Association of a Medicare Mandate for Shared Decision-Making With Cardiac Device Utilization.

This cohort study evaluates the association between a Medicare shared decision-making mandate for use of implantable cardioverter defibrillators with the rate of use for this device.

Measuring the Impact of Quantitative Information on Patient Understanding: Approaches for Assessing the Adequacy of Patient Knowledge about Colorectal Cancer Screening.

Background. Guidelines recommend that decision aids disclose quantitative information to patients considering colorectal cancer (CRC) screening, but the impact on patient knowledge and decision making is limited. An important challenge for assessing any disclosure involves determining when an individual has "adequate knowledge" to make a decision. Methods. We analyzed data from a trial that randomized 213 patients to view a decision aid about CRC screening that contained verbal information (qualitative arm) versus one containing verbal plus quantitative information (quantitative arm). We analyzed participants' answers to 8 "qualitative knowledge" questions, which did not cover the quantitative information, at baseline (T0) and after viewing the decision aid (T1). We introduce a novel approach that defines adequate knowledge as correctly answering all of a subset of questions that are particularly relevant because of the participant's test choice ("Choice-Based Knowledge Assessment"). Results. Participants in the quantitative arm answered a higher mean number of knowledge questions correctly at T1 than did participants in the qualitative arm (7.3 v. 6.9, P < 0.05), and they more frequently had adequate knowledge at T1 based on a cutoff of 6 or 7 correct out of 8 (94% v. 83%, P < 0.05, and 86% v. 71%, P < 0.05, respectively). Members of the quantitative group also more frequently had adequate knowledge at T1 when assessed by Choice-Based Knowledge Assessment (87% v. 76%, P < 0.05). Conclusions. Patients who viewed quantitative information in addition to verbal information had greater qualitative knowledge and more frequently had adequate knowledge compared with those who viewed verbal information alone, according to most ways of defining adequate knowledge. Quantitative information may have helped participants better understand qualitative or gist concepts. Trial Registration: ClinicalTrials.gov ID# NCT01415479. Highlights: Patients who viewed quantitative information in a decision aid about colorectal cancer screening were more knowledgeable about nonquantitative information and were more likely to have adequate knowledge according to a variety of approaches for assessing that, compared with individuals who viewed only qualitative information. This result supports the inclusion of quantitative information in decision aids.Researchers assessing patient understanding should consider a variety of ways to define adequate knowledge when assessing decision quality.

Pain clinic definitions in the medical literature and U.S. state laws: an integrative systematic review and comparison.

BACKGROUND: In response to widespread opioid misuse, ten U.S. states have implemented regulations for facilities that primarily manage and treat chronic pain, called "pain clinics." Whether a clinic falls into a state's pain clinic definition determines the extent to which it is subject to oversight. It is unclear whether state pain clinic definitions model those found in the medical literature, and potential differences lead to discrepancies between scientific and professionally guided advice found in the medical literature and actual pain clinic practice. Identifying discrepancies could assist states to design laws that are more compatible with best practices suggested in the medical literature. METHODS: We conducted an integrative systematic review to create a taxonomy of pain clinic definitions using academic medical literature. We then identified existing U.S. state pain clinic statutes and regulations and compared the developed taxonomy using a content analysis approach to understand the extent to which medical literature definitions are reflected in state policy. RESULTS: In the medical literature, we identified eight categories of pain clinic definitions: 1) patient case mix; 2) single-modality treatment; 3) multidisciplinary treatment; 4) interdisciplinary treatment; 5) provider supervision; 6) provider composition; 7) marketing; and 8) outcome. We identified ten states with pain clinic laws. State laws primarily include the following definitional categories: patient case mix; single-modality treatment, and marketing. Some definitional categories commonly found in the medical literature, such as multidisciplinary treatment and interdisciplinary treatment, rarely appear in state law definitions. CONCLUSIONS: This is the first study to our knowledge to develop a taxonomy of pain clinic definitions and to identify differences between pain clinic definitions in U.S. state law and medical literature. Future work should explore the impact of different legal pain clinic definitions on provider decision-making and state-level health outcomes.

Defending Opioid Treatment Agreements: Disclosure, Not Promises.

In order to receive controlled pain medications for chronic non-oncologic pain, patients often must sign a "narcotic contract" or "opioid treatment agreement" in which they promise not to give pills to others, use illegal drugs, or seek controlled medications from health care providers. In addition, they must agree to use the medication as prescribed and to come to the clinic for drug testing and pill counts. Patients acknowledge that if they violate the opioid treatment agreement (OTA), they may no longer receive controlled medications. OTAs have been widely implemented since they were recommended by multiple national bodies to decrease misuse and diversion of narcotic medications. But critics argue that OTAs are ethically suspect, if not unethical, and should be used with extreme care if at all. We agree that OTAs pose real dangers and must be implemented carefully. But we also believe that the most serious criticisms stem from a mistaken understanding of OTAs' purpose and ethical basis.

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest.

Relationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk. Moreover, conflict-of-interest strategies are not designed to promote best practices nor the scientific and social benefits of academic-industry collaboration. We propose a framework of principles and benchmarks for "ethically credible partnerships" between industry and academic health centers and describe how this framework may provide a practical and comprehensive approach for designing and evaluating such partnerships.