Practice guidelines on endoscopic surgery for qualified surgeons by the endoscopic surgical skill qualification system: Introduction

The first edition of the Practice Guidelines on Endoscopic Surgery was published on September 1, 2008 and the second edition 6 years later in September 2014. The Guideline Committee for the revision work of the third edition started its activities in December 2015 under the guidance of former Professor Toshiaki Watanabe of the University of Tokyo. However, Dr. Watanabe passed away suddenly amid the revision, whereupon I, who was appointed vice-chairman of the committee, assumed his duties. I am pleased to report that the revision process has been successfully completed, and I offer my prayers for the repose of Dr. Watanabe's soul.

This guideline covers almost all departments where endoscopic and robotic surgery are used. It was not easy to create a guideline in a uniform format as was mentioned in the first and second editions. In addition, it became clear that it would be a challenging task to keep up with the ever-increasing speed of technological progress in endoscopic surgery by publishing the guidelines in paper format since robotic surgery will be covered by insurance in many areas when the contents of the guidelines are nearly finalized. As a result, we have decided to publish these guidelines only in electronic media and not in a paper format from this guideline onward.

Although there were some difficulties in implementing Minds2017, we were able to successfully complete the guidelines with the help of special advisors Dr. Takeo Nakayama (Department of Health Informatics, Kyoto University Graduate School of Medicine and School of Public Health) and Dr. Masahiro Yoshida (Department of HBP & Gastrointestinal Surgery, International University of Health and Welfare). We would like to once again express our gratitude and appreciation. After its publication, we will immediately start work on the remaining issues such as robotic surgery, and those revision results will be published on the web sequentially.

Finally, I would like to express my gratitude to all those who worked so hard on this revision and sincerely hope that this guideline will contribute to the safe spread of endoscopic surgery.

Masafumi Nakamura.

Chairman of the Guidelines Committee of JSES.

September 2019.

These guidelines are intended for the qualified surgeons accredited by the Endoscopic Surgical Skill Qualification System of the JSES or its equivalent.

The revised guidelines are expected to promote the safe and widespread use of endoscopic surgery, improve treatment outcomes, and further enhance patient benefits.

The JSES shall be responsible for the content of these guidelines. However, responsibility for treatment results should be attributed to the direct treating physician, and the JSES will not be held accountable.

❶Progress of preparation: The description method, certainty of the evidence, and strength of recommendation were standardized in consultation with the related academic societies, including The Japanese Urological Association, Japanese Society of Endourology, Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy, The Japanese Association for Chest Surgery, Japanese Hernia Society, and The Japanese Orthopedic Association.

❷Methods for setting clinical questions (CQs) and collecting evidence: Key clinical issues were determined for each area, and CQs were developed based on these issues. The specific procedure for setting a CQ is to extract the components of the CQ (PICO/P: patients, problem, population, I: interventions, C: comparisons, controls, comparators O: outcomes), then evaluate the relative importance of the extracted Os, and finally use the extracted components to create a sentence in the CQ. Keywords (Japanese and English) were then listed for each CQ, and a literature search was conducted. A literature search was conducted by Japan Medical Library Association. The references retrieved ranged from 1990 to 2017, but new references were added during the work at the discretion of the committee members.

(1) Literature Adoption Criteria.

The retrieved references were classified according to the following definition of certainty of the evidence and were determined for inclusion in their order of certainty.

(2) Literature Exclusion Criteria.

Genetic and animal studies were excluded.

❸Method of recommendation decision: The risk of bias, inconsistency of results, indirectness of PICO, lack of precision in results, publication bias, relevance, confounding factors, and dose–response gradient were respectively evaluated for the selected papers to determine the certainty of the evidence. The overall evidence was then finally described, a draft recommendation was submitted to the recommendation decision meeting, and a vote was conducted.

❹Voting format (adopting a recommendation decision method using a Grade grid): Participants in the voting were the executive committee members, cooperation committee members, and collaborators of each group, and evaluation committee members were not included in the voting.

Participants voted for one of the following options.

If more than half of the participants voted for one orientation (do/not do) and less than 20% voted for the opposite orientation, the orientation voted for by more than half was recommended. Furthermore, if 70% of the participants voted “strongly recommended,” it was considered a strong recommendation. In cases where the above distribution of votes was not obtained, the issue was discussed again, and a second ballot was conducted. Note that (e) (abstention) was excluded from the population when the votes were opened.

❺Preparation of explanatory note: The explanatory note was finalized based on the discussion in the recommendation decision meeting mentioned above and the voting results. The explanatory note was prepared to make these contents easy for readers to read and useful in clinical practice.

❶ After the final draft was prepared in each area, it was reviewed by the external evaluation committee members in charge of the corresponding area.

❷If necessary, approval was obtained from the board of professional societies and associations of the area.

❸A public hearing was held at the 31st Annual Meeting of the JSES (December 6–8, 2018).

❹Public comments were accepted on the HP from the end of August 2019 through mid-September 2019, and the response paper was prepared and released in December 2019.

❺The finalized guidelines were posted on the members-only webpage of JSES. The guidelines will not be sold as a general book.

❶ The guidelines developed by the professional societies and associations of the area are copyrighted by the societies and associations concerned (Japanese Society of Endourology, The Japanese Association for Chest Surgery).

❷The copyrights to guidelines other than the above are the property of the JSES.

The development of the guidelines was funded by JSES, Japanese Society of Endourology, Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy, The Japanese Association for Chest Surgery, and other related societies and associations, and no support was received from any other companies or organizations. In addition, the intentions and interests of the various societies and associations did not influence the final recommendation.

❶The contents will be promptly posted on the JSES website and disseminated to JSES members.

❷The guidelines are intended for qualified surgeons in the Endoscopic surgical skill qualification system by JSES or its equivalent and are not sold in book form.

❸The contents will be posted on the website of the EBM Medical Information Department (Minds) of Japan Council for Quality Health Care.

The Guideline Committee Executive Committee members have verified any possible financial conflicts of interest through self-reporting over the past 3 years.

Furthermore, at the recommendation decision meeting, academic conflicts of interest were declared for each vote, and members with academic conflicts of interest abstained from voting on the CQ in question.

The Guidelines Committee of JSES shall serve as the core organization tasked to revise this guideline within a 5-year target period. Those articles requiring prompt revision shall be addressed by posting such revisions on the website.

The following experts were asked to conduct a comprehensive external review using AGREE II.

Dr. Satoru Shikata (Hospital Director, Mie Prefectural Ichishi Hospital).

The points that were raised can be summarized as follows. These are valuable suggestions so we should therefore reflect them in the next revisions.

1) Regarding the description of “significant difference” in the explanatory note

Some areas have issued many statements such as “significantly different” or “significantly lower.” Because the presence or absence of statistically significant differences is not necessarily related to the magnitude of clinical importance, it would prove more helpful information for clinicians if the magnitude of effect (mean value, incidence rate, survival rate, etc.) for both groups is specifically presented for each outcome.

2) Establishment of primary and secondary outcomes (primary and secondary endpoints)

It is unclear what the primary and secondary endpoints were in several discussions.

Although it is assumed that the evidence level classification is based on the research design of the article on which the evidence is established, I think it is necessary to consider lowering the level of evidence for secondary endpoints even if these are the results of a randomized controlled trial or systematic review (even if the article on which the evidence is based is the same, the level of evidence differs for each endpoint).

3) Patient-centered outcomes

There are areas where patient-driven subjective assessment items such as postoperative pain, duration of suffering, and QOL are not addressed. I therefore think that patient's concerns might not be reflected in the recommendations.

4) Evaluation by AGREE II

As a reference, I evaluated the guidelines using AGREE II (https://www.agreetrust.org/agree-ii/, Japanese version; 2016.7 edition of EBM Medical Information Department of Japan Council for Quality Health Care), which is a generic tool for methodological evaluation of guideline quality. However, given the unique nature of this guideline, which is intended for the qualified surgeons in the Endoscopic surgical skill qualification system by JSES or its equivalent, there are limitations on using AGREE II for quality evaluation. In addition, it is not necessarily appropriate to score the number of compliance items (summary score) and compare them with other practice guidelines.

PDF for the Japanese version.

All the authors are in agreement with the content of the manuscript.

Dr. Masahiko Watanabe is an Editorial Board member of ASES Journal and a co-author of this article. To minimize bias, he was excluded from all editorial decision-making related to the acceptance of this article for publication.