Browsing by Author "Roberts, Derek J"

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    Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations
    (2019-08-27) Roberts, Derek J; Zygun, David A; Ball, Chad G; Kirkpatrick, Andrew W; Faris, Peter D; James, Matthew T; Mrklas, Kelly J; Hemmelgarn, Brenda D; Manns, Braden; Stelfox, Henry T
    Abstract Background As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. Main Body In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. Conclusion We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
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    Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
    (2018-06-22) Kirkpatrick, Andrew W; Coccolini, Federico; Ansaloni, Luca; Roberts, Derek J; Tolonen, Matti; McKee, Jessica L; Leppaniemi, Ari; Faris, Peter; Doig, Christopher J; Catena, Fausto; Fabian, Timothy; Jenne, Craig N; Chiara, Osvaldo; Kubes, Paul; Manns, Braden; Kluger, Yoram; Fraga, Gustavo P; Pereira, Bruno M; Diaz, Jose J; Sugrue, Michael; Moore, Ernest E; Ren, Jianan; Ball, Chad G; Coimbra, Raul; Balogh, Zsolt J; Abu-Zidan, Fikri M; Dixon, Elijah; Biffl, Walter; MacLean, Anthony; Ball, Ian; Drover, John; McBeth, Paul B; Posadas-Calleja, Juan G; Parry, Neil G; Di Saverio, Salomone; Ordonez, Carlos A; Xiao, Jimmy; Sartelli, Massimo
    Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Principles of treatment include early antibiotic administration and operative source control. A further therapeutic option may be open abdomen (OA) management with active negative peritoneal pressure therapy (ANPPT) to remove inflammatory ascites and ameliorate the systemic damage from SCIAS. Although there is now a biologic rationale for such an intervention as well as non-standardized and erratic clinical utilization, this remains a novel therapy with potential side effects and clinical equipoise. Methods The Closed Or Open after Laparotomy (COOL) study will constitute a prospective randomized controlled trial that will randomly allocate eligible surgical patients intra-operatively to either formal closure of the fascia or use of the OA with application of an ANPTT dressing. Patients will be eligible if they have free uncontained intra-peritoneal contamination and physiologic derangements exemplified by septic shock OR a Predisposition-Infection-Response-Organ Dysfunction Score ≥ 3 or a World-Society-of-Emergency-Surgery-Sepsis-Severity-Score ≥ 8. The primary outcome will be 90-day survival. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy. Bio-mediator outcomes for participating centers will involve measurement of interleukin (IL)-6 and IL-10, procalcitonin, activated protein C (APC), high-mobility group box protein-1, complement factors, and mitochondrial DNA. Economic outcomes will comprise standard costing for utilization of health-care resources. Discussion Although facial closure after SCIAS is considered the current standard of care, many reports are suggesting that OA management may improve outcomes in these patients. This trial will be powered to demonstrate a mortality difference in this highly lethal and morbid condition to ensure critically ill patients are receiving the best care possible and not being harmed by inappropriate therapies based on opinion only. Trial registration ClinicalTrials.gov , NCT03163095 .
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    Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra- peritoneal Vacuum Trial): study protocol for a randomized controlled trial
    (BioMed Central, 2013-05-16) Roberts, Derek J; Jenne, Craig N; Ball, Chad G; Tiruta, Corina; Léger, Caroline; Xiao, Zhengwen; Faris, Peter D; McBeth, Paul B; Doig, Christopher J; Skinner, Christine R; Ruddell, Stacy G; Kubes, Paul; Kirkpatrick, Andrew W
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    Getting the invite list right: a discussion of sepsis severity scoring systems in severe complicated intra-abdominal sepsis and randomized trial inclusion criteria
    (2018-04-06) Tolonen, Matti; Coccolini, Federico; Ansaloni, Luca; Sartelli, Massimo; Roberts, Derek J; McKee, Jessica L; Leppaniemi, Ari; Doig, Christopher J; Catena, Fausto; Fabian, Timothy; Jenne, Craig N; Chiara, Osvaldo; Kubes, Paul; Kluger, Yoram; Fraga, Gustavo P; Pereira, Bruno M; Diaz, Jose J; Sugrue, Michael; Moore, Ernest E; Ren, Jianan; Ball, Chad G; Coimbra, Raul; Dixon, Elijah; Biffl, Walter; MacLean, Anthony; McBeth, Paul B; Posadas-Calleja, Juan G; Di Saverio, Salomone; Xiao, Jimmy; Kirkpatrick, Andrew W
    Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) is a worldwide challenge with increasing incidence. Open abdomen management with enhanced clearance of fluid and biomediators from the peritoneum is a potential therapy requiring prospective evaluation. Given the complexity of powering multi-center trials, it is essential to recruit an inception cohort sick enough to benefit from the intervention; otherwise, no effect of a potentially beneficial therapy may be apparent. An evaluation of abilities of recognized predictive systems to recognize SCIAS patients was conducted using an existing intra-abdominal sepsis (IAS) database. Methods All consecutive adult patients with a diffuse secondary peritonitis between 2012 and 2013 were collected from a quaternary care hospital in Finland, excluding appendicitis/cholecystitis. From this retrospectively collected database, a target population (93) of those with either ICU admission or mortality were selected. The performance metrics of the Third Consensus Definitions for Sepsis and Septic Shock based on both SOFA and quick SOFA, the World Society of Emergency Surgery Sepsis Severity Score (WSESSSS), the APACHE II score, Manheim Peritonitis Index (MPI), and the Calgary Predisposition, Infection, Response, and Organ dysfunction (CPIRO) score were all tested for their discriminant ability to identify this subgroup with SCIAS and to predict mortality. Results Predictive systems with an area under-the-receiving-operating characteristic (AUC) curve > 0.8 included SOFA, Sepsis-3 definitions, APACHE II, WSESSSS, and CPIRO scores with the overall best for CPIRO. The highest identification rates were SOFA score ≥ 2 (78.4%), followed by the WSESSSS score ≥ 8 (73.1%), SOFA ≥ 3 (75.2%), and APACHE II ≥ 14 (68.8%) identification. Combining the Sepsis-3 septic-shock definition and WSESSS ≥ 8 increased detection to 80%. Including CPIRO score ≥ 3 increased this to 82.8% (Sensitivity-SN; 83% Specificity-SP; 74%. Comparatively, SOFA ≥ 4 and WSESSSS ≥ 8 with or without septic-shock had 83.9% detection (SN; 84%, SP; 75%, 25% mortality). Conclusions No one scoring system behaves perfectly, and all are largely dominated by organ dysfunction. Utilizing combinations of SOFA, CPIRO, and WSESSSS scores in addition to the Sepsis-3 septic shock definition appears to offer the widest “inclusion-criteria” to recognize patients with a high chance of mortality and ICU admission. Trial registration https://clinicaltrials.gov/ct2/show/NCT03163095 ; Registered on May 22, 2017.
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    Incidence, prevalence, and occurrence rate of infection among adults hospitalized after traumatic brain injury: study protocol for a systematic review and meta-analysis
    (BioMed Central, 2013-08-24) Scott, Brittney NV; Roberts, Derek J; Robertson, Helen Lee; Kramer, Andreas H; Laupland, Kevin B; Ousman, Shalina S; Kubes, Paul; Zygun, David A
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    Outcomes of selective nonoperative management of civilian abdominal gunshot wounds: a systematic review and meta-analysis
    (2018-11-27) Al Rawahi, Aziza N; Al Hinai, Fatma A; Boyd, Jamie M; Doig, Christopher J; Ball, Chad G; Velmahos, George C; Kirkpatrick, Andrew W; Navsaria, Pradeep H; Roberts, Derek J
    Abstract Background Although mandatory laparotomy has been standard of care for patients with abdominal gunshot wounds (GSWs) for decades, this approach is associated with non-therapeutic operations, morbidity, and long hospital stays. This systematic review and meta-analysis sought to summarize outcomes of selective nonoperative management (SNOM) of civilian abdominal GSWs. Methods We searched electronic databases (March 1966–April 1, 2017) and reference lists of articles included in the systematic review for studies reporting outcomes of SNOM of civilian abdominal GSWs. We meta-analyzed the associated risks of SNOM-related failure (defined as laparotomy during hospital admission), mortality, and morbidity across included studies using DerSimonian and Laird random-effects models. Between-study heterogeneity was assessed by calculating I2 statistics and conducting tests of homogeneity. Results Of 7155 citations identified, we included 41 studies [n = 22,847 patients with abdominal GSWs, of whom 6777 (29.7%) underwent SNOM]. The pooled risk of failure of SNOM in hemodynamically stable patients without a reduced level of consciousness or signs of peritonitis was 7.0% [95% confidence interval (CI) = 3.9–10.1%; I2 = 92.6%, homogeneity p < 0.001] while the pooled mortality associated with use of SNOM in this patient population was 0.4% (95% CI = 0.2–0.6%; I2 = 0%, homogeneity p > 0.99). In patients who failed SNOM, the pooled estimate of the risk of therapeutic laparotomy was 68.0% (95% CI = 58.3–77.7%; I2 = 91.5%; homogeneity p < 0.001). Risks of failure of SNOM were lowest in studies that evaluated patients with right thoracoabdomen (3.4%; 95% CI = 0–7.0%; I2 = 0%; homogeneity p = 0.45), flank (7.0%; 95% CI = 3.9–10.1%), and back (3.1%; 95% CI = 0–6.5%) GSWs and highest in those that evaluated patients with anterior abdomen (13.2%; 95% CI = 6.3–20.1%) GSWs. In patients who underwent mandatory abdominopelvic computed tomography (CT), the pooled risk of failure was 4.1% versus 8.3% in those who underwent selective CT (p = 0.08). The overall sample-size-weighted mean hospital length of stay among patients who underwent SNOM was 6 days versus 10 days if they failed SNOM or developed an in-hospital complication. Conclusions SNOM of abdominal GSWs is safe when conducted in hemodynamically stable patients without a reduced level of consciousness or signs of peritonitis. Failure of SNOM may be lower in patients with GSWs to the back, flank, or right thoracoabdomen and be decreased by mandatory use of abdominopelvic CT scans.