Improved Surgeon Performance in Clinical Trials: An Analysis of Quality Assurance Audits from the American College of Surgeons Oncology Group

You, Y. N.; Jacobs, Lisa K.; Martinez, Elizabeth D.; Budinger, Susan C.; Wittlief, E. Jean; Myles, Shelley K.; Ota, David M.

doi:10.1016/j.jamcollsurg.2006.05.298

Cited by 9 publications

(5 citation statements)

References 14 publications

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“…Two articles were unobtainable [16,17]. The three other search methods identified 28 articles, resulting in a total of 57 articles for assessment [4,6,11,18–71].…”

Section: Resultsmentioning

confidence: 99%

“…Two articles that related to the NCI cooperative groups overall [4,58] were not included in Table 2 as the monitoring practices were represented in publications from the individual cooperative groups. Nineteen (90%) articles were in relation to non-commercial research groups: nine articles from two cancer organisations (the NCI Clinical Trials Cooperative Groups [4,27,38,43,46, 58,66] and the European Organisation for Research and Treatment of Cancer (EORTC) [41,42]), five articles from other disease-specific research groups [23,33,62,64,71], and five articles from generic research organisations such as the US Department of Veterans Affairs (VA) and the UK Medical Research Council (MRC) [11,20,22,59,65]. Two articles related to the pharmaceutical industry [6,45].…”

Section: Resultsmentioning

confidence: 99%

“…Twenty-three publications (40%) described some perceived benefits or disadvantages of on-site monitoring for clinical trials. These benefits included identification of problems at sites, errors or confusion about the protocol [18,29,41,42], improved adherence to the protocol and GCP [43,58,65], opportunities to share best practice [46,70], identifying staff educational needs [22], and improved communication between study staff [55]. Reported disadvantages generally related to the financial costs and staff time spent on site visits [42,64,67].…”

Section: Resultsmentioning

confidence: 99%

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A systematic review of on-site monitoring methods for health-care randomised controlled trials

et al. 2013

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“…Two articles were unobtainable [16,17]. The three other search methods identified 28 articles, resulting in a total of 57 articles for assessment [4,6,11,18–71].…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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A systematic review of on-site monitoring methods for health-care randomised controlled trials

et al. 2013

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“…9 Participating in trials and outcomes databases is credited with decreasing morbidity and mortality after surgical procedures by identifying outliers and offering support for improving performance. 10,11 We recently reported on a prospective, ongoing data registry to assess morbidity and mortality after therapeutic bronchoscopic interventions. 12 This effort showed that prospective data collection is feasible and valuable.…”

Section: Resultsmentioning

confidence: 99%

A Multicenter, Prospective, Advanced Diagnostic Bronchoscopy Outcomes Registry

Ernst

Simoff

Ost

et al. 2010

Chest

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The expense for medical care is increasing rapidly in the United States. New diagnostic and therapeutic technologies are frequently cited as a signifi cant contributor to increasing health-care costs. New technologies are usually expensive and may be of either unproven benefi t or of unclear improved effi cacy as compared with existing conventional modalities. 1 It has therefore been proposed that devices undergo more rigorous comparative evaluation to better assess their use in order to justify reimbursement levels. 2 A good example of structured comparative effectiveness analysis exists in Great Britain, with the National Institute for Health and Clinical Excellence program. 3 This group reviews the available evidence for medical interventions, assesses the potential impact on the patients and health-care systems by calculating the price to be paid for a quality-adjusted life years, and then makes recommendations regarding coverage to the respective agency. Designing trials that enable proper comparative technology evaluation is complex and expensive and funding mechanisms at least for now are limited for this kind of important research. Also lacking are Background: Multiple new diagnostic bronchoscopic technologies are available, but little is known about their comparative performance and specifi c yield when adjusted for location of lesions, target size, and diagnosis. We present a multi-institutional prospective-outcomes database to assess diagnostic yields of advanced bronchoscopic procedures, as well as related morbidity and mortality. Methods: Data were extracted and reviewed from an ongoing, paper-based, prospective, multiinstitutional outcomes database for advanced diagnostic bronchoscopic procedures. All consecutive eligible patients are entered into this database, and information on demographics, procedure, and lesion characteristics as well as complications were documented. Descriptive statistical analyses were performed. Results: A total of 310 diagnostic procedures were performed over a 1-year period in four institutions by 15 different clinicians. The majority of the patients were white (66%), male (56%), former smokers (55%), with a mean age of 61 6 14 years. The average procedure time was 36 min, and the most common procedure was transbronchial needle aspiration (TBNA) (n 5 198). Nodal tissue was obtained in 82.3% from TBNA sampling with a mean of three passes using endobronchial ultrasound guidance with a 22-gauge needle and mostly without on-site cytology. The overall diagnostic yield for all procedures was 75%. There were few complications, and none required a change in disposition. Conclusions: Prospective and ongoing data analysis for bronchoscopic procedures is feasible and valuable. Lesion-adjusted diagnostic yields can be documented and potentially used for comparative assessment of different technologies and operators, as well as benchmarking and quality improvement initiatives. Extending the number of participating centers and web-based submission to minimize missing data components ...

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“…Our results also supported other studies on effectiveness of data auditing in medical research. Clinical trials funded by the National Cancer Institute are regularly audited and researchers exhibited improved compliance with protocols, had deeper knowledge of RDM and had higher data quality [ 5 , 6 ]. Routine data auditing of clinical quality registries helped to improve data quality as well [ 7 , 8 ].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of data auditing as a tool to reinforce good research data management (RDM) practice: a Singapore study

2021

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Background Institutions, funding agencies and publishers are placing increasing emphasis on good research data management (RDM). RDM lapses in medical science can result in questionable data and cause the public’s confidence in the scientific community to crumble. A fledgling medical school in a young university in Singapore has mandated every funded research project to have a data management plan (DMP). However, researchers’ adherence to their DMPs was unknown until the school embarked on routine data auditing. We hypothesize that research data auditing improves RDM awareness, compliance and reception in the school. Methods We conducted surveys with research PIs and researchers before and after data auditing to evaluate differences in self-reported RDM awareness, compliance and reception. As it is mandatory to deposit research data in a central data repository system in the school, we tracked data deposition by each laboratory from 2 weeks before to 3 months after data auditing as a marker of actual RDM compliance. Results Research data auditing had an overall positive effect on self-reported RDM awareness, compliance and reception for both research PIs and researchers. Research PIs agreed more that RDM was important to scientific reproducibility, were more aware of proper RDM, had higher RDM strength in their laboratories and were more compliant with the DMP. Both research PIs and researchers believed data auditing helped them to be more compliant with data deposition in the repository. However, data auditing had no significant impact on laboratories’ data deposition rates over time, which could be due to the short sampling period. Conclusions Research PIs and researchers generally felt that data auditing was effective in improving RDM practices. It helped to evaluate their RDM practices objectively, propose corrective actions for RDM lapses and spread awareness of the university’s data management policies. Our findings corroborated other studies in medical research, geosciences, engineering and ethics that data auditing promotes good RDM practices. Hence, we recommend research institutions worldwide to adopt data auditing as a tool to reinforce research integrity.

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Improved Surgeon Performance in Clinical Trials: An Analysis of Quality Assurance Audits from the American College of Surgeons Oncology Group

Cited by 9 publications

References 14 publications

A systematic review of on-site monitoring methods for health-care randomised controlled trials

A systematic review of on-site monitoring methods for health-care randomised controlled trials

A Multicenter, Prospective, Advanced Diagnostic Bronchoscopy Outcomes Registry

Effectiveness of data auditing as a tool to reinforce good research data management (RDM) practice: a Singapore study

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