Clinical Practice Guidelines In Japan Research Articles

Association between Conflicts of Interest Disclosure and Quality of Clinical Practice Guidelines in Japan: A Meta-Epidemiological Study.

Accurate disclosure of financial conflicts of interest (COI) among clinical practice guideline (CPG) developers is critical to ensure the quality of CPGs. However, there is limited evidence on the impact of underreporting COIs on the quality of CPGs. This study aimed to examine the proportion of underreported COI disclosures in the development of Japanese CPGs and to estimate the association between underreported COIs and CPG quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II. Twenty-three Japanese CPGs published in 2019 and their 1114 developers were included in the study. The results show that underreporting of COIs occurred in 52% of the included CPGs and 8% of all CPG developers. Underreporting COI disclosures was negatively associated with low-quality CPG (Odds ratio [OR], 0.57; 95% confidence interval [CI]: 0.11, 3.04). On the other hand, CPGs that had more than 13% of CPG developers with voting rights on recommendation decisions and underreporting of COI disclosures were positively associated with low quality (OR, 1.78; 95% CI: 0.25, 12.45). For individual CPG developers with voting rights for recommendation decisions, the presence of a COI was positively associated with low quality (OR, 1.11; 95% CI: 0.71, 1.75). This study demonstrates that the involvement and underreporting of COIs did not seriously distort the CPG development process. However, the COI-related factors of CPG developers with voting rights for recommendation decisions may be associated with low CPG quality.

Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020.

The prevalence of sleep disordered breathing (SDB) is reportedly very high. Among SDBs, the incidence of obstructive sleep apnea (OSA) is higher than previously believed, with patients having moderate-to-severe OSA accounting for approximately 20% of adult males and 10% of postmenopausal women not only in Western countries but also in Eastern countries, including Japan. Since 1998, when health insurance coverage became available, the number of patients using continuous positive airway pressure (CPAP) therapy for sleep apnea has increased sharply, with the number of patients about to exceed 500,000 in Japan. Although the "Guidelines for Diagnosis and Treatment of Sleep Apnea Syndrome (SAS) in Adults" was published in 2005, a new guideline was prepared in order to indicate the standard medical care based on the latest trends, as supervised by and in cooperation with the Japanese Respiratory Society and the "Survey and Research on Refractory Respiratory Diseases and Pulmonary Hypertension" Group, of Ministry of Health, Labor and Welfare and other related academic societies, including the Japanese Society of Sleep Research, in addition to referring to the previous guidelines. Because sleep apnea is an interdisciplinary field covering many areas, this guideline was prepared including 36 clinical questions (CQs). In the English version, therapies and managements for SAS, which were written from CQ16 to 36, were shown. The Japanese version was published in July 2020 and permitted as well as published as one of the Medical Information Network Distribution Service (Minds) clinical practice guidelines in Japan in July 2021.

Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020

The prevalence of sleep-disordered breathing (SDB) is reportedly very high. Among SDBs, the incidence of obstructive sleep apnea (OSA) is higher than previously believed, with patients having moderate-to-severe OSA accounting for approximately 20% of adult males and 10% of postmenopausal women not only in Western countries but also in Eastern countries, including Japan. Since 1998, when health insurance coverage became available, the number of patients using continuous positive airway pressure (CPAP) therapy for sleep apnea has increased sharply, with the number of patients about to exceed 500,000 in Japan. Although the “Guidelines for Diagnosis and Treatment of Sleep Apnea Syndrome (SAS) in Adults” was published in 2005, a new guideline was prepared to indicate the standard medical care based on the latest trends, as supervised by and in cooperation with the Japanese Respiratory Society and the “Survey and Research on Refractory Respiratory Diseases and Pulmonary Hypertension” Group, of Ministry of Health, Labor and Welfare and other related academic societies, including the Japanese Society of Sleep Research, in addition to referring to the previous guidelines. Since sleep apnea is an interdisciplinary field covering many areas, this guideline was prepared including 36 clinical questions (CQs). In the English version, therapies and managements for SAS, which were written from CQ16 to 36, were shown. The Japanese version was published in July 2020 and permitted as well as published as one of the Medical Information Network Distribution Service (Minds) clinical practice guidelines in Japan in July 2021.

Quality of clinical practice guidelines in Japan remains low: A cross-sectional meta-epidemiological study

ObjectivesWe aimed to evaluate the characteristics, quality, and related factors of the Japanese Clinical Practice Guidelines (CPGs) published in recent years. Study design and settingIn this cross-sectional, meta-epidemiological study, we conducted a Google search for CPGs published by 30 Japanese medical societies that are the basis for training specialties between 2018 and 2019. We used the Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool and the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement to evaluate the quality. ResultsWe included 53 systematic review-based CPGs. The median score was 0.54 (IQR, 0.38-0.62) for Stakeholder involvement, 0.57 (IQR, 0.51–0.66) in Rigor of development, 0.33 (IQR 0.21–0.46) in Applicability, and 0.63 (IQR 0.46–0.73) in Editorial independence. The number of guideline developers/clinical question ratio (odds ratio [OR]: 4.14, 95% confidence interval [CI]: 1.97, 8.70) and the adopted guideline development methods (OR: 3.69, 95% CI: 1.14, 12.0) were significantly related to the Rigor of development. ConclusionThe quality of Japanese CPGs published in recent years remains low. Our study suggests that increasing contributors and adopting the latest guideline development methods at the beginning of the project may improve the quality of the Japanese CPGs.

Financial conflicts of interest between pharmaceutical companies and the authors of urology clinical practice guidelines in Japan.

In Japan, the authors of urology clinical practice guidelines (UCPG) used in patient-centered care are often targeted by pharmaceutical companies with financial payments. However, the financial relationship between UCPG authors and pharmaceutical companies remains unclear. This study aimed to determine the characteristics of industry payments to physicians that may influence recommendations in UCPG and to assess the transparency of payment disclosure. We considered 193 UCPG authors receiving payments from 79 companies between 2016 and 2017 and the 13 UCPG published by the Japanese Urological Association between 2015 and 2018. We determined 2-year combined mean and median payments to authors, total company payments, and associations between author attributes and payment values using multivariate negative binomial regression. Also, we assessed the extent of the financial disclosure policies among the 13 UCPG. Overall, 171 (88.6%) authors received payments with a combined value of $6,169,333. Median and mean payments were $7147 (interquartile range, $1512-$44,807) and $31,965 (standard deviation, $51,684), respectively. University professors working on multiple UCPG with new drug approvals were associated with higher payments. Twelve (92.3%) UCPG failed to disclose financial conflicts. While it remains unclear whether financial entanglements improperly influence the contents of UCPG, most Japanese authors received substantial payments from pharmaceutical companies with little or no disclosure. Because insufficient transparency in disclosure of these financial entanglements may compromise the integrity of UCPG, more rigorous regulation and greater disclosure of financial conflicts of interest are needed.

Clinical practice guidelines for diagnosis and treatment of chronic tinnitus in Japan

Clinical practice guidelines in Japan for tinnitus were published in May 2019. Effective treatment of tinnitus contributes to quality of life and may improve depression, anxiety, and cognitive function. The highest priority of treatment recommended by this guideline involves educational counseling, including an explanation of the mechanisms of tinnitus. Understanding tinnitus pathology has also been reported to be a therapeutically effective educational counseling strategy. Further, explaining how sound therapy such as tinnitus retraining therapy (TRT) works is effective. Psychological and cognitive behavioral therapies may be an option. Here, the hearing aid is coupled with a sound generator in order to administer sound therapy for patients with more-severe symptoms. In Japan, it can be difficult to perform psychotherapy alongside otorhinolaryngology, and exemplary sound therapy is more likely to be carried out. In any case, the purpose of treatment is not to eliminate tinnitus, but rather reduce distress that manifests in response to tinnitus by promoting sensory adaptation. Clinically, the most important subject is not the loudness of tinnitus, but the severity of tinnitus distress.TRT consists of educational counseling and sound therapy. The tinnitus handicap inventory (THI) is used to measure the distress level for tinnitus and to determine treatment priorities. Rehabilitation of tinnitus is important because anxiety and depression are often observed in patients with severe tinnitus.Additionally, drug administration should be avoided. As a surgical treatment, a cochlear implant can affect tinnitus symptoms. It is essential to establish a treatment policy according to the disease condition and degree of distress.

Evaluation of Pharmaceutical Company Payments and Conflict of Interest Disclosures Among Oncology Clinical Practice Guideline Authors in Japan

Clinical practice guidelines (CPGs) are important in advancing the quality of medical care. Financial relationships between physicians and pharmaceutical companies may influence clinical practice. In accordance with the Japan Pharmaceutical Manufacturers Association guidelines for transparency, pharmaceutical company payments to physicians have been disclosed since 2013. The distribution of pharmaceutical company payments among CPG authors in Japan has not been studied. To determine the characteristics and distribution of payments made by pharmaceutical companies to authors of oncologic CPGs in Japan and to assess the transparency of policies associated with conflict of interest (COI) disclosures in CPGs. This retrospective cross-sectional study of 326 authors from 6 prominent oncologic CPGs from Japan included annual payment data for 2016 from 78 pharmaceutical companies during varying times from January 1, 2016, through September 30, 2017. Amount and proportion of payments made by pharmaceutical companies to the authors; amount and proportion of payments made to the authors of each guideline; and information on policies for disclosing COIs in CPGs (Japanese yen were converted to US dollars based on the February 20, 2019 exchange rate of 110 yen per 1 US dollar). Of 326 eligible authors, 255 (78.2%) received payments from pharmaceutical companies in 2016. The total number of payments was 3947, and the total amount was $3 444 193 (¥378 861 220), including $2 696 777 for speaking, $181 944 for writing, $554 381 for consulting, and $11 091 for unclear fees. The median payment amount was $3233 (interquartile range [IQR], $506-$10 873), and the mean (SD) payment amount was $10 565 ($20 059); 84 authors (25.8%) received more than $10 000. The largest proportions of CPG authors receiving at least 1 payment were those for gastric carcinoma (92%) and colorectal carcinoma (92%). The median payment was highest for authors of colorectal carcinoma guidelines ($7781; IQR, $2506-$18 633), whereas it was lowest for authors of pancreatic carcinoma guidelines ($2207; IQR, $304-$9240). Only breast carcinoma CPGs published the authors' individual COI disclosure in an identifiable matter; guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma CPGs did not have a COI disclosure section. Most oncologic CPG authors received payments from pharmaceutical companies, and COI disclosure methods appeared to be insufficient. Given the possibility of bias in guideline content if authors have any financial relationships with pharmaceutical companies, CPGs from Japan may require improved transparency.

Trends in descriptions of palliative care in the cancer clinical practice guidelines before and after enactment of the Cancer Control Act (2007): content analysis

BackgroundPalliative care was a priority issue in the Cancer Control Act enacted in 2007 in Japan, and this has resulted in efforts being made toward educational goals in clinical settings. An investigation of how descriptions of palliative care for the treatment of cancer have changed in clinical practice guidelines (CPGs) could be expected to provide a better understanding of palliative care-related decision-making. This study aimed to identify trends in descriptions of palliative care in cancer CPGs in Japan before and after enactment of the Cancer Control Act.MethodsContent analysis was used to count the lines in all relevant CPGs. We then compared the number of lines and the proportion of descriptions mentioning palliative care at two time points: the first survey (selection period: February to June 2007) and the second survey (selection period: February to December 2015). Descriptions from the CPGs were independently selected from the Toho University Medical Media Center and Medical Information Network Distribution Service databases, and subsequently reviewed, by two investigators.ResultsDescriptions were analyzed for 10 types of cancer. The proportion of descriptions in the first survey (4.4%; 933/21,344 lines) was similar to that in the second survey (4.5%; 1325/29,269 lines).ConclusionsAfter the enactment of the Cancer Control Act, an increase was observed in the number, but not in the proportion, of palliative care descriptions in Japanese cancer CPGs. In the future, CPGs can be expected to play a major role in helping cancer patients to incorporate palliative care more smoothly.

Current status of projects for developing cancer-related clinical practice guidelines in Japan and recommendations for the future

BackgroundThe current status and adoption of cancer-related clinical practice guidelines in Japan has not been elucidated yet. The purpose of this study was to propose roles and suggestions to develop future cancer-related clinical guidelines.MethodsA questionnaire consisting of four domains with a total of 17 questions was developed. We distributed the questionnaire to 28 specific academic organizations in Japan which have developed any cancer-related clinical practice guidelines and which were funded by the Ministry of Health, Labor, and Welfare.ResultsMost organizations have investigated nationwide dissemination and adoption of clinical practice guidelines. The rate of adoption in clinical practice was estimated at approximately ≥ 70%. However, organizations with smaller budgets reported surveying approximately 60% of the time, whereas the ones with larger budgets reported approximately 100% success in surveying about their guidelines. The presidents of the organizations agreed that a new organization operated directly by the national government was necessary.ConclusionIn Japan, to develop cancer-related clinical practice guidelines, a study of clinical validation is necessary. Sufficient funds must be available to support the project to maintain and revise the guidelines. Furthermore, legal and ethical issues should be solved before establishing any registry system.

日本における系統的レビュー(コクラン)と医療技術評価と診療ガイドライン

日本における系統的レビュー(コクラン)と医療技術評価と診療ガイドライン

Effects of postoperative administration of celecoxib on pain management in patients after total knee arthroplasty: study protocol for an open-label randomized controlled trial.

BackgroundMultimodal analgesia is achieved by combining different analgesics and different methods of analgesic administration, synergistically providing superior pain relief when compared with conventional analgesia. Multimodal analgesia can also result in reductions in the side effects and complications of analgesia, thereby improving patient safety. Preventive analgesia, treatment before initiation of the surgical procedure, has a potential to be more effective in reducing pain sensitization than treatment initiated after surgery. Multimodal analgesia that includes prophylactic administration of selective cyclooxygenase-2 (COX-2) inhibitors can improve postoperative pain and reduce opioid analgesic consumption after total knee arthroplasty (TKA). However COX-2 inhibitors are not approved for use as preventive analgesia in Japan. Thus, assessing the effectiveness of COX-2 inhibitors during the early postoperative period is important to establish clinical practice guidelines in Japan. This study was designed to examine the effects of celecoxib administration immediately after surgery, in addition to multimodal analgesia, on postoperative pain management after TKA.Methods/DesignThis randomized, prospective, open-label controlled study will include 120 patients undergoing unilateral TKA. All patients will routinely receive single injections of femoral and sciatic nerve blocks, along with postoperative patient-controlled analgesia (PCA) with fentanyl. Patients will be randomly assigned to receive or not receive immediate postoperative administration of celecoxib. The primary outcome is a visual analog scale (VAS) pain score the second day after surgery. Secondary outcomes include opioid consumption, VAS pain score for 7 days after surgery, range of knee motion, evaluation of sleep quality, overall evaluations by patients and physicians, rates of postoperative nausea and vomiting, and consumption of rescue analgesics.DiscussionThe objective of this study is to evaluate the effects of celecoxib administration immediately after surgery on pain after TKA surgery. A randomized controlled trial design will address the hypothesis that administration of oral celecoxib immediately after surgery, along with multimodal analgesia that includes peripheral nerve block and PCA, could reduce VAS pain score after TKA surgery.Trial RegistrationUMIN-CTR 000014624 (23 July 2014)

Erratum to: Questionnaire survey for the development and publication of cancer clinical practice guidelines in Japan

Erratum to: Questionnaire survey for the development and publication of cancer clinical practice guidelines in Japan

Questionnaire survey for the development and publication of cancer clinical practice guidelines in Japan.

To understand the current situation of the development and publication of cancer clinical practice guidelines and discuss an ideal structure in future. A questionnaire survey pertaining to the development and publication of cancer clinical practice guidelines was conducted with funding by a Health and Labour Sciences Research Grant. Respondents included presidents and chairpersons of academic societies developing guidelines and members of the Cancer Guidelines Committee of the Japan Society of Clinical Oncology who were specialists in various cancer sites. Concerning the question of funding for the development and publication of the guidelines, 80.7 % of respondents indicated that partial public funding is required. As for the flow of public funds, 80.4 % of respondents thought that funds should be distributed appropriately to each academic society by a third-party organization. Regarding the question about the publication of the guidelines, 82.5 % of respondents replied that a comprehensive publication site needs to be established. In terms of the choice of organization that would be responsible for setting up and managing this site, the responses varied as follows: "a newly established organization" (38.3 %); "Center for Cancer Control and Information Services" (29.8 %); "Japan Society of Clinical Oncology" (23.4 %); and "Medical Information Network Distribution Service" (23.4 %) (multiple answers allowed). While the guidelines should be developed voluntarily by each academic society, partial public funding is also considered to be necessary for maintaining the continuous revision process. As for the publication of the guidelines, the establishment of a new comprehensive publication site would improve user convenience.

Current situation of evidence-based clinical practice guidelines in Japan

要 旨目的 : 1999年, 厚生省 (当時) が優先疾患として選定した47疾患の科学的根拠に基づく診療ガイドライン作成状況について検討する. 方法 : 47疾患と, 厚生労働省科学研究費の支援があった5疾患について2012年1月末までに公表された初版治療ガイドラインの作成母体, 公開方法につき検討した. 結果 : 優先47疾患のうち, 医療提供者向け43疾患, 一般医家向け13, 一般向け7についてガイドラインが作成された. このうち医学雑誌または報告書のガイドラインは34疾患 (72%), 書籍として販売されたのは37疾患 (79%), ウェブサイトで公開されているもの26疾患 (55%) であった. また, EBM型は14疾患であった. 結論 : 厚労科研費による支援があった25疾患はすべてガイドラインが公開され, ガイドライン作成には費用の問題が大きいことが示唆された. 今後は, 諸外国と同様, 改訂に対応しやすいフリーアクセスのウェブサイト公開が有効と考えられた.

Opinions of Japanese rheumatology physicians regarding clinical practice guidelines

To examine the views of rheumatology physicians concerning clinical practice guidelines in Japan, and changes to them following the dissemination of new guidelines for rheumatoid arthritis (RA) in 2004. Two cross-sectional questionnaire surveys, the first conducted before publication of new evidence-based RA clinical practice guidelines and the second conducted after implementation. Rheumatology-focused practices in Japan. A random sample of physicians registered with the Japan Rheumatism Foundation who satisfied the registration criteria with regard to experience with RA care. The percentage of guideline users increased from 48 to 60% following publication of the new RA guidelines in 2004 (P < 0.01). The majority agreed that clinical practice guidelines support decision-making in practice, although the proportion of supportive responses decreased slightly in the second survey, from 83 to 77% (P < 0.01) for decision-making, while concern about restricting physician autonomy increased from 18 to 22% (P = 0.01). While only 39% of physicians felt that clinical practice guidelines would contribute to malpractice litigation, the proportion of physicians who were concerned that clinical practice guidelines would be used to bring legal action against providers was larger than that who expected they would defend providers (58 vs 30%, P < 0.001). Clinical practice guidelines are well accepted among Japanese rheumatology physicians, albeit that the proportion decreased slightly after the introduction of new guidelines. One reason for this may be concern about the use of the guidelines in malpractice litigation. To facilitate implementation, trends in physician support for the guidelines should be closely monitored.

Contributions of Clinical Epidemiologists and Medical Librarians to Developing Evidence-Based Clinical Practice Guidelines in Japan: A Case of the Treatment of Rheumatoid Arthritis

Contributions of Clinical Epidemiologists and Medical Librarians to Developing Evidence-Based Clinical Practice Guidelines in Japan: A Case of the Treatment of Rheumatoid Arthritis