Publications by authors named "Hisashi Noma"

133 Publications

Predictive Factors for Pneumomediastinum During Management of Connective Tissue Disease-related Interstitial Lung Disease: A Retrospective Study.

Intern Med 2021 15;60(18):2887-2897. Epub 2021 Sep 15.

Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Japan.

Objective To identify factors associated with pneumomediastinum during management of connective tissue disease (CTD)-related interstitial lung disease (ILD). Methods Patients diagnosed with pneumomediastinum after the initiation of corticosteroid therapy for their CTD-ILD were enrolled. The baseline characteristics of patients who developed pneumomediastinum after the initiation of corticosteroid therapy (n=13, all occurring within 120 days) were compared to those of patients who did not develop pneumomediastinum (n=49). A multivariate logistic regression analysis was performed to identify factors associated with pneumomediastinum. A receiver operating characteristic (ROC) curve analysis was also performed to assess the predictive performance. Results The body mass index (BMI) [odds ratio (OR) (95% confidence interval (CI)) 0.482 (0.272-0.853)] and serum lactate dehydrogenase (LDH) [OR (95% CI) 1.013 (1-1.025)] levels at baseline were identified as independent factors associated with pneumomediastinum after corticosteroid initiation. The optimal cut-off points of the BMI and LDH levels for predicting pneumomediastinum development, as estimated by the Youden index, were 20.2 kg/m and 378 U/L, respectively. LDH showed a sensitivity of 61.5% and the highest specificity of 87.8%. Importantly, combining these markers resulted in the highest sensitivity of 100% and a specificity of 71.4%. Conclusion A low BMI and high serum LDH levels at baseline are useful predictive factors for pneumomediastinum development in CTD-ILD patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2169/internalmedicine.6892-20DOI Listing
September 2021

Prognostic Significance of the Number of Teeth in Patients with Colorectal Cancer.

J Anus Rectum Colon 2021 29;5(3):237-246. Epub 2021 Jul 29.

Department of Surgery, Graduate School of Medicine, Faculty of Medicine, Tottori University, Yonago, Japan.

Objectives: , which is the predominant subgingival microbial species found in chronic periodontitis, has been recently proposed as a risk factor for both the initiation and progression of colorectal cancer. We evaluated whether the number of teeth, which represents oral health, is a marker for the prognosis of patients with colorectal cancer.

Methods: This retrospective single-center study recruited 179 patients who underwent primary colorectal cancer resection with curative intent between 2015 and 2017. The baseline characteristics and survival were analyzed according to the number of teeth observed in dental panoramic radiographs taken before surgical resection as a part of the perioperative surveillance for oral function and hygiene.

Results: The median number of teeth was 20 (interquartile range: 6-25), including 28 patients with no teeth. Patients with 20 or more teeth had better overall survival ( = 0.002) and colorectal cancer-specific survival ( = 0.032) than those with less than 20 teeth. Multivariate analyses confirmed that the number of teeth was a significant prognostic factor for overall survival ( = 0.045) but not for colorectal cancer-specific survival ( = 0.258). We also took a propensity score-weighting approach using inverse probability weighting, and the -values of the number of teeth were 0.032 for overall survival and 0.180 for colorectal cancer-specific survival.

Conclusions: A low number of teeth, which can be easily and noninvasively assessed, has been a poor prognostic factor for overall survival in colorectal cancer patients who underwent surgery with curative intent.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23922/jarc.2020-091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8321593PMC
July 2021

The Multi-Domain Intervention Trial in Older Adults With Diabetes Mellitus for Prevention of Dementia in Japan: Study Protocol for a Multi-Center, Randomized, 18-Month Controlled Trial.

Front Aging Neurosci 2021 12;13:680341. Epub 2021 Jul 12.

Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology, Obu, Japan.

The Japan-Multi-domain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes (J-MIND-Diabetes) is an 18-month, multi-centered, open-labeled, randomized controlled trial designed to identify whether multi-domain intervention targeting modifiable risk factors for dementia could prevent the progression of cognitive decline among older adults with type 2 diabetes mellitus (T2DM). This manuscript describes the study protocol for the J-MIND-Diabetes trial. Subjects of this trial will comprise a total of 300 T2DM outpatients aged 70-85 years with mild cognitive impairment. Subjects will be centrally randomized into intervention and control groups at a 1:1 allocation ratio using the stratified permuted-block randomization methods. The intervention group will participate in multi-domain intervention programs aimed at: (1) management of metabolic and vascular risk factors; (2) physical exercise and self-monitoring of physical activity; (3) nutritional guidance; and (4) social participation. The control group will receive usual T2DM care and general instructions on dementia prevention. The primary and secondary outcomes will be assessed at baseline, at 6- and 18-month follow-up. The primary outcome is change from baseline at 18 months in a global composite score combining several neuropsychological domains, including global cognitive function, memory, attention, executive function, processing speed and language. Secondary outcomes include: (1) cognitive changes in neuropsychological tests; (2) changes in geriatrics assessments; (3) metabolic control and diabetic complications; (4) changes in blood and urinary markers. This trial will be the first trial to demonstrate the effectiveness of multi-domain intervention in preventing cognitive decline in older adults with T2DM at increased risk of dementia in Japan. UMIN000035911; Registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 18 February 2019. (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3389/fnagi.2021.680341DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8312849PMC
July 2021

Confidence intervals of prediction accuracy measures for multivariable prediction models based on the bootstrap-based optimism correction methods.

Stat Med 2021 Jul 24. Epub 2021 Jul 24.

Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Public Health, Kyoto, Japan.

In assessing prediction accuracy of multivariable prediction models, optimism corrections are essential for preventing biased results. However, in most published papers of clinical prediction models, the point estimates of the prediction accuracy measures are corrected by adequate bootstrap-based correction methods, but their confidence intervals are not corrected, for example, the DeLong's confidence interval is usually used for assessing the C-statistic. These naïve methods do not adjust for the optimism bias and do not account for statistical variability in the estimation of parameters in the prediction models. Therefore, their coverage probabilities of the true value of the prediction accuracy measure can be seriously below the nominal level (eg, 95%). In this article, we provide two generic bootstrap methods, namely, (1) location-shifted bootstrap confidence intervals and (2) two-stage bootstrap confidence intervals, that can be generally applied to the bootstrap-based optimism correction methods, that is, the Harrell's bias correction, 0.632, and 0.632+ methods. In addition, they can be widely applied to various methods for prediction model development involving modern shrinkage methods such as the ridge and lasso regressions. Through numerical evaluations by simulations, the proposed confidence intervals showed favorable coverage performances. Besides, the current standard practices based on the optimism-uncorrected methods showed serious undercoverage properties. To avoid erroneous results, the optimism-uncorrected confidence intervals should not be used in practice, and the adjusted methods are recommended instead. We also developed the R package predboot for implementing these methods ( https://github.com/nomahi/predboot). The effectiveness of the proposed methods are illustrated via applications to the GUSTO-I clinical trial.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/sim.9148DOI Listing
July 2021

Cognitive restructuring, behavioral activation and cognitive-behavioral therapy in the treatment of adult depression: A network meta-analysis.

J Consult Clin Psychol 2021 Jun;89(6):563-574

Department of Clinical, Neuro- and Developmental Psychology.

Objective: To examine if cognitive restructuring (CR), behavioral activation (BA), and cognitive-behavioral therapy (CBT) result in differential effects in the treatment of adult depression.

Method: We extracted randomized controlled trials (RCTs) from a database updated yearly from PubMed, PsycINFO, Embase, and Cochrane Library. Network and pairwise meta-analyses were conducted to investigate the effects of CR, BA, and CBT delivered in a face-to-face individual format, compared with waiting list (WL) and care-as-usual (CAU), on adult depression. The primary outcome was a standardized mean difference (SMD) in posttreatment depression severity. Tolerability of treatments and depression severity at follow-up were also assessed.

Results: A total of 45 studies with 3,382 participants were included. There was no evidence of a difference in effectiveness between CR, BA, and CBT. All three interventions were superior to CAU; SMD 0.57, 95% confidence interval [CI 0.08-1.07]; 0.52 [0.34-0.71]; 0.44 [0.28-0.60], respectively and WL 1.20 [0.69-1.70]; 1.15 [0.90-1.40]; 1.07 [0.87-1.26]. No difference in tolerability was found (risk ratio [RR] vs. CAU: 1.01 [0.04-22.81], 0.84 [0.63-1.11], and 0.96 [0.76-1.21], respectively). Metaregression and sensitivity analyses did not produce material differences.

Conclusions: Results suggest that CR or BA alone and their combination (CBT) may be effective interventions in comparison to WL and CAU in the treatment of adult depression. There was no evidence suggesting differences in effectiveness among the three treatments. More research is needed to derive conclusions about the performance of CR. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1037/ccp0000654DOI Listing
June 2021

Association with Ambient Air Pollutants and School Absence Due to Sickness in Schoolchildren: A Case-Crossover Study in a Provincial Town of Japan.

Int J Environ Res Public Health 2021 06 20;18(12). Epub 2021 Jun 20.

Allergy Center, Kindai University Hospital, Ohnohigashi 377-2, Osakasayama 589-0014, Japan.

The effect of ambient air pollutants and Asian dust (AD) on absence from school due to sickness has not been well researched. By conducting a case-crossover study, this study investigated the influence of ambient air pollutants and desert sand dust particles from East Asia on absence from school due to sickness. From November 2016 to July 2018, the daily cases of absence due to sickness were recorded in five elementary schools in Matsue, Japan. During the study period, a total of 16,915 absence cases were recorded, which included 4865 fever cases and 2458 cough cases. The relative risk of overall absence in a 10-μg/m increment of PM and a 0.1-km of desert sand dust particles from East Asia were found with 1.28 (95%CI: 1.15-1.42) and 2.15 (1.04-4.45) at lag0, respectively. The significant influence of PM persisted at lag5 and that of desert sand dust particles at lag2. NO had statistically significant effects at lag2, lag3, and lag4. However, there was no evidence of a positive association of O and SO with absence from school. These results suggested that PM, NO, and AD increased the risk of absence due to sickness in schoolchildren.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/ijerph18126631DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8296492PMC
June 2021

Psychologic Treatment of Depression Compared With Pharmacotherapy and Combined Treatment in Primary Care: A Network Meta-Analysis.

Ann Fam Med 2021 May-Jun;19(3):262-270

Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan (T.A.F.).

Purpose: Most patients with depression are treated by general practitioners, and most of those patients prefer psychotherapy over pharmacotherapy. No network meta-analyses have examined the effects of psychotherapy compared with pharmacotherapy, combined treatment, care as usual, and other control conditions among patients in primary care.

Methods: We conducted systematic searches of bibliographic databases to identify randomized trials comparing psychotherapy with pharmacotherapy, combined treatment, care as usual, waitlist, and pill placebo. The main outcome was treatment response (50% improvement of depressive symptoms from baseline to end point).

Results: A total of 58 studies with 9,301 patients were included. Both psychotherapy and pharmacotherapy were significantly more effective than care as usual (relative risk [RR] for response = 1.60; 95% CI, 1.40-1.83 and RR = 1.65; 95% CI, 1.35-2.03, respectively) and waitlist (RR = 2.35; 95% CI, 1.57-3.51 and RR = 2.43; 95% CI, 1.57-3.74, respectively) control groups. We found no significant differences between psychotherapy and pharmacotherapy (RR = 1.03; 95% CI, 0.88-1.22). The effects were significantly greater for combined treatment compared with psychotherapy alone (RR = 1.35; 95% CI, 1.00-1.81). The difference between combined treatment and pharmacotherapy became significant when limited to studies with low risk of bias and studies limited to cognitive behavior therapy.

Conclusions: Psychotherapy is likely effective for the treatment of depression when compared with care as usual or waitlist, with effects comparable to those of pharmacotherapy. Combined treatment might be better than either psychotherapy or pharmacotherapy alone.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1370/afm.2676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8118476PMC
December 2019

The effects of psychotherapies for depression on response, remission, reliable change, and deterioration: A meta-analysis.

Acta Psychiatr Scand 2021 09 4;144(3):288-299. Epub 2021 Jul 4.

Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.

Objective: Meta-analyses of psychotherapies usually report effects sizes, while clinicians and patients need to know the proportion of patients who benefit from therapy. We conducted a meta-analysis of therapies for depression reporting the rates of response (50% symptom reduction), remission (HAM-D <7), clinical significant deterioration for psychotherapy, and control conditions (CAU, waitlist, and pill placebo), as well as the relative risk of these outcomes and the numbers-needed-to-be-treated (NNTs).

Methods: We searched bibliographic databases and included 228 randomized trials comparing psychotherapy for depression against control conditions (75 with low risk of bias). Only therapies with at least 10 trials were included. We extracted outcomes from the studies, and for those studies not reporting the outcomes, we used a validated method to estimate the rates.

Results: The overall response rate in psychotherapies at 2 (±1) months after baseline was 41% (95% CI: 38~43), 17% (15~20) for usual care (CAU), and 16% (95% CI: 14~18) for waitlist. No significant differences between types of therapy were found. The NNT for therapy versus CAU was 5.3 and versus waitlist 3.9. About one third of patients remitted after therapy compared with 7%-13% in control conditions. The rates of deterioration were 5% versus 12%-13%, respectively. Most sensitivity analyses supported the general findings.

Conclusion: Psychotherapies for depression may be effective compared with control conditions, but more than half of patients receiving therapy do not respond and only one third remitted. More effective treatments and treatment strategies such as sequencing and combining treatments are clearly needed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/acps.13335DOI Listing
September 2021

Psychotherapies for depression: a network meta-analysis covering efficacy, acceptability and long-term outcomes of all main treatment types.

World Psychiatry 2021 Jun;20(2):283-293

Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine, School of Public Health, Kyoto, Japan.

The effects of psychotherapies for depression have been examined in several hundreds of randomized trials, but no recent network meta-analysis (NMA) has integrated the results of these studies. We conducted an NMA of trials comparing cognitive behavioural, interpersonal, psychodynamic, problem-solving, behavioural activation, life-review and "third wave" therapies and non-directive supportive counseling with each other and with care-as-usual, waiting list and pill placebo control conditions. Response (50% reduction in symptoms) was the primary outcome, but we also assessed remission, standardized mean difference, and acceptability (all-cause dropout rate). Random-effects pairwise and network meta-analyses were conducted on 331 randomized trials with 34,285 patients. All therapies were more efficacious than care-as-usual and waiting list control conditions, and all therapies - except non-directive supportive counseling and psychodynamic therapy - were more efficacious than pill placebo. Standardized mean differences compared with care-as-usual ranged from -0.81 for life-review therapy to -0.32 for non-directive supportive counseling. Individual psychotherapies did not differ significantly from each other, with the only exception of non-directive supportive counseling, which was less efficacious than all other therapies. The results were similar when only studies with low risk of bias were included. Most therapies still had significant effects at 12-month follow-up compared to care-as-usual, and problem-solving therapy was found to have a somewhat higher long-term efficacy than some other therapies. No consistent differences in acceptability were found. Our conclusion is that the most important types of psychotherapy are efficacious and acceptable in the acute treatment of adult depression, with few significant differences between them. Patient preference and availability of each treatment type may play a larger role in the choice between types of psychotherapy, although it is possible that a more detailed characterization of patients with a diagnosis of depression may lead to a more precise matching between individual patients and individual psychotherapies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/wps.20860DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129869PMC
June 2021

Impact of high-load resistance training on bone mineral density in osteoporosis and osteopenia: a meta-analysis.

J Bone Miner Metab 2021 Sep 13;39(5):787-803. Epub 2021 Apr 13.

Rehabilitation Division, Tottori University Hospital, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan.

Introduction: This study aimed to examine the effect of high-load resistance training (HLRT) on bone mineral density (BMD) in patients with osteoporosis and osteopenia using a meta-analysis.

Materials And Methods: We searched for randomized controlled trials (RCTs) on HLRT in patients with osteoporosis and osteopenia from medical databases. Our meta-analysis was performed with the primary endpoints being the standardized mean difference (SMD) of the change in BMD of the lumbar spine (LS), femoral neck (FN), and total hip (TH). The robustness of the results was assessed by subgroup analysis. Heterogeneity factors were examined by meta-regression. Publication bias was evaluated using a funnel plot.

Results: We selected nine RCTs, with 259 patients in the HLRT group (women, 55.2%) and 236 patients in the control group (women, 62.7%). The HLRT group showed a significant increase in BMD in the LS [SMD = 1.40, 95% confidence interval (CI) = 0.68-2.12, p < 0.001, I = 90%], the FN (SMD = 0.86, 95% CI = 0.05-1.67, p = 0.04, I = 92%), and the TH (SMD = 1.26, 95% CI = 0.45-2.08, p = 0.002, I = 91%). Subgroup analysis confirmed the robustness of the results only in LS. Total sessions and a high risk of bias were identified as the factors of heterogeneity in FN and TH (p < 0.05). The funnel plot showed asymmetry in all measurement sites.

Conclusion: This study suggested that HLRT can be effective in increasing BMD, mainly of LS, in patients with osteoporosis and osteopenia. However, due to high heterogeneity and publication bias, additional studies with a low risk of bias should be conducted to generalize our findings.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00774-021-01218-1DOI Listing
September 2021

Prediction of 11-year incidence of psychophysically dependent status or death among community-dwelling younger elderlies: from an age-specified community-based cohort study (the NISSIN project).

Environ Health Prev Med 2021 Apr 10;26(1):45. Epub 2021 Apr 10.

Department of Public Health, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan.

Background: Predicting adverse health events and implementing preventative measures are a necessary challenge. It is important for healthcare planners and policymakers to allocate the limited resource to high-risk persons. Prediction is also important for older individuals, their family members, and clinicians to prepare mentally and financially. The aim of this study is to develop a prediction model for within 11-year dependent status requiring long-term nursing care or death in older adults for each sex.

Methods: We carried out age-specified cohort study of community dwellers in Nisshin City, Japan. The older adults aged 64 years who underwent medical check-up between 1996 and 2000 were included in the study. The primary outcome was the incidence of the psychophysically dependent status or death or by the end of the year of age 75 years. Univariable logistic regression analyses were performed to assess the associations between candidate predictors and the outcome. Using the variables with p-values less than 0.1, multivariable logistic regression analyses were then performed with backward stepwise elimination to determine the final predictors for the model.

Results: Of the 1525 female participants at baseline, 105 had an incidence of the study outcome. The final prediction model consisted of 15 variables, and the c-statistics for predicting the outcome was 0.763 (95% confidence interval [CI] 0.714-0.813). Of the 1548 male participants at baseline, 211 had incidence of the study outcome. The final prediction model consisted of 16 variables, and the c-statistics for predicting the outcome was 0.735 (95% CI 0.699-0.771).

Conclusions: We developed a prediction model for older adults to forecast 11-year incidence of dependent status requiring nursing care or death in each sex. The predictability was fair, but we could not evaluate the external validity of this model. It could be of some help for healthcare planners, policy makers, clinicians, older individuals, and their family members to weigh the priority of support.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12199-021-00968-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8035719PMC
April 2021

Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study.

Diagnostics (Basel) 2021 Mar 17;11(3). Epub 2021 Mar 17.

Department of Gastroenterology, Yasugi Municipal Hospital, Shimane 692-0404, Japan.

This randomized trial aimed to compare the safety and efficacy of the GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD) with that of the conventional mouthpiece. In all, 90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups. The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events. Endoscopy was completed in all cases, and no complications were observed. VAS, when passing the scope through the pharynx, was 2.5 ± 2.4 and 2.0 ± 1.9 cm ( = 0.24) in the conventional and GAGLESS groups, respectively, and that, throughout the examination, was 2.5 ± 2.4 and 1.7 ± 1.5 cm ( = 0.06), respectively. The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP ( = 0.08) and significant for DBP ( = 0.03). The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/diagnostics11030538DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002750PMC
March 2021

Prediction of future wrinkles for middle-aged women: A 7-year longitudinal study on the progression of wrinkles in Japanese women.

Skin Res Technol 2021 Mar 31. Epub 2021 Mar 31.

Department of Data Science, The Institute of Statistical Mathematics, Tachikawa, Japan.

Background: It is commonly believed that there is serious heterogeneity in the rate of wrinkle progression among individuals. Although several skin characteristics have been shown to influence wrinkle progression, the ability to predict which individuals with skin characteristics are likely to develop wrinkles is still limited.

Objectives: The purpose of this study is to develop and validate an effective prediction model for longitudinal changes in wrinkles.

Methods: We collected annual wrinkle scores and multiple skin physiological characteristics in 48 Japanese women over a period of 7 years. We developed a multivariable prediction model for predicting future wrinkle status based on the various skin physiological characteristics using a linear mixed-effects model.

Results: After variable selection by backwards, the final wrinkle prediction model included age, sebum volume, redness of skin color, lightness of skin color, and an interaction term between sebum volume and redness of skin color. The developed prediction model showed favorable prediction accuracy (R  = 87.92%, 95% confidence interval 84.27%-90.68%).

Conclusions: The developed model accurately predicted levels of wrinkles in Japanese women aged 22-60 years. The prediction model is based on age and three practical skin characteristics, which might implicate an essential insight to prevent wrinkle progression in individuals.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/srt.13031DOI Listing
March 2021

Aldosterone antagonists for people with chronic kidney disease requiring dialysis.

Cochrane Database Syst Rev 2021 02 15;2:CD013109. Epub 2021 Feb 15.

Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.

Background: People with chronic kidney disease (CKD) requiring dialysis are at a particularly high risk of cardiovascular death and morbidity. Several clinical studies suggested that aldosterone antagonists would be a promising treatment option for people undergoing dialysis. However, the clinical efficacy and potential harm of aldosterone antagonists for people with CKD on dialysis has yet to be determined.

Objectives: This review aimed to evaluate the benefits and harms of aldosterone antagonists, both non-selective (spironolactone) and selective (eplerenone), in comparison to control (placebo or standard care) in people with CKD requiring haemodialysis (HD) or peritoneal dialysis (PD).

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 5 August 2020 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: We included parallel randomised controlled trials (RCTs), cross-over RCTs, and quasi-RCTs (where group allocation is by a method that is not truly random, such as alternation, assignment based on alternate medical records, date of birth, case record number, or other predictable methods) that compared aldosterone antagonists with placebo or standard care in people with CKD requiring dialysis.

Data Collection And Analysis: Two review authors independently extracted data and assessed risk of bias for included studies. We used a random-effects model meta-analysis to perform a quantitative synthesis of the data. We used the I² statistic to measure heterogeneity among the studies in each analysis. We indicated summary estimates as a risk ratio (RR) for dichotomous outcomes, mean difference (MD) for continuous outcomes, or standardised mean differences (SMD) if different scales were used, with their 95% confidence interval (CI). We assessed the certainty of the evidence for each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach.

Main Results: We included 16 studies (14 parallel RCTs and two cross-over RCTs) involving a total of 1446 participants. Thirteen studies compared spironolactone to placebo or standard care and one study compared eplerenone to a placebo. Most included studies had an unclear or high risk of bias. Compared to control, aldosterone antagonists probably reduced the risk of death (any cause) for people with CKD requiring dialysis (9 studies, 1119 participants: RR 0.45, 95% CI 0.30 to 0.67; I² = 0%; moderate certainty of evidence). Aldosterone antagonist probably decreased the risk of death due to cardiovascular disease (6 studies, 908 participants: RR 0.37, 95% CI 0.22 to 0.64; I² = 0%; moderate certainty of evidence) and cardiovascular and cerebrovascular morbidity (3 studies, 328 participants: RR 0.38, 95% CI 0.18 to 0.76; I² = 0%; moderate certainty of evidence). While aldosterone antagonists probably increased risk of gynaecomastia compared with control (4 studies, 768 participants: RR 5.95, 95% CI 1.93 to 18.3; I² = 0%; moderate certainty of evidence), aldosterone antagonists may make little or no difference to the risk of hyperkalaemia (9 studies, 981 participants: RR 1.41, 95% CI 0.72 to 2.78; I² = 47%; low certainty of evidence). Aldosterone antagonists had a marginal effect on left ventricular mass among participants undergoing dialysis (8 studies, 633 participants: SMD -0.42, 95% CI -0.78 to 0.05; I² = 77%). In people with CKD requiring dialysis received aldosterone antagonists compared to control, there were 72 fewer deaths from all causes per 1000 participants (95% CI 47 to 98) with a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 10 to 21) and for gynaecomastia were 26 events per 1000 participants (95% CI 15 to 39) with a number need to treat for an additional harmful outcome (NNTH) of 38 (95% CI 26 to 68).

Authors' Conclusions: Based on moderate certainty of the evidence, aldosterone antagonists probably reduces the risk of all-cause and cardiovascular death and probably reduces morbidity due to cardiovascular and cerebrovascular disease in people with CKD requiring dialysis. For the adverse effect of gynaecomastia, the risk was increased compared to control. For this outcome, the absolute risk was lower than the absolute risk of death. It is hoped the three large ongoing studies will provide better certainty of evidence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD013109.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094170PMC
February 2021

Meta-analysis using flexible random-effects distribution models.

J Epidemiol 2021 Feb 13. Epub 2021 Feb 13.

Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health.

Background: In meta-analysis, the normal distribution assumption has been adopted in most systematic reviews of random-effects distribution models due to its computational and conceptual simplicity. However, this restrictive model assumption is possibly unsuitable and might have serious influences in practices.

Methods: We provide two examples of real-world evidence that clearly show that the normal distribution assumption is explicitly unsuitable. We propose new random-effects meta-analysis methods using five flexible random-effects distribution models that can flexibly regulate skewness, kurtosis and tailweight: skew normal distribution, skew t-distribution, asymmetric Subbotin distribution, Jones-Faddy distribution, and sinh-arcsinh distribution. We also developed a statistical package, flexmeta, that can easily perform these methods.

Results: Using the flexible random-effects distribution models, the results of the two meta-analyses were markedly altered, potentially influencing the overall conclusions of these systematic reviews.

Conclusions: The restrictive normal distribution assumption in the random-effects model can yield misleading conclusions. The proposed flexible methods can provide more precise conclusions in systematic reviews.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2188/jea.JE20200376DOI Listing
February 2021

QTc interval prolongation in patients with systemic lupus erythematosus treated with hydroxychloroquine.

Mod Rheumatol 2021 Feb 9:1-10. Epub 2021 Feb 9.

Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.

Objectives: The primary objective is to reveal the effect of hydroxychloroquine (HCQ) treatment on corrected QT (QTc) interval in patients with systemic lupus erythematosus (SLE). The secondary objective is to investigate factors that affect QTc prolongation.

Methods: SLE patients who had electrocardiograms between 2015 and 2020 were recruited and assigned to two groups based on whether they were treated with HCQ (HCQ group) or not (control group). Change of QTc before and after HCQ administration in the HCQ group was measured and compared with the control group. Patients treated with HCQ were further divided into two groups based on presence or absence of QTc prolongation and the characteristics were compared.

Results: In total, 126 patients were recruited, of whom 42 were treated with HCQ. In the HCQ group, the mean QTc significantly increased ( < .001), while there was no significant difference of mean QTc in the control group. Moreover, those in the HCQ group with QTc prolongation showed a significantly higher proportion of hypertension and longer SLE duration compared to those without QTc prolongation. However, the multiple logistic regression analysis showed that there were no significant differences among them.

Conclusion: HCQ could induce QTc prolongation in SLE patients. It might be better that the possibility of QTc prolongation was taken into consideration when HCQ was administered in the patients with longer disease duration of SLE and coincidence of hypertension.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/14397595.2021.1879368DOI Listing
February 2021

Re-evaluation of the comparative effectiveness of bootstrap-based optimism correction methods in the development of multivariable clinical prediction models.

BMC Med Res Methodol 2021 01 7;21(1). Epub 2021 Jan 7.

Department of Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan.

Background: Multivariable prediction models are important statistical tools for providing synthetic diagnosis and prognostic algorithms based on patients' multiple characteristics. Their apparent measures for predictive accuracy usually have overestimation biases (known as 'optimism') relative to the actual performances for external populations. Existing statistical evidence and guidelines suggest that three bootstrap-based bias correction methods are preferable in practice, namely Harrell's bias correction and the .632 and .632+ estimators. Although Harrell's method has been widely adopted in clinical studies, simulation-based evidence indicates that the .632+ estimator may perform better than the other two methods. However, these methods' actual comparative effectiveness is still unclear due to limited numerical evidence.

Methods: We conducted extensive simulation studies to compare the effectiveness of these three bootstrapping methods, particularly using various model building strategies: conventional logistic regression, stepwise variable selections, Firth's penalized likelihood method, ridge, lasso, and elastic-net regression. We generated the simulation data based on the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO-I) trial Western dataset and considered how event per variable, event fraction, number of candidate predictors, and the regression coefficients of the predictors impacted the performances. The internal validity of C-statistics was evaluated.

Results: Under relatively large sample settings (roughly, events per variable ≥ 10), the three bootstrap-based methods were comparable and performed well. However, all three methods had biases under small sample settings, and the directions and sizes of biases were inconsistent. In general, Harrell's and .632 methods had overestimation biases when event fraction become lager. Besides, .632+ method had a slight underestimation bias when event fraction was very small. Although the bias of the .632+ estimator was relatively small, its root mean squared error (RMSE) was comparable or sometimes larger than those of the other two methods, especially for the regularized estimation methods.

Conclusions: In general, the three bootstrap estimators were comparable, but the .632+ estimator performed relatively well under small sample settings, except when the regularized estimation methods are adopted.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12874-020-01201-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789544PMC
January 2021

Sample size calculations for single-arm survival studies using transformations of the Kaplan-Meier estimator.

Pharm Stat 2021 05 21;20(3):499-511. Epub 2020 Dec 21.

Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.

In single-arm clinical trials with survival outcomes, the Kaplan-Meier estimator and its confidence interval are widely used to assess survival probability and median survival time. Since the asymptotic normality of the Kaplan-Meier estimator is a common result, the sample size calculation methods have not been studied in depth. An existing sample size calculation method is founded on the asymptotic normality of the Kaplan-Meier estimator using the log transformation. However, the small sample properties of the log transformed estimator are quite poor in small sample sizes (which are typical situations in single-arm trials), and the existing method uses an inappropriate standard normal approximation to calculate sample sizes. These issues can seriously influence the accuracy of results. In this paper, we propose alternative methods to determine sample sizes based on a valid standard normal approximation with several transformations that may give an accurate normal approximation even with small sample sizes. In numerical evaluations via simulations, some of the proposed methods provided more accurate results, and the empirical power of the proposed method with the arcsine square-root transformation tended to be closer to a prescribed power than the other transformations. These results were supported when methods were applied to data from three clinical trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/pst.2090DOI Listing
May 2021

Different control conditions can produce different effect estimates in psychotherapy trials for depression.

J Clin Epidemiol 2021 04 15;132:59-70. Epub 2020 Dec 15.

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Objectives: Control conditions' influence on effect estimates of active psychotherapeutic interventions for depression has not been fully elucidated. We used network meta-analysis to estimate the differences between control conditions.

Study Design And Setting: We have conducted a comprehensive literature search of randomized trials of psychotherapies for adults with depression up to January 1, 2019 in four major databases (PubMed, PsycINFO, Embase, and Cochrane). The network meta-analysis included broadly conceived cognitive behavior therapies in comparison with the following control conditions: Waiting List (WL), No Treatment (NT), Pill Placebo (PillPlacebo), Psychological Placebo (PsycholPlacebo).

Results: 123 studies with 12,596 participants were included. The I-squared was 55.9% (95% CI: 45.9%; to 64.0%) (moderate heterogeneity). The design-by-treatment global test of inconsistency was not significant (P = 0.44). Different control conditions led to different estimates of efficacy for the same intervention. WL appears to be the weakest control (odds ratio of response against NT = 1.93 (1.30 to 2.86), PsycholPlacebo = 2.03 (1.21 to 3.39), and PillPlacebo = 2.66 (1.45 to 4.89), respectively).

Conclusions: Different control conditions produce different effect estimates in psychotherapy randomized controlled trials for depression. WL was the weakest, followed by NT, PsycholPlacebo, and PillPlacebo in this order. When conducting meta-analyses of psychotherapy trials, different control conditions should not be lumped into a single group.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.12.012DOI Listing
April 2021

Deep Neural Network for Reducing the Screening Workload in Systematic Reviews for Clinical Guidelines: Algorithm Validation Study.

J Med Internet Res 2020 12 30;22(12):e22422. Epub 2020 Dec 30.

Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.

Background: Performing systematic reviews is a time-consuming and resource-intensive process.

Objective: We investigated whether a machine learning system could perform systematic reviews more efficiently.

Methods: All systematic reviews and meta-analyses of interventional randomized controlled trials cited in recent clinical guidelines from the American Diabetes Association, American College of Cardiology, American Heart Association (2 guidelines), and American Stroke Association were assessed. After reproducing the primary screening data set according to the published search strategy of each, we extracted correct articles (those actually reviewed) and incorrect articles (those not reviewed) from the data set. These 2 sets of articles were used to train a neural network-based artificial intelligence engine (Concept Encoder, Fronteo Inc). The primary endpoint was work saved over sampling at 95% recall ([email protected]%).

Results: Among 145 candidate reviews of randomized controlled trials, 8 reviews fulfilled the inclusion criteria. For these 8 reviews, the machine learning system significantly reduced the literature screening workload by at least 6-fold versus that of manual screening based on [email protected]%. When machine learning was initiated using 2 correct articles that were randomly selected by a researcher, a 10-fold reduction in workload was achieved versus that of manual screening based on the [email protected]% value, with high sensitivity for eligible studies. The area under the receiver operating characteristic curve increased dramatically every time the algorithm learned a correct article.

Conclusions: Concept Encoder achieved a 10-fold reduction of the screening workload for systematic review after learning from 2 randomly selected studies on the target topic. However, few meta-analyses of randomized controlled trials were included. Concept Encoder could facilitate the acquisition of evidence for clinical guidelines.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/22422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806440PMC
December 2020

Usefulness of a target sample check illuminator in the detection of target specimens in endoscopic ultrasound-guided fine-needle biopsy samples: Multicenter prospective study.

Dig Endosc 2021 Sep 28;33(6):970-976. Epub 2020 Dec 28.

Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori, Japan.

Objectives: Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) uses a thin needle, rendering unclear whether the collected sample contains pathological evidence. We examined the usefulness of our target sample check illuminator (TSCI) through a multicenter prospective trial.

Methods: We included 52 consecutive patients. After assessing EUS-FNB samples by conventional (visual observation) and TSCI methods, we evaluated consistency with the histopathological diagnosis. We compared the target sample confirmation rate between conventional and TSCI methods and evaluated the diagnostic ability separately.

Results: Comparison between the conventional and TSCI methods revealed the following: (i) for all cases: sensitivity, 51.0% (25/49) vs. 95.9% (47/49) (P = 0.001); specificity, 100% (3/3) vs. 66.7% (2/3); positive predictive value (PPV), 100% (25/25) vs. 97.9% (47/48); and negative predictive value (NPV), 11.1% (3/27) vs. 50.0% (2/4) (P = 0.002); (ii) for pancreatic masses: sensitivity, 28.0% (7/25) vs. 96.0% (24/25) (P < 0.001); specificity, 100% (2/2) vs. 100% (2/2); PPV, 100% (7/7) vs. 100% (24/24); and NPV, 10.0% (2/20) vs. 66.7% (2/3) (P < 0.001) (the TSCI method showed significantly better sensitivity and NPV than the conventional method); and (iii) for lymph node tumors: sensitivity, 75.0% (18/24) vs. 95.8% (23/24) (P = 0.025); specificity, 100% (1/1) vs. 0% (0/1); PPV, 100% (18/18) vs. 95.8% (23/24); and NPV, 14.3% (1/7) vs. 0% (0/1).

Conclusions: The TSCI improved the sensitivity, NPV, and accuracy of target sample confirmation for pancreatic mass EUS-FNB. Although the proportion of samples not including a target region was quite low, which could strongly influence our results, the TSCI method can be used in EUS-FNB when rapid on-site evaluation cannot be performed. (A multicenter prospective study for the utility of a target sample check illuminator, Clinical Trial ID: UMIN000023349).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/den.13903DOI Listing
September 2021

Frequentist performances of Bayesian prediction intervals for random-effects meta-analysis.

Biom J 2021 02 9;63(2):394-405. Epub 2020 Nov 9.

Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.

The prediction interval has been increasingly used in meta-analyses as a useful measure for assessing the magnitude of treatment effect and between-studies heterogeneity. In calculations of the prediction interval, although the Higgins-Thompson-Spiegelhalter method is used most often in practice, it might not have adequate coverage probability for the true treatment effect of a future study under realistic situations. An effective alternative candidate is the Bayesian prediction interval, which has also been widely used in general prediction problems. However, these prediction intervals are constructed based on the Bayesian philosophy, and their frequentist validities are only justified by large-sample approximations even if noninformative priors are adopted. There has been no certain evidence that evaluated their frequentist performances under realistic situations of meta-analyses. In this study, we conducted extensive simulation studies to assess the frequentist coverage performances of Bayesian prediction intervals with 11 noninformative prior distributions under general meta-analysis settings. Through these simulation studies, we found that frequentist coverage performances strongly depended on what prior distributions were adopted. In addition, when the number of studies was smaller than 10, there were no prior distributions that retained accurate frequentist coverage properties. We also illustrated these methods via applications to two real meta-analysis datasets. The resultant prediction intervals also differed according to the adopted prior distributions. Inaccurate prediction intervals may provide invalid evidence and misleading conclusions. Thus, if frequentist accuracy is required, Bayesian prediction intervals should be used cautiously in practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/bimj.201900351DOI Listing
February 2021

Clinicopathological features of polypoid basal cell carcinoma: the first study in Japan.

Eur J Dermatol 2020 Aug;30(4):433-435

Division of Dermatology, Department of Medicine of Sensory and Motor Organs, Tottori University, Faculty of Medicine, YonagoJapan.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1684/ejd.2020.3806DOI Listing
August 2020

Outlier detection and influence diagnostics in network meta-analysis.

Res Synth Methods 2020 Nov 1;11(6):891-902. Epub 2020 Oct 1.

Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.

Network meta-analysis has been gaining prominence as an evidence synthesis method that enables the comprehensive synthesis and simultaneous comparison of multiple treatments. In many network meta-analyses, some of the constituent studies may have markedly different characteristics from the others, and may be influential enough to change the overall results. The inclusion of these "outlying" studies might lead to biases, yielding misleading results. In this article, we propose effective methods for detecting outlying and influential studies in a frequentist framework. In particular, we propose suitable influence measures for network meta-analysis models that involve missing outcomes and adjust the degree of freedoms appropriately. We propose three influential measures by a leave-one-trial-out cross-validation scheme: (1) comparison-specific studentized residual, (2) relative change measure for covariance matrix of the comparative effectiveness parameters, (3) relative change measure for heterogeneity covariance matrix. We also propose (4) a model-based approach using a likelihood ratio statistic by a mean-shifted outlier detection model. We illustrate the effectiveness of the proposed methods via applications to a network meta-analysis of antihypertensive drugs. Using the four proposed methods, we could detect three potential influential trials involving an obvious outlier that was retracted because of data falsifications. We also demonstrate that the overall results of comparative efficacy estimates and the ranking of drugs were altered by omitting these three influential studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/jrsm.1455DOI Listing
November 2020

Discussion on "Testing small study effects in multivariate meta-analysis" by Chuan Hong, Georgia Salanti, Sally Morton, Richard Riley, Haitao Chu, Stephen E. Kimmel, and Yong Chen.

Authors:
Hisashi Noma

Biometrics 2020 12 29;76(4):1255-1259. Epub 2020 Aug 29.

Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/biom.13343DOI Listing
December 2020

Melancholic features (DSM-IV) predict but do not moderate response to antidepressants in major depression: an individual participant data meta-analysis of 1219 patients.

Eur Arch Psychiatry Clin Neurosci 2021 Apr 26;271(3):521-526. Epub 2020 Jul 26.

Department of Health Promotion and Human Behavior, Graduate School of Medicine/School of Public Health, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.

It is sometimes clinically believed that major depression with melancholic features is more responsive to antidepressants than non-melancholic depression. Proper analysis and, therefore, valid evidence to support or refute this common clinical lore is lacking. The sample was taken from three placebo-controlled randomized trials of duloxetine, escitalopram and paroxetine (n = 1219). We conducted a two-step individual participant data meta-analysis to combine linear mixed-effects regressions modeling melancholic features as prognostic factor (variable that predicts overall response regardless of the treatments) and as effect modifier (variable that predict differential response to drug over placebo). Melancholic features represented a statistically significant prognostic factor for greater reduction in depression severity both on antidepressants and on placebo, especially after 4 weeks of treatment. However, they were not an effect modifier of the antidepressant treatment through the acute phase treatment: in other words. The superiority of antidepressants over placebo was not influenced by the melancholic features. The treatment decision-making as to the benefits of antidepressant treatment for patients with major depression should not be influenced by the presence or absence of melancholic features.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00406-020-01173-4DOI Listing
April 2021

Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial.

Prev Sci 2020 11;21(8):1028-1036

Department of Obstetrics, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.

This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02-0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27-1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s11121-020-01145-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7569084PMC
November 2020

Prevalence and clinical characteristics of children with medical complexity in Tottori Prefecture, Japan: A population-based longitudinal study.

Brain Dev 2020 Nov 1;42(10):747-755. Epub 2020 Jul 1.

Division of Child Neurology, Department of Brain and Neurosciences, Faculty of Medicine, Tottori University, Yonago, Japan.

Objectives: To investigate the prevalence and background of children with medical complexity (CMC) and its secular trend in Japan.

Methods: CMC were defined as patients under the age of 20 years requiring medical care and devices. The patients were enrolled using the national health insurance claims data of three hospitals and two rehabilitation centers in Tottori Prefecture. The study period was divided into three periods: Period 1, 2007-2010; Period 2, 2011-2014; and Period 3, 2015-2018.

Results: A total of 378 CMC were enrolled. The prevalence of CMC was 1.88 per 1000 population among subjects aged <20 years in 2018, and it increased by approximately 1.9 times during the study period. The number of CMC who presented with severe motor and intellectual disabilities did not change from Period 1 to Period 3. Meanwhile, the number of CMC who had relatively preserved motor and intellectual abilities increased from 58 to 98. The proportion of CMC who required respiratory management and oxygen therapy increased by 1.3 and 1.8 times, respectively. By contrast, the proportion of CMC who need tube feeding decreased significantly between periods 1 and 3 (P < 0.05).

Conclusions: The prevalence of CMC increased almost twice during the 12-year study period; however, the increase in the number of patients with relatively preserved motor and intellectual abilities was pronounced. This study showed that the need for medical care and devices differed based on the underlying disorders and severity of CMC; therefore, individualized medical, welfare, and administrative services and education about the various types of CMC must be provided.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.braindev.2020.06.008DOI Listing
November 2020

Short-term effectiveness of biologics in patients with moderate-to-severe plaque psoriasis: A systematic review and network meta-analysis.

J Dermatol Sci 2020 Jul 18;99(1):53-61. Epub 2020 Jun 18.

Medical Affairs, Kyowa Kirin Co., Ltd., Tokyo, Japan.

Background: Complete lesion clearance is important to patients with psoriasis.

Objective: To conduct a network meta-analysis of randomized controlled trials of biologic agents available for psoriasis in Japan, using mixed-treatment comparisons.

Methods: MEDLINE and EMBASE were searched to identify randomized clinical trials (placebo-controlled or head-to-head) of infliximab, adalimumab, ustekinumab, secukinumab, ixekizumab, brodalumab, risankizumab or guselkumab in adult patients with moderate-to-severe plaque psoriasis published in English between 01 January 2000 and 31 August 2019. We assessed the proportion of patients who achieved a 100 %, 90 % and 75 % reduction in their Psoriasis Area and Severity Index (PASI) score (PASI100, PASI90 and PASI75) at 10, 12 or 16 weeks after starting biologic treatment, using contrast-based network meta-analysis methods and risk difference (RD). Probabilities of rank and surface under the cumulative ranking (SUCRA) were also estimated.

Results: Data were pooled from 41 trials in 19,248 patients. All biologics were significantly more effective than placebo for PASI100, PASI90 and PASI75. The RD for PASI100 for brodalumab vs ixekizumab was 0.05 (95 % Confidence intervals [CI] -0.02, 0.11), brodalumab vs risankizumab was 0.04 (95 %CI -0.03, 0.11), and risankizumab vs ixekizumab was -0.01 (95 %CI -0.08, 0.06). The SUCRA for PASI100 and PASI90 achievement was 96.8 % and 86.8 %, respectively, for brodalumab, 82.6 % and 90.3 %, respectively for risankizumab, and 78.3 %, 80.9 %, respectively, for ixekizumab.

Conclusion: Of the biologics assessed, brodalumab, ixekizumab and risankizumab were the greatest rates of PASI90 and PASI100 achievement, and a higher probability of being most effective in the induction phase, compared with the other biologics.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jdermsci.2020.06.003DOI Listing
July 2020
-->