Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial

<p>Abstract</p> <p>Background</p> <p>Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA.</p> <p>Methods/Design</p> <p>Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed.</p> <p>Discussion</p> <p>The results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry <url>http://www.trialregister.nl</url>: trial number <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1462">NTR1462</a>.</p

"Idealized" vs. "true" learning curves: The case of laparoscopic liver resection

Background Learning curves are believed to resemble an "idealized" model, in which continuous improvement occurs until a plateau is reached. We hypothesized that this "idealized" model would not adequately describe the learning process for a complex surgical technique, specifically laparoscopic liver resection (LLR). Methods We analyzed the first 150 LLRs performed by a surgeon with expertise in hepatobiliary/laparoscopic surgery but with no previous LLR experience. We divided the procedures performed in 5 consecutive groups of 30 procedures, then compared groups in terms of complications, operative time, length of stay, and estimated blood loss. Results We observed an increase in operative complexity (3.3% major operations in Group 1 vs. 23.3% in Group 5, p = 0.05). Complications decreased from Group 1 to Group 2 (20%-3%), but increased again as more complex procedures were performed (3% in Group 2-13% in Group 5). Similar improvement/regression patterns were observed for operative time and EBL. Discussion The "true" learning curve for LLR is more appropriately described as alternating periods of improvement and regression until mastery is achieved. Surgeons should understand the true learning curves of procedures they perform, recognizing and mitigating the increased risk they assume by taking on more complex procedures

The impact of major intraoperative adverse events on hospital readmissions

Hospital-wide readmission rates recently became a recognized benchmarking quality metric. We sought to study the independent impact of major intraoperative adverse events (iAEs) on 30-day readmission in abdominal surgery. The 2007 to 2012 institutional American College of Surgeons National Surgical Quality Improvement Program and administrative databases for abdominal operations were matched then screened for iAEs using the International Classification of Diseases, 9th Revision, Clinical Modification–based Patient Safety Indicator “Accidental Puncture/Laceration”. Flagged charts were reviewed to confirm the presence of iAEs. Major iAEs were defined as class 3 or above, as per our recently validated iAE Classification System. The inpatient database was queried for readmission within 30 days from discharge. Univariate and multivariable models were constructed to analyze the independent impact of major iAEs on readmission, controlling for demographics, comorbidities, American Society of Anesthesiology class, and procedure type/approach/complexity (using relative value units as proxy). Reasons for readmission were investigated using the Agency for Healthcare Research and Quality's International Classification of Diseases, 9th Revision, Clinical Modification–based Clinical Classification Software. Of 9,274 surgical procedures; 921 resulted in readmission (9.9%), 183 had confirmed iAEs, 73 of which were major iAEs. Procedures with major iAEs had a higher readmission rate compared with procedures with no iAEs [24.7% vs 9.8%, P < .001]. In multivariable analyses, major iAEs were independently associated with a 2-fold increase in readmission rates [OR = 2.17 (95% CI = 1.22 to 3.86); P = .008]; 67% of readmissions after major iAEs were caused by “complications of surgical procedures or medical care” as defined by Agency for Healthcare Research and Quality. Major iAEs are independently associated with increased rates of 30-day readmission. Preventing iAEs or mitigating their effects can serve as a quality improvement target to decrease surgical readmissions. •Patients experiencing major intraoperative adverse events (iAEs) are more likely to be readmitted to the hospital.•Major iAEs are independently associated with a 2-fold increase in readmissions.•Prevention of major iAEs should be a target for surgical quality improvement efforts

The Surgeon as the Second Victim? Results of the Boston Intraoperative Adverse Events Surgeons' Attitude (BISA) Study

An intraoperative adverse event (iAE) is often directly attributable to the surgeon's technical error and/or suboptimal intraoperative judgment. We aimed to examine the psychological impact of iAEs on surgeons as well as the surgeons' attitude about iAE reporting. We conducted a web-based cross-sectional survey of all surgeons at 3 major teaching hospitals of the same university. The 29-item questionnaire was developed using a systematic closed and open approach focused on assessing the surgeons' personal account of iAE incidence, emotional response to iAEs, available support systems, and perspective about the barriers to iAE reporting. The response rate was 44.8% (n = 126). Mean age of respondents was 49 years, 77% were male, and 83% performed >150 procedures/year. During the last year, 32% recalled 1 iAE, 39% recalled 2 to 5 iAEs, and 9% recalled >6 iAEs. The emotional toll of iAEs was significant, with 84% of respondents reporting a combination of anxiety (66%), guilt (60%), sadness (52%), shame/embarrassment (42%), and anger (29%). Colleagues constituted the most helpful support system (42%) rather than friends or family; a few surgeons needed psychological therapy/counseling. As for reporting, 26% preferred not to see their individual iAE rates, and 38% wanted it reported in comparison with their aggregate colleagues' rate. The most common barriers to reporting iAEs were fear of litigation (50%), lack of a standardized reporting system (49%), and absence of a clear iAE definition (48%). Intraoperative AEs occur often, have a significant negative impact on surgeons' well-being, and barriers to transparency are fear of litigation and absence of a well-defined reporting system. Efforts should be made to support surgeons and standardize reporting when iAEs occur

Creation of the first Hartford Consensus compliant elementary school in the USA

Background: The Hartford Consensus established a framework for minimizing deaths due to mass shootings, specifically eliminating preventable deaths due to limb exsanguination. Two major principles defined within this framework are (1) redefining the first responder role and (2) the ubiquitous availability of proper training in application of hemorrhage control techniques, including tourniquets. We hypothesized that this hemorrhage control posture could be fully translated into an elementary school. Methods: Following institutional review board approval, all teachers at a prekindergarten through 8th grade elementary school underwent short, intensive instruction on their role as a first responder, as well as indications and proper technique for hemorrhage control and tourniquet application for limb exsanguination. All teachers self-reported their confidence in their role as a first responder as well as tourniquet application indications and technique before and after instruction. Following instruction, teachers were evaluated on proper tourniquet application technique on a simulated limb to assess competence. Results: 26 elementary school teachers and 2 administrative staff underwent training. All reported low confidence in their role as a first responder and in tourniquet application indication and technique before training. Following training, all teachers reported high confidence. Testing demonstrated all teachers were competent in the tourniquet application technique. Following training, each classroom was equipped with a purpose-made commercial tourniquet, and a dedicated hemorrhage control bag was placed in the school's central administrative office. Conclusions: All teachers were successfully trained to act as first responders and in correct hemorrhage control techniques, which was verified by testing. This is the first elementary school to universally adopt a hemorrhage control posture to eliminate preventable deaths from limb exsanguination advocated by the Hartford Consensus

Novel Mobile App Allows for Fast and Validated Intraoperative Assessment of Otolaryngology Residents

Evaluation of resident operative skills is challenging in the fast-paced operating room environment and limited by lack of validated assessment metrics. We describe a smartphone-based app that enables rapid assessment of operative skills. Accreditation Council for Graduate Medical Education (ACGME) otolaryngology taxonomy surgical procedures (n = 593) were uploaded to the software platform. The app was piloted over 1 month. Outcomes included (1) completion of evaluation, (2) time spent completing the evaluation, and (3) quantification of case complexity, operative autonomy, and performance. During the study, 12 of 12 procedures, corresponding to 3 paired evaluated by the resident/attending dyad. Mean ± SD time of evaluation completion was 98.0 ± 24.2 and 123.0 ± 14.0 seconds for the resident and attending, respectively. Mean time between resident and attending evaluation completion was 27.9 ± 26.8 seconds. Resident and attending scores for case complexity, operative autonomy, and performance were strongly correlated ( P < .0001). Rapid evaluation of resident intraoperative performance is feasible using smartphone-based technology

The nature, patterns, clinical outcomes, and financial impact of intraoperative adverse events in emergency surgery

Little is known about intraoperative adverse events (iAEs) in emergency surgery (ES). We sought to describe iAEs in ES and to investigate their clinical and financial impact. The 2007 to 2012 administrative and American College of Surgeons-National Surgical Quality Improvement Program databases at our tertiary academic center were: (1) linked, (2) queried for all ES procedures, and then (3) screened for iAEs using the ICD-9-CM-based Patient Safety Indicator "accidental puncture/laceration". Flagged cases were systematically reviewed to: (1) confirm or exclude the occurrence of iAEs (defined as inadvertent injuries during the operation) and (2) extract additional variables such as procedure type, approach, complexity (measured by relative value units), need for adhesiolysis, and extent of repair. Univariate and multivariate analyses were performed to assess the independent impact of iAEs on 30-day morbidity, mortality, and hospital charges. Of a total of 9,288 patients, 1,284 (13.8%) patients underwent ES, of which 23 had iAEs (1.8%); 18 of 23 (78.3%) of the iAEs involved the small bowel or spleen, 10 of 23 (43.5%) required suture repair, and 8 of 23 (34.8%) required tissue or organ resection. Compared with those without iAEs, patients with iAEs were older (median age 62 vs 50; P = .04); their procedures were more complex (total relative value unit 46.7, interquartile range [27.5 to 52.6] vs 14.5 [.5 to 30.2]; P 3 hours: 52% vs 8%; P 7 days; odds ratio, 5.60 [1.54 to 20.35]; P = .01]. A trend toward increased mortality did not reach statistical significance. In ES, iAEs are independently associated with significantly higher postoperative morbidity and prolonged LOS

Does the emergency surgery score accurately predict outcomes in emergent laparotomies?

The emergency surgery score is a mortality-risk calculator for emergency general operation patients. We sought to examine whether the emergency surgery score predicts 30-day morbidity and mortality in a high-risk group of patients undergoing emergent laparotomy. Using the 2011-2012 American College of Surgeons National Surgical Quality Improvement Program database, we identified all patients who underwent emergent laparotomy using (1) the American College of Surgeons National Surgical Quality Improvement Program definition of "emergent," and (2) all Current Procedural Terminology codes denoting a laparotomy, excluding aortic aneurysm rupture. Multivariable logistic regression analyses were performed to measure the correlation (c-statistic) between the emergency surgery score and (1) 30-day mortality, and (2) 30-day morbidity after emergent laparotomy. As sensitivity analyses, the correlation between the emergency surgery score and 30-day mortality was also evaluated in prespecified subgroups based on Current Procedural Terminology codes. A total of 26,410 emergent laparotomy patients were included. Thirty-day mortality and morbidity were 10.2% and 43.8%, respectively. The emergency surgery score correlated well with mortality (c-statistic = 0.84); scores of 1, 11, and 22 correlated with mortalities of 0.4%, 39%, and 100%, respectively. Similarly, the emergency surgery score correlated well with morbidity (c-statistic = 0.74); scores of 0, 7, and 11 correlated with complication rates of 13%, 58%, and 79%, respectively. The morbidity rates plateaued for scores higher than 11. Sensitivity analyses demonstrated that the emergency surgery score effectively predicts mortality in patients undergoing emergent (1) splenic, (2) gastroduodenal, (3) intestinal, (4) hepatobiliary, or (5) incarcerated ventral hernia operation. The emergency surgery score accurately predicts outcomes in all types of emergent laparotomy patients and may prove valuable as a bedside decision-making tool for patient and family counseling, as well as for adequate risk-adjustment in emergent laparotomy quality benchmarking efforts

Derivation and validation of a novel Emergency Surgery Acuity Score (ESAS)

There currently exists no preoperative risk stratification system for emergency surgery (ES). We sought to develop an Emergency Surgery Acuity Score (ESAS) that helps predict perioperative mortality in ES patients. Using the 2011 American College of Surgeons' National Surgical Quality Improvement Program (ACS-NSQIP) database (derivation cohort), we identified all surgical procedures that were classified as "emergent." A three-step methodology was then performed. First, multiple logistic regression models were created to identify independent predictors (e.g., patient demographics, comorbidities, and preoperative laboratory variables) of 30-day mortality in ES. Second, based on the relative impact of each identified predictor (i.e., odds ratio), using weighted averages, a novel score was derived. Third, using the 2012 ACS-NSQIP database (validation cohort), the score was validated by calculating its C statistic and evaluating its ability to predict 30-day mortality. From 280,801 NSQIP cases, 18,439 ES cases were analyzed, of which 1,598 (8.7%) resulted in death at 30 days. The multiple logistic regression analyses identified 22 independent predictors of mortality. Based on the relative impact of these predictors, ESAS was derived with a total score range of 0 to 29. ESAS had a C statistic of 0.86; the probability of death at 30 days gradually increased from 0% to 36% then 100% at scores of 0, 11, and 22, respectively. In the validation phase, 19,552 patients were included, the mortality rate was 7.2%, and the ESAS C statistic stayed at 0.86. We have therefore developed and validated a novel score, ESAS, that accurately predicts mortality in ES patients. Such a score could prove useful for (1) preoperative patient counseling, (2) identification of patients needing close postoperative monitoring, and (3) risk adjustment in any efforts at benchmarking the quality of ES. Prognostic/epidemiologic study, level III