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Objective: The aim of this study was to propose an evidence-based blueprint for training, assessment, and certification of operative performance for surgical trainees., Summary Background Data: Operative skill is a critical aspect of surgical performance. High-quality assessment of operative skill therefore has profound implications for training, accreditation, certification, and the public trust of the profession. Current methods of operative skill assessment for surgeons rely heavily on global assessment strategies across a very broad domain of procedures. There is no mechanism to assure technical competence for individual procedures. The science and scalability of operative skill assessment has progressed significantly in recent decades, and can inform a much more meaningful strategy for competency-based assessment of operative skill than has been previously achieved., Methods: The present article reviews the current status and science of operative skill assessment and proposes a template for competency-based assessment which could be used to update training, accreditation, and certification processes. The proposal is made in reference to general surgery but is more generally applicable to other procedural specialties., Results: Streamlined, routine assessment of every procedure performed by surgical trainees is feasible and would enable a more competency-based educational paradigm. In light of the constraints imposed by both clinical volume and assessment bias, trainees should be expected to become proficient and be measured against a mastery learning standard only for the most important and highest-frequency procedures. For less frequently observed procedures, performance can be compared to a norm-referenced standard and, to provide an overall trajectory of performance, analyzed in aggregate. Key factors in implementing this approach are the number of evaluations, the number of raters, the timeliness of evaluation, and evaluation items., Conclusions: A competency-based operative skill assessment can be incorporated into surgical training, assessment, and certification. The time has come to develop a systematic approach to this issue as a means of demonstrating professional standards worthy of the public trust., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To establish the number of operative performance observations needed for reproducible assessments of operative competency., Background: Surgical training is transitioning from a time-based to a competency-based approach, but the number of assessments needed to reliably establish operative competency remains unknown., Methods: Using a smart phone based operative evaluation application (SIMPL), residents from 13 general surgery training programs were evaluated performing common surgical procedures. Two competency metrics were investigated separately: autonomy and overall performance. Analyses were performed for laparoscopic cholecystectomy performances alone and for all operative procedures combined. Variance component analyses determined operative performance score variance attributable to resident operative competency and measurement error. Generalizability and decision studies determined number of assessments needed to achieve desired reliability (0.80 or greater) and determine standard errors of measurement., Results: For laparoscopic cholecystectomy, 23 ratings are needed to achieve reproducible autonomy ratings and 17 ratings are needed to achieve reproducible overall operative performance ratings. For the undifferentiated mix of procedures, 60 ratings are needed to achieve reproducible autonomy ratings and 40 are needed for reproducible overall operative performance ratings., Conclusion: The number of observations needed to achieve reproducible assessments of operative competency far exceeds current certification requirements, yet remains an important and achievable goal. Attention should also be paid to the mix of cases and raters in order to assure fair judgments about operative competency and fair comparisons of trainees.

Objective: This study evaluates the current state of the General Surgery (GS) residency training model by investigating resident operative performance and autonomy., Background: The American Board of Surgery has designated 132 procedures as being "Core" to the practice of GS. GS residents are expected to be able to safely and independently perform those procedures by the time they graduate. There is growing concern that not all residents achieve that standard. Lack of operative autonomy may play a role., Methods: Attendings in 14 General Surgery programs were trained to use a) the 5-level System for Improving and Measuring Procedural Learning (SIMPL) Performance scale to assess resident readiness for independent practice and b) the 4-level Zwisch scale to assess the level of guidance (ie, autonomy) they provided to residents during specific procedures. Ratings were collected immediately after cases that involved a categorical GS resident. Data were analyzed using descriptive statistics and supplemented with Bayesian ordinal model-based estimation., Results: A total of 444 attending surgeons rated 536 categorical residents after 10,130 procedures. Performance: from the first to the last year of training, the proportion of Performance ratings for Core procedures (n = 6931) at "Practice Ready" or above increased from 12.3% to 77.1%. The predicted probability that a typical trainee would be rated as Competent after performing an average Core procedure on an average complexity patient during the last week of residency training is 90.5% (95% CI: 85.7%-94%). This falls to 84.6% for more complex patients and to less than 80% for more difficult Core procedures. Autonomy: for all procedures, the proportion of Zwisch ratings indicating meaningful autonomy ("Passive Help" or "Supervision Only") increased from 15.1% to 65.7% from the first to the last year of training. For the Core procedures performed by residents in their final 6 months of training (cholecystectomy, inguinal/femoral hernia repair, appendectomy, ventral hernia repair, and partial colectomy), the proportion of Zwisch ratings (n = 357) indicating near-independence ("Supervision Only") was 33.3%., Conclusions: US General Surgery residents are not universally ready to independently perform Core procedures by the time they complete residency training. Progressive resident autonomy is also limited. It is unknown if the amount of autonomy residents do achieve is sufficient to ensure readiness for the entire spectrum of independent practice.

Objective: To provide recommended practice guidelines for assessing single operative performances and for combining results of operative performance assessments into estimates of overall operative performance ability., Summary Background Data: Operative performance is one defining characteristic of surgeons. Assessment of operative performance is needed to provide feedback with learning benefits to surgical residents in training and to assist in making progress decisions for residents. Operative performance assessment has been a focus of investigation over the past 20 years. This review is designed to integrate findings of this research into a set of recommended operative performance practices., Methods: Literature from surgery and from other pertinent research areas (psychology, education, business) was reviewed looking for evidence to inform practice guideline development. Guidelines were created along with a conceptual and scientific foundation for each guideline., Results: Ten guidelines are provided for assessing individual operative performances and 10 are provided for combing data from individual operative performances into overall judgments of operative performance ability., Conclusions: The practice guidelines organize available information to be immediately useful to program directors, to support surgical training, and to provide a conceptual framework upon which to build as the base of pertinent knowledge expands through future research and development efforts.

Objective: This study evaluated operative performance rating (OPR) characteristics and measurement conditions necessary for reliable and valid operative performance (OP) assessment., Background: Operative performance is a signature surgical-practice characteristic that is not measured systematically and specifically during residency training., Methods: Expert surgeon raters from multiple institutions, blinded to resident characteristics, independently evaluated 8 open and laparoscopic OP recordings immediately after observation., Results: A plurality of raters agreed on operative performance ratings (OPRs) for all performances. Using 10 judges adjusted for rater idiosyncrasies. Interrater agreement was similar for procedure-specific and general items. Higher post graduate year (PGY) residents received higher OPRs. Supervising-surgeon ratings averaged 0.51 points (1.2 standard deviations) above expert ratings for the same performances., Conclusions: OPRs have measurement properties (reliability, validity) similar to those of other well-developed performance assessments (Mini-CEX [clinical evaluation exercise], standardized patient examinations) when ratings occur immediately after observation. OPRs by blinded expert judges reflect the level of resident training and are practically significant differences as the average rating for PGY 4 residents corresponded to a "Good" performance whereas those for PGY 5 residents corresponded to a "Very Good" performance. Supervising surgeon ratings are higher than expert judge ratings reflecting the effect of interpersonal factors on supervising surgeon ratings. Use of local and national norms for interpretation of OPRs would adjust for these interpersonal factors. The OPR system provides a practical means for measuring operative performance, which is a signature characteristic of surgical practice.

Objective: To determine the nature of surgeon information transfer and communication (ITC) errors that lead to adverse events and near misses. To recommend strategies for minimizing or preventing these errors., Summary Background Data: Surgical hospital practice is changing from a single provider to a team-based approach. This has put a premium on effective ITC. The Information Transfer and Communication Practices (ITCP) Project is a multi-institutional effort to: 1) better understand surgeon ITCP and their patient care consequences, 2) determine what has been done to improve ITCP in other professions, and 3) recommend ways to improve these practices among surgeons., Methods: Separate, semi-structured focus group sessions were conducted with surgical residents (n = 59), general surgery attending physicians (n = 36), and surgical nurses (n = 42) at 5 medical centers. Case descriptions and general comments were classified by the nature of ITC lapses and their effects on patients and medical care. Information learned was combined with a review of ITC strategies in other professions to develop principles and guidelines for re-engineering surgeon ITCP., Results: : A total of 328 case descriptions and general comments were obtained and classified. Incidents fell into 4 areas: blurred boundaries of responsibility (87 reports), decreased surgeon familiarity with patients (123 reports), diversion of surgeon attention (31 reports), and distorted or inhibited communication (67 reports). Results were subdivided into 30 contributing factors (eg, shift change, location change, number of providers). Consequences of ITC lapses included delays in patient care (77% of cases), wasted surgeon/staff time (48%), and serious adverse patient consequences (31%). Twelve principles and 5 institutional habit changes are recommended to guide ITCP re-engineering., Conclusions: Surgeon communication lapses are significant contributors to adverse patient consequences, and provider inefficiency. Re-engineering ITCP will require significant cultural changes.

Gabapentin (Neurontin) is a novel anticonvulsant with an as yet unknown mechanism of action. This electrophysiological study investigated the potential antinociceptive actions of systemically administered gabapentin in normal animals and after inflammation induced by the injection of carrageenan. Gabapentin facilitated the noxious evoked responses of dorsal horn neurones recorded in normal animals. In complete contrast, gabapentin strongly and dose-dependently inhibited the C-fibre evoked response and post-discharge, but not the A beta-fibre evoked response, of neurones recorded in animals 3 h after the injection of carrageenan. This unique and selective profile of gabapentin may provide a novel treatment for clinical inflammatory pain states.

Background: Repair of pulmonary atresia with intact ventricular septum (PA-IVS) is one of the more challenging problems in congenital heart surgery. The hypertrophied but hypoplastic right ventricle is suddenly presented with an increased volume load as the right-to-left shunt is abolished by closure of the atrial septal defect (ASD) as part of definitive repair. We have proposed that a restrictive, adjustable ASD that allows a controlled right-to-left shunt may prevent excessive venous hypertension and allow adequate left-sided filling after biventricular repair of PA-IVS., Methods and Results: From 1982 through 1991, 39 patients presented for definitive repair of PA-IVS. Nineteen of these patients were thought to be suitable candidates for biventricular repair, and the other 20 underwent a modified Fontan procedure. An adjustable ASD was used in 12 of the 19 patients undergoing biventricular repair. Mean age was 24 months (age range, 5-66 months). Two patients had their ASD snared closed in the operating room after coming off bypass. In the other 10 patients, closure of the ASD could not be tolerated at the time of surgery as evidenced by elevation of right atrial pressures by > 15 mm Hg and decreased blood pressure when closure was attempted. Seven patients had their open ASDs closed by the snare device, and one patient had his ASD narrowed in the early postoperative period. One patient underwent delayed closure 16 months after surgery. There was one hospital death., Conclusions: The snare-controlled adjustable ASD allows partial biventricular repair of PA-IVS, reducing the risk of low cardiac output and severe venous hypertension in the postoperative period.

Background: Initial experience with the modified Fontan procedure in patients < 4 years of age has met with variable success, with early reports showing a high mortality. More recently, improved results with the modified Fontan procedure in younger patients have been achieved. Important advantages of an early Fontan include protection of the pulmonary vascular bed and preservation of ventricular function by reduction in ventricular volume overload and chronic hypoxemia., Methods and Results: From 1982 through May 1991, 90 patients < 4 years of age underwent a modified Fontan procedure. The average age was 29 months (range, 7-48 months), and 30 patients were < 2 years of age. Diagnoses included tricuspid atresia in 36, single ventricle in 45, pulmonary atresia intact septum in seven, and hypoplastic left heart syndrome in two patients. An adjustable ASD was placed in 21. Early mortality was 8.9% (eight of 90), which is only slightly higher than our overall Fontan early mortality of 7.4% in 242 patients. The early mortality in the 30 patients < 2 years of age was 6.7% (two of 30). In a mean follow-up of 38 months (range, 7-89 months), there have been three late deaths (3.7%), and one patient has undergone cardiac transplantation., Conclusions: Early Fontan should be undertaken in patients > 6 months old who present with increasing cyanosis provided good hemodynamics are present. A modified Fontan procedure can be performed safely with good clinical results in patients < 4 years old.

Isolated noncompaction of left ventricular myocardium is a rare disorder of endomyocardial morphogenesis characterized by numerous, excessively prominent ventricular trabeculations and deep intertrabecular recesses. This study comprised eight cases, including three at necropsy. Ages ranged from 11 months to 22.5 years, with follow-up as long as 5 years. Gross morphological severity ranged from moderately abnormal ventricular trabeculations to profoundly abnormal, loosely compacted trabeculations. Echocardiographic images were diagnostic and corresponded to the morphological appearances at necropsy. The depths of the intertrabecular recesses were assessed by a quantitative echocardiographic X-to-Y ratio and were significantly greater than in normal control subjects (p less than 0.001). Clinical manifestations of the disorder included depressed left ventricular systolic function in five patients, ventricular arrhythmias in five, systemic embolization in three, distinctive facial dysmorphism in three, and familial recurrence in four patients. We conclude that isolated noncompaction of left ventricular myocardium is a rare if not unique disorder with characteristic morphological features that can be identified by two-dimensional echocardiography. The incidence of cardiovascular complications is high. The disorder may be associated with facial dysmorphism and familial recurrence.

Propranolol (3.6 mg kg-1 day-1) was administered to guinea pigs for 14 days via subcutaneously implanted "Alzet" osmotic minipumps. Blockade of cardiac and vascular beta-adrenoceptors was confirmed by a depression of heart rate and blood pressure responses to isoprenaline in anaesthetized animals. After 14 days of propranolol treatment, minipumps were removed and 48 h later beta-adrenoceptor sensitivity was determined in cardiac and lung tissues. Left atrial inotropic responses were unaltered following propranolol withdrawal. However, right atrial chronotropic responses to sympathomimetic amines were supersensitive when compared with tissues from animals implanted with empty minipumps. Relaxation responses of lung strip preparations to beta-adrenoceptor agonists after withdrawal of propranolol were similar to controls. (3H)Dihydroalprenolol binding to ventricular and lung tissue indicated that there was no change in either the dissociation constant (KD) or the maximum number of (3H)DHA binding sites (Bm) in these tissues. These results suggest that following withdrawal from beta-adrenoceptor antagonist treatment there is a selective increase in the chronotropic sensitivity of the heart to sympathomimetic amines.

The echocardiographic features of congenital left ventricular inflow obstruction are described in six patients. The echocardiograms in two patients with cor triatriatum were distinguished by normal mitral valve motion and an abnormal echo within the left atrium. In two patients with supravalvar mitral ring, in addition to abnormal mitral valve motion, an abnormal echo, presumably originating from the obstructive membrane, was located between the anterior and posterior mitral leaflets. In two cases of parachute mitral valve, mitral valve motion was abnormal. In one of these cases there were multiple mitral valve echoes similar to those found in supravalvar mitral ring. The echocardiographic identification of an obstructive membrane within the left atrium is difficult because of the occurrence of artifacts. However, membranes may be identified if careful scanning techniques are employed in patients in whom left ventricular inflow obstruction is suspected. The echocardiogram is useful in detecting mitral valve abnormalities in these patients and is valuable in cases where mitral valve replacement is contemplated.

Despite increasing use of Fontan or modified Fontan repairs, the comparative hemodynamic efficacy of different types of connections are unresolved. Accordingly, we undertook a prospective study designed to determine postoperative flow patterns after Fontan's operation. Seven subjects had tricuspid atresia and eight had single ventricle. Ages ranged from 5 to 38 years (mean 16.4). Ten subjects had nonvalved right atrial-to-pulmonary arterial connection, and four had nonvalved right atrial-to-right ventricular communication. A valved conduit established continuity between the right atrium and right ventricle in one subject. Doppler flow profiles were recorded in the pulmonary artery and in the superior and inferior venae cavae of each. A reference electrocardiogram was used for timing purposes. In 14 patients, forward flow in the pulmonary artery was biphasic. Flow began at the end of the T wave (early ventricular diastole), peaked at or before the P wave (atrial systole), and returned to baseline by the peak of the R wave. Forward flow recommenced at the peak of the R wave (ventricular systole) and returned to baseline at the end of the T wave. Flow in the superior vena cava varied, and could not be recorded in three subjects. Between the end of the P wave and peak of the R wave (atrial systole) flow was reversed in eight, absent in three, and forward in one patient. Forward flow occurred between the peak of the R wave and the end of the T wave and was either continuous or biphasic. Fourteen patients had adequate studies of inferior vena cava flow; reversed flow during atrial systole occurred in 10 subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

The courses of 22 consecutive patients with pulmonary atresia and intact ventricular septum who underwent surgery between 1977 and 1984 were reviewed. This included 18 patients undergoing an initial surgical palliation, and four patients referred for a definitive procedure. A surgically oriented classification based on the degree of right ventricular hypoplasia was developed and applied. Three groups were identified and were termed the mild, moderate, and severe hypoplasia groups. Those in the mild and moderate groups had mild or moderate right ventricular and tricuspid hypoplasia with well-developed right ventricular outflow tracts and were therefore acceptable candidates for procedures to create an opening between the right ventricle and pulmonary artery. Those in the severe hypoplasia group and severe hypoplasia of the tricuspid valve, the right ventricle, and the right ventricle outflow tract so that attempts at establishing continuity with the pulmonary artery were thought to be unlikely to succeed. There were three patients with mild, 11 with moderate, and eight with severe hypoplasia. In the mild hypoplasia group, all three patients initially underwent valvotomy alone, but two required a shunt in the early postoperative period. In the moderate hypoplasia group, all patients underwent a valvotomy and received a central shunt with a snare, which allowed subsequent adjustment of pulmonary flow without thoracotomy in four patients. In the severe hypoplasia group, five patients received a shunt alone and one underwent valvotomy with atrial septectomy. This last patient represents the only early (less than 30 days) death in the series (6% mortality).(ABSTRACT TRUNCATED AT 250 WORDS)

The objective of this study was to establish a dependable technique for imaging the interventricular septum and ventricular septal defects in infants. Subxiphoid two-dimensional echocardiograms were performed on 81 infants who were 1 day to 12 months (median 43 days) old and weighed 1.6-8.6 kg (median 3.4 kg). A short-focus, 5-MHz crystal with a 13-mm active element diameter was used in all studies. The interventricular septum was visualized in 80 of 81 infants. Defects in the membranous, atrioventricular canal, conoventricular and muscular segments of the sentum were identified using three standard transverse subxiphoid projections. All defects in the membranous and atrioventricular canal segments, as well as malalignment type conoventricular communications, were correctly identified when compared with selective angled cineangiocardiography. Only two of the three subpulmonic and four of 11 muscular defects were identified successfully. Limitations in imaging defects in the muscular septum reflected the varied morphology of these interventricular communications and the tangential orientation of the echo beam to the extreme apical and anterior segments of the muscular septum.

Subxiphoid, two-dimensional echocardiograms (S2DE) were performed and interpreted before diagnostic cardiac catheterization on 59 neonates who weighed 1.3--6.0 kg (median 3.3 kg) and were 1--35 days old (median 4.5 days). The echocardiographic studies were successfully performed on 58 of 59 infants. Using appropriate longitudinal and transverse projections, S2DE permitted simultaneous visualization of the branch pulmonary arteries, proximal thoracic aorta and ventriculoarterial attachments. D-transposition of the great arteries was correctly predicted in all 16 infants with levocardia, situs solitus and atrioventricular concordance. In these patients, the standard left ventricular longitudinal projection demonstrated the bifurcating main pulmonary artery attached to the posterior ventricle; the transverse projection displayed the relationship of the proximal thoracic aorta to the anterior ventricle. The broad acoustical window using the subxiphoid approach in conjunction with a high-frequency focused transducer and a large active-element diameter permitted detailed imaging of intra- and supracardiac structures.

The interatrial septum (IAS) was studied by subxiphoid two-dimensional echocardiography (S2DE) in 88 infants under 12 months of age who weighed 1.2-9.1 kg. The IAS was adequately displayed in 87 of 88 patients. The morphology, presence and localization of defects in the IAS were evaluated by S2DE and retrospectively related to the findings at cardiac catheterization. In seven patients with no interatrial communication at cardiac catheterization, the IAS was straight, with an area of central thinning corresponding to the veil-like cover of the septum primum over the foramen ovale. The morphology of the IAS with a stretched, patent foramen ovale (56 patients) indicated the coexistence of a right or left ventricular volume or pressure overload, and was readily distinguishable from the IAS with a secundum type communication (13 patients). In patients with a stretched, patent foramen ovale and left ventricular overload lesions, the IAS was a nearly homogenous, curvilinear structure bowing into the right atrium, with a small area of septal dropout at the superior rim of the septum primum. In the presence of right ventricular overload lesions, the central defect of the foramen ovale was associated with a redundant flap valve of the septum primum billowing into the left atrium. In secundum type communications, the centrally located defect represented a deficiency rather than a redundancy of the septum primum. Balloon atrial septostomy (BAS) in 17 patients produced a secundum-type defect bordered by the flail remnants of the torn septum primum. Blalock-Hanlon septectomy (two patients) resulted in a large, posterior, sinus venosus-type communication which incorporated the preexisting BAS. Ostium primum defects (seven patients) were distinguished from the secundum lesions by their eccentric position in the IAS adjacent to the atrioventricular ring.