Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials.

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the United States (U.S.). The recent development of ICF templates by the National Cancer Institute, National Institutes of Health, and the National Heart Blood and Lung Institute have not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet U.S. federal requirements and pass institutional review board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a 2-column format. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension, and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared with the traditional format on the informed consent process.

Barriers to accessing health care for hematopoietic cell transplantation recipients living in rural areas: perspectives from healthcare providers.

Hematopoietic cell transplantation (HCT) is a curative therapy for patients with malignant and nonmalignant bone marrow disorders. Life after transplantation can vary significantly among HCT recipients, who deal with a variety of physical and emotional issues. This presents numerous challenges, particularly for rural recipients who are required to travel long distances to access specialized HCT care. The objective of this study was to better understand barriers to providing care for HCT recipients living in rural areas. This study uses a cross-sectional design to collect primary data via an Internet survey of HCT healthcare providers. The authors analyzed factors restricting post-HCT care and whether having standard post-transplantation care instructions influenced the resources provided to distant-to-care recipients. Respondents reported limited transportation, coordination of care, and distance to facility as major barriers to post-HCT care, regardless of the number of distant-to-care recipients treated annually. HCT centers with standard post-transplantation care instructions were more likely to provide visits from social workers and medical leave resources to distant-to-care recipients. These instructions may improve recipient and local provider ability to make informed decisions regarding post-HCT care. The findings will help guide the development of programs and resources targeted to recipients of HCT who are distant to care.