The Current Informed Consent Process & Missed/Misinterpreted Findings

Radiology and Imaging deal with a lot of images. The potential for missing or misinterpreting findings are there and has consequences for the patient (and provider).

There are several reasons why a finding may be missed/misinterpreted

• Quality of Equipment
• Resolution of Images
• Skill & Training of the provider
• An understanding of the condition
• Client end factors like Obesity
• Position of the fetus
• Developmental-consider possibility that abnormality developed later in gestation and could not be detected in earlier studies
• Incomplete Information from Referring Doctor
• Incomplete Information from Patient

Either Way, once a finding is missed or misinterpreted, the team of doctors have to inform the patient regarding this. This is not an easy conversation for any one and can cause considerable distress to the patient. It may lead to medico-legal issues. A honest, empathetic conversation may alleviate some of the medico-legal concerns.

It is important that the conversation (honest, empathetic) happens with every patient and starts before the imaging studies. The informed consent is one way to have this discussion in a participatory, interactive manner.

The Informed Consent

Obtaining informed consent is a fundamental non-negotiable principle prior to performing any intervention for a human. Diagnostic tests can be considered to fall under the purview of interventions.

There are several key elements to this document that primarily focus on protecting the rights, dignity, safety and well-being of subjects in alignment with the principles of autonomy, beneficence and non-maleficence and justice  that are the cornerstone of modern medical ethics.

The signatory on the form is a subject, who is deemed to be competent to understand, assimilate, and clarify the information provided, in a manner that allows the person to make an informed decision. In certain circumstances, the legal guardian, immediate family member or a legally designated representative may take the decision on behalf of the subject.

Understanding the primary purpose of the informed consent is an important pre-requisite.

1. Provide appropriate information to the subject in “plain” language that demystifies medical or health related jargon.
2. To help or aid the subject to make an informed decision on participation with the procedure.

The quality of information and the presentation of information is important. The information should be based on a high quality of evidence, factual and backed by science. The presentation should be simple, yet retaining the important information, to allow subjects to make a decision based on facts and science. The quality of data and science are important.

WHAT SHOULD THE CONTENT INCLUDE- A CHECKLIST

1. The Names and Designation of the Investigators (Persons performing the investigation) and the location where the test will be done.  

Providing Information about Options

1. What should the subject know? Describe the health condition or problem
2. The purpose of the procedure or why do we need this procedure?
3. What will be done as part of this procedure? What should the subject expect as part of the procedure? Also, make sure to clarify what will not be done as part of the procedure.
4. Are there any benefits from the procedure? Describe advantages FROM participation. This may be to the individual or societal. Are there any incentives to participate? Describe potential advantages FROM NOT participating.
5. Are there any risks? Describe disadvantages FROM participation. This may be to the individual or societal. Are these risks short term, long term, reversible or irreversible? Are these risks manageable? Do they increase cumulative risk for other conditions? Are there any additional costs in participating? Describe disadvantages FROM NOT participating.
6. Provide a comparison of advantages and disadvantages. In other words, describe a comparison of potential benefits and potential harm. Discuss the potential impact on life from the perceived benefits and perceived harm.

Present Probabilities of events, risks and benefits

10. Information on probabilities of all potential benefits
11. Information on probabilities of all potential disadvantages/harm
12. Use the same denominator to compare probabilities – that allows the subject to have a better picture (remember, this is not a maths exercise and the purpose is to inform the subject). If possible, use visual information.
13. Provide information on the uncertainty around the probabilities- provide the confidence intervals and explanations of what that means.
14. Information on probabilities using more than one method- numbers, percentages, text, pictorial. Describe the probabilities in multiple frames (example: 60 of 100 people who have the intervention may die in 2 weeks or 40 of 100 people who have the intervention survive beyond 2 weeks) to limit framing biases.
15. Specify the population (s) that the probabilities are based on
16. The time period for which the probabilities apply (example, if the probabilities apply for a period of 6 months follow up etc.) is specified

Clarify and express preferred outcomes

17.  Provide time for the subject to think about which of the outcomes are most important and discuss those. Provide options for further discussion, comments and questions. This means, provide information on alternate approaches as well.
18. Provide a step by step process that can help potential participants to decide whether to participate or not
19. Can the subject refuse to participate? Will refusal affect clinical care? Explain what happens in such a scenario. These should be factual explanations backed by data and not speculative explanations.
20. Explain the potential interpretations of the results and the possibility of follow up tests/procedures.

Using Evidence

21. Describe the level of evidence used
22. Describe the different levels of evidence used and their implications.
23. How will the results be used for further management?
24.  Whom are the results shared with?

Other Considerations

25. Disclose any conflicts of interest
26. Whom can the subject contact if they need any further clarification or in case of an emergency?

HOW SHOULD THE CONTENT BE PRESENTED?

The language has to be simple and arranged in a logical flow of information that enables the participant to make an informed choice. The use of audio, video, multimedia, pictorial representations to explain key areas is recommended.

Please note: 

1. Any subject that provides consent to participate in a procedure is helping the investigators and the progress of science besides advancing their own care. Investigators have to respect the contribution of the subject to the progress of science and their specialty, as well as to the benefits that accrue to other individuals and society through the actions of the subject even if the subject does this considering only their own clinical improvement.
2. The informed consent document is a reflection of this respect to the subject.
3. Diagnostic tests or procedures do not supersede the dignity, rights, safety and wellbeing of the person who consents to help science. Such consent has to be sought respectfully and with full disclosure. Partial or selective disclosure is unethical.

Concerns or Discussion Points

• • Informed Consent Form or Patient Information Leaflet- What should we use?
  • Who obtains the consent and when?
  • Time Necessary to Obtain Consent/Provide Information- What do we do in emergency situations?
  • How much information should we provide? Do we have all such information? Are specific data available to base decisions on?
  • Potential for error, misclassification and missing findings- Do we explain these?
  • What are the medico-legal implications of providing incomplete information?
  • What are the medico-legal implications of information provided on incomplete or insufficient data?
  • Information freely available on the internet can be used for medicolegal purposes. Are there professional society derived guidelines for India based on India specific studies and data?
  • Is the lack of locally relevant guidelines based on locally mined data acceptable in medico-legal situations? As professionals, is that a reason we can legally cite?
  • Should we have a centrally, professional society developed informed consent form that can be used by all practitioners at all levels of care? Will this be better than leaving the contents of the form to individual wisdom?

Article attribution to RAG- AMMA ERF