Definition: A Clinical Investigation relates to direct patient care, clinical trials, QI/PI and/or health services delivery. Learn more…

NOTE: Authors are responsible to ensure that all Institutional Review Board (IRB) oversight requirements are met for any submitted work.

Authors submitting reports should prepare an abstract of no more than 300 words that excludes the following headings: Introduction, Methods, Results, and Conclusions. The Methods section includes the following subheadings: Design, Setting, Study Populations, Intervention(s) (if any), Main Outcome Measure(s), Statistical Test(s) Used. For brevity, the subheading parts of the Methods section can be written in phrases rather than complete sentences (e.g. Design. Double-blind randomized trial). The content following each heading should be as follows: Learn more…

  1. Introduction – Set the stage for the contribution the study makes to the literature. Address why readers should care about the clinical area being studied. Include a precise statement (1-2 sentences) of the primary objective or question addressed by the research. State the hypothesis tested (if applicable).

  2. Methods – Include the following subheadings in your description of the methods.

    1. Design – Describe the basic design of your study. State the duration of follow-up, if any. Select your design from the various research methods listed below:

      • Intervention studies: randomized control trial; nonrandomized control trial; double-blind; placebo control; crossover trial; before-after trial.

      • Studies of screening and diagnostic tests: criterion (“gold”) standard; blinded or masked comparison.

      • Studies of prognosis: inception cohort (subjects assembled at a similar and early time in the course of the disorder and followed thereafter); cohort (subjects followed forward in time, but not necessarily from a common starting point); validation cohort or validation sample if the study involves the modeling of clinical predictions.

      • Studies of causation: randomized control trial; cohort; case-control; survey (preferred to “cross-sectional study”).

      • Descriptions of the clinical features of medical disorders: survey; case series.

      • Studies that include a formal economic evaluation: cost-effective analysis; cost-utility analysis; cost-benefit analysis.

    2. Setting – Describe the study setting(s). This helps determine applicability and generalizability. Of particular importance is whether the setting is the general community, a primary care or referral center, private or institutional practice, ambulatory or hospitalized care.

    3. Study Populations – State the clinical disorders, important eligibility criteria, and key sociodemographic features of patients. Provide the number of participants and how they were selected, including the number of otherwise eligible subjects who were approached but refused. If matching is used for comparison groups, state the characteristics that are matched. In follow-up studies, indicate the proportion of participants who completed the study. In intervention studies, give the number of patients withdrawn for adverse effects. For selection procedures, use these terms, if appropriate: random sample (where “random” refers to a formal, randomized selection in which all eligible subjects have a fixed and usually equal chance of selection); population-based sample; referred sample; consecutive sample; volunteer sample; convenience sample. These terms assist the judges to determine an important element of the generalizability of the study.

    4. Interventions(s) – Describe the essential features of any interventions, including their method and duration of administration. The intervention should be named by its most common clinical name. If no interventions were made, say so.

    5. Main Outcome Measure(s)  Indicate the primary outcome(s) and measurement(s) used.

    6. Statistical Test(s) Used – State what tests you used in the statistical analysis. Learn more…

  3. Results – What are the main results of the study? The results should be accompanied by confidence intervals and the exact level of statistical significance (if applicable). If appropriate, studies of screening and diagnostic tests should use the terms “sensitivity,” “specificity,” and “likelihood ratio.” Just DESCRIBE findings – don’t DISCUSS them.

  4. Conclusions – Give only those conclusions of the study that are directly supported by the evidence reported, along with their clinical application (avoid speculation and overgeneralization), and indicate whether additional study is required before the information should be used in other clinical settings.