Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea.

INTRODUCTION: With the availability of retrospective pharmacovigilance data, the common data model (CDM) has been identified as an efficient approach towards anonymized multicenter analysis; however, the establishment of a suitable model for individual medical systems and applications supporting their analysis is a challenge. OBJECTIVE: The aim of this study was to construct a specialized Korean CDM (K-CDM) for pharmacovigilance systems based on a clinical scenario to detect adverse drug reactions (ADRs). METHODS: De-identified patient records (n = 5,402,129) from 13 institutions were converted to the K-CDM. From 2005 to 2017, 37,698,535 visits, 39,910,849 conditions, 259,594,727 drug exposures, and 30,176,929 procedures were recorded. The K-CDM, which comprises three layers, is compatible with existing models and is potentially adaptable to extended clinical research. Local codes for electronic medical records (EMRs), including diagnosis, drug prescriptions, and procedures, were mapped using standard vocabulary. Distributed queries based on clinical scenarios were developed and applied to K-CDM through decentralized or distributed networks. RESULTS: Meta-analysis of drug relative risk ratios from ten institutions revealed that non-steroidal anti-inflammatory drugs (NSAIDs) increased the risk of gastrointestinal hemorrhage by twofold compared with aspirin, and non-vitamin K anticoagulants decreased cerebrovascular bleeding risk by 0.18-fold compared with warfarin. CONCLUSION: These results are similar to those from previous studies and are conducive for new research, thereby demonstrating the feasibility of K-CDM for pharmacovigilance. However, the low quality of original EMR data, incomplete mapping, and heterogeneity between institutions reduced the validity of the analysis, thus necessitating continuous calibration among researchers, clinicians, and the government.

Comparison of screw-home movement between patients with knee osteoarthritis and normal adults.

BACKGROUND: Tibial rotation accompanying sagittal movement contains the phenomenon of screw-home movement (SHM) of the knee, which plays an important role in knee stability during extension. OBJECTIVE: This study aimed to investigate the change of SHM in patients with knee osteoarthritis (OA). METHODS: Thirty-one sex-matched patients with knee OA and 31 normal subjects were recruited. The total tibial rotation was obtained during knee sagittal movement (extension and flexion) using an inertial measurement unit. The acquired angle of tibial rotation was divided into eight periods. The total tibial rotation and the variation of each period were compared between the OA and control groups. The difference in tibial rotation according to Kellgren-Lawrence (KL) grade was compared. RESULTS: The total tibial rotation of the OA group decreased compared with the control group during knee extension and flexion (P< 0.001). Variations of tibial rotation were significantly different between groups in all periods (P< 0.001) except for knee extension at 70∘ to 45∘ (P= 0.081). There was no significant difference in tibial rotations among the KA grades of OA patients. CONCLUSION: We found a reduction in the total tibial rotation and loss of the SHM in the unloaded OA knee. It could be predicted that reduced SHM appeared early in knee OA.

Sports injury and illness incidence among South Korean elite athletes in the 2018 Asian Games: a single-physician prospective study of 782 athletes.

OBJECTIVE: The increasing incidence of sports injury among athletes calls for systemic surveillance of injuries and illnesses in this field to develop preventive measures. The patterns of injuries and illnesses that occurred among Korean athletes during the 2018 Asian Games held in Indonesia were studied. METHODS: We recorded the occurrence of all injuries and illnesses reported to the chief medical officer, coordinated with the help of an instant social messaging application in real time. RESULTS: A total of 782 elite athletes participated in 46 sporting events. A total of 141 (18.03%) injuries were recorded, with 121 (15.47%) athletes suffering at least one injury. Out of 141 injuries 80 (56.74%) were in male athletes and 61 (43.26%) were in female athletes. The highest number of injuries was seen among sport climbing athletes (n=10, 71.43%), followed by sepak takraw. A total of 16 (11.35%) injuries were expected to prevent athletes from participation in competition/training. Most of the injuries occurred during training (46.10%), with lower lumbar spine being the most common part injured. A total of 209 (26.72%) illnesses were reported, with at least one illness in 170 (21.73%) athletes. The incidence among female athletes (26.90%) was comparable with that of male athletes (26.90%). Maximum illness rate was reported in table tennis (100%). The most common system involved was gastrointestinal (n=93, 44.49%), followed by respiratory (n=53, 25.36%). Environmental factors were causative in 111 athletes (53.11%) and infection in 79 (37.79%). Illnesses resulted in loss of at least 1 day among 30 (14.35%) athletes. CONCLUSION: Overall 15.47% of athletes suffered at least one injury and 21.73% suffered at least one illness; the incidence of injury and illness varied depending on the type of sports.

Does magnetic resonance imaging appearance of supraspinatus muscle atrophy change after repairing rotator cuff tears?

BACKGROUND: This study was conducted to determine whether supraspinatus muscle atrophy appearance changes after arthroscopic rotator cuff repair and to quantify the change in appearance on magnetic resonance imaging (MRI), if any, based on age and tendon retraction. METHODS: We retrospectively reviewed patients who underwent arthroscopic rotator cuff repair and considered only 209 patients who had both preoperative and immediate postoperative MRI. Patients were grouped by age <60 years and >60 years. They were further subdivided into stage 1 (mild), stage 2 (moderate), and stage 3 (severe), depending on preoperative supraspinatus tendon retraction on the coronal view of MRI according to Patte classification. The postoperative occupancy ratio was compared with the preoperative occupancy ratio within the subgroups, and change in the occupancy ratio was used for comparison between the subgroups. RESULTS: There was a significant increase in the occupancy ratio in the mild (P =.001) and moderate-severe (P =.003) subgroup from their preoperative values. In the mild subgroup, the occupancy ratio was significantly greater in the group aged <60 years compared with the group aged >60 years (P =.010). But in the moderate subgroup there was no significant difference between the 2 age groups (P =.710). CONCLUSIONS: A significant change in supraspinatus muscle atrophy occurs in every patient, provided the patient has some tendon retraction preoperatively. The amount of change in supraspinatus muscle atrophy after surgery depends on the age to some extent, but tendon retraction is the most important thing that decides how much change in atrophy can occur postoperatively.

Clinical and ultrasonographic outcomes of arthroscopic suture bridge repair for massive rotator cuff tear.

PURPOSE: The purpose of this study was to analyze the outcomes of arthroscopic suture bridge repairs of massive rotator cuff tears. METHODS: Thirty-six patients with massive rotator cuff tears that had been repaired by arthroscopic suture bridge repair were enrolled in this study. The mean follow-up period after surgery was 37.6 ± 8.9 months (range, 25 to 56). Arthroscopic en masse suture bridge repair was used in delaminated tears. The integrity of the repaired rotator cuff was examined by ultrasonography 4.5 months, 1 year, and 2 years after surgery. Functional outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) shoulder score, Constant score, range of motion, and muscle power. RESULTS: Twenty-seven cases (75%) showed complete healing on serial ultrasonography, whereas recurrent tears were detected in the remaining 9 cases (25%). Five retears were smaller than, and the other 4 were the same as or larger than, the initial tear. Overall mean functional scores and values improved after surgery. Although the 4 larger retears had a poorer outcome with respect to ASES score than the healed group (P = .005), the Constant score for these 4 retears did not significantly differ at the last follow-up (P = .175). Mean ASES and Constant scores for the larger tear group were also relatively satisfactory (64.2 and 63.0, respectively). Fatty degeneration of the supraspinatus on preoperative magnetic resonance images was associated with a high retear rate (P = .003, odds ratio = 13.664). CONCLUSIONS: Massive rotator cuff tears can be treated successfully by arthroscopic en masse suture bridge repair with satisfactory results. Larger retears had some adverse effects on functional outcome, whereas patients with smaller retears did not significantly differ in functional outcome from the healed group. Fatty degeneration of the supraspinatus on preoperative magnetic resonance images is a poor prognostic indicator. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Is arthroscopic coracoplasty necessary in subcoracoid impingement syndrome?

PURPOSE: The purpose of this study was to analyze the outcomes of arthroscopic coracoplasty in the treatment of subcoracoid impingement syndrome. METHODS: We compared 23 shoulders that underwent arthroscopic coracoplasty for the treatment of subcoracoid impingement syndrome with 28 shoulders that did not undergo arthroscopic coracoplasty for the treatment of subcoracoid impingement syndrome, which comprised the control group. All the shoulders had subcoracoid and subacromial impingement syndrome with or without rotator cuff tear. Subcoracoid impingement was defined as a coracohumeral distance of less than 6 mm on the preoperative magnetic resonance image with anterior shoulder pain or tenderness. The 2 groups were further divided into several subgroups according to the size of concomitant rotator cuff tear, and a comparative analysis of functional outcomes after surgery among the subgroups was performed. RESULTS: In the 2 groups, the overall functional outcomes improved after surgery. The study group showed a significant increase in internal rotation compared with that in the control group (P = .001) at the last follow-up. The large to massive rotator cuff tear subgroup of the study group showed a significant increase in internal rotation (P = .017). On the other hand, no significant difference was seen in the subgroups with small to medium rotator cuff tears including isolated subscapularis tears. The no rotator cuff tear subgroup of the study group showed a significant increase in internal rotation (P = .046). CONCLUSIONS: Arthroscopic coracoplasty for subcoracoid impingement syndrome can provide a satisfactory outcome. In particular, a significant increase in internal rotation of the treated group was achieved after surgery in comparison with the untreated group, especially in the large to massive rotator cuff tear subgroup and in the no rotator cuff tear subgroup. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Change in labrum height after arthroscopic Bankart repair: correlation with preoperative tissue quality and clinical outcome.

HYPOTHESIS: Arthroscopic factors, such as labral and capsular tissue quality or anterior labral periosteal sleeve avulsion (ALPSA) lesion, affect postoperative labral height stability. Labral height stability has a correlation with clinical outcome. METHODS: The study included 40 patients who underwent arthroscopic surgery for a Bankart lesion between August 2005 and May 2009. The mean follow-up and patient age were 29.1 ± 10.9 months (range, 15-60 months) and 24.7 ± 8.4 years (range, 12-55 years), respectively. Labral and capsular tissue quality, ALPSA lesions, Hill-Sachs lesions, glenoid erosion, and superior labrum anterior-posterior tears were identified by arthroscopic examination. Stepwise postoperative computed tomography arthrography to estimate the labral height was performed at 3 months and 1 year. RESULTS: Correlation of postoperative 1 year Rowe scores with labral height maintenance was statistically significant (P < .01). Correlation of Rowe scores at 1 year postoperatively with labral height at 1 year postoperatively was also statistically significant (P < .01). The mean postoperative labral height at 3 months and at 1 year was 5.13 ± 1.56 mm (range, 2.9-8.8 mm) and 4.69 ± 1.75 mm (range, 1.6-8.5 mm), respectively (P < .01). The decrease in labral height at 1 year after surgery was significant in those patients with ALPSA lesions, Hill-Sachs lesions, and a poor labrum along with a poor capsule (P < .01). CONCLUSIONS: The patients with less labral height decrease between 3 months and 1 year or higher labral height at 1 year postoperatively showed higher Rowe scores at 1 year postoperatively. Shoulders with ALPSA lesions, Hill-Sachs lesions, and a poor labrum with poor capsular tissue quality correlated more strongly with postoperative labral height decrease.

Follow-up computed tomography arthrographic evaluation of bony Bankart lesions after arthroscopic repair.

PURPOSE: The follow-up results of bony union after an arthroscopic bony Bankart repair have not been reported. We studied follow-up computed tomography (CT) arthrograms to evaluate radiographic healing of bony Bankart fragments. METHODS: Among 41 patients who underwent arthroscopy for a bony Bankart lesion between July 2006 and May 2009, 31 cases in 30 patients who had undergone sequential follow-up CT arthrography preoperatively, at 3 months postoperatively, and at 1 year postoperatively were enrolled. Radiologic patterns of fracture healing were classified into bony healing and fibrous healing. The mean age was 23.4 years, and the mean follow-up was 30.5 months. The mean interval from the first trauma to surgery was 32.5 months, and the mean preoperative dislocation number was 12.1. RESULTS: The mean preoperative glenoid defect was 14.1%. The fracture healing patterns included 26 bony and 5 fibrous unions. There was a significant positive relation between the total dislocation number and the preoperative glenoid defect (P = .003). The proportion of the mean fragment dimension to a circle drawn through the outer cortex of the inferior glenoid was 8.4% preoperatively, 6.6% at 3 months postoperatively, and 6.2% at 1 year postoperatively. The fragment size decreased from that measured preoperatively to the size measured 3 months after surgery (P < .05). However, the fragment size was maintained between 3 months and 1 year postoperatively (P > .05). The mean Rowe score at 1 year postoperatively was 97.2. CONCLUSIONS: Follow-up CT arthrographic evaluation showed that small bony Bankart fragments survived without resorption until 1 year postoperatively, even with fibrous union, and that reattached bone fragment fixation to the anatomic position with the labrum could survive. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

The importance of inferomedial support in the hot air balloon technique for treatment of 3-part proximal humeral fractures.

HYPOTHESIS: Inferomedial support may affect the results of the hot air balloon technique for the treatment of displaced, 3-part fractures of the proximal humerus. METHODS: Forty-three patients with displaced, 3-part fractures of the proximal humerus treated with the hot air balloon technique between 1995 and 2007 were included in the study. All patients were classified into 4 subgroups based on the presence or absence of medial buttress restoration and inferomedial screw insertion (R+, restored with inferomedial screw; R-, restored without inferomedial screw; NR+, non-restored with inferomedial screw; and NR-, non-restored without inferomedial screw). Assessment of radiologic and clinical outcome among subgroups was based on evaluation of neck-shaft angle, American Shoulder and Elbow Surgeons score, and Neer score. RESULTS: The mean follow-up duration was 65 ± 29.7 months. The change in the neck-shaft angle in the R+, R-, NR+, and NR- groups was 3°, 2°, 3°, and 11°, respectively. The mean American Shoulder and Elbow Surgeons scores in the R+, R-, NR+, and NR- groups were 91 ± 4.8, 86 ± 5.4, 85 ± 1.9, and 77 ± 5.8, respectively. The mean Neer scores in the R+, R-, NR+, and NR- groups were 92 ± 4.3, 88 ± 4.0, 87 ± 2.1, and 76 ± 8.2, respectively. CONCLUSIONS: Medial buttress restoration and inferomedial screw insertion affect bone-nail construct stability and clinical outcomes.

Perianchor radiolucency after knotless anchor repair for shoulder instability: correlation with clinical results of 69 cases.

BACKGROUND: Although there would seem to be a logical relationship between radiolucency around the suture anchor and clinical result in Bankart repair, the correlation has not been demonstrated so far. HYPOTHESIS: Knotless suture anchor is a viable alternative for arthroscopic Bankart repair, but postoperative radiologic findings of radiolucency around anchors are correlated with poor clinical results. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Sixty-nine consecutive patients with Bankart lesions were treated with arthroscopic reconstruction using knotless metal suture anchors. The mean follow-up was 40 months. Clinical and radiologic analysis was performed retrospectively. A new concept of perianchor radiolucency was introduced and, according to this radiologic finding, patients were divided into 2 subgroups: the perianchor radiolucency group and those who did not reveal perianchor radiolucency. The perianchor radiolucency group was further subdivided by shape and location. "Root type" was defined as a radiolucent halo at the root of the anchor, and perianchor radiolucency without any root halo was named "branch type." Location of perianchor radiolucency was described as above or below the equator of the glenoid. RESULTS: After operation, the mean Rowe score increased to 93.8 from 43.1, and computed tomography arthrogram showed a 97% healing rate. Reoperations were performed due to 1 case of redislocation and 2 cases of anchor arthropathy. All these reoperated cases revealed perianchor radiolucency before reoperation. Other than reoperated cases, 2 patients showed apprehension at final evaluation. The perianchor radiolucency group had a significantly lower Rowe scores than the group that showed no perianchor radiolucency. Some of the patients in the perianchor radiolucency group had peculiar radiologic findings frequently associated with complications. The radiologic findings that consisted of root-type perianchor radiolucency located below the equator of the glenoid was termed the "ominous sign." Osteophytes of the humeral head together with the ominous sign is considered a warning sign of forthcoming progression of anchor arthropathy, and the authors suggest early surgical intervention with these findings. CONCLUSION: After Bankart repair using knotless suture anchor, the ominous sign might be an important warning sign for possible forthcoming complications including redislocation, anchor arthropathy, and residual instability.

Comparison of the clinical outcomes of single- and double-row repairs in rotator cuff tears.

BACKGROUND: Although research has demonstrated the superiority of double-row rotator cuff repair over single-row methods from a biological and mechanical point of view, few studies have compared clinical outcome of the 2 methods, and no articles have been published describing the superiority of double-row methods in clinical aspects. HYPOTHESIS: Arthroscopic double-row repair of a rotator cuff tear has superior clinical outcome to single-row repair. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: The study included 78 patients operated on for full-thickness rotator cuff tears between May 2002 and May 2004. A single-row fixation method was used in the first consecutive 40 patients, and a double-row fixation method was used in the next consecutive 38 patients. The mean age at surgery was 56 years. At 2 years after surgery, final evaluation was done with American Shoulder and Elbow Surgeons and Constant scoring systems and the Shoulder Strength Index. The Shoulder Strength Index is a new evaluation method to estimate relative shoulder strength compared with the unaffected shoulder. RESULTS: At final follow-up, the average American Shoulder and Elbow Surgeons scores were 91.6 in the single-row group and 93.0 in the double-row group. The Constant score was 76.7 in the single-row group and 80.0 in the double-row group. Functional outcome was improved in both groups after surgery, but there was no significant difference between the 2 groups. When the patients were further divided by size of tear, there was still no difference between the repair techniques in the patients with small to medium (<3 cm) tears. However, in patients with large to massive tears (>3 cm), the American Shoulder and Elbow Surgeons and Constant scores and Shoulder Strength Index were all significantly better in the group that had double-row repair. CONCLUSION: Small to medium rotator cuff tears should be repaired with the single-row method, and large to massive tears should be repaired with the double-row method.

Rupture of latissimus dorsi muscle in a tennis player.

Spontaneous rupture of the latissimus dorsi muscle is a rare injury, and few reported cases were avulsion injuries at their humeral insertion. Seven cases of spontaneous rupture of the latissimus dorsi muscle have been reported, but only 1 occurred at the myotendinous junction. The mechanism of this injury is reported to be forceful resisted arm adduction or extension, and reported injuries were rock climbing and attempting to pull up on an overhead handhold, waterskiing injury during pull-up with ski rope, overuse in golf in the leading arm, and abduction-external rotation with horizontally extended arm during a professional steer wrestling performance. The latissimus dorsi muscle is not a critical muscle for activities of daily living; however, the significance of the muscle is increased in professional or elite athletes. This article presents a case of rupture of the latissimus dorsi muscle at the myotendinous junction that occurred during a sports activity.