Do Authors Report Surgical Expertise in Open Spine Surgery Related Randomized Controlled Trials?

Brief review

이 논문은 개방척추수술에 대한 무작위대조연구(RCT)에서 보고하는 수술적 기술의 quality를 체계적 문헌고찰을 통해 평가하는 논문 입니다.

2005년부터 2010년에 출판된 RCT논문 중 MEDLINE, Cochrane Library, EMBASE을 통해 검색된  논문을 가지고 사전에 설정한 inclusion, exclusion criteria에 맞추어 총 99개의 논문을 정했습니다 (method에 첨부된 flow chart참고).

이 99개의 RCT논문을 토대로 13개의 질문을 통해 논문에 보고된 내용의 quality를 평가하였습니다 (질문내용: 연구참여자들은 적절히 blinded 되었는가? 모든 치료법들은 무작위로 배정된 그룹에 동일하게 적용되었는가?등. 아래 bibliography에 링크된 사이트로 가서 본문 내용을 참고하세요).

평가결과, 전체의 10%에 해당하는 논문만이 learning curve와 관련하여 수술적 기술 및 경험을  설명한 것으로 나타났습니다.

개방척추수술에 대한 RCT논문에서 수술기술과 논문에 대한 정보는 거의 보고되어 있지 않으며, 이렇게 저자들이 기초적인 안전성 보호에 대해 보고하지 않으면 전문기술의 편차가 나타날 수도 있다는 결론 입니다.

*Title: Do Authors Report Surgical Expertise in Open Spine Surgery Related Randomized Controlled Trials?: A Systematic Review on Quality of Reporting

저자들은 무작위대조연구와 관련된 개방척추수술에서 수술적인 전문기술을 보고하는가?: 보고의 질에 대한 체계적 고찰.

*Authors: Jakob van Oldenrijk, Youri van Berkel, Gino M. M. J. Kerkhoffs, Mohit Bhandari, Rudolf W. Poolman

*Bibliography: Spine (Phila Pa 1976). 2013 May1;38(10):857-64.

STUDY DESIGN

A systematic review of published trials in orthopedic spine literature.

OBJECTIVE

To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) with special focus on the reporting of surgical skill or expertise (2005~2010).

SUMMARY OF BACKGROUND DATA

In spine surgery, a surgeon's skill and expertise is important role in the outcome of the procedure.

To appraise the reported treatment effect of spine surgery related RCTs adequately, any potential skill or experience bias must be reported.

METHODS

-MEDLINE, Cochrane Library, EMBASE were systematically searched for open spine surgery RCTs published (2005.1.1~2010.12.31)

>searching word: spine, surgery, spine surgery

>Inclusion criteria:

1) nonpharmaceutical RCT dealing with open surgical interventions of the spine on patients in an operating room.

(2) published between 2005.1.1~2010.12.31 in the English, French, German, or Dutch language.

>Exclusion criteria:

1) Percutaneous techniques

2) Studies dealing with animals, cadavers, manipulation, or acupuncture.

3) Studies summarizing results of a previously published study.

-To determined the quality of reporting eligible studies, using the checklist.

-The reporting of surgeons' skill and experience was scored additionally.

-Subsequently, all authors were surveyed to determine if any information on methodological safeguards was omitted from their reports.

-All data were analyzed in 2-year time frames.

RESULTS

-99 RCTs were included.

10 studies (10%) described surgical skill or experience, mostly as a description of the learning curve.

-The majority of publications were unclear about "concealment of treatment allocation" (77%), "blinding of participants" (68%), "blinding of outcome assessors" (77%), and "adhering to the intention-to-treat principle" (67%).

-Of the 99 surveys, we received 22 (22%) completed questionnaires.

In these questionnaires, information about essential methodological safeguards was often available, although not reported in the primary publication.

CONCLUSION

-In open spine surgery RCTs information on skill and experience is scarcely reported.

-Authors often fail to report essential methodological safeguards.

-Therefore these studies may be prone to expertise bias.