Incidence, prevalence and clinical management of achalasia since the introduction of high-resolution manometry in Western Australia.

BACKGROUND: Epidemiological studies in achalasia and its clinical management in Australia are limited. AIMS: To determine the prevalence and trends in incidence rates and describe the types of treatment stratified by subtypes of achalasia. METHODS: A retrospective observational study was conducted at a single site that offers a state-wide high-resolution manometry (HRM) service in Western Australia (WA). Patients (aged ≥ 18 years) newly diagnosed with achalasia based on HRM findings between 2012 and 2021 were extracted from the HRM database. The crude incidence rate and age-standardised incidence rate (ASIR) along with the 2021-point prevalence were calculated. Trends were assessed by the Kendall τb test. The patients' initial and subsequent treatment modalities were described. RESULTS: A total of 296 new cases were identified, and the median age at diagnosis was 56 years. The patient's median age, sex and year of the first treatment did not vary significantly with the subtypes. The lowest and highest ASIR (cases/100 000 person-years) were 0.8 in 2012 and 2.1 in 2021, respectively. Only type 2 achalasia showed a significant increasing trend (P = 0.009). The 2021-point prevalence was 16.9 cases/100 000 people and increased with age. Pneumatic balloon dilatation (PBD) was the most common treatment for types 1 and 2, while laparoscopic Heller myotomy was most common for type 3. Peroral endoscopic myotomy (POEM) has become common in the past 5 years. CONCLUSION: The ASIR of type 2 achalasia significantly increased in WA. PBD was most commonly performed, although peroral endoscopic myotomy has recently increased as a preferred treatment option.

Quality indicators in Barrett's endoscopy: Best is yet to come.

There is growing interest in establishing quality indicators (QIs) for endoscopic screening and surveillance in Barrett's esophagus (BE). QIs are objective, measurable, and evidence-based metrics that are applicable in a health-care setting to monitor a process and identify key performance indicators (KPIs) to achieve defined goals. In the Barrett's endoscopy setting, QIs can offer a standardized approach to monitor and maintain high-quality endoscopy for BE screening and surveillance that will allow measuring performance of an endoscopist as an individual, a group, or a facility. Since BE is an endoscopically identifiable premalignant condition with histological corroboration, adherence to QIs is paramount for the early and accurate detection of dysplasia and neoplasia. It is the holy grail for BE screening and surveillance. Although several suggested QIs for Barrett's endoscopy exist, issues remain in determining the most appropriate ones. These issues include inconsistent use of terminology, unclear definitions, and a scarcity of studies linking these QIs with relevant patient outcomes, making it difficult for clinicians to understand the concept and clinical importance. Hence, there is an urgent need to determine what should constitute appropriate QIs for Barrett's endoscopy, clearly define items used in the QIs, and identify ways to measure these KPIs. Ultimately, well-defined and validated QIs will contribute to clinically effective, safe, timely, and patient-focused care. In this review, we summarize recent literature and discuss four proposed QIs: (i) neoplasia detection rate; (ii) postendoscopy Barrett's neoplasia; (iii) Barrett's inspection time; and (iv) adherence to the Seattle biopsy protocol.

[Coagulative complete remission following early gastric cancer resection in a patient with steroid-resistant acquired hemophilia A and nephrotic syndrome].

During laparoscopic cholecystectomy, an 89-year-old man was discovered to have a prolonged APTT. He was transferred to our hospital for a thorough examination because wound bleeding necessitated a reoperation. Based on coagulation factor VIII activity (FVIII:C) of 3.6% and FVIII inhibitor levels of 48.5 BU/ml, he was diagnosed with acquired hemophilia A (AHA). Due to concerns about his advanced age and postoperative infection, immunosuppressive therapy with prednisolone 0.5 mg/kg/day was initiated. His clinical course was favorable, except hemorrhagic shock caused by intramuscular hemorrhage on the right back, although low FVIII inhibitor levels persisted for more than a month; additionally, lower leg edema and increased urinary protein were also observed. He was diagnosed as with AHA and secondary nephrotic syndrome, possibly because of early gastric cancer. As a result, radical endoscopic submucosal dissection (ESD) was performed while a recombinant coagulation factor VIIa preparation was administered. AHA improved rapidly following ESD, and coagulative remission was achieved. Simultaneously, the nephrotic syndrome improved. Because the control of malignant tumors may improve the status of AHA, the timing of malignant tumor intervention must be considered considering the risk of bleeding and infection associated with immunosuppression.

[Spontaneous disappearance of the inhibitor during emicizumab therapy in a patient with mild hemophilia A].

From a young age, a 63-year-old Japanese man had experienced difficulties with hemostasis during tooth extraction and epistaxis and swelling of bruised areas. He had previously been diagnosed with mild hemophilia (FVIII:C 8.5%) at age of 60 due to swelling of a right hip bruise and was administered FVIII concentrate for the first time. He had frequent bleeding around his shoulder joints and was given FVIII concentrates every time, but his hemostasis was poor. He was referred to our hospital because his FVIII activity decreased to<1% and a low-titer inhibitor (2.0 BU/ml) was detected. Because of a shoulder hematoma and new subcutaneous bleeding on both forearms, recombinant FVIIa was used to perform the hemostatic treatment. Following hemostasis, emicizumab was administered subcutaneously every 2 weeks at a dose of 3.0 mg/kg. Approximately 2 months after starting emicizumab, inhibitors were no longer detected, and FVIII activity increased to 8% after 9 months. We encountered a case of mild hemophilia A with an inhibitor that was first diagnosed in old age. The incidence of inhibitors in non-severe hemophilia A is about 10%, and about 70% of those resolves spontaneously. In this case, suppression of bleeding by emicizumab may have contributed to the spontaneous disappearance of the inhibitor.

Osteosynthesis for Geriatric Acetabular Fractures: An Epidemiological and Clinico-Radiological Study Related to Marginal or Roof Impaction.

This retrospective study sought to elucidate the incidence rates of roof impaction (RI) and marginal impaction (MI) and radiological and clinical outcomes of open reduction and internal fixation (ORIF) for RI and MI in geriatric acetabular fractures. The cases of 68 patients aged ≥ 65 years (mean 71 years) treated with ORIF were analyzed. MI was present in 12 fractures (67%) and an RI of the weight-bearing surface was present in 24 (46%) of the potential fracture types. Regarding the reduction quality, 54% of the reductions were graded as anatomical, 37% as imperfect, and 9% as poor. In the clinical evaluations of the 45 patients who had > 1-year follow-up (follow-up rate: 66.2%), 18% were graded as excellent, 53% as good, 16% as fair, and 13% as poor. An anatomic reduction was strongly associated with good or excellent clinical and radiological outcomes. CT was superior to radiographs for detecting the residual displacement postoperatively. Postoperative deep infection occurred in four patients. Three patients (6.7%) underwent a total hip arthroplasty conversion due to secondary osteoarthritis of the hip. We recommend ORIF as the preferred surgical treatment option for displaced acetabular fractures in elderly patients.

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan.

In consultation with academia and the Pharmaceuticals and Medical Devices Agency (PMDA), we have developed guidance for drafting protocols for clinical trials concerning medical devices for the healing of hard-to-heal wounds without ischaemia. The guidance summarises the validity of single-arm trials for hard-to-heal wounds, the definition of hard-to-heal wounds without ischaemia, methods of patient enrolment and clinical endpoints. This review focuses on the logical thinking process that was used when establishing the guidance for improving the efficiency of clinical trials concerning medical devices for hard-to-heal wounds. We particularly focused on the feasibility of conducting single-arm trials and also tried to clarify the definition of hard-to-heal wounds. If the feasibility of randomised control trials is low, conducting single-arm trials should be considered for the benefit of patients. In addition, hard-to-heal wounds were defined as meeting the following two conditions: wounds with a wound area reduction <50% at four weeks despite appropriate standards of care; and wounds which cannot be closed by a relatively simple procedure (for example, suture, skin graft and small flaps). Medical devices for hard-to-heal wound healing are classified into two types: (1) devices for promoting re-epithelialisation; and (2) devices for improving the wound bed. For medical devices for promoting re-epithelialisation, we suggest setting complete wound closure, percent wound area reduction or distance moved by the wound edge as the primary endpoint in single-arm trials for hard-to-heal wounds. For medical devices for improving the wound bed, we suggest setting the period in which wounds can be closed by secondary intention or a simple procedure, such as the primary endpoint.

Successful Management of Acquired Factor V Inhibitor by Monitoring Factor V Activity, Antigen, and Inhibitor Values during Immunosuppressive Therapy.

Acquired factor V inhibitor (AFVI) results from the formation of autoantibodies to coagulation factor V (FV), and the clinical phenotype can range from asymptomatic laboratory abnormalities to life-threatening bleeds. We describe a 74-year-old man who developed AFVI along with a massive subcutaneous hematoma. He was initially treated with prednisolone (PSL), but AFVI recurred when the dose was reduced after a short period. We subsequently increased the PSL dose and added cyclophosphamide (CY), which resulted in a complete response. We then gradually tapered PSL and stopped CY, and the patient has since remained free of recurrent AFVI symptoms. We monitored FV activity, antigen concentrations, and inhibitor titers of this patient throughout the clinical course. The ratio of FV activity to antigen concentration was low at diagnosis and gradually increased along with the patient's improvement. This ratio might be a useful parameter for evaluating the effects of immunosuppressive therapy in patients with AFVI.

[Successful management of acquired factor V deficiency developing shortly after induction of hemodialysis].

Autoimmune factor V deficiency (AiF5D) is caused by autoantibodies to coagulation factor V (FV); its clinical manifestations range from asymptomatic to fatal hemorrhage. Herein, we report the case of a 68-year-old man who was diagnosed with end-stage renal disease at the time of a femoral fracture and developed AiF5D after initiating hemodialysis. A wound infection that occurred after joint replacement was treated with antibiotics; however, it was poorly controlled. One month after the procedure, his coagulation time prolonged. The infection was improved by debridement and antibiotics; however, the coagulation time was not decreased and poor hemostasis at the shunt was still persistent. Because ELISA detected anti-FV-binding IgG with FV activity of <2.8% and FV inhibitor levels were 11.8 BU/ml, AiF5D was diagnosed. Oral prednisolone (PSL) was started. Dialysis was initially performed without anticoagulants, but blood clots were not found in the circuit. Anticoagulants were resumed when the coagulation time decreased. After achieving complete remission, PSL dose was tapered and finally discontinued. Few reports have described the management of AiF5D via dialysis. We consider that our report would be useful for the management of patients with similar manifestations.

[Recurrence of acquired factor V inhibitor after four years of remission].

Acquired factor V inhibitor (AFV-I) is a rare bleeding disorder wherein autoantibodies are developed against coagulation factor V (FV). The clinical symptoms are variable, from laboratory abnormalities without bleeding to life-threatening hemorrhage. We report herein the case of a patient with AFV-I with two relapses 4 years after the first remission. A 66-year-old male was diagnosed with AFV-I in March 20XX-4. He was treated with prednisolone (PSL) at 50 mg/day and achieved remission within 1 month. PSL dose was tapered to oral administration of 2.5 mg every other day, and long-term remission was maintained. He had been treated with dual antiplatelet therapy (DAPT) for old myocardial infarction. FV activity was markedly reduced to 3.4%, and FV inhibitor was detected (1.0 BU/ml) in May 20XX. We followed the patient without increasing the treatment dose for 2 months, but no spontaneous improvement was seen. Because DAPT was ongoing, we judged that the bleeding risk was high, although only minor bleeding symptoms appeared. PSL was therefore increased to 40 mg/day in June. FV inhibitor rapidly disappeared. When PSL dose was gradually decreased, FV activity decreased, and subcutaneous bleeding occurred in February 20XX＋1. PSL dose was increased again for the second relapse, and the patient achieved remission. Few reports have described recurrent AFV-I, and no cases of two relapses have been reported. We believe that this case report is useful for examining the long-term management of AFV-I.

[Congenital factor V and factor VIII deficiency discovered in an elderly patient with abnormal bleeding after trauma].

Congenital combined deficiency of coagulation factor V (FV) and factor VIII (FVIII) (F5F8D) is a rare autosomal recessive bleeding disorder caused by mutations in lectin mannose-binding type 1 (LMAN1) or multiple coagulation factor deficiency 2 (MCFD2) encoding chaperone molecules involved in the intracellular transport of FV and FVIII. Here, we report a case of F5F8D in an elderly patient diagnosed with hematoma after a right thigh injury. A 71-year-old male had a history of abnormal bleeding after tooth extraction and cholecystectomy. The patient injured his right thigh with a kitchen knife; he was urgently hospitalized to a referral hospital 8 days later due to the occurrence of hematoma at the same site. Owing to prolongation of the coagulation time (PT 16.1 s, 1.72; APTT, 66.1 s), he received hemostatic treatment with fresh-frozen plasma. He was then referred to our hospital for examination of PT and APTT prolongation. FV and FVIII activities were moderately decreased to about 15%, and no inhibitor was detected. Whole-exome sequencing identified a previously reported homozygous nonsense mutation in LMAN1, revealing F5F8D in the proband. In this case, FFP infusion alone was not sufficient for increasing coagulation factor activities. Definitive diagnosis of F5F8D provides him with the treatment option with FVIII concentrates.

[Development of acquired hemophilia A during maintenance therapy for immune thrombocytopenia].

Acquired hemophilia A (AHA) is a rare coagulation disorder caused by autoantibodies against coagulation factor VIII (FVIII). We report herein a very rare case of AHA complicated by immune thrombocytopenia (ITP). A 30-year-old woman was hospitalized with severe thrombocytopenia. Her platelet count was 5,000/µl on admission, at which time APTT was normal. ITP was diagnosed and she was treated with γ-globulin, platelet transfusion, and prednisolone at 1 mg/kg/day. She was discharged after platelet count normalization and prednisolone was tapered to 5 mg/day. During the prednisolone tapering, purpura appeared on both thighs and in the left inguinal region, and APTT was found to be prolonged. She was referred to our hospital for examination of APTT prolongation. FVIII activity was markedly decreased to 7.7% and the FVIII inhibitor was positive (1.5 BU/ml), based on which AHA was diagnosed. We carefully followed this patient without intensification of immunosuppressive therapy for 7 weeks, but her platelet count decreased from 150,000/µl to 70,000/µl and the FVIII inhibitor increased to 4 BU/ml. We therefore increased prednisolone to 30 mg/day, after which her platelet count increased and complete remission of AHA was achieved by day 42. In addition, we examined the relationship of the FVIII inhibitor and FVIII binding antibody in this case.

Latent Dirichlet allocation topic modeling of free-text responses exploring the negative impact of the early COVID-19 pandemic on research in nursing.

AIM: To derive latent topics from free-text responses on the negative impact of the pandemic on research activities and determine similarities and differences in the resulting themes between academic-based and clinical-based researchers. METHODS: We performed a secondary analysis of free-text responses from a cross-sectional online survey conducted by the Japan Academy of Nursing Science of its members in early 2020. The participants were categorized into two groups by workplace (academic-based and clinical-based researchers). Latent Dirichlet allocation (LDA) topic modeling was used to extract latent topics statistically and list important keywords/text associated with the topics. After organizing similar topics by principal component analysis (PCA), we finally derived topic-associated themes by reading the keywords/texts and determining the similarity and differences of the themes between the two groups. RESULTS: A total of 201 respondents (163 academic-based and 38 clinical-based researchers) provided free-text responses. LDA identified eight and three latent topics for the academic-based and clinical-based researchers, respectively. While PCA re-grouped the eight topics derived from the former group into four themes, no merging of the topics from the latter group was performed resulting in three themes. The only theme common to the two groups was "barriers to conducting research," with the remaining themes differing between the groups. CONCLUSIONS: Using LDA topic modeling with PCA, we identified similarities and differences in the themes described in free-text responses about the negative impact of the pandemic between academic-based and clinical-based researchers. Measures to mitigate the negative impact of pandemics on nursing research may need to be tailored separately.

[Improvement in peripheral blood T cell subset imbalance in a house with an elimination system for various allergens].

We analyzed the change of peripheral blood T cell subsets after moving into a house with a Healthy Air system (HAS) elimination system for various allergens, e.g. pollens, house dusts, etc. The 20 subjects were divided into an allergic group (13 subjects) and control group (7 subjects). We measured complete blood counts (CBC), white blood cell differentiation (DIFF), CD4/CD8 ratio, Th1/Th2 ratio, and percentage of CD4+CD25+T-cells and regulatory T-cells in peripheral blood, and these data were compared before and 3 and 6 months after moving into the HAS house. There was no significant difference in CBC, DIFF, CD4/CD8 ratio, and Th1/Th2 ratio before and after the move. The mean levels and 95% confidence interval of CD4+CD25+T-cells in the allergic group were as follows: before, 16.66% (12.99-20.34%); at 3 months, 13.86% (10.49-17.22%); and at 6 months, 12.66% (9.28-16.05%), respectively. Those in the control group were as follows: before, 13.60% (5.27-21.93%); at 3 months, 12.51%(5.41-19.61%); and at 6 months, 11.77% (3.93-19.61%), respectively. CD4+CD25+T-cells were significantly decreased at 6 months after the move compared to before the move in the allergic group (p < 0.01). However, there was no significant difference between before and after the move in the control group. The mean levels of regulatory T-cells were not different between before and after the move in both groups. The mean level of CD4+CD25+T-cells in subjects that had improved allergic condition was significantly decreased at 6 months after the move compared to before the move (p < 0.05). These results suggest that decreases in allergens in the home environment may affect lymphocyte subsets.

Propensity-matched comparisons of factors negatively affecting research activities during the COVID-19 pandemic between nursing researchers working in academic and clinical settings in Japan.

AIM: To determine the factors associated with reduced research activities during the COVID-19 pandemic in 2020 by comparing nursing researchers working in academic and clinical settings. METHODS: This was a secondary analysis of data collected by the Japan Academy of Nursing Sciences, which conducted a cross-sectional online survey when the pandemic began. We included respondents who worked in either academic or clinical settings and responded that the pandemic negatively affected their research activities. First, we computed a propensity score (PS) using a logistic regression model. Then we performed a one-to-one ratio matching between the groups based on the PS to control imbalances between the groups. We identified the factors negatively affecting research activities and who to consult about research concerns by comparing the groups using Chi-square or Fisher's exact tests. RESULTS: There were 1,532 participants, with a response rate of 16.1%. After PS matching, 214 participants (107 for each group) were included. We identified three significant factors associated with reduced research activities: (i) time required for learning new information and communication technology (ICT) skills; (ii) time required for supporting colleagues with ICT issues; and (iii) time required for preparing and evaluating teaching materials. Approximately 20% of our participants in both settings had nobody to consult regarding research concerns. CONCLUSION: We found that the time spent on ICT-related issues negatively affected the research activities of nursing researchers when the pandemic began in Japan. In such an emergency, nursing researchers needed an opportunity to share their difficulties as a part of a support service.

Below- or above-elbow immobilization in conservative treatment of distal radius fractures: a systematic review and meta-analysis.

INTRODUCTION: There is no consensus regarding the range of immobilization in the conservative treatment of distal radius fractures (DRFs). Therefore, this systematic review and meta-analysis aimed to compare the clinical outcome of patients with DRFs treated conservatively with below- or above-elbow immobilization. MATERIALS AND METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines, two independent reviewers searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov and World Health Organization International Clinical Trials Registry Platform in April 2020; a subsequent update search was conducted in April 2021. We identified all randomised controlled trials comparing two immobilization methods in DRFs. The primary outcome measures were the Disabilities of the Arm, Shoulder and Hand (DASH) or QuickDASH questionnaire scores in the short- and long-term (≤ and >six weeks, respectively) follow-up as well as the treatment failure rate. The secondary outcome measures were radiographic outcome, patient-rated wrist evaluation (PRWE) score, pain score and adverse events. Risk of bias was evaluated using the Cochrane Risk of Bias tool version 2. We used the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of evidence. RESULTS: The initial search revealed 1,775 records, and ten studies with 909 participants in total were included. There was no significant difference in DASH score in the short-term follow-up (4.99 lower, 95% confidence interval (CI): 10.45 lower to 0.46 higher; very low certainty) and treatment failure (risk ratio: 0.91, 95% CI: 0.59 to 1.40; low certainty). A clinically irrelevant but significant mean difference (0.83 lower, 95%CI: 1.64 lower to 0.03 lower; low certainty) was found in the DASH score in favour of below-elbow immobilization in the long-term follow-up. The overall risk of bias in DASH scores was high based on the measurement bias. Furthermore, there was no significant difference in secondary outcome measures. CONCLUSION: This meta-analysis did not demonstrate clinically meaningful difference between below- and above-elbow immobilization in terms of DASH score both in the short- and long-term follow-ups. However, overall certainty of evidence was considered very low, based on the very serious risk of bias, inconsistency and imprecision. Hence, there is a need for further higher quality research. TRIAL REGISTRATION NUMBER: UMIN000040134 (4/14/2020).

Association between Immediate Postoperative Radiographic Findings and Failed Internal Fixation for Trochanteric Fractures: Systematic Review and Meta-Analysis.

Failed internal fixations for trochanteric fractures have a strong negative impact owing to increased postoperative mortality and high medical costs. However, evidence on the prognostic value of postoperative radiographic findings for failed internal fixations is limited. We aimed to clarify the association between comprehensive immediate postoperative radiographic findings and failed internal fixation using relative and absolute risk measures. We followed the meta-analysis of observational studies in epidemiology guidelines and the Cochrane handbook. We searched specific databases in November 2021. The outcomes of interest were failed internal fixation and cut-out. We pooled the odds ratios and 95% confidence intervals using a random-effects model and calculated the number needed to harm for each outcome. Thirty-six studies involving 8938 patients were included. The certainty of evidence in the association between postoperative radiographic findings and failed internal fixation or cut-out was mainly low or very low except for the association between intramedullary malreduction on the anteromedial cortex and failed internal fixation. Moderate certainty of evidence supported that intramedullary malreduction on the anteromedial cortex was associated with failed internal fixation. Most postoperative radiographic findings on immediate postoperative radiographs for trochanteric fractures were uncertain as prognostic factors for failed internal fixations.

Modic type I changes of the lumbar spine in golfers.

Low back pain (LBP) is the most prevalent musculoskeletal complaint among professional and amateur golfers; however, associated radiological changes in golf-related LBP have not been examined in the literature. We suspect that Modic Type 1 changes in the lumbar spine are linked to golf-related LBP. In this retrospective case series, four middle-aged golfers (one professional and three high-level amateurs) presented to our clinic with LBP. Inflammation of the right side of endplates in the lumbar spine was suspected based on Modic Type 1 changes detected by magnetic resonance imaging (MRI) in each patient. All four cases were diagnosed with right-sided endplate inflammation and administered intradiscal steroid injections with a non-steroidal anti-inflammatory drug (NSAID). Treatment swiftly alleviated LBP and diminished Modic Type 1 changes on follow-up MRI 3-6 months later in all four patients. We suggest that Modic Type 1 changes play a significant role in the diagnosis and treatment of golf-related LBP.

Bed Exit Action Detection Based on Patient Posture with Long Short-Term Memory.

It has been known that the fall of a patient in a hospital is a serious accident. In order to prevent such accidents, we have been studying the fall prevention using image processing technology. Our previous studies have detected the patient's end sitting position with high accuracy, but have problems responding to the sitting position of patients who are eating or responding to visitors. In order to solve these problems, this paper proposes a method to detect the patient's bed exit action by analyzing the posture of the patient extracted from the image of the monocular camera by long short-term memory (LSTM). Our proposed method introduces two strategies - abstraction of input information and use of relative position information for the input time-series human images, achieving a 99.2[%] detection rate of bed exit action with a 5.7[%] false detection rate. Detecting the bed exit action with high accuracy contributes to preventing the patient from falling down. The proposed solution handles only posture information that abstracts camera images for patient privacy purposes.