Issues to debate on the Women's Health Initiative (WHI) study. Hormone replacement therapy: an epidemiological dilemma?

In July 2002 the data of the prematurely stopped Estrogen plus Progestin study of the Women's Health Initiative (WHI) were presented in the Journal of the American Medical Association. The results of the Heart and Estrogen/Progestin Replacement Study (HERS/HERS II) were published in the same issue. The results of WHI for healthy postmenopausal women often are interpreted to be in analogy with the HERS/HERS II results for postmenopausal women with established coronary heart disease. As a result of HERS/HERS II and WHI, use of HRT in general became questionable. This is an unjustified judgement of HRT in general. This synoptic review and criticism of both studies will show the methodological weaknesses and their consequences and the reasons for limited generalizability of the study results from WHI and HERS/HERS II on normal HRT users.     

Issues to debate on the Women's Health Initiative (WHI) study. Epidemiology or randomized clinical trials--time out for hormone replacement therapy studies?

Over the last 40 years, there has been increasing epidemiological evidence that post-menopausal treatment with sex steroids in physiological doses may reduce the relative risk of cardiovascular disease (CVD). These findings have been supported by biological studies showing favourable changes in cardiovascular risk factors with estrogen supplementation. The impact of the so-called 'healthy user' bias has been eagerly debated, and the results of the first and only randomized long-term clinical trial of HRT for primary prevention have therefore been long awaited. The dramatic decision to halt the Women's Health Initiative (WHI) study before completion came unexpectedly as the consequence of not only an increased risk of breast cancer but also increased occurrence of cardiovascular events with HRT. Due to the superior design of the study, the results from the WHI study have had an enormous impact on the clinical recommendations of HRT to post-menopausal women, concurrent with a degradation of evidence from observational studies. It is not very likely that other long-term randomized clinical trials (RCTs) will be completed and epidemiology has certainly been disreputed-so is this 'time out' for HRT studies?     

Autopsy today: an obsolete practice or an instrument for improving the quality of health care?

INTRODUCTION: Autopsies are a fundamental moment of clinical audit that have been progressively decaying. MATERIALS AND METHODS: The autoptic rates of 6 hospitals of Piedmont Region (1639 autopsies, years 1995-97) were calculated. The Positive Predictive Value and Sensitivity (indicators of concordance between clinical and autoptic diagnosis) were calculated for each diagnosis; all discrepancies were classified as type I (adverse impact on patient's survival) and type II (uncertain impact) clinical errors. The diagnostic performance of medical, surgical and emergency staffs were compared with one another. RESULTS: Autopsies are rarely performed on the patients who died in hospital (7.13%). Independently from the diagnosis, the global concordance expresses a Positive Predictive Value of 37.22% and a Sensitivity of 47.71%. 401 type I errors and 307 type II errors were found. The best performance is reached by emergency staff. AIM: To evaluate the use and the meaning of autopsies in today's Italian healthcare organisations.     

Health information on the internet: patient empowerment or patient deceit?

Internet is the biggest medical library in the world. It has transformed the way many health seekers find health information. Seekers on net have exponentially increased from 54 million in 1998 to 110 million in 2002 (U.S. figures) and are ever increasing. Act of looking for health or medical information is the third most popular activities online. Search engines are used by almost 81% of the e-patients to look for the information they want. Internet is fast becoming an influential force as more than 70% consumers say that the information on the net has influenced their treatment decisions. However, the reliability of all the health information available on the Internet is questionable. Numerous studies have indicated deficiencies in the quality of information on the Internet. Due to technical and commercial reasons, the results provided by various search engines can be potentially biased. Only about a quarter of health seekers thoroughly check the source, timeliness of information every time they search for health information. In fact, most adults from USA, Japan, France and Germany who participated in a recent survey thought online health care information to be trustworthy, of good quality, easy to understand and easy to find. Efforts are now being taken to ensure the quality of health information on the Internet. Patients need to be educated about the worthiness of a site and also be prescribed the right sites to be consulted for information.     

Division of labour within the visual system: fact or fiction? Which kind of evidence is appropriate to clarify this debate?

The perception versus action hypothesis of Goodale and Milner (Trends Neurosci 15:20–25, 1992) and Milner and Goodale (The visual brain in action. Oxford University Press, Oxford, 1995) postulated two different pathways within the visual system—one for action and one for perception. With the help of pictorial illusions, evidence for this dissociation was found in various studies. There is an ongoing debate, however, as to whether or not this evidence is biased by methodological issues. Indeed, relevant and decisive data can come only from those studies that (1) match conditions appropriately with respect to task demands, (2) use illusions that do not provide any potential obstacles for the hand, (3) do not risk that grasping is either memory driven (when the target is not visible) or online corrected (due to a direct comparison of the grip aperture with the size of the target object), (4) do not confound differences between perception and action conditions with differences in visual feedback, and (5) correct for differences in response functions between grasping and perception. In following all these points outlined above we found support for the perception versus action hypothesis: grip aperture follows actual size independent of illusory effects, while perceived length as indicated by finger–thumb span clearly was subject to the illusion.     

Systematic VIQ/PIQ differences on the WAIS: An artifact of this instrument?

Investigated the possibility that there exists a systematic VIQ/PIQ discrepancy on the WAIS that did not exist on the WBI or WBII. Five hundred and ten psychiatric patients who were referred for psychological testing were assigned randomly to one of three groups: Ss in Group 1 were administered the WAIS as a part of the test battery, Ss in Group 2 were administered the WBI and Ss in Group 3 were administered the WBII. Results indicated that the IQ scores provided by the WAIS were significantly (p < 0.01) lower than those provided by the other instruments and that a systematic VIQ/PIQ discrepancy in favor of the VIQ exists on this test, which was not found on the other instruments. Implications of these findings were discussed in regard to both clinical use of the WAIS and continuing research on its diagnostic utility.     

Are Inflammatory and Coagulation Biomarkers Related to Sleep Characteristics in Mid-Life Women?: Study of Women's Health Across the Nation Sleep Study

Study Objectives:

Inflammation and pro-coagulation biomarkers may be a link between sleep characteristics and risk for cardiometabolic disorders. We tested the hypothesis that worse sleep characteristics would be associated with C-reactive protein (CRP), fibrinogen, factor VIIc, and plasminogen activator inhibitor (PAI)-1 in a multi-ethnic subsample of mid-life women enrolled in the Study of Women''s Health across the Nation.

Design:

Cross-sectional.

Measurements and Results:

African American, Chinese, and Caucasian women (N = 340) participated in 3 days of in-home polysomnographic (PSG) monitoring and had measures of inflammation and coagulation. Regression analyses revealed that each of the biomarkers were associated with indicators of sleep disordered breathing after adjusting for age, duration between sleep study and blood draw, site, menopausal status, ethnicity, residualized body mass index, smoking status, and medications that affect sleep or biomarkers. Among African American women, those who had higher levels of CRP had shorter PSG-sleep duration and those who had higher levels of fibrinogen had less efficient sleep in multivariate models.

Conclusions:

These results suggest that inflammation and pro-coagulation processes may be an important pathway connecting sleep disordered breathing and cardiometabolic disorders in women of these ethnic groups and that inflammation may be a particularly important pathway in African Americans.

Citation:

Matthews KA; Zheng H; Kravitz HM; Sowers M; Bromberger JT; Buysse DJ; Owens JF; Sanders M; Hall M. Are inflammatory and coagulation biomarkers related to sleep characteristics in mid-life women?: Study of Women''s Health Across the Nation Sleep Study. SLEEP 2010;33(12):1649-1655.     

Health care in the information society: evolution or revolution?

This brief article is a commentary on the Haux et al. paper on Health Care in the Information Society: a prognosis for the year 2013. The commentary concentrates in particular on the underlying assumptions, which are at the core of the Haux et al. vision for healthcare in 2013. They assume that while there will be a shift towards increased patient-centred, community-based shared care, the underlying healthcare system will remain essentially the same. This commentary suggests that this is a conservative view and indeed questions its validity. Radical financial pressures to control costs as well as demands for equity fueled by more knowledgeable and better informed patients have the potential to bring about fundamental changes, with consequences for the way in which healthcare is delivered and in turn in how information and communications technologies are utilised.     

Bridging the transmission gap: an end to an important mystery of attachment research?

The authors provide a context for this special section by arguing that the attachment relationships of infancy fulfil an evolutionary role in ensuring that the brain structures that come to subserve social cognition are appropriately organised and prepared to equip the individual for the collaborative existence with other people for which his or her brain was designed. Processes as fundamental as gene expression or changes in receptor densities can be seen as direct functions of the extent of understanding of mental states provided by the caregiving environment. If the attachment relationship is indeed a major organiser of brain development, it is even more important to understand the processes that underpin the transgenerational transmission of attachment patterns. The contributions of the papers in the special section to understanding the role of reflective function in the development of attachment and social cognition are reviewed, and the implications for the development of both theory and practice are explored.     

Desquamation of the epithelium of the villi of the small intestine—an element of functional morphology or an artefact?

Summary As shown on rats, dogs, guinea pigs and monkeys, detachment of the epithelial layer from the stroma of intestinal villi with exposure of the stroma is actually an artefact. The latter may occur in autolysis, fixation and histological treatment of material. The normal interrelationship of the epithelium and the stroma may be obtained by fixation in a cooled solution or by stretching the intestine, thus prventing the villi from coming in contact with each other.(Presented by Active Member AMN SSSR V. N. Chernigovskii) Translated from Byulleten' Éksperimental'noi Biologii i Meditsiny Vol. 49, No. 5, pp. 114–119, May, 1960