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When should potentially false research findings be considered acceptable?

ABSTRACT: Ioannidis estimated that most published research findings are false, but he did not indicate when, if at all, potentially false research results may be considered as acceptable to society. We combined our two previously published models to calculate the probability above which research findings may become acceptable. A new model indicates that the probability above which research results should be accepted depends on the expected payback from the research (the benefits) and the inadvertent consequences (the harms). This probability may dramatically change depending on our willingness to tolerate error in accepting false research findings. Our acceptance of research findings changes as a function of what we call "acceptable regret," i.e., our tolerance of making a wrong decision in accepting the research hypothesis. We illustrate our findings by providing a new framework for early stopping rules in clinical research (i.e., when should we accept early findings from a clinical trial indicating the benefits as true?). Obtaining absolute "truth" in research is impossible, and so society has to decide when less-than-perfect results may become acceptable.

SUBMITTER: Djulbegovic B

PROVIDER: S-EPMC1808081 | biostudies-literature | 2007 Feb

REPOSITORIES: biostudies-literature

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When should potentially false research findings be considered acceptable?

Djulbegovic Benjamin B Hozo Iztok I

PLoS medicine 20070201 2

Ioannidis estimated that most published research findings are false, but he did not indicate when, if at all, potentially false research results may be considered as acceptable to society. We combined our two previously published models to calculate the probability above which research findings may become acceptable. A new model indicates that the probability above which research results should be accepted depends on the expected payback from the research (the benefits) and the inadvertent conse ...[more]

PMID: 17326703

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Project description:BACKGROUND:Surgical site infections (SSI) are associated with increased morbidity and mortality. To lower the incidence of SSI, antimicrobial prophylaxis is given 30-60 min before certain types of surgeries in both human and veterinary patients. However, due to the increasing concern of antimicrobial resistance, the benefit of antimicrobial prophylaxis in clean orthopaedic and neurosurgeries warrants investigation. The aims of this retrospective cross-sectional study were to review the rate of SSI and evaluate the compliance with antimicrobial guidelines in dogs at a veterinary teaching hospital in 2012-2016. In addition, possible risk factors for SSI were assessed. RESULTS:Nearly all dogs (377/406; 92.9%) received antimicrobial prophylaxis. Twenty-nine dogs (7.1%) did not receive any antimicrobials and only four (1.1%) received postoperative antimicrobials. The compliance with in-house and national protocols was excellent regarding the choice of prophylactic antimicrobial (cefazolin), but there was room for improvement in the timing of prophylaxis administration. Follow-up data was available for 89.4% (363/406) of the dogs. Mean follow-up time was 464 days (range: 3-2600 days). The overall SSI rate was 6.3%: in orthopaedic surgeries it was 6.7%, and in neurosurgeries it was 4.2%. The lowest SSI rates (0%) were seen in extracapsular repair of cranial cruciate ligament rupture, ulnar ostectomy, femoral head and neck excision, arthrotomy and coxofemoral luxation repair. The highest SSI rate (25.0%) was seen in arthrodesis. Omission of antimicrobials did not increase the risk for SSI (P?=?0.56; OR 1.7; CI95% 0.4-5.0). Several risk factors for SSI were identified, including methicillin-resistant Staphylococcus pseudintermedius carriage (P?=?0.02; OR 9.0; CI95% 1.4-57.9) and higher body temperature (P?=?0.03; OR 1.69; CI95% 1.0-2.7; mean difference +?0.4 °C compared to dogs without SSI). CONCLUSIONS:Antimicrobial prophylaxis without postoperative antimicrobials is sufficient to maintain the overall rate of SSI at a level similar to published data in canine clean orthopedic and neurosurgeries.

Project description:Auditory localization (i.e. turning the head and/or the eyes towards an auditory stimulus) is often part of the clinical evaluation of patients recovering from coma. The objective of this study is to determine whether auditory localization could be considered as a new sign of minimally conscious state, using a multimodal approach. The presence of auditory localization and the clinical outcome at 2 years of follow-up were evaluated in 186 patients with severe brain injury, including 64 with unresponsive wakefulness syndrome, 28 in minimally conscious state minus, 71 in minimally conscious state plus and 23 who emerged from the minimally conscious state. Brain metabolism, functional connectivity and graph theory measures were investigated by means of 18F-fluorodeoxyglucose positron emission tomography, functional MRI and high-density electroencephalography in two subgroups of unresponsive patients, with and without auditory localization. These two subgroups were also compared to a subgroup of patients in minimally conscious state minus. Auditory localization was observed in 13% of unresponsive patients, 46% of patients in minimally conscious state minus, 62% of patients in minimally conscious state plus and 78% of patients who emerged from the minimally conscious state. The probability to observe an auditory localization increased along with the level of consciousness, and the presence of auditory localization could predict the level of consciousness. Patients with auditory localization had higher survival rates (at 2-year follow-up) than those without localization. Differences in brain function were found between unresponsive patients with and without auditory localization. Higher connectivity in unresponsive patients with auditory localization was measured between the fronto-parietal network and secondary visual areas, and in the alpha band electroencephalography network. Moreover, patients in minimally conscious state minus significantly differed from unresponsive patients without auditory localization in terms of brain metabolism and alpha network centrality, whereas no difference was found with unresponsive patients who presented auditory localization. Our multimodal findings suggest differences in brain function between unresponsive patients with and without auditory localization, which support our hypothesis that auditory localization should be considered as a new sign of minimally conscious state. Unresponsive patients showing auditory localization should therefore no longer be considered unresponsive but minimally conscious. This would have crucial consequences on these patients' lives as it would directly impact the therapeutic orientation or end-of-life decisions usually taken based on the diagnosis.

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When should potentially false research findings be considered acceptable?

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When should potentially false research findings be considered acceptable?

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