Whither Cochrane?

The ouster of Professor Peter Gotzsche who headed the Nordic Cochrane Centre, from Cochrane, a respected international research organisation, has provoked a crisis of confidence in the organisation's future. Disputant and bystander reactions on this issue are presented, as well as concerns regarding conflicts of interest and the reliability of Cochrane reviews. Cochrane's crisis mirrors the larger crisis of confidence that pervades the entire enterprise of medical research. We note that within weeks after Gotzsche was expelled from Cochrane, the HPV vaccine (whose Cochrane review he had publicly criticised for conflicts of interest and poor science) received a license expansion in the United States that might be worth billions of dollars to the manufacturer. Finally, we suggest a variety of new approaches that could strengthen the value of Cochrane analyses, broaden Cochrane's approach to include additional methodologies, and enhance its independence from financial interests.

"Trust the researchers": flying in the face of evidence.

There are always rival hypotheses to explain away the one that is posited as the most likely to be true. Context and Occam's razor - the principle that among competing hypotheses, the one with the fewest assumptions should be selected - ultimately point to which hypothesis is the most likely to be true.

Truth in research labelling.

This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories. It addresses the several reservations of the World Association of Medical Editors (WAME) with citations of evidence for the petition's assertions. The report suggests that some medical journals are not unknowing victims but rather complicit enablers of the post hoc adjusted RCT results that they publish. Its closing remarks dwell on the negative impact that embrace of a neoliberal, anti-regulatory philosophy of government will likely have on any regulatory reform to promote the integrity of biomedical science and the future of evidence-based medicine.

Grade-induced beliefs about undergraduate generalist social work practice competency.

Standardized criterion-referenced achievement testing of undergraduate generalist social work knowledge based on correct answers to specific questions is compared to several norm-referenced measures of student learning, including student self-reports and the instructor-imposed cumulative grade point average (GPA). Two hypotheses are tested, namely, (a) norm-referenced measures systematically overstate content knowledge, and (b) student perception or belief about the ascribed meaning of the GPA inflates self-rated attainments. The implications of additional confirming evidence for the hypotheses are explored with a view to limiting the number of social workers with undergraduate degrees who are permitted to enter the field each year overconfident about their knowledge and practice capabilities.

Meta-analysis: Methods, strengths, weaknesses, and political uses.

The general methodology, strengths and weaknesses, and political uses of meta-analysis are examined. As a systematic study of all studies that have been conducted to answer a specific question or hypothesis, meta-analysis is strong in revealing structural flaws and sources of bias in primary research and in posing promising research questions for future study. It cannot exceed, however, the limits of what is reported by primary researchers. Meta-analysis is particularly challenged to quantify the size of a common effect of treatment across reported trials because of (1) the clinical diversity of the trials and (2) the myriad of potential differences among patients with varying characteristics within the trials. Without access to the original data of reported trials, meta-analysis cannot overcome the bias of underpowered trials toward overstatement of the size of main treatment effects, nor the tendency for such trials to falsely conclude there were no statistically significant adverse events. Although severely compromised by ghost-written or honorary-authored reports of primary research, meta-analysis can make use of its methods to focus on the conflicts of interest and likely sources of bias of such research and make known what precautions should be taken by would-be consumers. Examples show how meta-analysis has clarified thinking about the off-label use of selective serotonin reuptake inhibitors for treating child and adolescent depression, use of low-tidal volume respirator assistance for acute lung injury and acute respiratory distress syndrome patients, and the long-term use of COX-2 inhibitors for relieving arthritic pain. Recommendations are made for Congressional action.

Post-civil war adaptation and need in Managua, Nicaragua.

Within seven years after the end of the Nicaraguan civil war in 1990, forced migrants, whose lives had been most disrupted by the conflict, were self-settled in a squatter community in the capital city of Managua and lived in extreme poverty with minimal health, education, security and social service supports. Compared with voluntary migrant neighbours, whose lives had been less affected by the conflict, forced migrants exhibited equal clinically significant symptoms of physical and mental health and psychosocial maladaptation. These findings run counter to generally held theory and assumptions about the negative long-lasting effects of the trauma and stress of war, forced migration and resettlement. Explanations are offered to explain the discrepancies between theory and the study findings as well as the dominance of poverty and socioeconomic status. Implications are also drawn for increasing social support and other durable forms of assistance that emerge from the study as important to meeting the needs of equally poor and unhealthy forced and voluntary migrants in proliferating squatter communities throughout the Third World.