Biomedical subjects

Jane L Hall

Publications and source records attributed to Jane L Hall.

4 recordsLinked to original sources

PubMed2005

Evolution of methodological standards in surgical trials.

BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) Statement outlines acceptable ways of performing and reporting clinical trials. The objective of the present study was to identify evolving patterns in the methodological standards of surgical trials. METHODS: Compliance with 12 key standards from the CONSORT statement were evaluated in 490 trials published in either the ANZ Journal of Surgery or the British Journal of Surgery between January 1969 and December 2003. RESULTS: There has been an irregular but progressive improvement in the methodological standards of published trials. The criteria with the greatest improvement related to estimation of sample size, randomization, concealment of the allocated intervention, baseline comparisons, and the method of expressing outcomes. Compliance rates were <50% for three criteria during the last decade of the review, that is, concealment of the allocated intervention, blindness of assessment, and the method of expressing outcomes. CONCLUSION: The results of surgical trials need to be interpreted with care.

Australia↗

PubMed2002

Baseline comparisons in surgical trials.

INTRODUCTION: Baseline measurements are an essential component of clinical trials. They should establish that the groups involved are clinically equivalent so that any observed differences can be attributed to the intervention under evaluation. The objective of this study was to review the use of baseline comparisons in surgical trials. METHODS: A standardized format was used to evaluate 206 surgical trials published within 10 prestigious journals between January 1997 and December 1999. RESULTS: One hundred and fifty-one (73%) of the trials used the first table in the article to record baseline data. More than one-quarter of the trials declared less than five items and one-third of the trials inappropriately used 'P-values' as a measure of baseline equivalence. Only nine of the 54 multicentre studies (17%) mentioned the individual centres as possible confounding factors. DISCUSSION: Greater attention needs to be paid to baseline comparisons in surgical trials. One way of developing this type of critical ability is to use a checklist while reading a surgical trial of interest. Good resources include the CONSORT Statement by a group of prominent international biostaticians and the CLEAR (Critical Literature Evaluation and Research) Courses run by the Royal Australasian College of Surgeons.

Clinical Trials as Topic↗

PubMed2002

Randomization in surgical trials.

BACKGROUND: There are concerns that use of the term "randomized" conveys a form of legitimacy to surgical trials that may sometimes be inappropriate. The objective of this study was to review the nature and use of randomization techniques in surgical trials. METHODS: We evaluated aspects of the randomization process in 619 surgical trials published within 10 prestigious journals between January 1990 and December 1999. RESULTS: Only 33% of the published trials (202/619) adequately described a valid randomization process. Furthermore, 78% (484/619) did not declare the use or extent of a blinding technique and almost two-thirds of the published trials failed to state how they concealed the randomization process. CONCLUSIONS: Our study indicates that many published surgical trials ignore basic aspects of the randomization process. It is difficult for surgeons to have faith in trials that fail to demonstrate an unbiased allocation of patients and ignore the need to maintain some confidentiality about the allocation of patients into groups.

Humans↗

PubMedDate not supplied

The measurement of wound infection after breast surgery.

Infection in breast wounds often occurs in the form of cellulitis, but the conventional criteria for wound infection are the presence of either pus or a serous discharge containing pathogens. Wound scoring systems may offer a more quantitative and clinically relevant approach when evaluating the morbidity caused by infection in wounds. The aim of this study was to develop a wound scoring system for patients undergoing breast surgery. The components of previously described wound scoring systems were measured in 218 women undergoing nonreconstructive breast surgery. Using conventional criteria, the incidence of wound infection was 5.5% (12/218). However, 22% of the patients exhibited at least one sign of wound infection, and 11% of the patients received antibiotics for cellulitis without any other indication of a wound infection. The validity of the wound scoring system was supported by its strong content validity, the presence of construct validity as evidenced by concordance with the conventional criteria (p < 0.001), and criterion validity in the form of an association between the presence of a seroma and a positive wound score (p < 0.001). It was also noted that 27% of the patients with an appreciable wound score (more than 40 points) had cellulitis but did not satisfy the conventional criteria for a wound infection. In conclusion, it is advisable to use a wound scoring system that includes cellulitis when evaluating patients who have undergone breast surgery.

Aged↗