View in EDS

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Saved in:
Bibliographic Details
Title: Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).
Authors: Beard, David J (AUTHOR), Campbell, Marion K (AUTHOR), Blazeby, Jane M (AUTHOR), Carr, Andrew J (AUTHOR), Weijer, Charles (AUTHOR), Cuthbertson, Brian H (AUTHOR), Buchbinder, Rachelle (AUTHOR), Pinkney, Thomas (AUTHOR), Bishop, Felicity L (AUTHOR), Pugh, Jonathan (AUTHOR), Cousins, Sian (AUTHOR), Harris, Ian A (AUTHOR), Lohmander, L Stefan (AUTHOR), Blencowe, Natalie (AUTHOR), Gillies, Katie (AUTHOR), Probst, Pascal (AUTHOR), Brennan, Carol (AUTHOR), Cook, Andrew (AUTHOR), Farrar-Hockley, Dair (AUTHOR), Savulescu, Julian (AUTHOR)
Source: Lancet. 3/7/2020, Vol. 395 Issue 10226, p828-838. 11p.
Subjects: Placebos, Guidelines, Best practices, Experimental design, Clinical trials, Operative surgery, Medical protocols, Research funding
Abstract: Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
FullText Text:
  Availability: 0
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 142167633
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Beard%2C+David+J%22">Beard, David J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Campbell%2C+Marion+K%22">Campbell, Marion K</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Blazeby%2C+Jane+M%22">Blazeby, Jane M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Carr%2C+Andrew+J%22">Carr, Andrew J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Weijer%2C+Charles%22">Weijer, Charles</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cuthbertson%2C+Brian+H%22">Cuthbertson, Brian H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Buchbinder%2C+Rachelle%22">Buchbinder, Rachelle</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pinkney%2C+Thomas%22">Pinkney, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bishop%2C+Felicity+L%22">Bishop, Felicity L</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pugh%2C+Jonathan%22">Pugh, Jonathan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cousins%2C+Sian%22">Cousins, Sian</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Harris%2C+Ian+A%22">Harris, Ian A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lohmander%2C+L+Stefan%22">Lohmander, L Stefan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Blencowe%2C+Natalie%22">Blencowe, Natalie</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gillies%2C+Katie%22">Gillies, Katie</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Probst%2C+Pascal%22">Probst, Pascal</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brennan%2C+Carol%22">Brennan, Carol</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cook%2C+Andrew%22">Cook, Andrew</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Farrar-Hockley%2C+Dair%22">Farrar-Hockley, Dair</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Savulescu%2C+Julian%22">Savulescu, Julian</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 3/7/2020, Vol. 395 Issue 10226, p828-838. 11p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Placebos%22">Placebos</searchLink><br /><searchLink fieldCode="DE" term="%22Guidelines%22">Guidelines</searchLink><br /><searchLink fieldCode="DE" term="%22Best+practices%22">Best practices</searchLink><br /><searchLink fieldCode="DE" term="%22Experimental+design%22">Experimental design</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Operative+surgery%22">Operative surgery</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+protocols%22">Medical protocols</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=142167633
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S0140-6736(19)33137-X
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 11
        StartPage: 828
    Subjects:
      – SubjectFull: Placebos
        Type: general
      – SubjectFull: Guidelines
        Type: general
      – SubjectFull: Best practices
        Type: general
      – SubjectFull: Experimental design
        Type: general
      – SubjectFull: Clinical trials
        Type: general
      – SubjectFull: Operative surgery
        Type: general
      – SubjectFull: Medical protocols
        Type: general
      – SubjectFull: Research funding
        Type: general
    Titles:
      – TitleFull: Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Beard, David J
      – PersonEntity:
          Name:
            NameFull: Campbell, Marion K
      – PersonEntity:
          Name:
            NameFull: Blazeby, Jane M
      – PersonEntity:
          Name:
            NameFull: Carr, Andrew J
      – PersonEntity:
          Name:
            NameFull: Weijer, Charles
      – PersonEntity:
          Name:
            NameFull: Cuthbertson, Brian H
      – PersonEntity:
          Name:
            NameFull: Buchbinder, Rachelle
      – PersonEntity:
          Name:
            NameFull: Pinkney, Thomas
      – PersonEntity:
          Name:
            NameFull: Bishop, Felicity L
      – PersonEntity:
          Name:
            NameFull: Pugh, Jonathan
      – PersonEntity:
          Name:
            NameFull: Cousins, Sian
      – PersonEntity:
          Name:
            NameFull: Harris, Ian A
      – PersonEntity:
          Name:
            NameFull: Lohmander, L Stefan
      – PersonEntity:
          Name:
            NameFull: Blencowe, Natalie
      – PersonEntity:
          Name:
            NameFull: Gillies, Katie
      – PersonEntity:
          Name:
            NameFull: Probst, Pascal
      – PersonEntity:
          Name:
            NameFull: Brennan, Carol
      – PersonEntity:
          Name:
            NameFull: Cook, Andrew
      – PersonEntity:
          Name:
            NameFull: Farrar-Hockley, Dair
      – PersonEntity:
          Name:
            NameFull: Savulescu, Julian
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 07
              M: 03
              Text: 3/7/2020
              Type: published
              Y: 2020
          Identifiers:
            – Type: issn-print
              Value: 01406736
          Numbering:
            – Type: volume
              Value: 395
            – Type: issue
              Value: 10226
          Titles:
            – TitleFull: Lancet
              Type: main
ResultId 1