Standardizing the Consent Form: A Quality Improvement

Informed Consent for transplant patients is not only a requirement by law but an integral part of the patient education. Transplant centers often use treatment plans for standard of care.  It is a daunting challenge to maintain and update treatment plan consent forms.

Over the past 20 years, transplant centers have diversified and now use multiple conditioning and graft versus host disease (GVHD) prophylaxis regimens. In transplant centers that have been in operation for many years, the use of consents for standard of care treatment plans have been augmented and changed as needed over time. These changes are due to the introduction of novel therapies, newly identified side effects, changes in regulatory and legal requirements and standardization of terminology.

Standardizing the language of consents presents several dilemmas.   

• Should we try to create a treatment plan consent that could be used for multiple treatment plans? 
• Will this be confusing for patients?
• Will physicians forget to check the boxes for specific drugs that are being used?
• Should we describe side effects by organ system or by drug or both? 
• Should we list side effects in a table? 
• Should we incorporate blank spaces for personalized information to be completed by the MD at the time of consent? 
• Will this be more cumbersome for physicians?
• Will the consent be missing information?
• What is the easiest way to present this information?
• What is the most readable format?

 At our center, we developed a unique approach to enable the swift update of treatment plan consents and to homogenize the language employed in consents for our patients.  Employing tools in Microsoft Word®, we created templated paragraphs that could be inserted into different documents.  These master paragraphs can be changed and when changed will automatically update the wording in all the other documents to which they have been linked.

 We created master paragraphs or modules for each section of the consent and for allogeneic and autologous transplant consents. Our “Consentapedia” includes sections for each conditioning or GVHD drug, potential side effects of each drug stratified by likelihood of occurrence, risks associated with the various procedures involved in transplant, frequently asked questions such as benefits of treatment, language regarding privacy and confidentiality and other required information.

 Ultimately, we were easily able to create standardized consent forms for over 27 treatment plans. This system facilitates the editing of consent forms allowing us to keep them current while maximizing staff resources.  It standardizes the language for patients and provides consistent patient education. It also allows for ease in translation to other languages. This innovation is simple for other transplant centers to adopt.  This is a quality improvement initiative that provides benefits to our practice and is feasible and applicable across other disciplines.