Appropriateness criteria

The categorisation of a certain practice as inappropriate requires a reliable definition of when it is appropriate (33). The definition is provided by the best evidence available, as indicated in the definitions of appropriateness set out above. The best available evidence comes from valid scientific studies that can demonstrate the efficacy and safety of a particular benefit. Systematic reviews of randomised clinical trials, and well-designed randomised clinical trials themselves are the most reliable source, because they assess the efficacy of the intervention against a control group, minimising the risk of bias (34).

However, clinical trials may have some limitations on their capacity to reflect the effectiveness of a given intervention in routine clinical practice, including highly selected groups of subjects, not measuring relevant outcomes for patients or society (35), and publication bias of negative results on the efficacy and safety of health interventions (36).

Good quality systematic reviews are hierarchically superior to clinical trials as a source of evidence as they may indicate some of the limitations of individual studies (37).

Systematic reviews achieve this by analysing and contrasting a set of individual studies, rating their methodological quality, and, in the case of those reviews that include a meta-analysis, surpassing the statistical power of individual studies through the combination of the numerical results from several studies (38). Cochrane systematic reviews are widely recognised for their methodological rigor and for

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incorporating the analysis of the effects of health interventions through relevant outcomes for patients using the GRADE system (39).

A common source for the scientific evidence widely used by health professionals are clinical practice guidelines. These documents are useful for decision-making because they provide clinical recommendations on which interventions are the most appropriate according to the characteristics of the patient (40). In evidence based guidelines the clinical recommendations are built based on scientific studies, considering the benefits and risks of health interventions, either for the screening, diagnosis or treatment of a certain health problem (41).

In the 1980s, the RAND Corporation developed the Appropriateness Method®. This method defines a set of criteria establishing the circumstances in which a certain practice is more or less appropriate (3). They are based mostly on expert consensus, after a literature review.

In the Appropriateness Method®, first, an exhaustive review of the literature is carried out, synthesising the most recent evidence on the intervention in question (diagnostic test, treatment, etc.). Simultaneously, a list of specific clinical scenarios or indications is defined, indicating which patients could receive the intervention in terms of their symptoms, history and the results of preliminary relevant diagnostic tests. Both the synthesis of the evidence and the list of indications are sent to a panel of experts. For each indication, each expert assesses the benefits and risks of the intervention using a scale from 1 to 9, where 1 means that the expected damages outweigh the expected benefits, and 9 means that the expected benefits exceed the expected damages. This process is repeated in two rounds, one at the individual level and the other in a plenary of the panel of experts (3,42).

Table 1 shows an example of the appropriateness criteria proposed by the American College of Radiology for diagnostic imaging in hip dysplasia in children, applying the Appropriateness Method® (43). In this example, six different clinical variants are considered, depending on the age of the child and the findings of the initial physical examination. Following the method, it is defined that ultrasound or hip radiography are considered inappropriate in children younger than 4 weeks of age with suspected

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dysplasia or risk factors. Between 4 weeks and 4 months of age, an ultrasound would be appropriate. Radiography, on the other hand, would be appropriate between 4 and 6 months of age.

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Table 1. American College of Radiology ACR Appropriateness Criteria® for diagnostic images (ultrasound, radiography, tomography, and magnetic resonance imaging of the pelvis) on developmental dysplasia of the hip in child (six clinical variants).

Variant Procedure Appropriateness Category Relative Radiation

Level 1

Child, younger than 4 weeks of age. Equivocal physical examination or risk factors for DDH. Initial imaging

US hips Usually Not Appropriate O

Radiography pelvis Usually Not Appropriate ☢☢

2

Child, between 4 weeks to 4 months of age.

Equivocal physical examination or risk factors for DDH. Initial imaging

US hips Usually Appropriate O

Radiography pelvis Usually Not Appropriate ☢☢

3 Child, younger than 4 months of age. Physical findings of DDH. Initial imaging

US hips Usually Appropriate O

Radiography pelvis Usually Not Appropriate ☢☢

4 Child, between 4 to 6 months of age. Concern for DDH. Initial imaging

Radiography pelvis Usually Appropriate ☢☢

US hips May Be Appropriate O

5 Child, older than 6 months of age. Concern for DDH.

Initial imaging

Radiography pelvis Usually Appropriate ☢☢

US hips Usually Not Appropriate O

6

Child, younger than 6 months of age. Known

diagnosis of DDH, nonoperative surveillance imaging in harness.

US hips Usually Appropriate O

Radiography pelvis Usually Not Appropriate ☢☢

CT pelvis with IV contrast Usually Not Appropriate ☢☢☢☢

CT pelvis without and with IV

contrast Usually Not Appropriate ☢☢☢☢

CT pelvis without IV contrast Usually Not Appropriate ☢☢☢☢

MRI pelvis without and with IV

contrast Usually Not Appropriate O

MRI pelvis without IV contrast Usually Not Appropriate O Based on ACR Appropriateness Criteria® Developmental Dysplasia of the Hip-Child (43). US: ultrasound; CT: computed tomography

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As is shown in this example, the appropriateness of a certain intervention depends on the context and characteristics of the patient (19). A given diagnostic test or treatment may be effective in one patient, but ineffective in another. The need for detailed information may be a limitation for establishing and quantifying the appropriateness of clinical practice (18).

Unlike clinical practice guidelines, the appropriateness criteria based on the RAND method are documents with a much narrower scope, since they focus on the indications of a certain intervention. Furthermore, they do not start from clinical questions as clinical guidelines, the evaluation rounds are not intended to reach an expert consensus, they do not always consider cost-effectiveness, and they do not involve patients in the process or prioritise their values and preferences.