Psychometric properties of the Japanese version of the Kansas City Cardiomyopathy Questionnaire in Japanese patients with chronic heart failure.

BACKGROUND: Heart failure is a worldwide health problem that significantly affects patients' physical function and health state. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcome measure commonly used for the assessment of health states of patients with heart failure. This study aimed to evaluate the psychometric properties of the Japanese version of the KCCQ. METHODS: Using pooled data of 141 Japanese patients with chronic heart failure from three clinical trials, the Japanese version of the KCCQ was evaluated for validity and reliability, with a focus on the clinical summary score (CSS) and its component domains. For construct validity, the associations of baseline KCCQ scores with New York Heart Association (NYHA) class and the EuroQol five-dimension, three-level (EQ-5D-3L) scores at baseline were analyzed. For reliability, internal consistency was assessed using Cronbach's α, and test-retest reliability (reproducibility) was assessed among stable patients. Responsiveness to changes in patients' clinical status was assessed by analyzing score changes between two timepoints among patients whose health states improved. RESULTS: Among 141 patients (mean age, 73.7 ± 10.9 years), 76.6% were NYHA class II at baseline. For CSS and its component domains (physical limitations, symptom frequency, and symptom severity), baseline scores were all significantly lower in patients with a higher NYHA class (p <  0.001 for all, Jonckheere-Terpstra test). The physical limitations domain and CSS showed a moderate correlation (Spearman's ρ = - 0.40 to - 0.54) with three functional status-related EQ-5D dimensions (mobility, self-care, and usual activities). The Cronbach's standardized α was high (> 0.70) for all KCCQ domain/summary scores. In the test-retest analysis among 58 stable patients, all domain/summary scores minimally changed by 0.3-4.2 points with intraclass correlation coefficients of 0.65-0.84, demonstrating moderate to good reproducibility, except for the symptom stability domain. Among 44 patients with improved health states, all domain/summary scores except for the symptom stability and self-efficacy domains substantially improved from baseline with a medium to large effect size of 0.62-0.88. CONCLUSIONS: The Japanese version of the KCCQ was demonstrated to be a valid and reliable tool for the assessment of symptoms and physical function of Japanese patients with chronic heart failure.

A Cost-Effectiveness Analysis Of Pregabalin For The Treatment Of Patients With Chronic Cervical Pain With A Neuropathic Component In Japan.

PURPOSE: To evaluate the cost-effectiveness of pregabalin versus other analgesics among patients with chronic cervical pain with neuropathic components during routine clinical practice in Japan. PATIENTS AND METHODS: The analysis considered patients with chronic cervical pain with a neuropathic pain component (radiating pain to the upper limb) and who were treated with pregabalin with or without other analgesics (pregabalin-containing treatments) or other analgesics alone (usual care) for 8 weeks. Other analgesics included non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, antidepressants, and antiepileptic drugs. A Markov cohort simulation model was constructed to estimate costs and effectiveness (in terms of quality-adjusted life-years, QALYs) of each treatment over a 12-month time horizon. In the model, patients transitioned among three states of pain severity (no/mild, moderate, and severe). Data were derived from a previous observational study (pregabalin-containing treatments, n = 138; usual care, n = 211). Cost inputs included medical costs and productivity losses. QALYs were calculated using the EuroQol five-dimensional, five-level questionnaire. The cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to assess the robustness of results. RESULTS: From the payer's perspective, pregabalin-containing treatments were more costly (JPY 61,779 versus JPY 26,428) but also more effective (0.763 QALYs versus 0.727 QALYs) than the usual care, with an ICER of JPY 970,314 per QALY gained. From the societal perspective, which also included productivity losses, the ICER reduced to JPY 458,307 per QALY gained. One-way sensitivity analyses demonstrated the robustness of the results. Given a hypothetical threshold value of one additional QALY of JPY 5,000,000, the probability of pregabalin-containing treatments being cost-effective was 100%. CONCLUSION: Compared with using other analgesics alone, the use of pregabalin, alone or in addition to other analgesics, was cost-effective for the treatment of chronic cervical pain with a neuropathic pain component in Japan.

Assessment of risk factors for non-specific chronic disabling low back pain in Japanese workers-findings from the CUPID (Cultural and Psychosocial Influences on Disability) study.

The majority of patients with non-specific low back pain (LBP) suffer from chronic pain. Psychosocial factors play an important role in the chronicity of LBP. To explore the risk factors for chronic disabling LBP in detail, we assessed its various risk factors in Japanese workers, using data from the Cultural and Psychosocial Influences on Disability (CUPID) study. Data were drawn from a 1 yr follow-up of 20‒59 yr-old workers who participated in the CUPID study. A self-administered questionnaire assessed various factors, including individual characteristics, ergonomic work demands, and work-related or other psychosocial factors. Logistic regression analyses were performed to assess the associations between these factors and chronic disabling LBP. Of 198 participants, 35 (17.7%) had chronic disabling LBP during the 1 yr follow-up. Multivariate logistic regression analysis revealed that the interaction effect of the two factors, expectation of LBP problems and excessive working hours (≥ 60 h per week), was associated with chronic disabling LBP. Chronic disabling LBP was present in 42.5% of participants with both of these two risk factors, whereas it was present in 11.8% of participants without these risk factors. In conclusion, among various factors, the combination of two psychosocial factors was particularly associated with chronic disabling LBP.

Pregabalin as an analgesic option for patients undergoing thoracotomy: cost analysis of pregabalin versus epidural analgesia for post-thoracotomy pain relief.

BACKGROUND: Our previous randomized controlled trial (RCT) to evaluate the effects of pregabalin on acute post-thoracotomy pain compared with epidural analgesia showed that pregabalin is a safe and effective treatment and that it may be an alternative to epidural analgesia for acute post-thoracotomy pain. In this analysis, to additionally analyze the economic aspects of pregabalin in patients undergoing thoracotomy, we compared the medical costs between pregabalin and epidural analgesia as an analgesic technique for post-thoracotomy pain. METHODS: Costs for patients undergoing thoracotomy and receiving either pregabalin or epidural analgesia for post-thoracotomy pain relief in the previous RCT were retrospectively collected from health insurance claims data. The following five cost categories were compared between the groups: (I) surgery costs; (II) costs for surgical materials and medications; (III) costs for anesthetic management; (IV) total hospitalization costs; and (V) costs for outpatient pain-relief medications (from hospital discharge to 6 months after thoracotomy). RESULTS: We analyzed data from 90 patients (45 patients for each group). Median costs for surgical materials and medications and those for anesthetic management were significantly lower in the pregabalin group than in the epidural analgesia group [(Japanese yen) ¥69,720 vs. ¥77,180, P=0.017; ¥161,000 vs. ¥195,500, P<0.001, respectively]. However, total hospitalization costs and costs for outpatient pain-relief medications were similar between the groups. Pregabalin was prescribed to more patients in the pregabalin group than those in the epidural analgesia group as outpatient treatment (75.0% vs. 37.5%), but median prescribed doses were much smaller in the pregabalin group. CONCLUSIONS: Although the use of pregabalin did not result in lower total hospitalization costs, it may reduce fee-for-service surgery- and anesthesia-related costs. The economic benefits of pregabalin may reinforce its usefulness as an alternative to epidural analgesia, especially for patients who are unsuitable for epidural analgesia.

Clinical and economic burdens experienced by patients with painful diabetic peripheral neuropathy: An observational study using a Japanese claims database.

BACKGROUND: Diabetic peripheral neuropathy (DPN) may often be painful. Despite the high prevalence of painful DPN (pDPN) among patients with diabetes mellitus (DM), understanding of its clinical and economic burden is limited. This study aimed to describe the clinical and economic burdens faced by patients with pDPN in Japan, and compared them with those experienced by patients with DPN but without painful symptoms (non-pDPN). METHODS: This retrospective, observational study used data from a large-scale, hospital-based Japanese claims database collected from April 2008 to June 2015. Comorbidities, clinical departments visited, length of hospital stay, and medical costs for the period of ± 6 months from the diagnosis of pDPN or non-pDPN were described for each group. Glycemic control status was examined for each group for patients with glycated hemoglobin data. RESULTS: The data of 8,740 patients with pDPN (mean age 70.0 years, 53.4% male) and 12,592 patients with non-pDPN (mean age 67.7 years, 55.7% male) were analyzed. Patients with pDPN had more comorbidities than patients with non-pDPN; 48.7% and 30.9% of patients in the respective groups had 20 or more comorbidities. The median length of hospital stay was 5 days longer in patients with pDPN. The median total medical costs were higher in patients with pDPN (\517,762) than in patients with non-pDPN (\359,909). Patients with pDPN spent higher median costs for medications, but the costs for glycemic control drugs were similar in both groups. For 3,372 patients with glycated hemoglobin data, glycemic control was similar between the two groups. CONCLUSION: Patients with pDPN experienced greater clinical and economic burdens than patients with non-pDPN, suggesting that patients who develop pDPN may suffer not only from the complications of DM and pain, but also from other comorbid disorders.

Estimated risk for chronic pain determined using the generic STarT Back 5-item screening tool.

OBJECTIVE: The generic STarT Back 5-item screening tool (STarT-G) is used to manage chronic pain in the lower back and elsewhere. This study evaluated the validity of the Japanese version of this generic screening tool. MATERIALS AND METHODS: Japanese participants between the ages of 20 and 64 years completed online surveys regarding pain. Survey reliability was assessed with internal consistency, as calculated using Cronbach's alpha coefficients. Spearman's correlation coefficients were used to evaluate concurrent validity between the STarT-G score and standard reference questionnaires. Associations between STarT-G scores and the presence of a disability due to chronic pain (DCP) were analyzed using receiver operator characteristic (ROC) curves. RESULTS: Analyses ultimately included data obtained from 52,842 Japanese participants (54.4% male) with a mean (standard deviation) age of 47.7 (9.4) years. Approximately 1.5% of participants had DCP, and the mean STarT-G score was 1.2 (1.4). The Cronbach's alpha coefficient was 0.71, indicating an acceptable reliability. The STarT-G score moderately correlated with the pain numerical rating scale (NRS) score (Spearman's correlation coefficient: r = 0.34). When the STarT-G threshold was set at 4, the sensitivity and specificity of the DCP predictive model were 65.8% and 82.4%, respectively, and the area under the ROC was 0.808. CONCLUSION: The STarT-G was internally consistent and was able to distinguish between subjects with and without a DCP. Therefore, the STarT-G can reliably be used in the Japanese population to identify patients with DCP.

The Japanese version of the STarT Back Tool predicts 6-month clinical outcomes of low back pain.

BACKGROUND: The STarT Back Tool classifies patients into low-, medium-, or high-risk groups according to risk for chronic low back pain. The Japanese version of the STarT Back Tool (STarT-J) has been translated and psychometrically validated. The present analysis investigated the predictive ability of the STarT-J. METHODS: Baseline data were collected through an online survey conducted with Japanese patients with low back pain. Long-term outcomes were assessed in a 6-month follow-up survey. Clinical outcomes at 6 months were evaluated with a pain numerical rating scale, the Roland-Morris Disability Questionnaire, and the EuroQol 5 Dimension. Differences in these scores among the three STarT-J risk groups were analyzed. Participants' perceived changes in low back pain and overall health status were examined to determine associations between the chronicity of low back pain at 6 months and STarT-J risk groups. RESULTS: Data of 1228 volunteers who responded to the baseline and follow-up surveys were included in this analysis. Mean ± standard deviation (SD) scores for the pain numerical rating scale and the Roland-Morris Disability Questionnaire were highest in the high-risk group (5.6 ± 1.9 and 9.6 ± 7.5) and lowest in the low-risk group (3.9 ± 1.6 and 2.1 ± 3.5). Mean ± SD EuroQol 5 Dimension index scores were lowest in the high-risk group (0.66 ± 0.20) and highest in the low-risk group (0.86 ± 0.14). A small percentage of high-risk patients (5.3%) perceived improvement in low back pain at the 6-month follow-up. CONCLUSIONS: The STarT-J predicted 6-month pain and disability outcomes. The STarT-J is an easy-to-use tool to screen for patients who are more likely to have chronic low back pain, and may be useful to initiate stratified care in primary care settings.

Psychometric Properties of the Japanese Version of the STarT Back Tool in Patients with Low Back Pain.

BACKGROUND AND OBJECTIVE: The STarT Back Tool uses prognostic indicators to classify patients with low back pain into three risk groups to guide early secondary prevention in primary care. The present study aimed to evaluate the psychometric properties of the Japanese version of the tool (STarT-J). METHODS: An online survey was conducted among Japanese patients with low back pain aged 20-64 years. Reliability was assessed by examining the internal consistency of the overall and psychosocial subscales using Cronbach's alpha coefficients. Spearman's correlation coefficients were used to evaluate the concurrent validity between the STarT-J total score/psychosocial subscore and standard reference questionnaires. Discriminant validity was evaluated by calculating the area under the curves (AUCs) for the total and psychosocial subscale scores against standard reference cases. Known-groups validity was assessed by examining the relationship between low back pain-related disability and STarT-J scores. RESULTS: The analysis included data for 2000 Japanese patients with low back pain; the mean (standard deviation [SD]) age was 47.7 (9.3) years, and 54.1% were male. The mean (SD) STarT-J score was 2.2 (2.1). The Cronbach's alpha coefficient was 0.75 for the overall scale and 0.66 for the psychosocial subscale. Spearman's correlation coefficients ranged from 0.30 to 0.59, demonstrating moderate to strong concurrent validity. The AUCs for the total score ranged from 0.65 to 0.83, mostly demonstrating acceptable discriminative ability. For known-groups validity, participants with more somatic symptoms had higher total scores. Those in higher STarT-J risk groups had experienced more low back pain-related absences. CONCLUSIONS: The overall STarT-J scale was internally consistent and had acceptable concurrent, discriminant, and known-groups validity. The STarT-J can be used with Japanese patients with low back pain.