Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer?

Zola, Paolo; Volpe, T.; Castelli, Gian Luigi; Sismondi, P; Nicolucci, Antonio; Parazzini, Fabio; Liberati, Anna Marina

doi:10.1016/0360-3016(89)90498-7

Cited by 22 publications

(2 citation statements)

References 88 publications

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“…Further, they commented that there is a need to agree on critical elements for assessing susceptibility to bias in epidemiology and to develop appropriate evaluation tools. They identified a total of 86 tools comprised of 41 simple checklists, 33 scales, and 12 checklists with additional summary judgments (149)(150)(151)(152)(153)156,160,(174)(175)(176)(177)(178)(179)(180)(181)(182)(183)(184)(185)(186)(187)(188)(189). Among these a number of groups were designed to address specific www.painphysicianjournal.com Table 3.…”

Section: Can Methodologic Quality Of Observational Studies Be Assessed?mentioning

confidence: 99%

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Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies

Manchikanti

Singh²,

Hs³

et al. 2009

Pain Phys

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Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigms, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. There is competition, contrast, and a feeling of inferiority and uselessness for observational studies, created by a lack of understanding of medical research. However, observational studies and randomized clinical trials (RCTs) can be viewed as the steps of observation and experimentation that form the basis of the scientific methodology. Further, rational healthcare practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis, and treatment of disorders. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, design, implementation, and reporting of observational studies is crucial. The biased interpretation of results from observational studies, either in favor of or opposed to a treatment, and lack of proper understanding of observational studies, leads to a poor appraisal of the quality. Similar to the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of randomized trials, the Strengthening of the Reporting of Observational Studies in Epidemiology (STROBE) statement was developed with recommendations to improve the quality of reporting observational studies. The STROBE statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Multiple types of observational studies are conducted; however, 3 types have been highlighted in the STROBE document and also in the present review, which include cohort studies, case-controlled studies, and cross-sectional studies. This comprehensive review provides an introduction and rationale, types, design, and reporting of observational studies; outcomes assessment and data presentation and analysis; statistical analysis, results, and a discussion of observational studies. Key words: Observational studies, cohort studies, case control studies, cross-sectional studies, allocation bias, sample size, Strengthening of the Reporting of Observational Studies in Epidemiology (STROBE)

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Section: Can Methodologic Quality Of Observational Studies Be Assessed?mentioning

confidence: 99%

“…• Primary/secondary outcomes clearly defined Observational Studies study design types: case-control studies alone (19%), cohort studies alone (27%), and cross-sectional studies alone (7%). Table 3 and weighting has also been addressed in some reports (168)(169)(170)(171)(172)(173)(174)(175)(176)(177)(178)(179).…”

Section: Outcome Measures 20mentioning

confidence: 99%

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies

Manchikanti

Singh²,

Hs³

et al. 2009

Pain Phys

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Quality, Evolution, and Clinical Implications of Randomized, Controlled Trials on the Treatment of Lung Cancer

Nicolucci¹

1989

JAMA

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A review of 150 published randomized trials on the treatment of lung cancer showed serious methodological drawbacks. Handling of withdrawals (only 7 trials had no dropouts), a priori estimates of sample size (only 9 trials specified the required number of patients), blinding of randomization (only 22 trials had a satisfactory procedure), and information on eligible nonrandomized patients (only 13 studies reported it precisely) were areas of major concern. Although trial quality improved over time both in design/execution (study size estimation and analysis by prognostic factors became more frequent) and reporting (information on patients' characteristics and side effects were more thoroughly reported), their evolution was inconsistent. For non-small-cell lung cancer-despite the persistent lack of proof of efficacy of any active treatment-an untreated control arm was prematurely abandoned and a wide variety of tested regimens prevailed even in better-quality studies. Slightly more promising is the picture for small-cell lung cancer, where research indicates somewhat more reliable-though limited-progress. While clinical research in lung cancer has contributed little to defining the best standard care, we conclude that its heterogeneity makes it unlikely that quantitative meta-analysis of existing trials will be constructive.

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Cancer of the Cervix

Morita

1997

Radiation Oncology of Gynecological Cancers

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Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer?

Cited by 22 publications

References 88 publications

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies

Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies

Quality, Evolution, and Clinical Implications of Randomized, Controlled Trials on the Treatment of Lung Cancer

Cancer of the Cervix

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