Key Concepts for assessing claims about treatment effects and making well-informed treatment choices

Background: The Informed Health Choices (IHC) Key Concepts are standards for judgement, or principles for evaluating the trustworthiness of treatment claims and treatment comparisons (evidence) used to support claims, and for making treatment choices. The list of concepts provides a framework, or starting point, for teachers, journalists and other intermediaries for identifying and developing resources (such as longer explanations, examples, games and interactive applications) to help people to understand and apply the concepts. The first version of the list was published in 2015 and has been updated yearly since then. We report here the changes that have been made from when the list was first published up to the current (2018) version. Methods: We developed the IHC Key Concepts by searching the literature and checklists written for the public, journalists, and health professionals; and by considering concepts related to assessing the certainty of evidence about the effects of treatments. We have revised the Key Concepts yearly, based on feedback and suggestions; and learning from using the IHC Key Concepts, other relevant frameworks, and adaptation of the IHC Key Concepts to other types of interventions besides treatments. Results: We have made many changes since the Key Concepts were first published in 2015. There are now 44 Key Concepts compared to the original 32; the concepts have been reorganised from six to three groups; we have added higher-level concepts in each of those groups; we have added short titles; and we have made changes to many of the concepts. Conclusions: The IHC Key Concepts have proven useful in designing learning resources, evaluating them, and organising them. We will continue to revise the IHC Key Concepts in response to feedback. We welcome suggestions for how to do this.


Background
You cannot make informed decisions without information. For decisions about actions to improve or maintain the health of individuals or communities ('treatments') to be well-informed and not misinformed, you need reliable information about the effects of treatments. Unfortunately, we are bombarded with claims about the benefits and harms of treatments, many of which are not reliable. Therefore people need to learn how to distinguish reliable from unreliable claims.
Unreliable claims about the benefits and harms of treatments are made in the mass media and social media, as well as in personal communications with family, friends, quacks, and health professionals [1][2][3][4][5][6][7][8][9][10] . They are made by governments, celebrities, journalists, advertisers, researchers, gurus, aunts, and uncles. They include claims about medicines, surgery and other types of "modern medicine"; lifestyle changes, such as changes in what you eat or how you exercise; herbal remedies and other types of "traditional" or "alternative medicine"; public health and environmental interventions; and changes in how healthcare is financed, delivered, and governed.
Many, if not most people are unable to assess the reliability of these claims. For example, in a survey of a random sample of Norwegian adults, we found that less than 20% of respondents recognized that lung cancer can be associated with drinking alcohol but not necessarily caused by it 11 . This mirrors misleading claims that are commonly made in the media. For instance, stories about coffee frequently use language suggesting that cause and effect has been established, such as "coffee can kill you", when reporting on associations that have been found between drinking coffee and various health outcomes 12 . Personal experiences (anecdotes) are often used as a basis for treatment claims, and people are more likely to trust anecdotes than research. For example, surveys in the UK have shown that only about one third (37%) of the public trust evidence from medical research, while about two thirds (65%) trust the experiences of friends and family 13 . In addition, anecdotes often exaggerate the alleged benefits of treatments (for cancer, for example) and ignore or downplay harms 14 . At the same time, people in need or desperation hope that treatments will work and ignore potential harms.
Consequences of people's inability to assess the reliability of treatment claims include overuse of ineffective and sometimes harmful treatments and underuse of effective treatments, both of which result in unnecessary suffering and waste 15,16 . For example, billions of dollars are wasted on alternative medicine and nutritional supplements for which there is no reliable evidence of benefits 17,18 . At the same time, millions of children die unnecessarily, in part because their parents do not seek and use effective treatments that are available to them 19,20 , and they don't trust reliable claims about effective preventive treatments such as effective vaccines 21 .
To address this problem, the Informed Health Choices (IHC) group is developing and evaluating resources to help people learn how to assess the trustworthiness of treatment claims and make well-informed decisions about treatments 22,23 . The first step in this work was to identify the key concepts that people need to understand and apply to do this 24,25 . We refer to these as the IHC Key Concepts. We review and update this list of concepts yearly. In this article we report the changes that we have made to the IHC Key Concepts since they were first published 24 and present the most recent (2018) version.

Methods
The IHC Key Concepts are standards for judgment, or principles for evaluating the trustworthiness of treatment claims and treatment comparisons (research) used to support claims, and for making treatment choices. The list is intended to be relevant to people everywhere and to any type of treatment. Many of the concepts can be learned and used successfully by primary school children 22,26,27 . Although we have developed and framed the Key Concepts to address treatment claims, people in other fields have also found them relevant. Work to adapt these concepts to apply to interventions in other fields is ongoing, including agricultural, economic, educational, environmental, international development, management, nutrition, policing, social welfare, and veterinary interventions.
The IHC Key Concepts are a starting point for developing learning resources to help people make judgements about the trustworthiness of claims about the effects of treatments (and other interventions), and to make well-informed decisions about treatments. They are also the basis for a database of multiplechoice questions that can be used to assess people's abilities to assess treatment claims and make treatment choices 28 . We have written the concepts and explanations in plain language. However, some of them may be unfamiliar and difficult to understand. The Key Concepts list is not intended to be a learning resource. It is a framework that can be used by teachers and others to identify and develop learning resources.
To develop the IHC Key Concepts, we first extracted all of the concepts addressed in Testing Treatments 29 , a book that was written to promote more critical public assessment of claims about the effects of treatments. We then searched the literature for other relevant material, including books and checklists for the public, journalists, and health professionals 24 . We also considered concepts related to making judgements about the certainty of evidence of the effects of treatments 30 .
Our aim has been to include all concepts that are important for people to consider. At the same time, we have tried to minimise redundancy. We have organised the concepts in a way that we believe is logical, and we have sought feedback on this logic. The concepts are not organised based on how complex or difficult they are to understand and apply, or in the order in which they should be taught.

Amendments from Version 1
In response to a comment by Catherine Mathews, we have edited the conclusion of the Abstract. In response to David Colquhoun's comment, we have deleted the suggestion that p-values "indicate the probability of something having occurred by chance" from Table 2.

REVISED
We have collected structured written feedback on the Key Concepts using a form with four questions (Box 1). We initially obtained feedback from 29 members of an international advisory group 24 . We have subsequently obtained responses to these questions at three workshops: In 2016 53 , we added two new concepts and reorganised the concepts into three groups. The two new concepts were: • Unpublished results of fair comparisons may result in biased estimates of treatment effects.
• A lack of evidence is not the same as evidence of "no difference".
The decision to reorganise the concepts into three groups grew out of our efforts to simplify the concepts and teach them to primary school children. The suggestion to use three groups -claims, comparisons, and choices -came from Matt Oxman, who had primary responsibility for writing the text for The Health Choices Book for primary school children 54 . The book, which has been shown to be an effective learning resource in a randomised trial with over 10,000 children in Uganda, is a story in comic book format which introduces and explains 12 Key Concepts.
In 2017 55 , we added short titles for all the concepts and two new concepts: • Peer-reviewed and published treatment comparisons may not be fair comparisons. In the 2018 version (Supplementary File 1), we merged two Key Concepts and added nine new concepts. We reorganised the concepts within each of the three main groups and added three subgroups to each of the three main groups of concepts.
We also replaced all of the short titles and introduced emojis.
We removed the concept that "hope or fear can lead to unrealistic expectations about the effects of treatments" and incorporated this in the explanation of the concept "treatments may be harmful". The explanation begins with "People often exaggerate the benefits of treatments and ignore or downplay potential harms." We added: "Similarly, people in need or desperation hope that treatments will work and ignore potential harms." The nine new concepts were: • We can rarely, if ever, be 100% certain about the effects of treatments.
• People often recover from illness without treatment.
• More data is not necessarily better data, whatever the source.
• It is rarely possible to know in advance who will benefit, who will not, and who will be harmed by using a treatment.
• Indirect comparisons of treatments can be misleading.
• Outcomes should be assessed reliably in treatment comparisons.
• Treatment comparisons may be sensitive to assumptions that are made.
• Verbal descriptions of treatment effects can be misleading.
• The problem and the treatment options being considered may not be the right ones.
We introduced three higher level concepts within each of the three groups of Key Concepts and reframed the titles of the three groups as shown in Box 2.

Box 2. Higher-level concepts used to reorganise the Informed Health Choices (IHC) Key Concepts in 2018
1. Beware of treatment claims like these 1.1 Beware of claims that are too good to be true. We did this in response to feedback that the organisation of concepts within the three main groups was not logical, and that having long lists of concepts was overwhelming. The subgroups of concepts, using these higher-level concepts, provides a more transparent logic for how the concepts are organised in each main group. Having just three higher level concepts for each group may also make it easier to get the gist of the concepts and make the list less overwhelming and easier to remember.
There were three reasons for changing the short titles used for each of the Key concepts. First, we had received feedback that the short titles were not consistent with some of the concepts and that some were not short; and it was difficult to come up with a short, catchy title that accurately reflected each concept. Second, we wanted short titles that were consistent with the new organisation of the concepts. Third, short titles that we were developing for posters and a website targeted at school children seemed to be a solution to this problem. We added emojis to make the poster and website that we are developing more appealing. When presenting these to colleagues and others, the emojis appeared to appeal across age groups and to reflect the content accurately, which also may help to convey the gist of the concepts. The full list of short titles for the Key Concepts and the emojis are shown in Box 3.

Other changes made to the IHC Key Concepts
In addition to adding 13 new Key Concepts and removing one since the first version was published in 2015, and reorganising the concepts, we have modified several of them. Most of these changes have been in response to suggestions to add new concepts when we concluded that it made more sense to incorporate the suggestion in an existing concept. These changes are summarised in Table 1.
Suggestions that have been made when we concluded no change was needed In addition to feedback from three workshops over the past two years, we have received 61 suggestions for revisions over the past three years. For many of these we concluded that no change was needed. Several suggestions were similar. We summarise these suggestions and our reasons for not making any changes in Table 2.

Beware of treatment claims like these
We hear claims about the effects of treatments all the time. Many of these are not trustworthy. When you hear someone use one of these reasons to support a claim about the effects of a treatment, you should beware and ask where the evidence is.

1.3)
Beware of claims based on trust alone. a) "As advertised!" b) "It worked for me!" c) "Recommended by experts!" d) "Peer reviewed!"

Check the evidence from treatment comparisons
A treatment has to be compared to something else to know what would happen without the treatment. For treatment comparisons to be FAIR, the only important difference between comparison groups should be the treatments they receive. Unfair treatment comparisons and unsystematic summaries of treatment comparisons can be misleading. The way that treatment effects are described can also be misleading.

Make well-informed treatment choices
Deciding what to do requires judgements about the relevance of the evidence, how important the good and bad outcomes are to you, and how sure you can be about the treatment effects.  We added this to the explanation: And even if there is plausible evidence that a treatment works in ways likely to be beneficial, the size of any such treatment effect, and its safety, cannot be predicted. For example, most drugs in a class of heart medicines called beta-blockers have beneficial effects in reducing recurrence of heart attacks; but one of the drugs in the class -practolol -caused unpredicted serious complications in patients' eyes and abdomens.

Replication
The results of single comparisons of treatments can be misleading We clarified that this is addressed by adding "replications" to the explanation: Systematic reviews of these other comparisons (replications) may yield different results from those based on the initial studies, and these should help to provide more reliable and precise estimates of treatment differences.
Technology is always better. New, brand-named, technologically impressive, or more expensive treatments may not be better than available alternatives We added "technologically impressive" to the concept that new is not necessarily better.

Disease mongering Earlier detection of 'disease' is not necessarily better
We put 'disease' in quotes. We also added "statistical risk of disease" to the explanation: People often assume that early detection of disease and 'treating' people who are at statistical risk of disease lead to better outcomes.
Regression to the mean Personal experiences or anecdotes (stories) are an unreliable basis for assessing the effects of most treatments We added the following to the explanation: One reason that personal experiences -including a series of personal experiences -are sometimes misleading is that experiences, such as pain, fluctuate and tend to return to a more normal or average level. This is sometimes referred to as "regression to the mean". For example, people often treat symptoms such as pain when they are very bad and would improve anyway without treatment. The same applies to a series of experiences. For example, if there is a spike in the number of traffic crashes someplace, traffic lights may be installed to reduce these. A subsequent reduction may give the appearance that the traffic lights caused this change. However, it is possible that the number of crashes would have returned to a more normal level without the traffic lights.
Common lay opinion is also not always right.
Opinions of experts or authorities do not alone provide a reliable basis for judging the benefits and harms of treatments We added "like anyone else" to the explanation: Doctors, researchers, and patients -like anyone else -often disagree about the effects of treatments.
We can be misled by liking the expert or person who says something.
Opinions of experts or authorities do not alone provide a reliable basis for judging the benefits and harms of treatments We addressed this suggestion in the explanation for this concept: Who makes a treatment claim, how likable they are, or how much experience and expertise they have are not a reliable basis for assessing how reliable their claim is.

Key Concept that was modified Change that was made
Just because evidence is widely or easily accessible does not mean that it is trustworthy.
Peer-reviewed and published treatment comparisons may not be fair comparisons We added this to the explanation: Similarly, just because a study is widely publicised does not mean that it is trustworthy.
Include nocebo effect If possible, people should not know which of the treatments being compared they are receiving We added this to the explanation: People in a treatment group may also experience harms (for example, more pain) because of their expectations (this is called a nocebo effect). And we added 'or worse' here: If individuals know that they are receiving a treatment that they believe is better or worse . . .

Contamination
People's outcomes should be counted in the group to which they were allocated We added the following to the explanation: We added the following to the explanation for the first concept: To avoid these problems, systematic reviews of fair comparisons begin with protocols, which should be registered and searchable in registries such as Prospero.
And we added the following to the explanation for the second concept: Selective reporting is an important reason why fair comparisons of treatments should have protocols that are registered and searchable in registries such as clinicaltrials.gov.
Short-term effects may not reflect longterm effects.
A systematic review of fair comparisons of treatments should report outcomes that are important We added "short and long-term" to the first sentence of the explanation: A fair comparison may not include all outcomes -short and longterm -that are important to you. And we added this to the end of the explanation: Similarly, short-term effects may not reflect long-term effects.
Patient preference Decisions about treatments should not be based on considering only their benefits We added this to the explanation: The balance also depends on how much people value (how much weight they give to) the treatment advantages and disadvantages. Different people may value outcomes differently and sometimes make different decisions because of this.
The word 'unlike' is confusing. 'Dissimilar' would make more sense.

Don't be misled by unfair comparisons
We had changed 'dissimilar' to 'unlike' because we thought that unlike is more likely to be understood by most English speakers, including children. It is also consistent with the idea of 'comparing like with like'. However, based on the feedback we received, we changed unlike back to dissimilar. Other criteria that are used to assess health information -for example, readability -are outside the scope of the IHC Key Concepts.

Related IHC Key Concepts Reason for not making a change
Quality of systematic reviews Reviews of treatment comparisons that do not use systematic methods can be misleading

This suggestion is addressed by this concept
It may be helpful to specify than advantages/ disadvantages may be different between patients, clinicians and policy makers.
Decisions about treatments should not be based on considering only their benefits We have made clear in all of the concepts in the third group that the focus is on judgements made from 'your' perspective in the new short titles and the explanations. Although we have not specified that policymakers may have different perspectives than individual patients, this is implicit and can be included in learning-resources when this is relevant.
Systematic reviews currently described as a threshold of reliability but this isn't the casemany systematic reviews are not reliable and many other types of evidence can be reliable or better than nothing in certain contexts.
The results of single comparisons of treatments can be misleading

Don't be misled by unfair comparisons
Reviews of treatment comparisons that do not use systematic methods can be misleading Systematic reviews are not described as a threshold; they are described as the starting point for making judgements about the certainty of the evidence. These concepts explain why systematic reviews are needed and the need to assess the trustworthiness of treatment comparisons. They do not suggest that nothing is necessarily better than a single study, when that is the only evidence that is readily available.
Clear questions are necessary for fair comparisons.
The problem and the treatment options being considered may not be the right ones This suggestion is relevant for researchers, not for people using research. We added the parallel concept that is relevant for people making decisions to the third group of concepts.
Treatments should be provided by someone with the necessary skills.

The treatments evaluated in fair comparisons may not be relevant or applicable
This suggestion is addressed by this concept.
Beware of manipulative use of language and pictures.
Verbal descriptions of treatment effects can be misleading We incorporated this suggestion in the explanation for this new concept.
Having started and invested in a treatment doesn't mean that it works and you should keep taking it.
Treatments may be harmful This suggestion is similar to the concept that hope or fear can lead to unrealistic expectations about the effects of treatments, and does not warrant a separate concept. The concept about hope is now incorporated in the explanation for the concept that people often exaggerate the benefits of treatments and ignore or downplay potential harms.

Don't be distracted by irrelevant information. Verbal descriptions of treatment effects can be misleading
This suggestion is addressed by this new concept, which we have added.
Was the recommendation made by a group with an appropriate mix of skills and perspectives?
This suggestion is outside the scope of the IHC Key Concepts.

Related IHC Key Concepts Reason for not making a change
There should be something about the difference between slow and fast thinking. This is not a concept. It is addressed as a competence -Recognise when to go from quick to slow thinking about treatment claims -and as a disposition -Go from fast to slow thinking before forming an opinion about a treatment claim, making a claim, or taking a decision Not all treatments always feel comfortable. A systematic review of fair comparisons of treatments should report outcomes that are important This suggestion is addressed in the explanation for this concept Uncertain about 'personalised medicine' as a claim, having never come across this It is rarely possible to know in advance who will benefit, who will not, and who will be harmed by using a treatment Claims about personalised medicine are widespread. And the concept that it is rarely possible to know who will benefit, who will not, and who will be harmed by a treatment is fundamental.
The ability to recognise or challenge claims that come from sources that are considered reliable We added this as a competence: Communicate with others about the advantages and disadvantages of treatments Be critical of the source of the claim. Beware of claims based on trust alone This is addressed by these concepts.
Some of these are true.
Beware of claims that seem too good to be true We do not say that they are never true.
Unfair to compare interventions that are apples and oranges or chalk and cheese; e.g. by combining them in a meta-analysis Unfair comparisons This is implicitly a consideration for 'Unsystematic summaries' and could be added explicitly to the explanation. However, it is one of many considerations that could be added as concepts under 'unreliable summaries of comparisons'. It is outside of the scope of the IHC Key Concepts to go into that level of detail and we do not see a compelling argument for adding this specific consideration and not others that could be included in a checklist for assessing the reliability of a systematic review.
and we have made changes to many of the concepts. We will continue to revise the IHC Key Concepts in response to feedback. Although we and others have found the concepts helpful since they were first published 24 , we anticipate that there will still be ways in which they can be further improved. We welcome suggestions on ways of doing this.
The most common misunderstanding in the feedback we have received is that the Key Concepts list is a learning resource intended for people with no relevant research background. As noted in the Methods section, the list of Key Concepts serves as the basis for developing learning resources. It is not designed as a learning resource. It is a framework, or starting point, for identifying and developing learning resources.
Another common misunderstanding is that the Key Concepts are organised in the order in which they should be taught or learned. We have organised the Key Concepts logically by grouping them first in three groups and then within those three groups using higher-level concepts (Box 2). This logic does not reflect the difficulty of the concepts or the order in which they should be learned.
When teaching the concepts, it may make sense to start with ones in the first group, followed by ones in the second group, followed by ones in the third group. However, it does not necessarily make sense to teach them in that order or in the order that they are organised within each group. For example, at least 24 of the Key Concepts can be understood and applied by primary school children 31 , whereas other concepts are likely too difficult for primary school children to understand and use. Thus, it would obviously make sense to hop over those concepts when teaching primary school children.
Also, it is important not to try to teach or learn too much at one time. We initially tried teaching 24 Key Concepts to primary school children in one go, and found that was too much to teach in a single school term 31 . Our efforts to teach IHC Key Concepts to both primary school children and their parents support our initial hypothesis that the time to start learning these concepts is in primary school -if not even younger 59 . Ideally, these concepts should be taught and learned using a spiral curriculum 60 In addition to continuing to seek and review feedback and suggestions, we will further develop the Key Concepts by continuing to learn from using the IHC Key Concepts, other relevant frameworks, and adaptation of the IHC Key Concepts to other types of interventions. We also plan to summarise the evidence supporting each of the Key Concepts.

Conclusions
The IHC Key Concepts have proven useful in designing learning resources, evaluating them, and organising them 25  2. Our concern about the IHC concepts is the generally negative tone. The framing language is always skeptical and to a degree this is understandable and hard to avoid. We are inundated with claims daily and cannot start from a position of equipoise in judging and acting upon those that are relevant to us. The book 'Testing Treatments' documents some of the most important advances in medical science, including vaccination, treatment of heart disease, treatment of HIV and some cancers. As the journalist Nick Ross said in a foreword to the first edition of the book "it warmly admires much of what modern medicine has achieved. Its ambitions are always to improve medical practice, not disparage it." The IHC concept list as a stand alone document lacks this balance. The underlying tone could be interpreted (wrongly) as 'nothing works' and 'be suspicious of all medical claims'. We believe the authors should look for opportunities to use positive framing for some concepts. The preamble to the list should acknowledge the massive progress made by modern medicine and public health, including large reductions in all-cause and some cause-specific mortality rates over the last 50 years. Much of this progress has been made in small increments that individually might not have seemed compelling, but in summation have been dramatic. In our view the main targets of the IHC concepts should be claims that are intentionally misleading, often made by those with vested interests. There are plenty to deal with. more rigorous. We are unaware of any evidence suggesting that any of those methods would result in a better framework -however one chooses to define 'better'. None of the frameworks that we have reviewed so far have been formally evaluated. Some possible criteria for assessing how sensible a framework is are listed in Box 1. Those are questions that we put to our advisory group (as reported in our first report of the Key Concepts), and that we have continued to ask others, as reported in this article. For the most part, we have received positive feedback in response to those questions. However, we have received many suggestions for improvements, as reported in this article, and the framework has continued to improve. We could assess more rigorously than we have done up to now the extent to which the Key Concepts are sensible, and we will consider doing this in future. Something else that we plan to do more rigorously in future (as noted in the Discussion section) is to systematically summarise the evidence supporting each of the concepts.
2. Is the overall tone too negative? Can healthy skepticism turn into cynicism?
We share this implied concern about the second group of concepts and we will likely reframe at least some of those in the next update. However, we believe the first group of concepts must be framed negatively. The last group of concepts are framed as questions. This same concern came up at a meeting in December at which people from different disciplines discussed the applicability of the IHC Key Concepts to interventions beyond those in health care. This included agricultural, economic, educational, environmental, development, health, informal learning, management, nutritional, planetary health, policing, social welfare, speech and language, and veterinary interventions. We arrived at a list of concepts that participants agreed are relevant to a wide range of interventions. We must reiterate, however, that the Key Concepts by themselves are not a learning resource. We believe that teachers and those developing teaching/learning resources must be aware of this concern, regardless of how the Key Concepts are framed, and that they must be careful to encourage their students to be healthy sceptics without being nihilists.
No competing interests were disclosed.

Richard Lehman
Institute of Applied Health Sciences, University of Birmingham, Birmingham, UK This description of the development of Key Concepts is clear and comprehensive. It is a real pleasure to read such strong and well-chosen English in a biomedical paper. The authors' sensitivity to language and meaning is also clear from the thoughtful way they have handled suggestions for changes in the wording of Key Concepts themselves.
I have no suggestions for changes in the text. The concepts themselves are of permanent value and their authors have given the world a model of openness and rigour. It would be good to hear about their dissemination plan as clearly they have been successful in many ways but deserve to reach the widest audience possible.

Is the work clearly and accurately presented and does it cite the current literature?
Yes