A Comparative Study of Clinical Outcomes Between Cruciate-Retaining and Posterior-Stabilized Total Knee Arthroplasty: A Propensity Score-Matched Cohort Study.

INTRODUCTION: We investigated a comparison of clinical outcomes between cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty. However, it is still controversial which design leads to better clinical results. In clinical settings, choosing either CR or PS is likely based on the surgeon's preferences. In this study, short-term clinical outcomes between CR and PS in patients who received a single knee prosthesis were compared using propensity score matching. METHODS: Two hundred and twelve CR and 43 PS of a single knee prosthesis were enrolled in this study. After propensity score matching, 34 knees each in the CR and PS groups were chosen and were without significant differences in age at operation, gender, BMI, preoperative range of motion (ROM), preoperative femorotibial angle (FTA), and presence or absence of patellar replacement. Clinical scores, including ROM, Knee Society score (KSS), knee injury and osteoarthritis outcome score (KOOS), except for the sports subscale, were compared between the CR and PS groups preoperatively and two years postoperatively. RESULTS: Postoperatively, there were no significant differences in FTA, ROM, or KSS. Preoperative scores for the KOOS except for the pain subscale were comparable between the groups. Postoperatively, however, the PS group had a significantly higher score in the ADL subscale compared to the CR group (PS: 89.5 vs. CR: 80.8, p = 0.017). The KOOS subscales other than activities of daily living (ADL) were comparable between the groups. CONCLUSIONS: In this propensity score-matched cohort study, PS showed a better outcome for the ADL than the CR design. These findings suggest that choosing either CR or PS should not depend on the surgeon's preferences. A PS design may be preferable to CR for elderly patients.

General public's understanding of rare diseases and their opinions on medical resource allocation in Japan: a cross-sectional study.

BACKGROUND: Rare diseases (RDs) may impose a considerable financial burden on patients and their families. Public acceptance is essential to ensure sustainable public systems supporting RDs, especially in countries with universal healthcare coverage, such as Japan. This study aimed to explore the public's understanding of RDs and identify crucial factors associated with the public acceptance of prioritizing financial support for RDs in Japan. METHODS: An online questionnaire was sent to 131,220 Japanese residents aged 20-69 years. The items included in the questionnaire were general interest in medical science and medical care, general knowledge regarding RDs and health care systems, opinions on the cost of medical care, opinions on the research and development of RDs and common diseases, and individual characteristics. RESULTS: The responses of 11,019 respondents were analyzed. Several respondents agreed to partially cover the medication cost of adult and pediatric RDs (59.5% and 66.8%, respectively) with public funding. The major reasons for agreeing were the huge financial burden imposed on patients and their families, limited available treatment options, effects of RDs on the life planning of patients, and difficulties caused by RDs in the patient's social life. Furthermore, the respondents ranked RDs (56.0%) higher than common diseases (44.0%) for government funding for research and development. The reasons for supporting government-funded research and development for RDs included the lack of treatment options for numerous RDs (34.9%) and difficulty of studying RDs owing to the small number of researchers (25.9%). The chief reasons for supporting government-funded research and development for common diseases were the large number of affected patients (59.7%) and the possibility of more treatment options becoming available through the promotion of research and development (22.1%). CONCLUSIONS: The general public considers burdens associated with daily living or finance more than the epidemiological characteristics of RD while making funding decisions, demonstrating that rarity was less prioritized. A gap appears to exist between the general public and RD experts regarding the understanding of the epidemiological characteristics of RD and its thresholds. This gap should be bridged to ensure that prioritization of financial support for RDs is accepted by the society.

The impact of postoperative inclination of the joint line on clinical outcomes in total knee arthroplasty using a prosthesis with anatomical geometry.

The goal of this study was to investigate the impact of postoperative inclination of the joint line on clinical results after total knee arthroplasty (TKA) using a prosthesis with anatomical geometry. This study included 145 primary cruciate-retaining type of knee prosthesis with anatomical geometry. Three years postoperatively, clinical outcomes including the patient-reported outcomes (PROs) were recorded. Limb alignment was evaluated by the hip-knee-ankle (HKA) axis and inclination of the joint line was assessed by the joint line orientation angle (JLOA). Knees were divided into two groups according to the HKA: in-range (- 3 to 3°) and outlier group (< - 3° or > 3°) or the JLOA: in-range (2-4°) and outlier group (< 2° or > 4°), and clinical outcomes were compared between the groups. Postoperative Knee Society Function Score (KS-FS) was significantly higher in the HKA in-range group than the outlier group (p = 0.01). The Knee Society Knee Score and all subscales of the Knee injury Osteoarthritis Outcome Score were comparable between the groups. A multivariate analysis revealed a significant association between age at operation and postoperative KS-FS > of 80 points. Neither HKA in-range nor JLOA in-range were associated with the higher knee function. In conclusion, TKA-postoperative inclination of the joint line was not relevant to the short-term PROs. Treatment strategies that attempt to make joint line inclination in order to improve postoperative PROs should be avoided, and alignment goals such as kinematic alignment should be considered carefully.

Effect of Continuous Box-trainer Training on Laparoscopic Skills of Surgical Residents: A Prospective, Observational Study.

BACKGROUND/AIM: As opportunities for hands-on surgical training during residency have decreased, off-the-job training before surgery is gaining importance. We developed a training program using a box-trainer for surgical residents. This study aimed to verify the effectiveness of the program. Using task-achievement time, we demonstrated the learning curve through continuous task training and verified the efficiency of our training tasks. In addition, we examined the circularity of the cut circle to evaluate the task accuracy and summarized the questionnaire results. PATIENTS AND METHODS: A prospective, observational study was conducted at a single center with five trainees from April 2019 to March 2020. The training consisted of four tasks based on the Fundamentals of Laparoscopic Surgery module. The trainees had to achieve expert proficiency time targets. The task-achievement time and circularity of the cut circle were used for objective assessment; subjective evaluation was done using a questionnaire. RESULTS: Although the learning curves of the task-achievement time seemed to reach a plateau between the third and the fifth skills lab, all the trainees achieved expert proficiency times for the three tasks. Circularity of the cut circle tended to be more accurate after training. All trainees perceived an improvement in their skills after the training program. The level of satisfaction of the training program was rated as 'very satisfied' or 'satisfied'. CONCLUSION: Continuous box-trainer training for 1 year may be effective for improvement in preoperative laparoscopic surgical skills of surgical residents.

Is It Worth Knowing That You Might Die Tomorrow? Revisiting the Ethics of Prognosis Disclosure.

Ethical discourse on prognosis disclosure is not yet well established. The core of the problem continues to be the dilemma between the right of self-determination and non-maleficence of patients. The prognosis disclosure policy based on Kantian autonomy provides a good solution for the problem. The policy includes demand for strict truth telling and its compatibility with patients' best interest. However, there remains a discrepancy between theory and practice, especially when prognosis is disclosed just prior to their death. Kantian theory of prognosis is supplemented by a moralistic perspective. The moralistic perspective places high importance on temporality and relationships with others, which all human beings inherently possess. From the moralistic viewpoint, decisions about prognosis disclosure at the final stages of life must be individualized in order to be authentically autonomous. The decision to disclose a prognosis or not can only be determined by the relationships fostered over time with patients.

Lateral shift of the femoral condyle after total knee arthroplasty: simulation using 2D-templates of the medial pivot design on knee radiographs of young Japanese patients.

BACKGROUND: Total knee arthroplasty (TKA) is an established surgical treatment for advanced knee osteoarthritis by which patients can expect improvement of knee pain and function. Although many surgeons have investigated limb alignment after TKA, changes in coronal positional relation between the femur and tibia are not known well. METHODS: Radiographs of 105 knees of young Japanese patients between 20 and 49 years-old (60 men and 45 women) without osteoarthritic changes who received arthroscopic surgeries at our hospital were used in this study. Using 2D-templates of the medial pivot design (the FINE total knee), we simulated TKA on a SYNAPSE-PACS software. First, the femoral component was placed in normal knee alignment and then was merged to the medial concave of the insert where the tibial component was placed in neutral alignment. The length of the mediolateral shift of the femoral component was measured as an estimate of lateral shift of the femoral condyle, of which association with radiographic parameters including the femorotibial angle (FTA), lateral distal femoral angle (LDFA), and medial proximal tibial angle (MPTA) was analyzed. Subjects were classified into three groups according to the femoral component size that was chosen in simulation of TKA, and the lateral shift of the femoral condyle was compared between groups. RESULTS: The estimated mean lateral shift of the femoral condyle was 5.99 ± 1.98 mm and was greater in males than females (p < 0.05). Also, it was most highly correlated with the medial proximal tibial angle (MPTA) (r = - 0.553, p < 0.01). A group receiving larger component sizes significantly shifted more laterally compared with a group receiving smaller component sizes (p < 0.01). CONCLUSIONS: These results suggest that the coronal positional relation between the femur and tibia is altered and subsequent ligament imbalance may occur after mechanically aligned TKA using the medial pivot design.

An American's Experience with End-of-Life Care in Japan: Comparing Brain Death, Limiting and Withdrawing Life-Prolonging Interventions, and Healthcare Ethics Consultation Practices in Japan and the United States.

American and Japanese laws, customs, and practices in end-of-life decision-making differ significantly. We present a case with which one of the authors was involved to illustrate some of the key legal and cultural differences in the declaration of brain death, limiting and withdrawing life-prolonging interventions, and healthcare ethics consultation practices. The analysis presented facilitates understanding of similarities and differences between Japanese and American healthcare ethics specifically in regards to end-of-life care. Further, the analysis provides insights that can aid in developing policies and practices in regions where multiple cultures coexist.

Giant ovarian tumor with colorectal cancer: suggestion concerning the need for colonoscopy screening in cases with large ovarian tumor-a report of three cases.

BACKGROUND: Patients with giant ovarian tumor often have severe symptoms, such as abdominal distention, and the tumor tends to grow rapidly; therefore, sufficient preoperative assessments are difficult to perform. It is not always easy to differentiate between primary and metastatic ovarian cancer, especially when the ovarian tumor is huge, since a precise diagnosis of ovarian tumor depends on the histopathological findings of the excised specimen. Although metastatic ovarian tumors account for over 20% of all malignant ovarian tumors, preoperative colonoscopy is not considered a routine examination before surgery for giant ovarian tumor. CASE PRESENTATION: We herein report 3 cases of giant (> 25 cm) ovarian tumor with colorectal cancer. All three patients visited the clinic with progressing abdominal distention, and were referred with primary ovarian malignancy. Case 1: Rectal tumor was suspected by a digital examination at the outpatient clinic, and rectal cancer was diagnosed preoperatively by colonoscopy. Computed tomography revealed a single-nodule liver tumor. Ovariectomy, rectal resection, and partial hepatectomy were performed. A histological examination revealed both primary mucinous ovarian carcinoma and rectal carcinoma with liver metastasis. Case 2: Initially, the ovarian tumor was diagnosed as primary carcinoma based on the histological findings of an incision biopsy at the previous hospital. Chemotherapy for ovarian cancer was administered without remission, and subsequently, the patient was referred to our hospital. Since the CEA level was high (142 ng/ml), colonoscopy was performed and cecal cancer was diagnosed. Ovariectomy and right colectomy were performed, and the ovarian tumor was histologically diagnosed as metastatic adenocarcinoma. Case 3: Initial ovariectomy was performed, and rectal cancer was suspected at intra-operative surveillance. Colonoscopy was performed after surgery, and rectal cancer was diagnosed. The ovarian tumor was diagnosed as metastatic adenocarcinoma. After six cycles of FOLFOX, rectal resection was performed. CONCLUSION: Regrettably, two of three cases in the current series were not diagnosed with colorectal cancer at the start of treatment. This experience suggests that screening colonoscopy should be considered before treatment for every case of giant ovarian tumor.

A systematic approach to the disclosure of genomic findings in clinical practice and research: a proposed framework with colored matrix and decision-making pathways.

BACKGROUND: Whether and how to disclose genomic findings obtained in the course of genomic clinical practice and medical research has been a controversial global bioethical issue over the past two decades. Although several recommendations and judgment tools for the disclosure of genomic findings have been proposed, none are sufficiently systematic or inclusive or even consistent with each other. In order to approach the disclosure/non-disclosure practice in an ethical manner, optimal and easy-to-use tools for supporting the judgment of physicians/researchers in genomic medicine are necessary. METHODS: The bioethics literature on this topic was analyzed to parse and deconstruct the somewhat overlapping and therefore ill-defined key concepts of genomic findings, such as incidental, primary, secondary, and other findings. Based on the deconstruction and conceptual analyses of these findings, we then defined key parameters from which to identify the strength of duty to disclose (SDD) for a genomic finding. These analyses were then applied to develop a framework with the SDD matrix and systematic decision-making pathways for the disclosure of genomic findings. RESULTS: The following six major parameters (axes), along with sub-axes, were identified: Axis 1 (settings and institutions where findings emerge); Axis 2 (presence or absence of intention and anticipatability in discovery); Axis 3 (maximal actionability at the time of discovery); Axis 4 (net medical importance); Axis 5 (expertise of treating physician/researcher); and Axis 6 (preferences of individual patients/research subjects for disclosure). For Axes 1 to 4, a colored SDD matrix for genomic findings was developed in which levels of obligation for disclosing a finding can be categorized. For Axes 5 and 6, systematic decision-making pathways were developed via the SDD matrix. CONCLUSION: We analyzed the SDD of genomic findings and developed subsequent systematic decision-making pathways of whether and how to disclose genomic findings to patients/research subjects and their relatives in an ethical manner. Our comprehensive framework may help physicians and researchers in genomic medicine make consistent ethical judgments regarding the disclosure of genomic findings.

Solitary death and new lifestyles during and after COVID-19: wearable devices and public health ethics.

BACKGROUND: Solitary death (kodokushi) has recently become recognized as a social issue in Japan. The social isolation of older people leads to death without dignity. With the outbreak of COVID-19, efforts to eliminate solitary death need to be adjusted in line with changes in lifestyle and accompanying changes in social structure. Health monitoring services that utilize wearable devices may contribute to this end. Our goals are to outline how wearable devices might be used to (1) detect emergency situations involving solitary older people and swiftly connect them with medical treatment, to (2) reduce the frequency of deaths that remain undiscovered and (3) to reduce social isolation by promoting social interaction. METHODS: Theoretical and philosophical approaches were adopted to examine ethical issues surrounding the application of wearable devices and cloud-based information processing systems to prevent solitary death in the world with/after COVID-19. MAIN BODY: (1) Technology cannot replace social connections; without social support necessary to foster understanding of the benefits of health management through wearable devices among older adults, such devices may remain unused, or not used properly. (2) Maturity of the technology; systems face the difficult task of detecting and responding to a wide range of health conditions and life-threatening events in time to avert avoidable morbidity and mortality. (3) Autonomy and personhood; promoting the voluntary use of wearable devices that are a part of larger efforts to connect isolated individuals to a community or social services might be effective. Legal force should be avoided if possible. There is some concern that landlords may require an older person to sign a contract agreeing to wear a device. The autonomy of solitary older people should be respected. (4) Governance: policies must be developed to limit access to data from wearables and the purposes for which data can be used. CONCLUSION: If thoughtfully deployed under proper policy constraints, wearable devices offer a way to connect solitary older people to health services and could reduce cases of solitary death while respecting the personhood of the user.

SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Healthy Young Adults First.

In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (WHO) as an alternative to conventional approaches. In such trials, healthy volunteers are deliberately infected with the pathogen of interest, enabling scientists to study the infection process and facilitate further research on treatments or prophylactics, including vaccines. While human challenge trials would offer a collective benefit to society, minimizing the risks is always difficult. Ethical controversy thus inevitably surrounds these trials. Typically, healthy young adults are recruited to serve as the first candidate subjects for human challenge trials because they are generally considered to represent a low-risk population. Here, we present three reasons for doubt about this healthy-young-adults-first criterion and give justification for also recruiting healthy older adults (or not-young adults), meaning those over 30 years of age, to participate in such trials for SARS-CoV-2.

Three-year clinical and radiological results of a cruciate-retaining type of the knee prosthesis with anatomical geometry developed in Japan.

BACKGROUND: The FINE total knee was developed in Japan and clinical use began in 2001. It has unique design features, including an oblique 3o femorotibial joint line that reproduces anatomical geometry. Although 20 years have passed since the FINE knee was clinically used for the first time in Japan, a formal clinical evaluation including patient-reported and radiographic outcomes has not been undertaken. METHODS: A total of 175 consecutive primary cruciate-retaining (CR)-FINE total knee arthroplasties (TKAs) at our hospital between February 2015 and March 2017 were included in this study. Three years postoperatively, range of motion (ROM), Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Forgotten Joint Score (FJS) were recorded and compared with preoperative scores. Radiographic analyses including mechanical alignment, component alignment, and incidence of radiolucent lines also were undertaken based on the radiographs 3 years postoperatively. RESULTS: One-hundred twenty-two knees (70%) were available for 3-year follow-up data using KOOS, except for the sports subscale. Postoperative KOOS-symptom, -pain and -ADL were > 85 points, but KOOS-sports, -QOL and FJS were less satisfactory. ROM, KSS and all the subscales of KOOS were significantly improved compared with preoperative scores. Postoperative mean FJS was 66 and was significantly correlated with all the subscales of KOOS, but not with postoperative ROM. Radiolucent lines ≧1 mm wide were detected in five knees (4.1%). There were no major complications needing revision surgeries. CONCLUSIONS: Patient-reported outcomes (PROs) for symptoms, pain and ADL after the CR-FINE TKA were generally improved, but those for sports, QOL and FJS were improved less. The incidence of radiolucent lines was rare but detected around the femoral components. With the mid- to long-term follow-up, improvements of surgical technique will be necessary to achieve better PROs from patients receiving the FINE knee.

Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies' Activities in Japan.

OBJECTIVE: The objective of this study is to assess public attitudes toward pharmaceutical companies' secondary uses of patient records and public preferences regarding consent approaches. METHOD: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of "clinical trials"; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents. RESULTS: The public benefit from secondary use of records by academic institutions for scientific research was rated highest. All of the activities by pharmaceutical companies were rated higher than those by governmental institutions and other for-profit companies. Regarding consent approaches, 37.9% preferred an "opt-in" approach for new drug development by pharmaceutical companies, 79.7% of whom would change their preference to an "opt-out" approach under specific conditions, such as ensuring intended uses only. CONCLUSION: Our respondents consider the "public benefit" as dependent on the relative distance from "promoting public health" when assessing the secondary purpose of patient record use. Pharmaceutical companies should include the beneficial purposes when using patient records with "opt-out" approach. Policy makers should pay more attention to the purposes of use when developing personal information protection policies.

Differences in Conceptual Understanding of the "Actionability" of Incidental Findings and the Resultant Difference in Ethical Responsibility: An Empirical Study in Japan.

BACKGROUND: The issue of incidental findings encountered in medical researches and in clinical practices becomes controversial in recent years. In what situations should researchers and clinicians disclose incidental findings to study participants or patients? According to previous studies, the concept of "actionability" is one of most important notions in determining the management of incidental findings, however, the understanding of this concept is also inconsistent among people and the inconsistency can affect the management of incidental findings. That is why we surveyed the difference in conceptual understanding of "actionability" for incidental findings with genomic researches in Japan. Methods: We conducted focus groups with individuals conducting genomics research or genetic testing at the National Centers in Japan, all of which are expected to contribute significantly to genomics research and subsequent clinical practice in Japan. Results: As far as our survey and analysis, there exists crucial discrepancy; one might consider that an "actionable" finding should be one that would be useful in treatment or prevention; another might consider if the finding could lead to a definitive diagnosis, it should be considered "actionable," regardless of the treatment potential of the disease; moreover another might considered that a finding that would lead to the opportunity to participate in a clinical trial was "actionable". Conclusion: Based on the present study which we conducted, we have examined thus far the concept of "actionability", which may influence the management of incidental findings. The present study revealed discrepancies in the understanding of this concept among the National Centers in Japan, which all bear similar expectations from society. And this difference in "actionability" would lead to variations in management of incidental findings.

Surgical Treatment for Central Sleep Apnea due to Occipitocervical Compression Myelopathy in a Patient with Klippel-Feil Syndrome.

BACKGROUND: Central sleep apnea (CSA) due to occipitocervical compression myelopathy is an extremely rare condition. Here we report a case of surgical treatment for CSA due to occipitocervical compression myelopathy in a patient with Klippel-Feil syndrome. CASE DESCRIPTION: A 60-year-old man had become aware of a gradually progressive clumsiness and gait disturbance without any cause of injury 5 years before. He had complicated respiratory discomfort during sleep for the previous month and visited our hospital. Neurologic examination revealed severe myelopathy. Polysomnography showed CSA and Cheyne-Stokes respiration. Imaging findings showed C2-3 vertebral fusion and severe spinal cord compression caused by hypoplasia of the C1 posterior arch complicated by an anomaly of the vertebral artery. We diagnosed the patient with CSA due to occipitocervical compression myelopathy complicated by Klippel-Feil syndrome. After a simulation using a full-scale 3-dimensional model, resection of the C1 posterior arch and C4-5 laminoplasty was performed. After surgery, both clumsiness and gait disturbance gradually improved. Polysomnography 1 month after surgery showed that the CSA and the Cheyne-Stokes respiration disappeared. CONCLUSIONS: Although a recent report has indicated the cause of sleep apnea in patients with rheumatoid arthritis and occipitocervical disorders as obstructive sleep apnea, a significant improvement of CSA was observed with decompression surgery in this case. Appropriate surgical planning resulted in a favorable outcome.