World journal of surgery
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World journal of surgery · Dec 1999
Development of clinical practice guidelines: surgical perspective.
Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. The implications of this definition are that: the methodologic perspective and operations for systematic development must be specified, a strategy is needed to account for the patient's perspective in the CPG development process and the clinical decision, and a mechanism is required to determine how appropriateness ought to be conceptualized and defined. Addressing these issues, we review models of CPG development, outline challenges to evidence-based approaches to CPG development, address unique factors relevant to the development of guidelines for the surgical community, introduce an Ontario practice guidelines strategy that uses complementary methods of CPG development, and summarize the feedback provided by the surgical community regarding the practice guidelines produced in Ontario's cancer system.
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As technology expands and health care resources become more limited, there is increasing pressure on surgeons to evaluate surgical procedures and technology to ensure they are effective. No longer is evidence from case series acceptable, and treatments must be evaluated in randomized controlled trials. ⋯ Many cite methodologic issues related to surgical issues as the reason for this, including concerns related to standardization of the surgical procedure, timing of surgical trials, difficulties with blinding of subjects and investigators, ethics of surgical trials, and patient and surgeon acceptance of surgical trials. These issues are discussed in this paper as are possible strategies to minimize their effect.
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The randomized clinical trial (RCT) is often referred to as the gold standard for the assessment of treatment efficacy. RCTs are receiving greater attention in the literature and higher priority by funding agencies than they have in the past. In this paper, the basic principles of clinical trial design are reviewed using examples from the neurosurgical literature. The importance of designing the trial to answer one question well is emphasized.
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All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. ⋯ Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.
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World journal of surgery · Dec 1999
Hemodynamic patterns of survivors and nonsurvivors during high risk elective surgical operations.
Postoperative survivors' and nonsurvivors' hemodynamic and oxygen transport patterns have been extensively studied, and the early postoperative circulatory events leading to organ failures and death have been documented. Outcome was improved when potentially lethal circulatory patterns were treated during the early (the first 8-12 hours) postoperative period; but after the appearance of organ failure, reversal of nonsurvival patterns did not improve the outcome. The purpose of this study was to describe prospectively intraoperative circulatory deficiencies that precede shock, organ failures, and death. ⋯ Low oxygen consumption was partly compensated by increased oxygen extraction rates, and arterial pressures were maintained by increasing systemic vascular resistance. The early temporal pattern of nonsurvivors' changes were similar to those described during the postoperative period that preceded development of organ failure and death. This suggests that lethal circulatory dysfunctions may begin during the intraoperative period but become more apparent before and after organs fail during later postoperative stages.