FOR RESEARCHERS

What is the problem?

  • Major Depressive Disorder (MDD), with life-time prevalence rates of 11% in adolescents, results in significant disease burden worldwide.

  • Treatments to date have yielded suboptimal results in reducing the burden of disease, reflecting the need for ongoing evaluative research to identify the most effective treatments.

  • However, the current disparity in outcome selection in adolescent MDD clinical trials can restrict the synthesis and interpretation of results through systematic reviews and meta-analyses, thereby limiting the ability to yield meaningful estimates of treatment effect.

Two clincians with 6 different outcomes (3 on each side), which do not match each other (symbolized by not equal to sign)

Where is the gap?

  • The heterogeneity of possible outcomes to select and measure was noted in a scoping review recently conducted by our group.

  • In 46 articles, 86 unique outcomes were measured using 118 different outcome measurement instruments across adolescent (ages 12 to 18 years) MDD clinical trials published in the English language between 2008 and 2017, highlighting the need for the development of a core outcome set (COS).

86 outcomes in 32 trials

118 outcome measurement instruments 

Arrow pointing to rectangle stating 118 outcome measure instruments
Arrow pointing to rectange stating 45% only measured once

45% only measured once

How will IN-ROADS help?

  • A COS is defined by COMET as an agreed, standardized minimum set of outcomes that should be measured and reported in all clinical trials in specific areas of health or health care.

  • From multiple perspectives of key stakeholders, the importance of which outcomes to measure is becoming a pressing priority.

  • Development of a COS for adolescent MDD will allow for greater standardization of outcome selection and measurement. Take a look at Our Approach to learn more. 

Two clinicians pointing to a circle representing a core outcome set, with 3 outcomes merged together
Who will use IN-ROADS?
  • IN-ROADS will be used by clinicians, researchers and other individuals responsible for outcome selection, measurement, and reporting in adolescent MDD clinical trials.

  • IN-ROADS may also help policy makers and health-care professionals in making decisions that will ultimately improve care and reduce both costs and disease burden for adolescent MDD.