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Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process.(More)
Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study(More)
Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against(More)
OBJECTIVE To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. STUDY DESIGN AND SETTING Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?,"(More)
OBJECTIVES The UK's National Institute of Health and Clinical Excellence (NICE) has an explicit cost-effectiveness threshold for deciding whether or not services are to be provided in the National Health Service (NHS), but there is currently little evidence to support the level at which it is set. This study examines whether it is possible to obtain such(More)
There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients, clinicians, and payers wishing to make evidence-based clinical and health policy decisions. This has been a major driver in the rapid increase in interest in comparative effectiveness research (CER), which aims(More)
Overuse, which is defined as the provision of medical services that are more likely to cause harm than good, is a pervasive problem. Direct measurement of overuse through documentation of delivery of inappropriate services is challenging given the difficulty of defining appropriate care for patients with individual preferences and needs; overuse can also be(More)
Information generated from economic evaluation is increasingly being used to inform health resource allocation decisions globally, including in low- and middle- income countries. However, a crucial consideration for users of the information at a policy level, e.g. funding agencies, is whether the studies are comparable, provide sufficient detail to inform(More)
Making Fair Choices on the Path to Universal Health Coverage [UHC; World Health Organization (WHO), 2014] is to be welcomed because tackling the relationship between cost-effectiveness and fairness has been given too little attention in policy-making. The consensus that universal coverage is a good thing quickly disperses as the concept is translated into(More)