A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study

Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the “...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical medicine 2024-08, Vol.13 (17), p.5181
Main Authors: Zambonin Mazzoleni, Gabriele, Bergna, Andrea, Buffone, Francesca, Sacchi, Andrea, Misseroni, Serena, Tramontano, Marco, Dal Farra, Fulvio
Format: Article
Language:English
Subjects:
Bias
Clinical trials
Content analysis
Osteopathic medicine
Regression analysis
Reproducibility
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites cdi_FETCH-LOGICAL-c1341-3b9a4f09cb7338d3c6bb3e046da7d6bcd6b4ac1e9ce0fd2a66875734cea698073
container_end_page
container_issue 17
container_start_page 5181
container_title Journal of clinical medicine
container_volume 13
creator Zambonin Mazzoleni, Gabriele
Bergna, Andrea
Buffone, Francesca
Sacchi, Andrea
Misseroni, Serena
Tramontano, Marco
Dal Farra, Fulvio
description Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the “Open Science Framework (OSF)” website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being “other information” (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The “results” section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs.
doi_str_mv 10.3390/jcm13175181
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3104541952</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3104541952</sourcerecordid><originalsourceid>FETCH-LOGICAL-c1341-3b9a4f09cb7338d3c6bb3e046da7d6bcd6b4ac1e9ce0fd2a66875734cea698073</originalsourceid><addsrcrecordid>eNpdkd1KxDAQhYsouKhXvkDAG0GqSdM2rXdl8WdBWVj1ukzTqZulTWqSLqxv4Fsbfy7EgWEOzMfhwImiU0YvOS_p1UYOjDORsYLtRbOEChFTXvD9P_owOnFuQ8MURZowMYs-KjK3yisJPanG0YJyQZmOrHA01iv9SpQmK9CtGdQ7tmRutLem74N8tgp6RxZ6i86rV_iml86jGcGvlSSPoNU49eGxxUAj-AG1vyYVeUQP8QodgpVr8uSndnccHXTBDk9-71H0cnvzPL-PH5Z3i3n1EEvGUxbzpoS0o6VsBOdFy2XeNBxpmrcg2ryRYVOQDEuJtGsTyPNCZIKnEiEvCyr4UXT-4zta8zaF5PWgnMS-B41mcjVnNM1SVmZJQM_-oRszWR3SfVOUJYyWgbr4oaQ1zlns6tGqAeyuZrT-aqb-0wz_BA3Igls</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3104012109</pqid></control><display><type>article</type><title>A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study</title><source>Publicly Available Content Database</source><source>PubMed Central</source><creator>Zambonin Mazzoleni, Gabriele ; Bergna, Andrea ; Buffone, Francesca ; Sacchi, Andrea ; Misseroni, Serena ; Tramontano, Marco ; Dal Farra, Fulvio</creator><creatorcontrib>Zambonin Mazzoleni, Gabriele ; Bergna, Andrea ; Buffone, Francesca ; Sacchi, Andrea ; Misseroni, Serena ; Tramontano, Marco ; Dal Farra, Fulvio</creatorcontrib><description>Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the “Open Science Framework (OSF)” website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being “other information” (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The “results” section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p &lt; 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs.</description><identifier>ISSN: 2077-0383</identifier><identifier>EISSN: 2077-0383</identifier><identifier>DOI: 10.3390/jcm13175181</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Bias ; Clinical trials ; Content analysis ; Osteopathic medicine ; Regression analysis ; Reproducibility</subject><ispartof>Journal of clinical medicine, 2024-08, Vol.13 (17), p.5181</ispartof><rights>2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1341-3b9a4f09cb7338d3c6bb3e046da7d6bcd6b4ac1e9ce0fd2a66875734cea698073</cites><orcidid>0000-0002-9363-9190 ; 0000-0001-6034-0638 ; 0000-0002-2526-9642 ; 0000-0001-8431-600X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/3104012109/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/3104012109?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>315,786,790,25783,27957,27958,37047,37048,44625,75483</link.rule.ids></links><search><creatorcontrib>Zambonin Mazzoleni, Gabriele</creatorcontrib><creatorcontrib>Bergna, Andrea</creatorcontrib><creatorcontrib>Buffone, Francesca</creatorcontrib><creatorcontrib>Sacchi, Andrea</creatorcontrib><creatorcontrib>Misseroni, Serena</creatorcontrib><creatorcontrib>Tramontano, Marco</creatorcontrib><creatorcontrib>Dal Farra, Fulvio</creatorcontrib><title>A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study</title><title>Journal of clinical medicine</title><description>Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the “Open Science Framework (OSF)” website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being “other information” (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The “results” section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p &lt; 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs.</description><subject>Bias</subject><subject>Clinical trials</subject><subject>Content analysis</subject><subject>Osteopathic medicine</subject><subject>Regression analysis</subject><subject>Reproducibility</subject><issn>2077-0383</issn><issn>2077-0383</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><recordid>eNpdkd1KxDAQhYsouKhXvkDAG0GqSdM2rXdl8WdBWVj1ukzTqZulTWqSLqxv4Fsbfy7EgWEOzMfhwImiU0YvOS_p1UYOjDORsYLtRbOEChFTXvD9P_owOnFuQ8MURZowMYs-KjK3yisJPanG0YJyQZmOrHA01iv9SpQmK9CtGdQ7tmRutLem74N8tgp6RxZ6i86rV_iml86jGcGvlSSPoNU49eGxxUAj-AG1vyYVeUQP8QodgpVr8uSndnccHXTBDk9-71H0cnvzPL-PH5Z3i3n1EEvGUxbzpoS0o6VsBOdFy2XeNBxpmrcg2ryRYVOQDEuJtGsTyPNCZIKnEiEvCyr4UXT-4zta8zaF5PWgnMS-B41mcjVnNM1SVmZJQM_-oRszWR3SfVOUJYyWgbr4oaQ1zlns6tGqAeyuZrT-aqb-0wz_BA3Igls</recordid><startdate>20240831</startdate><enddate>20240831</enddate><creator>Zambonin Mazzoleni, Gabriele</creator><creator>Bergna, Andrea</creator><creator>Buffone, Francesca</creator><creator>Sacchi, Andrea</creator><creator>Misseroni, Serena</creator><creator>Tramontano, Marco</creator><creator>Dal Farra, Fulvio</creator><general>MDPI AG</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9363-9190</orcidid><orcidid>https://orcid.org/0000-0001-6034-0638</orcidid><orcidid>https://orcid.org/0000-0002-2526-9642</orcidid><orcidid>https://orcid.org/0000-0001-8431-600X</orcidid></search><sort><creationdate>20240831</creationdate><title>A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study</title><author>Zambonin Mazzoleni, Gabriele ; Bergna, Andrea ; Buffone, Francesca ; Sacchi, Andrea ; Misseroni, Serena ; Tramontano, Marco ; Dal Farra, Fulvio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1341-3b9a4f09cb7338d3c6bb3e046da7d6bcd6b4ac1e9ce0fd2a66875734cea698073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Bias</topic><topic>Clinical trials</topic><topic>Content analysis</topic><topic>Osteopathic medicine</topic><topic>Regression analysis</topic><topic>Reproducibility</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zambonin Mazzoleni, Gabriele</creatorcontrib><creatorcontrib>Bergna, Andrea</creatorcontrib><creatorcontrib>Buffone, Francesca</creatorcontrib><creatorcontrib>Sacchi, Andrea</creatorcontrib><creatorcontrib>Misseroni, Serena</creatorcontrib><creatorcontrib>Tramontano, Marco</creatorcontrib><creatorcontrib>Dal Farra, Fulvio</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection (Proquest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zambonin Mazzoleni, Gabriele</au><au>Bergna, Andrea</au><au>Buffone, Francesca</au><au>Sacchi, Andrea</au><au>Misseroni, Serena</au><au>Tramontano, Marco</au><au>Dal Farra, Fulvio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study</atitle><jtitle>Journal of clinical medicine</jtitle><date>2024-08-31</date><risdate>2024</risdate><volume>13</volume><issue>17</issue><spage>5181</spage><pages>5181-</pages><issn>2077-0383</issn><eissn>2077-0383</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>ObjectType-Review-3</notes><notes>content type line 23</notes><abstract>Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the “Open Science Framework (OSF)” website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being “other information” (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The “results” section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p &lt; 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs.</abstract><cop>Basel</cop><pub>MDPI AG</pub><doi>10.3390/jcm13175181</doi><orcidid>https://orcid.org/0000-0002-9363-9190</orcidid><orcidid>https://orcid.org/0000-0001-6034-0638</orcidid><orcidid>https://orcid.org/0000-0002-2526-9642</orcidid><orcidid>https://orcid.org/0000-0001-8431-600X</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 2077-0383
ispartof Journal of clinical medicine, 2024-08, Vol.13 (17), p.5181
issn 2077-0383
2077-0383
language eng
recordid cdi_proquest_miscellaneous_3104541952
source Publicly Available Content Database; PubMed Central
subjects Bias
Clinical trials
Content analysis
Osteopathic medicine
Regression analysis
Reproducibility
title A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-22T17%3A42%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Critical%20Appraisal%20of%20Reporting%20in%20Randomized%20Controlled%20Trials%20Investigating%20Osteopathic%20Manipulative%20Treatment:%20A%20Meta-Research%20Study&rft.jtitle=Journal%20of%20clinical%20medicine&rft.au=Zambonin%20Mazzoleni,%20Gabriele&rft.date=2024-08-31&rft.volume=13&rft.issue=17&rft.spage=5181&rft.pages=5181-&rft.issn=2077-0383&rft.eissn=2077-0383&rft_id=info:doi/10.3390/jcm13175181&rft_dat=%3Cproquest_cross%3E3104541952%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c1341-3b9a4f09cb7338d3c6bb3e046da7d6bcd6b4ac1e9ce0fd2a66875734cea698073%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3104012109&rft_id=info:pmid/&rfr_iscdi=true