Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404)
Introduction Successful completion of randomized controlled trials (RCT) is dependent on informed consent (IC) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed IC acquisition. Meth...
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| Veröffentlicht in: | Asian journal of endoscopic surgery 2015-11, Vol.8 (4), p.419-423 |
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| container_title | Asian journal of endoscopic surgery |
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| creator | Etoh, Tsuyoshi Inomata, Masafumi Watanabe, Masahiko Konishi, Fumio Kawamura, Yutaka Ueda, Yoshitake Toujigamori, Manabu Shiroshita, Hidefumi Katayama, Hiroshi Kitano, Seigo |
| description | Introduction
Successful completion of randomized controlled trials (RCT) is dependent on informed consent (IC) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed IC acquisition.
Methods
A 30‐institute RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage II/III colon cancer (JCOG0404: UMIN‐CTR C000000105). The success rate of obtaining IC, which was supported by a DVD that helped patients understand this trial, was evaluated in eight periods between October 2004 and March 2009. In addition, reasons for failed IC acquisition were identified from questionnaires.
Results
A total of 1767 patients were informed of their eligibility for the trial, and 1057 (60%) were randomly assigned to either the laparoscopic surgery (n = 529) or open surgery (n = 528) group. The success rate of IC acquisition ranged from 50% to 62% in eight periods. The most common reasons for failed IC acquisition were anxiety/unhappiness about the randomization, patients' preference for one form of surgery, and strong recommendations from referring doctors or relatives.
Conclusions
With the assistance of a DVD, high success rates of IC acquisition were obtained for an RCT of laparoscopic versus open surgery for stage II/III colon cancers. To obtain such a rate, investigators should make efforts to inform patients, their relatives, and referring doctors about the medical contributions a surgical RCT can make. |
| doi_str_mv | 10.1111/ases.12204 |
| format | Article |
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Successful completion of randomized controlled trials (RCT) is dependent on informed consent (IC) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed IC acquisition.
Methods
A 30‐institute RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage II/III colon cancer (JCOG0404: UMIN‐CTR C000000105). The success rate of obtaining IC, which was supported by a DVD that helped patients understand this trial, was evaluated in eight periods between October 2004 and March 2009. In addition, reasons for failed IC acquisition were identified from questionnaires.
Results
A total of 1767 patients were informed of their eligibility for the trial, and 1057 (60%) were randomly assigned to either the laparoscopic surgery (n = 529) or open surgery (n = 528) group. The success rate of IC acquisition ranged from 50% to 62% in eight periods. The most common reasons for failed IC acquisition were anxiety/unhappiness about the randomization, patients' preference for one form of surgery, and strong recommendations from referring doctors or relatives.
Conclusions
With the assistance of a DVD, high success rates of IC acquisition were obtained for an RCT of laparoscopic versus open surgery for stage II/III colon cancers. To obtain such a rate, investigators should make efforts to inform patients, their relatives, and referring doctors about the medical contributions a surgical RCT can make.</description><identifier>ISSN: 1758-5902</identifier><identifier>EISSN: 1758-5910</identifier><identifier>DOI: 10.1111/ases.12204</identifier><identifier>PMID: 26176956</identifier><language>eng</language><publisher>Japan: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Colectomy - methods ; Colonic Neoplasms - pathology ; Colonic Neoplasms - surgery ; Colorectal cancer ; Female ; Humans ; Informed Consent - statistics & numerical data ; Japan ; Laparoscopic surgery ; Laparoscopy ; Male ; Middle Aged ; Neoplasm Staging ; Patient Selection ; Prospective Studies ; randomized controlled trial ; Success ; success rate of informed consent ; Surgery</subject><ispartof>Asian journal of endoscopic surgery, 2015-11, Vol.8 (4), p.419-423</ispartof><rights>2015 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd</rights><rights>2015 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.</rights><rights>Copyright © 2015 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fases.12204$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fases.12204$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26176956$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Etoh, Tsuyoshi</creatorcontrib><creatorcontrib>Inomata, Masafumi</creatorcontrib><creatorcontrib>Watanabe, Masahiko</creatorcontrib><creatorcontrib>Konishi, Fumio</creatorcontrib><creatorcontrib>Kawamura, Yutaka</creatorcontrib><creatorcontrib>Ueda, Yoshitake</creatorcontrib><creatorcontrib>Toujigamori, Manabu</creatorcontrib><creatorcontrib>Shiroshita, Hidefumi</creatorcontrib><creatorcontrib>Katayama, Hiroshi</creatorcontrib><creatorcontrib>Kitano, Seigo</creatorcontrib><title>Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404)</title><title>Asian journal of endoscopic surgery</title><addtitle>Asian J Endosc Surg</addtitle><description>Introduction
Successful completion of randomized controlled trials (RCT) is dependent on informed consent (IC) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed IC acquisition.
Methods
A 30‐institute RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage II/III colon cancer (JCOG0404: UMIN‐CTR C000000105). The success rate of obtaining IC, which was supported by a DVD that helped patients understand this trial, was evaluated in eight periods between October 2004 and March 2009. In addition, reasons for failed IC acquisition were identified from questionnaires.
Results
A total of 1767 patients were informed of their eligibility for the trial, and 1057 (60%) were randomly assigned to either the laparoscopic surgery (n = 529) or open surgery (n = 528) group. The success rate of IC acquisition ranged from 50% to 62% in eight periods. The most common reasons for failed IC acquisition were anxiety/unhappiness about the randomization, patients' preference for one form of surgery, and strong recommendations from referring doctors or relatives.
Conclusions
With the assistance of a DVD, high success rates of IC acquisition were obtained for an RCT of laparoscopic versus open surgery for stage II/III colon cancers. To obtain such a rate, investigators should make efforts to inform patients, their relatives, and referring doctors about the medical contributions a surgical RCT can make.</description><subject>Adult</subject><subject>Aged</subject><subject>Colectomy - methods</subject><subject>Colonic Neoplasms - pathology</subject><subject>Colonic Neoplasms - surgery</subject><subject>Colorectal cancer</subject><subject>Female</subject><subject>Humans</subject><subject>Informed Consent - statistics & numerical data</subject><subject>Japan</subject><subject>Laparoscopic surgery</subject><subject>Laparoscopy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Patient Selection</subject><subject>Prospective Studies</subject><subject>randomized controlled trial</subject><subject>Success</subject><subject>success rate of informed consent</subject><subject>Surgery</subject><issn>1758-5902</issn><issn>1758-5910</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdks1u1DAUhSMEoqWw4QGQJTZlkdY_iT1ZVqN2JlWhiwGxtFznZuTisVM7Lkzfs--DM1NmgTe-sr9zzpXuLYqPBJ-RfM5VhHhGKMXVq-KYiHpW1g3Brw81pkfFuxjvMeaCVOxtcUQ5Ebyp-XHxvEpaQ4woqBGQ75FxvQ8b6JD2LoIbkdIPyUQzGu-Qch3qlR59iBNoEzht3BoNKoxGm0HtKJNBtEk2P2UDCNnbdX5jnvauY_DW5nIMRtkp0qqs91H7wWj0CCGmiPwADsUU1hC2KHeE4qjWgNr2vG3b7GJzjlZOZ_ccd50dHDq9nt8ucIWrL--LN72yET683CfFj6vL7_NleXO7aOcXN6WpcFOVDW6E7pkSvcCcEgG0oj3vesCi0ZgIDGomGNCG3DHOuK5Uo6nGouO6I7qn7KQ43fsOwT8kiKPcmKjBWuXApyjzACirGZlVGf38H3rvU3C5u4kiDa855pn69EKluzwEOQSzUWEr_w0sA2QP_DYWtod_guW0CnJaBblbBXmxulztqqwp9xoTR_hz0KjwS3LBRC1_flvIr82yulqylZyxv8zQuH8</recordid><startdate>201511</startdate><enddate>201511</enddate><creator>Etoh, Tsuyoshi</creator><creator>Inomata, Masafumi</creator><creator>Watanabe, Masahiko</creator><creator>Konishi, Fumio</creator><creator>Kawamura, Yutaka</creator><creator>Ueda, Yoshitake</creator><creator>Toujigamori, Manabu</creator><creator>Shiroshita, Hidefumi</creator><creator>Katayama, Hiroshi</creator><creator>Kitano, Seigo</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201511</creationdate><title>Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404)</title><author>Etoh, Tsuyoshi ; Inomata, Masafumi ; Watanabe, Masahiko ; Konishi, Fumio ; Kawamura, Yutaka ; Ueda, Yoshitake ; Toujigamori, Manabu ; Shiroshita, Hidefumi ; Katayama, Hiroshi ; Kitano, Seigo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i4094-9097cf3a7f706217e242f6dfe079c0170ea873e291b3636c4a9c2c07d6cd1cf23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Colectomy - methods</topic><topic>Colonic Neoplasms - pathology</topic><topic>Colonic Neoplasms - surgery</topic><topic>Colorectal cancer</topic><topic>Female</topic><topic>Humans</topic><topic>Informed Consent - statistics & numerical data</topic><topic>Japan</topic><topic>Laparoscopic surgery</topic><topic>Laparoscopy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Patient Selection</topic><topic>Prospective Studies</topic><topic>randomized controlled trial</topic><topic>Success</topic><topic>success rate of informed consent</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Etoh, Tsuyoshi</creatorcontrib><creatorcontrib>Inomata, Masafumi</creatorcontrib><creatorcontrib>Watanabe, Masahiko</creatorcontrib><creatorcontrib>Konishi, Fumio</creatorcontrib><creatorcontrib>Kawamura, Yutaka</creatorcontrib><creatorcontrib>Ueda, Yoshitake</creatorcontrib><creatorcontrib>Toujigamori, Manabu</creatorcontrib><creatorcontrib>Shiroshita, Hidefumi</creatorcontrib><creatorcontrib>Katayama, Hiroshi</creatorcontrib><creatorcontrib>Kitano, Seigo</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Asian journal of endoscopic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Etoh, Tsuyoshi</au><au>Inomata, Masafumi</au><au>Watanabe, Masahiko</au><au>Konishi, Fumio</au><au>Kawamura, Yutaka</au><au>Ueda, Yoshitake</au><au>Toujigamori, Manabu</au><au>Shiroshita, Hidefumi</au><au>Katayama, Hiroshi</au><au>Kitano, Seigo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404)</atitle><jtitle>Asian journal of endoscopic surgery</jtitle><addtitle>Asian J Endosc Surg</addtitle><date>2015-11</date><risdate>2015</risdate><volume>8</volume><issue>4</issue><spage>419</spage><epage>423</epage><pages>419-423</pages><issn>1758-5902</issn><eissn>1758-5910</eissn><abstract>Introduction
Successful completion of randomized controlled trials (RCT) is dependent on informed consent (IC) acquisition from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed IC acquisition.
Methods
A 30‐institute RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage II/III colon cancer (JCOG0404: UMIN‐CTR C000000105). The success rate of obtaining IC, which was supported by a DVD that helped patients understand this trial, was evaluated in eight periods between October 2004 and March 2009. In addition, reasons for failed IC acquisition were identified from questionnaires.
Results
A total of 1767 patients were informed of their eligibility for the trial, and 1057 (60%) were randomly assigned to either the laparoscopic surgery (n = 529) or open surgery (n = 528) group. The success rate of IC acquisition ranged from 50% to 62% in eight periods. The most common reasons for failed IC acquisition were anxiety/unhappiness about the randomization, patients' preference for one form of surgery, and strong recommendations from referring doctors or relatives.
Conclusions
With the assistance of a DVD, high success rates of IC acquisition were obtained for an RCT of laparoscopic versus open surgery for stage II/III colon cancers. To obtain such a rate, investigators should make efforts to inform patients, their relatives, and referring doctors about the medical contributions a surgical RCT can make.</abstract><cop>Japan</cop><pub>Blackwell Publishing Ltd</pub><pmid>26176956</pmid><doi>10.1111/ases.12204</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1758-5902 |
| ispartof | Asian journal of endoscopic surgery, 2015-11, Vol.8 (4), p.419-423 |
| issn | 1758-5902 1758-5910 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Colectomy - methods Colonic Neoplasms - pathology Colonic Neoplasms - surgery Colorectal cancer Female Humans Informed Consent - statistics & numerical data Japan Laparoscopic surgery Laparoscopy Male Middle Aged Neoplasm Staging Patient Selection Prospective Studies randomized controlled trial Success success rate of informed consent Surgery |
| title | Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404) |
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