Kay Dickersin

The fellow eye in NAION: Report from the Ischemic Optic neuropathy decompression Trial Follow-up study

PURPOSEnTo examine the prevalence and incidence of second eye nonarteritic anterior ischemic optic neuropathy (NAION) and associated patient characteristics in patients enrolled in the Ischemic Optic Neuropathy Decompression Trial (IONDT) Follow-up Study.nnnDESIGNnRandomized clinical trial with observational cohort.nnnMETHODSnPatients randomized to optic nerve sheath decompression surgery or careful follow-up had a diagnosis of acute unilateral NAION, visual acuity between 20/64 and light perception, and were aged 50 years or older. Eligible patients who declined randomization or whose visual acuity was better than 20/64 were not randomized but followed as part of an observational cohort. Follow-up examinations took place at 3, 6, 12, 18, and 24 months and annually thereafter.nnnRESULTSnFour hundred eighteen patients were enrolled; 258 randomized and 160 observed. Previous NAION or other optic neuropathy was present in the fellow eye of 21.1% (88/418) of patients at baseline. Four patients developed optic neuropathy in the fellow eye at follow up that could not be conclusively diagnosed as NAION. New NAION in the fellow eye occurred in 14.7% (48/326) of patients at risk during a median follow up of 5.1 years. Randomized patients experienced a higher incidence (35/201; 17.4%) than nonrandomized patients (13/125; 10.4%). A history of diabetes and baseline visual acuity of 20/200 or worse in the study eye, but not age, sex, aspirin use, or smoking were significantly associated with new NAION in the fellow eye. Final fellow eye visual acuity was significantly worse in those patients with new fellow eye NAION whose baseline study eye visual acuity was 20/200 or worse.nnnCONCLUSIONSnFollow-up data from the IONDT cohort provide evidence that the incidence of fellow eye NAION is lower than expected: new NAION was diagnosed in 14.7% of IONDT patients over approximately 5 years. Increased incidence is associated with poor baseline visual acuity in the study eye and diabetes, but not age, sex, smoking history, or aspirin use.

Hormone replacement therapy, cancer, controversies, and women’s health: historical, epidemiological, biological, clinical, and advocacy perspectives

Routine acceptance of use of hormone replacement therapy (HRT) was shattered in 2002 when results of the largest HRT randomised clinical trial, the women’s health initiative, indicated that long term use of oestrogen plus progestin HRT not only was associated with increased risk of cancer but, contrary to expectations, did not decrease, and may have increased, risk of cardiovascular disease. In June 2004 a group of historians, epidemiologists, biologists, clinicians, and women’s health advocates met to discuss the scientific and social context of and response to these findings. It was found that understanding the evolving and contending knowledge on hormones and health requires: (1) considering its societal context, including the impact of the pharmaceutical industry, the biomedical emphasis on individualised risk and preventive medicine, and the gendering of hormones; and (2) asking why, for four decades, since the mid-1960s, were millions of women prescribed powerful pharmacological agents already demonstrated, three decades earlier, to be carcinogenic? Answering this question requires engaging with core issues of accountability, complexity, fear of mortality, and the conduct of socially responsible science.

Quantitative Impact of Including Consumers in the Scientific Review of Breast Cancer Research Proposals

OBJECTIVEnTo evaluate the impact of having breast cancer survivors with advocacy experience (consumers) participate as voting members of scientific review panels for proposals on breast cancer research. As major stakeholders, patients and other consumer advocates sought inclusion in all decision-making processes affecting funding of disease-targeted research.nnnMETHODnCross-sectional analysis of assigned proposal scores ranging from 5.0 (acceptable) to 1.0 (outstanding); before (prepanel) and after (postpanel) opinion questionnaires. Forty-six panels reviewed 2206 proposals for the Fiscal Year 1995 Department of Defense (DOD) Breast Cancer Research Program. Analyses were limited to the 42 panels scheduled to meet on site and the 2190 proposals scored by both participant groups. There were 85 consumers and 638 scientists. The main outcome measures were proposal merit scores (raw, overall, and participant-specific means) and opinions concerning perceived benefits and drawbacks of consumer involvement.nnnRESULTSnIn general, the voting patterns of consumers were similar to those of scientists. Final proposal scores were the same as those that would have been obtained without consumer voting for 76.2% of the proposals, more favorable for 15.2% of the proposals, and less favorable for 8.6% of the proposals. For all but 13 proposals, the difference was +/-0.1. Prepanel opinions regarding consumer involvement were generally positive. Prepanel and postpanel comparisons almost always showed that significantly greater proportions of participants had positive postpanel opinions than had negative postpanel opinions. Having consumers on review panels was reported to be beneficial (83.9% and 98.2% for scientists and consumers, respectively) and to not have drawbacks (74.7% and 87.3%, respectively).nnnCONCLUSIONSnOur results support continued participation of consumers in our peer review process. The DOD program can serve as a model for other research programs considering consumer involvement.

Defining race/ethnicity and explaining difference in research studies on lung function

The 2005 guidelines of the American Thoracic Society/European Respiratory Society recommend the use of race- and/or ethnic-specific reference standards for spirometry. Yet definitions of the key variables of race and ethnicity vary worldwide. The purpose of this study was to determine whether researchers defined race and/or ethnicity in studies of lung function and how they explained any observed differences. Using the methodology of the systematic review, we searched PubMed in July 2008 and screened 10 471 titles and abstracts to identify potentially eligible articles that compared “white” to “other racial and ethnic groups”. Of the 226 eligible articles published between 1922 and 2008, race and/or ethnicity was defined in 17.3%, with the proportion increasing to 70% in the 2000s for those using parallel controls. Most articles (83.6%) reported that “other racial and ethnic groups” have a lower lung capacity compared to “white”; 94% of articles failed to examine socioeconomic status. In the 189 studies that reported lower lung function in “other racial and ethnic groups”, 21.8% and 29.4% of explanations cited inherent factors and anthropometric differences, respectively, whereas 23.1% of explanations cited environmental and social factors. Even though researchers sought to determine differences in lung function by race/ethnicity, they typically failed to define their terms and frequently assumed inherent (or genetic) differences.

Development and implementation of a science training course for breast cancer activists: Project LEAD (leadership, education and advocacy development)

Objectiveu2002To develop and implement Project LEAD (leadership, education, and advocacy development), a science course for breast cancer activists.

Surgical treatments outcomes project for dysfunctional uterine bleeding (STOP-DUB): design and methods

The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) was a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief. Resource centers included a coordinating center, a chairs office, the American College of Obstetricians and Gynecologists, the Agency for Healthcare Research and Quality Project Office and 33 clinical centers in the United States and Canada. STOP-DUB enrolled: (1) eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA and (2) an observational cohort of patients who were provisionally ineligible or who were eligible but did not wish to be randomized. Enrollment began in October 1997 and ended in June 2001. The primary outcome addressed by the randomized trial was the impact of surgery on bleeding, pain, fatigue, and the major problem (symptom) that led the woman to seek treatment for her condition, measured 1 year following surgery. Additional outcomes included the impact of surgery at time points after 1 year; changes in quality of life, activity limitation, sexual functioning, and urinary incontinence; surgical complications; additional surgery; and resource utilization. The costs and the relative cost-effectiveness of the two surgeries were calculated. The main scientific objective for the observational study was to examine changes over time in terms of treatment selected, DUB-related symptoms, and quality of life.

Surgical quality assurance in the Ischemic Optic Neuropathy Decompression Trial (IONDT).

The purpose of this article is to report the methods and results of the surgical quality assurance program associated with the Ischemic Optic Neuropathy Decompression Trial (IONDT). A surgical quality assurance committee developed and implemented a quality assurance program for a randomized clinical trial requiring surgical intervention. A surgical technique questionnaire was administered at two times during the study course, and maintenance of surgeon certification required submission and approval of a masked videotape of an optic nerve sheath decompression surgery by each study surgeon. Surgical quality was assessed through completion of surgical report forms and standardized, masked review of operative notes. Rates of compliance and intra- and interreviewer agreement were assessed for each aspect of the program. Twenty-five of 32 surgeons (81%) successfully completed and maintained certification. Item agreement varied from 21-92% among reviewers of satisfactory videotapes and 22-89% on unsatisfactory videotapes. Intrarater agreement for videotape acceptability was 11 of 13 (85%), and for specific surgical steps, 147 of 182 (81%). Operative notes were submitted for 123 of 125 (98%) patients receiving surgery. Interrater agreement on individual items ranged from 73-100%. Classification of individual items was identical on first and second review for 1285 of 1344 (95.6%) items. Overall agreement for individual reviewers was 93.8-97.8%. We conclude that use of a small peer review committee, which developed and oversaw a quality assurance program, allowed for consistent certification and monitoring of surgical performance. This in turn increased the credibility of the IONDT results, which demonstrated no difference in outcome between operated and unoperated groups of patients.

Purchasing oncology services: Summary recommendations

A multidisciplinary panel representing various stakeholders in the health care delivery and oncology services marketplace was convened to develop specific criteria for healthcare purchasers to consider when evaluating the structures and processes of health plans. These rank ordered criteria also can be used by oncologic service providers and health plan designers as a yardstick for the services they offer.