ABSTRACT
Although community-acquired acute kidney injury (CA-AKI) represents a significant subset of all AKI incidence, evidence is limited due to the lack of comprehensive data prior to diagnosis. Here, we examined the risk of drug use for CA-AKI by using exhaustive pre-diagnostic prescription data. We included 78,754 working-age healthy individuals who underwent an annual health checkup program. We conducted a cohort study to assess the association between prevalent drug use and subsequent CA-AKI incidence using the Cox proportional hazard model. Subsequently, we conducted a case-crossover study to compare the new drug use in the case period directly before the CA-AKI incidence (- 3 to 0 months) with that in the control period far before the CA-AKI incidence (- 15 to - 12 months and - 9 to - 6 months) using the conditional Poisson regression model. The prevalent use of renin-angiotensin-aldosterone system (RAAS) inhibitors was associated with an increased CA-AKI incidence, but the new use was not. The new use of diuretics, anti-infectious drugs, and contrast medium was also associated with an increased CA-AKI incidence. These results suggest we need to pay attention for the incidence of AKI among the general population taking those common drugs.
Subject(s)
Acute Kidney Injury , Cross-Over Studies , Humans , Acute Kidney Injury/epidemiology , Acute Kidney Injury/chemically induced , Female , Male , Incidence , Adult , Middle Aged , Cohort Studies , Diuretics/adverse effects , Diuretics/therapeutic use , Contrast Media/adverse effects , PrevalenceABSTRACT
BACKGROUND: The optimal management of pediatric patients with high-grade blunt pancreatic injury (BPI) involving the main pancreatic duct remains controversial. This study aimed to assess the nationwide trends in the management of pediatric high-grade BPI at pediatric (PTC), mixed (MTC), and adult trauma centers (ATC). STUDY DESIGN: This is a retrospective observational study of the National Trauma Data Bank. We included pediatric patients (age 16 years or less) sustaining high-grade BPI (Abbreviated Injury Scale 3 or more) from 2011 to 2021. Patients who did not undergo pancreatic operation were categorized into the nonoperative management (NOM) group. Trauma centers were defined as PTC (level I/II pediatric only), MTC (level I/II adult and pediatric), and ATC (level I/II adult only). Primary outcome was the proportion of patients undergoing NOM, and secondary outcomes included the use of ERCP and in-hospital mortality. A Cochran-Armitage test was used to analyze the trend. RESULTS: A total of 811 patients were analyzed. The median age was 9 years (interquartile range 6 to 13), 64% were male patients, and the median injury severity score was 17 (interquartile range 10 to 25). During the study period, there was a significant upward linear trend in the use of NOM and ERCP among the overall cohort (range 48% to 66%; p trend = 0.033, range 6.1% to 19%; p trend = 0.030, respectively). The significant upward trend for NOM was maintained in the subgroup of patients at PTC and MTC (p trend = 0.037), whereas no significant trend was observed at ATC (p trend = 0.61). There was no significant trend in in-hospital mortality (p trend = 0.38). CONCLUSIONS: For the management of pediatric patients with high-grade BPI, this study found a significant trend toward increasing use of NOM and ERCP without mortality deterioration, especially at PTC and MTC.
Subject(s)
Injury Severity Score , Pancreas , Wounds, Nonpenetrating , Humans , Wounds, Nonpenetrating/therapy , Wounds, Nonpenetrating/mortality , Wounds, Nonpenetrating/diagnosis , Wounds, Nonpenetrating/surgery , Male , Female , Retrospective Studies , Child , Adolescent , Pancreas/injuries , Pancreas/surgery , Trauma Centers/statistics & numerical data , Hospital Mortality/trends , United States/epidemiology , Cholangiopancreatography, Endoscopic Retrograde/statistics & numerical data , Child, Preschool , Abdominal Injuries/therapy , Abdominal Injuries/mortality , Abdominal Injuries/diagnosis , Abdominal Injuries/surgeryABSTRACT
OBJECTIVES: To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: PubMed, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases were systematically searched in September 2023. STUDY SELECTION: Randomised controlled trials evaluating the efficacy of acoustic stimulations on patients undergoing venipuncture were eligible. Acoustic stimulations were classified into seven categories: five types of acoustic stimulations (music medicine (researcher selected), music medicine (patient selected), music therapy, sounds with linguistic meaning and sounds without linguistic meaning) and two controls (only wearing headphones and no treatment). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes included self-reported pain intensity assessed during venipuncture and treatment cost, and secondary outcomes were self-reported mental distress and adverse events. RESULTS: Of 6406 citations, this network meta-analysis included 27 studies including 3416 participants; the mean age was 31.5 years, and 57% were men. Among the five types of acoustic stimulations, only musical interventions, such as music medicine (patient selected) (standardised mean difference (SMD) -0.44 (95% CI: -0.84 to -0.03); low confidence), music medicine (researcher selected) (SMD -0.76 (95% CI: -1.10 to -0.42); low confidence) and music therapy (SMD -0.79 (95% CI: -1.44 to -0.14); low confidence), were associated with improved pain relief during venipuncture compared with no treatment. No significant differences existed between the types of acoustic stimulations. Free-of-charge acoustic stimulations were provided to patients, and no specific adverse events were reported. In many studies, the risk of bias was rated high because of the difficulty of blinding the intervention to the participants and the self-reported pain outcome. CONCLUSIONS: Music interventions were associated with reduced venipuncture pain. Comparisons between types of acoustic stimulations revealed no significant differences. Therefore, music intervention could be a safe and inexpensive pain relief method for venipuncture. PROSPERO REGISTRATION NUMBER: CRD42022303852.
Subject(s)
Music Therapy , Phlebotomy , Male , Humans , Adult , Female , Phlebotomy/adverse effects , Acoustic Stimulation , Network Meta-Analysis , Pain/etiology , Pain/prevention & control , Music Therapy/methodsABSTRACT
We aimed to evaluate the renoprotective effects of remote ischemic preconditioning (RIPC) in patients undergoing robot-assisted laparoscopic partial nephrectomy (RAPN). Data from 59 patients with solitary renal tumors who underwent RAPN with RIPC comprising three cycles of 5-min inflation to 200 mmHg of a blood pressure cuff applied to one lower limb followed by 5-min reperfusion by cuff deflation, from 2018 to 2020 were analyzed. Patients who underwent RAPN for solitary renal tumors without RIPC between 2018 and 2020 were selected as controls. The postoperative estimated glomerular filtration rate (eGFR) at the nadir during hospitalization and the percentage change from baseline were compared using propensity score matching analysis. We performed a sensitivity analysis with imputations for missing postoperative renal function data weighted by the inverse probability of the data being observed. Of the 59 patients with RIPC and 482 patients without RIPC, 53 each were matched based on propensity scores. No significant differences in the postoperative eGFR in mL/min/1.73 m2 at nadir (mean difference 3.8; 95% confidence interval [CI] - 2.8 to 10.4) and its percentage change from baseline (mean difference 4.7; 95% CI - 1.6 to 11.1) were observed between the two groups. Sensitivity analysis also indicated no significant differences. No complications were associated with the RIPC. In conclusion, we found no significant evidence of the protective effect of RIPC against renal dysfunction after RAPN. Further research is required to determine whether specific patient subgroups benefit from RIPC.Trial registration number: UMIN000030305 (December 8, 2017).
Subject(s)
Ischemic Preconditioning , Kidney Neoplasms , Laparoscopy , Robotic Surgical Procedures , Robotics , Humans , Robotic Surgical Procedures/methods , Kidney/surgery , Kidney/physiology , Kidney/pathology , Nephrectomy/adverse effects , Kidney Neoplasms/pathology , Laparoscopy/adverse effects , Treatment OutcomeABSTRACT
Immune thrombocytopenia (ITP) is a thrombocytopenic condition induced by autoimmune mechanisms and includes secondary ITP with underlying diseases such as connective tissue diseases (CTD). In recent years, it has been elucidated that the subsets of the ITP are associated with complement abnormalities but much remains unclear. To perform a literature review and identify the characteristics of complement abnormalities in ITP. PUBMED was used to collect the literature published up to June 2022 related to ITP and complement abnormalities. Primary and secondary ITP (CTD-related) were examined. Out of the collected articles, 17 were extracted. Eight articles were related to primary ITP (pITP) and 9 to CTD-related ITP. Analysis of the literature revealed that the ITP severity was inversely correlated with serum C3, C4 levels in both ITP subgroups. In pITP, a wide range of complement abnormalities was reported, including abnormalities of initial proteins, complement regulatory proteins, or the end products. In CTD-related ITP, reported complement abnormalities were limited to the initial proteins. Activation of the early complement system, mainly through activation of C3 and its precursor protein C4, was reported for both ITPs. On the other hand, more extensive complement activation has been reported in pITP.
Subject(s)
Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Humans , Complement System Proteins , Complement Activation , Hereditary Complement Deficiency DiseasesABSTRACT
OBJECTIVES: Social distancing due to the coronavirus disease 2019 crisis can exacerbate inactivity in older adults. Novel approaches for older adults must be designed to improve their activity and maintain their health. This study examined the effect of nudge-based behavioral interventions on health-promoting activities in older adults in Japan. DESIGN: Two-arm, participant-blinded randomized controlled trial. SETTING AND PARTICIPANTS: Japanese continuing care retirement community residents (n = 99, median age 82 years, 73% women) INTERVENTION: Two-step nudge-based behavioral intervention promoting tablet usage. METHODS: We enrolled participants from an ongoing Internet of Things project in a retirement community in Japan. For the health promotion program, tablet computers were installed in a common area for participants to receive information about their health. The intervention group received a 1-time loss-emphasized nudge (first step), followed by asking questions about when they planned to use it again (second step). The control group used the tablet computers without being asked those questions. The main outcome was the participants' mean daily tablet activity every 4 weeks for the next 16 weeks. RESULTS: Ninety-nine individuals were randomly assigned to the intervention or control group. The rate ratios for tablet use were significantly higher in the intervention group in the second and third periods. The subgroup analysis showed that these effects were largely attributable to men. CONCLUSIONS AND IMPLICATIONS: Nudge-based interventions can be effective in promoting activities for older adults, especially older men. The finding of this study indicates a possible intervention to engage people who are socially isolated.
Subject(s)
COVID-19 , Male , Humans , Female , Aged , Aged, 80 and over , Health Promotion , Activities of Daily Living , JapanABSTRACT
INTRODUCTION: Computed tomography (CT) can accurately measure muscle mass, which is necessary for diagnosing sarcopenia, even in dialysis patients. However, CT-based screening for such patients is challenging, especially considering the availability of equipment within dialysis facilities. We therefore aimed to develop a bedside prediction model for low muscle mass, defined by the psoas muscle mass index (PMI) from CT measurement. METHODS: Hemodialysis patients (n = 619) who had undergone abdominal CT screening were divided into the development (n = 441) and validation (n = 178) groups. PMI was manually measured using abdominal CT images to diagnose low muscle mass by two independent investigators. The development group's data were used to create a logistic regression model using 42 items extracted from clinical information as predictive variables; variables were selected using the stepwise method. External validity was examined using the validation group's data, and the area under the curve (AUC), sensitivity, and specificity were calculated. RESULTS: Of all subjects, 226 (37%) were diagnosed with low muscle mass using PMI. A predictive model for low muscle mass was calculated using ten variables: each grip strength, sex, height, dry weight, primary cause of end-stage renal disease, diastolic blood pressure at start of session, pre-dialysis potassium and albumin level, and dialysis water removal in a session. The development group's adjusted AUC, sensitivity, and specificity were 0.81, 60%, and 87%, respectively. The validation group's adjusted AUC, sensitivity, and specificity were 0.73, 64%, and 82%, respectively. DISCUSSION/CONCLUSION: Our results facilitate skeletal muscle screening in hemodialysis patients, assisting in sarcopenia prophylaxis and intervention decisions.
Subject(s)
Kidney Failure, Chronic , Sarcopenia , Humans , Sarcopenia/diagnostic imaging , Sarcopenia/etiology , Muscle, Skeletal/diagnostic imaging , Psoas Muscles/pathology , Renal Dialysis/adverse effects , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/pathology , Mass Screening , Retrospective StudiesABSTRACT
BACKGROUND AND OBJECTIVES: Pain during cannulation for vascular access is a considerable problem for patients with kidney disease who are undergoing hemodialysis. We examined whether listening to music can reduce cannulation pain in these patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a multicenter, single-blind, crossover, randomized trial of 121 patients who reported pain during cannulation for hemodialysis. We compared participants listening to "Sonata for Two Pianos in D Major, K.448" or white noise as control while undergoing the cannulation procedure. The cannulation operator was blinded to the intervention, and the hypothesized superiority of music over white noise was concealed during explanations to the participants. The primary end point was the visual analog scale score for cannulation pain independently evaluated by participants. RESULTS: The primary analysis was on the basis of the modified intention-to-treat principle. The median baseline visual analog scale pain score was 24.7 mm (interquartile range, 16.5-42.3). Median change of the visual analog scale pain score from the "no sound" to the music period was -2.7 mm (interquartile range, -9.2 to 3.6), whereas it was -0.3 mm (interquartile range, -5.8 to 4.5) from "no sound" to white noise. The visual analog scale pain score decreased when listening to music compared with white noise. (Adjusted difference of visual analog scale pain score: -12%; 95% confidence interval, -21 to -2; P=0.02.) There were no significant differences in the secondary outcomes of anxiety, BP, or stress assessed by salivary amylase (adjusted difference of visual analog scale anxiety score -8%, 95% confidence interval, -18 to 4; P=0.17). No intervention-related adverse events were reported. CONCLUSIONS: Listening to music reduced cannulation pain in patients on hemodialysis, although there was no significant effect on anxiety, BP, or stress markers.
Subject(s)
Music , Humans , Single-Blind Method , Pain/etiology , Pain/prevention & control , Renal Dialysis/adverse effects , Anxiety/etiology , Anxiety/prevention & control , Catheterization/adverse effectsABSTRACT
INTRODUCTION: In Japan, patients with coronavirus disease 2019 (COVID-19) who do not require medical intervention are provided care in recovery accommodation facilities (RAFs). However, some patients may require hospitalization if their symptoms become more severe during their stay. We conducted an observational study using epidemiological data of patients with COVID-19 admitted to RAFs in Tokyo. METHODS: This was an observational cohort study using data from COVID-19 patients admitted to one of the RAFs in Tokyo from December 2020 to November 2021. Admissions to the facilities were limited to patients with asymptomatic or mild COVID-19 with no underlying disease or at least stable underlying disease at the time of admission. Patients were hospitalized when they required oxygen administration or when they had, or persistent fever, or severe respiratory symptoms. We evaluated the association between hospitalization and the risk factors for hospitalization using a Cox regression model. RESULTS: The number of patients with COVID-19 admitted to the RAF was 6176. The number of hospitalized patients was 393 (6.4%), and the median length of stay was 5.50 days (IQR: 4.50, 6.50). In the Cox regression analysis, the hazard ratio increased with age and was significantly higher among patients aged >60 years (HR = 10.23, 95% CI: 6.72-15.57) than those in other age groups. This trend is similar to that observed in the sensitivity analysis. CONCLUSION: Patients with diabetes, the elderly, obesity, and medications for gout and psychiatric diseases may be at a high risk of hospitalization. In particular, an age over 60 years was strongly associated with hospitalization.
Subject(s)
COVID-19 , Aged , COVID-19/epidemiology , COVID-19/therapy , Hospitalization , Humans , Retrospective Studies , Risk Factors , SARS-CoV-2 , Tokyo/epidemiologyABSTRACT
Background: We developed and validated a machine learning diagnostic model for the novel coronavirus (COVID-19) disease, integrating artificial-intelligence-based computed tomography (CT) imaging and clinical features. Methods: We conducted a retrospective cohort study in 11 Japanese tertiary care facilities that treated COVID-19 patients. Participants were tested using both real-time reverse transcription polymerase chain reaction (RT-PCR) and chest CTs between January 1 and May 30, 2020. We chronologically split the dataset in each hospital into training and test sets, containing patients in a 7:3 ratio. A Light Gradient Boosting Machine model was used for the analysis. Results: A total of 703 patients were included, and two models-the full model and the A-blood model-were developed for their diagnosis. The A-blood model included eight variables (the Ali-M3 confidence, along with seven clinical features of blood counts and biochemistry markers). The areas under the receiver-operator curve of both models [0.91, 95% confidence interval (CI): 0.86 to 0.95 for the full model and 0.90, 95% CI: 0.86 to 0.94 for the A-blood model] were better than that of the Ali-M3 confidence (0.78, 95% CI: 0.71 to 0.83) in the test set. Conclusions: The A-blood model, a COVID-19 diagnostic model developed in this study, combines machine-learning and CT evaluation with blood test data and performs better than the Ali-M3 framework existing for this purpose. This would significantly aid physicians in making a quicker diagnosis of COVID-19.
ABSTRACT
OBJECTIVES: The association between frailty and short-term prognosis has not been established in critically ill older adults presenting to the emergency department. We sought to examine the association between premorbid frailty and 30-day mortality in this patient population. METHODS: This is a retrospective observational study on older adults aged over 75 who were triaged as Level 1 resuscitation with subsequent admissions to intermediate units or intensive care units (ICUs) in a single critical care center, from January to December 2019. We excluded patients with out-of-hospital cardiac arrest or those transferred from other hospitals. Frailty was evaluated by the Clinical Frailty Scale (CFS) from the patients' chart reviews. The primary outcome was 30-day mortality, and we examined the association between frailty scored on the CFS and 30-day mortality using a multivariable logistic regression model with CFS 1-4 as a reference. RESULTS: A total of 544 patients, median age: 82 years (interquartile rang 78 to 87), were included in the study. Of these, 29% were in shock and 33% were in respiratory failure. The overall 30-day mortality was 15.1%. The adjusted risk difference (95% confidence interval [CI]) in mortality for CFS 5, CFS 6, and CFS 7-9 was 6.3% (-3.4 to 15.9), 11.2% (0.4 to 22.0), and 17.7% (5.3 to 30.1), respectively; and the adjusted risk ratio (95% CI) was 1.45 (0.87 to 2.41), 1.85 (1.13 to 3.03), and 2.44 (1.50 to 3.96), respectively. CONCLUSION: The risk of 30-day mortality increased as frailty advanced in critically ill older adults. Given this high risk of short-term outcomes, ED clinicians should consider goals of care conversations carefully to avoid unwanted medical care for these patients.
ABSTRACT
BACKGROUND: We aimed to develop and externally validate a novel machine learning model that can classify CT image findings as positive or negative for SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR). METHODS: We used 2,928 images from a wide variety of case-control type data sources for the development and internal validation of the machine learning model. A total of 633 COVID-19 cases and 2,295 non-COVID-19 cases were included in the study. We randomly divided cases into training and tuning sets at a ratio of 8:2. For external validation, we used 893 images from 740 consecutive patients at 11 acute care hospitals suspected of having COVID-19 at the time of diagnosis. The dataset included 343 COVID-19 patients. The reference standard was RT-PCR. RESULTS: In external validation, the sensitivity and specificity of the model were 0.869 and 0.432, at the low-level cutoff, 0.724 and 0.721, at the high-level cutoff. Area under the receiver operating characteristic was 0.76. CONCLUSIONS: Our machine learning model exhibited a high sensitivity in external validation datasets and may assist physicians to rule out COVID-19 diagnosis in a timely manner at emergency departments. Further studies are warranted to improve model specificity.
ABSTRACT
BACKGROUND: Patients on haemodialysis (HD) are often constipated. This study aimed to assess the relationship between constipation and mortality in such patients. In this study, constipation was defined as receiving prescription laxatives, based on the investigation results of "a need to take laxatives is the most common conception of constipation" reported by the World Gastroenterology Organization Global Guidelines. METHODS: This cohort study included 12,217 adult patients on HD enrolled in the Japan-Dialysis Outcomes and Practice Patterns study phases 1 to 5 (1998 to 2015). The participants were grouped into two based on whether they were prescribed laxatives during enrolment at baseline. The primary endpoint was all-cause mortality in 3 years, and the secondary endpoint was cause-specific death. Missing values were imputed using multiple imputation methods. All estimations were calculated using a Cox proportional hazards model with an inverse probability of treatment weighting using the propensity score. RESULTS: Laxatives were prescribed in 30.5% of the patients, and there were 1240 all-cause deaths. There was a significant association between laxative prescription and all-cause mortality [adjusted hazard ratio (AHR), 1.12; 95% confidence interval (CI): 1.03 to 1.21]. Because the Kaplan-Meier curves of the two groups crossed over, we examined 8345 patients observed for more than 1.5 years. Laxative prescription was significantly associated with all-cause mortality (AHR, 1.35; 95% CI: 1.17 to 1.55). The AHR of infectious death was 1.62 (95% CI: 1.14 to 2.29), and that of cancerous death was 1.60 (95% CI: 1.08 to 2.36). However, cardiovascular death did not show a significant inter-group difference. CONCLUSIONS: Constipation requiring use of laxatives was associated with an increased risk of death in patients on HD. It is important to prevent patients receiving HD from developing constipation and to reduce the number of patients requiring laxatives.
Subject(s)
Constipation/drug therapy , Constipation/mortality , Laxatives/therapeutic use , Renal Dialysis , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Prospective StudiesABSTRACT
Ali-M3, an artificial intelligence program, analyzes chest computed tomography (CT) and detects the likelihood of coronavirus disease (COVID-19) based on scores ranging from 0 to 1. However, Ali-M3 has not been externally validated. Our aim was to evaluate the accuracy of Ali-M3 for detecting COVID-19 and discuss its clinical value. We evaluated the external validity of Ali-M3 using sequential Japanese sampling data. In this retrospective cohort study, COVID-19 infection probabilities for 617 symptomatic patients were determined using Ali-M3. In 11 Japanese tertiary care facilities, these patients underwent reverse transcription-polymerase chain reaction (RT-PCR) testing. They also underwent chest CT to confirm a diagnosis of COVID-19. Of the 617 patients, 289 (46.8%) were RT-PCR-positive. The area under the curve (AUC) of Ali-M3 for predicting a COVID-19 diagnosis was 0.797 (95% confidence interval: 0.762â0.833) and the goodness-of-fit was P = 0.156. With a cut-off probability of a diagnosis of COVID-19 by Ali-M3 set at 0.5, the sensitivity and specificity were 80.6% and 68.3%, respectively. A cut-off of 0.2 yielded a sensitivity and specificity of 89.2% and 43.2%, respectively. Among the 223 patients who required oxygen, the AUC was 0.825. Sensitivity at a cut-off of 0.5% and 0.2% was 88.7% and 97.9%, respectively. Although the sensitivity was lower when the days from symptom onset were fewer, the sensitivity increased for both cut-off values after 5 days. We evaluated Ali-M3 using external validation with symptomatic patient data from Japanese tertiary care facilities. As Ali-M3 showed sufficient sensitivity performance, despite a lower specificity performance, Ali-M3 could be useful in excluding a diagnosis of COVID-19.
Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , Deep Learning , Diagnosis, Computer-Assisted/methods , Tomography, X-Ray Computed/methods , Adult , Aged , Algorithms , Area Under Curve , Cohort Studies , Female , Humans , Image Processing, Computer-Assisted , Japan/epidemiology , Male , Middle Aged , Probability , ROC Curve , Reproducibility of Results , Retrospective Studies , Reverse Transcriptase Polymerase Chain Reaction , SARS-CoV-2 , Sensitivity and SpecificityABSTRACT
Treatment of anaemia and reduction of transfusion are major therapeutic goals in patients with low-risk myelodysplastic syndrome (MDS). Although erythropoiesis-stimulating agents (ESAs) are widely used to reduce transfusion requirement, ESAs lose effectiveness within 12 months. We report a 65-year-old Japanese woman diagnosed with low-risk MDS who underwent long-term use of continuous epoetin ß pegol, an erythropoietin receptor activator (CERA), and her treatment after CERA failure. She received darbepoetin alpha (DPO) for transfusion-dependent anaemia and was free from transfusion. However, after 8 months, DPO lost effectiveness. She then received CERA and recovered from anaemia. Her haemoglobin level remained >10 g/dl for 3 years and 4 months. However, even CERA lost effectiveness, and she received roxadustat treatment with CERA, leading to recovery from anaemia again. Although further evidence is required, the extension of the no-transfusion period provided by ESAs and roxadustat is important and is awaited among low-risk MDS patients.
ABSTRACT
BACKGROUND: Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. METHODS: We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. RESULTS: The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. CONCLUSIONS: The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of "successful" clinical trials, making the net effect not zero but negative.
Subject(s)
Angiotensin Receptor Antagonists/therapeutic use , Clinical Trials as Topic/ethics , Drug Utilization/statistics & numerical data , Publications/statistics & numerical data , Humans , Interrupted Time Series Analysis , JapanABSTRACT
Importance: Obesity and cardiovascular risks have become major public health problems. However, evidence is limited as to whether population-level lifestyle interventions for obesity and cardiovascular risk factors are associated with improved population health outcomes. Objective: To investigate the association of the national health guidance intervention in Japan with population health outcomes. Design, Setting, and Participants: This cohort study used a regression discontinuity design that included men aged 40 to 74 years who participated in the national health screening program in Japan from April 2013 to March 2018. Exposures: Assignment to the national health guidance intervention (counseling on healthy lifestyle and appropriate clinical follow-up for individuals found to have waist circumference of 85 cm or greater with 1 or more cardiovascular risk factors during annual national health screening program). Main Outcomes and Measures: Changes in obesity status (body weight, body mass index, waist circumference), and cardiovascular risk factors (blood pressure, hemoglobin A1c level, and low-density lipoprotein cholesterol level) 1 to 4 years after screening. Results: Of 74â¯693 men (mean [SD] age, 52.1 [7.8] years; mean [SD] baseline waist circumference, 86.3 [9.0] cm), the assignment to the health guidance intervention was associated with lower weight (adjusted difference, -0.29 kg; 95% CI, -0.50 to -0.08; P = .005), body mass index (-0.10; 95% CI, -0.17 to -0.03; P = .008), and waist circumference (-0.34 cm; 95% CI, -0.59 to -0.04; P = .02) 1 year after screening. The observed association of the guidance assignment attenuated over time and was no longer significant by years 3 to 4. No evidence was found that the health guidance intervention was associated with changes in participants' systolic blood pressure, diastolic blood pressure, hemoglobin A1c level, or low-density lipoprotein cholesterol level in years 1 to 4. Conclusions and Relevance: Among working-age men in Japan, the national health guidance intervention was not associated with clinically meaningful weight loss or other cardiovascular risk factor reduction. Further research is warranted to understand the specific design of lifestyle interventions that are effective in improving obesity and cardiovascular risk factors.
Subject(s)
Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Health Promotion , Life Style , Obesity/complications , Obesity/prevention & control , Adult , Aged , Body Mass Index , Cohort Studies , Heart Disease Risk Factors , Humans , Japan , Male , Middle Aged , Time Factors , Waist Circumference , Weight LossABSTRACT
BACKGROUND: Patient journeys for hypertensive individuals after detection at screening have not been well examined in a general population. Thus, we aimed to assess the medical treatment status and subsequent longitudinal changes in blood pressure in a middle-aged Japanese population. METHODS: We conducted a cohort study using a nationwide Japanese health screening cohort, from April 2014 to March 2019. Among health screening participants aged 40-74 years who had not previously received treatment for hypertension, hypertensive patients were newly identified based on screening results, and their medical treatment status for hypertension during the year following their initial screening was assessed. The main outcomes were longitudinal changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 4 years after initial screening. RESULTS: Of the 153,523 screening participants (mean age = 49.7 years), 16,720 (10.9%) and 4150 (2.7%) were newly detected as having hypertension, with baseline SBP of 140-159 mmHg (grade 1) and ≥ 160 mmHg (grade 2-3), respectively. Among them, 15.9% of the grade 1 hypertensive participants and 36.3% of the grade 2-3 hypertensive participants started receiving medical treatment during the year following initial screening. A linear generalised estimating equation with propensity score matching showed that receiving medical treatment was associated with 5.77 mmHg lower SBP (95% CI - 6.64 to - 4.90) and 3.82 mmHg lower DBP (95% CI - 4.47 to - 3.16) in the grade 1 hypertensive group, and 14.69 mmHg lower SBP (95% CI - 16.35 to - 13.04) and 8.42 mmHg lower DBP (95% CI - 9.49 to - 7.34) in the grade 2-3 hypertensive group. CONCLUSIONS: Health screenings detected hypertension in a substantial percentage of the middle-aged population in this study. However, detection was often followed by insufficient medical treatment and inappropriate blood pressure management. These findings indicate an inadequate link between health screenings and medical treatments in patients with hypertension.