Limits to clinical trials in surgical areas
Randomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Elsevier España
2011-01-01
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| Series: | Clinics |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322011000100027 |
| _version_ | 1818470659463839744 |
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| author | Marco Kawamura Demange Felipe Fregni |
| author_facet | Marco Kawamura Demange Felipe Fregni |
| author_sort | Marco Kawamura Demange |
| collection | DOAJ |
| description | Randomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed ''inferiority'' of surgical scientific works under the optics of the current quality criteria for a ''suitable'' clinical trial |
| first_indexed | 2024-04-13T21:40:11Z |
| format | Article |
| id | doaj.art-b967ac38859f45cca7884607b5bebd0e |
| institution | Directory Open Access Journal |
| issn | 1807-5932 1980-5322 |
| language | English |
| last_indexed | 2024-04-13T21:40:11Z |
| publishDate | 2011-01-01 |
| publisher | Elsevier España |
| record_format | Article |
| series | Clinics |
| spelling | doaj.art-b967ac38859f45cca7884607b5bebd0e2022-12-22T02:28:48ZengElsevier EspañaClinics1807-59321980-53222011-01-01661159161Limits to clinical trials in surgical areasMarco Kawamura DemangeFelipe FregniRandomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed ''inferiority'' of surgical scientific works under the optics of the current quality criteria for a ''suitable'' clinical trialhttp://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322011000100027Clinical TrialSurgeryRandomizationBlindingEvidence Level |
| spellingShingle | Marco Kawamura Demange Felipe Fregni Limits to clinical trials in surgical areas Clinics Clinical Trial Surgery Randomization Blinding Evidence Level |
| title | Limits to clinical trials in surgical areas |
| title_full | Limits to clinical trials in surgical areas |
| title_fullStr | Limits to clinical trials in surgical areas |
| title_full_unstemmed | Limits to clinical trials in surgical areas |
| title_short | Limits to clinical trials in surgical areas |
| title_sort | limits to clinical trials in surgical areas |
| topic | Clinical Trial Surgery Randomization Blinding Evidence Level |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322011000100027 |
| work_keys_str_mv | AT marcokawamurademange limitstoclinicaltrialsinsurgicalareas AT felipefregni limitstoclinicaltrialsinsurgicalareas |