A Conceptual Framework for Life-Cycle Health Technology Assessment.

OBJECTIVES: Health technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders. METHODS: Under the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty. RESULTS: LC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive. CONCLUSIONS: The LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value.

Evaluating facts and facting evaluations: On the fact-value relationship in HTA.

Health technology assessment (HTA) is an evaluation of health technologies in terms of facts and evidence. However, the relationship between facts and values is still not clear in HTA. This is problematic in an era of "fake facts" and "truth production." Accordingly, the objective of this study is to clarify the relationship between facts and values in HTA. We start with the perspectives of the traditional positivist account of "evaluating facts" and the social-constructivist account of "facting values." Our analysis reveals diverse relationships between facts and a spectrum of values, ranging from basic human values, to the values of health professionals, and values of and in HTA, as well as for decision making. We argue for sensitivity to the relationship between facts and values on all levels of HTA, for being open and transparent about the values guiding the production of facts, and for a primacy for the values close to the principal goals of health care, ie, relieving suffering. We maintain that philosophy (in particular ethics) may have an important role in addressing the relationship between facts and values in HTA. Philosophy may help us to avoid fallacies of inferring values from facts; to disentangle the normative assumptions in the production or presentation of facts and to tease out implicit value judgements in HTA; to analyse evaluative argumentation relating to facts about technologies; to address conceptual issues of normative importance; and to promote reflection on HTA's own value system. In this we argue for a(n Aristotelian) middle way between the traditional positivist account of "evaluating facts" and the social-constructivist account of "facting values," which we call "factuation." We conclude that HTA is unique in bringing together facts and values and that being conscious and explicit about this "factuation" is key to making HTA valuable to both individual decision makers and society as a whole.

USING THE INTEGRATE-HTA GUIDANCE: EXPERIENCE FROM CADTH.

OBJECTIVES: The aim of this study was to describe an initial exploration by CADTH, Canada's pan-Canadian health technology assessment (HTA) agency, in using the INTEGRATE-HTA guidance in the production of an HTA that examined the use of both in-center and in-home dialysis modalities for the treatment of end-stage kidney disease in adults in Canada. METHODS AND RESULTS: We outline CADTH's standard HTA production process and context and then describe the experience of the assessment team in using the INTEGRATE-HTA guidance, specifically to help structure and guide the use of a logic model, the identification of implementation issues, and the identification and examination of ethical issues. For each of the aspects, we describe and reflect on how the assessment team used the guidance, challenges that were encountered in its use, and whether and how we might address these challenges when using the INTEGRATE-HTA guidance in the future. CONCLUSIONS: INTEGRATE-HTA provided detailed and helpful guidance for truly integrating wide-ranging aspects of HTA. Our agency was challenged by a steep learning curve for assessment team members, tight project timelines, and a misalignment of current HTA processes with those required to implement the guidance. Nevertheless, using the guidance initiated a dialogue about what might be needed to assess complex interventions and the potential process changes that could facilitate conducting more integrated assessments.

The nature and influence of pharmaceutical industry involvement in asthma trials.

BACKGROUND: Pharmaceutical industry-sponsored research has been shown to be biased toward reporting positive results. Frequent industry participation in trials assessing the efficacy of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination treatment makes assessing industry influence difficult and warrants an assessment of specific potential publication bias in this area. OBJECTIVE: To describe the frequency of industry involvement in ICS/LABA trials and explore associations among significant outcomes, type of industry involvement and type of primary outcome. METHODS: A systematic review of trials comparing ICS/LABA combination therapy with ICS monotherapy for asthma was conducted. Data concerning the type of industry sponsorship, primary outcome and statistical results were collected. Comparisons between type of sponsorship and significant results were analyzed using Pearson's chi squared test and relative risk. RESULTS: Of 91 included studies (median year of publication 2005 [interquartile range 1994 to 2008]), 86 (95%) reported pharmaceutical involvement. Author affiliation was reported in 49 of 86 (57%), and 19 of 86 (22%) were industry-reported trials without full publications. The remainder were published journal articles. Studies with a first or senior author affiliated with industry were 1.5 times more likely to report statistically significant results for the primary outcome compared with studies with other types of industry involvement. Pulmonary measures were 1.5 times more likely to be statistically significant than were measures of asthma control. CONCLUSIONS: The potential biases identified were consistent with other research focused on author role and industry involvement, and suggest that degree of bias may vary with type of affiliation.

Procedural sedation and analgesia in a Canadian ED: a time-in-motion study.

INTRODUCTION: Some patients presenting to emergency departments (EDs) suffer from conditions requiring potentially painful treatment; procedural sedation and analgesia (PSA) are important components of their management. The purpose of this study was to determine the resources used during the administration of PSA. METHODS: This prospective observational study was conducted in a Canadian urban teaching center. Detailed data concerning the dosage of PSA medications, adverse events, and ED times for patients requiring PSA for treatment of fractures, reductions of joint dislocations, and cardioversion for atrial fibrillation were collected. Descriptive analyses included proportions, means with standard deviations, and medians with interquartile ranges. RESULTS: Of the 177 PSA cases considered for analysis, 69.5% were orthopedic manipulations and 30.5% were cardioversions. Propofol alone or combined with fentanyl was the commonest medication, and 27 minor adverse events were documented. The median number of staff used in each PSA was 4 (4, 4). The median time from triage to the start of the procedure was 175 minutes (98, 259). The median time from the end of monitoring to discharge was 186 minutes (104, 316). The median time from the start of PSA administration to the end of patient monitoring was 12 minutes for fractures/dislocations and 7 minutes for cardioversion. The total ED length of stay was 6.6 hours. CONCLUSION: Procedural sedation and analgesia are potentially time-consuming interventions requiring the coordination of ED staff; delays in procedures represent opportunities to reduce ED overcrowding. Procedural sedation and analgesia guidelines may assist with standardization.