Background.The 25-question Geriatric Locomotive Function Scale (GLFS-25) is widely used in daily clinical practice in evaluating locomotive syndrome (LS).The questionnaire contains 25 questions aiming to describe 6 aspects, including body pain, movement-related difficulty, usual care, social activities, cognitive status, and daily activities.However, its potential underlying latent factor structure of the questionnaire has not been fully examined so far.Methods.Five hundred participants who were 60 years or older and were able to walk independently with or without a cane but had complaints of musculoskeletal disorders were recruited face to face at the out-patient ward of Aichi Medical University Hospital between April 2018 and June 2019.All participants completed the GLFS-25.Confirmatory factor analysis (CFA) models (single-factor model, 6-factor model as designed by the developers of the GLFS-25) were fitted and compared using Mplus 8.3 with a maximum likelihood minimization function.Modification indices, standardized expected parameter change were used, a standard strategy for scale development was followed in the search for an alternative and simpler model that could well fit the collected data.Cronbach's α and its 95% confidence interval (CI) were also calculated.Results.Mean (standard deviation) participants age was 72.6 (7.4) years old; 63.6% of them were women.Under the current criteria, 132 (26.4%) and 262 (52.4%) of the study subjects would be classified as LS stage 1 and stage 2, respectively.Overall, the Cronbach's α for GLFS-25 evaluated using these data was 0.959 (95%CI: 0.953, 0.964).The single-and 6-factor models were rejected due to poor fit.The alternative models with either full 25 questions or a shortened GLFS-16 were found to fit the data better.These alternative models included three latent factors (body pain, movement-related difficulty, and psycho-social complication) and allowed for cross-loading and residual correlations.Discussion.The findings of the CFA models provided evidence that the factor structure of the GLFS-25 might be simpler than the 6-factor model as suggested by the designers.The complex relationships between the latent factors and the observed items may also indicate that individual sub-scale use or simply combining the raw scores for evaluation is likely to be inadequate or unsatisfactory.Thus, future revisions of the scoring algorithm or questions of the GLFS-25 may be required.
Background. The aim of this study was to confirm the effectiveness of open-label placebo (OLP) in Japanese patients with chronic low back pain (CLBP), similar to previous reports, and to investigate its short- and medium-term effects in this study population. Methods. Fifty-two patients with CLBP were randomized into a treatment as usual (TAU) group (n = 26) or an OLP + TAU group (n = 26) for 12 weeks. The TAU included advice to remain active and exercise in conjunction with recent psychological education based on a self-management strategy. In contrast, participants in the OLP + TAU group were instructed to take two OLP capsules a day. Outcome measures were assessed at baseline and at weeks 3 and 12 using the Roland–Morris Disability Questionnaire (RMDQ), Numerical Rating Scale (NRS) for pain intensity, and the Timed-Up-and-Go (TUG) test. Difference in outcomes between the two groups was compared at the two follow-up points. Results. Although all participants completed the 3-week follow-up, four patients (two in each group) were lost to follow-up beyond week 3. There were no significant intergroup differences in changes in the RMDQ score ( ), pain-NRS score ( ), and TUG time ( ) at week 3. Two-way repeated measure analyses of covariance showed significant time-course effects but did not show group effects or any interactions between the time-course and group in terms of the RMDQ score. However, it did not show any effects in the pain-NRS score and TUG time at week 12. Conclusions. The OLP + TAU group showed no superior findings in comparison with the TAU group after 3 weeks and 12 weeks for Japanese patients with CLBP. Nonetheless, significant improvements in functional disability were observed in both groups.
Diffuse idiopathic skeletal hyperostosis (DISH) is prone to be accompanied by a spinal column fracture which is resistant to conservative therapy. This major characteristic of DISH is not recognized adequately by physicians, because the disease's detailed pathological condition has not yet been investigated. Therefore, the purposes of this study were to investigate the prevalence of DISH using computed tomography (CT), and to validate the reliability of CT interpretation.Subjects were 558 patients (300 male and 258 female) who underwent both CT of chest to pelvis and x-ray of chest and abdomen from August 2011 to July 2012 at any department other than orthopedic surgery in our institution. The definition of DISH based on x-ray as well as CT was the presence of consecutive fused vertebral bodies according to Resnick's criteria. The prevalence of DISH based on both modalities was calculated in all subjects. For 107 subjects extracted at random, intra- (Cohen kappa) and inter-observer error (Fleiss kappa) were calculated and the levels of fused segments were investigated.Ninety-eight of 558 subjects (17.6%) were diagnosed as DISH by x-ray, and 152 (27.2%) by CT. Among males, 70 of 300 subjects (23.3%) were diagnosed by x-ray, and 116 (38.7%) by CT. Among females, 28 of 258 subjects (10.9%) were diagnosed by x-ray and 36 (14.0%) by CT. The levels of fused segments were presented from thoracic spine to lumbar spine, especially the middle and lower thoracic spine. Cohen kappa of x-ray was 0.587, and that of CT was 0.825. Fleiss kappa of x-ray was 0.552, and that of CT was 0.643.The prevalence of DISH based on CT was 27.1%, which was higher than that of x-ray. In addition, intra- and inter-observer error by review of CT was less than that of x-ray. CT evaluation would be a better method for precise understanding of the state of DISH.
A multicenter retrospective analysis of a prospectively maintained database.To examine the characteristics of reoperation for surgical site infection (SSI) after spinal instrumentation surgery, including the efficacy of treatment for SSI and instrumentation retention.Aging of the population and advances in surgical techniques have increased the demand for spinal surgery in elderly patients. Treatment of SSI after this surgery has the main goals of eliminating infection and retaining instrumentation.The subjects were 16,707 patients who underwent spine surgery with instrumentation in 11 hospitals affiliated with the Nagoya Spine Group from 2004 to 2015. Details of those requiring reoperations for SSI were obtained from surgical records at each hospital.There were significant increases in the mean age at the time of surgery (54.6-63.7 years) and the number of instrumentation surgeries (726-1977) from 2004 to 2015. The incidence of reoperation for SSI varied from 0.9% to 1.8%, with a decreasing trend over time. Reoperation for SSI was performed in 206 cases (115 men, 91 women; mean age 63.2 years). The average number of reoperations (1.4 vs. 2.3, P < 0.05), time from SSI to first reoperation (4.3 vs. 9.5 days, P < 0.05), and the methicillin-resistant Staphylococcus identification rate (20% vs. 37%, P < 0.01) were all significantly lower in cases with instrumentation retention (n = 145) compared to those with instrumentation removal (n = 61).There were marked trends of aging of patients and an increase in operations over the study period; however, the incidences of reoperation and instrumentation removal due to SSI significantly decreased over the same period. Rapid debridement after SSI diagnosis may have contributed to instrumentation retention. These results can serve as a guide for developing strategies for SSI treatment and for improved planning of spine surgery in an aging society.3.
Although patients with osteoporotic delayed vertebral collapse (ODVC) have frequently been treated surgically, the efficacy and limitation of conservative treatment for it have not yet been reported. The purpose of this study was to investigate the effectiveness and limitation of further intensive conservative treatment for patients with ODVC. Patients treated for ODVC from 2011 to 2014 with a follow-up period of more than 1 year were eligible. The fundamental treatment strategy consisted of surgical treatment following intensive conservative treatment with daily teriparatide and rehabilitation for 3 months. We conducted a surgical treatment for patients who could not keep standing position by themselves because of prolonged leg paralysis or intolerable back pain. We performed a logistic regression model in which surgical treatment was set as an objective variable, and other related factors including sex, age, the level of affected vertebrae, the quality of paralysis, changing rate (δ) of spinal canal encroachment, local kyphotic angle, mobility of collapsed vertebrae, EuroQol questionnaires (EQ5D), numerical rating scale (NRS), and Frankel grade as explanatory variables. We also plotted receiver operating curves (ROCs) to investigate the cutoff values of parameters at the baseline. Thirty patients (6 males and 24 females, mean age 76.7 years) were enrolled. Eventually 12 out of 30 patients avoided surgical treatment because their symptoms were improved. Logistic regression showed that δ of local kyphotic angle (odds ratio: 1.072), P = .01), mobility of collapsed vertebrae (1.063, 0.01), EQ5D (0.98, 0.04), and NRS (1.113, 0.01) were significantly correlated with the need for surgical treatments. Among the factors at baseline, only the mobility of collapsed vertebrae showed a significant value of area under a curve (AUC = 0.727, P = .008). The results that 40% of patients with ODVC did not need further surgical treatment after the intensive conservative treatment was of great significance. Patients with greater mobility of collapsed vertebrae might be treated surgically as quickly as possible.
OBJECTIVE Retrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion. METHODS In this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery. RESULTS The trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus ) and one deep infection (0.9%, S. aureus ) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus ) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8). CONCLUSIONS This double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III. Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr)
CS-834 is a novel oral carbapenem antibiotic. This compound is an ester-type prodrug of the active metabolite R-95867. The antibacterial activity of R-95867 was tested against 1,323 clinical isolates of 35 species and was compared with those of oral cephems, i.e., cefteram, cefpodoxime, cefdinir, and cefditoren, and that of a parenteral carbapenem, imipenem. R-95867 exhibited a broad spectrum of activity covering both gram-positive and -negative aerobes and anaerobes. Its activity was superior to those of the other compounds tested against most of the bacterial species tested. R-95867 showed potent antibacterial activity against clinically significant pathogens: methicillin-susceptible Staphylococcus aureus including ofloxacin-resistant strains, Streptococcus pneumoniae including penicillin-resistant strains, Clostridium perfringens, Neisseria spp., Moraxella catarrhalis, most members of the family Enterobacteriaceae, and Haemophilus influenzae (MIC at which 90% of strains are inhibited, < or =0.006 to 0.78 microg/ml). R-95867 was quite stable to hydrolysis by most of the beta-lactamases tested except the metallo-beta-lactamases from Stenotrophomonas maltophilia and Bacteroides fragilis. R-95867 showed potent bactericidal activity against S. aureus and Escherichia coli. Penicillin-binding proteins 1 and 4 of S. aureus and 1Bs, 2, 3, and 4 of E. coli had high affinities for R-95867. The in vivo efficacy of CS-834 was evaluated in murine systemic infections caused by 16 strains of gram-positive and -negative pathogens. The efficacy of CS-834 was in many cases superior to those of cefteram pivoxil, cefpodoxime proxetil, cefdinir, and cefditoren pivoxil, especially against infections caused by S. aureus, penicillin-resistant S. pneumoniae, E. coli, Citrobacter freundii, and Proteus vulgaris. Among the drugs tested, CS-834 showed the highest efficacy against experimental pneumonia in mice caused by penicillin-resistant S. pneumoniae.
Background The 25-question Geriatric Locomotive Function Scale (GLFS-25) is widely used in daily clinical practice in evaluating locomotive syndrome (LS). The questionnaire contains 25 questions aiming to describe 6 aspects, including body pain, movement-related difficulty, usual care, social activities, cognitive status, and daily activities. However, its potential underlying latent factor structure of the questionnaire has not been fully examined so far. Methods Five hundred participants who were 60 years or older and were able to walk independently with or without a cane but had complaints of musculoskeletal disorders were recruited face to face at the out-patient ward of Aichi Medical University Hospital between April 2018 and June 2019. All participants completed the GLFS-25. Confirmatory factor analysis (CFA) models (single-factor model, 6-factor model as designed by the developers of the GLFS-25) were fitted and compared using Mplus 8.3 with a maximum likelihood minimization function. Modification indices, standardized expected parameter change were used, a standard strategy for scale development was followed in the search for an alternative and simpler model that could well fit the collected data. Cronbach’s α and its 95% confidence interval (CI) were also calculated. Results Mean (standard deviation) participants age was 72.6 (7.4) years old; 63.6% of them were women. Under the current criteria, 132 (26.4%) and 262 (52.4%) of the study subjects would be classified as LS stage 1 and stage 2, respectively. Overall, the Cronbach’s α (95% CI) for GLFS-25 evaluated using these data was 0.959 (0.953, 0.964). The single- and 6-factor models were rejected due to poor fit. The alternative models with either full 25 questions or a shortened GLFS-16 were found to fit the data better. These alternative models included three latent factors (body pain, movement-related difficulty, and psycho-social complication) and allowed for cross-loading and residual correlations. Discussion The findings of the CFA models provided evidence that the factor structure of the GLFS-25 might be simpler than the 6-factor model as suggested by the designers. The complex relationships between the latent factors and the observed items may also indicate that individual sub-scale use or simply combining the raw scores for evaluation is likely to be inadequate or unsatisfactory. Thus, future revisions of the scoring algorithm or questions of the GLFS-25 may be required.
Study Design. We retrospectively reviewed computed tomography (CT) records of patients in Japan and Sweden, which are both aging populations. Objective. To research the influence of ethnicity and region on diffuse idiopathic skeletal hyperostosis (DISH) prevalence. Summary of Background Data. DISH can complicate non-surgical treatment of spinal fractures and often requires surgical intervention. We previously reported a prevalence of DISH in Japan that was higher than that reported in other studies. Methods. We retrospectively reviewed CT records of patients in Japan and Sweden, which have both aging populations. Patients undergoing whole body CT during trauma examinations at an acute outpatient clinic in Uppsala University Hospital in a 1-year period were eligible for inclusion. Excluded were those less than 40 and more than or equal to 90 years old, and those with previous spinal surgery. The prevalence of DISH by sex and age was determined according to radiographic criteria by Resnick. Results from Sweden were compared with the Japan data, which we previously reported. Results. Age of the eligible subjects (265 men and 153 women) ranged from 40 to 89 years, with a mean age of 63.4 years. Among men, 86 (32.5%) were diagnosed with DISH, and the results by age (40s, 50s, 60s, 70s, and 80s) were: 6 (10.7%), 13 (22%), 35 (46.1%), 17 (34%), and 15 (62.5%) patients, respectively. Among women, 16 (10.5%) had DISH, and the results by age were as follows: 1 (2.6%), 1 (3.3%), 2 (6.7%), 6 (22.2%), and 6 (22.2%) patients, respectively. These results did not differ from those previously published for Japan (Fisher exact test, men: P = 1, 0.27, 0.12, 0.06, and 1, respectively; women: P = 0.49, 0.62, 0.5, 0.8, and 0.3, respectively). Conclusion. The presented cohort study revealed that ethnicity and region may not be notable factors of DISH prevalence, since patients from both Japan and Sweden had similar DISH prevalence. Level of Evidence: 3
Background.The 25-question Geriatric Locomotive Function Scale (GLFS-25) is widely used in daily clinical practice in evaluating locomotive syndrome (LS).The questionnaire contains 25 questions aiming to describe 6 aspects, including body pain, movement-related difficulty, usual care, social activities, cognitive status, and daily activities.However, its potential underlying latent factor structure of the questionnaire has not been fully examined so far.Methods.Five hundred participants who were 60 years or older and were able to walk independently with or without a cane but had complaints of musculoskeletal disorders were recruited face to face at the out-patient ward of Aichi Medical University Hospital between April 2018 and June 2019.All participants completed the GLFS-25.Confirmatory factor analysis (CFA) models (single-factor model, 6-factor model as designed by the developers of the GLFS-25) were fitted and compared using Mplus 8.3 with a maximum likelihood minimization function.Modification indices, standardized expected parameter change were used, a standard strategy for scale development was followed in the search for an alternative and simpler model that could well fit the collected data.Cronbach's α and its 95% confidence interval (CI) were also calculated.Results.Mean (standard deviation) participants age was 72.6 (7.4) years old; 63.6% of them were women.Under the current criteria, 132 (26.4%) and 262 (52.4%) of the study subjects would be classified as LS stage 1 and stage 2, respectively.Overall, the Cronbach's α for GLFS-25 evaluated using these data was 0.959 (95%CI: 0.953, 0.964).The single-and 6-factor models were rejected due to poor fit.The alternative models with either full 25 questions or a shortened GLFS-16 were found to fit the data better.These alternative models included three latent factors (body pain, movement-related difficulty, and psycho-social complication) and allowed for cross-loading and residual correlations.Discussion.The findings of the CFA models provided evidence that the factor structure of the GLFS-25 might be simpler than the 6-factor model as suggested by the designers.The complex relationships between the latent factors and the observed items may also indicate that individual sub-scale use or simply combining the raw scores for evaluation is likely to be inadequate or unsatisfactory.Thus, future revisions of the scoring algorithm or questions of the GLFS-25 may be required.
