How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance.

BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.

Comparison of four value sets derived using different TTO and DCE approaches: application to the new region-specific PBM, AP-7D.

BACKGROUND: AP-7D is a newly developed preference-based measure (PBM) in East and Southeast Asia. However, no value set has been established yet. Comparison of the characteristics of value sets obtained by different methods is necessary to consider the most appropriate methodology for valuation survey of AP-7D. METHOD: We surveyed the general population's preference of AP-7D health states by four valuation methods (a) composite time trade-off (cTTO); (b) simple discrete choice experiment (DCE); (c) DCE with duration; and (d) ternary DCE. In Japan, we collected approximately 1,000 samples for cTTO tasks through a face-to-face survey and 2,500 samples for each of the three DCE tasks. Respondents were selected through quota sampling based on the sex and age. The cTTO data were analyzed using a linear mixed and tobit model; the DCE data were analyzed using a simple and panel conditional logit model. Where the results of the analysis showed inconsistencies, a constrained model was used. RESULTS: Since all the unconstrained models, except simple DCE, showed one or more inconsistencies, the constrained model was used for the analyses. The minimum values for the models were as follows: TTO model, -0.101; simple DCE model, -0.106; DCE with duration model, -0.706; ternary DCE model, -0.306. The score for the DCE with the duration model was much lower than that for the other models. Although the value sets for AP-7D differed among the four valuation methods, the ternary DCE model showed intermediate characteristics between those of the cTTO and DCE with duration models. As compared with to EQ-5D-5L, the distributions of all the scores on the Japanese AP-7D moved to the left. Although "Energy" was one of the domains with the least influence on the AP-7D score in all four models, "Burden to others" had the largest impact on the preferences. CONCLUSION: We constructed four value sets using different TTO and DCE methods. Our findings are expected not only to contribute to the development of AP-7D, but also other preference-based measures.

Real-world experience with calcitonin gene-related peptide-targeted antibodies for migraine prevention: a retrospective observational cohort study at two Japanese headache centers.

BACKGROUND: Although randomized controlled trials (RCTs) have shown that calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (CGRP mAbs) are an efficacious and safe therapeutic modality for migraine prevention, their clinical benefits have not been well validated in Japanese patients in the real-world setting. The present study aimed to evaluate the real-world efficacy and safety of galcanezumab, fremanezumab, and erenumab in Japanese patients with migraine. METHODS: This observational retrospective cohort study was conducted at two headache centers in Japan. Patients with migraine who had experienced treatment failure with at least one traditional oral migraine preventive agent were treated with a CGRP mAb de novo. The primary efficacy endpoints were the changes from baseline in monthly migraine days (MMDs) and Headache Impact Test-6 (HIT-6) score after 3 dosing intervals (V3). We explored whether demographic and clinical characteristics predicted therapeutic outcomes at V3. RESULTS: Sixty-eight patients who completed three doses of a CGRP mAb (85.3% female [58/68], mean age: 46.2 ± 13.1 years) were included in the analysis. There were 19 patients with chronic migraine. The baseline MMDs were 13.4 ± 6.0. After 3 doses, the MMDs significantly decreased to 7.4 ± 5.5 (p < 0.0001), and the 50% response rate was 50.0%. HIT-6 score was significantly reduced from 66.7 ± 5.4 to 56.2 ± 8.7 after 3 doses (P = 0.0001). There was a positive correlation between the changes in MMDs and HIT-6 score from baseline after 2 doses (p = 0.0189). Those who achieved a ≥ 50% therapeutic response after the first and second doses were significantly more likely to do so at V3 (crude odds ratio: 3.474 [95% CI: 1.037 to 10.4], p = 0.0467). The most frequent adverse event was constipation (7.4%). None of the adverse events were serious, and there was no need for treatment discontinuation. CONCLUSIONS: This real-world study demonstrated that CGRP mAbs conferred Japanese patients with efficacious and safe migraine prevention, and an initial positive therapeutic response was predictive of subsequent favorable outcomes. Concomitant measurement of MMDs and HIT-6 score was useful in evaluating the efficacy of CGRP mAbs in migraine prevention.

Reliability and validity of the Japanese version of the Chemotherapy-induced Alopecia Distress Scale.

BACKGROUND: The Chemotherapy-induced Alopecia Distress Scale (CADS) is a patient-reported outcome measure for assessing distress associated with Chemotherapy-induced alopecia (CIA). This study aimed to confirm the psychometric validity of the Japanese version of the CADS (CADS-J). METHODS: A total of 132 patients with breast cancer who developed CIA were asked to complete the CADS-J twice at 2 week intervals to confirm test-retest reliability. The body image domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) breast cancer-specific module, the self-esteem scale from the Rosenberg Self-Esteem Scale, and the emotional domain of the EORTC QLQ Core 30 were used to confirm the convergent validity of the CADS-J. The overall quality of life and physical domains of the EORTC QLQ Core 30 were used to confirm the discriminant validity of the CADS-J. RESULTS: In total, 125 participants provided valid responses. The mean age was 52.2 years. The overall Cronbach's alpha for the CADS-J was 0.903. The intraclass correlation coefficients of the first and second responses were r = 0.874, r = 0.952, r = 0.911, and r = 0.959 for the physical domain, emotional domain, activity domain, and relationship domain, respectively. In terms of convergent validity, the total CADS-J score was moderately correlated with body image (r = - 0.63), self-esteem (r = - 0.48), and the emotional domain (r = - 0.61). Regarding discriminant validity, the total CADS-J score was weakly correlated with the overall quality of life (r = - 0.34) and physical domain (r = - 0.24). CONCLUSIONS: The CADS-J is psychometrically reliable and valid for evaluating the distress caused by CIA. It is expected to be used in daily practice and as an endpoint in various studies.

Differentiation of Active Ulcerative Colitis vs Noninflammatory Bowel Disease Proctitis by Transperineal Superb Microvascular Imaging.

BACKGROUND: Transabdominal ultrasonography and transperineal ultrasonography (TPUS) appear correspond to colonoscopy (CS) for evaluating ulcerative colitis (UC) activity, but their utility in UC diagnosis remains unclear. This research compared the accuracy of TPUS and CS for assessing rectal activity and differentiating noninflammatory bowel disease proctitis from UC in pediatric cases. METHODS: The study is a blinded, prospective, and controlled trial. Prospectively, values of fecal calprotectin (FCP) and findings of the TPUS and CS were compared between child cases of UC and non-IBD proctitis. Findings of rectal wall thickening (RWT), rectal wall flow (RWF) on power Doppler, and microvascular signal at wall circumference (MSWC) on monochrome superb microvascular imaging assessed using TPUS were compared with the CS. RESULTS: Thirty patients with Mayo endoscopic subscore (MES) 0 to 1 UC, 57 with MES 2 to 3 UC, and 44 with proctitis were registered. Fecal calprotectin, RWF, and MSWC indicated significant differences among the groups (P < .05). Rectal wall thickening showed no significant difference between MES 0-1 and proctitis (P = .76). Rectal wall thickening and MSWC were independent predictors of endoscopic activity of UC, resulting in a sensitivity and specificity of 100% for RWT ≥4.5 mm and positive MSWC. Fecal calprotectin and RWF were independent predictors for differentiating MES 0 to 1 and proctitis, and FCP and RWT were independent predictors for differentiating MES 2 to 3 and proctitis. Sensitivity and specificity were 77.2% and 80.9%, respectively, for FCP >242.5 µg/g and RWF negative; and they were both 100% for RWT >4.1 mm and MSWC positive. CONCLUSIONS: Transperineal ultrasonography with mSMI may enable the evaluation of rectal activity and differentiation of UC from non-IBD proctitis with accuracy comparable to endoscopy.

Transperineal ultrasonography with superb microvascular imaging can differentiate ulcerative colitis from noninflammatory bowel disease proctitis and is therefore useful in distinguishing whether diarrhea and bloody stool during the treatments of ulcerative colitis are due to recurrence or infection.

Development of a Model for Quantitative Assessment of Newborn Screening in Japan Using the Analytic Hierarchy Process.

Whether or not conditions should be included in publicly funded newborn screening (NBS) programs should be discussed according to objective and transparent criteria. Certain criteria have been developed for the introduction of NBS programs in the context of individual countries; however, there are no standard selection criteria for NBS programs in Japan. This study aimed to develop a quantitative scoring model to assess newborn screening that incorporates the views of a variety of stakeholders in Japan. The five recommended eligibility criteria for NBS were stratified based on previous studies and expert opinions, using the analytic hierarchy process. We conducted a cross-sectional, web-based questionnaire targeting a wide range of people involved in NBS to investigate pairwise comparisons of the evaluation items between February and April of 2022. There were 143 respondents. Most of our respondents (44.1%) were physicians. Fifty-eight respondents (40.6%) had been engaged in NBS-related research or work for more than 10 years. The distribution of allocation points was the highest for 'intervention', 'screening test', 'follow-up setting', 'economic evaluation', and 'disease/condition', in that order. The algorithm in this study will guide decision makers in collecting and evaluating objective data, thus enabling transparent discussions to occur.

Age at surgery and native liver survival in biliary atresia: a systematic review and meta-analysis.

Biliary atresia (BA) is a childhood rare disease of the liver and bile ducts that requires prompt surgical intervention. Age at surgery is an important prognostic factor; however, controversy exists with regard to the benefit of early Kasai procedure (KP). We aimed to conduct a systematic review and meta-analysis to examine the relationship between the age at KP and native liver survival (NLS) of BA patients. We performed the electronic database search using Pubmed, EMBASE, Cochrane, and Ichushi Web and included all relevant studies published from 1968 up to May 3, 2022. Studies that examined the timing of KP at ages 30, 45, 60, 75, 90, 120, and/or 150 days were included. The outcome measures of interest were NLS rates at 5, 10, 15, 20, and 30 years post-KP and the hazard ratio or risk ratio for NLS. The quality assessment was used using the ROBINS-I tool. Among 1653 potentially eligible studies, nine articles met the inclusion criteria for the meta-analysis. Meta-analysis for hazard ratios revealed that there was a significantly faster time to liver transplantation in the group of patients who had KP at later timing as compared with earlier KP (HR = 2.12, 95% CI 1.51-2.97). The risk ratio comparing KP ≤ 30 days and KP ≥ 31 days on native liver survival was 1.22 (95% CI 1.13-1.31). The sensitivity analysis showed that comparing KP ≤ 30 days and KP 31-60 days, the risk ratio was 1.13, 95% CI 1.04-1.22.  Conclusion: Our meta-analysis showed the importance of early diagnosis and surgical interventions ideally before 30 days of life in infants with BA on native liver survival on 5, 10, and 20 years. Therefore, effective newborn screening of BA targeting KP ≤ 30 days is needed to ensure prompt diagnosis of affected infants. What is Known: • Age at surgery is an important prognostic factor. What is New: • Our study performed an updated systematic review and meta-analysis to examine the relationship between age at Kasai procedure and native liver survival in patients with BA.

Accuracy of Transperineal Ultrasonography for Assessing Rectal Lesions in Paediatric Ulcerative Colitis: A Prospective Study.

BACKGROUND AND AIMS: Transabdominal ultrasonography [TAUS] appears comparable to colonoscopy for evaluating ulcerative colitis [UC] activity, but it has low accuracy in rectal evaluation. In this study, the accuracy of transperineal ultrasonography [TPUS] for evaluating rectal activity was compared to that of colonoscopy in paediatric UC cases. METHODS: Faecal calprotectin [FCP] values and TPUS and colonoscopic findings were compared prospectively in paediatric UC cases. Rectal wall thickening [RWT] and rectal wall flow [RWF] on power Doppler evaluated by TPUS were compared with the colonoscopy findings and were also measured on TAUS and assessed for the concordance rate of each finding. RESULTS: Thirty Mayo endoscopic sub-score [MES] 0-1 UC cases and 57 MES 2-3 UC cases were enrolled. FCP, RWT and RWF showed significant differences between the two groups [p < 0.05]. RWT and RWF were independent predictors of UC endoscopic activity, showing sensitivity of 95.8% and specificity of 100% with RWT ≥ 4.5 mm and positive RWF. The concordance rates between TPUS and TAUS findings in MES 2-3 were moderate to fair, whereas those in MES 0-1 were fair to poor. The concordance rates between ultrasonic examiners were good for both TAUS and TPUS. CONCLUSIONS: TPUS may evaluate rectal activity of UC with accuracy comparable to endoscopy. If accurate ultrasonic screening for the total colon can be performed by TPUS and TAUS, repeated evaluation of short-term treatment response may be possible.

Cost-Effectiveness Analysis of Universal Screening for Biliary Atresia in Japan.

OBJECTIVE: To evaluate the cost-effectiveness of universal newborn screening using stool color card or direct bilirubin (DB) testing when comparing with no screening for biliary atresia in Japanese setting. STUDY DESIGN: A decision analytic Markov microsimulation model was developed to evaluate the universal screening for biliary atresia. Our screening strategies included stool color card, DB, or no screening. The outcomes of all newborns undergoing 3 strategies were simulated to analyze event-free life-years defined as liver transplant-free survival, costs, and incremental cost-effectiveness ratio (ICER) over a 25-year period with an annual discount rate of 2% applied for both costs and outcomes. A 1-way sensitivity analysis was performed to assess the uncertainty. RESULTS: There were 941 000 newborn infants in our cohort and 114 cases of biliary atresia. The base case analysis showed that the stool color card strategy was $14 927 337 higher than no screening with an increase in 44 more event-free life-years gained, resulting in an ICER of $339 258 per event-free life-year gained. The DB screening strategy compared with stool color card was $138 994 060 higher with an increase in 271 more event-free life-years gained and an ICER of $512 893 per event-free life-year gained. The DB screening strategy compared with no screening resulted in an ICER of $488 639 per event-free life-year gained. The DB screening resulted in 16 fewer liver transplants than stool color card and stool color card had 2 fewer liver transplants than no screening. CONCLUSIONS: Universal screening for biliary atresia could be cost-effective depending on the willingness to pay thresholds for health benefits.

Strategies for cost-effectiveness analysis of rehabilitation for older patients with acute heart failure.

The prevalence of heart failure (HF) is increasing in the ageing world population, and its burden on the medical and health economic fields is enormous. Rehabilitation is an essential component of the nonpharmacological treatment of patients with HF; however, its efficacy and cost-effectiveness for patients with acute HF remain unclear. A trial assessed the cost-effectiveness of acute cardiac rehabilitation among older adults. Herein, we discussed strategies for the cost-effectiveness analysis of acute cardiac rehabilitation using the rehabilitation therapy in older acute heart failure patients trial.

Association of Oral Function and Dysphagia with Frailty and Sarcopenia in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis.

Studies investigating the associations of oral function and dysphagia with frailty and sarcopenia in community-dwelling older adults are increasing; however, they have not been systematically summarized. We conducted a systematic review to investigate these associations. We searched electronic databases and synthesized relevant data using conventional (frequentist-style) and Bayesian meta-analyses. Twenty-four studies were found to be eligible for our review, including 20 cross-sectional and four prospective cohort studies. Older adults with frailty or sarcopenia had lower tongue pressure, according to the results of conventional meta-analysis (mean difference [95% confidence interval or credible interval]: -6.80 kPa [-10.22 to -3.38] for frailty and -5.40 kPa [-6.62 to -4.17] for sarcopenia) and Bayesian meta-analysis (-6.90 kPa [-9.0 to -4.8] for frailty, -5.35 kPa [-6.78 to -3.89] for sarcopenia). People with frailty had a higher odds ratio (OR) for dysphagia according to the results of conventional meta-analysis (3.99 [2.17 to 7.32]) and Bayesian meta-analysis (1.38 [0.77 to 1.98]). However, the results were inconclusive for people with sarcopenia. A prospective association could not be determined because of the lack of information and the limited number of studies. Decreased oral function and dysphagia can be important characteristics of frailty and sarcopenia in community-dwelling older adults.

Direct health care cost of treatment and medication of biliary atresia patients using the National Database of Health Insurance Claims and Specific Health Checkups.

BACKGROUND: Treatment of biliary atresia (BA), which typically requires an initial surgical intervention called the Kasai procedure (KP) and possible liver transplant (LT) afterwards, is quite resource-intensive and would affect patients and families for a lifetime; yet a comprehensive view of the economic burden has not been reported. We estimated direct health care costs from the public payer perspective using the National Database of Health Insurance Claims and Specific Health Checkups of Japan. METHODS: Children newly diagnosed at ages 0 days to 4 years between April 2010 and September 2019 were identified. Costs of treatment were estimated for six phases of care: prediagnosis, KP and inpatient hospitalization, follow-up after KP, pre-transplant checkup, LT and inpatient hospitalization, and follow-up after LT. RESULTS: Mean total prediagnosis medical cost was $6847 (USD) and KP and inpatient hospitalization was $42,157 per year. Follow-up after KP was $15,499, and pre-transplant checkup after KP was $36,015 per year. Mean cost for LT and inpatient hospitalization was $105,334, and follow-up after liver transplant was $25,459 per year. CONCLUSIONS: Treatment of BA requires extensive medical resource consumption. The use of the comprehensive national database allowed us to estimate the costs which will be useful for health service planning and cost-effectiveness analysis.

Utility of magnetic resonance imaging for differentiating malignant mesenchymal tumors of the uterus from T2-weighted hyperintense leiomyomas.

PURPOSE: To generate a new discrimination method to distinguish between malignant mesenchymal tumors of the uterus and T2-weighted hyperintense leiomyoma based on magnetic resonance imaging findings and clinical features. MATERIALS AND METHODS: Data from 32 tumors of 32 patients with malignant mesenchymal tumors of the uterus and from 34 tumors of 30 patients with T2-weighted hyperintense leiomyoma were analyzed. Clinical parameters, qualitative magnetic resonance imaging features, including computed diffusion-weighted imaging, and quantitative characteristics of magnetic resonance imaging of these two tumor types were compared. Predictive values for malignant mesenchymal tumors of the uterus were calculated using variant discriminant analysis. RESULTS: The T1 bright area on qualitative assessment and mean apparent diffusion coefficient value on quantitative assessment yielded the most independent magnetic resonance imaging differentiators of malignant mesenchymal tumors of the uterus and T2-weighted hyperintense leiomyoma. The classification accuracy of the variant discriminant analysis based on three selected findings, i.e., a T1 bright area, computed diffusion-weighted imaging with a b-value of 2000s/mm2 (cDWI2000), and T2-hypointense bands, was 84.8% (56/66), indicating high accuracy. CONCLUSIONS: Variant discriminant analysis using the T1 bright area, cDWI2000, and T2-hypointense bands yielded high accuracy for differentiating between malignant mesenchymal tumors of the uterus and T2-weighted hyperintense leiomyoma.

A Machine Learning-Based Screening Test for Sarcopenic Dysphagia Using Image Recognition.

BACKGROUND: Sarcopenic dysphagia, a swallowing disorder caused by sarcopenia, is prevalent in older patients and can cause malnutrition and aspiration pneumonia. This study aimed to develop a simple screening test using image recognition with a low risk of droplet transmission for sarcopenic dysphagia. METHODS: Older patients admitted to a post-acute care hospital were enrolled in this cross-sectional study. As a main variable for the development of a screening test, we photographed the anterior neck to analyze the image features of sarcopenic dysphagia. The studied image features included the pixel values and the number of feature points. We constructed screening models using the image features, age, sex, and body mass index. The prediction performance of each model was investigated. RESULTS: A total of 308 patients participated, including 175 (56.82%) patients without dysphagia and 133 (43.18%) with sarcopenic dysphagia. The area under the receiver operating characteristic curve (ROC-AUC), sensitivity, specificity, positive predictive value, negative predictive value, and area under the precision-recall curve (PR-AUC) values of the best model were 0.877, 87.50%, 76.67%, 66.67%, 92.00%, and 0.838, respectively. The model with image features alone showed an ROC-AUC of 0.814 and PR-AUC of 0.726. CONCLUSIONS: The screening test for sarcopenic dysphagia using image recognition of neck appearance had high prediction performance.

A Cost Projection of Scheduled Physician Home-Visit Services in Japan: 2014 to 2064.

This study predicts the volume and spending on scheduled physician home-visit (SPHV) services over five decades. This model-based evaluation study considered the following scenarios in Japan: (1) change in services-delivery; (2) technology-assisted services; (3) a combination of (1) and (2). The model predicted that the volume and spending on SPHV will increase as the population and working-age population decline. Scenario analysis indicated that a combined strategy could reduce the relative rate of spending to less than 2.00 in 2064, indicating that home health-care service reforms through changes in services-delivery and cost-reduction through technology-assisted services are promising in countries facing aging population.

Association of tetralogy of Fallot with multiple variations of the cerebral arteries diagnosed by magnetic resonance angiography.

Tetralogy of Fallot very rarely manifests with variations of the cerebral arteries, but we detected an extremely rare combination comprising 3 such variants -bilateral carotid-anterior cerebral arteries anastomoses, the vertebral-anterior inferior cerebellar arteries anastomosis (proximal basilar artery duplication) and a nonbifurcating cervical carotid artery- in a 19-year-old man during magnetic resonance angiography to evaluate syncope. Recognition and correct diagnosis of these variations are crucial prior to surgical or radiological cerebrovascular intervention. Both partial maximum-intensity-projection images and source images are useful in identifying these vessels on MR angiography.

Direct and indirect costs of home healthcare in Japan: A cross-sectional study.

To tackle the rising healthcare expenditure in an ageing society in Japan, home healthcare has been promoted over the past several years. However, there is a dearth of literature on total costs incurring for home healthcare. In this study, we conducted a cross-sectional study among patients, who received home healthcare in the month of May, 2018. Direct healthcare costs and patients' clinical characteristics were collected from medical records and long-term care databases (n = 166). Indirect costs were estimated using a questionnaire survey which obtained information on job absenteeism and care time from the caregiver. A total of 112 patients responded to the survey. The median age was 82 years (interquartile range: 74-88). Total per-person per month home-care costs averaged USD 6,163 with direct costs (USD 2,547) and indirect costs (USD 3,596) accounted for 41.3% and 58.3% of the total costs, respectively. The largest components of direct costs were long-term care costs (48%) and medical costs (47%). Multivariable adjusted model showed that those with heavy healthcare were more likely to incur higher total as well as direct and indirect home healthcare cost (p<.05 for each). Patients aged >75 years (p = .041) were less likely and those who used oxygen at home were more likely to incur direct home healthcare cost (p = .001) than their counterpart. Our study findings show that indirect cost is a major contributor to total home healthcare costs in Japan. Also for patients who need heavy healthcare, both direct and indirect costs are large burden.

Enhanced outcomes for coronary artery disease obtained by a multidisciplinary heart team approach.

BACKGROUND: We implemented our multidisciplinary heart team (MHT) approach since 2012 for patients with coronary artery disease (CAD) and assessed the effectiveness of it by comparing outcomes in patients treated before and after the introduction of the MHT approach. METHODS: Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for CAD were performed in 802 and 57 patients from 2009 to 2011 in Group NH, and were performed in 867 and 160 patients from 2012 to 2014 in Group H, respectively. The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stroke, cardiac-related readmission and target vessel repeat revascularisation (TVR) for PCI or revascularisation on grafted vessels for CABG. RESULTS: MACCE occurred significantly more often in Group NH than in Group H at 3 years postoperatively (28.1% vs 21.1%) (log rank P = 0.001). Cox regression analysis showed that the MHT approach [hazard ratio (HR), 0.737; 95% confidence interval (CI), 0.60-0.91; P = 0.004] and ejection fraction (HR 0.976; 95% CI, 0.97-0.98; P < 0.0001) were associated with significantly lower rates of MACCE events, while SYNTAX score (HR 1.023; 95% CI 1.00-1.03, P < 0.0001) and EuroSCORE II (HR 1.014, 95% CI 0.60-0.91, P = 0.004) were associated with a higher rate of MACCE events. CONCLUSION: Our MHT approach was able to reduce the MACCE events of treatment for CAD. The dedicated MHT approach might be beneficial for patients with CAD.

Variation in somatic symptoms by patient health questionnaire-9 depression scores in a representative Japanese sample.

BACKGROUND: This study aims to evaluate variation in somatic symptoms by age using patient health questionnaire-9 (PHQ) depression scores, which may be helpful in identifying depression. METHODS: The study evaluated a nationally representative cross-sectional sample of community-dwelling adults in Japan in 2013. We utilized the PHQ to identify risk for depression, with PHQ ≥ 10 defining at least moderate depression. Bivariate and factor analyses were used to capture underlying patterns in self-reported symptoms over a 30 day period; aged-stratified multivariate logistic regression was performed to further explore associations between age, symptoms, and depression. RESULTS: Of 3753 respondents, 296 (8, 95% CI 7.0-8.8) reported a PHQ ≥ 10; 42% of these were male and mean age was 51.7 years old (SD = 18.6). Multivariate analysis showed that presence of fatigue and malaise (OR = 1.7, 95% CI 1.3-2.4) was significantly associated with PHQ ≥ 10. After stratification by age, PHQ ≥ 10 was associated with gastrointestinal complaints among 18-39 year olds (OR = 1.7, 95% CI 1.0-2.9); fatigue and malaise (OR = 1.8, 95% CI 1.1-3.1) among 40-64 year olds; and fatigue and malaise (OR = 1.8, 95% CI 1.1-3.0) as well as extremity pain (OR = 1.7, 95% CI 1.0-2.8) in over 65 year olds. CONCLUSION: Age-related somatic symptom correlates of PHQ ≥ 10 differ across the lifespan. Predominantly gastrointestinal symptoms in younger patients, and generalized fatigue, malaise, and musculoskeletal pain in older groups were observed. In order for screening physicians to proactively identify depression, awareness of age-related somatic symptoms is warranted.