In pharmacoepidemiology, interest of studies conducted using real-world data has been increasing. RECORD-PE was developed as a reporting guideline specialized for pharmacoepidemiological studies conducted using routinely collected health data. RECORD-PE is a best practice guideline developed by the RECORD Steering Committee in order to cope with the complexity of research on pharmacoepidemiology which cannot be fully covered by STROBE and RECORD. RECORD-PE was endorsed by the International Society for Pharmacoepidemiology. We translated RECORD-PE checklist and explanation, and report it here with additional brief explanation about the situation in Japan. We hope that RECORD-PE will be widely disseminated to academic journal reviewers and readers and that the quality of reports on pharmacoepidemiological studies using routinely collected health data in Japan will improve.

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OBJECTIVE: To examine the effect of incentive spirometry (IS) on respiratory function after laparotomy.
DESIGN and PARTICIPANTS: This was a randomized controlled trial. Study participants were patients who underwent elective laparotomy with general anesthesia from September 20, 2015 to May 28, 2016.
INTERVENTION: All patients received a routine program to prevent pulmonary complication, including instructions for deep breathing and early ambulation. The intervention group was requested to use incentive spirometry for 10 breaths, 4 times per day from the first postoperative day to the seventh. We used Coach2（R) (PORTEX).
PRIMARY ENDPOINT: We assessed the recovery rate of the inspiratory capacity (IC) on the 3rd postoperative day (POD) relative to the preoperative IC. We further conducted exploratory analysis regarding the factors related to the recovery rate of the IC.
RESULTS: Each group consisted of 36 participants. The mean IC recovery rate on the 3rd POD was 54.1 ± 23.7% in the control group and 55.0 ± 22.5% in the intervention group (p = 0.86) without statistically significant difference. In the control group, the IC recovery rate on the 3rd POD was statistically significantly lower in the group with the initial walking day equal to or later than the 2nd POD than the group with the initial walking day equal to the 1st POD [40.9 ± 22.5%, 60.8 ± 21.7% (p = 0.015)], whereas there was no statistically significant difference in the intervention group [51.9 ± 27.3%, 55.9 ± 21.4% (p = 0.662)].
CONCLUSION: Postoperative treatment with IS of 10 breaths, 4 times per day did not improve the inspiratory capacity from the routine program group after laparotomy. IS training may potentially be preventing the effect from delay in ambulation. Further study specifically targeting patients who cannot ambulate early after operations is warranted.

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Purpose: To assess changes in the subjective effects of organizational patient advocacy services in the three years following the introduction of the new fee schedule for these services in registered Japanese hospitals.
Methods: The results of two self-administered questionnaire surveys were compared: the Central Social Insurance Medical Council (CSIMC) survey administered to 1,500 hospitals in November and December 2012 and the Japan Council for Quality Health Care (JQ) survey administered to 3,434 hospitals in March and April 2015. The surveys questioned basic information about the hospitals, and both surveys included seven items related to the subjective effects of the patient advocacy services in the hospital. The proportions of “Very true” and “Quite true” responses to these items were compared.
Results: The valid response rates were 28.6% (429/1,500) for CSIMC and 42.2% (1,450/3,434) for JQ. There was a significant difference between the two surveys (p = 0.007) in the response to “Effective for preventing the recurrence of complaints from patients and their families,” with a higher level of agreement in the later survey.
Conclusion: The finding demonstrated an improvement in patient advocacy services in the three years since the start of new Japanese medical fee schedule. It suggested that one of the expected roles of patient advocacy services is being provided in Japanese hospitals.

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The original report by the medical accident investigation committee for postoperative death with laparoscopic hepatectomy at Gunma University Hospital was considerably criticized for the reasons such as an addition of negligence. Even though it was in the middle of the unexpected confusion, such description was a misjudgment as an organization. There may be a number of backgrounds behind the criticism, but as one of the issues, there would be confusion between the committee report with the participation of external members and the hospital decision. This committee was a different establishment from an ordinary hospital medical accident investigation committee, but there were a number of aspects for improvement when re-examining the hospital medical accident investigation system along with the review of the investigation process. Since there was a delay to initially correspond with bereaved family during the confusion, explanation at the start of the survey and disclosure of medical records were also clearly documented in writing. It is now required to standardize a method or process in accident investigation. While making an effort to maintain common recognition among the relevant people for accident investigation in the hospital, we need to review assured correspondence at the time of accident.

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Background: In clinical situation, the medical professions who untrained how to handling of an infusion pump, make the infusion pump move for patient conveyance frequently. So we held “workshop for appropriate handling of an infusion pump” targeted for the medical professions. The purpose of this research will make the reaction of each profession after a workshop clear and get suggestion to future’s medical safety training. (Method) Participate profession were radiological technologist (n=51), medical technologist (n=41), physiotherapist (PT) (n=20), occupational therapist (OT) (n=9) and speech therapist (ST) (n=5). It was investigated about the current state and future’s match by a questionnaire after a workshop. (Results) All professions answered that the workshop was useful. By an answer about future, radiology technologist, “the current state is fine”, “air bubble mixture release” was half mostly. There were a lot of answers about “the current state is fine” of medical technologist. “Air bubble mixture release” was a lot of results significantly in PT OT ST.(Conclusion) A possibility that a handling skill of a infusion pump needed between the professions is different was suggested.

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Since FY2013, the Working Group (WG) on Health Operating Systems from Quality and Safety Perspectives and a To-be Operational Environment has been conducting investigations toward a safe work environment in health services. During FY2018, on June 29, 2018, a bill related to the Workstyle Reform Act was passed based on the Workstyle Reform Implementation Plan, which was finalized on March 28, 2017. Given the passing of the bill, we requested 47 prefectures to disclose information related to workstyle reform for health organizations and health professionals (hereinafter referred to as Health Organizations and Others), in accordance with the three-year on-site inspections of prefectural hospitals conducted from FY2014 by the Labour Standards Inspection Office. Through the inspections, the Office issued reform recommendation documents and instruction forms and requested the health organizations to submit reports on reforms. With the aim of exploring methods for making progress on the overall workstyle reform of Health organizations and Others, mainly including the long-term issue of the overwork of doctors, we checked the number of infringements and details found in the provided information against each article and paragraph of the Labour Standards Act and analyzed them. We also checked and analyzed the details of reform reports that had been submitted by health organizations in response to recommendations and instructions, as well as improvement reports submitted by the organizations in response to improvement instructions.
Given the above, for the 13th Academic Conference of the Japanese Society for Quality and Safety in Healthcare, to make progress on workstyle reform for Health Organizations and Others, a group of doctors, pharmacists, nurses, and labor and social security attorneys held a discussion regarding the checked and analyzed details to find methods for smoothly implementing workstyle reform by exploring the issues faced by health organizations. The discussion also looked at measures to be adopted from the perspective of the Labour Standards Act, which had undergone a drastic revision for the first time in the last 70 years.
The present paper reports the details presented at the 13th Academic Conference of the Japanese Society for Quality and Safety in Healthcare Working Group Plan 3.

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Safe insertion and management of central venous catheterization (CVC) is an important patient safety issue. Studies in several countries have shown that vascular access teams (VATs) are effective for maintaining patient safety. In this study, we reviewed VATs and their efficacy, and discussed the possibility of introducing VATs to Japan.
Although the precise efficacy of VATs remains unclear, some reports have indicated that they can decrease CVC complications and ensure good service quality. Introducing VATs to Japan might promote clinical practice reforms (work style reforms) and improve healthcare quality. Two problems must be overcome to introduce VAT to Japan: namely, the recruitment of vascular access specialists and education for novice team members. Referring to VAT recruitment in other countries can help in solving the recruitment problem. The education problem might be resolved via high quality education. To this end, we have created a new web-learning system that might help team members obtain expertise through step-by-step self-education.
Overall, we believe that introducing VAT will make significant contributions to healthcare quality and safety in Japan.

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This perspective focuses on followership to influence the performance of healthcare teams within patient safety context. Although followers have traditionally been underestimated in leadership-followership relations, and seen as simply passive recipients, leadership cannot be fully understood without an understanding of followership.
Followership does not imply blind obedience. Kelley’s model of followership categorized followers into five distinct styles; exemplary followers contribute with critical thinking, offering their opinions to their leaders, giving a good impact on their teams. However, as a human nature, receiving criticism is not pleasant experience for everyone, especially, when a person is tired or under a stressful environment. Conflict may arise among team members, when followers express their concerns threatening patient safety. Managing conflict is of great importance for patient safety, to reach agreement at higher levels. Healthcare professionals should behave as exemplary followers and not be afraid of conflict.
To be exemplary followers, healthcare professionals should be encouraged to learn non-technical skills. DESC Script, a TeamSTEPPS tool, and a mnemonic for: D = Describe the specific situation; E = Express your concerns about the action; S = Suggest other alternatives; C = Consequences, is very useful for consensus building among team members in daily practice.

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