whilst other QALY assessments, and other cost-effectiveness approaches, had shown this new treatment to be cost-effective. This means that should conventional anti-rheumatic drugs stop working or cause major side effects, as drugs may sometimes do, some patients may not be switched to this innovative medicine although it had been shown to provide a clinically safe, effective and cost-effective alternative.

Ariel Beresniak, CEO of Data Mining International and ECHOUTCOME Project Leader said: “The research provides robust scientific evidence that QALYs produce hugely inconsistent, wrong results, on which important decisions are being made.”

“Agencies such as NICE should abandon QALY in favour of other approaches. European HTAs currently looking to adopt the NICE model must seriously reconsider”.

Alastair Kent, Director of Genetic Alliance UK, a group working to improve the lives of people affected by genetic conditions, says: “We recognise that there is a limited budget and tough decisions to be made. But the QALY system in its current form is an inadequate, incomplete measure which neglects important issues. Any system for allocating medical resources must carry confidence of clinicians, patients and society at large, and the current system does not.”

The consortium recommends that QALY should never be used in healthcare decisions. Beresniak says “Each case is different and each should use adequate evaluation tools. There should be list of adequate validated tools to make these decisions with guidance on when to use each, instead of one non-validated tool.”

For example a cost per remission approach would be welcome for drugs targeting Rheumatoid Arthritis, which could then be issued along with guidance as to when a patient can be granted the drug. This is a clear, scientifically robust assessment as remission rate can be defined and cost calculated simply and quickly.

In other cases a cost-benefit approach is appropriate, ie the cost of disease avoided by investing in wide scale vaccinations.

Beresniak says “The pro-QALY lobby will respond that such a system doesn t compare different treatments for different diseases. But we never need to do this in real life medical situations.”

http://www.echoutcome.eu/

About the consortium
ECHOUTCOME (European Consortium in Healthcare Outcomes and Cost-Benefit research) is made up of experts in healthcare, mathematics and economics from Data Mining International (Switzerland – Project leader), the University of Bocconi (Italy), the Université Libre de Bruxelles (Belgium), the French Society of Health Economics (SFES), Cyklad Group (France), Lyon Ingénierie Projets and the Claude Bernard University (France).

About QALY
The QALY is a formula calculated from additional life expectancy and a measure of the quality of the remaining life-years that would be added by the medical intervention.

Each year in perfect health is assigned the value of 1.0, down to a value of 0.0 for being dead. If the extra years would not be lived in full health then the extra life-years are given a value between 0 and 1 to account for this.

There are many different ways to calculate quality of life. A number of factors are considered including the level of pain the person is in, their mobility and their general mood.

A value is then assigned which is multiplied by the number of additional life years to reach the QALY value. . If the incremental cost per QALY (= cost of one additional life year in perfect health) is below £30,000 then the treatment is usually recommended by NICE to be reimbursable from the NHS.

Most of the cases, data to assess quality of life is mapped from published studies of how people rank different life situations, rather than individual tests for each drug. Much of the process is speculative, and the different methods will produce different results.

Results from pharma companies tend to come in below £30,000 per QALY. Results from NICE studies, where they feel the need to reappraise pharma results, tend to be over the threshold.

How a QALY is calculated (from the NICE website):

Patient x has a serious, life-threatening condition.

If he continues receiving standard treatment he will live for 1 year and his quality of life will be 0.4 (0 or below = worst possible health, 1= best possible health)

If he receives the new drug he will live for 1 year 3 months (1.25 years), with a quality of life of 0.6.
The new treatment is compared with standard care in terms of the QALYs gained:
Standard treatment: 1 (year s extra life) x 0.4 = 0.4 QALY
New treatment: 1.25 (1 year, 3 months extra life) x 0.6 = 0.75 QALY

Therefore, the new treatment leads to 0.35 additional QALYs (that is: 0.75 -0.4 QALY = 0.35 QALYs)
The cost of the new drug is assumed to be £10,000, standard treatment costs £3000.

The difference in treatment costs (£7000) is divided by the QALYs gained (0.35) to calculate the cost per QALY. So the new treatment would cost £20,000 per QALY.

QUALITY OF LIFE IMPROVED BY COSMETIC PRODUCTS 
Nov 20th 2012

For the first time at a global level, it is now possible to really know how cosmetic products could improve life ! A new measuring tool, BeautyQol, has been specifically developed to scientifically establish that cosmetic products and good physical appearance improve Quality of Life.

The new study published today in the Archives of Dermatology (JAMA Dermatology – USA) confirms that cosmetic products and good physical appearance significantly improve Quality of Life (QOL). In order to be able to investigate this topic, the authors have developed a new international QOL measuring instrument called “BeautyQol”. This instrument has been tested on 3231 subjects confirming the validity and reliability of the measure in 13 countries in the world representing 16 languages: France, UK, Germany, Spain, Italy, Sweden, Russia, USA, Brazil, Japan, India (Hindi and Indian English) China and South Africa (Zulu, Sotho and South-African English). The instrument provides one overall QOL score, as well as five sub-scores according to five key dimensions of QOL: Social Life, Self confidence, Mood, Energy and Attractiveness.

Dr Ariel Beresniak, MD, MPH, PhD, Chief Executive Officer of Data Mining International said: “The positive impact of cosmetics on self esteem and well-being has been well-known since the Antique period, but this is the first time that we are able to scientifically measure this impact in the key dimensions of Quality of Life. This new instrument will allow numerous comparative research according to populations, products and situations”. Pilot application studies have been carried out to assess the impact in QOL of pigmentary disorders, camouflage products, oily skins, hair colouring, make up, etc.

Co-author of the study, Yolaine de Linares, Director of the Department of Social and Innovation Prospective Research, L’Oréal, moderator of the BeautyQol international scientific committee, said: “This research will allow a growing body of evidence about the value of cosmetic products. This is the reason why the BeautyQol instrument is going to become a gold standard in perceived effectiveness assessment”. By measuring how much cosmetic products improve QOL, BeautyQol allows to evaluate how much they also improve general health, according to the World Health Organization definition of health: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”.

The BeautyQol instrument is going to be adapted to more countries in order to better assess cultural differences in the use of cosmetic products.

health

DIABETES PREVALENCE LOWER IN HIGH TEA DRINKING POPULATIONS 

Nov 8th 2012

Populations which drink high quantities of black tea have a significantly lower prevalence of diabetes, research has found.

A new study, published today in the British Medical Journal Open, has discovered a linear correlation between the quantity of black tea consumed and the incidence of diabetes across 42 nations worldwide. The research found that on average, a population which consumes double the amount of black tea to another has about one quarter less cases of diabetes. However, the study, which was carried out by Geneva-based research agency Data Mining International in partnership with consumer goods company Unilever, does not suggest that there is a causal relationship between black tea consumption and reduced risk of diabetes in individuals.

To carry out the research, Data Mining International assessed the black tea consumption rates of 42 different countries and analysed them against each country’s rates of respiratory, infectious and cardiovascular disease, as well as cancer and diabetes. The data was sourced from Euromonitor’s World Tea Consumption Survey and the World Health Survey, conducted by the World Health Organization. The only correlation found was between a population’s black tea consumption and its diabetes prevalence.

Dr Ariel Beresniak, Chief Executive Officer of Data Mining International said: “This is the first time that a robust statistical relationship has been established between black tea consumption and diabetes prevalence in the world. While we cannot confirm a cause-effect relationship between tea drinking and diabetes, our findings are consistent with a number of biological, physiological, epidemiological and clinical studies suggesting that black tea components have a positive effect on glucose metabolism.”

Co-author of the study, Professor Genevieve Berger, Chief Research & Development Officer, Unilever said: “This research adds to a growing body of evidence which points to black tea’s health-giving properties. Further investigation is required to understand if there is a causal relationship between the two, but the fact that populations which drink lots of black tea suffer less cases of diabetes is an interesting finding, and one which gives us good cause to carry out more research to further understand the driving factors behind this exciting research.”

The research has also been presented at the last World Congress of Diabetes and International Congress of Dietetics.

health

PATIENTS DENIED ACCESS TO LIFE-SAVING TREATMENTS DUE TO FLAWED METHODS

Nov 10th, 2014

The methods used by some countries to decide which medical treatments should be made available to patients are dangerously flawed and should be abandoned. This conclusion is based on the ECHOUTCOME research project funded by the European Commission, and led by Data Mining International, a Swiss independent research agency.

The full results, recently published in a peer-reviewed scientific article, highlight major failings in the way that some Health Technology Assessment (HTA) agencies, such as the UK’s National Institute for Health and Care Excellence (NICE), recommend which treatments should be made available to patients, and warn against this system being adopted elsewhere in Europe or beyond. NICE assesses innovative medicines and recommends whether or not to provide access to treatment using Quality Adjusted Life Years (QALY), a formula that weighs life duration with quality of life.

The findings show that perception about health cannot be captured using a simple multiplication. In addition, the project tracked various situations (“counter-examples”) leading to divergent results derived from the same dataset, confirming that the QALY approach does not meet basic requirements for serious scientific evidence. According to scientific reasoning, a theory is valid until one single counter-example invalidates this theory. If so, the theory is considered as a metaphysical doctrine.

Ariel Beresniak, CEO of Data Mining International specialized in providing robust cost-effectiveness alternative solutions, said: “Patients associations should be aware that life-saving treatmentsare denied based on a flawed metric.This research provides strong scientific evidence that QALYs produce hugely inconsistent, wrong results, based on which important decisions are still being made in Europe. HTA agencies promoting QALY should abandon this metric in favour of robust methods if they want to protect citizens”.

While many users acknowledge that the QALY outcome is ‘not perfect’, they insist that it would be the ‘best method available’ for resource allocation decisions. Beresniak said that maintaining such defensive attitude could denote a lack of attention towards patient populations. In the aviation industry, when misconceptions are identified for an aircraft, the model is usually grounded until it can be either fixed or replaced.
The article concludes that QALY is an invalid method for assisting health decisions, and should be immediately replaced by other robust cost-effectiveness methods.

Beresniak A et al. Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project. Pharmacoeconomics. 2014 Sep 18.

THE INTERNATIONALLY VALIDATED QUALITY OF LIFE INSTRUMENT BEAUTYQOL PROVIDES SCIENTIFIC PROOF ABOUT THE LINK BETWEEN PHYSICAL APPEARANCE AND QUALITY OF LIFE 

Oct 27, 2015

What if cosmetic products and interventions could not only improve one’s physical appearance but also one’s quality of life and its different dimensions – emotional life, relationships, energy level, mood etc.? As we all know, looking good has always been associated with feeling good. For the first time, this correlation can be scientifically proved with the internationally validated Quality of Life instrument called BeautyQoL®. This original initiative, supported by L’Oréal Research & Innovation, has been developed in collaboration with an international expert panel composed of dermatologists, plastic surgeons, evaluation specialists and mathematicians, and is the subject of a recent article published by the Journal of Cosmetic Dermatology:“Quality of life assessment in cosmetics: specificity and interest of the international BeautyQol instrument”.

The BeautyQoL® instrument, is composed of 42 questions covering different aspects related to Quality of Life and has been validated in 16 languages and 13 countries. Not only is BeautyQoL® specific to cosmetic products and physical appearance but also thanks to its advanced scoring procedure and comprehensive analytical potential, it is highly sensitive and is capable of capturing even smallest variations in Quality of Life, brought about by the use of innovative cosmetic and beauty care products, or changes in the physical appearance following aesthetic interventions.

Our society values beauty, youth and health. Therefore, people living with various physical appearance issues, distinctive aesthetic features or noticeable skin conditions can feel a great strain on their lives, the repercussions of which can be quite significant, influencing their emotional, professional and social interactions and overall well-being. According to the World Health Organization’s determination of health, it is not only about the absence of disease but about a state of complete physical, mental and social well-being. Therefore, if an instrument such as BeautyQoL® can prove the link between the improved physical appearance and improved well-being – another paramount pillar of our society – it can contribute to demonstrating the added value of cosmetic interventions on Quality of Life – and indirectly health – which goes well beyond the superficial dimension that the use of cosmetics used to be associated with.

Dr Ariel Beresniak, Chief Executive Officer of Data Mining International, an independent research agency based in Geneva, Switzerland, and project leader of the BeautyQoL® international initiative, said: “The BeautyQoL® questionnaire is the only existing instrument in the world specifically built to discriminate small differences of Quality of Life cross-culturally, relevant to cosmetics and physical appearance, thus providing the most robust tool for scientific and market research applications in cosmetology.” The BeautyQoL® instrument is currently being used in various studies promoted either by cosmetic and beauty care industry or by academic research organizations.

As BeautyQoL® measures the improvement in quality of life related to physical appearance, its potential applications are wide-ranging, including for valuing and differentiating cosmetic and beauty care products, dermatological treatments, aesthetic procedures, anti-ageing interventions, plastic surgeries, aesthetic dentistry, etc. The BeautyQoL® instrument being specially designed and internationally validated to assess physical appearance and quality of life, it represents an important advancement in the field of quality of life and health outcomes research. By generating robust quantitative evidence, for the first time, BeautyQoL® enables to scientifically assess and firmly establish the humanistic benefits of improving quality of life and overall well-being related to physical appearance.

Scientific references:

Beresniak A, Auray JP, Duru G, Aractingi S, Krueger GG, Talarico S, Tsutani K, Dupont D, de Linares Y, Quality of life assessment in cosmetics: specificity and interest of the international BeautyQol instrument, J Cosmet Dermatol. 2015 Sep;14(3):260-5.

Beresniak A, de Linares Y, Krueger GG, Talarico S, Tsutani K, Duru G, Berger G. Validation of a New International Quality-of-life Instrument Specific to Cosmetics and Physical Appearance. BeautyQoL Questionnaire. Arch Dematol 2012; 148 (11): 1275-1282.

A L’OREAL STUDY IN JAPAN USING BEAUTYQOL

Nov 5, 2015

Cosmetic skin concerns and their impact on the quality of life is once again the subject of a scientific article published recently by the Journal of Cosmetic and Laser Therapy*. This study run by L’Oréal Research & Innovation in collaboration with Data Mining International, a Swiss independent research agency and the project leader of the development of the BeautyQoL® measuring instrument, aimed to assess the link between the skin pigmentary disorders among the Japanese women and the various aspects of their lives, all of which contribute to their quality of life. As fairer skin tone is culturally more desirable in Japan and Asian countries in general, the hypothesis that the uneven skin tone and facial dark spots do indeed influence negatively the quality of life, was confirmed by this research project.

The BeautyQoL® instrument has been specifically designed to scientifically measure the impact of cosmetic products and physical appearance on Quality of Life (QOL). By providing both a global score and specific scores for each of the five dimensions, namely social life, self-confidence, mood, energy, and attractiveness, the BeautyQoL® questionnaire enables the assessment of each dimension contributing to the overall QoL of subjects having cosmetic concerns, as well as the potential benefits of cosmetic products used to either treat or camouflage them.

The specificity and the sensitivity of the BeautyQoL® instrument make it possible to capture even the smallest variations in QoL influenced by the physical appearance or the use of cosmetic products, thanks to which, the study in question was able to discover, for instance, which of the five dimensions of QoL was impacted the most (mood) but also, how the other four dimensions were distributed with regards to how the Japanese women were gravely concerned or not with their skin issues. Overall, both the global score and the five dimensions measured in the study, point to the fact that the Quality of Life does appear to be affected in the subjects with skin tone problems and dark spots.

The BeautyQoL® instrument is currently the only existing scientific instrument validated in 16 cultures and built specifically to discriminate small variations in the Quality of Life relevant to the physical appearance. BeautyQol® provides the most robust tool for scientific and market research application in cosmetology. Indeed, with its wide-ranging potential applications it is currently being used in various studies both in the cosmetic and beauty care industry as well as in the academic research projects. As a pioneer in its field, BeautyQoL® represents an important advancement in the domain of the quality of life, reserved until recently mostly to the pharmaceutical research. By generating robust quantitative evidence, for the first time, BeautyQoL® can scientifically assess and firmly establish the humanistic impact of pigmentary (and other aesthetic) disorders as well as to differentiate and demonstrate the added value of cosmetic products and interventions.

Scientific references:

*Beresniak A, Auray JP, Duru G, Aractingi S, Krueger GG, Talarico S, Adam AS, Piot B, Dupont D, de Linares Y. Impact of pigmentary disorders on quality of life in Japan: Interest of the BeautyQoL instrument. J Cosmet Laser Ther. 2015 Dec;17(6):313-7. doi: 10.3109/14764172.2015.1039034. Epub 2015 Jul 2.

Beresniak A, de Linares Y, Krueger GG, Talarico S, Tsutani K, Duru G, Berger G. Validation of a New International Quality-of-life Instrument Specific to Cosmetics and Physical Appearance. BeautyQoL Questionnaire. Arch Dematol 2012; 148 (11): 1275-1282.

HAIR COLORING IMPROVES QUALITY OF LIFE

April 14th, 2016

Hair coloring positively impacts Quality of Life, says a new scientific study. The role that the hair plays on both men and women’s identity has been evident throughout history, the hair – its style, color, abundance or luck thereof – representing often femininity, virility, freedom, beauty, as well as belonging to a specific religion and culture. While we all intuitively know about the link between our physical appearance and our well-being, very little research has been carried out in order to ascertain that relationship.

Some cosmetics companies work together with hospitals in order to speed up recovery of patients suffering of cancer in organizing cosmetic workshops inside the hospital. The successful results of these initiatives that often involve hairstyle variations point out not only to the impact on general well-being but indirectly also on general health.

The new measuring instrument, BeautyQoL has been specifically developed to scientifically assess the effect of cosmetic products on Quality of Life, leveraging the common fact that the way we look can indeed influence the way we feel, think and interact with others. The scientific article recently published in the Journal of Cosmetology and Trichology presents the results of this study assessing two popular haircoloring products from L’Oréal (Excellence® by L’Oréal Paris and Olia® by Garnier).

Tested on a total of 240 adult women whose age ranged from 45 to 70, BeautyQoL confirmed the improvement of quality of life both on the general index as well as dimension-specific scores, demonstrating the added value of the tested hair coloring products.

The importance of this new generation of studies using BeautyQoL is that it scientifically demonstrates how the cosmetic products – in this case hair color – don’t just enhance one’s physical appearance in a superficial way but actually impact one’s self-esteem, social relations and general well-being.

According to Dr Ariel Beresniak, project leader of the BeautyQoL initiative and Chief Executive Officer of Data Mining International, an independent research agency based in Geneva, Switzerland:

“For the very first time, these findings confirm the interest, sensitivity and robustness of the BeautyQoL instrument in assessing branded cosmetic products that relate to physical appearance”.

Indeed, considering the financial importance of the hair and beauty industry as well as the deep psychological and emotional relationship that women (and men) of all ages and all cultures have with their hair style, this innovative scientific approach shows the marketed hair coloring products and their impact in a completely new light, demonstrating how a seemingly simple action can have significant and far reaching positive consequences on people’s lives.

*Assessing the Hair Colourings’ Impact on Quality of Life. Beresniak et al., J Cosmo Trichol 2015, 1:1. http://dx.doi.org/10.4172/jctt.1000103