ACNE CORE OUTCOMES RESEARCH NETWORK
The ACNE CORE OUTCOMES RESEARCH NETWORK, known as ACORN, aims to develop a standardized set of measures for all future acne treatment trials to assess efficacy and compare treatments. By focusing on patient perspectives and determining core outcomes, ACORN seeks to enhance the reliability and accuracy of measuring treatment effectiveness. The initiative involves defining and validating core outcomes, agreeing on measurement methods, and implementing these standardized measures in clinical trials. This comprehensive approach is designed to optimize the evaluation of acne treatments and outcomes.
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Presentation Transcript
ACNE CORE OUTCOMES RESEARCH NETWORK Information for new patient members 01/2016
What is ACORN and what problem will it address? ACORN will develop a set of measures to be used in all future clinical trials to find out how well new acne treatments work and how they compare with existing ones. As a first step, ACORN will determine what to measure using methods which put patients views at the centre. The next step will be to ask everyone with an interest in the effectiveness of acne treatments to agree a minimum set of items which should always be measured because they are the most important ones. Other people with an interest include doctors, people who manufacture or test acne treatments and regulators who license them. Once we know which items are most important, we ll find out the best ways to measure them reliably and accurately.
What does outcome mean? Doctors call the items we want to measure in clinical trials outcomes . By that they mean a symptom, sign or impact of a medical condition which effective treatment should improve. A symptom is something the patient feels but a doctor cannot assess e.g. stomach ache, fatigue or anxiety A sign is a feature of a medical condition which can be observed by a doctor e.g. difficulty walking, a rash, breathlessness An impact is an effect of having a medical condition on everyday life, interactions with others or on mental wellbeing e.g. difficulty sleeping, inability to play sports, needing a carer Here are some examples of outcomes: the amount of hearing loss in someone with deafness the amount of pain in someone with toothache the impact on the family of caring for someone with dementia Methods used to assess changes in these outcomes are called outcome measures . For example, pain might be measured on a 0 to 10 scale, vision with a series of sight tests, etc.
What is a core outcome? Something which should be measured in ALL future acne trials It may be a symptom, a sign or an impact Sometimes it might be a combination of symptoms, signs or impacts A core outcome set will include several outcomes Each of these outcomes will be measured using methods which have been rigorously tested (this is called validation) The methods are called core outcome measures There might be one for measuring symptoms, one for signs and another one for impacts
4 steps to better acne clinical trials Symptoms Signs Impacts Agree what to measure (core outcomes) Agree how to measure core outcomes Devise core outcome measure set Adapt existing methods OR Develop and validate new ones Adopt core outcome measure set in ALL future clinical trials
What about side effects? You might be wondering why side effects of treatments haven t been mentioned. Side effects will almost always be measured in clinical trials of medicines or medical devices Information on incidence and severity of side effects is required by the organisations which license these products In other words, side effects WILL be included as a core outcome but they are not the focus of ACORN s research
What else might be included in a core outcome measure set? Sometimes tests which reveal how a treatment works are included in clinical trials An example would be blood sugar levels in patients with diabetes Sometimes it might be important to compare costs of treatment to patients or the country s healthcare system ACORN members, including people with acne, will decide if either or both of these should be included in the core outcome measure set Even if they aren t, anyone who conducts a clinical trial can choose to include them in addition to the core outcome measure set
Why join ACORN? Much of the time, money and energy spent on acne clinical trials to date has been wasted Different outcomes are measured using different methods Reporting standards are inconsistent We measure what doctors decided should be measured Patient input into the identification of what to measure has been minimal ACORN gives people with acne, health care professionals and everyone involved in the conduct of clinical trials an equal voice A large diverse team of ACORN members from all over the world means faster progress towards better trials
