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PubMed1997

Accumulating scientific evidence in cardiology with special reference to the Japanese contribution.

Clinical practice guidelines have been released as a current summary of the most recent scientific evidence in various areas. The paradigm by which evidence is regarded important is called evidence-based medicine (EBM). Sources of EBM are valid randomized controlled trials (RCT) and meta-analyses (MA). Only well-qualified studies should be used for the EBM. The characteristics for both RCTs and MAs are considered. controversial issues are also discussed, such as the safety of calcium channel blockers and the efficacy of magnesium for acute myocardial infarction. Finally, Japanese RCTs, either finished or ongoing, are summarized. International collaboration will become more important for registering and evaluating evidence followed by summarizing and updating the evidence.

Cardiology↗

PubMed1998

Coronary heart disease risk factors in women.

Despite the obvious predominance of coronary heart disease in middle-aged men, cardiovascular disease including coronary heart disease and cerebrovascular accidents is currently the major cause of death in women (54% cardiovascular mortality, 46% coronary mortality; 28% of all deaths). Before menopause, coronary heart disease is infrequent which suggests that female hormones and metabolism offer protection. Without hormone replacement therapy after menopause women may develop coronary atherosclerosis. Ageing is among the non-modifiable risk factors for coronary heart disease in women, while genetic predisposition and environmental factors remain controversial. The modifiable risk factors are mostly common to both sexes and include heavy cigarette smoking (especially in women under oral contraception) dyslipidaemia, high blood pressure, and diabetes; some factors are peculiar to women. The delayed onset of coronary heart disease in women, roughly 10 years later than in men, and greater feminine longevity (81 years vs 74 in men on average) points to the potential benefit of post-menopause hormone replacement therapy together with reduction of other modifiable risk factors. After menopause, the protective HDL cholesterol decreases whereas high LDL cholesterol, high triglycerides and high blood pressure are major risk factors for coronary heart disease as well as for cerebrovascular accident. The role of hormone replacement therapy in the prevention of cardiovascular disease in women is still controversial despite the results of meta-analyses which suggest a 25% to 44% reduction in coronary heart disease following oestrogen therapy alone or in combination with progestogen, depending on the hormonal regime. In conclusion, menopause, now considered as the marker for the end of natural protection against coronary heart disease, should be followed by early and prolonged combined hormone replacement therapy in order to reduce the low compliance with long-term hormone replacement therapy.

Aging↗

PubMed1998

Do beta-blockers prolong survival in chronic heart failure? A review of the experimental and clinical evidence.

The results of both experimental studies and clinical trials indicate that prolonged activation of the sympathetic nervous system can adversely affect the course of heart failure, and that this deleterious effect can be attenuated with the use of beta-blocking agents. Studies with beta-1 selective agents such as metoprolol and bisoprolol, have demonstrated that beta-blockers can reduce the risk of worsening heart failure but have shown little or equivocal effect on survival. In contrast, recent trials with non-selective vasodilating beta-blockers (i.e. carvedilol) have reported a reduction in the risk of both death and hospitalization. It is uncertain, however, whether these survival effects represent a class effect of beta-blockers or a specific effect of carvedilol. Carvedilol antagonizes several biological mechanisms (not blocked by metoprolol or bisoprolol) that may be important in mediating the progression of heart failure. In three meta-analyses, the survival effects of non-selective vasodilating beta-blockers (primarily carvedilol) were greater than those of beta-1 selective non-vasodilating beta-blockers. A clear answer to the question as to whether mortality reduction is a class effect of beta-blockers will be provided by several large-scale survival trials, which are currently in progress.

Adrenergic beta-Antagonists↗

PubMed1997

Maternal cocaine use and low birth weight newborns: a meta-analysis.

AIM/DESIGN: Many epidemiological studies published on the association between maternal cocaine/crack use and birth weight have either lacked precision or failed to control for major confounding, predominantly by tobacco smoking. Meta-analysis enables a single summary measure of effect to be calculated by combining data from any number of individual studies, thus enhancing statistical power. We undertook a number of meta-analyses using only studies that had adjusted for tobacco smoking to estimate more precisely the effect of maternal cocaine use on birth weight. FINDINGS: A meta-analysis of five studies presenting data for 'any' prenatal cocaine exposure, adjusted for tobacco smoking but unadjusted for gestational age, produced a pooled relative risk estimate from a fixed effects analysis of 2.15 (95% CI 1.75-2.64). However, there was substantial heterogeneity among studies (p < 0.001), and the relative risk from a random effects analysis was smaller (1.65) with a confidence interval that included unity (95% CI 0.94-2.83). Addition of a further study adjusted for gestational age had minimal effect on the pooled estimate: the fixed effects relative risk was 2.14 (1.77-2.60) and the random effects estimate 1.77 (1.15-2.71). When data on more intense prenatal exposure were analysed, the fixed and random effects analysis produced the same pooled estimate of the relative risk of 4.42 (2.24-8.71), suggesting that more frequent cocaine exposure was associated with a higher relative risk for low birth weight. Data from studies on mean reduction in birth weight produced a pooled estimate of 112 g (95% CI 62-161 g). CONCLUSIONS: The current study suggests that maternal cocaine use causes low birth weight, and that the effect is greater with heavier use. However, despite the adjustment for tobacco and the adjustment by some studies for other confounders such as race, maternal age, gravidity and socio-economic status, it could be argued that other life-style factors not controlled for may account for the observed effects. While this argument is not supported by some other types of study, the issue of residual confounding can only be finally addressed by analytical studies which adequately control for important variables.

Cocaine↗

PubMed1997

The relationship between maternal use of heroin and methadone and infant birth weight.

UNLABELLED: AIMS/DESIGN: Reduction in mean birth weight and increased incidence of low birth weight are both associated with exposure to illicit heroin in pregnancy. Many studies examining neonatal outcomes in pregnant heroin users treated with methadone report improvements in birth weight. As a consequence, methadone treatment has become the 'gold standard' for the management of the pregnant heroin user. However, not all studies report significant birth weight increases associated with methadone. We undertook a number of meta-analyses on reduction in mean birth weight and incidence of low birth weight to estimate more precisely the effect of illicit heroin and methadone. FINDINGS: Results showed mean reduction in birth weight associated with heroin use: 489 g (95% CI 284-693 g), compared with methadone: 279 g (229-328 g). Similarly, the pooled relative risk estimate for low birth weight for maternal heroin use was 4.61 (95% CI 2.78-7.65), compared with 1.36 (0.83-2.22) for methadone. Analysis of data on combined heroin and methadone use produced a pooled mean reduction in birth weight of 557 g (403-710 g), with a pooled relative risk estimate for low birth weight of 3.28 (2.47-4.39). Pooling 'any' methadone data, regardless of heroin use, produced an estimated reduction in birth weight of 395 g (311-478 g) and a relative risk estimate for low birth weight of 1.90 (1.29-2.81). Combining all data in an 'any' opiate use analysis also produced a mean reduction in birth weight of 483 g (386-583 g) and a relative risk estimate for low birth weight of 3.81 (2.57-5.65). CONCLUSIONS: The current findings suggest that heroin use while receiving methadone may counteract the birth weight advantage gained from methadone alone. Whether this is due to fetal exposure to heroin plus methadone, to reduced antenatal care, other behavioural and environmental factors associated with concurrent use of heroin and methadone or a combination of these is unclear. Nevertheless, these results challenge the current belief that the pregnant user is always better off receiving methadone than not, and suggests that methadone may not be the appropriate treatment for the pregnant women who continue to use illicit heroin.

Birth Weight↗

PubMed1998

Left ventricular hypertrophy: how to influence an important risk factor in hypertension.

LVH AND RISK: Left ventricular hypertrophy (LVH) is a powerful predictor of cardiovascular morbidity and mortality, independent from blood pressure and other cardiovascular risk factors. Available data indicate that patients who fail to achieve a reduction in LVH are much more likely to suffer cardiovascular events than those in whom LVH is reduced or even normalized using antihypertensive treatment. Reversal of LVH, therefore, represents a major goal in the treatment of hypertensive patients. REGRESSION OF LVH: Since obesity and dietary sodium intake may modulate the degree of LVH, non-pharmacological intervention has achieved a successful reduction in left ventricular mass (LVM). LVM is more closely related to 24-h blood pressure values than to clinical blood pressure values. Recent evidence from the Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation has shown that the regression of cardiac hypertrophy is predicted to a greater degree by the effect of antihypertensive treatment on 24-h average blood pressure than by that on clinic or home blood pressure. The increase in blood pressure variability may also be an independent determinant of cardiovascular target-organ damage, particularly of cardiac hypertrophy. However, the effects of antihypertensive drugs on blood pressure variability can be difficult to determine, mainly because a correct measurement of variability requires a beat-to-beat measurement of ambulatory blood pressure; several measures have been proposed to evaluate the smoothness of blood pressure control during antihypertensive treatment. Other important determinants of LVH reduction are represented by baseline values of LVM, extent of blood pressure reduction and duration of treatment. Furthermore, the degree of cardiac hypertrophy reduction is not the same for the different classes of antihypertensive drugs because, beyond the control of blood pressure, they may interfere differently with several non-haemodynamic stimuli, including the renin-angiotensin-aldosterone and the adrenergic systems or other growth factors. A more pronounced reduction in LVM with angiotensin converting enzyme inhibitors and calcium antagonists has been demonstrated in several recent meta-analyses. The results of further multicenter on-going trials are awaited to evaluate definitely whether various antihypertensive strategies differ in their ability to reverse LVH and to adequately assess the relationship between changes in LVM and subsequent prognosis, with serial control of blood pressure values measured in the clinic and by ambulatory monitoring.

Antihypertensive Agents↗

PubMed1998

Protocol for prospective collaborative overviews of major randomized trials of blood-pressure-lowering treatments. World Health Organization-International Society of Hypertension Blood Pressure Lowering Treatment Trialists' Collaboration.

OBJECTIVE: To conduct prospectively planned overviews (meta-analyses) of the ongoing randomized trials of blood-pressure-lowering drugs. These overviews should provide reliable data about the effects of newer classes of blood-pressure-lowering drugs (such as angiotensin converting enzyme inhibitors and calcium antagonists) on major causes of cardiovascular mortality and morbidity for a variety of patient groups. METHODS: A registry of major ongoing or planned randomized trials (with more than 1000 patient-years of follow-up for each randomized group) of blood-pressure-lowering agents has been established. The principal investigators of each of these studies have been invited to collaborate in the project and to provide, upon completion of the study, a limited data set for inclusion in the overview analyses. The principal comparisons will be of newer versus older classes of blood-pressure-lowering drugs in treating patients with hypertension and of newer blood-pressure-lowering treatments versus untreated or less treated control conditions for a variety of other groups of patients with a high risk of cardiovascular events. Separate analyses will be conducted for the main drug classes and for major subgroups of patients defined by characteristics such as age, gender, blood pressure, diabetes, and history of renal disease, coronary heart disease or cerebrovascular disease. The principal study outcomes are stroke, major coronary heart disease events, heart failure, total cardiovascular deaths, total cardiovascular events and total mortality. RESULTS: In total 36 trials of blood-pressure-lowering treatments potentially eligible for inclusion in this project have been identified and agreement to collaborate has been confirmed by the investigators in 30 trials, with collaboration pending for six recently identified studies. The first round of analyses will be conducted in 1999 and will be based on total cardiovascular events observed among a total of about 64,000 patients, involving about 240,000 patient-years of follow-up. The second round of analyses will be conducted in 2003 on data from at least 195,000 patients and 899,000 patient-years of follow-up. By that time it is estimated that a total of about 8000 strokes, 12,000 coronary heart disease events and 23,000 cardiovascular events in total will have occurred. This should provide good statistical power to detect even modest cause-specific differences in the incidence of the main study outcomes. CONCLUSIONS: The combination of trial results in prospectively planned, systematic overviews both reduces random errors and avoids biases. As a consequence, this project should provide more reliable information about the effects of newer blood-pressure-lowering drugs than would any one study alone. The use of data from individual patients in these overviews will facilitate investigation of the separate effects of various drug regimens in treating members of major patient subgroups.

Antihypertensive Agents↗

PubMed1998

Etoposide plus ifosfamide plus cisplatin in the treatment of small cell lung cancer.

Approximately 25% of all lung cancer cases diagnosed in 1993 were due to small cell lung cancer (SCLC). Approximately one third of all SCLC patients present with limited disease. Efforts to improve treatment results for patients with limited-stage SCLC include two recent meta-analyses of combined-modality treatment involving chemotherapy with thoracic radiotherapy versus chemotherapy alone. Both of these studies showed improvements in survival with the combined-modality approach. In addition, preliminary results of a Hoosier Oncology Group phase II study of cisplatin/ifosfamide/etoposide (VIP) in combination with thoracic radiotherapy in patients with limited disease indicate that VIP has an acceptable toxicity profile and should be studied further. For patients presenting with extensive-stage SCLC, several combination regimens have been shown to be effective in inducing responses of approximately 60%, although none has established superiority. Results of several studies evaluating the standard cyclophosphamide/doxorubicin/vincristine (CAV) regimen versus cisplatin-containing combination regimens have shown no obvious survival advantage of the cisplatin regimens over CAV. On the other hand, results of a Hoosier Oncology Group study of VIP versus cisplatin/etoposide in extensive-disease SCLC showed that overall survival favored (P = .044) the VIP arm (9.1 months v 7.3 months), although these results need to be confirmed in another trial.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1998

Who needs evidence-based health care?

The vast amount of published material in clinical and biomedical sciences, and conflicting results on diagnostic and therapeutic procedures may introduce doubts in decision-making for patient care. Information retrieving skills and the critical appraisal of published literature, together with elaboration of practice guidelines based on epidemiological methodology, form the basis of the trend towards evidence-based health care, which aims to overcome these problems. A survey conducted by questionnaire at the Chaim Sheba Medical Center analyzed which types of information sources are considered most relevant and useful for patient care by a cross-section of physicians with varying degrees of experience. They considered review articles and meta-analyses extremely reliable for information purposes, while for practical patient-care purposes they tended to rely more on the opinions of peers and experts. As the requirements of evidence-based health care may influence the attitudes of clinicians to the published literature and its evaluation, they have implications for medical libraries and information centers. Specifically, information specialists will be called upon more and more to impart information-retrieval and critical appraisal skills to clinicians. The involvement of information specialists in information gathering and selection will provide added value to the expertise and knowledge of in-house experts for decision-making.

Attitude of Health Personnel↗

PubMed1997

[Effect of protein restriction on deterioration of kidney function].

The results of meta-analyses and of the recent 'modification of diet in renal disease' study show that dietary protein restriction slows down deterioration of renal function in patients with a moderately impaired renal function. However, this effect appears to be less pronounced than previously assumed. Protein restriction probably leads to narrowing of the preglomerular blood vessel, which reduces the raised intraglomerular pressure. The resulting decrease in the filtering glomerular pressure initially leads to a slight loss of renal function, but there after to a decelerated deterioration of renal function. The aim should be a protein intake of 0.6-0.75 g per kg per day. Dietary compliance should not be predicted anamnestically but should be calculated according to the (modified) Maroni equation (protein intake = (0.18 x urinary urea excretion in mmol per 24 hours) + 15 + urinary protein excretion in g per 24 hours). This kind of protein restriction as a rule does not lead to nutritional deficiencies.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed1997

Lung cancer.

In small cell lung cancer (SCLC) combination chemotherapy including agents such as etoposide, teniposide, cisplatinum, carboplatin, and vincristine, doxorubicin, and cyclophosphamide, or ifosfamide continues to be the back-bone of therapy. The epipodophyllotoxin derivatives together with cisplatin or carboplatin are being used increasingly as part of the initial therapy, and these combinations are by most investigators considered standard therapy. Complete plus partial responses to combination therapy occur in 80-90% of all patients with a median duration of 9-12 months. The median survival in these studies is at present 11-18 months depending on the initial tumour stage. The 5-year survival data remain still around 5% including a small fraction of patients (2%) initially presenting with extensive disease. The tendency is to shorten the duration of treatment to 5-8 months. The results of intensifying the treatment with the use of haematopoietic growth factors continue to be disappointing, although these are not conclusive. With respect to squamous cell carcinoma, adenocarcinoma, and large cell carcinoma several meta-analyses indicate that there is a statistically significant, albeit small advantage favouring cisplatinum containing chemotherapy when added to surgery in stage I and II disease and to radiotherapy in stage III NSCLC. Similarly, cisplatin containing chemotherapy is statistically superior to best supportive care in stage IV disease. The results from the latter analyses are significant at 1 and 2 years, respectively, but not at 3 and 5 years of survival. These data must, however, be considered in the light of their clinical relevance and of the balance between quality of life, toxicity, and cost of chemotherapy. The results of recently published phase III trials in stage III disease support the use of combined modalities of chemotherapy and radiotherapy versus radiotherapy alone. For both small cell and non-small cell lung cancer a number of new agents have been evaluated over the last 2 to 3 years and among those navelbine, topotecan, gemcitabine, and taxanes (taxol and taxotere) have yielded the most encouraging results. For mesothelioma the therapeutic results are unchanged, and no standard chemotherapy has yet been developed.

Carcinoma, Non-Small-Cell Lung↗

PubMed1998

Which interventions for neonatal respiratory failure are effective?

AIM: To review the evidence from clinical trials of various interventions to treat and prevent respiratory failure in the neonate and to determine which interventions are effective and which require further study. METHODS: Randomized controlled trials and/or meta-analyses of trials of interventions for neonatal respiratory failure were sought from databases including the Cochrane Collaboration. The results were synthesized as typical relative risks and typical risk differences, with 95% confidence intervals (CI). RESULTS: The following interventions were effective: conventional mechanical ventilation (absolute reduction in mortality 12%, 95% CI 4-21%), continuous positive airway pressure (absolute reduction in mortality 15%, 95% CI 1-28%), surfactant therapy (absolute reduction in mortality 4 to 9%, 95% CI 1-13%), and extracorporeal membrane oxygenation (absolute reduction in mortality 29%; 95% CI 15-42%). High frequency oscillatory ventilation with a volume recruitment strategy and inhaled nitric oxide appeared promising, but have not yet reduced mortality. Prenatal corticosteroids (absolute reduction in mortality 4%; 95% CI 2-6%) and amnioinfusion (effect on mortality not yet possible to estimate) prevented respiratory failure, but routine endotracheal intubation and suctioning of the airways at birth in vigorous meconium-stained term babies did not prove effective. CONCLUSIONS: Assisted ventilation, surfactant therapy, and extra-corporeal membrane oxygenation are effective, but it is uncertain how each should be applied in an individual infant. More research is needed to evaluate combinations of effective interventions, and effectiveness of high frequency oscillation and inhaled nitric oxide. Routine intubation and suctioning of the airways at birth in meconium-stained vigorous neonates is not recommended.

Humans↗

PubMed1998

Revascularization in coronary artery disease. A review of randomized trial data.

Since the advent of bypass surgery in the late 1960s and catheter-based intervention in the late 1970s, the treatment of coronary artery disease has been revolutionized by the concept of revascularization. Surveys have demonstrated that the practice patterns around the world and within the US are inconsistent for these important treatment options and are often driven by availability and economics rather than evidence-based data. In addition, the studies examining the use of medical therapy, balloon angioplasty, atherectomy, coronary stenting, and bypass surgery are consistently lagging behind the technological advances in this field. This article reviews the data that randomized trials and meta-analyses provide to compare these modalities. We attempt to provide a framework for reasoned clinical decision making to help guide patient care. While the breakpoints between the medicine bottle, cath lab, and operating room will continue to evolve, we offer a revascularization strategy for patient subgroups based on what clinical data supports.

Angioplasty, Balloon, Coronary↗

PubMed1998

SSRIS versus tricyclic antidepressants in depressed inpatients: a meta-analysis of efficacy and tolerability.

A meta-analysis of the efficacy and tolerability of selective serotonin reuptake inhibitors (SSRIs) against nonselective and noradrenergic reuptake inhibitors (mainly tricyclic antidepressants, TCAs) in depressed inpatients was carried out. Twenty-five double-blind studies provided data on relative efficacy which was determined by a summary variance-weighted mean effect size calculated from the difference in the reduction in mean Hamilton Depression Rating Scale (HDRS) scores for the two antidepressants in each study. Twenty-three studies provided data on dropouts and relative tolerability which was determined as the variance-weighted pooling of the relative risk (RR) of dropout for all reasons and for adverse effects from each study. TCAs were significantly more effective than SSRIs (effect size = -0.23, 95% CI -0.40 to -0.05, P = 0.011), although sensitivity analyses by analysing larger studies (> 100 patients) and those providing complete data reduced the advantage to TCAs to a trend (P < 0.10). When the TCAs were grouped into those with dual action on 5-hydroxytryptamine (HT) and noradrenaline reuptake (clomipramine and amitriptyline) and those with predominantly noradrenaline reuptake (imipramine, desipramine and maprotiline), only the dual action TCAs had greater efficacy than SSRIs (effect size = -0.30, 95% CI -0.54 to -0.05, P = 0.017). When TCAs were considered individually, only amitriptyline was significantly more effective than comparator SSRIs (effect size = -0.37, 95% CI -0.67 to -0.07, P = 0.015). More patients overall discontinued treatment on TCAs than on SSRIs (29.0% vs. 25.5%), although this did not reach statistical significance (RR = 0.88, 95% CI 0.75 to 1.03, P = 0.121). However, significantly more patients stopped treatment due to adverse effects on TCAs compared to SSRIs (14.2% vs. 9.1%, RR = 0.66, 95% CI 0.50 to 0.87, P = 0.003) with no difference in discontinuations due to treatment failure (10% vs. 11.6%, RR = 1.13, 95% CI 0.84 to 1.51, P = 0.42). This meta-analysis suggests that at least some TCAs may be more effective than SSRIs in depressed inpatients, with there being the strongest evidence for amitriptyline. A possible explanation is that this is related to a dual action in inhibiting both 5-HT and noradrenaline reuptake. In agreement with previous meta-analyses, TCAs appear less well tolerated than SSRIs, although the absolute risk difference for discontinuation due to adverse effects (4.9%, 95% CI -8.1 to -1.7%) is of uncertain clinical significance.

Antidepressive Agents, Tricyclic↗

PubMed1998

[Evidence-based medicine. How to use biomedical literature to solve clinical problems. Italian Group on Evidence-Based Medicine-GIMBE].

Clinical practice is constantly changing, the rate of changing is accelerating and consequently it may even take years before the results of clinical research will be incorporated in day-to-day practice. So, there is a large gap between what the biomedical literature contains and the care that most of patients receive. The gap is widened by the extensive processing that results of clinical research require before they can be used. Evidence-based medicine is a new approach to health care promoting the collection, interpretation, and integration of valid, important and applicable research-derived evidence. The best available evidence, moderated by patient circumstances and preferences, is applied to improve the quality of clinical judgements. There are many information tools that facilitate the practice of evidence-based medicine. These include users' guides to the medical literature, strategies to improve the yield of MEDLINE searches, standardized formats for abstracts of journal articles and guidelines, new journals, systematic reviews and meta-analyses, resources on-line and software tools bringing high quality information to the point of clinical decision making. However, these tools are poorly spread and physicians lack of necessary skills for their effective utilization. In this article the authors describe guidelines for efficient and effective utilization of biomedical information tools to solve clinical problems and improve the quality and the cost/effectiveness of health care.

Evidence-Based Medicine↗

PubMed1998

Evidence-based practice.

Evidence-based practice (EBP) is spreading in popularity in many health care disciplines. One of its main features is the reliance on the partnership among hard scientific evidence, clinical expertise, and individual patient needs and choices. Librarians play an important role in the spread of EBP because of the importance of identifying and retrieving appropriate literature from various sources for use in making health care decisions. This article gives an overview of how to search for therapy, diagnosis, etiology, and prognosis both for original studies and secondary publications such as systematic reviews, meta-analyses, and clinical practice guidelines. Understanding how this research is done, how it is indexed, and how to retrieve the clinical evidence are an important set of skills that librarians can provide for clinicians interested in EBP.

Evidence-Based Medicine↗

PubMedDate not supplied

The role of H2-receptor antagonists in the pathogenesis of nosocomial pneumonia in mechanically ventilated patients.

We conducted a computerized MEDLINE search and selected controlled studies and meta-analyses correlating the frequency of nosocomial pneumonia (NP) with the administration of histamine2-receptor antagonists (H2RAs) as stress ulcer prophylaxis in critically ill patients. Although such a correlation does exist, the literature supports the theory that gastric bacterial overcolonization through alkalinization by H2RAs is not a risk factor for NP in critically ill patients. Further well-designed studies are necessary to resolve the issue and clarify the role of H2RAs in the pathogenesis of NP.

Cross Infection↗

PubMed1998

Reporting of gender-related information in clinical trials of drug therapy for myocardial infarction.

BACKGROUND: Concern has been expressed that women are not adequately represented in clinical trials evaluating treatments for medical conditions they commonly experience. This study was designed to assess the reporting of data on women in recently published trials of drug therapy for myocardial infarction, including those funded by an agency with a gender-related policy. METHODS: All randomized controlled trials and meta-analyses of drug therapies for myocardial infarction published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, the Annals of Internal Medicine and the British Medical Journal from January 1992 to December 1996 were evaluated. On preliminary review 102 articles met the inclusion criteria; these were reviewed in detail, and 59 were excluded. Two reviewers independently extracted gender-related information from the 43 articles; discrepancies were resolved by consensus. RESULTS: Women presented up to 48% of the trial participants (mean 24.1%). In the trials funded by an agency with a gender-related policy, only 16.8% of participants, on average, were women. Of the 43 articles in the sample, only 14 (32%) provided gender-related results. Funding from an agency with gender-related policy did not affect the reporting of gender-related information. Subgroup analyses were provided for 14 (32%) of the 43 trials, including 2 (29%) of 7 trials funded by an agency with a gender-related policy. Of the 12 trials that included interaction analyses (excluding the 2 trials in which secondary analyses were conducted specifically to identify differences between women and men), 7 (58%) conducted an interaction analysis to determine if women responded differently than men; for one of these the interaction analysis was for a secondary outcome measure (drug safety). Only 5 (12%) of the 43 articles mentioned the differences between men and women in the Discussion section; 2 of these were studies that used secondary analyses to examine sex differences. Of the 5, only 1 was funded by an agency with a gender-related policy. INTERPRETATION: Women were poorly represented in the randomized controlled trials in this sample, regardless of whether the trials were funded by an agency with a gender-related policy. Structured reporting of gender-related information for clinical trials may improve the quality of information available about women and therefore facilitate the application of research findings to the care of women.

Angiotensin-Converting Enzyme Inhibitors↗