Container Closure Integrity Test Method Development on Vials Stored at -80°C Using Headspace Carbon Dioxide Analysis.

Maintaining container closure integrity (CCI) is challenging for vials that are packaged at room temperature and stored and/or transported at a colder temperature, such as -80°C. Cold temperatures can affect the sealing mechanisms of the package because of the glass transition temperature (-50°C to -70°C) of the rubber stopper used to seal the vial and the different coefficients of thermal expansion of each of the primary packaging components. Most CCI tests are conducted at room temperature and detect leaks from permanent defects that always exist under all storage conditions. However, previous research shows that temporary leaks that develop during cold storage can reseal when the vials are brought back up to room temperature and, therefore, can no longer be detected. The following study demonstrates two methods for CCI testing that can be performed with product-filled, frozen vials, packaged with unmodified headspace conditions using carbon dioxide ingress as a leak indicator. The two methods utilize different gas flow depending on the storage conditions. The first method generates effusive flow through a leaking defect, whereas the second generates diffusive flow. Experimental data revealed the effusive procedure detected laser-drilled defects ≥2 µm in empty glass vials and microwire defects in empty glass and plastic vials with effective defect sizes ≥0.4 and 0.6 µm, respectively. The diffusive procedure detected laser-drilled defects ≥2 µm in empty glass vials and microwire defects in empty glass and plastic vials with effective defect sizes ≥ 0.8 and 2.6 µm, respectively. Liquid product interactions with the defect as well as length of the storage period were also explored.

Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas.

As described in USP <1207>, the container closure integrity (CCI) of a pharmaceutical package must be maintained throughout the product lifecycle to ensure sterility and stability. Current CCI test methods can be time-consuming, destructive, and lack the required sensitivity. This study presents a novel, fast, and nondestructive method for CCI testing that uses carbon dioxide as a tracer gas under effusive pressure conditions. Two types of defects were tested: laser-drilled defects located in the glass body (2, 5, and 10 µm nominal diameter) and tungsten wires inserted between the stopper and the landing seal of the vial (41, 64, and 80 µm outer diameter). During each test session, vials were placed in a pressure vessel, isolated from ambient conditions, and pressure-cycled by first pulling a vacuum and then applying an overpressure of pure carbon dioxide gas. After being exposed to 20 psig (34.7 psia) of carbon dioxide for 30 min, the overpressure was released and the vials were measured on an FMS-Carbon Dioxide Headspace Analyzer. This headspace gas analyzer utilizes a tunable diode laser absorption spectroscopy technique that employs frequency modulation to enhance measurement sensitivity. An increase of ≥1 torr in the headspace carbon dioxide content after completion of the pressure cycling procedure was intended to serve as confirmation of leak detection. All empty vials with either a 2 µm laser-drilled defect or 41 µm wire (effective defect size ∼2 µm), or greater, at the stopper-seal interface were detected by this method. Furthermore, vials filled with 1 mg/mL bovine serum albumin in phosphate-buffered saline containing a 5 µm laser-drilled defect below the liquid level or a 64 µm wire (effective defect size ∼6.1 µm), or greater, at the stopper-seal interface (defect above the liquid level) were detected. This test can be used for a wide variety of vial types and headspace compositions.

Classification of playing position in elite junior Australian football using technical skill indicators.

​In team sport, classifying playing position based on a players' expressed skill sets can provide a guide to talent identification by enabling the recognition of performance attributes relative to playing position. Here, elite junior Australian football players were a priori classified into 1 of 4 common playing positions; forward, midfield, defence, and ruck. Three analysis approaches were used to assess the extent to which 12 in-game skill performance indicators could classify playing position. These were a linear discriminant analysis (LDA), random forest, and a PART decision list. The LDA produced classification accuracy of 56.8%, with class errors ranging from 19.6% (midfielders) to 75.0% (ruck). The random forest model performed at a slightly worse level (51.62%), with class errors ranging from 27.8% (midfielders) to 100% (ruck). The decision list revealed 6 rules capable of classifying playing position at accuracy of 70.1%, with class errors ranging from 14.4% (midfielders) to 100% (ruck). Although the PART decision list produced the greatest relative classification accuracy, the technical skill indicators reported were generally unable to accurately classify players according to their position using the 3 analysis approaches. This player homogeneity may complicate recruitment by constraining talent recruiter's ability to objectively recognise distinctive positional attributes.

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit. The primary goals of the work presented herein were to demonstrate the viability of the nondestructive, deterministic method known as laser-based gas headspace analysis for evaluating container closure integrity and to provide a physical model for predicting leak rates for a variety of container volumes, headspace conditions, and defect sizes. The results demonstrate that laser-based headspace analysis provides sensitive, accurate, and reproducible measurements of the gas ingress into glass vial-stopper package assemblies that are under either diffusive or effusive leak conditions. Two different types of positive controls were examined. First, laser-drilled micro-holes in thin metal disks that were crimped on top of 15R glass vials served as positive controls with a well-characterized defect geometry. For these, a strong correlation was observed between the measured ingress parameter and the size of the defect for both diffusive and effusive conditions. Second, laser-drilled holes in the wall of glass vials served as controls that more closely simulate real-world defects. Due to their complex defect geometries, their diffusive and effusive ingress parameters did not necessarily correlate; this is an important observation that has significant implications for standardizing the characterization of container defects. Regardless, laser-based headspace analysis could readily differentiate positive and negative controls for all leak conditions, and the results provide a guide for method development of container closure integrity tests.LAY ABSTRACT: The new USP 39 <1207>, "Package Integrity Evaluation-Sterile Products", states in section 3.4.1: "tracer gas tests performed using … laser-based gas headspace analysis [have] been shown to be sensitive enough to quantitatively analyze leakage through the smallest leak paths found to pose the smallest chance of liquid leakage or microbial ingress in rigid packaging." In addition, USP <1207> also states that "for such methods, the limit of detection can be mathematically predicted on the basis of gas flow kinetics." Using the above statements as a foundation, this paper presents a theoretical basis for predicting the gas ingress through well-defined defects in product vials sealed under a variety of headspace conditions. These calculated predictions were experimentally validated by comparing them to measurements of changes in the headspace oxygen content or total pressure for several different positive controls using laser-based headspace analysis. The results demonstrated that laser-based headspace analysis can, by readily differentiating between negative controls and positive controls with a range of defect sizes on the micron scale, be used to assess container closure integrity. The work also demontrated that caution must be used when attempting to correlate a leak rate to an idealized defect-size parameter.

The use of player physical and technical skill match activity profiles to predict position in the Australian Football League draft.

This study investigated the extent to which position in the Australian Football League (AFL) national draft is associated with individual game performance metrics. Physical/technical skill performance metrics were collated from all participants in the 2014 national under 18 (U18) championships (18 games) drafted into the AFL (n = 65; 17.8 ± 0.5 y); 232 observations. Players were subdivided into draft position (ranked 1-65) and then draft round (1-4). Here, earlier draft selection (i.e., closer to 1) reflects a more desirable player. Microtechnology and a commercial provider facilitated the quantification of individual game performance metrics (n = 16). Linear mixed models were fitted to data, modelling the extent to which draft position was associated with these metrics. Draft position in the first/second round was negatively associated with "contested possessions" and "contested marks", respectively. Physical performance metrics were positively associated with draft position in these rounds. Correlations weakened for the third/fourth rounds. Contested possessions/marks were associated with an earlier draft selection. Physical performance metrics were associated with a later draft selection. Recruiters change the type of U18 player they draft as the selection pool reduces. juniors with contested skill appear prioritised.

The relationship between game-based performance indicators and developmental level in junior Australian football: Implications for coaching.

Identifying performance differences between juniors at different stages of a talent pathway may assist with the development of prospective talent. This study investigated the relationship between game-based performance indicators and developmental level in junior Australian football (AF). Players were categorised into 2 groups according to developmental level; U16 and U18. Physical and technical skill performance indicators were collated for all U16 (n = 200) and U18 (n = 244) participants of their respective 2014 national championships. Data were acquired from all 28 games (12 U16, 16 U18); resulting in 1360 player observations (568 U16, 792 U18). Microtechnology and a commercial provider facilitated the quantification of 15 performance indicators. Generalised estimating equations (GEEs) modelled the extent to which these performance indicators were associated with developmental level. The GEE model revealed that "contested marks" and "contested possessions" had the strongest association with the U16 level, while "total marks" and "clearances" had the strongest association with the U18 level. The remaining performance indicators were not developmentally discriminant. These results indicate that there are distinctive features of gameplay more associated with the U16 and U18 levels in AF. Coaches may wish to consider these results when constructing training drills designed to minimise developmental gaps.

The Application of Noninvasive Headspace Analysis to Media Fill Inspection.

The results of a proof-of-principle study demonstrating a new analytical technique for detecting microbial growth directly in pharmaceutical containers are described. This analytical technique, laser-based headspace analysis, uses tunable diode laser absorption spectroscopy to nondestructively determine gas concentrations in the headspace of a media-filled pharmaceutical container. For detecting microbial growth, the levels of headspace oxygen and carbon dioxide are measured. Once aerobic microorganisms begin to divide after the lag phase and enter the exponential growth phase, there will be significant consumption of oxygen and concomitant production of carbon dioxide in the sealed container. Laser-based headspace analysis can accurately measure these changes in the headspace gas composition. The carbon dioxide and oxygen measurement data for the representative microorganisms Staphylococcus aureus, Bacillus subtilis, Candida albicans, and Aspergillus brasiliensis were modeled using the Baranyi-Roberts equation. The mathematical modeling allowed quantitative comparisons to be made between the data from the different microorganisms as well as to the known growth curves based on microbial count. Because laser-based headspace analysis is noninvasive and can be automated to analyze the headspace of pharmaceutical containers at inspection speeds of several hundred containers per minute on-line, some potential new applications are enabled. These include replacing the current manual human visual inspection with an automated analytical inspection machine to determine microbial contamination of media fill and pharmaceutical drug product vials. LAY ABSTRACT: A novel analytical technique has been demonstrated for detecting microbial growth in media-filled pharmaceutical containers. This analytical technique, laser-based headspace analysis, uses tunable diode laser absorption spectroscopy to determine gas concentrations in the headspace of a pharmaceutical container. For detecting microbial growth, the levels of headspace oxygen and carbon dioxide are measured. The study shows that once aerobic microorganisms begin to grow after the lag phase and enter the exponential growth phase there will be a significant consumption of oxygen in the sealed container as well as a corresponding production of carbon dioxide. Headspace analysis can accurately measure and monitor these changes in the headspace gas composition and could therefore be used to detect contaminated pharmaceutical containers. Because the technique can be automated to analyze hundreds of containers a minute on-line, there are opportunities for implementing a headspace inspection machine to perform automated inspection of media fills used to validate aseptic filling operations.

Reliability and validity of a reactive agility test for Australian football.

PURPOSE: The aim of this study was to test the reliability and construct validity of a reactive agility test (RAT), designed for Australian Football (AF). METHODS: Study I tested the reliability of the RAT, with 20 elite junior AF players (17.44 +/- 0.55 y) completing the test on two occasions separated by 1 wk. Study II tested its construct validity by comparing the performance of 60 participants (16.60 +/- 0.50 y) spread over three aged-matched population groups: 20 athletes participating in a State Under-18 AF league who had represented their state at national competitions (elite), 20 athletes participating in the same league who had not represented their state (subelite), and 20 healthy males who did not play AF (controls). RESULTS: Test-retest reliability reported a strong correlation (0.91), with no significant difference (P = .22) between the mean results (1.74 +/- 0.07 s and 1.76 +/- 0.07 s) obtained (split 2+3). Nonparametric tests (Kruskal-Wallis and Mann-Whitney) revealed both AF groups performed significantly faster on all measures than the control group (ranging from P = .001 to .005), with significant differences also reported between the two AF groups (ranging from P = .001 to .046). Stepwise discriminant analyses found total time discriminated between the groups, correctly classifying 75% of the participants. CONCLUSIONS: The RAT used within this study demonstrates evidence of reliability and construct validity. It further suggests the ability of a reactive component within agility test designs to discriminate among athletes of different competition levels, highlighting its importance within training activities.

Anthropometric profiling of elite junior and senior Australian football players.

PURPOSE: Body structure and physical development must be addressed when preparing junior athletes for their first season in a senior competition. The aim of this preliminary study was to measure the extent of the assumption that final year junior Australian Football (AF) athletes are at a physical mismatch to their senior counterparts. METHODS: Twenty-one male participants (17.71 ± 0.27 y) were recruited from one state based elite junior AF competition and forty-one male participants (22.80 ± 4.24 y) were recruited from one club competing in the senior elite Australian Football League (AFL), who were subsequently divided into two groups; professional rookies aged 18-20 y (19.44 ± 0.70 y; n = 18) and professional seniors aged 21+ y (25.43 ± 3.98 y; n = 23). Dual energy X-ray absorptiometry (DEXA) scans of all participants were completed. RESULTS: Despite being an average 6.0% and 6.1% lighter in total weight and lean mass respectively, no significant difference was found between the elite junior athletes and their professional AFL rookie counterparts. However, significant differences were demonstrated in comparison with the professional AFL senior athletes (P < .01). Both professional AFL groups demonstrated greater than 0.3 kg total bone mineral content (BMC) than the elite junior athletes (P < .01) and significantly greater segmental BMC and bone mineral density (BMD) results (P < .05). CONCLUSION: While the results identify the differences in body composition of the elite junior athletes, development in a linear fashion is noted, providing useful information for the creation of age appropriate expectations and training programs.

Hip adductor muscle strength is reduced preceding and during the onset of groin pain in elite junior Australian football players.

Groin pain is a condition with a high prevalence in young Australian football players. It is considered that early identification of this condition allows for optimal management. Eighty-six players from two elite under-age Australian football sides were screened weekly for hip adductor muscle strength, using a hand-held dynamometer and for the onset of groin pain. The maximum variation in the average hip adductor muscle strength values of the sample was a 2.6% decrease from baseline in week 7 of the study. Twelve players (14% of the sample studied) reported groin pain for two consecutive weeks and were considered to have an onset of groin injury. The mean hip adductor muscle strength of these players was decreased significantly from baseline by an average of 11.75+/-2.50% at the week of pain onset (F=264.76 (1,11), p<0.001), and 5.82+/-5.16% in the week preceding the onset of pain (F=14.03 (1,10), p=0.004). These results confirm that hip adductor muscle strength is decreased both preceding and during the onset of groin injury in elite under-age Australian footballers.

The Yo-Yo Intermittent Recovery Test (Level 1) to discriminate elite junior Australian football players.

The Yo-Yo Intermittent Recovery (IR) Test is currently used to assess endurance performance in team sport athletes. However, to date, no data has been presented on its application to an elite junior Australian football (AF) playing group. Therefore, the aim of this study was to evaluate the Yo-Yo Intermittent Recovery Test Level 1 (IR1) ability to discriminate between junior AF players at two different playing standards and a group of non-athletic healthy males. Sixty age matched participants (16.6+/-0.5 years) spread over three groups (20 per group): elite junior footballers; sub-elite junior footballers; and non-athletic healthy males participated in this study. Participants undertook a single Yo-Yo test performance on an indoor basketball court for each group. A one-way ANOVA with Scheffe's post hoc analysis revealed the elite junior footballers covered a significantly greater total distance (p<0.001) and completed a significantly greater number of high-intensity efforts (p<0.001) in comparison to their sub-elite counterparts, whilst both AF groups performed significantly better (p<0.001) than the non-athletic healthy males. This study demonstrates the ability of the Yo-Yo IR1 to discriminate endurance performance between elite and sub-elite AF players, whilst further distinguishing AF players from a non-athletic healthy control group.

Physiological responses of elite junior Australian rules footballers during match-play.

Australian Football (AF) is Australia's major football code. Despite research in other football codes, to date, no data has been published on the physiological responses of AF players during match play. Fifteen athletes (17.28 ± 0.76 yrs) participated in four pre-season matches, sanctioned by Australian Football League (AFL) Victoria, investigating Heart Rate (HR), Blood Lactate (BLa), Core Temperature (Tcore), and Hydration status. Match HR was measured continuously using HR monitors. BLa was measured via finger prick lancet at the end of each quarter of play. Tcore was measured by use of ingestible temperature sensor and measured wirelessly at the end of each quarter of play. Hydration status was measured using refractometry, measuring urine specific gravity, and body weight pre and post-match. Environmental conditions were measured continuously during matches. Results of HR responses showed a high exertion of players in the 85-95% maximum HR range. Elevated mean BLa levels, compared to rest, were observed in all players over the duration of the matches (p = 0.007). Mean Tcore rose 0.68 °C between start and end of matches. Mean USG increased between 0.008 g/ml (p = 0.001) with mean body weight decreasing 1.88 kg (p = 0.001). This study illustrates physiological responses in junior AF players playing in the heat as well as providing physiological data for consideration by AF coaching staff when developing specific training programs. Continued research should consider physiological measurements under varying environments, and at all playing levels of AF, to ascertain full physiological responses during AF matches. Key pointsSpecific conditioning sessions for junior athletes should include high intensity bouts; greater than 85% of heart rate maximum zone.Football anaerobic conditioning activities (e.g. sprint training) should be randomised throughout training sessions to replicate demands of the game (e.g. training in a fatigued state).Coaches and fitness staff should provide education and player management strategies for fluid replacement at key opportunities (pre-match, formal breaks and substation on and off the field) during matches.

Profile of position movement demands in elite junior Australian rules footballers.

This study investigated the positional movement patterns in elite junior Australian Football (AF). Thirty players (17.1 ± 0.9 years) participating in this study were tracked over seven home games of the regular 2006 Victorian junior (Under 18) league season. Using lapsed-time video analysis, each position for an entire match was videotaped on three separate occasions over the course of the season. Data analysed included the number of individual efforts, duration and frequency of efforts; distance and percentage time for the classifications of standing, walking jogging, running and sprinting. Results showed that the midfield position travelled the greatest distance (4173 ± 238 m per quarter; p < 0.05; ES = .94) whilst the full forward/full back travelled the least (2605 ± 348 m per quarter, p < 0.05, ES = 1.21). For all positions, walking or jogging accounted for the greatest number of efforts (45-55%), conversely running and sprinting accounted for 5-13% of match efforts. The majority of efforts across all classifications were between 0-3.99 s. The data from this study provides further evidence that AF is an intermittent sport characterised by high intensity movements separated by low intensity movements at a ratio of one high intensity effort every 12-40 s. However, careful interpretation of the data is required when training junior AF players for specific positions, given the specific group studied. Key pointsTraining for Australian Football should incorporate repeated sprint bouts rather than long continuous running that reflect the characteristics of the sport.Specialised positional training (involving distances and repetitions) can be prescribed to prepare junior athletes for specialist roles in senior level Australian Football.Differences between elite junior and senior Australian football provides further evidence to coaches that junior athletes should not be trained as adults.

Performance and anthropometric characteristics of prospective elite junior Australian footballers: a case study in one junior team.

The aim of the study was to compare anthropometric and physical performance data of players who were selected for a Victorian elite junior U18 Australian rules football squad. Prior to the selection of the final training squad, 54 players were assessed using a battery of standard anthropometric and physical performance tests. Multivariate analysis (MANOVA) showed significant (p<0.05) differences between selected and non-selected players when height, mass, 20-m sprint, agility and vertical jump height were considered collectively. Univariate analysis revealed that the vertical jump was the only significant (p<0.05) individual test and a near significant trend (p=0.07) for height differentiating between selected and non-selected players with medium effect sizes for all other tests except endurance. In this elite junior football squad, physical characteristics can be observed that discriminate between players selected and non-selected, and demonstrates the value of physical fitness testing within the talent identification process of junior (16-18 years) players for squad and/or team selection. Based on MANOVA results, the findings from this study suggest team selection appeared to be related to a generally higher performance across the range of tests. Further, age was not a confounding variable as players selected tended to be younger than those non-selected. These findings reflect the general consensus that, in state-based junior competition, there is evidence of promoting overall player development, selecting those who are generally able to fulfil a range of positions and selecting players on their potential.

Player movement patterns in an elite junior Australian rules football team: an exploratory study.

This study explored the physical movement patterns associated with an elite Under 18 Australian Football (AF) team. Five field positions were selected with observations recording the number and relative per cent of "working "efforts (jogging, running, and sprinting), "resting "efforts (walking) and the total distances associated with "working "or "resting "efforts. Intra-observer reliability, using test- retest method, showed correlations were r = 0.98 or greater. The Wing position covered 11,877 m, the greatest total distance during an entire game, whilst the HBF and Centre positions both recorded 11,545 m and 11,537 m respectively and the Ruck position covered 9,203 m. The HBF recorded the greatest frequency of 'working' and 'resting' efforts (180 and 182 respectively), whilst the Wing (166 and 158), Centre (162 and 149) and Ruck (161 and 166) showed similarities in their results. The Wing position recorded the longest average distance per 'working' effort (58 m) whilst the Centre position recorded the longest average distance per 'resting' effort (17 m). Results also show the completion of less total efforts and smaller total distances, in Under 18 players, recorded compared to professional senior AF data. The results from this study suggest that further in-depth research is required into movement patterns and game activity demands in this AF playing group. Key pointsLittle information currently exists in the movement patterns and physical activity levels in Australian football at both senior and junior levels.The results from this preliminary study found differences in the number of physical efforts and the total volume of work completed in junior Australian football players when compared to previous research in senior players.Further in-depth research is required in movement analysis, particularly at the junior level, in order to assist junior coaching staff in developing specific programs for this population group.

Use of bivalirudin as an anticoagulant during cardiopulmonary bypass.

Bivalirudin is a short-acting direct thrombin inhibitor that has been used in cardiac surgical patients with heparin-induced thrombocytopenia (HIT) or suspected HIT. Although no direct thrombin inhibitor is indicated for anticoagulation during cardiac surgery in patients with heparin-induced thrombocytopenia (HIT) or suspected HIT, use of heparin-alternatives are increasing as the awareness of HIT increases. Reports of anticoagulation with bivalirudin are sporadic, however, with variable dosing and management strategies. In this report, we describe our management techniques for cardiopulmonary bypass with bivalirudin based upon our personal experience. Although the reported clinical experience with bivalirudin in cardiac surgery is reviewed, operative techniques for the perfusionist/surgeon team are discussed in detail. We recognize that the use of bivalirudin during cardiopulmonary bypass is evolving and modifications of technique will undoubtedly occur as further data and experience accumulate.

Preemptive use of bivalirudin for urgent on-pump coronary artery bypass grafting in patients with potential heparin-induced thrombocytopenia.

PURPOSE: The use of heparin in patients with heparin-induced thrombocytopenia (HIT) may result in severe complications or death. The diagnosis of HIT is frequently uncertain, however. Alternative anticoagulants in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass remain problematic. The novel short-acting, direct-thrombin inhibitor bivalirudin is the only alternative to heparin/protamine being used in elective non-HIT patients during CPB. DESCRIPTION: Four patients with severe thrombocytopenia after heparin exposure and suspected acute HIT underwent on-pump coronary artery bypass grafting surgery with preemptive use of bivalirudin. A continuous bivalirudin infusion was used during cardiopulmonary bypass, and activated clotting times were used to monitor anticoagulation. EVALUATION: Anticoagulation with bivalirudin during cardiopulmonary bypass was effective and uncomplicated. Duration of operation was not prolonged, and perioperative blood loss and transfusion rates were acceptable. Activated clotting times were helpful for monitoring anticoagulation in these patients. CONCLUSIONS: These data provide further evidence of the feasibility of bivalirudin for anticoagulation during on-pump coronary artery bypass graft surgery in urgent clinical situations.

The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study.

PURPOSE: The purpose of this pilot study was to determine the effectiveness of using feedback from a standardized patient (SP) to teach a surgical resident (SR) informed consent (IC) protocol. METHODS: Four general case types of increasing difficulty were tested in a longitudinal experimental design format. The four types of cases were appendectomy, cholecystectomy, colorectal cancer, and breast cancer. Eight SRs of varying years of completion in medical school served as subjects-four in the experimental group (received performance feedback from an SP) and four in the control group (received no SP feedback). Both the control and experimental groups participated in two patient encounters per case type. The first patient encounter served as the pretest, and the second patient encounter was the posttest. In each encounter, an SP rated the resident on 14 measures using an open-ended seven-point rating scale adopted and modified from the Brown University Interpersonal Skill Evaluation (BUISE). Each resident also reviewed a videotape of an expert giving IC between pretest and the posttest for basic instructional protocol. Random stratified sampling was used to equally distribute the residents by postgraduate years. A total of 16 SPs were used in this study. All patient/SR encounters were videotaped. RESULTS: There was a statistically significant overall change--pretest to posttest and across cases (p = 0.001). The group effect was statistically significant (p = 0.000), with the experimental group averaging about 10 points greater than the control group. CONCLUSIONS: Standardized patient feedback is an effective modality in teaching surgical residents informed consent protocol. This conclusion is tentative, due to the limitations of sample size. The results of this study support continued research on the effects of standardized patient feedback to teach informed consent to surgical residents.