A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation☆

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Procedures for Performing Systematic Reviews

High quality protocols facilitate proper conduct, reporting, and external review
 of clinical trials. However, the completeness of trial protocols is often
 inadequate. To help improve the content and quality of protocols, an
 international group of stakeholders developed the SPIRIT 2013 Statement
 (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT
 Statement provides guidance in the form of a checklist of recommended items to
 include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important
 information to promote full understanding of the checklist recommendations. For
 each checklist item, we provide a rationale and detailed description; a model
 example from an actual protocol; and relevant references supporting its
 importance. We strongly recommend that this explanatory paper be used in
 conjunction with the SPIRIT Statement. A website of resources is also available
 (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement,
 should help with the drafting of trial protocols. Complete documentation of key
 trial elements can facilitate transparency and protocol review for the benefit
 of all stakeholders.

https://www.bmj.com/content/bmj/346/bmj.e7586.full.pdf

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of stroke among individuals who have not previously experienced a stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches to atherosclerotic disease of the cervicocephalic circulation, and antithrombotic treatments for preventing thrombotic and thromboembolic stroke. Further recommendations are provided for genetic and pharmacogenetic testing and for the prevention of stroke in a variety of other specific circumstances, including sickle cell disease and patent foramen ovale.

Guidelines for the Primary Prevention of Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(04)17670-8.pdf

External validity of randomised controlled trials: “To whom do the results of this trial apply?”

The problem of generalisability in randomised clinical trials was highlighted by studies that entered only 10-14% of screened patients. To determine the magnitude and source of prerandomisation losses in clinical trials a survey was conducted of 41 trials listed in the 1979 inventory of the National Institute of Health. Two thirds of the trials maintained screening logs, but only half maintained any records of the number of patients who met the eligibility criteria but were not entered into the trial. Among 21 trials (51%) that kept data on the number of patients who were eligible but not entered, losses of eligible subjects were attributable to refusals by patients in 25% and refusals by physicians in 29%. Other protocol requirements accounted for the remaining losses of eligible patients. Only a few trials documented the characteristics of patients who were eligible but not entered; in those trials the patients who were not entered were similar demographically but differed clinically from those enrolled. Thus minimising prerandomisation losses of eligible patients requires the use of less restrictive criteria for entering patients. Twenty four of the trials achieved 75% or more of their recruitment goals, eight between 25% and 74%, and six less than 25%. Among trials that screened less than twice their projected sample size, only three out of 13 (23%) achieved 75% or more of their recruitment goal. By contrast, 12 out of 16 trials (75%) that screened more than twice their projected sample size achieved 75% or more of their recruitment goal. Screening large numbers of patients appears to be a pragmatic requirement for success in achieving recruitment goals; therefore, trials should not be criticised as lacking generalisability on that basis alone. The number and characteristics of eligible patients who were not entered, however, were documented by only a few trials; these data are critical in the assessment of generalisability. Additionally, the number of patients with the index disease who did not meet the eligibility criteria should also be documented. Together, these two types of data characterise the population to whom the trial results may be applied.

https://www.bmj.com/content/bmj/289/6454/1281.full.pdf

Applying results of randomised trials to clinical practice: impact of losses before randomisation.

Background and Purpose— To identify risk factors for intracerebral hemorrhage (ICH), we examined data from the Hemorrhagic Stroke Project (HSP), a case-control study of hemorrhagic stroke among men and women aged 18 to 49 years. Methods— Case subjects for the HSP were recruited from 44 hospitals in the United States. Eligibility criteria included an ICH within 30 days preceding enrollment, no history of stroke or known brain lesion. For this report, we focused on patients with primary ICH, defined as not associated with an aneurysm, arteriovenous malformation or other structural lesion. Two control subjects were sought for each case subject. A multivariate regression analysis was performed to determine risk factors for primary ICH. Results— A total of 1714 patients with hemorrhagic stroke were identified for participation in the HSP. Of these, 217 cases met the criteria for primary ICH. Cases with primary ICH were matched to 419 controls. Independent risk factors for ICH included hypertension (adjusted od...

Major Risk Factors for Intracerebral Hemorrhage in the Young Are Modifiable

Beyond randomised versus observational studies

Estrogen therapy and risk of cognitive decline: results from the Women's Estrogen for Stroke Trial (WEST)

Depressed autonomic nervous system function in African Americans and individuals of lower social class: a potential mechanism of race- and class-related disparities in health outcomes.

Ralph I. Horwitz

Papers

Applying results of randomised trials to clinical practice: impact of losses before randomisation.

Major Risk Factors for Intracerebral Hemorrhage in the Young Are Modifiable

Beyond randomised versus observational studies

Estrogen therapy and risk of cognitive decline: results from the Women's Estrogen for Stroke Trial (WEST)

Depressed autonomic nervous system function in African Americans and individuals of lower social class: a potential mechanism of race- and class-related disparities in health outcomes.