ORIGINAL ARTICLE

Clinical Imaging Guidelines Part 1: A Proposal for Uniform Methodology Denis Remedios, MA, MB.BS, MRCP a, James Brink, MDb, Ola Holmberg, PhDc, Michael Kawooya, MBChB, M.Med (Rad), PhDd, Richard Mendelsone, Anusha Naidoo, BHB, MBChB f, Martin Reed, MD g, Michael Bettmann, MDh, on Behalf of Members of the IAEA Technical Meetings on Radiation Protection of Patients Through the Development of Appropriateness Criteria in Diagnostic Imaging Abstract Inappropriate imaging can lead to unnecessary medical radiologic exposures and cost and may not answer the clinical question. Imaging referral guidelines inform the justification of radiologic procedures and facilitate the choice of the best test first, but their acceptance by referrers, use, and value may be limited by shortcomings in the methodology of development. Focusing on common, essential elements of methodology will help guideline developers. In 2012 and 2013, the International Atomic Energy Agency hosted Technical Meetings on Radiation Protection of Patients Through the Development of Appropriateness Criteria in Diagnostic Imaging. Participants identified and agreed on issues concerning development of imaging referral guidelines. Items based on the Appraisal of Guidelines for Research and Evaluation II instrument were amended with additional items including development and consensus group composition. Consensus was sought on 28 items, 18 of which were agreed should be uniform, and 10 should allow for regional differences. Further work is required to encourage, provide, and identify higher quality evidence and to agree on a grading system for recommendations. Many key areas are common to guideline developers globally, opening the way for international collaboration to help demystify, simplify, and justify. Key Words: Imaging, guidelines, justification, appropriateness J Am Coll Radiol 2015;12:45-50. Copyright  2015 American College of Radiology

INTRODUCTION It is widely acknowledged that there is inappropriate imaging in clinical care [1]. This is of concern to radiologists, to referring clinical health care providers, and to patients, as well as to regulatory bodies. Particular concerns are efficacy, cost, and radiation exposure. Guidance to change referral practice and behavior is most likely to be successful if it comes from professional medical groups, representing those who perform a

Department of Clinical Radiology, Northwick Park Hospital, Harrow, United Kingdom. b Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts. c Radiation Protection of Patients Unit, Division of Radiation, Transport and Waste Safety, International Atomic Energy Agency, Vienna, Austria. d Department of Radiology, Ernest Cook Ultrasound Research and Education Institute, Mengo Hospital, Kampala, Uganda. e Department of Radiology, Royal Perth Hospital, Perth, Australia. f Future Medical Imaging Group, Melbourne, Australia. g Department of Diagnostic Imaging, Winnipeg Children’s Hospital, Winnipeg, Manitoba, Canada. h Department of Radiology, Wake Forest University, North Carolina. Corresponding author and reprints: Denis Remedios, Department of Clinical Radiology, Northwick Park Hospital, Harrow HA1 3UJ, UK; e-mail: [email protected].

ª 2015 American College of Radiology 1546-1440/14/$36.00 n http://dx.doi.org/10.1016/j.jacr.2014.07.023

as well as request imaging. Several different organizations, including the ACR [2], the UK Royal College of Radiologists [3], the Canadian Association of Radiologists, and the Health Department of Western Australia [4], currently produce and disseminate imaging referral guidelines. All such efforts share the goal of increasing the percentage of cases in which imaging is appropriately used in medical care, as supported by highquality clinical guidelines. National society and college representatives with guidelines experience from 6 global regions met in Vienna, Austria, in 2012 and 2013 for the Technical Meetings on Radiation Protection of Patients Through the Development of Appropriateness Criteria in Diagnostic Imaging, hosted by the International Atomic Energy Agency, with the involvement of the World Health Organization in 2013.The aim of these meetings was to promote improved appropriateness of imaging and to reduce unnecessary, unhelpful medical exposures through the analysis, definition, and dissemination of a harmonized methodology for the development of imaging appropriateness, among other elements. Clinical practice guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical

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circumstances [5]. Guidelines can play an important role in health policy formation [6,7] and may influence the planning of diagnostic and therapeutic services. The Guidelines International Network has determined minimum standards for high-quality guidelines [8]. Criteria for guidelines assessment have been set out by the Appraisal of Guidelines for Research and Evaluation (AGREE) organization [9] for more than 20 years. Notable agencies such as the World Health Organization [10] and the National Institute for Health and Clinical Excellence [11] use such criteria for the assessment of global or national guidelines to ensure quality. The Royal College of Radiology’s iRefer: Making the Best Use of Clinical Radiology [3] and Western Australia Diagnostic Imaging Pathways [4] have been retrospectively assessed as satisfactorily using the AGREE instrument [12,13]. To ensure the quality of imaging referral guidelines, a prospective application of AGREE criteria, among others, would be advantageous. The opportunity was taken to identify common components of imaging referral guideline methodology on the basis of AGREE criteria to facilitate and hasten the process of imaging guideline development globally.

DISCUSSION Notable areas of uniformity in guideline methodology include the involvement of patient-group representatives, editorial independence, and transparency of funding mechanisms to promote stakeholder buy-in. Participants were clear that allowances should be made for limitations of expertise, equipment, and prevalence of disease, which is needed to allow for global variation and also national variation within some regions. Acceptance of different techniques was felt appropriate for regional and cultural differences, including methods of distribution and tools for facilitation (eg, clinical decision support systems); monitoring processes (eg, clinical audit); format, allowing both web and paper versions, particularly for regions where web access is limited; and layout, for which tabular and flowchart algorithms are in common use, with their own advantages. Barriers to implementation (and their solutions) may be similar, but there are likely to be national and cultural differences. Important areas for further work include the following: n n

METHODS The 23 items of the AGREE II instrument [9] (arranged in 6 domains: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence), together with 5 additional general principles for guidelines (see Appendix [14-17]), were used to form the 28 items of guideline methodology for consideration. Consensus was obtained through a meeting of experts from different backgrounds, countries, and health care settings. All were actively involved in guideline development. Initial consensus was obtained from 4 experts from different global regions: Africa, the Americas, the Western Pacific, and Europe. Consensus for each item was deemed present when there was agreement by 3 of these 4 experts. Consensus was sought for each item to accept either a single criterion or limited different criteria that would be needed to allow for geographic and cultural variations globally. Initial consensus was refined by discussion with the larger group of participants at both of the two technical meetings, at which additional information was used to inform consensus. Representation was present from all 6 global regions, including Southeast Asia and the Eastern Mediterranean.

RESULTS The items for agreement and consensus reached are shown in Appendix. Of the 28 items, 18 reached consensus for uniformity. For 10 items, there was agreement that reasonable differences among regions and countries should be accepted. 46

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Identifying supporting global evidence for guidance, needed by all guidelines developers. Encouraging researchers to produce high-quality imaging evidence, particularly for patient outcomes or therapeutic impact [18]. An agreed grading system for recommendations from imaging referral guidelines, acceptable to referrers and radiologists.

A global, shared, regularly updated repository for evidence would facilitate the identification of supporting evidence. Inclusion of evidence levels in imaging literature abstracts or key words would help identify higher quality evidence, as well as encourage researchers to plan better studies, and may be of advantage to journals advocating such practice. This practice is established in some clinical journals [19]. In addition, national and international professional societies could provide impetus by encouraging the presentation of new supporting evidence at scientific meetings. Stakeholders from all global regions have lent their support to this framework for guideline methodology and for suggested initiatives. The value of imaging referral guidelines for reducing inappropriate imaging is undisputed. The need is to make such guidance acceptable, available, and affordable to the end user. Much work has been done in reaching consensus on a structured guideline methodology, but further work is required to encourage, provide, and identify higher quality evidence and to agree on a grading system for recommendations. We believe that the proposed framework for methodology will help provide a sound basis for imaging referral guidance that may be developed, adopted, or adapted worldwide and will help demystify, simplify, and justify. Journal of the American College of Radiology Volume 12 n Number 1 n January 2015

TAKE-HOME POINTS n n

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Imaging referral guideline methodology must be robust to be acceptable to referrers and radiologists. The framework proposed is based on an international instrument accepted by experts from all regions of the world. The framework should help imaging referral guidelines be developed, adopted, or adapted worldwide.

REFERENCES 1. Hendee W, Becker G, Borgstede J, et al. Addressing overutilization in medical imaging. Radiology 2010;257:240-5. 2. American College of Radiology. ACR Appropriateness Criteria. Available at: http://www.acr.org/ac. Accessed May 29, 2013. 3. The Royal College of Radiologists. iRefer: Making the Best Use of Clinical Radiology. London, United Kingdom: The Royal College of Radiologists; 2012. 4. Government of Western Australia. Diagnostic Imaging Pathways. Available at: http://www.imagingpathways.health.wa.gov.au/includes/ index.html. Accessed May 29, 2013. 5. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ 1999;318:527-30. 6. Institute of Medicine, Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical practice guidelines: directions for a new program. Washington, District of Columbia: National Academy Press; 1990. 7. Browman GP, Snider A, Ellis P. Negotiating for change. The healthcare manager as catalyst for evidence-based practice: changing the healthcare environment and sharing experience. Healthc Pap 2003;3:10-22. 8. Qaseem A, Forland F, Macbeth F, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med 2012;156:525-31.

9. AGREE Enterprise. The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Available at: http://www.agreetrust. org. Accessed May 29, 2013. 10. World Health Organization. Handbook for guideline development. Geneva, Switzerland: World Health Organization; 2012. 11. National Institute for Health and Clinical Excellence. NHS evidence. Available at: http://www.nice.org.uk/aboutnice/aboutnhsevidence.jsp. Accessed May 29, 2013. 12. NHS Evidence. The Royal College of Radiologists: referral guidelines. Final accreditation report. June 29, 2010. Available at: https://www. evidence.nhs.uk/documents/accreditation/reports/nice-data-users-profile folders-mderry-desktop-maggie-rcr-final-accreditation-report-1.3.pdf. Accessed May 29, 2013. 13. Government of Western Australia Department of Health. Diagnostic Imaging Pathways. Final accreditation report. April 30, 2012. Available at: https://www.evidence.nhs.uk/accreditation/accreditation-decisions/ p-accreditation-submissions-international-diagnostic-imaging-pathwayswestern-australia-accreditation-reports-accreditation-decision-report-dipwa.pdf. Accessed May 29, 2013. 14. Guyatt GH, Oxman AD, Vist G, et al, for the GRADE Working Group. Rating quality of evidence and strength of recommendations GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 15. Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches. The GRADE Working Group. BMC Health Serv Res 2004;4:38. 16. Oxford Centre for Evidence-Based Medicine. The Oxford 2011 levels of evidence. Available at: http://www.cebm.net/mod_product/design/ files/CEBM-Levels-of-Evidence-2.1.pdf. Accessed May 29, 2013. 17. Oxford Centre for Evidence-Based Medicine. Levels of evidence (March 2009) and grades of recommendations. Available at: http:// www.cebm.net/index.aspx?o¼1025. Accessed May 29, 2013. 18. Fryback D, Thornbury J. The efficacy of diagnostic imaging. Med Decis Making 1991;11:88-94. 19. The Journal of Bone and Joint Surgery. Instructions to authors. Available at: http://www.jbjs.org/public/instructionsauthors.aspx. Accessed May 29, 2013.

Appendix. Items for consideration for development of imaging referral guidelines

Item 0. Group members, media & format (not in AGREE) 0.1 Recruitment of guideline development group steering committee: Composition of group 0.2 Recruitment of Delphi group: Composition of group

0.3 Media

Criterion

Diversity in background and geography essential

Diversity in background and geography essential

Paper/web

Comments

Avoidance/minimizing/balancing of bias (modality/specialty/ geographical/eminence) in selection of steering committee members Avoidance/minimizing/balancing of bias (modality/specialty/ geographical/eminence) in selection of steering committee members Different media needed for different regions. Web versions should include applications for tablet devices. Power supply and internet access may be limited in some countries. Both paper and web versions may be needed.

A ¼ Agree, D ¼ Regional Difference Accepted

A

A

D

(continued)

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Appendix. Continued

0.4 Format

Item

Criterion Narrative/tabular/flowchart algorithm

0.5 Criteria for choice of best imaging procedure/ recommendation

Efficacy of test Radiation safety Cost-effectiveness

1. Scope and purpose AGREE Item 1.1 Overall objective 1.2 The health question(s) covered by the guideline is (are) specifically described.

1.3 The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described. 2. Stakeholder involvement AGREE Item 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance 2.2 The views and preferences of the target population (patients, public, etc.) have been sought. 2.3 Representatives of intended users in developing guidance.

Appropriateness of imaging for clinical situations Individual clinical situations: identified by imaging specialists or by referrers

Comments May need one or a combination of formats: narrative, tabular flow-chart algorithm. The ideal format will depend on complexity of problem, inclusion of clinical criteria (red flags) for pretest probability and the evidence supporting pathways eg venous thrombo-embolic disease. The media used may limit possibilities (see 0.3). These criteria [3] will enable selection of the best test and will determine the order for selection of effective tests.

Referring clinician representative essential.

A

A Clinical situations will not be exhaustive but should include common scenarios and areas where guidance is felt to be needed by either referrer, imaging specialist or both. Consideration should be given to: Size/scope of suite of guidelines Regional diseases & needs Differences in expertise & equipment.

Patients and public

Imaging specialists, medical physicists, Radiographers, Referrers (esp. GPs and specialists), patient group representatives Patient group representative essential

A ¼ Agree, D ¼ Regional Difference Accepted D

A

A

Although all stakeholder groups are essential, there may be regional differences in their roles.

A

See 2.1 No question as to inclusion, but some latitude as to where within the pathway this should be. See 2.1 No question as to inclusion, debate as to where within the pathway

A

A

(continued)

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Appendix. Continued

Item 3. Rigour of development AGREE Item 3.1 Use of systematic methods to search for evidence and provide details of the search strategy 3.2 State the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review 3.3 Strengths and limitations of the body of evidence and acknowledges any areas of uncertainty

3.4 Method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) 3.5 Consideration of the health benefits against the side effects and risks in formulating recommendations 3.6 Processes of external peer review

3.7 Process of updating guidance and maintaining and improving guidance quality 4. Clarity and presentation AGREE item 4.1 Recommendations are specific, unambiguous and clearly identifiable

4.2 The different options for management of the condition or health issue are clearly presented.

Criterion

Comments

A ¼ Agree, D ¼ Regional Difference Accepted

Systematic search strategy essential.

Actual process used may vary.

A

Strategy for inclusion of evidence essential.

Actual process used may vary.

A

Strengths and limitations of evidence essential.

Actual process used may vary but must be compliant with accepted EBM techniques. Little imaging evidence is considered to be at a high level by criteria used for conventional therapeutic studies. The Delphi process limits bias.

A

Either a Delphi process or an expert consensus meeting or both.

The principles of justification and good medical practice.

Review and approval by college council with consideration of conflicts of interest. Cycle for review essential.

Clarity of recommendation essential as to whether a procedure is indicated or not. Grading of recommendation is needed and the system for grading specified eg GRADE [14,15], Oxford [16,17]. Recommendations should identify the best test and the order for selection of effective tests. (See also 0.5)

D

A

Different methods for accepted peer review but must be defined.

D

Actual review period variable but should be stated.

A

Although recommendations will often identify procedures which are indicated or not indicated, there should be latitude to allow for specialised investigations which may be indicated in specific circumstances.

D

Must allow latitude for limitations of expertise, equipment and prevalence of disease.

A

(continued)

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Appendix. Continued

Item 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated 4.4 The content of the guidance is suitable for the specified target audience. If patients or service users are part of this audience, the language should be appropriate. 5. Applicability AGREE Item 5.1 The guideline describes facilitators and barriers to its application.

Criterion Essential to have: the date of search, the date of publication or last update and the proposed date for review. Clarity of language and accuracy of translation, where needed, essential.

Reference should be made to facilitators and potential barriers. These will differ between and within regions.

5.2 The guideline provides advice and/or tools on how recommendations can be put into practice.

Tools eg Clinical decision support systems (CDS) to aid uptake and use are desirable.

5.3 The potential resource implications of applying the recommendations have been considered.

Staff, equipment and training resource should be considered.

5.4 The guideline presents monitoring and/or auditing criteria.

Use of local internal clinical audit, external clinical audit, voluntary monitoring and regulation may all be considered.

6. Editorial independence AGREE Item 6.1 The views of the funding body have not influenced the content of the guideline. 6.2 Competing interests of guideline development group members have been recorded and addressed.

Comments Dates for each guideline may differ but should be stated.

Decision to invite public/patient to use guidelines will determine language.

A

Facilitators include referring clinicians committed to the process, and supportive regulatory bodies, professional societies, and ministries of health. Potential barriers include lack of resource, human and financial; language and translation. Clinical decision support works better in an electronic environment within work flow but print versions (patient care pathways) are also valuable. Cost and availability of tools may be limiting e.g. computerised CDS. The financial cost is difficult to quantify and will vary between and within regions. Although indicative costs or relative costs are feasible, actual costs are difficult to give. Monitoring process should be decided regionally/nationally.

D

Independence essential to achieve acceptance. Essential to be transparent for acceptance.

A ¼ Agree, D ¼ Regional Difference Accepted A

D

D

D

A

Conflicts of interest are inevitable and must be declared. Management of conflicts of interest important but will differ between countries.

D

Source: Adapted from the AGREE II instrument [9]. Note: AGREE ¼ Appraisal of Guidelines for Research and Evaluation; EBM ¼ evidence-based medicine; GP ¼ general practitioner; GRADE ¼ Grading of Recommendations Assessment, Development and Evaluation.

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Journal of the American College of Radiology Volume 12 n Number 1 n January 2015

Clinical imaging guidelines part 1: a proposal for uniform methodology.

Inappropriate imaging can lead to unnecessary medical radiologic exposures and cost and may not answer the clinical question. Imaging referral guideli...
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