The Japanese Society for Surgery of the Foot (JSSF) is developing a QOL questionnaire instrument for use in pathological conditions related to the foot and ankle. The main body of the outcome ...instrument (the Self-Administered Foot Evaluation Questionnaire, SAFE-Q version 2) consists of 34 questionnaire items, which provide five subscale scores (1: Pain and Pain-Related; 2: Physical Functioning and Daily Living; 3: Social Functioning; 4: Shoe-Related; and 5: General Health and Well-Being). In addition, the instrument has nine optional questionnaire items that provide a Sports Activity subscale score. The purpose of this study was to evaluate the test-retest reliability of the SAFE-Q.
Version 2 of the SAFE-Q was administered to 876 patients and 491 non-patients, and the test-retest reliability was evaluated for 131 patients. In addition, the SF-36 questionnaire and the JSSF Scale scoring form were administered to all of the participants. Subscale scores were scaled such that the final sum of scores ranged between zero (least healthy) to 100 (healthiest).
The intraclass correlation coefficients were larger than 0.7 for all of the scores. The means of the five subscale scores were between 60 and 75. The five subscales easily separated patients from non-patients. The coefficients for the correlations of the subscale scores with the scores on the JSSF Scale and the SF-36 subscales were all highly statistically significantly greater than zero (p<0.001). The means for the five JSSF Scale classification groups fell within a relatively narrow range, indicating that the SAFE-Q labels are sufficiently similar to permit their use for all of the JSSF Scale classifications.
The present study revealed that the test-retest reliability is high for each subscale. Consequently, the SAFE-Q is valid and reliable. In the future, it will be beneficial to test the responsiveness of the SAFE-Q.
OBJECTIVE: Urinary liver-type fatty acid-binding protein (L-FABP) is a promising indicator of tubular but not glomerular damage. The aim of this study was to evaluate the clinical usefulness of ...urinary L-FABP as a prognostic biomarker in impaired diabetic nephropathy in type 2 diabetes. RESEARCH DESIGN AND METHODS: This investigation involved a cross-sectional and longitudinal analysis of the relationship between urinary L-FABP levels and progressive nephropathy. Urinary L-FABP was measured with enzyme-linked immunosorbent assay. In the cross-sectional analysis, the association of urinary L-FABP, with the severity of diabetic nephropathy, was investigated in 140 patients with type 2 diabetes and in 412 healthy control subjects. Of the patients in the former study, 104 have been followed for 4 years. The progression of diabetic nephropathy was defined as progressive albuminuria, end-stage renal disease, or induction of hemodialysis. RESULTS: Urinary L-FABP levels were progressively increased in subjects with normo-, micro-, or macroalbuminuria and further increased in patients with end-stage renal disease. In the longitudinal analysis, high urinary L-FABP levels were associated with the increase in albuminuria, progression to end-stage renal disease, or induction of hemodialysis. This was particularly demonstrated in the subgroup of patients without renal dysfunction (n = 59), where high urinary L-FABP levels were associated with the progression of diabetic nephropathy. CONCLUSIONS: Urinary L-FABP accurately reflected the severity of diabetic nephropathy in type 2 diabetes, and its level was high in the patients with normoalbuminuria. Moreover, higher urinary L-FABP was a risk factor for progression of diabetic nephropathy.
Introduction: Helium is known to reduce airway resistance and improve ventilatory physiology. Helium also has a high CO2 diffusion coefficient. Thus, CO2 diffusion occurs faster in a helium gas ...mixture than in air or oxygen. Helium-oxygen mixture has been used with mechanical ventilator settings such as conventional mechanical ventilation (CMV) or high-frequency oscillatory ventilation (HFOV). Although helium-oxygen mixture was shown to promote CO2 excretion in combination with either CMV or HFOV, it has not been examined which ventilatory mode is more effective in promoting CO2 excretion when used with helium-oxygen mixture. This study aimed to compare the changes of arterial partial pressure of CO2 (PaCO2) by using helium-oxygen mixture between CMV and HFOV.Methods: Six Japanese white rabbits were used, and following tracheostomy, they were connected to the ventilator. A control PaCO2 between 40 and 70 mmHg was maintained before administration of helium-oxygen mixture, and blood gas analysis was performed during and after administration of helium-oxygen mixture. The 2-way type repeated measures analysis of variance was used for comparison of PaCO2, and it was followed by post hoc tests. Simple pairwise comparisons were performed for oxygenation at each time points between under CMV and HFOV.Results: There was a statistical significance for the differences of time points (P-value＜0.000001) as well as for the interaction term (P-value＜0.001). According to the post hoc tests, under HFOV, PaCO2 during administration of helium-oxygen mixture was significantly lower compared to both before and after administration. In intergroup comparison, PaCO2 during helium-oxygen inhalation under HFOV was significantly lower than that under CMV. Arterial partial pressure of oxygen/fraction of inspiratory oxygen ratio during administration under HFOV was significantly higher than that under CMV.Conclusions: This study demonstrated that ventilatory management of healthy lung rabbits with helium-oxygen mixture results in more efficient ventilation and better oxygenation with piston-driven HFOV than with CMV.
Purpose: It is not clear whether women with non-small-cell lung cancer (NSCLC) live significantly longer than men. Thus, we conducted a meta-analysis of published studies to quantitatively compare ...NSCLC survival data between genders. Materials and Methods: A MEDLINE Web search for computer-archived bibliographic data regarding overall survival differences between genders was performed. DerSimonian-Laird random effects analysis was used to estimate the pooled hazard ratio (HR). Results: We selected 39 articles as appropriate data sources, involving 86 800 patients including 32 701 women and 54 099 men. Combined HRs for women vs. men in studies using univariate and multivariate analyses respectively were 0.79 (p <0.0001) and 0.78 (p <0.0001). Pooled HRs for 3 study subgroups having (1) fewer than 30% stage I cases, (2) fewer than 50% adenocarcinoma cases, and (3) statistical adjustment for smoking status all indicated the survival advantage of women. Conclusion: This meta-analysis of published data concerning NSCLC patients indicated significantly better survival for women.
In this study, we investigated the responsiveness of the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) for patient's assessment before and after hallux valgus surgery.
Patient-reported ...answers on the SAFE-Q and Short Form-36 (SF-36) before and at a mean of 3-4 and 9-12 months after hallux valgus surgery were analyzed. Data of 100 patients (92 women, eight men) from 36 institutions throughout Japan were used for analysis.
In all subscales of the SAFE-Q, the trend of increased scores after surgery was statistically significant (P < 0.001). Among the patients with available scores both before and at 9-12 months after surgery (n = 66), the largest effect sizes (ESs) were observed for shoe-related (1.60), pain and pain-related (1.05), and general health and well-being (0.84) scales. In the SF-36 (n = 64), the largest ES was observed for the bodily pain scale (0.86). Less notable changes were observed for the remaining SF-36 domains.
The SAFE-Q is the first patient-reported outcome measure which includes a quality of life assessment of shoes. In our cohort, the most remarkable responsiveness was observed for the shoe-related subscale. Based on its responsiveness, the SAFE-Q appears to be sufficient for evaluation of foot-related quality of life before and after surgery.
Background
To improve outcomes in patients with chronic kidney disease (CKD), it is important to identify prognostic factors for end-stage renal disease (ESRD) as well as cardiovascular disease ...(CVD). This study assessed urinary concentrations of albumin,
N
-acetyl-β-D-glucosaminidase (NAG), and liver-type fatty acid-binding protein (L-FABP), as predictors of ESRD and CVD.
Methods
A prospective, observational, multicenter study, comprising 244 Japanese outpatients with CKD who had a follow-up period of at least 3 months. The primary endpoint was the first onset of a nonfatal or fatal CVD event and progression to ESRD, defined as myocardial infarction, stroke, or artery revascularization (coronary, carotid or peripheral), and initiation of dialysis.
Results
During a median follow-up of 3.8 years, the primary endpoint occurred in 39 (15.8 %) patients. Irrespective of diabetes, high urinary L-FABP correlated with the development of ESRD and CVD. The areas under the receiver-operator characteristic curves (AUCs) for predicting the primary endpoint for urinary concentrations of L-FABP, albumin, and NAG were 0.825, 0.797, and 0.722, respectively. Cox regression analyses, which were adjusted for factors known to influence the primary endpoint, including patient characteristics, and serum and urinary parameters, demonstrated that the primary outcome was associated with high urinary L-FABP and low eGFR
p
= 0.049, hazard ratio = 1.341 (95 % CI 1.005–1.790); and
p
< 0.000, hazard ratio = 0.953 (95 % CI 0.930–0.976), respectively.
Conclusions
Urinary L-FABP may be a useful prognostic marker of progression to ESRD and the onset of CVD in patients with CKD.
The aim of this study was to report the five scales comprising the rating system that the Japanese Society for Surgery of the Foot (JSSF) devised (JSSF standard rating system) and the newly offered ...interpretations and criteria for determinations of each assessment item.
We produced the new scales for the JSSF standard system by modifying the clinical rating systems established by the American Orthopaedic Foot and Ankle Society (AOFAS scales) and the Japanese Orthopaedic Association’s foot rating scale (JOA scale). We also provided interpretations of each assessment item and the criteria of determinations in the new standard system.
We improved the ambiguous expressions and content in the conventional standard rating systems so they would be easily understood by Japanese people. The result was five scales in total. Four were designed for use specifically for ankle-hindfoot, midfoot, hallux metatarsophalangeal- interphalangeal, and lesser metatarsophalangeal- ineterphalangeal sites; and the fifth was for the foot and ankle with rheumatoid arthritis. Furthermore, we described interpretations and criteria for determinations with regard to evaluation items in each scale.
Conventionally, the AOFAS scales or the JOA scale have been separately applied depending on the sites or disorders concerned, but it was often difficult to decide on scores during practical evaluations because of differing expressions in different languages and also because of ambiguity in the interpretation of each evaluation item and in scoring standards as well. JSSF improved these scales and added definite interpretations of evaluation items as well as criteria for the rating (to be reported here in part I). Because these steps were expected to improve the reliability of outcomes assessed by each scale, we examined the reliability in scores of the newly developed scales, which are reported in part II (in this issue).
The high use of long-term antiparkinsonian anticholinergic drugs with antipsychotics has been identified as an important issue in the treatment of schizophrenia in Japan. The aim of this study was to ...evaluate the effects of gradual discontinuation of biperiden, an anticholinergic drug, on cognitive function and quality of life (QOL) in schizophrenia.
Thirty-four schizophrenic patients who had received a second-generation antipsychotic (SGA) with concomitant biperiden for at least 3months were enrolled. Before and 4weeks after discontinuation of biperiden, the Japanese version of the Brief Assessment of Cognition in Schizophrenia (BACS-J) and the Schizophrenia Quality of Life Scale (SQLS-J) were administered. Clinical evaluation also included the Positive and Negative Syndrome Scale (PANSS). To compare the practice effect on BACS-J, 10 chronic patients with schizophrenia were assessed without tapering biperiden.
Biperiden was discontinued safely in most patients, and no emergent extrapyramidal symptoms were observed. Significant improvements were shown in attention, processing speed, and composite score, as measured by the BACS-J without practice effect. In addition, the psychosocial condition score on the SQLS-J and the general psychopathology score on the PANSS significantly improved after biperiden discontinuation.
Discontinuation of long-term biperiden use may be warranted in patients with schizophrenia treated with SGAs, as it may improve cognitive function, subjective QOL, and psychiatric symptoms with no significant adverse effects.
► The chronic use of biperiden may decrease cognitive function in schizophrenia. ► Biperiden can be discontinued by gradual dose reduction without adverse effects. ► Biperiden reduction at a rate of 1 mg/2-4weeks is a safe discontinuation strategy. ► Discontinuing biperiden use can improve attention and processing speed. ► Discontinuing biperiden use can improve subjective QOL and psychiatric symptoms.
Background
In recent papers, Ki67 labeling index (LI) has been used to classify breast cancer patients into the low and high Ki67LI groups for comparison studies, which showed significant differences ...in many prognostic factors. It has not been clarified whether image analysis software can be used for calculating LI in breast cancer. In our study, we examined whether Ki67LI in breast cancer calculated using image analysis software correlates with that measured on the basis of visual.
Methods
Fifty patients were randomly selected among breast cancer patients who underwent surgical operation from March, 2010 to May, 2010 in our hospital without preoperative chemotherapy. In this study, for the virtual slide system (VSS: VS120-L100, Olympus, Tokyo, Japan), the high-resolution VSs of all the 50 patients were prepared as samples. The image analysis software use for calculating LI was Tissuemorph Digital Pathology (Tissuemorph DP: Visiopharm, Hoersholm, Denmark). The calculated LI was extracted from 3 to 5 views containing hot spots. The LI calculated using Tissuemorph DP was designed as LI/image/T. The digital image of 3 to 5 LI/image/T views was printed out, and on the digital photograph, we counted visually the number of Ki67-immunopositive cells in exactly the same area, and the percentage of Ki67-immunopositive cells was designed as LI/direct. Moreover, a pathologist’s assistant (PA) determined the tumor area in the same specimen using VSS and calculated LI using Tissuemorph DP, which was designed as LI/image/PA. The chief pathologist (CP) similarly calculated LI which was designed as LI/image/CP. We evaluated the degree of agreement between different data sets “LI/image/T and LI/direct” and “LI/image/T, LI/image/CP, and LI/image/PA” by using interclass correlation coefficient (ICC).
Results
The average counts of cells were as follows: LI/direct, 3209.7 ± 1970.4 (SD); LI/image/T, 2601.6 ± 1697.1; LI/image/PA, 2886.5 ± 2027.5; LI/image/CP, 18805.5 ± 22293.4. The values of LI/direct and LI/image/T showed almost perfect agreement as showed by an ICC of 0.885 (95 % CI, 0.806–0.933;
p
< 0.001). The agreement among three investigators was almost perfect. The obtained ICC was 0.825 (95 % CI, 0.739–0.890;
p
< 0.001) among the data of LI/image/T, LI/image/CP and LI/image/PA. There were five cases that immunopositivity for Ki67 showed a more than 10 % disagreement between LI/direct and LI/image/T.
Conclusion
The merits of calculating Ki67 LI using Tissuemorph DP are as follows. First, the staining intensity of the cells to be counted can be adjusted. Second, the portion of a tumor including “hot spots” for counting can be chosen. Third, many cancer cells can be counted more rapidly using Tissuemorph DP than by visual observation. However, it is important that pathologist should check and carry out the final decision of the data, when Ki67 LI using Tissuemorph DP is calculated.
This study evaluated the validity and inter- and intraclinician reliability of (1) the Japanese Society of Surgery of the Foot (JSSF) standard rating system for four sites ankle-hindfoot (AH), ...midfoot (MF), hallux (HL), and lesser toe (LT) and the rheumatoid arthritis (RA) foot and ankle scale and (2) the Japanese Orthopaedic Association's foot rating scale (JOA scale).
Clinicians from the same institute independently evaluated participating patients from their institute by two evaluations at a 1- to 4-week interval. Statistical evaluation was as follows. (1) The intraclass correlation coefficient (ICC) was calculated from data collected from at least two examinations of each patient by at least two evaluating clinicians (Data A). (2) Total scores for the two evaluations were determined from the distribution of differences in data between the two evaluations (Data B); each item was evaluated by determining Cohen's coefficient of agreement. (3) The relation between patient satisfaction and total score was investigated only for patients who underwent surgery (Data C). Spearman's rank correlation coefficient was obtained.
Participants were 65 clinicians and 610 patients, including those with disorders of the AH (313), MF (47), HL (153), and LT (50) and those with RA (47). From Data A, the ICC was high for AH and HL by JSSF scales and for AH, MF, and LT by the JOA scale. From Data B, the coefficient showed high validity for both scales for AH, with almost no difference between the two scales; the validity for HL was higher with the JOA scale than with the JSSF scale. From Data C, correlations were significant between patient satisfaction and outcome for AH and HL by the JSSF scales and for AH, HL, and LT by the JOA scale.
The validity of both scales was high. Clinical evaluation of the therapeutic results using these scales would be highly reliable.
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