Guidelines and Preferences for Specific Research Study Designs

Original Research and Brief Research Reports should, when feasible, be conducted in accordance with generally accepted structural guidelines specific to the specific project design. Please identify and justify deviations in your manuscript and in your cover letter.

To follow are Annals' philosophies regarding various types of studies; note that more than one category may apply to any given project.

Most common formats:

Other formats:


Randomized controlled trials

Randomized controlled trials must be reported in accordance with the CONSORT statement, summarized as follows:

  • Title includes the phrase "randomized controlled trial"
  • Trial registration source and number reported
  • Clear depiction of the three elements of randomization: sequence generation, allocation, and concealment
  • Clear description of which outcome assessments were and were not blinded
  • A figure summarizing participant flow through the trial
  • Protocol deviations described, and whether analysis is intention to treat
  • Outcomes each reported with size of effect and associated confidence intervals.

Chart reviews

Annals subscribes to a set of methodological elements for retrospective research (ICOGilbert: Chart reviews in emergency medicine research: Where are the methods? Ann Emerg Med 1996; 27:305-308), with key elements as follows:

  • Trained and monitored abstractors use explicit protocols, precisely defined variables, and standardized abstraction instruments.
  • Authors clearly describe how missing, conflicting, and/or ambiguous chart elements were coded.
  • Interrater agreement assessed by having a sample of charts reviewed independently by two or more abstractors, particularly when chart elements are not wholly objective.
  • When possible, blinding abstractors are blinded to the study hypothesis and/or study group assignment, particularly for chart elements that are not wholly objective.

Observational studies

Annals prefers observational studies to be compliant with the STROBE guidelines.

Studies on diagnostic tests

Annals prefers studies on diagnostic tests to be compliant with the STARD guidelines.

Clinical prediction rules

Annals subscribes to a set of methodological elements for the derivation of clinical prediction rules (also known as clinical decision rules): ICOStiell: Methodologic standards for the development of clinical decision rules in emergency medicine. Ann Emerg Med 1999;33:437-447.

Additionally, Annals emphasizes the critical importance of deriving and validating these instruments in comparison to unstructured clinical judgment. A rule that replicates but does not improve upon unstructured clinical judgment would not appear to have actually improved clinical care. Please see the following for a full discussion: ICOSchriger: Medical decisionmaking: Let's not forget the physician. Ann Emerg Med 2012.


Basic science studies

Annals is a clinically oriented journal and we publish animal research only if the condition being studied has clear clinical implications and is not one likely to be studied in humans or, despite the use of an animal model, where the findings exhibit unusual clinical importance.

Clinical practice guidelines or advisories

Annals is willing to consider guidelines developed by knowledgeable experts who are free from competing interests in commercial ventures, and/or drawn from formal societies that represent the specialties to which the guidelines apply. We prefer those prepared in accordance with the Institute of Medicine's guidelines entitled Clinical Practice Guidelines We Can Trust.

Cost-effectiveness analyses

Economic evaluations and cost-effectiveness analyses should be based upon principles outlined in the following references:

  • Gold MR, Siegel JE, Russell LB, et al, eds. Cost-Effectiveness in Health and Medicine. Oxford, United Kingdom: Oxford University Press; 1996.
  • Russell LB, Gold MR, Siegel JE, et al. The role of cost-effectiveness analysis in health and medicine. JAMA 1996; 276:1172-1177.
  • Siegel JE, Weinstein MC, Russell LB, et al. Recommendations for reporting cost-effectiveness analyses. JAMA 1996; 276:1339-1341.
  • Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA 1996; 276:1253-1258.

Decision analyses

Annals occasionally publishes research describing computerized decision models that do not include any new patient data. Given that such models are only as strong as their underlying assumptions; however, many such works do not achieve sufficient publication priority relative to other research submitted. We believe that the ideal computerized decision model should include an on-line interactive version that permits readers to independently adjust the assumptions and view the dynamic results.

Methodology reports

Annals publishes very few reports describing methodology prior to initiation of a trial, believing that in most cases such methodology is better reported concurrent with the results. To be considered, methodology reports must be highly innovative and of unusual importance.

Replication studies

Replication of original results is an important part of the scientific process, and Annals will seriously consider high quality replication studies, particularly on topics which have had few or no other such studies published yet.

Qualitative research

Annals believes that well-done qualitative research on issues relevant to emergency medicine can be an important method of hypothesis generation. Such research should be based upon principles outlined in the following references:

  • Mays N, Pope C. Qualitative research in health care. Assessing quality in qualitative research. BMJ. 2000;320:50-52.
  • Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care. A. Are the results valid? JAMA 2000; 284:357-362.
  • Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care. B. What are the results and how do they help me care for my patients? Evidence-Based Medicine Working Group. JAMA 2000; 284:478-482.
  • Pope C, Mays N, eds. Qualitative Research in Health Care. London, United Kingdom: BMJ Books; 2000.

Meta-analyses

Meta-analyses of therapeutic trials should be compliant with the PRISMA guidelines, while meta-analyses of observational studies should be compliant with the ICOMOOSE guidelines. Meta-analyses of diagnostic tests should be based upon principles in the following references:

  • Leeflang MMG, Deeks JJ, Gatsonis C, et al. Systematic reviews of diagnostic test accuracy. Ann Intern Med. 2008;149(12):889-897.
  • Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Chapter 10: Analysing and Presenting Results. In: Deeks JJ, Bossuyt PM, Gatsonis C (editors), Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration, 2010. Available from: http://srdta.cochrane.org/.

Surveys

Annals only rarely publishes surveys given their potent methodological limitations. To be seriously considered, manuscripts describing surveys must show evidence of rigorous instrument development and testing, a high response rate, and a topic of unusual importance to emergency physicians. The survey itself should be included as an online appendix.


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