Study Translational Focus

Resources:

  • See the full metadata model in PDF or Markdown.
  • See the Study Translational Focus element of the full metadata model.
  • See guidance to respond to each field, and their use cases, by clicking the arrow to the left of the bold field names below.

Extra context:

  • The HEAL Initiative was founded to reduce deaths and other negative consequences of opioid use disorder (OUD), opioid overdose, and opioid exposure.
  • The HEAL Initiative also focuses on finding new solutions to human pain and pain management (largely because opioid pain treatment has historically been foundational in initiating OUD, and in increasing supply and access to opioid pills for pain patients and the general population).
  • Even when HEAL studies don’t involve human subjects, they generally focus on learning more about a human pain or opioid use condition (Condition-focused) or they focus on learning more about a treatment, intervention, or solution for a human pain or opioid use condition (Treatment-focused).
  • We expect that many HEAL Platform users will look for studies, study data, and study-generated knowledge from a condition- or treatment-focused perspective; they will either want to find new information about a human pain or opioid use condition, or treatment for a human pain or opioid use condition.
  • Classifying your study in this way (i.e. identifying your study as either Condition- or Treatment-focused) allows Platform users to quickly find the studies, study data, or study-generated knowledge that will get them closer to the information they are looking for.
  • HEAL studies that are NOT Condition- or Treatment-focused (e.g. career development, increasing diversity, developing general study recruitment or consenting procedures, etc.), may skip this section. Contact heal-support@gen3.org if you are unsure or need guidance.

Fill out this section of the CEDAR form:

Expand the Study Translational Focus section. This section has two fields; click below to expand guidance for each field.

Study Translational Focus

How to answer

This field allows selection of a single answer from a limited set of choices, including: “Condition” for Condition-focused studies, and “Treatment of a condition” for Treatment-focused studies (see above for definitions).

Human subjects study examples:

  • Condition-focused: an observational prospective cohort study, following developmental markers in babies exposed to opioids in utero, from birth through adolescence
  • Treatment-focused: a randomized control trial, testing efficacy of a novel non-opioid drug for pain versus status quo use of an opioid drug.

Basic science or non-human subjects study examples:

  • Condition-focused: a biochemical study investigating the molecular mechanisms of cell signaling in pain/nociception
  • Treatment-focused: a small molecule screen to discover chemical drugs that activate or deactivate a molecular target involved in opioid-addictive or overdose pathways.

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page. As noted above, a wide variety of Platform users will likely seek condition- or treatment-focused studies, study data, and study-generated knowledge, allowing them to better study and/or understand 1) a human opioid or pain condition and/or 2) opioid or pain treatments, interventions, or solutions at the individual or community level. Identification of your study as either Condition- or Treatment-focused, allows these users to more rapidly filter studies and discover the information they need.

Types of Determinants/Mechanisms the study is investigating

How to answer

This field allows multiple selections from a limited set of answers, including:

  • Biology and Health
  • Mental Health
  • Social Determinants
  • Public Attitudes or Stigma
  • Stigma

Select all that apply.

For Condition-focused studies, consider the determinants or mechanisms of the human opioid or pain condition you are investigating. For example:

  • Biology and Health: A study focused on molecular or biophysical mechanisms of bodily injury and pain perception
  • Mental Health: An observational study measuring the incidence and timing of onset of rumination and other anxiety or depressive symptoms/states in patients that do or do not transition from acute to chronic pain
  • Social Determinants: A study measuring items such as income and education level, family support, access to healthcare and food, etc.
  • Public Attitudes or Stigma: A study measuring items such as individual perceptions of stigma from friends, family, and employers around their pain experience
  • Public Attitudes or Stigma AND Social Determinants: A study randomly surveying individuals’ attitudes towards those with OUD (public attitudes and stigma are a subset of all social determinants).

For Treatment-focused studies, think about the mechanism of the treatment, intervention, or solution you are investigating. For example:

  • Biology and Health: A small molecule screen study looking for drugs that inhibit a novel protein target in the opioid reward pathway as a possible drug candidate to treat OUD, or a study investigating efficacy of a drug or surgical procedure to treat chronic back pain
  • Mental Health: A study investigating relative efficacy of group therapy versus one-on-one therapy to prevent opioid use relapse
  • Biology and Health AND Social Determinants: A study investigating efficacy of providing individuals leaving jail, with a history of opioid use, either 1) MOUD alone or 2) MOUD plus supports such as housing, food, and education/employment assistance
  • Public Attitudes or Stigma: A study investigating efficacy of a community-level communications campaign, discussing OUD as a disease, to change public attitudes and reduce stigma towards sufferers

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page. Platform users can use this field to filter studies based on their treatment mode. For example:

  • Mental Health: A patient with OUD may seek a mental health intervention/treatment, if they are reluctant to use medication or are in a rehabilitation facility that does not allow medication.
  • Biology and Health: A pain clinician, who has historically treated patients with opioids and seen some resulting addictions, may seek information on non-opioid-based pain treatments.
  • Social Determinants: A public health official, in an area with high opioid overdose rates, despite high naloxone availability, might suspect social determinants (e.g. attitudes/stigma, lack of communication/education, lack of transportation to distribution centers, etc.) play a role in low uptake/effective use of naloxone.

Filtering will allow Platform users to quickly find broad, relevant studies, study data, or study-generated knowledge.

Once complete, collapse the Study Translational Focus section and save your form.