Capturing adverse events in elective orthopedic surgery: comparison of administrative, surgeon and reviewer reporting

Summary: Ensuring adverse event (AE) recording is standardized and accurate is paramount for patient safety. In this discussion, we outline our comparison of AE data collected by orthopedic surgeons and independent clinical reviewers using the Spine Adverse Events Severity System (SAVES) and Orthopedic Surgical Adverse Events Severity System (OrthoSAVES) against AE data recorded by hospital administrative discharge abstract coders. In 164 spine, hip, knee and shoulder patients, reviewers recorded significantly more AEs than coders, and coders recorded significantly more AEs than surgeons. The AEs were recorded similarly by reviewers using SAVES and OrthoSAVES in 48 spine patients. Despite our small sample size and use of different AE tools, we believe it is important to highlight that coders, surgeons and reviewers recorded AEs differently. While further investigations on its utility and cost-effectiveness are necessary, we assert that it is feasible to use Ortho-SAVES to prospectively record AEs across all orthopedic subspecialties.

Systematic Review and Meta-analysis of Restrictive Perioperative Fluid Management in Pancreaticoduodenectomy.

BACKGROUND: There is significant interest and controversy surrounding the effect of restrictive fluid management on outcomes in major gastrointestinal surgery. This has been most studied in colorectal surgery, although the literature relating to pancreaticoduodenectomy (PD) patients is growing. The aim of this paper was to generate a comprehensive review of the available evidence for restrictive perioperative fluid management strategies and outcomes in PD. METHODS: MEDLINE/PubMed, Embase, and the Cochrane Library were searched from inception to April 2017. A review protocol was utilized and registered with PROSPERO. Primary citations that evaluated perioperative fluid management in PD, including those as part of a clinical pathway, were considered. The primary outcome was postoperative pancreatic fistula (POPF). Secondary outcomes included delayed gastric emptying (DGE), complication rate, length of stay (LOS), mortality, and readmission. RESULTS: A total of six studies involving 846 patients were included (2009-2015), of which four were RCTs. Pooled analysis of RCTs and high-quality observational studies found no effect of restrictive intraoperative fluid management on POPF, DGE, complication rate, LOS, mortality, and readmission. Only one study assessed postoperative fluid management exclusively and found prolonged LOS in patients in the restricted fluid group. CONCLUSION: Based on results of RCTs and high-quality observational studies, intraoperative fluid restriction in PD has not been shown to significantly affect postoperative outcomes. There are too few studies assessing postoperative fluid management to draw conclusions at this time.

Use and acceptance of the International Study Group for Pancreatic Fistula (ISGPF) definition and criteria in the surgical literature.

BACKGROUND: The level of utilization and acceptance of the 2005 International Study Group for Pancreatic Fistula (ISGPF) definition for postoperative pancreatic fistula (POPF) has not be quantified. The aim of this study was to determine the uptake of the ISGPF definition and evaluate its use in the surgical literature. METHODS: A sample of primary studies, review articles, and textbooks were identified through screening of literature searches. Included citations were assessed for their definition of POPF and use of the ISGPF criteria. RESULTS: From 2006 to 2009, 6%-63% of primary papers were compliant with the ISGPF definition compared to 84%-98% from 2010 onwards. Of the primary studies compliant with the ISGPF criteria, 36% focused on grade B and C fistula and 15% did not report grade A fistula. 88% of European papers used the criteria compared to 77% and 72% of Asian and North American papers, respectively (p = 0.033). 46% of review articles and textbooks did not define POPF. Among those that defined POPF, 74% cited the ISGPF definition exclusively while 26% mentioned other definitions. CONCLUSION: The ISGPF criteria have been widely adopted and accepted as the standard for defining POPF, although the utility of grade A fistulas is questionable.

Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer.

PURPOSE: High complication rates following colorectal surgery render many patients unable to fully regain functional capacity, thus seriously compromising quality of life. The aim of this study was to assess whether a 4-week trimodal prehabilitation program (exercise, nutritional supplementation, and counseling on relaxation techniques), implemented during the preoperative period, is sufficient to modify exercise behaviors and improve functional capacity of elderly patients scheduled for colorectal cancer surgery. METHODS: Patients were assigned to either a prehabilitation (PREHAB; n = 57) or matched time control group (CTRL; n = 59). Over the 4-week period prior to surgery, patients in PREHAB participated in a trimodal prehabilitation program. Patients in CTRL received the same program but only postoperatively. The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire was used to measure physical activity levels, while the 6-min walk test (6MWT) was used for assessment of functional walking capacity. Measurements were collected at baseline and at the time of surgery. RESULTS: Over the preoperative period, patients in PREHAB significantly increased the amount of moderate- and vigorous-intensity physical activities that they performed. PREHAB patients also demonstrated a greater improvement in 6MWT compared to CTRL. At the time of surgery, a greater proportion of patients in PREHAB met current physical activity guidelines, as compared to CTRL. CONCLUSIONS: These findings highlight the positive effects of a trimodal prehabilitation program on patients' physical activity levels and functional walking capacity and demonstrate that modifying exercise behaviors and improving physical function within the 4-week preoperative period are an achievable goal.

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES?

BACKGROUND: Physicians have consistently shown poor adverse-event reporting practices in the literature and yet they have the clinical acumen to properly stratify and appraise these events. The Spine Adverse Events Severity System (SAVES) and Orthopaedic Surgical Adverse Events Severity System (OrthoSAVES) are standardized assessment tools designed to record adverse events in orthopaedic patients. These tools provide a list of prespecified adverse events for users to choose from-an aid that may improve adverse-event reporting by physicians. QUESTIONS/PURPOSES: The primary objective was to compare surgeons' adverse-event reporting with reporting by independent clinical reviewers using SAVES Version 2 (SAVES V2) and OrthoSAVES in elective orthopaedic procedures. METHOD: This was a 10-week prospective study where SAVES V2 and OrthoSAVES were used by six orthopaedic surgeons and two independent, non-MD clinical reviewers to record adverse events after all elective procedures to the point of patient discharge. Neither surgeons nor reviewers received specific training on adverse-event reporting. Surgeons were aware of the ongoing study, and reported adverse events based on their clinical interactions with the patients. Reviewers recorded adverse events by reviewing clinical notes by surgeons and other healthcare professionals (such as nurses and physiotherapists). Adverse events were graded using the severity-grading system included in SAVES V2 and OrthoSAVES. At discharge, adverse events recorded by surgeons and reviewers were recorded in our database. RESULTS: Adverse-event data for 164 patients were collected (48 patients who had spine surgery, 51 who had hip surgery, 34 who had knee surgery, and 31 who had shoulder surgery). Overall, 99 adverse events were captured by the reviewers, compared with 14 captured by the surgeons (p < 0.001). Surgeons adequately captured major adverse events, but failed to record minor events that were captured by the reviewers. A total of 93 of 99 (94%) adverse events reported by reviewers required only simple or minor treatment and had no long-term adverse effect. Three patients experienced adverse events that resulted in use of invasive or complex treatment that had a temporary adverse effect on outcome. CONCLUSION: Using SAVES V2 and OrthoSAVES, independent reviewers reported more minor adverse events compared with surgeons. The value of third-party reviewers requires further investigation in a detailed cost-benefit analysis. LEVEL OF EVIDENCE: Level II, therapeutic study.

Impact of Definition and Timeframe on Capturing Surgery-Related Readmissions After Primary Joint Arthroplasty.

BACKGROUND: Readmission rate has emerged as an important metric to measure quality, but varying definitions and timeframes are used. We aimed to evaluate the impact of different readmission definitions (postoperative vs postdischarge) and timeframes (30 vs 90-day) on capturing surgery-related readmissions after primary total joint arthroplasty. METHODS: Patients who underwent primary total hip or knee arthroplasty between January 1, 2013 and December 31, 2015 were included. The electronic medical records of readmitted patients were reviewed to determine whether a surgery-related event was most responsible for readmission. The performances of 4 definition-timeframe combinations in capturing surgery-related readmissions were evaluated. RESULTS: A total of 2586 patients were included. Using both postoperative and postdischarge definitions, there were no differences in the proportion of readmissions that were surgery-related when comparing 30 and 90-day timeframes (postoperative: 71% vs 60%, P = .118; postdischarge: 68% vs 60%, P = .219). Greater proportion of readmissions between days 0 and 30 were for surgery-related reasons compared with readmissions between days 31 and 90 using both postoperative and postdischarge definitions (postoperative: 71% vs 47%, P = .005; postdischarge: 68% vs 49%, P = .022). Among 104 patients readmitted for surgery-related reasons within 1 year of discharge, 52% were readmitted within 30 days of surgery compared with 79% within 90 days (P < .001). Similarly, 53% and 81% of readmissions were captured by the 30 and 90-day postdischarge definitions, respectively (P < .001). CONCLUSION: A 90-day timeframe is superior in capturing surgery-related readmissions after total joint arthroplasty. Important Total hip and knee arthroplasty adverse events may be missed using a 30-day timeframe.

In meeting the increasing demands for total knee arthroplasty, can we achieve high levels of quality care in a small community hospital? A mixed-methods study.

Purpose: Small community hospitals (SCHs) help meet the demand for total knee arthroplasty (TKA). This mixed-methods study compares outcomes and analyses of environmental differences following TKA at a SCH and a tertiary care hospital (TCH). Methods: Quantitative: A retrospective review of 352 propensity-matched primary TKA procedures at both a SCH and a TCH, based on age, body mass index, and American Society of Anesthesiologists class, was completed. Groups were compared by length of stay (LOS), 90-day emergency department visits, 90-day readmissions, reoperations, and mortality. Qualitative: Based on the Theoretical Domains Framework, seven prospective semistructured interviews were performed. Interview transcripts were coded and belief statements were generated and summarized by two reviewers. Discrepancies were resolved by a third reviewer. Results: Quantitative: The average LOS for the SCH was significantly shorter than that for the TCH (2.0 ± 0.2 vs. 3.6 ± 2.7 days; p < 0.001), a difference that persisted following a subgroup analysis of ASA I/II patients (2.0 ± 0.2 vs. 3.2 ± 2.2; p < 0.001). There were no significant differences in other outcomes. Qualitative: The main themes that revolved around a higher case load for physiotherapy at the TCH resulted in patients waiting longer to be mobilized after surgery. Patient disposition also affected their discharge rates. Conclusion: Given the increasing demand for TKA, the SCH represents a viable option to increase capacity, while reducing LOS. Future directions to reduce LOS include addressing social barriers to discharge and patient prioritization for assessment by allied health services. When TKA is performed by the same set of surgeons, the SCH provides quality care with a shorter LOS and comparable with urban hospitals, and this can be attributed to the differences in resource utilization in the two hospital settings.

Multilayer Watertight Closure to Address Adverse Events From Primary Total Knee and Hip Arthroplasty: A Systematic Review of Wound Closure Methods by Tissue Layer.

BACKGROUND: Wound closure is a key, and often underrecognized, component of hip and knee arthroplasty. Methods for wound closure are an important consideration to better avoid wound-related adverse events; however, there is a lack of consensus on optimal methods. The objective of the following review was twofold: to characterize the wound closure methods used by layer in the total knee arthroplasty and total hip arthroplasty literature and summarize optimal wound-healing strategies to address the risk of adverse events. METHODS: A systematic literature review was performed to identify total knee arthroplasty and total hip arthroplasty randomized controlled trials and nonrandomized studies reporting wound closure methods by layer and wound-healing adverse events (including superficial, deep, or periprosthetic joint infections, wound dehiscence, or prolonged wound drainage). Studies on revision procedures were excluded. Wound closure methods and adverse events were summarized qualitatively as meta-analyses were not possible because of study heterogeneity. RESULTS: Forty studies met the inclusion criteria: 22 randomized controlled trials and 18 observational studies. Across studies, 6 categories and 22 unique techniques for closure were identified. Conventional closure methods exhibited large ranges of adverse event rates. Studies of multilayer barbed sutures with topical skin adhesives and polyester mesh or multilayer antimicrobial sutures reported narrow ranges of adverse events rates. CONCLUSIONS: Considerable variability exists for wound closure methods, with a wide range reported in adverse events. Recent technologies and methods for standardized watertight, multilayer closure show promise for avoiding adverse events and unnecessary health-care costs; however, higher quality, comparative studies are required to enable future meta-analyses. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Economic and clinical outcomes of spinal fusion surgeries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape.

BACKGROUND CONTEXT: Spinal fusion surgeries are one of the most common types of operations performed during inpatient stays in the United States. Successful wound closure, including watertight closure at the skin layer, plays in important role in patient outcomes. PURPOSE: To compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (SSWWD) or 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT). STUDY DESIGN/SETTING: Retrospective study using a multi-hospital database. PATIENT SAMPLE: Patients undergoing inpatient spinal fusion surgery for a spine disorder between October 1, 2015 and March 31, 2019. OUTCOME MEASURES: Total costs from the hospital perspective, operating room time (ORT), hospital length of stay (LOS), non-home discharge, infection/wound complications during the 90-day global period (index surgery through 90 days post-discharge), and 30/60/90-day all-cause readmissions. METHODS: Outcomes were compared between study groups using nearest neighbor propensity score matching with exact matching on 45 primary procedure/diagnosis code groupings and generalized estimating equations to account for hospital-level clustering. This study was sponsored by Ethicon, Inc., a Johnson & Johnson company; the authors are employees or consultants of Johnson & Johnson. RESULTS: A total of 11,991 patients met the study criteria (2OPMT=5,961; SSWWD=6,030), of which 3,602 were included in each post-match study comparison group (total=7,204). As compared with the SSWWD group, the 2OPMT group had statistically significant lower median ORT (240 vs. 270 minutes; p=0.002), mean LOS (3.35 [SD=2.6] vs. 3.86 [SD=2.8] days, p=0.031), risks of non-home discharge status (17.63% vs. 23.10%, p=0.035), overall infections/wound complications (1.37% vs. 2.48%, p=0.015), and surgical site infection (1.11% vs. 2.07%, p=0.023). Differences between the study groups in total hospital costs, all-cause readmissions, and other sub-components of the infection/wound complication composite outcome were statistically insignificant (p>0.05). CONCLUSIONS: In this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2OPMT for skin closure was associated with significantly lower ORT, LOS, non-home discharge, and 90-day rates of infections/wound complications as compared with SSWWD.

Global hospital and operative costs associated with various ventral cavity procedures: a comprehensive literature review and analysis across regions.

Objectives: The aim of this literature review was to provide a comprehensive report on hospital costs, and cost components, for a range of ventral cavity surgical procedures across three regions of focus: (1) Americas, (2) Europe, Middle East and Africa (EMEA), and (3) Asia-Pacific. Methods: A structured search was performed and utilized a combination of controlled vocabulary (e.g., "Hepatectomy", "Colectomy", "Costs and Cost Analysis") and keywords (e.g. "liver resection", "bowel removal", "economics"). Studies were considered eligible for inclusion if they reported hospital-related costs associated with the procedures of interest. Cost outcomes included operating room (OR) time costs, total OR costs, ward stay costs, total admission costs, OR cost per minute and ward cost per day. All costs were converted to 2018 USD. Results: Total admission costs were observed to be highest in the Americas, with an average cost of $15,791. The average OR time cost per minute was found to vary by region: $24.83 (Americas), $14.29 (Asia-Pacific), and $13.90 (EMEA). A cost-breakdown demonstrated that OR costs typically comprised close to 50%, or more, of hospital admission costs. This review also demonstrates that decreasing OR time by 30 min provides cost savings approximately equivalent to a 1-day reduction in ward time. Conclusion: This literature review provided a comprehensive assessment of hospital costs across various surgical procedures, approaches, and geographical regions. Our findings indicate that novel processes and healthcare technologies that aim to reduce resources such as operating time and hospital stay, can potentially provide resource savings for hospital payers.

A pilot validation study of crowdsourcing systematic reviews: update of a searchable database of pediatric clinical trials of high-dose vitamin D.

BACKGROUND: Completing large systematic reviews and maintaining them up to date poses significant challenges. This is mainly due to the toll required of a small group of experts to screen and extract potentially eligible citations. Automated approaches have failed so far in providing an accessible and adaptable tool to the research community. Over the past decade, crowdsourcing has become attractive in the scientific field, and implementing it in citation screening could save the investigative team significant work and decrease the time to publication. METHODS: Citations from the 2015 update of a pediatrics vitamin D systematic review were uploaded to an online platform designed for crowdsourcing the screening process (http://www.CHEORI.org/en/CrowdScreenOverview). Three sets of exclusion criteria were used for screening, with a review of abstracts at level one, and full-text eligibility determined through two screening stages. Two trained reviewers, who participated in the initial systematic review, established citation eligibility. In parallel, each citation received four independent assessments from an untrained crowd with a medical background. Citations were retained or excluded if they received three congruent assessments. Otherwise, they were reviewed by the principal investigator. Measured outcomes included sensitivity of the crowd to retain eligible studies, and potential work saved defined as citations sorted by the crowd (excluded or retained) without involvement of the principal investigator. RESULTS: A total of 148 citations for screening were identified, of which 20 met eligibility criteria (true positives). The four reviewers from the crowd agreed completely on 63% (95% CI: 57-69%) of assessments, and achieved a sensitivity of 100% (95% CI: 88-100%) and a specificity of 99% (95% CI: 96-100%). Potential work saved to the research team was 84% (95% CI: 77-89%) at the abstract screening stage, and 73% (95% CI: 67-79%) through all three levels. In addition, different thresholds for citation retention and exclusion were assessed. With an algorithm favoring sensitivity (citation excluded only if all four reviewers agree), sensitivity was maintained at 100%, with a decrease of potential work saved to 66% (95% CI: 59-71%). In contrast, increasing the threshold required for retention (exclude all citations not obtaining 3/4 retain assessments) decreased sensitivity to 85% (95% CI: 65-96%), while improving potential workload saved to 92% (95% CI: 88-95%). CONCLUSIONS: This study demonstrates the accuracy of crowdsourcing for systematic review citations screening, with retention of all eligible articles and a significant reduction in the work required from the investigative team. Together, these two findings suggest that crowdsourcing could represent a significant advancement in the area of systematic review. Future directions include further study to assess validity across medical fields and determination of the capacity of a non-medical crowd.

Assessment of selective motor control in clinical Gillette's test using electromyography.

BACKGROUND: Selective motor control (SMC), the ability to isolate selected muscle activation during a functional task, is often impaired. Gillette's SMC scale is commonly used to classify the impairment level; however it may not be sensitive to muscle coactivation. AIM: To characterize differences in muscle activation levels and coactivation incidence in Gillette's SMC grade levels. DESIGN: Non-randomized observational study. SETTING: Participants were recruited and examined in the motion analysis laboratory of a university hospital. POPULATION: Forty-two participants were enrolled: 23 patients with CP (13 females, 10 males; 15±5.59 years, range: 7-28 years; bilateral involvement; GMFCS levels I to III) and 19 able-bodied volunteers (14 females, 5 males; 22±1.54 years, range: 20-24 years). METHODS: Participants flexed each knee three times at self-paced velocity. Each limb was classified into one of three types using Gillette's SMC scale: Type 0 (CP limbs with no ability to isolate movement), Type 2 (CP limbs with complete isolation of movement) and Type C (Control limbs of able-bodied volunteers). Surface electromyography recorded muscle activation levels of hamstring, rectus femoris, hip adductor, gastrocnemius and tibialis anterior muscles. We applied the Friedman ANOVA χ2 Test to analyze muscle co-activation incidence and Kruskal-Wallis ANOVA and Median Tests to analyze muscle activation levels. We used the Wilcoxon Matched-Pairs Test to compare results between SMC Types. RESULTS: Comparing mean activation levels of the majority of muscles, we found: CP limbs (Type 0+2) > Control limbs (P<0.001); Type 0 > Type 2 (P<0.05); and Type 2 > Type C (P<0.01). The incidence of muscle co-activation was affected by CP (P=0.008) and differed by SMC type (P<0.001). CONCLUSIONS: Our quantitative study confirmed that SMC is worse in Gillette's Type 0 limbs than in Type 2 limbs. We also found that the SMC of Type 2 limbs of CP patients in CP patents is not equivalent to that of Type 2 limbs in able-bodied volunteers. CLINICAL REHABILITATION IMPACT: A better characterization of this clinical test will help gauge its usefulness in evaluating the effectiveness of rehabilitation treatments.

Micro CT Analysis of Spine Architecture in a Mouse Model of Scoliosis.

OBJECTIVE: Mice homozygous for targeted deletion of the gene encoding fibroblast growth factor receptor 3 (FGFR3(-/-)) develop kyphoscoliosis by 2 months of age. The first objective of this study was to use high resolution X-ray to characterize curve progression in vivo and micro CT to quantify spine architecture ex vivo in FGFR3(-/-) mice. The second objective was to determine if slow release of the bone anabolic peptide parathyroid hormone related protein (PTHrP-1-34) from a pellet placed adjacent to the thoracic spine could inhibit progressive kyphoscoliosis. MATERIALS AND METHODS: Pellets loaded with placebo or PTHrP-1-34 were implanted adjacent to the thoracic spine of 1-month-old FGFR3(-/-) mice obtained from in house breeding. X rays were captured at monthly intervals up to 4 months to quantify curve progression using the Cobb method. High resolution post-mortem scans of FGFR3(-/-) and FGFR3(+/+) spines, from C5/6 to L4/5, were captured to evaluate the 3D structure, rotation, and micro-architecture of the affected vertebrae. Un-decalcified and decalcified histology were performed on the apical and adjacent vertebrae of FGFR3(-/-) spines, and the corresponding vertebrae from FGFR3(+/+) spines. RESULTS: The mean Cobb angle was significantly greater at all ages in FGFR3(-/-) mice compared with wild type mice and appeared to stabilize around skeletal maturity at 4 months. 3D reconstructions of the thoracic spine of 4-month-old FGFR3(-/-) mice treated with PTHrP-1-34 revealed correction of left/right asymmetry, vertebral rotation, and lateral displacement compared with mice treated with placebo. Histologic analysis of the apical vertebrae confirmed correction of the asymmetry in PTHrP-1-34 treated mice, in the absence of any change in bone volume, and a significant reduction in the wedging of intervertebral disks (IVD) seen in placebo treated mice. CONCLUSION: Local treatment of the thoracic spine of juvenile FGFR3(-/-) mice with a bone anabolic agent inhibited progression of scoliosis, but with little impact on kyphosis. The significant improvement in IVD integrity suggests PTHrP-1-34 might also be considered as a therapeutic agent for degenerative disk disorders.