title: Development and validation of a low-literacy opioid contract.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Tennessee Graduate School of Medicine, Department of Family Medicine, Knoxville, Tennessee 37920, USA. lwallace@mc.utmck.edu
authors.forename: Lorraine S
authors.initials: LS
authors.lastname: Wallace
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Keenum
authors.forename: Steven E
authors.initials: SE
authors.lastname: Roskos
authors.forename: Kelly S
authors.initials: KS
authors.lastname: McDaniel
mesh_terms: D000701:Analgesics, Opioid / Q000627:therapeutic use*; D032882:Comprehension; D032982:Contracts / Q000592:standards*; D004522:Educational Status; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D010353:Patient Education as Topic / Q000379:methods* / Q000592:standards; D010865:Pilot Projects; D013664:Teaching Materials / Q000592:standards
chemical_list: D000701:Analgesics, Opioid