Development and validation of a low-literacy opioid contract

J Pain. 2007 Oct;8(10):759-66. doi: 10.1016/j.jpain.2007.05.004. Epub 2007 Jun 13.


Opioid contracts (OPCs) are often used to outline the criteria and circumstances for which opioid medications are prescribed. The purpose of this study was to develop and validate an English-language, low-literacy OPC. Specifically, the low-literacy OPC was designed to outline proper administration of prescribed medication(s) as well as highlight patient responsibilities and expectations. A 4-step process was used to develop and validate the low-literacy OPC, including: (1) content identification; (2) attention to low-literacy guidelines; (3) evaluation based on Suitability Assessment of Materials (SAM) criteria; and (4) pilot testing with patients (n = 18) to assess comprehension. Final OPC content, presented largely in bulleted format, was based on current literature and consensus of the first 3 authors. The 4-part OPC was formatted on 8(1/2) x 11 inch paper using 16- to 24-point size Arial-style font. The 6-page OPC, written at the 7(th) reading grade level, included 12 recognizable clipart-type illustrations to supplement written text. Two reviewers scored the OPC in the superior range based on total SAM percentage scores. Nineteen (n = 19) of the 26 statements were comprehended by all patients completing the pilot testing. Overall, the low-literacy OPC is comprehensive, valid, readable, and formatted according to established low-literacy guidelines.

Perspective: This study describes the development and validation of a low-literacy, English-language OPC. The OPC was formatted using low-literacy guidelines and validated with a sample of patients to confirm understanding of content. Accordingly, the low-literacy OPC is suitable for use in routine clinical practice.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Analgesics, Opioid / therapeutic use*
  • Comprehension*
  • Contracts / standards*
  • Educational Status
  • Humans
  • Pain / drug therapy*
  • Patient Education as Topic / methods*
  • Patient Education as Topic / standards
  • Pilot Projects
  • Teaching Materials / standards


  • Analgesics, Opioid