The Outcomes Research Consortium (stylized as OUTCOMES RESEARCH) [1] is an international clinical research group that focuses on the perioperative period (during and after surgery), along with critical care and pain management.[2][3] The Consortium's aim is to improve the quality of care for surgical, critical care, and chronic pain patients and to "Provide the evidence for evidence-based practice."[4] Members of the Consortium are especially interested in testing simple, low-risk, and inexpensive treatments that have the potential to markedly improve patients' surgical experiences.
The 25-year anniversary of the Consortium and its accomplishments were celebrated in an editorial in Anesthesiology.[5] The editorial starts:
Imagine a research group made up of more than 100 members working both independently and collaboratively across many countries having no legal standing, no bank account, and loosely organized, but devoted to the goal of improving health care through the understanding of the results of health care practices. Furthermore, imagine that members of this organization have published more than 900 full journal articles since its inception and publish a new full paper every 5 days. It may be hard to believe that such a unique organization exists, but it does. It is known as the Outcomes Research Consortium.
The Outcomes Research Group was formed in 1990 at the University of California San Francisco, and thus celebrated its 25th anniversary in 2015. The Consortium now includes about 130 university-based investigators at more than 20 hospitals in 10 countries. The primary requirement for membership is ongoing active collaboration with Consortium members. It is by far the world's largest and most productive clinical anesthesia research group. The Consortium's administrative center is the Department of Outcomes Research in the Anesthesiology Institute at the Cleveland Clinic in Cleveland, Ohio, United States. The director is Daniel I. Sessler, MD and the associate director is Andrea Kurz, MD.
The Consortium differs from many organizations in not being a society, association, or foundation. Nor it is a company. In fact, the Consortium does not legally exist. A consequence is that grant funding always flows directly to members' institutions, an intentionally unusual structure designed to prevent members from having perceived conflicts of commitment between the Consortium and their academic institutions.
Consortium members were among the first anesthesia investigators to conduct large-scale outcome trials.[7][8] That is, randomized trials with meaningful "hard" primary outcomes. Large outcome trials remain a focus for the group.[9][10][11][12] They were also among the first anesthesia investigators to conduct large-scale registry research.[13][14]
Taking advantage of dense interconnected registries at the Cleveland Clinic, along with half-a-dozen national databases, the group has conducted hundreds of cohort, case-control, and health policy analyses.[15][16][17] For example, they have developed several accurate risk-stratification models which permit accurate comparisons across divergent patient groups (i.e., risk-adjusted comparisons amongst hospitals).[18][19]
Temperature regulation during surgery
Body temperature is normally tightly regulated to about 37°C (98.6°F), with women being slightly warmer than men. [20][21][22] The Consortium is perhaps best known for perioperative thermoregulation, with members having published far more on the subject than all other investigators combined.[23]
In a series of several hundred studies, for example, Consortium members identified dose-dependent effects of every major anesthetic [24][25] and sedative [26][27][28][29] on thermoregulatory control, and consequent alterations in heat balance. [30][31][32] Impaired temperature control, combined with a cold operating room environment, makes most unwarmed surgical patients hypothermic by 1-3°C. [33][34] In contrast, patients warmed with forced-air are usually normothermic by the end of surgery. [35]
Randomized trials by the Consortium have shown that just a 1-2°C reduction in body temperature markedly increases the risk of wound infection,[7] prolongs recovery and hospitalization, [36] increases blood loss and transfusion requirement, [37] and slows drug metabolism. [38][39][40][41]
150 years after their discovery, how anesthetic gases work remains unknown. They work well in all mammals, rodents, insects, worms, fish, bacteria, and even plants.[44] The dose required in various species doesn't differ much from the dose in humans. In non-human species, there are distinct genetic characteristics that clearly influence anesthetic sensitivity. But until recently, no genetic factors were known to influence anesthetic requirement in humans. In a series of studies, Consortium members have shown that the effective dose of anesthetic gases is about 20% greater in natural redheads than in people with other hair colors.[45][46]
Red hair results from a mutation of the melanocortin-1 receptor. The Consortium's results thus indicate that something about this receptor influences anesthetic action. Red hair was the first phenotype (physically apparent characteristics linked to a genetic mutation) linked to anesthetic requirement in humans, and remains the only one. Consortium research on red hair and anesthetic requirement has been covered by the San Francisco Examiner,[47]The Globe and Mail,[48]Reader's Digest,[49] and National Geographic.[50]
In further research, members of the Consortium found that redheads are resistant to local anesthetics.[51] Consequently, they are more likely to suffer pain during dental procedures — and are therefore reluctant to receive needed dental care.[52] Consortium research on red hair and dental avoidance has been covered by Macleans,[53] the Boston Herald,[54] and The New York Times.[55]
Postoperative Myocardial Injury after Noncardiac Surgery (MINS)
All-cause one-month mortality after non-cardiac surgery is about 1%; amongst inpatients, it is about 2%. In fact, if the postoperative period were considered a distinct disease, it would be the third leading cause of death in the United States. [59] The leading cause of unexpected death after otherwise routine surgery is myocardial infarction. Worldwide, 9% of surgical inpatients over the age of 45 years have a postoperative myocardial infarction — making infarctions by far the leading cause of unexpected death after otherwise routine surgery. [60] Only 15% of postoperative infarctions present with chest pain, and 65% are entirely clinically silent which means that they will not be detected without routine blood testing for troponin (a sensitive biomarker for myocardial injury). Thirty-day mortality in patients with elevated postoperative troponin (with or without symptoms) is 10% which represents a factor-of-five increase. [61]
The number-needed-to-test to detect postoperative infarctions that would otherwise be missed is roughly 1/(9%-2%) = 14 patients. This is a much smaller number than for many other tests we do routinely for conditions that are far less deadly. Consistent with this logic, the current Universal Definition of MI guidelines recommends: "Routine monitoring of cardiac biomarkers in high-risk patients after major surgery is therefore recommended." [62] Although how perioperative myocardial infarctions should be treated remains under active investigation, it is nonetheless well worth monitoring troponin to screen for infarctions because the prognosis is poor, and infarctions represent opportunities to make sure blood pressure, heart rate, and lipids are controlled. They are also an opportunity for life-style guidance, including recommendations related to smoking cessation, exercise, and diet.
How to prevent postoperative myocardial injury remains unknown. Beta blockers prevent myocardial infarctions, but at the cost of devastating strokes. [63] Avoiding nitrous oxide does not prevent infarctions, but also does no harm. [12] Aspirin also does not prevent infarctions, while promoting serious surgical bleeding.: [64] Clonidine does not prevent infarctions, while promoting serious hypotension. [65] And neither prevents acute kidney injury. [66] How to prevent perioperative myocardial injury remains under active investigation, but preventing hypotension may help. [67][68] The Consortium's work in this area was summarized in the New England Journal of Medicine. [69]
Acute and persistent surgical pain
About a hundred Consortium studies evaluate aspects of acute pain including peripheral nerve blocks and multimodal analgesia; the group is now especially interested in persistent incisional pain. Persistent pain after surgery is surprisingly common, with 10-20% of patients reporting pain 6 or 12 months after surgery. After high risk operations such as hernia repair, mastectomy, and thoracotomy, the reported risk is up to 50%. [70] Pain that persists at 12 months is often permanent, and many patients with pain report that it significantly interferes with their lives. Persistent incisional pain is notoriously difficult to treat.
What causes acute surgical pain to become persistent remains unclear. However, it seems likely to result from some combination of local tissue injury, inflammation, and abnormal activation of excitatory pain pathways. How to prevent, much less treat persistent pain remains unknown. [71] About a dozen current Consortium studies address this major public health issue.
Other research areas
Major ongoing initiatives for the consortium include acute[72][73] and chronic[74][75]pain management, automative or continuous vital sign monitoring,[76][77] fluid management,[78][79] control of the surgical stress response. [80] A recent study shows that inadequate oxygenation after surgery is surprisingly common, severe, and long-lasting. [81]
A particular interest of the group is long-term outcomes of anesthetic management. While the effects of anesthesia have traditionally been considered to dissipate within hours of surgery, there is increasing evidence that anesthetic management may alter patient outcomes weeks, months, or even years after surgery.[82] For example, unlikely as it might seem, there is strong basic science and animal evidence suggesting the regional analgesia (such as spinal and epidural blocks, or paravertebral nerve blocks) might reduce the risk of recurrence after potentially curative cancer surgery. [83] The Consortium is currently conducting several large randomized trials of regional analgesia and cancer recurrence.
Outcomes Research statisticians routinely publish methodology articles, and their analyses set standards for statistical approaches throughout the specialty. [84][85][86][87][88][89] Furthermore, the group has also developed entirely new research methods including alternating intervention studies [90] and automated trials coordinated by background decision support systems with completely electronic data acquisition — both being novel approaches to large-scale research. Consortium members also write about conduct of clinical research, and research directions. [91][92]
Consortium sites
Site directors administer the most active Consortium affiliates at universities in Dublin, Tel Aviv, Vienna, Melbourne, Kyoto, Beijing, Shanghai, Hamburg, Hamilton, and Dallas.[6]
Sevoflurane, sold under the brand name Sevorane, among others, is a sweet-smelling, nonflammable, highly fluorinated methyl isopropyl ether used as an inhalational anaesthetic for induction and maintenance of general anesthesia. After desflurane, it is the volatile anesthetic with the fastest onset. While its offset may be faster than agents other than desflurane in a few circumstances, its offset is more often similar to that of the much older agent isoflurane. While sevoflurane is only half as soluble as isoflurane in blood, the tissue blood partition coefficients of isoflurane and sevoflurane are quite similar. For example, in the muscle group: isoflurane 2.62 vs. sevoflurane 2.57. In the fat group: isoflurane 52 vs. sevoflurane 50. As a result, the longer the case, the more similar will be the emergence times for sevoflurane and isoflurane.
General anaesthesia (UK) or general anesthesia (US) is a method of medically inducing loss of consciousness that renders a patient unarousable even with painful stimuli. This effect is achieved by administering either intravenous or inhalational general anaesthetic medications, which often act in combination with an analgesic and neuromuscular blocking agent. Spontaneous ventilation is often inadequate during the procedure and intervention is often necessary to protect the airway. General anaesthesia is generally performed in an operating theater to allow surgical procedures that would otherwise be intolerably painful for a patient, or in an intensive care unit or emergency department to facilitate endotracheal intubation and mechanical ventilation in critically ill patients.
An anesthetic or anaesthetic is a drug used to induce anesthesia — in other words, to result in a temporary loss of sensation or awareness. They may be divided into two broad classes: general anesthetics, which result in a reversible loss of consciousness, and local anesthetics, which cause a reversible loss of sensation for a limited region of the body without necessarily affecting consciousness.
Awareness under anesthesia, also referred to as intraoperative awareness or accidental awareness during general anesthesia (AAGA), is a rare complication of general anesthesia where patients regain varying levels of consciousness during their surgical procedures. While anesthesia awareness is possible without resulting in any long-term memory of the experience, it is also possible for victims to have awareness with explicit recall, where they can remember the events related to their surgery.
Epidural administration is a method of medication administration in which a medicine is injected into the epidural space around the spinal cord. The epidural route is used by physicians and nurse anesthetists to administer local anesthetic agents, analgesics, diagnostic medicines such as radiocontrast agents, and other medicines such as glucocorticoids. Epidural administration involves the placement of a catheter into the epidural space, which may remain in place for the duration of the treatment. The technique of intentional epidural administration of medication was first described in 1921 by Spanish military surgeon Fidel Pagés.
Remifentanil, marketed under the brand name Ultiva is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high-dose opioid and low-dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.
Perioperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital. Globally, 4.2 million people are estimated to die within 30 days of surgery each year. An important consideration in the decision to perform any surgical procedure is to weigh the benefits against the risks. Anesthesiologists and surgeons employ various methods in assessing whether a patient is in optimal condition from a medical standpoint prior to undertaking surgery, and various statistical tools are available. ASA score is the most well known of these.
Postoperative cognitive dysfunction (POCD) is a decline in cognitive function that may last from 1–12 months after surgery, or longer. In some cases, this disorder may persist for several years after major surgery. POCD is distinct from emergence delirium. Its causes are under investigation and occurs commonly in older patients and those with pre-existing cognitive impairment.
The ASA physical status classification system is a system for assessing the fitness of patients before surgery. In 1963 the American Society of Anesthesiologists (ASA) adopted the five-category physical status classification system; a sixth category was later added. These are:
Healthy person.
Mild systemic disease.
Severe systemic disease.
Severe systemic disease that is a constant threat to life.
A moribund person who is not expected to survive without the operation.
A declared brain-dead person whose organs are being removed for donor purposes.
Guedel's classification is a means of assessing the depth of general anesthesia introduced by Arthur Ernest Guedel (1883–1956) in 1920.
David L. Reich is an American academic anesthesiologist, who has been President & Chief Operating Officer of The Mount Sinai Hospital, and President of Mount Sinai Queens, since October 2013.
Continuous wound infiltration (CWI) refers to the continuous infiltration of a local anesthetic into a surgical wound to aid in pain management during post-operative recovery.
Postanesthetic shivering (PAS) is shivering after anesthesia.
Emergence delirium is a condition in which emergence from general anesthesia is accompanied by psychomotor agitation. Some see a relation to pavor nocturnus while others see a relation to the excitement stage of anesthesia.
The history of neuraxial anaesthesia dates back to the late 1800s and is closely intertwined with the development of anaesthesia in general. Neuraxial anaesthesia, in particular, is a form of regional analgesia placed in or around the Central Nervous System, used for pain management and anaesthesia for certain surgeries and procedures.
Surgical humidification is the conditioning of insufflation gas with water vapour (humidity) and heat during surgery. Surgical humidification is used to reduce the risk of tissue drying and evaporative cooling.
Intercostal nerve block is a nerve block which temporarily or permanently interrupts the flow of signals along an intercostal nerve, usually performed to relieve pain.
Peter Kranke is anesthetist and professor of anesthesiology at the University of Würzburg, Germany. Kranke is known for the design and conduct of clinical studies and for performing systematic reviews in the context of perioperative medicine. He published numerous papers on research focussed on evidence-based medicine and interventional and observational trials on postoperative nausea and vomiting and other issues in conjunction with perioperative medicine and associated topics including patient blood management. The area of his clinical responsibility and interest, among others, is the safe provision of anesthesia and analgesia in obstetrics and gynecology.
Alex Bekker is a physician, author and academic. He is a professor and chair at the Department of Anesthesiology, Rutgers New Jersey Medical School. He is also professor at the Department of Physiology, Pharmacology & Neurosciences. He serves as the Chief of Anesthesiology Service at the University Hospital in Newark.
Alex Macario is an American anesthesiologist, academic and author. He is a vice-chair for education, a professor in the Department of Anesthesiology, Perioperative and Pain Medicine, and program director for the anesthesiology residency at Stanford University School of Medicine.
↑ Knight, Will (2002-10-15). "Red heads suffer more pain". New Scientist. Reed Business Information Ltd. Archived from the original on 2008-05-09. Retrieved 2010-06-01.
↑ "Outcomes Research Consortium: About". Outcomes Research Consortium. Retrieved 2010-06-01. By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care.
↑ Fleischmann E, Lenhardt R, Kurz A, Herbst F, Fulesdi B, Greif R, Sessler DI, Akca O (September 2005). "Nitrous oxide and risk of surgical wound infection: a randomised trial". Lancet. 366 (9491): 1101–7. doi:10.1016/s0140-6736(05)67422-3. PMID16182898. S2CID23643339.
1 2 Myles PS, Leslie K, Chan MT, Forbes A, Peyton PJ, Paech MJ, Beattie WS, Sessler DI, Devereaux PJ, Silbert B, Schricker T, Wallace S, ANZCA Trials Group for the ENIGMA-II investigators (August 2014). "The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial". Lancet. 384 (9952): 1446–54. doi:10.1016/s0140-6736(14)60893-x. PMID25142708. S2CID38720409.{{cite journal}}: CS1 maint: multiple names: authors list (link)
↑ McGuire J, Belani K, Sessler DI, Lee KA (1992). "Enflurane anesthesia and circadian temperature cycles in humans (abstract)". Anesthesiology. 77: A193. doi:10.1097/00000542-199209001-00193.
↑ Tayefeh F; Plattner O; Sessler DI; Ikeda T; Marder D. (February 1998). "Circadian changes in the sweating-to-vasoconstriction interthreshold range". Pflügers Arch. 435 (3): 402–6. doi:10.1007/s004240050530. PMID9426297. S2CID14826110.
↑ Kurz A, Go JC, Sessler DI, Kaer K, Larson M, Bjorksten AR (1995). "Alfentanil slightly increases the sweating threshold and markedly reduces the vasoconstriction and shivering thresholds". Anesthesiology. 83 (2): 293–9. doi:10.1097/00000542-199508000-00009. PMID7631951. S2CID24171472.
↑ Heier T, Clough D, Wright PM, Sharma ML, Sessler DI, Caldwell JE (2002). "The influence of mild hypothermia on the pharmacokinetics and time course of action of neostigmine in anesthetized volunteers". Anesthesiology. 97 (1): 90–5. doi:10.1097/00000542-200207000-00013. PMID12131108. S2CID19343264.
↑ The Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators (2012). "Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery". JAMA. 307 (21): 2295–304. doi:10.1001/jama.2012.5502. PMID22706835.
↑ The Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators (2014). "Myocardial injury after noncardiac surgery: A large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes". Anesthesiology. 120 (3): 564–78. doi:10.1097/ALN.0000000000000113. hdl:2434/662644. PMID24534856. S2CID205456286.
↑ P.J. Devereaux, M.D.; Daniel I. Sessler, M.D. (December 3, 2015). "Cardiac Complications in Patients Undergoing Major Noncardiac Surgery". New England Journal of Medicine. 373 (23): 2258–2269. doi:10.1056/NEJMra1502824. PMID26630144.
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