Table 1. Overview of the IHC Key Concepts.
1. Claims
Claims about effects that are not supported by evidence from fair comparisons are not necessarily wrong, but there is an insufficient basis for believing them. |
2. Comparisons
Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance). |
3. Choices
What to do depends on judgements about a problem, the relevance of the evidence available, and the balance of expected benefits, harms, and costs. |
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1.1 It should not be assumed that treatments are
safe or effective - or that they are not. a) Treatments can cause harms as well as benefits. b) Large, dramatic effects are rare. c) It is rarely possible to be certain about the effects of treatments. 1.2 Seemingly logical assumptions are not a sufficient basis for claims. a) Treatment may not be needed. b) Beliefs alone about how treatments work are not reliable predictors of the presence or size of effects. c) Assumptions that fair comparisons of treatments in research are not applicable in practice can be misleading. d) An outcome may be associated with a treatment but not caused by it. e) More data is not necessarily better data. f) Identifying effects of treatments depends on making comparisons. g) The results of one study considered in isolation can be misleading. h) Widely used treatments or those that have been used for decades are not necessarily beneficial or safe. i) Treatments that are new or technologically impressive may not be better than available alternatives. j) Increasing the amount of a treatment does not necessarily increase its benefits and may cause harm. k) Earlier detection of ‘disease’ is not necessarily better. l) It is rarely possible to know in advance who will benefit, who will not, and who will be harmed by using a treatment. 1.3 Trust in a source alone is not a sufficient basis for believing a claim. a) Your existing beliefs may be wrong. b) Competing interests may result in misleading claims. c) Personal experiences or anecdotes alone are an unreliable basis for most claims. d) Opinions alone are not a reliable basis for claims. e) Peer review and publication by a journal do not guarantee that comparisons have been fair. |
2.1 Comparisons of treatments should be fair.
a) Comparison groups should be as similar as possible. b) Indirect comparisons of treatments across different studies can be misleading. c) The people being compared should be cared for similarly apart from the treatments being studied. d) If possible, people should not know which of the treatments being compared they are receiving. e) Outcomes should be assessed in the same way in all the groups being compared. f) Outcomes should be assessed using methods that have been shown to be reliable. g) It is important to assess outcomes in all (or nearly all) the people in a study. h) People’s outcomes should be counted in the group to which they were allocated . 2.2 Syntheses of studies need to be reliable. a) Reviews of studies comparing treatments should use systematic methods. b) Failure to consider unpublished results of fair comparisons may result in estimates of effects that are misleading. c) Treatment claims based on models may be sensitive to underlying assumptions. 2.3 Descriptions should clearly reflect the size of effects and the risk of being misled by the play of chance. a) Verbal descriptions of the size of effects alone can be misleading. b) Relative effects of treatments alone can be misleading. c) Average differences between treatments can be misleading. d) Small studies may be misleading. e) Results for a selected group of people within a study can be misleading. f) The use of p-values may be misleading; confidence intervals are more informative. g) Deeming results to be “statistically significant” or “nonsignificant” can be misleading. h) Lack of evidence of a difference is not the same as evidence of “no difference”. |
3.1 Problems and options should
be clear. a) Be clear about what the problem or goal is and what the options are. 3.2 Evidence should be relevant. a) Attention should focus on all important effects of treatments, and not surrogate outcomes. b) Fair comparisons of treatments in animals or highly selected groups of people may not be relevant. c) The treatments compared should be similar to those of interest. d) There should not be important differences between the circumstances in which the treatments were compared and those of interest. 3.3 Expected advantages should outweigh expected disadvantages. a) Weigh the benefits and savings against the harms and costs of acting or not. b) Consider the baseline risk or the severity of the symptoms when estimating the size of expected effects. c) Consider how important each advantage and disadvantage is when weighing the pros and cons. d) Consider how certain you can be about each advantage and disadvantage. e) Important uncertainties about the effects of treatments should be addressed in further fair comparisons. |