George P. Browman

Conceptual and practical challenges for implementing the communities of practice model on a national scale - a Canadian cancer control initiative

BackgroundCancer program delivery, like the rest of health care in Canada, faces two ongoing challenges: to coordinate a pan-Canadian approach across complex provincial jurisdictions, and to facilitate the rapid translation of knowledge into clinical practice. Communities of practice, or CoPs, which have been described by Etienne Wenger as a collaborative learning platform, represent a promising solution to these challenges because they rely on bottom-up rather than top-down social structures for integrating knowledge and practice across regions and agencies. The communities of practice model has been realized in the corporate (e.g., Royal Dutch Shell, Xerox, IBM, etc) and development (e.g., World Bank) sectors, but its application to health care is relatively new. The Canadian Partnership Against Cancer (CPAC) is exploring the potential of Wengers concept in the Canadian health care context. This paper provides an in-depth analysis of Wengers concept with a focus on its applicability to the health care sector.DiscussionEmpirical studies and social science theory are used to examine the utility of Wengers concept. Its value lies in emphasizing learning from peers and through practice in settings where innovation is valued. Yet the communities of practice concept lacks conceptual clarity because Wenger defines it so broadly and sidelines issues of decision making within CoPs. We consider the implications of his broad definition to establishing an informed nomenclature around this specific type of collaborative group. The CoP Project under CPAC and communities of practice in Canadian health care are discussed.SummaryThe use of communities of practice in Canadian health care has been shown in some instances to facilitate quality improvements, encourage buy in among participants, and generate high levels of satisfaction with clinical leadership and knowledge translation among participating physicians. Despite these individual success stories, more information is required on how group decisions are made and applied to the practice world in order to leverage the potential of Wengers concept more fully, and advance the science of knowledge translation within an accountability framework.

A Time-Trend Economic Analysis of Cancer Drug Trials

BACKGROUND Scientific advances have led to the discovery of novel treatments with high prices. The cost to publicly fund high-cost drugs may threaten the sustainability of drug budgets in different health care systems. In oncology, there are concerns that health-benefit gains are diminishing over time and that the economic evidence to support funding decisions is too limited. METHODS To assess the additional costs and benefits gained from oncology drugs over time, we used treatment protocols and efficacy results from U.S. Food and Drug Administration records to calculate cost-effectiveness ratios for drugs approved to treat first- and second-line metastatic or advanced breast, colorectal, and non-small cell lung cancer during the years 1994-2013. We assessed reimbursement recommendations reached by health technology assessment agencies in the U.K., Australia, and Canada. RESULTS Cost-effectiveness ratios were calculated for 50 drugs approved by the U.S. regulator. The more recent approvals were often based on surrogate efficacy outcomes and had extremely high costs, often triple the costs of drugs approved in previous years. Over time, the effectiveness gains have increased for some cancer indications; however, for other indications (non-small cell lung and second-line colorectal cancer), the magnitude of gains in effectiveness decreased. Reimbursement recommendations for drugs with the highest cost-effectiveness ratios were the most inconsistent. CONCLUSION Evaluation of the clinical benefits that oncology drugs offer as a function of their cost has become highly complex, and for some clinical indications, health benefits are diminishing over time. There is an urgent need for better economic evidence from oncology drug trials and systematic processes to inform funding decisions. IMPLICATIONS FOR PRACTICE High-cost oncology drugs may threaten the ability of health care systems to provide access to promising new drugs for patients. In order to make better drug-funding decisions and enable equitable access to breakthrough treatments, discussions in the oncology community should include economic evidence. This study summarizes the extra benefits and costs of newly approved drugs from pivotal trials during the postgenomic era of drug discovery. The reader will gain an appreciation of the need for economic evidence to make better drug-reimbursement decisions and the dynamics at play in todays oncology drug market.

When is good, good enough? Methodological pragmatism for sustainable guideline development

BackgroundContinuous escalation in methodological and procedural rigor for evidence-based processes in guideline development is associated with increasing costs and production delays that threaten sustainability. While health research methodologists are appropriately responsible for promoting increasing rigor in guideline development, guideline sponsors are responsible for funding such processes.DiscussionThis paper acknowledges that other stakeholders in addition to methodologists should be more involved in negotiating trade-offs between methodological procedures and efficiency in guideline production to produce guidelines that are ‘good enough’ to be trustworthy and affordable under specific circumstances. The argument for reasonable methodological compromise to meet practical circumstances is consistent with current implicit methodological practice. This paper proposes a conceptual tool as a framework to be used by different stakeholders in negotiating, and explicitly reporting, reasonable compromises for trustworthy as well as cost-worthy guidelines. The framework helps fill a transparency gap in how methodological choices in guideline development are made. The principle, ‘when good is good enough’ can serve as a basis for this approach.SummaryThe conceptual tool ‘Efficiency-Validity Methodological Continuum’ acknowledges trade-offs between validity and efficiency in evidence-based guideline development and allows for negotiation, guided by methodologists, of reasonable methodological compromises among stakeholders. Collaboration among guideline stakeholders in the development process is necessary if evidence-based guideline development is to be sustainable.

Special Series on Comparative Effectiveness Research: Challenges to Real-World Solutions to Quality Improvement in Personalized Medicine

McShane and Hayes and Ginsburg and Kuderer in the special series issue of the Journal provide a comprehensive vision for improved conduct and reporting of predictive/prognostic biomarker research in personalized cancer medicine. Their visions are prompted by the need for more methodologic rigor for validation studies in this field as highlighted by a critical appraisal of 37 published reports in a systematic review. They invoke three strategies for improving study quality: first, comparative effectiveness research (CER) that addresses population-level effects of alternative interventions; second, quality improvement (QI) tools as methodologic standards; and third, infrastructure development for informatics and data linkage, and institutional networking with data sharing.