A modified Delphi consensus statement on patellar instability: part I.

Aims: The aim of this study was to establish consensus statements on the diagnosis, nonoperative management, and indications, if any, for medial patellofemoral complex (MPFC) repair in patients with patellar instability, using the modified Delphi approach. Methods: A total of 60 surgeons from 11 countries were invited to develop consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest within patellar instability. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered to be unanimous. Results: Of 27 questions and statements on patellar instability, three achieved unanimous consensus, 14 achieved strong consensus, five achieved consensus, and five did not achieve consensus. Conclusion: The statements that reached unanimous consensus were that an assessment of physeal status is critical for paediatric patients with patellar instability. There was also unanimous consensus on early mobilization and resistance training following nonoperative management once there is no apprehension. The statements that did not achieve consensus were on the importance of immobilization of the knee, the use of orthobiologics in nonoperative management, the indications for MPFC repair, and whether a vastus medialis oblique advancement should be performed.

A modified Delphi consensus statement on patellar instability: part II.

Aims: The aim of this study was to establish consensus statements on medial patellofemoral ligament (MPFL) reconstruction, anteromedialization tibial tubercle osteotomy, trochleoplasty, and rehabilitation and return to sporting activity in patients with patellar instability, using the modified Delphi process. Methods: This was the second part of a study dealing with these aspects of management in these patients. As in part I, a total of 60 surgeons from 11 countries contributed to the development of consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered unanimous. Results: Of 41 questions and statements on patellar instability, none achieved unanimous consensus, 19 achieved strong consensus, 15 achieved consensus, and seven did not achieve consensus. Conclusion: Most statements reached some degree of consensus, without any achieving unanimous consensus. There was no consensus on the use of anchors in MPFL reconstruction, and the order of fixation of the graft (patella first versus femur first). There was also no consensus on the indications for trochleoplasty or its effect on the viability of the cartilage after elevation of the osteochondral flap. There was also no consensus on postoperative immobilization or weightbearing, or whether paediatric patients should avoid an early return to sport.

Utility of Stability and Tear Location in a Classification System for Discoid Meniscus Surgical Planning.

BACKGROUND: Despite the presence of multiple classification systems for discoid meniscus, no system has yet to demonstrate utility in predicting the need for meniscal repair. The purpose of this study was to correlate characteristics associated with meniscal repair and propose a model that can inform preoperative planning and initial counseling of surgical plans and expectations. METHODS: Medical and operative records of 434 knees with lateral discoid meniscus in children and adolescents treated between 1991 and 2016 were reviewed retrospectively to determine the surgical procedure performed (saucerization with or without meniscal repair), discoid meniscal morphology and stability, and location and type of any associated tear. Univariate associations between discoid meniscal characteristics and surgery type were calculated and a logistic regression model of surgery type was generated. RESULTS: In univariate models, unstable menisci (93%, or 179/204, P<0.001) and menisci with tears extending peripherally (75%, or 85/204, P<0.001) were more likely to receive surgery with repair. In isolation, instability demonstrated 89% sensitivity and 94% specificity in predicting surgery with repair. A logistic regression model including stability, tear, and their interaction (stability×tear) showed that that the odds of unstable lateral discoid menisci receiving surgery with repair was 114 times higher than stable menisci (P<0.001) while lateral discoid menisci with peripherally extending tears had 6.4 times higher odds of receiving repair than those that had an isolated central tear (P<0.001). CONCLUSION: Stability and tear location of lateral discoid menisci were associated with surgical treatment in univariate and logistic regression models. The proposed classification system, in which menisci are classified by stability [Stable (S0), Unstable (S1), morphology (Incomplete (M0), Complete (M1))], and tear [No tear (T0), Central tear, isolated (T1), or Central tear, peripheral extension (T2)], is easily remembered and predicts surgical repair for discoid menisci. This scheme can serve to inform preoperative planning and initial counseling of primary surgical management and postoperative expectations. Subsequent research should develop a system that predicts meniscal survival and patient outcomes following the index operation. LEVEL OF EVIDENCE: Level III.

Symptomatic Discoid Meniscus in Children and Adolescents: A Review of 470 Cases.

BACKGROUND: Discoid meniscus is a congenital variant, typically involving the lateral meniscus, that comprises a spectrum of meniscal shapes and degrees of instability in an estimated 1% to 15% of the population. The purpose of this study was to describe the clinical and operative course of a large cohort of children and adolescents patients with symptomatic lateral discoid meniscus. METHODS: Medical records of 470 knees with symptomatic lateral discoid meniscus in 401 patients ages 18 years or younger diagnosed at a single institution between 1991 and 2016 were reviewed retrospectively for patient characteristics, treatment course (nonoperative and/or operative), and complications. Surgical reports were reviewed in the operative group. RESULTS: The series included 401 patients of mean age 11.6 years (range: 1 mo-18.9 y), of which 222 (55%) were female, and 69 (17%) had bilateral involvement. Of 470 knees, 83 (18%) were initially managed nonoperatively. Of these, 32 knees (39%) failed nonoperative management and were converted to surgical treatment at a median of 7.9 months (interquartile range: 4.0-15.1). In total, 419 knees were managed surgically with saucerization (partial meniscectomy) with or without meniscal repair/stabilization; 84 knees (20%) required at least one concurrent nonmeniscal procedure. Discoid meniscus tears were reported in 264/419 knees (63%) intraoperatively; horizontal cleavage tears were most common. Reoperation was required for 66/379 cases (17%) with clinical follow-up, at a median of 19.6 months (range: 9.2-34.9) after index saucerization; 60/379 cases (16%) had ongoing pain and/or mechanical symptoms at final follow-up. CONCLUSION: With a failure rate of 39% (32/83 knees), nonoperative management for discoid lateral meniscus frequently convert to surgical treatment. During surgery, meniscus tearing and instability are common and should be anticipated. Postoperatively, 33% (126/379) of knees with clinical follow-up underwent either reoperation, or had ongoing symptoms of the knee at final follow-up. Discoid mensical retear is the most common complication (94%, 62/66) prompting repeat surgery, and should be discussed with families before the index operation. LEVEL OF EVIDENCE: Level IV-descriptive case series.

The Beneficial Effect of an Intra-articular Injection of Losartan on Microfracture-Mediated Cartilage Repair Is Dose Dependent.

BACKGROUND: A previous publication demonstrated that the oral intake of losartan promoted microfracture-mediated hyaline-like cartilage repair in osteochondral defects of a rabbit knee model. However, an intra-articular (IA) injection of losartan may have direct beneficial effects on cartilage repair and has not been studied. PURPOSE: To determine the dosage and beneficial effects of an IA injection of losartan on microfracture-mediated cartilage repair and normal cartilage homeostasis. STUDY DESIGN: Controlled laboratory study. METHODS: Rabbits were divided into 5 groups (n = 6 each): a microfracture group (MFX group) and 4 different losartan treatment groups that received varying doses of IA losartan (0.1, 1, 10, and 100 mg per knee). An osteochondral defect (5 mm) was created in the trochlear groove cartilage of 1 limb in each rabbit, and 5 microfracture perforations were made in the osteochondral defect. Both the injured and the contralateral knee joints were injected with IA losartan immediately after microfracture and at 2 and 4 weeks after surgery. Rabbits were sacrificed at 6 weeks after surgery for analysis including gross observation, micro-computed tomography, histology, and reverse transcription quantitative polymerase chain reaction. RESULTS: Micro-computed tomography and gross observation demonstrated comparable subchondral bone healing and hyaline-like cartilage morphology in the 0.1-, 1-, and 10-mg losartan groups relative to the MFX group. Conversely, the 100-mg losartan group showed neither bony defect healing nor cartilage repair. Histology revealed higher O'Driscoll scores and hyaline-like cartilage regeneration in the 1-mg losartan group compared with the MFX group. In contrast, the 100-mg losartan group showed the lowest histology score and no cartilage repair. An IA injection of losartan at the doses of 0.1, 1, and 10 mg did not cause adverse effects on uninjured cartilage, while the 100-mg dose induced cartilage damage. Quantitative polymerase chain reaction results showed downregulation of the transforming growth factor ß (TGF-ß) signaling pathway after IA losartan injection. CONCLUSION: An IA injection of losartan at the dose of 1 mg was most effective for the enhancement of microfracture-mediated cartilage repair without adversely affecting uninjured cartilage. Conversely, a high dose (100 mg) IA injection of losartan inhibited cartilage repair in the osteochondral defect and was chondrotoxic to normal articular cartilage. CLINICAL RELEVANCE: An IA injection of losartan at an optimal dosage represents a novel microfracture enhancement therapy and warrants a clinical trial for future clinical applications.

OSTEOCHONDRAL ALLOGRAFT TRANSPLANTATION for the KNEE: POST-OPERATIVE REHABILITATION.

Articular cartilage injuries of the knee are common among young, active patients presenting with knee pain, swelling, and/or mechanical symptoms. These injuries have limited healing potential due to the avascular nature of hyaline cartilage. While several treatment options exist, osteochondral allograft (OCA) transplantation for the knee has been used successfully in primary management of large chondral or osteochondral defects and salvage of previously failed cartilage repair. OCA transplantation potentially yields a natural, matching contour of the native recipient surface anatomy and transplants mature, viable hyaline cartilage to the affected defect. Following OCA transplantation, strict compliance with a rehabilitation protocol is essential to enable optimal recovery. The outlined rehabilitation protocol is informed by the existing literature and incorporates current rehabilitation principles, the science of osteochondral incorporation, and adaptations based on an individual's readiness to progress through subsequent phases. The purpose of this clinical commentary is to discuss the diagnosis, surgical management, and post-operative rehabilitation following OCA transplantation and to assist the physical therapist in returning athletes to full sports participation.

Influence of Medial Meniscus Bucket-Handle Repair in Setting of Anterior Cruciate Ligament Reconstruction on Tibiofemoral Contact Mechanics: A Biomechanical Study.

PURPOSE: To compare the impact of an inside-out repair versus meniscectomy of a medial meniscus bucket-handle tear in restoring native contact areas and pressures across the tibial plateaus in the setting of an anterior cruciate ligament (ACL) reconstruction (ACLR). METHODS: Ten fresh-frozen cadaveric knees were tested in 6 knee conditions (1: intact; 2: ACL torn and bucket-handle tear of medial meniscus, flipped; 3: bucket-handle tear of medial meniscus, reduced; 4: bucket-handle tear of medial meniscus, repaired via inside-out vertical mattress suture technique; 5: ACLR with bone patella tendon bone autograft and bucket-handle repair; 6: ACLR and medial meniscus bucket-handle tear debridement) at 4 flexion angles (0°, 30°, 45°, and 60°), under a 1,000-N axial load. Contact area and pressure were measured with Tekscan sensors. RESULTS: ACLR with a concurrent medial meniscectomy for a medial meniscus bucket-handle tear resulted in significantly decreased contact area (P < .05) and increased mean and peak pressure in both the medial and lateral compartments across all tested flexion angles (P < .05). The ACLR with medial meniscectomy state also demonstrated significantly lower contact area than the bucket-handle repair state between 30° and 60° of flexion (all P < .05). CONCLUSIONS: Resection of a bucket-handle medial meniscus tear concurrent with an ACLR resulted in significant increases in mean and peak contact pressures in not only the medial but also the lateral compartment. Preservation of the medial meniscus in the face of a bucket-handle tear is essential to more closely restore native tibiofemoral biomechanics. CLINICAL RELEVANCE: The increased mean and peak tibiofemoral contact pressure seen with excision of a bucket-handle medial meniscus tear would over time result in increased cartilaginous degradation and resultant osteoarthritis. Decreasing both of these factors through concomitant ACLR and inside-out bucket-handle meniscal repairs should improve patient outcomes by restoring knee biomechanics and kinematics closer to that of the native state.

REHABILITATION FOLLOWING DISTAL BICEPS REPAIR.

BACKGROUND AND PURPOSE: Distal biceps rupture is less common than injury to the proximal biceps; however, injury distally has profound functional implications on activities which rely on power during elbow flexion and forearm supination. The majority of distal biceps ruptures can be treated with surgical repair of the distal biceps utilizing either a single or two-incision technique; both of which achieve comparable improved outcomes and reported minimal pain and disability at two years. Safe and effective rehabilitation following distal biceps repair is accomplished through a phased progression, with avoidance of premature stress to the healing soft tissue repair.The purpose of this clinical commentary is to provide a concise review of distal biceps tendon injury, including relevant anatomy, etiology, diagnosis, and operative intervention as well as post-operative factors influencing the pursuit of a criterion based, progressive rehabilitation program after distal biceps tendon repair. This commentary seeks to provide an update on current treatment strategies used in distal biceps rehabilitation with accompanying scientific rationale. LEVEL OF EVIDENCE: 5.

Fibular Collateral Ligament Reconstruction in Adolescent Patients.

Fibular collateral ligament (FCL) injuries can present as lateral-sided knee pain with feelings of side-to-side instability during activity. Patients with FCL injuries can have accompanying symptoms related to irritation of the common peroneal nerve. Preoperative diagnosis is imperative and should include a thorough physical examination complemented with varus stress radiographs before surgical reconstruction is indicated. In the adolescent cohort, surgical planning can be complicated by the presence of open physes, and caution must be taken to avoid drilling through or placing screw fixation across the physes. Potential complications include growth arrest and limb length discrepancy. Therefore, the purpose of this Technical Note is to describe an anatomic FCL reconstruction technique in the skeletally immature adolescent patient.

Medial Collateral Ligament Injuries Identified at the National Football League Scouting Combine: Assessment of Epidemiological Characteristics, Imaging Findings, and Initial Career Performance.

BACKGROUND: The medial collateral ligament (MCL) is one of the most commonly injured structures in the knee, especially in young athletes. The impact of MCL injury on National Football League (NFL) performance in elite collegiate athletes has not yet been described in the literature. PURPOSE: We aim to (1) describe the prevalence and severity of MCL injuries in NFL Combine participants, (2) detail injury management, and (3) analyze the impact of MCL injury on NFL performance in terms of draft position, games played, games started, and snap percentage. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A retrospective review of all NFL Combine participants from 2009 to 2015 was performed by reviewing medical records and imaging reports from the combine to identify all players with MCL injuries. A control group was developed from the players evaluated at the combine without MCL injury. For each affected knee, the MCL injury was classified by location and severity based on results of magnetic resonance imaging (MRI). Each player's respective NFL draft position, number of NFL games played, number of NFL games started, and NFL snap percentage for the first 2 seasons in the league were collected through the use of NFL.com and Pro-Football-Focus, which are web-based, publicly accessible, comprehensive sports statistics databases. RESULTS: A total of 2285 players participated in the NFL Combine between 2009 and 2015. Three hundred one athletes (13.2%) were identified as having MCL injuries; 36 (12%) of the athletes with MCL injury presented with bilateral injuries, for a total of 337 MCL injuries. Additional soft tissue injury was identified on 187 of 337 (55%) MRIs. Players with a history of MCL injury were more likely to play at least 2 years in the NFL compared with those in the control group (P = .003). Players who had isolated MCL injury performed significantly better compared with athletes who had combined injuries with regard to draft position (P = .034), proportion playing at least 2 seasons in the NFL (P = .022), games played (P = .014), and games started (P = .020) in the first 2 years. No significant difference was found between players who underwent operative versus nonoperative management of their MCL injury. CONCLUSION: A relatively high percentage of players at the NFL Combine had evidence of MCL injury (13%). A prior history of MCL tear had no negative impact on an athlete's NFL performance. Players who had isolated MCL injury performed significantly better compared with athletes who had combined injuries with regard to draft position, proportion playing 2 seasons or more in the NFL, and games played and started in the first 2 years.

Posterior Cruciate Ligament Injuries of the Knee at the National Football League Combine: An Imaging and Epidemiology Study.

PURPOSE: To determine the epidemiology by player position, examination, imaging findings, and associated injuries of posterior cruciate ligament (PCL) injuries in players participating in the National Football League (NFL) Combine. METHODS: All PCL injuries identified at the NFL Combine (2009-2015) were reviewed. Data were obtained from the database organized by the NFL medical personnel for the compilation of the medical and physical performance examination results of NFL Draftees participating in the NFL Combine from 2009 to 2015. Inclusion criteria were any player with clinical findings or a previous surgery consistent with a PCL injury who participated in the NFL Combine. RESULTS: Of the 2,285 players who participated in the NFL Combine between 2009 and 2015, 69 (3%) had evidence of a PCL injury, of which 11 players (15.9%) were managed surgically. On physical examination, 35 players (52%) had a grade II or III posterior drawer. Concomitant injuries were present frequently and included medial collateral ligament (MCL; 42%), anterior cruciate ligament (ACL; 11.6%), and chondral injuries (31.8%), especially in the lateral tibiofemoral compartment. CONCLUSIONS: Three percent of the players at the NFL Combine presented with a PCL injury, with a significant amount being either running backs (14/69, 20.2%) or offensive linemen (14/69, 20.2%). Approximately half of the players with a PCL tear had a residual grade II or III posterior drawer after sustaining a PCL injury. Concomitant injuries were present frequently and included MCL (42%), ACL (11.6%), and chondral injuries (31.8%), especially in the lateral tibiofemoral compartment. For those players with clinical concern for PCL ligamentous laxity, there should be a complete comprehensive workup that includes plain and PCL stress view radiographs, and magnetic resonance imaging. LEVEL OF EVIDENCE: Level IV, case series.

Discoid Lateral Meniscus in Children: Diagnosis, Management, and Outcomes.

Discoid meniscus is a congenital variant of the knee joint that typically involves abnormal morphology and potential instability of the lateral meniscus. Some discoid menisci have abnormal peripheral attachments and are unstable. Discoid menisci are prone to tearing secondary to increased thickness, poor tissue quality, and instability. Patients may or may not be symptomatic. Torn or unstable discoid menisci cause mechanical symptoms, pain, and swelling. Symptomatic patients in whom nonsurgical management fails most frequently are treated with arthroscopic surgery. Historically, complete meniscectomy has successfully alleviated symptoms but has resulted in poor midterm results, with degenerative changes to the knee joint. Current treatment emphasizes the saucerization of the meniscus, with removal of the central disk and retention of the peripheral crescent. Peripheral meniscal repair is performed when instability is present. Short-term results are good; however, degenerative changes have been reported at intermediate follow-up.

Epidemiology of Navicular Injury at the NFL Combine and Their Impact on an Athlete's Prospective NFL Career.

BACKGROUND: Navicular injuries can result in persistent pain, posttraumatic osteoarthritis, and diminished performance and function. PURPOSE: To determine the epidemiology of navicular fracture in players participating in the National Football League (NFL) Scouting Combine and evaluate the impact of a navicular injury on the NFL draft position and NFL game play compared with matched controls. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Data were collected on players who previously sustained a navicular injury and participated in the NFL Combine between 2009 and 2015. The epidemiology of navicular injury was determined through an evaluation of the number of injuries, surgeries, and collegiate games missed as well as the position played, a physical examination, the surgical technique, and imaging findings. Players with a previous navicular injury (2009-2013) were compared with a set of matched controls. NFL performance outcomes included the draft position, career length ≥2 years, and number of games played and started within the first 2 years. RESULTS: Between 2009 and 2015, 14 of 2285 (0.6%) players were identified as having sustained a navicular injury. A total of 11 of 14 (79%) athletes had sustained an overt navicular fracture, while 3 of 14 (21%) were diagnosed with stress reactions on magnetic resonance imaging. Eight patients who sustained a navicular fracture underwent surgery. There was evidence of ipsilateral talonavicular arthritis in 75% of players with a navicular fracture versus only 60% in the uninjured foot (odds ratio, 1.3; P = .04). Fifty-seven percent of players with navicular injury (72.7% of fractures) were undrafted versus 30.9% in the control group (P = .001). Overall, 28.6% of players with navicular fracture played ≥2 years in the NFL compared with 69.6% in the control group (P = .02). CONCLUSION: A previous navicular fracture results in a greater risk of developing posttraumatic osteoarthritis. Although only a low prevalence of navicular injury in prospective NFL players was noted, players with these injuries had a greater probability of not being drafted and not competing in at least 2 NFL seasons when compared with matched controls without an injury history to the NFL Combine.

The Role of Therapeutic Modalities in Surgical and Nonsurgical Management of Orthopaedic Injuries.

Rehabilitation professionals often use therapeutic modalities as a component of the surgical and nonsurgical management of orthopaedic injuries. Myriad therapeutic modalities, including cryotherapy, thermotherapy, ultrasonography, electrical stimulation, iontophoresis, and laser therapy, are available. Knowledge of the scientific basis of each modality and the principles of implementation for specific injuries enables musculoskeletal treatment providers to prescribe these modalities effectively. The selection of specific therapeutic modalities is based on their efficacy during a particular phase of rehabilitation. Therapeutic modalities are an adjunct to standard exercise and manual therapy techniques and should not be used in isolation.

Systematic Review of the Effect of Taping Techniques on Patellofemoral Pain Syndrome.

CONTEXT: Taping is commonly used in the management of several musculoskeletal conditions, including patellofemoral pain syndrome (PFPS). Specific guidelines for taping are unknown. OBJECTIVE: To investigate the efficacy of knee taping in the management of PFPS. Our hypothesis was that tension taping and exercise would be superior to placebo taping and exercise as well as to exercise or taping alone. DATA SOURCES: The PubMed/MEDLINE, Cochrane, Rehabilitation and Sports Medicine Source, and CINAHL databases were reviewed for English-language randomized controlled trials (RCTs) evaluating the efficacy of various taping techniques that were published between 1995 and April 2015. Keywords utilized included taping, McConnell, kinesio-taping, kinesiotaping, patellofemoral pain, and knee. STUDY SELECTION: Studies included consisted of RCTs (level 1 or 2) with participants of all ages who had anterior knee or patellofemoral pain symptoms and had received nonsurgical management using any taping technique. STUDY DESIGN: Systematic review. LEVEL OF EVIDENCE: Level 2. DATA EXTRACTION: A checklist method was used to determine selection, performance, detection, and attrition bias for each article. A quality of evidence grading was then referenced using the validated PEDro database for RCTs. Three difference comparison groups were compared: tension taping and exercise versus placebo taping and exercise (group 1), placebo taping and exercise versus exercise alone (group 2), and tension taping and exercise versus taping alone (group 3). RESULTS: Five RCTs with 235 total patients with multiple intervention arms were included. Taping strategies included McConnell and Kinesiotaping. Visual analog scale (VAS) scores indicated improvement in all 3 comparison groups (group 1: 91 patients, 39% of total, mean VAS improvement 44.9 [tension taping + exercise] vs 66 [placebo taping + exercise]; group 2: 56 patients, 24% of total, mean VAS improvement 66 [placebo taping + exercise] vs 47.6 [exercise alone]; and group 3: 112 patients, 48% of total, mean VAS improvement 44.9 [tension taping + exercise] vs 14.1 [taping alone]). CONCLUSION: This systematic review supports knee taping only as an adjunct to traditional exercise therapy for PFPS; however, it does not support taping in isolation.

POST OPERATIVE REHABILITATION OF GRADE III MEDIAL COLLATERAL LIGAMENT INJURIES: EVIDENCE BASED REHABILITATION AND RETURN TO PLAY.

The medial collateral ligament is the most commonly injured ligament of the knee, with injury generally sustained in the athletic population as a result of valgus contact with or without tibial external rotation. The capacity of the medial collateral ligament to heal has been demonstrated in both laboratory and clinical studies; however, complete ruptures heal less consistently and may result in persistent instability. When operative intervention is deemed necessary, anatomical medial knee reconstruction is recommended. Post-operative rehabilitation focuses on early motion and the return of normal neuromuscular firing patterns with progression based on attainment of specific phase criteria and goals. The purpose of this clinical commentary is to discuss the determinants of phase progression and the importance of objectively assessing readiness for advancement that is consistent with post-operative healing. Additional tests and validated measures to assess readiness for sport are also presented. LEVEL OF EVIDENCE: 5.

Monitoring universal protocol compliance through real-time clandestine observation by medical students results in performance improvement.

OBJECTIVE: To measure universal protocol compliance through real-time, clandestine observation by medical students compared with chart audit reviews, and to enable medical students the opportunity to become conscious of the importance of medical errors and safety initiatives. DESIGN: With endorsement from Tufts Medical Center's (TMC's) Chief Medical Officer and Surgeon-in-Chief, 8 medical students performed clandestine observation audits of 98 cases from April to August 2009. A compliance checklist was based on TMC's presurgical checklist. Our initial results led to interventions to improve our universal protocol procedures, including modifications to the operating room white board and presurgical checklist, and specific feedback to surgical departments. One year later, 6 medical students performed observations of 100 cases from June to August 2010. SETTING: Tufts Medical Center, Boston, Massachusetts, which is an academic medical center and the principal teaching hospital for Tufts University School of Medicine. PARTICIPANTS: An operating room coordinator placed the medical students into 1 of our 25 operating rooms with students entering under the premise of observing the anesthesiologist for clinical education. The observations were performed Monday to Friday between 7 am and 4 pm. Although observations were not randomized, no single service or type of surgery was targeted for observation. RESULTS: A broad range of departments was observed. In 8.2% of cases, the surgical site was unmarked. A Time Out occurred in 89.7% of cases. The entire surgical team was attentive during the time out in 82% of cases. The presurgical checklist was incomplete before incision in 13 cases. Images were displayed in 82% of cases. The operating room "white board" was filled out completely in 49% of cases. Team introductions occurred in 13 cases. One year later, compliance increased in all Universal Protocol dimensions. CONCLUSIONS: Direct, real-time observation by medical students provides an accurate and granular assessment of compliance with specific components of the universal protocol and engages medical students in the quality improvement process, raises their awareness of the gravity of medical errors, and ensures appreciation of the importance of quality and safety initiatives.

Coordinated clinical and financial analysis as a powerful tool to influence vendor pricing.

BACKGROUND: As costs continue to outpace reimbursements, hospital administrators and clinicians face increasing pressure to justify new capital purchases. Massachusetts Health Care Reform has added further economic challenges for Disproportionate Share Hospitals (DSH), as resources formerly available to treat the uninsured have been redirected. In this challenging climate, many hospitals still lack a standardized process for technology planning and/or vendor negotiation. PURPOSE: : The purpose of this study was to determine whether a simple, coordinated clinical and financial analysis of a technology, Endoscopic Carpal Tunnel Release (ECTR), is sufficient to impact vendor pricing at Cambridge Health Alliance (CHA), a disproportionate share hospital (DSH) in Cambridge, Massachusetts. METHODOLOGY: This case study addressed the topic of technology adoption, a complex decision-making process every hospital administration faces. Taking note of other hospitals approaches to instill a strategic management culture, CHA combined a literature review on clinical outcomes and financial analysis on profitability. Clinical effectiveness was evaluated through a literature review. The financial analysis was based on a retrospective inquiry of fixed and variable costs, reimbursement rates, actual payer mix, and profitability of adopting ECTR over open carpal tunnel release at CHA. This clinical and financial analysis was then shared with the vendor. FINDINGS: A literature review revealed that although there are short-term benefits to ECTR, there is little to no difference in long-term outcomes to justify a calculated incremental loss of $91.49 in revenue per case. Sharing this analysis with the vendor resulted in a 30% price reduction. A revised cost analysis demonstrated a $53.51 incremental gain in revenue per case. CHA has since elected to offer ECTR to its patients. PRACTICE IMPLICATIONS: Smaller hospital systems often have modest leverage in vendor negotiations. Our results suggest that the development of adoption criteria and an evidence-based managerial approach can create dialogue with vendors and directly impact pricing. Coordinated clinical and financial analysis is a powerful tool, enabling administrators, clinicians, and medical device suppliers to work constructively to provide patients access to innovative technology, even in the face of a challenging payer mix. Ongoing assessment of clinical outcomes and financial data must be performed to reflect the most up-to-date scientific and economic climate.