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Kathleen Cranley Glass

Publications and source records attributed to Kathleen Cranley Glass.

16 recordsLinked to original sources
PubMed2005

Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials.

OBJECTIVE: To establish whether an association exists between use of selective serotonin reuptake inhibitors (SSRIs) and suicide attempts. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Medline and the Cochrane Collaboration's register of controlled trials (November 2004) for trials produced by the Cochrane depression, anxiety, and neurosis group. SELECTION OF STUDIES: Studies had to be randomised controlled trials comparing an SSRI with either placebo or an active non-SSRI control. We included clinical trials that evaluated SSRIs for any clinical condition. We excluded abstracts, crossover trials, and all trials whose follow up was less than one week. RESULTS: Seven hundred and two trials met our inclusion criteria. A significant increase in the odds of suicide attempts (odds ratio 2.28, 95% confidence 1.14 to 4.55, number needed to treat to harm 684) was observed for patients receiving SSRIs compared with placebo. An increase in the odds ratio of suicide attempts was also observed in comparing SSRIs with therapeutic interventions other than tricyclic antidepressants (1.94, 1.06 to 3.57, 239). In the pooled analysis of SSRIs versus tricyclic antidepressants, we did not detect a difference in the odds ratio of suicide attempts (0.88, 0.54 to 1.42). DISCUSSION: Our systematic review, which included a total of 87 650 patients, documented an association between suicide attempts and the use of SSRIs. We also observed several major methodological limitations in the published trials. A more accurate estimation of risks of suicide could be garnered from investigators fully disclosing all events.

Adult↗
PubMed2005

Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?

BACKGROUND: Aprotinin is a serine protease inhibitor used to limit perioperative bleeding and reduce the need for donated blood transfusions during cardiac surgery. Randomized controlled trials of aprotinin evaluating its effect on the outcome of perioperative transfusion have been published since 1987, and systematic reviews were conducted in 1992 and 1997. METHODS: A systematic search was conducted for all RCTs of aprotinin that used placebo controls or were open-label with no active control treatment. Data collected included the primary outcome, objective of each study, whether a systematic review was cited or conducted as part of the background and/or rationale for the study and the number of previously published RCTs cited. Cumulative meta-analyses were performed. RESULTS: Sixty-four randomized, controlled trials of aprotinin were found, conducted between 1987 and 2002, reporting an endpoint of perioperative transfusion. Median trial size was 64 subjects, with a range of 20 to 1784. A cumulative meta-analysis indicated that aprotinin greatly decreased the need for perioperative transfusion, stabilizing at an odds ratio of 0.25 (p < 10 - 6) by the 12th study, published in June of 1992. The upper limit of the confidence interval never exceeded 0.65 and results were similar in all subgroups. Citation of previous RCTs was extremely low, with a median of 20% of prior trials cited. Only 7 of 44 (15%) of subsequent reports referenced the largest trial (N = 1784), which was 28 times larger than the median trial size. CONCLUSIONS: This study demonstrates that investigators evaluating aprotinin were not adequately citing previous research, resulting in a large number of RCTs being conducted to address efficacy questions that prior trials had already definitively answered. Institutional review boards and journals could reduce the number of redundant trials by requiring investigators to conduct adequate searches for prior evidence and conducting systematic reviews.

Aprotinin↗
PubMed2004

Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials.

OBJECTIVE: To examine the reporting and success of double blinding in a sample of randomised, placebo controlled trials from leading general medicine and psychiatry journals. METHODS: Identification of placebo controlled, randomised controlled trials from prespecified general medical and psychiatric journals indexed on Medline between 1 January 1998 and 1 October 2001, from which a random sample of 200 randomised clinical trials was chosen, of which 191 trials were evaluated. RESULTS: Only seven of the 97 (7%) general medicine trials provided evidence on the success of blinding, with five reporting that the success of blinding was imperfect. In trials from psychiatric journals, the success of blinding was reported in eight of the 94 trials, with four reporting that the blinding was imperfect. Overall, only four of the 191 (2%) trials assessed blinding in the participants and either the outcome assessors or the investigators. CONCLUSIONS: The current lack of reporting on the success of blinding provides little evidence that success of blinding is maintained in placebo controlled trials. Trialists and editors should make a concerted effort to incorporate, report, and publish such information and its potential effect on study results.

Double-Blind Method↗
PubMed2002

Science and society: children and incompetent adults in genetic research: consent and safeguards.

Recent changes to the legal and ethical criteria that govern the inclusion of children and incompetent adults in genetic research are likely to lead to advances in research, but might leave the rights of the participants in this research in need of additional safeguards. Here, we discuss why this might be and propose policy considerations that could help to protect the rights of these particularly vulnerable groups of research participants.

Adolescent↗
PubMed2002

Ethical issues in neonatal intensive care: perspectives for the neurologist.

Intensive medical care for neonates may present medically complex and ethically challenging issues affecting not only patients but also their families and the professionals caring for them. The consulting neurologist working with these infants and their families is frequently a key figure in determining diagnoses and prognoses. This places the neurology specialist at the center of the process by which the treating team provides parents with appropriate information, collaborates with them in making medical and ethical decisions, and supports them through immeasurably difficult times.

Brain Damage, Chronic↗
PubMed2002

Learning from the experience of others: ethical issues surrounding the use of clinical data for teaching and other professional activities.

Effective education in medicine and other health sciences commonly relies on the use of clinical cases. This enables learners to advance their understanding of complex clinical problems. It also allows experienced clinicians to impart their knowledge of unusual problems or innovative approaches. Can the use without consent of private patient information be justified? This article reviews the practitioner's obligations toward confidentiality, and examines the ethical issues involved with the non-clinical use of information about patients. Strategies for ensuring sound ethical standards are recommended.

Biomedical Research↗