scholarly journals Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

2020 ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  

Abstract Background: Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconcile these information with legal requirements. Methods: The development, piloting and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.Discussion: The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competences to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased.Trial Registration: ClinicalTrials.gov, NCT04669483. Registered 15 December 2020, https://www.clinicaltrials.gov/ct2/show/NCT04669483?term=NCT04669483&draw=2&rank=1German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022571


2021 ◽  
Vol 23 ◽  
pp. 208-215
Author(s):  
Christian Suren ◽  
Igor Lazic ◽  
Maximilian Stephan ◽  
Florian Walter Lenze ◽  
Florian Pohlig ◽  
...  

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mark C. Kendall ◽  
Alexander D. Cohen ◽  
Stephanie Principe-Marrero ◽  
Peter Sidhom ◽  
Patricia Apruzzese ◽  
...  

Abstract Background A comparison of different anesthetic techniques to evaluate short term outcomes has yet to be performed for patients undergoing outpatient knee replacements. The aim of this investigation was to compare short term outcomes of spinal (SA) versus general anesthesia (GA) in patients undergoing outpatient total knee replacements. Methods The ACS NSQIP datasets were queried to extract patients who underwent primary, elective, unilateral total knee arthroplasty (TKA) between 2005 and 2018 performed as an outpatient procedure. The primary outcome was a composite score of serious adverse events (SAE). The primary independent variable was the type of anesthesia (e.g., general vs. spinal). Results A total of 353,970 patients who underwent TKA procedures were identified comprising of 6,339 primary, elective outpatient TKA procedures. Of these, 2,034 patients received GA and 3,540 received SA. A cohort of 1,962 patients who underwent outpatient TKA under GA were propensity matched for covariates with patients who underwent outpatient TKA under SA. SAE rates at 72 h after surgery were not greater in patients receiving GA compared to SA (0.92%, 0.66%, P = 0.369). In contrast, minor adverse events were greater in the GA group compared to SA (2.09%, 0.51%), P < 0.001. The rate of postoperative transfusion was greater in the patients receiving GA. Conclusions The type of anesthetic technique, general or spinal anesthesia does not alter short term SAEs, readmissions and failure to rescue in patients undergoing outpatient TKR surgery. Recognizing the benefits of SA tailored to the anesthetic management may maximize the clinical benefits in this patient population.


2019 ◽  
Vol 32 (08) ◽  
pp. 719-729 ◽  
Author(s):  
Jaymeson R. Arthur ◽  
Mark J. Spangehl

AbstractTourniquet use in total knee arthroplasty has become a controversial topic. There are several benefits of its use including improved visualization, decreased blood loss, shorter operative times, and improved antibiotic delivery. Conversely, there are several significant downsides associated with tourniquet use including postoperative pain, neuromuscular injuries, wound complications, reperfusion injury, increased risk of thrombosis, patellar tracking issues, delayed rehabilitation including decreased postoperative range of motion, and its negative effect on patients with vascular disease. However, objectively, the literature does not definitively push us toward or away from the use of a tourniquet. Furthermore, several alternatives have been developed to help mitigate some of the adverse effects associated with its use. This article summarizes the evidence for and against tourniquet use and provides an evidence-based approach to help guide surgeons in their own practice.


2021 ◽  
Vol 64 (4) ◽  
pp. E414-E418
Author(s):  
Andrew Buckley ◽  
Paul Duffy ◽  
Robert Korley

Background: In older adults facing knee arthroplasty, the ability to resume downhill skiing postoperatively is unclear. This study aimed to determine the perspectives of Alberta orthopedic surgeons and senior residents regarding downhill skiing after total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA). Methods: In May 2019, a Web-based survey was sent through the Alberta Orthopaedic Society to poll orthopedic surgeons performing arthroplasty and senior orthopedic residents (postgraduate year 4 or 5) in Alberta regarding the permissibility of downhill skiing after TKA or UKA. The survey also elicited information regarding under which conditions or restrictions, if any, surgeons would allow patients to return to downhill skiing, whether these recommendations were evidence based, and whether surgeons had seen complications from downhill skiing in their patients who had undergone knee arthroplasty. Results: Of the 41 respondents, 21 (51%) were full-time fellowship-trained orthopedic surgeons, 15 (37%) were specialists with some arthroplasty in their practice, and 5 (12%) were orthopedic residents. Ten of 40 respondents (25%) would allow unrestricted downhill skiing after TKA, and 1 (2%) would not allow any skiing at all. The remaining 29 (72%) indicated that they might allow downhill skiing under specific conditions, with the top 3 being limitations on speed and intensity (29 [71%]), return of full range of motion and strength in the operative knee (26 [63%]), and years of downhill ski experience (23 [56%]). Fourteen respondents (34%) would allow unrestricted downhill skiing after UKA, and 27 (66%) would allow skiing with the same top 3 conditions as for TKA. Thirty-two respondents (78%) reported that their decisions were not evidence based, and 35 (85%) had never seen complications from downhill skiing after TKA or UKA. Conclusion: Alberta orthopedic surgeons and senior residents are cautious regarding skiing after knee arthroplasty. The majority reported that their restrictions were not evidence based, which indicates the need for further investigation to develop an approach for surgeons to consistently and safely address return to downhill skiing after TKA or UKA.


2017 ◽  
Vol 20 (02) ◽  
pp. 1750009 ◽  
Author(s):  
Mohammed Tayyem ◽  
Fadi Elhadid ◽  
Ra’d Haddad ◽  
Omar Samarah ◽  
Mohammed Ananzah ◽  
...  

Purpose: Pregabalin is a new neuropathic drug that gained recent popularity in treatment of acute postoperative pain. The purpose of this study is to study the effect of pregabalin in pain management in the first 24 h after total knee arthroplasty. Methods: PubMed, Scopus, EBSCO, and Web of science were searched for randomized controlled trials that study the effect of pregabalin in the management of pain after total knee arthroplasty. Pain scores at rest and with movement and opioid consumption in the first 24 h and the occurrence of adverse events were the primary outcome measure. The statistical software RevMan 5.3 was used to analyze the statistical significance of the results. Results: A total of 5 randomized controlled trials with 608 were collected. There was no significant benefit from the use of pregabalin in the management of pain in the perioperative period in patients undergoing primary total knee arthroplasty. Pain score after 24[Formula: see text]h at rest using 150 mg/day was (MD [Formula: see text]0.53, P value 0.23). Pain score after 24 h with movement using doses less than 300 mg/day was (MD [Formula: see text]1.11, P value 0.79). Opioid intake was not significantly reduced in patient taking pregabalin using doses less than 300 mg/day or doses higher than 300 mg/day (SMD [Formula: see text]0.42, 0.59. P value 0.10, 0.42, respectively). Most of studies observed increased occurrence of adverse events with the use of pregabalin. Conclusion: This study demonstrates that pregabalin does not decrease pain scores in the first 24 h after total knee arthroplasty while it increases the occurrence of side effects.


2009 ◽  
Vol 24 (2) ◽  
pp. e6
Author(s):  
James Huddleston ◽  
William J. Maloney ◽  
Nancy Verzier ◽  
Yun Wang ◽  
David R. Hunt ◽  
...  

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