Human Condition Applicability

How to answer

This field allows multiple selections, included in the full metadata model definitions. Select all that apply. Regardless of study type, HEAL studies pertain to understanding more about human pain or opioid related conditions and/or related treatments, interventions, or solutions. Which human pain or opioid related condition(s) does your study contribute to understanding? For example:

• A pragmatic clinical trial to treat fibromyalgia pain with a combination of physical therapy and electro physiotherapy, would likely select “Pain," “Pain, chronic," and “Pain, resulting from chronic illness.”
• A basic biochemistry study to understand the mechanism of fentanyl binding to opioid receptors in the brain and the resulting signaling triggered systems, might choose “Opioid overdose” and/or “Opioid use and opioid use disorder.”

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, and will allow users to quickly find broad, relevant studies, study data, or study-generated knowledge. For example:

• Opioid Exposure: A pre-K/K school teacher knows their surrounding community has high rates of OUD and wonders if student behavioral issues can be attributed to in utero opioid exposure. They also want to recognize exposure impacts and support intervention for students and their parents.
• Opioid use and opioid use disorder, relapse; Opioid use and opioid use disorder, chronic: A family member or case manager of a person at high risk of relapse and taking medication for chronic OUD, wants to identify appropriate OUD treatment(s), and learn about geographic and other factors impacting treatment access.
• Opioid use and opioid use disorder, relapse: A clinician treating OUD notices a high rate of relapse in patients. They seek research on relapse risk factors, or preventive and therapeutic interventions to target OUD relapse.
• Pain, acute; Pain, resulting from surgery: A patient scheduled for surgery, whose doctor recommends opioids for acute post-surgical pain, does not want to take opioids due to addiction risks or triggering a relapse (if they have a previous OUD) and seeks research on non-drug or non-opioid treatments to address acute post-surgical pain.

How to answer

This field allows multiple selections, included in the full metadata model definitions. Select all that apply. For example:

Incidence of condition:

• A national survey about pain experience
• A study using admin data, healthcare claims, or fire department and ambulance run data to estimate opioid overdose incidences per county in IL

Risk (or differential risk) of condition:

• A study looking for biomarkers of those at higher risk of opioid dependence following short term use for acute post surgical pain
• A study looking at differential risk, by strata, of sociodemographic factors for pain-related condition development, in circumstances like end stage renal disease or fibromyalgia

Mechanism of condition:

• A natural experiment to investigate biological or social/environmental factors that explain differential risk for pain related condition like end stage renal disease or fibromyalgia, across the strata of sociodemographic factors

Impact of condition:

• A study investigating OUD’s impact on the likelihood of completing a degree, getting a job, starting/maintaining a family or romantic relationship, or securing/maintaining housing
• A study investigating the impact of a high community OUD rate on community crime levels, economic stability, and social cohesion

Public attitudes towards or perception of a condition:

• A national survey asking for attitudes about 1) employing those with OUD, 2) befriending them, 3) having them marry into the family, 4) allowing them access to public funding for long term medical and social support treatment
• A study testing efficacy of a community-based communications and education campaign to increase previous OUD sufferers’ employability

Treatment of a condition:

• A study investigating whether providing housing and job training support, to people leaving jail on an opioid use or possession charge, prevents OUD relapse or further involvement in the criminal justice system
• A phase 3 clinical trial investigating efficacy of a novel non-opioid drug to treat chronic pain * A study investigating whether a novel implanted device, providing long-term and slow release of an established MAT drug for OUD, can prevent relapse

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page and will allow users to quickly find broad, relevant studies, study data, or study-generated knowledge. Examples include:

• A school teacher who knows the local community has high OUD rates and:

• Impact of condition: wonders if student behavioral issues may be attributed in utero exposure to opioids and
• Treatment of condition: how to recognize exposure impacts, to provide support and intervention for students and parents, while
• Public attitudes towards or perception of a condition: learning about how/how much opioid use stigma should weigh into an offer to help, as it may expose them to further stigma-related harm

• A clinician treating OUD patients notices a high rate of patient relapse, who

• Risk for condition; Differential risk for condition: seeks research on relapse risk factors or
• Treatment of condition: on preventive or therapeutic interventions that target OUD relapse

• A patient scheduled for surgery, whose doctor recommended opioids for acute post-surgical pain but

• Risk for condition; Differential risk for condition: does not want to take opioids because they worry about opioid addiction, or (with a previous OUD) triggering a relapse, and wants to find research on clear risk factors for these outcomes, and/or
• Incidence of condition; Differential risk for Condition: rates for these negative outcomes is in the general population or populations with known risk factors

How to answer

This field ONLY APPLIES to your study if you selected “Pain” and/or a modifier of “Pain” (e.g. “Pain, chronic”) for the “Relevant Opioid use and/or Pain condition” category(ies) above. This field allows multiple selections. Select all that apply.

This field is an array. The controlled vocabulary/pick-list is the NLM MeSH (National Library of Medicine Medical Subject Headings – see the tree view of this vocabulary here), which covers a wide-ranging set of terms over many health-related categories including Diseases/Health Conditions (containing most terms you will need for this field). When you first click into this field, you may see an “odd” value, belonging to a category of NLM MeSH that does not apply to this field. Ignore that. Start typing the health condition of interest, and the drop down list will populate with items based on your inputs.

If you are studying a human pain condition or a pain treatment, intervention, or solution, is there a source/causal condition(s) for the pain condition? If so, indicate it here (e.g. A study investigating mechanism of, or risk for, disabling chronic pain in fibromyalgia patients would select “fibromyalgia”; A study measuring incidence and intensity of pain following back surgery would select “surgery” and/or “failed back surgery syndrome"). NLM MeSH allows you to be general (e.g. “chronic disease," “multiple chronic conditions”) and/or specific (e.g. “end stage liver disease," “osteoarthritis, knee”). Use this range of specificity to add all applicable terms.

How this field will be used

The values from this field will likely be available as 1) an “Advanced Search” filter on the HEAL Platform Discovery page (depending on the range of answers, a simple filter may not be useful, but we may implement an auto-complete to make a long filter list tenable and retain utility), allowing users to quickly filter to broad, relevant studies, study data, or study-generated knowledge, and/or 2) accessible to free text search and discovery tools that leverage elastic and semantic search, so users can find your study with exact or close/related terms. For example:

• A clinician who treats fibromyalgia patients seeks research/data on better ways to address fibromyalgia-associated pain, increasing the functional status of patients (filter on Causal condition: “fibromyalgia”; Target condition: “pain," “chronic pain”; Outcome condition: “physical function”).
• A clinician who treats fibromyalgia patients seeks research/data on better ways to address/treat the underlying disease and make fibromyalgia- associated pain development less likely or severe (filter on Causal condition: “fibromyalgia”; Target condition: “fibromyalgia”; Outcome condition: “pain," “chronic pain”). * A patient with end stage renal disease (ESRD), and associated pain, seeks research on treatment development to reduce ESRD pain and pain- associated sleep deprivation (filter on Causal condition: “end stage renal disease” or “chronic kidney disease”; Target condition: “pain," “chronic pain”; Outcome condition: “pain," “chronic pain," “sleep deprivation”).
• A mayor with crisis rates of opioid overdose deaths seeks interventions to reduce immediate catastrophic harms in their town as soon as possible (filter on Causal condition: Not applicable (non-pain condition focus); Target condition: “opiate overdose”; Outcome condition: “death”).

How to answer

Saving will not close the page or redirect you. This field allows multiple selections, included in the full metadata model definitions. Select all that apply. If the pain condition your study focuses on has a causal condition, does your study focus on 1) the causal condition or its treatment (select “Causal condition”), or 2) on the resulting pain/pain condition its treatment (select “Pain”). For example:

Causal condition:

• A study testing efficacy of a fibromyalgia disease-modifying treatment agent/mechanism, to induce or maintain remission, measured by several disease activity/severity markers, including pain
• A study investigating the impact of sleep deficit on the risk for various work- related injuries associated with development of chronic pain

Pain:

• A study testing efficacy of a novel, non-opioid analgesic drug to treat fibromyalgia pain flares, or prevent fibromyalgia-associated chronic pain development when used early in the disease course
• A study investigating the impact of sleep deficit on the risk of chronic pain development following a work related injury associated with chronic pain

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, allowing users to quickly find broad, relevant studies, study data, or study-generated knowledge. For example:

• A clinician who treats fibromyalgia patients seeks research/data for better ways to:

• Pain: address fibromyalgia-associated pain AND
• Causal condition: address/treat the underlying disease to make fibromyalgia- associated pain development less likely or severe.

• Pain: A patient with end stage renal disease, and associated pain, seeks research on treatment development for ESRD pain patients.

How to answer

This field allows multiple selections. Select all that apply.

This field is an array. The controlled vocabulary/pick-list is the NLM MeSH (National Library of Medicine Medical Subject Headings – see the tree view of this vocabulary here), which covers a wide-ranging set of terms over many health-related categories including Diseases/Health Conditions (containing most terms you will need for this field). When you first click into this field, you may see an “odd” value, belonging to a category of NLM MeSH that does not apply to this field. Ignore that. Start typing the health condition of interest, and the drop down list will populate with items based on your inputs.

For condition studies, what condition does the study focus on observing, understanding, or otherwise investigating? For treatment studies, what condition is the target of treatment? For pain studies with a causal condition of pain (e.g. fibromyalgia, end stage renal disease, surgical procedure, lower back injury) above, that indicated the causal condition is the study’s target condition (above), add use this as your ‘Target condition.’ If you indicated that causal condition resultant or associated pain is the target condition of your study (above), add ‘Pain’ (or more specific modifiers of ‘Pain’, e.g. ‘chronic pain’, ‘idiopathic pain’, ‘back pain’) as your study’s ‘Target condition’. NLM MeSH allows you to be general (e.g. “chronic disease," “multiple chronic conditions”) and/or specific (e.g. “end stage liver disease," “osteoarthritis, knee”). Use this range of specificity to add all applicable terms.

How this field will be used

The values from this field will likely be available as 1) an “Advanced Search” filter on the HEAL Platform Discovery page (depending on the range of answers, a simple filter may not be useful, but we may implement an auto-complete to make a long filter list tenable and retain utility), allowing users to quickly filter to broad, relevant studies, study data, or study-generated knowledge, and/or 2) accessible to free text search and discovery tools that leverage elastic and semantic search, so users can find your study with exact or close/related terms. For example:

• A clinician treating fibromyalgia patients seeks research/data on better ways to address fibromyalgia-associated pain, especially to increase the functional status of my patients (filter on Causal condition: “fibromyalgia”; Target condition: “pain," “chronic pain”; Outcome condition: “physical function”).
• A clinician treating fibromyalgia patients seeks research/data on better ways to address/treat the underlying disease to make fibromyalgia-associated pain development less likely or severe (filter on Causal condition: “fibromyalgia”; Target condition: “fibromyalgia”; Outcome condition: “pain," “chronic pain”).
• A patient with end stage renal disease, and associated pain, seeks research developing treatments for ESRD pain and pain-associated sleep deprivation (filter on Causal condition: “end stage renal disease” or “chronic kidney disease”; Target condition: “pain," “chronic pain”; Outcome condition: “pain," “chronic pain," “sleep deprivation”).
• A mayor with crisis rates of opioid overdose deaths seeks interventions to rapidly reduce these catastrophic harms in their town (filter on Causal condition: Not applicable (non-pain condition focus); Target condition: “opiate overdose”; Outcome condition: “death”).

How to answer

This field allows multiple selections. Select all that apply.

This field is an array. The controlled vocabulary/pick-list is the NLM MeSH (National Library of Medicine Medical Subject Headings – see the tree view of this vocabulary here), which covers a wide-ranging set of terms over many health-related categories including Diseases/Health Conditions (containing most terms you will need for this field). When you first click into this field, you may see an “odd” value, belonging to a category of NLM MeSH that does not apply to this field. Ignore that. Start typing the health condition of interest, and the drop down list will populate with items based on your inputs.

For condition studies, what (if any) other causally related conditions is the study measuring, observing, understanding, or otherwise investigating? For treatment studies, what condition and treatment outcomes are being measured? For example:

• A basic science study, using single cell DRG neuron pain stimuli exposures (in cultures), to investigate the timing and mechanistic relationship, at the cellular level, between acute pain signaling and transition to chronic pain signaling signatures (Causal condition: “pain," “acute pain”; Target condition: “pain," “acute pain”; Outcome condition: “pain,"“chronic pain”).

NLM MeSH allows you to be general (e.g. “chronic disease," “multiple chronic conditions”) and/or specific (e.g. “end stage liver disease," “osteoarthritis, knee”). Use this range of specificity to add all applicable terms.

How this field will be used

The values from this field will likely be available either as 1) an "Advanced Search" filter on the HEAL Platform Discovery page (depending on the range of answers across HEAL studies we get for this field, a simple filter may not be useful if the list is too long; we may be able to implement an auto-complete feature that would make a long filter list tenable and retain utility), to will allow Platform users to quickly filter down to the broad type of study, study data, or study-generated knowledge in which they are most interested, and/or as 2) accessible to free text search and discovery tools that leverage elastic and semantic search to make it possible for Platform users to find your study based on the exact term you selected, or a close/related match to that term. Examples include:

• I'm a clinician who treats fibromyalgia patients and want to find research/data that may point to ways to better address fibromyalgia-associated pain, especially with the goal of increasing the functional status of my patients (filter on Causal condition: "fibromyalgia"; Target condition: "pain", "chronic pain"; Outcome condition: "physical function")
• I'm a clinician who treats fibromyalgia patients and want to find research/data that may point to ways to better address/treat the underlying disease to make development of fibromyalgia-associated pain less likely or severe (filter on Causal condition: "fibromyalgia"; Target condition: "fibromyalgia"; Outcome condition: "pain", "chronic pain")
• I'm a patient with end stage renal disease and a lot of associated pain - I want to see what research is going on to develop treatments for pain in ESRD patients, to reduce pain and pain-associated sleep deprivation (filter on Causal condition: "end stage renal disease" or "chronic kidney disease"; Target condition: "pain", "chronic pain"; Outcome condition: "pain", "chronic pain", "sleep deprivation")
• I'm a mayor of a town with crisis rates of deaths from opioid overdose and I want to look for interventions that will reduce these immediate catastrophic harms in my town as soon as possible (filter on Causal condition: Not applicable (non-pain condition focus); Target condition: "opiate overdose"; Outcome condition: "death")

How to answer

This field is an array. The controlled vocabulary/pick-list is the NLM MeSH (National Library of Medicine Medical Subject Headings – see the tree view of this vocabulary here), which covers a wide-ranging set of terms over many health-related categories including Diseases/Health Conditions (containing most terms you will need for this field). When you first click into this field, you may see an “odd” value, belonging to a category of NLM MeSH that does not apply to this field. Ignore that. Start typing the health condition of interest, and the drop down list will populate with items based on your inputs.

For condition studies, what (if any) other causally related conditions is the study measuring, observing, understanding, or otherwise investigating? For treatment studies, what condition and treatment outcomes are being measured? For example:

• A trial to determine efficacy of modifying ESRD dialysis regimens to reduce pain and mortality, while collecting self-reported baseline (and other) depression and anxiety metrics (Causal condition: “end stage renal disease”; Target condition: end stage renal disease; Outcome condition: “pain,"“death”; Other condition: “depression,"“anxiety," “mental health”)
• A basic science study, using single cell DRG neuron pain stimuli exposures (in cultures), to investigate the timing and mechanistic relationship, at the cellular level, between acute pain signaling and transition to chronic pain signaling signatures, while also measuring neuron inflammatory molecule/ cytokine production status (Causal condition: “pain," “acute pain”; Target condition: “pain," “acute pain”; Outcome condition: “pain,"“chronic pain”; Other condition: “inflammation,"“neurogenic inflammation”).

NLM MeSH allows you to be general (e.g. “chronic disease," “multiple chronic conditions”) and/or specific (e.g. “end stage liver disease," “osteoarthritis, knee”). Use this range of specificity to add all applicable terms.

How this field will be used

The values from this field will likely be available as 1) an “Advanced Search” filter on the HEAL Platform Discovery page (depending on the range of answers, a simple filter may not be useful, but we may implement an auto-complete to make a long filter list tenable and retain utility), allowing users to quickly filter to broad, relevant studies, study data, or study-generated knowledge, and/or 2) accessible to free text search and discovery tools that leverage elastic and semantic search, so users can find your study with exact or close/related terms. For example:

• A researcher hypothesizing a link between anxiety and conversion to chronic pain seeks studies following cohorts of acute pain patients over time that also track conversion to chronic pain and measure anxiety (Causal condition: “pain," “acute pain”; Target condition: “pain," “acute pain”; Outcome condition: “pain,"“chronic pain”; Other condition: “anxiety”)