Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation.

BACKGROUND: The patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the English version and (2) evaluating the psychometric properties of the Japanese version of the COMI in Japanese volunteers with chronic back problems. METHODS: The English version of the COMI was cross-culturally adapted for the Japanese language using established guidelines. The pre-final version was pilot-tested in five Japanese-speaking patients with low back pain (LBP) and a history of spine surgery. The psychometric properties of the Japanese COMI were tested in a group of 1052 individuals with chronic LBP (LBP ≥3 months), aged 20-69 years, who were recruited through a web-based survey. The psychometric properties that were evaluated included convergent and known-group validity, using the following reference questionnaires: EuroQol 5 Dimension, Roland Morris Disability Questionnaire, Short Form 8™ Health Survey, and the Keele STarT Back Screening Tool. RESULTS: The pre-final version of the cross-culturally adapted Japanese COMI was completed without any major problems of understanding or acceptability. For the evaluation of its psychometric properties, tests for convergent validity showed moderate correlations between COMI items and the respective reference questionnaires for symptom-specific well-being [- 0.33--0.48] and disability domains [0.48] and strong correlations (> 0.5) for the other domains and the COMI summary score. The analysis of known-group validity showed a linear trend for the COMI score in relation to prognostic risk (P < 0.001). CONCLUSIONS: The Japanese COMI retained conceptual equivalence to the original using comprehensible and acceptable Japanese expressions. We developed a Japanese version of the COMI that displayed qualities that support its convergent and known-group validity. The availability of a Japanese version of the COMI should allow for improved documentation of the care provided to patients with back problems.

A survey on total parenteral nutrition in 55,000 hospitalized patients: Retrospective cohort study using a medical claims database.

BACKGROUND & AIMS: Identifying the prevalence of underfed patients and risk factors for underfeeding in patients with total parenteral nutrition (TPN) is essential to improve the management of patients receiving TPN. The aim of this study was to examine the prevalence and risk factors for underfeeding using a medical claims database. METHODS: In this retrospective cohort study using a medical claims database, we analyzed patient characteristics, timing and duration of nutrition prescription, daily dose of nutrients, and types of parenteral nutrition products administered after central venous catheter (CVC) insertion in hospitalized Japanese patients between 2009 and 2018. The mean prescriptions of energy <20 kcal/kg/day, amino acids <1.0 g/kg/day, and fat <2.5 g/day received by patients between the 4th and 10th day after CVC insertion were regarded as underfeeding. To study the association between nutritional adequacy and body mass index (BMI) with TPN, the proportions of patients with a prescription of energy ≥20 kcal/kg/day or amino acids ≥1.0 g/kg/day were calculated and categorized according to BMI, and the Cochran-Armitage trend test was performed. RESULTS: Of 54,687 patients included in the study, 70.3% were aged ≥70 years, and 31.3% had a BMI <18.5. The mean prescription of energy was insufficient in 49.9% of patients, and 82.9% were insufficiently prescribed with amino acids. In addition, 44.4% of the patients were never prescribed a single dose of fat emulsion during their hospital stay. On the 10th day after CVC insertion, the majority of patients used commercial 2-in-1 compounds containing carbohydrates and amino acids. A higher BMI was associated with underfeeding of energy and amino acids (both p < 0.001). CONCLUSIONS: It is important to adjust the nutrition dose according to the patient's body size and weight, and it is necessary to supplement inadequate nutrients by single-nutrition solutions in addition to compounded solutions.

Patterns of drug treatment in patients with osteoarthritis and chronic low back pain in Japan: a retrospective database study.

Purpose: Musculoskeletal diseases, including osteoarthritis (OA) and low back pain (LBP), are the leading causes of years lived with disability, and are associated with lowered quality-of-life, lost productivity, and increased healthcare costs. However, information publicly available regarding the Japanese real-world usage of prescription medications is limited. This study aimed to describe the clinical characteristics of patients with OA and chronic LBP (CLBP), and to investigate the patterns of medications and opioid use in Japanese real-world settings. Materials and methods: A retrospective study was conducted using a Japanese administrative claims database between 2013 and 2017. The outcomes were patient characteristics and prescription medications, and they were evaluated separately for OA and CLBP. Results: The mean age of 118,996 patients with OA and 256,402 patients with CLBP was 68.8±13.1 years and 64.8±16.4 years, respectively. Approximately 90% of patients with OA and CLBP were prescribed non-steroidal anti-inflammatory drugs (NSAIDs). Other prescriptions included hyaluronate injection (35.6%), acetaminophen (21.4%), and steroid injection (20.0%) in patients with OA, and pregabalin (39.0%) and acetaminophen (22.4%) in patients with CLBP. Weak opioids were prescribed to 10.7% and 20.6% of patients with OA and CLBP, respectively. The prescription of COX-2 inhibitors (OA: +6.5%; CLBP: +6.7%) and acetaminophen (OA: +16.4%; CLBP: +14.4%) increased between 2013 and 2017. The first commonly prescribed medication among patients with OA and CLBP were NSAIDs; hyaluronate injection (patients with OA) and pregabalin (patients with CLBP) were also common first-line medications. Acetaminophen, steroid injection (patients with OA), and weak opioids were prescribed more in the later phases of treatment. Conclusion: Most patients were prescribed limited classes of pain drugs, with NSAIDs being the most common pain medication in Japan for patients with OA and CLBP. Opioid prescription was uncommon, and were weak opioids when prescribed.