Objective: Standardized clinical data are invaluable for secondary use of medical information. We constructed a standardized database and a data warehouse called D*D, based on the Standardized Structured Medical Information Exchange(SS-MIX)scheme. D*D enables physicians and researchers to perform complex searches with combined conditions, e.g. time to event. It contains data from 1999 for approximately 400,000 individual patients. The objective of this study was to provide an overview of the features of this database system, especially from the perspective of drug safety research.
Methods: Three models of research questions were identified from established drug-risk combinations:1)gatifloxacin and hypoglycemia;2)statins and rhabdomyolysis;and 3)oral 5-fluorouracil S-1 and hepatotoxicity. D*D was searched using predefined keywords and conditions.
Results: 1)A total of 3,635 patients were treated for diabetes. Among 20 diabetic patients prescribed gatifloxacin, hypoglycemia was recorded in one patient(1/38 prescriptions). 2)Among 5,926 patients who had been prescribed any statin within 10 years in our hospital, 6 patients(0.1%)experienced rhabdomyolysis. The incidence was similar to that for fibrate (1/740, 0.1%). The most confounded diagnosis was stiff shoulder. 3)Among 244 patients prescribed S-1, 19 patients(7.8%) experienced hepatotoxicity higher than CTCAE grade3 within 2 months from the prescription.
Conclusion: With limited data items and search keys in standardized data storage, definitions of exposures and outcomes require careful assessment during protocol development. Considering that the system can be implemented at more than half of the hospitals that have already installed ordering systems, D*D can be one of the Japanese models for distributed research network.

The conventional management of scalp laceration has its drawbacks. Most patients complain of scalp itching, sticky hair and pain at the time of dressing change, because the washing of the hair is restricted and the wound is covered with gauze before the patients have their stitches removed. In this paper, we report the results of trial given to a new management method. The wound was exposed to the air two days after suturing and washing the hair was allowed at the same time. The trial involved 40 outpatients with scalp laceration. There were no complications of wound infection or delayed healing due to this method. And also most patients (90%) said they felt comfortable. Thus, as an alternative management of scalp laceration this method proved useful for comfortable wound treatment.
Scalp ; Laceration ; Injury wounds ; Hair ; Complications Specific to Antepartum or Postpartum

Although visual examination and palpation are used to assess shoulder motion in clinical practice, there is no consensus on shoulder motion under dynamic and static conditions. This study aimed to compare shoulder joint motion under dynamic and static conditions. Methods: The dominant arm of 14 healthy adult males was investigated. Electromagnetic sensors attached to the scapular, thorax, and humerus were used to measure three-dimensional shoulder joint motion under dynamic and static elevation conditions and compare scapular upward rotation and glenohumeral joint elevation in different elevation planes and angles. Results: At 120° of elevation in the scapular and coronal planes, the scapular upward rotation angle was higher in the static condition and the glenohumeral joint elevation angle was higher in the dynamic condition (P<0.05). In scapular plane and coronal plane elevation 90°– 120°, the angular change in scapular upward rotation was higher in the static condition and the angular change in scapulohumeral joint elevation was higher in the dynamic condition (P<0.05). No differences were found in shoulder joint motion in the sagittal plane elevation between the dynamic and static conditions. No interaction effects were found between elevation condition and elevation angle in all elevation planes. Conclusions: Differences in shoulder joint motion should be noted when assessing shoulder joint motion in different dynamic and static conditions. Level of evidence: Level III, diagnostic cross-sectional study.

Background: A supervised physiotherapy program (SPP) is a standard regimen after surgical rotator cuff repair (RCR); however, the effect of a home-based exercise program (HEP), as an alternative, on postoperative functional recovery remains unclear. Therefore, the purpose of this meta-analysis was to compare the functional effects of SPP and HEP after RCR. Methods: We searched electronic databases including Central, Medline, and Embase in April 2022. The primary outcomes included the Constant score, American Shoulder and Elbow Surgeons score, University of California Los Angeles shoulder score, and pain score. Secondary outcomes included range of motion, muscle strength, retear rate, and patient satisfaction rate. A meta-analysis using random-effects models was performed on the pooled results to determine the significance. Results: The initial database search yielded 848 records, five of which met our criteria. Variables at 3 months after surgery were successfully analyzed, including the Constant score (mean difference, −8.51 points; 95% confidence interval [CI], −32.72 to 15.69; P=0.49) and pain score (mean difference, 0.02 cm; 95% CI, −2.29 to 2.33; P=0.99). There were no significant differences between the SPP and HEP. Other variables were not analyzed owing to the lack of data. Conclusions Our data showed no significant differences between SSP and HEP with regard to the Constant and pain scores at 3 months after RCR. These results suggest that HEP may be an alternative regimen after RCR.Level of evidence: I.

The quantitation of serum tocilizumab using liquid chromatography tandem-mass spectrometry(LC-MS/MS)method has not been widely applied in clinical settings because of its time-consuming and costly sample pretreatments.The present study aimed to develop a validated LC-MS/MS method for detecting serum tocilizumab by utilizing immobilized trypsin without an immunoglobulin G purification step and evaluate its applicability in the treatment of rheumatoid arthritis(RA)patients administered intrave-nously or subcutaneously with tocilizumab.The tocilizumab-derived signature peptide was deciphered using a nano-LC system coupled to a hybrid quadrupole-orbitrap mass spectrometer.The serum tocili-zumab was rapidly digested by immobilized trypsin for 30 min.The chromatographic peak of the signature peptide and that of the internal standard were separated from the serum digests for a total run time of 15 min.The calibration curve of serum tocilizumab concentration was linear with a range of 2-200 μg/mL.The intra-and inter-day accuracy and relative standard deviation(RSD)were 90.7％-109.4％and＜10％,respectively.The serum tocilizumab concentrations in the RA patients receiving intravenous and subcutaneous injections were 5.8-28.9 and 2.4-63.5 pg/mL,respectively.The serum tocilizumab concentrations using the current method positively correlated with those using the enzyme-linked immunosorbent assay,although a systematic error was observed between these methods.In conclu-sion,a validated LC-MS/MS method with minimal sample pretreatments for monitoring serum tocili-zumab concentrations in RA patients was developed.

Background: Several systematic reviews have reported on the conservative treatment of full-thickness rotator cuff tears; however, clinical results of this treatment still remain determined. Methods: PubMed, Cochrane Library, PEDro, and CINAHL databases were systematically searched for randomized clinical trials and observational studies. Two independent researchers reviewed a total of 2,981 articles, 28 of which met the criteria for inclusion in the study. Clinical outcome measures included Constant score, visual analog scale score for pain, range of motion, and short-form 36. The meta-analysis used a linear mixed model weighted with the variance of the estimate. Results: The meta-analysis showed a significant improvement after surgery. Pain score is 26.2 mm (1 month) to 26.4 mm (3 months) and 24.8 mm (12 months) (P<0.05); active abduction: 153.2º (2 months), 159.0º (6 months), 168.1º (12 months) (P<0.05); Constant score: 67.8 points (2 months) to 77.2 points (12 months) (P<0.05); short-form 36 “vitality” section: 57.0 points (6 months) and 70.0 points (12 months) (P<0.05). Conclusions Our data confirmed the effectiveness of conservative treatment in patients with full-thickness rotator cuff tears 12 months post-intervention. The results suggest that conservative treatment for patients with full-thickness rotator cuff tears should be the first line of treatment before considering surgery.