Evaluation of the pharmacoepidemiology literature

Pharmacoepidemiologic journals use standard format used for manuscript preparation:

Abstract

o Introduction/Background

o Methods

o Results

o Discussion

Usually 250-300 words or less

o Brief summary of each major section of the paper (Introduction, Methods, Results, Conclusions)

Abstract

Most important part of the paper

manuscript

Typically limited to a few paragraphs.

o Frames the purpose and public health significance of the research by contrasting the study objective with a brief literature review of current state of knowledge

introduction

Where the research hypothesis to be investigated is clearly stated?

introduction

Describes how the study was carried out.

o Includes a description of the study population, exposure and outcome variables, data collection methods, and statistical analyses.

o Should be of sufficient detail so that the reader can critically evaluate the work without having to consult outside sources

Methods

Describes what was found in the study.

o Should correspond directly with the stated research hypothesis(es).

o Tables and figures should be judiciously used; text descriptions should not be largely redundant with data in tables and figures

results

Describes what was learned from the study and public health implications of the findings.

o Should not be a large re-statement of text from the Results section.

o Should not include presentation of "new" findings not presented in the Results section

Discussion

Is the purpose of the research supported by a relevant review of the literature?

introduction

Does the study address an important population-based benefits/risks of drug use related question?

Abstract and introduction

Is the study design appropriate for the research hypothesis(es) (specific)?

methods

Does the study use an experimental or observational design?

abstract and methods

Is the method in which the study design was carried out clearly articulated?

method

Does the design represent an advance over prior approaches?

method

Is it clear how study participants were identified and selected?

abstract and methods

Were the inclusion and exclusion criteria clearly defined and appropriate?

Were the methods used in selecting study participants appropriate (e.g. cases, controls)?

methods

Is it clear how exposure variables/ exposed and unexposed persons were identified?

abstract, methods

Is the assessment of exposure likely to be precise and accurate?

Was the method of exposure quantification/classification appropriate?

Was exposure ascertainment uniformly applied for all study participants?

methods

Do the results presented correspond

directly to the research hypothesis(es)?

abstract and results

Are the results presented by appropriate

use of text, tables, and figures?

results

Is it clear which potential confounding

variables were controlled for in the analysis?

results

Overall, are the author's conclusions justified by the data presented?

abstract and discussion

Do the authors appropriately interpret the clinical, biologic, and statistical significance of the results?

discussion

Are the study findings compared and contrasted with similar prior research?

discussion

Were measurement errors with regard to exposure/disease classification discussed?

discussion

Has chance been discussed as a potential explanation of the study results?

For non-significant results, do the authors discuss if they had sufficient power?

Is the impact of the major possible sources of bias (e.g. selection bias) discussed?

Do the authors consider/discuss whether confounders could account for the observed study results?

Discussion

Do the authors appropriately acknowledge limitations of their study?

abstract and discussion

Are the generalizability of the study findings discussed and appropriate?

Do the authors provide suggestions for future areas of investigation?

discussion