Health Technology Agency insights: informing modification of a qualitative benefit risk framework for Health Technology Reassessment of prescription medications.

OBJECTIVES: This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit-Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination. METHODS: A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks. RESULTS: Participant interviews lead to four common themes: "adoption of a qualitative benefit risk framework," "data (either too much or not enough)," "importance of incorporating stakeholder values," and "feasibility of the UMBRA framework." Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants. CONCLUSIONS: Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

DRUG DISINVESTMENT FRAMEWORKS: COMPONENTS, CHALLENGES, AND SOLUTIONS.

OBJECTIVES: Value assessments of marketed drug technologies have been developed through disinvestment frameworks. Components of these frameworks are varied and implementation challenges are prevalent. The objective of this systematic literature review was to describe disinvestment framework process components for drugs and to report on framework components, challenges, and solutions. METHODS: A systematic literature search was conducted using the terms: reassessment, reallocation, reinvestment, disinvestment, delist, decommission or obsolescence in MEDLINE, EMBASE, NLM PubMed, the Cochrane Library, and CINAHL from January 1, 2000, until November 14, 2015. Additional citations were identified through a gray literature search of Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) member Web sites and from bibliographies of full-text reviewed manuscripts. RESULTS: Sixty-three articles underwent full text review and forty were included in the qualitative analysis. Framework components including disinvestment terms and definitions, identification and prioritization criteria and methods, assessment processes, stakeholders and dissemination strategies, challenges, and solutions were compiled. This review finds that stakeholders lack the political, administrative, and clinical will to support disinvestment and that there is not one disinvestment framework that is considered best practice. CONCLUSIONS: Drug technology disinvestment components and processes vary and challenges are numerous. Future research should focus on lessening value assessment challenges. This could include adopting more neutral framework terminology, setting fixed reassessment timelines, conducting therapeutic reviews, and modifying current qualitative decision-making assessment frameworks.

"I take what I think works for me": a qualitative study to explore patient perception of diabetes treatment benefits and risks.

BACKGROUND: Diabetes is impacting more and more people each year. A key aspect of disease management is patient adherence to prescribed treatments. Treatment adherence is influenced by many factors, including the understanding of a treatment's benefits and risks. OBJECTIVE: This study sought to describe the experience of benefit and risk assessment for people with type 2 diabetes when making treatment decisions. METHODS: This study utilized qualitative research methods. Individual interviews were conducted using a semi-structured interview guide. Both purposeful and theoretical sampling was used. A grounded theory approach was employed to facilitate data collection and analysis. RESULTS: The 18 study participants were on varying treatment regimens for diabetes (diet therapy, oral medications, and insulin). Many people felt that they had not received enough information about the benefits and risks of treatment at the point of decision-making and later sought this information on their own. Participants did not seem to consciously assess treatment benefits and risks when treatments were prescribed or suggested, but rather continued to make decisions after the clinical encounter by means of experimentation or experience with treatments. In general, benefits and risks were conceptualized very broadly, and some people were not able to verbally articulate their perceptions of treatment benefits and risks. CONCLUSION: Patients' assessment of treatment benefits and risks is an ongoing, often unconscious process that requires continuous interaction with the health care system. Access to information and an opportunity to discuss treatment options with health care providers are important to people with diabetes when making treatment decisions.