Ultrasonographic Assessment of Glenohumeral Joint Stability Immediately After Arthroscopic Bankart-Bristow Procedure.

Background: The changes in glenohumeral joint stability after surgery in a clinical setting are yet unknown. Purpose/Hypothesis: This study aimed to compare the anterior humeral head translation between pre- and postsurgical conditions using ultrasonography. It was hypothesized that ultrasonographic assessment would reveal decreased anterior translation. Study Design: Case series; Level of evidence, 4. Methods: A total of 27 patients (24 male, 3 female; mean age, 24.1 ± 9.7 years) with anterior shoulder instability were studied prospectively. All the patients underwent the arthroscopic Bankart-Bristow procedure under general anesthesia, and ultrasonographic evaluation was performed before and immediately after surgery. The forearm was fixed with an arm positioner in the beach-chair position, and the ultrasonographic transducer was located at the posterior part of the shoulder to visualize the humeral head and glenoid rim at the level of interval between the infraspinatus tendon and teres minor tendon. The upper arm was drawn anteriorly with a 40-N force at 0°, 45°, and 90° of shoulder abduction with neutral rotation. The distance from the posterior edge of the glenoid to that of the humeral head was measured using ultrasonography with and without anterior force. Anterior translation was defined by subtracting the distance with anterior force from the distance without anterior force. Results: The humeral head position was translated posteriorly immediately after surgery in all patients. Anterior translation decreased significantly after surgery at 45° (7.7 ± 4.3 vs 5.8 ± 2.0 mm; P = .031) and 90° (8.9 ± 3.4 vs 6.1 ± 2.2 mm; P < .001) of abduction, whereas there was no difference between pre- and postsurgical translation at 0° of abduction (4.9 ± 2.3 vs 4.0 ± 2.1 mm, P = .089). Conclusion: Ultrasonographic assessment immediately after a Bankart-Bristow procedure showed the humeral head was translated posteriorly relative to the glenoid at 0°, 45°, and 90° of abduction. The surgery also decreased anterior translation in response to an anteriorly directed force at 45° and 90° of abduction.

Ultrasound Assessment of Anterior Humeral Head Translation in Patients With Anterior Shoulder Instability: Correlation With Demographic, Radiographic, and Clinical Data.

Background: Ultrasonography can be used to quantitatively assess anterior humeral head translation (AHHT) at different degrees of shoulder abduction. Risk factors for recurrent shoulder instability have been identified. Hypothesis: It was hypothesized that the number of dislocations or glenoid or humeral bone loss would be associated with more AHHT as measured using ultrasound. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 39 patients who underwent surgery for anterior shoulder instability were prospectively studied. Ultrasound assessment of AHHT was performed immediately after general anesthesia was induced. The upper arm was placed at 0°, 45°, and 90° of abduction, and a 40-N anterior force was applied to the proximal third of the arm. The distance from the posterior edge of the glenoid to that of the humeral head was measured at each abduction angle using ultrasound with and without a 40-N anterior force, and the AHHT was calculated. The differences in translation at each shoulder angle were compared. Additionally, the authors investigated the association between AHHT and demographic, radiographic, and clinical data. Results: Compared with the AHHT at 0° of abduction (5.29 mm), translation was significantly larger at 45° of abduction (8.90 mm; P < .01) and 90° of abduction (9.46 mm; P < .01). The mean translation was significantly larger in female patients than in male patients at all degrees of abduction (P ≤ .036 for all). There was no correlation between AHHT at any abduction angle and number of dislocations, clinical data, or radiographic data (including bone loss). Conclusion: Ultrasound assessment of AHHT showed larger amounts of laxity at 45° and 90° than at 0° of abduction. Anterior glenohumeral laxity was greater in female than male patients. Glenoid or humeral bone loss did not correlate with AHHT, thereby clarifying that bone loss has no direct effect on measurements of capsular laxity in neutral rotation.

Forecasting of Future Medical Care Expenditure in Japan Using a System Dynamics Model.

BACKGROUND: The aim of this study was to construct a system dynamics (SD) model to estimate the future medical care expenditure and to address the dynamic issues of health care that should be resolved. In particular, the measures for promoting the spread of generic drug (GE drug) usage in Japan and reducing cancer-related medical expenses were investigated regarding their future impact on medical finances. METHODS: The SD model was constructed from FY 2018 to FY 2050. The change in the future GE drug quantity share was analyzed by using a regression equation. The impact of the increase in medical expense for cancer and the change in the future national medical care expenditure were also estimated. RESULTS: The annual total medical care expenditure in FY 2050 would arrive at 58.9-64.2 trillion JPY (US$ 535.1-584.0 billion) (1.3-1.5 times higher than that in FY 2018) with different trends in age groups. The cumulative total medical care expenditure was expected to decrease by about 787.0-989.4 billion JPY (US$ 7.2-9.0 billion) if the impact of the spread of GE drug usage was considered. On the other hand, due to the continuous increase in the cancer-related medical expense, the cumulative total medical care expenditure was estimated to increase about 7554.3-11715.0 billion JPY (US$ 68.7-106.5 billion). CONCLUSIONS: If the cancer-related medical expense continues to increase in the future, an increase of 686.4-1104.2 billion JPY (US$ 6.2-10.0 billion) in FY 2050 is expected which suggests that this disease field should be prioritized regarding the measures to maintain medical finances.

Fall prediction using decision tree analysis in acute care units.

[Purpose] To present an accurate and straight-forward system of fall prediction by performing decision tree analysis using both the fall assessment sheet and Berg balance scale (BBS). [Participants and Methods] The participants in this retrospective study were inpatients from acute care units. We extracted the risk factors for falls from the fall assessment and performed a decision tree analysis using the extracted fall risk factors and BBS score. [Results] "History of more than one fall in the last 1 year", "Muscle weakness", "Use of a walking aid or wheelchair", "Requires assistance for transfer", "Use of Narcotics", "Dangerous behavior", and "High degree of self-reliance" were fall risk factors. The decision tree analysis extracted five fall risk factors, with an area under the curve of 0.7919. Patients with no history of falls and who did not require assistance for transfer or those with a BBS score ≥51 did not fall. [Conclusion] Decision tree-based fall prediction was useful and straightforward and revealed that patients with no history of falling and those who did not require assistance for transfer or had a BBS score ≥51 had a low risk of falling.

Development of a multiplicative, multi-attribute utility function and eight single-attribute utility functions for the Health Utilities Index Mark 3 in Japan.

BACKGROUND: The Health Utilities Index Mark 3 (HUI3) is a generic multi-attribute, preference-based system for assessing health-related quality of life. It is widely used overseas as an outcome measure and for estimating quality-adjusted life years. We aimed to estimate a multi-attribute and eight single-attribute utility functions for the HUI3 system based on community preferences in Japan. We conducted two preference surveys in this study. The first survey was designed to estimate a model of utility function and collect preference scores, and the second survey was designed to evaluate predictive validity of the utility function and provide independent scores. Values obtained from the feeling thermometer and standard gamble scores obtained from using a chance board were included in the preference scale. We recruited 1043 respondents (age: 20-79 years) from five cities in Japan through the general population classified by sex and age groups. Respondents were further randomly divided into a modeling group (n = 774) and a direct group (n = 263). RESULTS: We acquired the estimation for eight single-attribute and a global multi-attribute utility function. The minimum expected multi-attribute utility score was - 0.002. The intraclass correlation coefficient between the directly measured utility score and the score generated by multi-attribute function in terms of 53 health conditions was 0.742. CONCLUSIONS: The HUI3 scoring function developed in Japan has a strong theoretical and empirical basis. It will be useful in future to predict the directly measured score of health technology assessments in Japan.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

Field Assessment of Critical Stroke by Emergency Services for Acute Delivery to a Comprehensive Stroke Center: FACE2AD.

Patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) should be triaged to an endovascular-capable hospital by the emergency medical service (EMS). We designed a prehospital LVO prediction scale based on EMS assessments. In the derivation cohort, 1157 patients transferred to our hospital by the EMS because of suspected stroke within 24 h of onset were retrospectively examined. Factors associated with AIS due to LVO were identified based on the EMS assessment, and a prehospital scale identifying LVO was developed. The accuracy of this scale was validated in 502 consecutive patients who were transferred to 4 stroke centers, and its accuracy was compared with those of 4 previously reported scales. AIS due to LVO was diagnosed in 149 of 1157 patients (13%) in the derivation cohort. One point each was assigned for facial palsy, arm weakness, consciousness impairment (cannot say his/her name), atrial fibrillation, and diastolic blood pressure ≤ 85 mmHg, with two points for conjugate eye deviation (FACE2AD scale). In the derivation cohort, with the optimal cut-point of FACE2AD ≥ 3 determined by the area under the curve (AUC; 0.88; 95% confidence interval 0.87-0.90), sensitivity, specificity, positive predictive value, and negative predictive value for FACE2AD to predict LVO were 0.85, 0.80, 0.39, and 0.97, respectively. In the validation cohort, the FACE2AD scale had higher accuracy, with an AUC value of 0.84 for predicting LVO compared with the other scales (all p < 0.01). The FACE2AD scale is a simple, reliable tool for identifying AIS due to LVO by the EMS.

Cost-effectiveness of surveillance and prevention strategies in BRCA1/2 mutation carriers.

BACKGROUND: Cost-effectiveness analysis is an important aspect of healthcare, including in Japan, where preventive measures for BRCA1/2 mutation carriers are not covered by health insurance. METHODS: We developed Markov models in a simulated cohort of women aged 35-70 years, and compared outcomes of surveillance with risk-reducing mastectomy (RRM) at age 35, risk-reducing salpingo-oophorectomy (RRSO) at age 45, and both (RRM&RRSO). We used breast and ovarian cancer incidences and adverse event rates from the previous studies, adjuvant chemotherapy, and hormonal therapy rates from the Hereditary Breast and Ovarian Cancer Registration 2015 in Japan, mortality rates from the National Cancer Center Hospital, Japan Society of Clinical Oncology, and Ministry of Health, Labour and Welfare, and direct costs from St. Luke's International Hospital and Keio University Hospital. We used previously published preference ratings of women without known high risk to adjust survival for quality of life. The discount rate was 2%. RESULTS: Compared with surveillance, RRSO and RRM&RRSO were dominant (both cost-saving and more effective), and RRM was cost-effective in BRCA1 mutation carriers, while RRM and RRM&RRSO were dominant and RRSO was cost-effective in BRCA2. Among the four strategies including surveillance, RRM&RRSO and RRM were the most cost-effective in BRCA1 and BRCA2 mutation carriers, respectively. CONCLUSIONS: With quality adjustment, RRM, RRSO, and RRM&RRSO were all cost-effective preventive strategies in BRCA1/2 mutation carriers, with RRM&RRSO being the most cost-effective in BRCA1 and RRM in BRCA2. This result supports the inclusion of insurance coverage for BRCA mutation carriers in Japan.

Cost-effectiveness analysis of pregabalin for treatment of chronic low back pain in patients with accompanying lower limb pain (neuropathic component) in Japan.

OBJECTIVE: To assess the cost-effectiveness of pregabalin for the treatment of chronic low back pain with accompanying neuropathic pain (CLBP-NeP) from the health care payer and societal perspectives. METHODS: The cost-effectiveness of pregabalin versus usual care for treatment of CLBP-NeP was evaluated over a 12-month time horizon using the incremental cost-effectiveness ratio (ICER). Quality-adjusted life years (QALYs), derived from the five-dimension, five-level EuroQol (EQ-5D-5L) questionnaire, was the measure of effectiveness. Medical costs and productivity losses were both calculated. Expected costs and outcomes were estimated via cohort simulation using a state-transition model, which mimics pain state transitions among mild, moderate, and severe pain. Distributions of pain severity were obtained from an 8-week noninterventional study. Health care resource consumption for estimation of direct medical costs for pain severity levels was derived from a physician survey. The ICER per additional QALY gained was calculated and sensitivity analyses were performed to evaluate the robustness of the assumptions across a range of values. RESULTS: Direct medical costs and hospitalization costs were both lower in the pregabalin arm compared with usual care. The estimated ICERs in the base case scenarios were approximately ¥2,025,000 and ¥1,435,000 per QALY gained with pregabalin from the payer and societal perspectives, respectively; the latter included indirect costs related to lost productivity. Sensitivity analyses using alternate values for postsurgical pain scores (0 and 5), initial pain severity levels (either all moderate or all severe), and the actual EQ-5D-5L scores from the noninterventional study showed robustness of results, with ICERs that were similar to the base case. Development of a cost-effectiveness acceptability curve showed high probability (≥75%) of pregabalin being cost-effective. CONCLUSION: Using data and assumptions from routine clinical practice, pregabalin is cost-effective for the treatment of CLBP-NeP in Japan.

Expected value of the additional state in evaluating the method of quantification and uncertainty of additional states in an analytical model of grade I hypertension.

BACKGROUND: In the construction of pharmacoeoconomic models, simplicity is desirable for transparency (people can see how the model is built), ease of analysis, validation (how well the model reproduces reality), and description. Few reports have described concrete methods for constructing simpler models. Therefore we focused on the value of additional states and uncertainty in disease models with multiple complications. OBJECTIVES: The objective of this study was to examine the possibility of ranking additional states in disease models with multiple complications using a method for evaluating the quantification and uncertainty of additional states. METHODS: The expected value of additional states (EVAS) was formulated to calculate the value of additional states from the variation between analytic models using the net benefit method, and uncertainty was subtracted from the variation. We also verified the usefulness and availability of this method in grade I hypertension as a verification of the disease model. We assumed that stroke was recognized as an associated complication of hypertension in the basic model. In addition, stroke recurrence, coronary heart disease (CHD), and end-stage renal disease (ESRD) were assumed to represent other complications of hypertension. Ten thousand Monte Carlo simulations were performed, and the probability distribution was assumed to be the beta distribution in clinical parameters. The ranges of clinical parameters were ±6.25%, 12.5%, 25%, and 50% of the standard deviation from the mean value. RESULTS: The EVAS in complications of CHD showed the greatest uncertainty. In contrast, the EVAS of ESRD differed from stroke recurrence in the value ranking by uncertainty. CONCLUSIONS: The EVAS has the potential to determine the ranking of additional states based on the quantitative value and uncertainty in disease models with multiple complications.

Molecular epidemiology and genetic history of European-type genotype 3 hepatitis E virus indigenized in the central region of Japan.

In Mie prefecture in Japan, 12 cases of sporadic hepatitis E occurred from 2004 to 2011. Mie prefecture is located in the central region of Japan, far from the most prevalent regions of hepatitis E virus (HEV) infection in Japan, the north and northeastern part. These 12 cases did not have any common risk factors of HEV infection. We analyzed the molecular epidemiology of the cases in Mie prefecture. We obtained the nucleotide sequences of the HEV strains and analyzed them with the sequences of other HEV strains by phylogenetic and coalescent analyses. Japan-indigenous genotype 3 HEV strains were divided into two major subtypes, namely, 3a and 3b; one minor subtype, 3e; and a few other unassigned lineages. The Japan-indigenous subtype 3e strains were closely related to European subtype 3e HEV strains and were comparatively rare in Japan; however, eight strains of the 12 cases we examined belonged to subtype 3e, indicating a close phylogenetic relationship, despite the lack of common risk factors. Coalescent analyses indicated that the Mie 3e strains seemed to have intruded into Mie prefecture about 10 years ago. Sporadic acute hepatitis E cases caused by the 3e strains occurred consistently from 2004 to 2011 in Mie prefecture. This is the first report of unexpected persistent occurrence of hepatitis by the European-type genotype 3 HEV, subtype 3e, in a country outside of Europe. Phylogenetic and coalescent analyses traced the history of the indigenization of the Mie 3e strains from Europe. Because hepatitis E cases caused by 3e strains are relatively rare in Japan, molecular evolutionary analyses of HEV infection in Mie prefecture is important for preventing a future hepatitis endemic or epidemic by 3e strains in Japan.

New findings regarding the epidemic history and population dynamics of Japan-indigenous genotype 3 hepatitis E virus inferred by molecular evolution.

BACKGROUND: Since previous studies have investigated the population dynamics of Japan-indigenous genotype 3 hepatitis E virus (HEV) using virus sequences, more nucleotide sequences have been determined, and new techniques have been developed for such analysis. AIMS: To prevent future hepatitis E epidemic in Japan, this study aimed to elucidate the cause of past HEV expansion. METHODS: The epidemic history of Japan-indigenous genotype 3 HEV was determined using the coalescent analysis framework. Bayesian skyline plot (BSP) and Bayesian estimate of phylogeny with relaxed molecular clock models were calculated using Markov chain Monte Carlo sampling. RESULTS: Japan-indigenous strains consist of New World strains (subtype 3a), Japanese strains (3b) and European strains (3e). The oldest lineage, 3b, appeared around 1929. Lineages 3a and 3e appeared around 1960. BSPs indicated similar radical population growth of the 3a and 3b lineages from 1960 to 1980. CONCLUSIONS: Population dynamics of the three lineages shared some common characteristics, but had distinguishing features. The appearance of 3a and 3e lineages coincides with the increase of large-race pig importation from Europe and the USA after 1960. The epidemic phase of 3a and 3b strains from 1960 to 1980 could be related to increased opportunity for HEV infection arising from large-scale pig breeding since 1960. Our observations revealed new findings concerning the close relationship between the epidemic history of Japan-indigenous genotype 3 HEV and the improvement of the Japanese pig industry. Infection control in pig farms should be an effective method of preventing HEV infection in humans.

[Risk management in regional anesthesia: current trends in medical professional liability insurance].

This article aims to highlight current trends in medical professional liability insurance. We present two cases of the lawsuit associated with regional anesthesia. Case 1: Cardiac arrest during femoral neck fracture surgery under combined general anesthesia and epidural anesthesia. Case 2: Neurologic complications following cystectomy under combined general anesthesia and epidural anesthesia. To avoid malpractice risks, it is important to fully understand the risks of this clinical role and how to protect yourself from potential lawsuits. Every anesthesiologist should feel obliged to pay attention to legal questions concerning medical subjects, though judgments on the contents and the extent of the informationthat must be given to patients are complex and difficult to understand for anybody not experienced in law.

[Cost effectiveness of hypertension treatment based on the measurement of ambulatory blood pressure].

In recent years soaring medical costs have become a major social problem in developed countries. Ambulatory blood pressure (ABP) measurements have a stronger predictive power for cardiovascular events than clinic blood pressure (CBP) measurements. Therefore the introduction of ABP measurement for the diagnosis and treatment of hypertension should lead to a decrease in medical expenditure. This study presents calculations of the cost saving and life years associated with changing from CBP to ABP measurement as diagnostic tool. We constructed a Markov model using data from the Ohasama study and a Japanese national database. Study population was 7.042 million individuals aged 40 years and above living in Japan. The introduction of ABP for hypertension would result in a reduction of about 9.48 trillion yen per 10 years. We conducted a sensitivity analysis and found that the introduction of ABP was associated with at least a cost reduction of 47500 billion yen. But it did not provide significant extension of average life years. However the introduction of ABP for hypertension treatment would be a very effective method in perspective of public health because it reduced about 59600 individuals of stroke and about 18900 individuals of death. Given its cost-effectiveness, extensive application of ABP measurement in clinical practice is expected.

Impact of the Japanese diagnosis procedure combination-based payment system in Japan.

In the health insurance system of Japan, a fee-for-service system has been applied to individual treatment services since 1958. This system involves a structural problem of causing an increase in examination and drug administration. A flat-fee payment system called DPC was introduced in April 2003 to solve the problems of the fee-for-service system. Based on the data of 2003 and 2004, we assessed the impact of DPC in Japan, and obtained the following conclusions: First, the introduction of DPC in Japan could not decrease the absolute value of medical costs; second, the internal efficiency of the institutions was improved, for example, by reducing the mean length of hospitalizations; third, the DPC-based diagnosis classification is considered to be effective for simplifying the medical fee system within the framework of EBM and for providing patients with information; and fourth, after introduction of the DPC, structural problems remain in the flat-fee payment system, such as examination and treatment of low quality, selection of patients and up coding. Its introduction should thus be performed with sufficient caution. We will make greater efforts to establish a better medical fee system by evaluating these problems.

Cost-effectiveness analysis of voglibose for prevention of type 2 diabetes mellitus in Japanese patients with impaired glucose tolerance.

UNLABELLED: Aims/Introduction: The objective of this study was to estimate the cost-effectiveness of administering voglibose, in addition to standard care of diet and exercise, compared with standard care alone for high-risk Japanese patients with impaired glucose tolerance. MATERIALS AND METHODS: A Markov model was constructed to estimate the long-term prognosis of individuals with impaired glucose tolerance, in terms of expected medical costs and life expectancy. Transition probabilities were derived from the results of a clinical trial of voglibose, as well as the epidemiological information. Effectiveness was evaluated by life expectancy and only direct costs were considered. The future costs and effectiveness were discounted by 3% per year. RESULTS: Estimated expected lifetime costs for the voglibose administration group and the standard care group was JPY718,724 ($US7598) and JPY1,365,405 ($US14,433), respectively, with voglibose administration resulting in saving of JPY646,681 ($US6836). Estimated life expectancy was 18.672 and 18.073 years, respectively, with life expectancy prolonged by 0.599 years when voglibose was administered together with the standard care. CONCLUSIONS: In order to prevent type 2 diabetes among Japanese patients with impaired glucose tolerance, voglibose with standard care resulted in cost-saving, as well as prolongation of life expectancy, compared with standard care alone. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.0052.x, 2010).

Ability and limitation of radiographic assessment of fracture healing in rats.

The purpose of the present study was to assess whether clinicians are actually able to evaluate the mechanical status of fracture healing from radiograms. Fifteen orthopaedic surgeons evaluated the radiograms of experimentally produced femur fractures in rats and predicted mechanical strength (%) of the affected side compared to the unaffected control side. Following this, actual mechanical strength of the affected and control side was determined by a three-point bending test. The median of the strength in the transverse fracture model predicted from radiograms was 33% (2 weeks), 72% (4 weeks), 88% (6 weeks), 84% (8 weeks), and 89% (12 weeks). The actual measured recovery ratio of mechanical strength (exp/control x 100) was 36%, 76%, 93%, 89%, and 106% in each observation period respectively. The tendency was almost the same in a comminuted fracture model. The mean recovery rate determined by interpretation of the surgeons correlated linearly to the actual measured mechanical strength determined by mechanical testing (R(2): 0.80 in transverse fracture, 0.60 in comminuted fracture). Clinicians demonstrated that a comparatively good evaluation of the mechanical status of fracture healing is possible from radiograms up to approximately 80% recovery. However, they tended to make less accurate, weaker assessments at the final stages. In conclusion, radiograms may be inadequate for evaluation of fracture healing completion.