<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426812</url>
  </required_header>
  <id_info>
    <org_study_id>RHINO ID 2019-0651</org_study_id>
    <secondary_id>1R01AT010402-01A1</secondary_id>
    <nct_id>NCT04426812</nct_id>
  </id_info>
  <brief_title>Measuring Chronic Pain Impact: Measurement Enhancement for Chronic Pain</brief_title>
  <official_title>Measuring Chronic Pain Impact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many complementary and integrative health approaches have been shown to be effective for&#xD;
      chronic pain and included in guidelines. This evidence of effectiveness is built on hundreds&#xD;
      of studies representing millions of research dollars, and the ability to analyze and better&#xD;
      compare results across these studies is essential to obtain the full value of this&#xD;
      investment. However, useful across-study comparisons which would allow better understanding&#xD;
      and targeting of these interventions are hampered by at least two challenges: the lack of&#xD;
      common outcome measures and the inability to meaningfully stratify or classify patients.&#xD;
&#xD;
      The first two Aims of this study each address one of these two challenges. The last Aim takes&#xD;
      advantage of this study to further test the viability of MTurk as a data collection platform.&#xD;
&#xD;
      Specific Aim 1 addresses the lack of common outcome measures. This Aim is to develop and&#xD;
      evaluate links or crosswalks between the PROMIS-29 and other common (legacy) measures used&#xD;
      for chronic pain so that the results of studies using different measures can be compared. Our&#xD;
      hypothesis here is that we will be able to create some sort of linkage between PROMIS and&#xD;
      legacy measures that will allow for each pair estimates of one to be made from the other.&#xD;
&#xD;
      Specific Aim 2 addresses the inability to meaningfully stratify or subclassify chronic pain&#xD;
      patients. This Aim is to evaluate and refine the chronic pain impact stratification scheme&#xD;
      (ISS) proposes by the NIH Research Task Force on chronic low back pain, which is based on 9&#xD;
      PROMIS-29 items. Our hypothesis here is that the ISS can be refined so that it can identify&#xD;
      subgroups of chronic pain patients with different levels of morbidity and different needs for&#xD;
      treatment.&#xD;
&#xD;
      Specific Aim 3 addresses the potential for more efficient data collection using the MTurk&#xD;
      platform. This Aim is to evaluate MTurk as a cost- and time-efficient method to collect&#xD;
      quality data on individuals with chronic pain. Our hypothesis here is that we find that MTurk&#xD;
      produces data of sufficient quality to be of use to future research projects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While there is an extensive literature on the effectiveness of pharmaceutical and&#xD;
      nonpharmacologic interventions for chronic low back pain (CLBP), it is challenging to&#xD;
      synthesize the findings because of differences in the CLBP samples and in the outcome&#xD;
      measures used. The NIH Research Task Force (RTF) on CLBP noted that these differences make it&#xD;
      &quot;difficult to compare epidemiologic data and studies of similar or competing interventions,&#xD;
      replicate findings, pool data from multiple studies, resolve conflicting conclusions, develop&#xD;
      multidisciplinary consensus, or even achieve consensus within a discipline regarding&#xD;
      interpretation of findings.&quot; To this list we would add that these differences also prevent&#xD;
      the use of the results to answer questions such as 'Which therapies work best? And for whom?'&#xD;
      This project tackles two things that are needed to address these differences and allow for&#xD;
      better cross-study comparisons: we will develop empirical links between different outcome&#xD;
      measures to allow their expression in similar units (Aim 1), and we will refine the RTF's&#xD;
      proposed stratification (subgrouping) of patients by the impact of their CLBP (Aim 2).&#xD;
&#xD;
      To address the first challenge, in Aim 1 this study will develop and evaluate crosswalks or&#xD;
      links between components of the 29-item Patient-Reported Outcomes Measurement Information&#xD;
      System (PROMIS®) short form (PROMIS-29) and common legacy measures used for chronic pain. The&#xD;
      purpose of these crosswalks or links is to allow researchers who measured outcomes using one&#xD;
      instrument to estimate what the outcome would be if it had been measured using the other&#xD;
      instrument. In particular, we will create crosswalks/links for the two most commonly used&#xD;
      instruments used to measure outcomes for CLBP: the Roland-Morris Disability Questionnaire&#xD;
      (RMDQ) and the Oswestry Disability Index (ODI). In addition, depending on data availability&#xD;
      and input from our Advisory Council we will create at least two other crosswalks/links&#xD;
      between the PROMIS-29 and other legacy measures for CLBP (e.g., the Back Pain Functional&#xD;
      Scale) or legacy measures for other types of chronic pain (e.g., the Neck Disability Index&#xD;
      for chronic neck pain).&#xD;
&#xD;
      To address the second challenge, in Aim 2 we will evaluate and refine the chronic pain impact&#xD;
      stratification scheme proposed by the NIH Research Task Force on chronic low back pain. The&#xD;
      proposed scheme uses the Impact Stratification Score (ISS) which is calculated using 9 items&#xD;
      from the PROMIS-29. This ISS was intended to identify and categorize patients with chronic&#xD;
      pain into groups based on the severity of their condition so that treatment can be better&#xD;
      targeted. We will first evaluate the ISS and its properties to determine whether they are&#xD;
      stable across different samples and determine whether they can be improved. After we have&#xD;
      finalized the components and calculation of the ISS, we will examine its effect on the&#xD;
      impacts of chronic pain (e.g., health-related quality of life, healthcare utilization, worker&#xD;
      productivity) to identify meaningful cut-points to use to stratify chronic pain patients into&#xD;
      subgroups who exhibit different levels of chronic pain impact.&#xD;
&#xD;
      Three types of data will be used in the analyses to address Aims 1 and 2: data from existing&#xD;
      datasets built during other studies, data collected from an anonymous national convenience&#xD;
      sample using Amazon's Mechanical Turk (MTurk) crowdsourcing platform, and data from members&#xD;
      of the probability-based nationally representative KnowledgePanel. Aim 3 will evaluate&#xD;
      whether MTurk is a reliable, efficient method to collect data on individuals with chronic&#xD;
      pain. One part of this evaluation will involve comparison of the results from MTurk to what&#xD;
      was found using KnowledgePanel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 30, 2021</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of function for those with chronic back pain; range 0-100; higher is worse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of function for those with chronic back pain; range 0-100; higher is worse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact Stratification Score (ISS)</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of the level of impact chronic pain has on individual's lives; range 8-50; higher is worse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS pain intensity</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of pain intensity; range 0-10; higher is worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS pain interference</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of the amount of interference pain causes in life; range 4-20; higher is worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS physical function</measure>
    <time_frame>Baseline only</time_frame>
    <description>Measure of the impact of a condition on physical function; range 4-20; higher is worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Impact Stratification Score (ISS)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measure of the change in the level of impact chronic pain has on individual's lives; range -42 to +42; positive values are a worsening of impact</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>MTurk sample</arm_group_label>
    <description>Data collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KnowledgePanel</arm_group_label>
    <description>Data collected from a sample of panel members in an online representative panel called KnowledgePanel who self-identify as having chronic pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention; just data collection</intervention_name>
    <description>No intervention; just data collection</description>
    <arm_group_label>KnowledgePanel</arm_group_label>
    <arm_group_label>MTurk sample</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We have two cohorts. Both will have similar inclusion and exclusion criteria. The first&#xD;
        from MTurk is a non-probability sample, and the second is from KnowledgePanel and is a&#xD;
        probability-based sample, but one that has been established by the group who owns this&#xD;
        panel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult&#xD;
&#xD;
          -  self-described chronic pain&#xD;
&#xD;
          -  member of one of the panels (MTurk or KnowledgePanel) we are using for data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwillingness to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia M Herman, ND, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RAND</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Online recruitment only - nationwide</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Herman PM, Edelen MO, Rodriguez A, Hilton LG, Hays RD. A protocol for chronic pain outcome measurement enhancement by linking PROMIS-29 scale to legacy measures and improving chronic pain stratification. BMC Musculoskelet Disord. 2020 Oct 10;21(1):671. doi: 10.1186/s12891-020-03696-2.</citation>
    <PMID>33038933</PMID>
  </reference>
  <results_reference>
    <citation>Edelen MO, Rodriguez A, Herman P, Hays RD. Crosswalking the Patient-Reported Outcomes Measurement Information System Physical Function, Pain Interference, and Pain Intensity Scores to the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. Arch Phys Med Rehabil. 2021 Jul;102(7):1317-1323. doi: 10.1016/j.apmr.2021.02.014. Epub 2021 Mar 5.</citation>
    <PMID>33684368</PMID>
  </results_reference>
  <results_reference>
    <citation>Dunbar MS, Rodriguez A, Edelen MO, Hays RD, Coulter ID, Siconolfi D, Herman PM. Longitudinal Associations of PROMIS-29 Anxiety and Depression Symptoms With Low Back Pain Impact in a Sample of U.S. Military Service Members. Mil Med. 2023 Mar 20;188(3-4):e630-e636. doi: 10.1093/milmed/usab339.</citation>
    <PMID>34417805</PMID>
  </results_reference>
  <results_reference>
    <citation>PROMIS(R) Health Organization (PHO) 2021 Conference Abstracts. J Patient Rep Outcomes. 2021 Oct 1;5(Suppl 1):90. doi: 10.1186/s41687-021-00349-3. No abstract available.</citation>
    <PMID>34595566</PMID>
  </results_reference>
  <results_reference>
    <citation>Hays RD, Orlando Edelen M, Rodriguez A, Herman P. Support for the Reliability and Validity of the National Institutes of Health Impact Stratification Score in a Sample of Active-Duty U.S. Military Personnel with Low Back Pain. Pain Med. 2021 Oct 8;22(10):2185-2190. doi: 10.1093/pm/pnab175.</citation>
    <PMID>34022052</PMID>
  </results_reference>
  <results_reference>
    <citation>Hays RD, Shannon ZK, Long CR, Spritzer KL, Vining RD, Coulter ID, Pohlman KA, Walter JA, Goertz CM. Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial. Pain Med. 2022 Aug 31;23(9):1550-1559. doi: 10.1093/pm/pnac009. Erratum In: Pain Med. 2022 May 30;23(6):1198.</citation>
    <PMID>35060609</PMID>
  </results_reference>
  <results_reference>
    <citation>Hilton LG, Coulter ID, Ryan GW, Hays RD. Comparing the Recruitment of Research Participants With Chronic Low Back Pain Using Amazon Mechanical Turk With the Recruitment of Patients From Chiropractic Clinics: A Quasi-Experimental Study. J Manipulative Physiol Ther. 2021 Oct;44(8):601-611. doi: 10.1016/j.jmpt.2022.02.004. Epub 2022 Jun 18.</citation>
    <PMID>35728997</PMID>
  </results_reference>
  <results_reference>
    <citation>Hays RD, Slaughter ME, Spritzer KL, Herman PM. Assessing the Significance of Individual Change in 2 Samples of Patients in Treatment for Low Back Pain Using 5 Different Statistical Indicators. J Manipulative Physiol Ther. 2021 Nov-Dec;44(9):699-706. doi: 10.1016/j.jmpt.2022.03.002. Epub 2022 Jun 23.</citation>
    <PMID>35753878</PMID>
  </results_reference>
  <results_reference>
    <citation>Herman PM, Coulter ID, Hays RD, Rodriguez A, Edelen MO. A Scoping Review of Chronic Low Back Pain Classification Schemes Based on Patient-Reported Outcomes. Pain Physician. 2022 Sep;25(6):471-482.</citation>
    <PMID>36122256</PMID>
  </results_reference>
  <results_reference>
    <citation>Hays RD, Slaughter M, Rodriguez A, Edelen MO, Herman PM. Analyses of Cross-Sectional Data to Link the PEG With the Patient Reported Outcomes Measurement and Information System (PROMIS) Global Physical Health Scale. J Pain. 2022 Nov;23(11):1904-1911. doi: 10.1016/j.jpain.2022.06.006. Epub 2022 Jun 26.</citation>
    <PMID>35768043</PMID>
  </results_reference>
  <results_reference>
    <citation>Hays RD, Qureshi N, Edelen M, Rodriguez A, Slaughter M, Herman PM. Crosswalking the National Institutes of Health Impact Stratification Score to the PEG. Arch Phys Med Rehabil. 2023 Mar;104(3):425-429. doi: 10.1016/j.apmr.2022.08.006. Epub 2022 Aug 27.</citation>
    <PMID>36030893</PMID>
  </results_reference>
  <results_reference>
    <citation>Qureshi N, Edelen M, Hilton L, Rodriguez A, Hays RD, Herman PM. Comparing Data Collected on Amazon's Mechanical Turk to National Surveys. Am J Health Behav. 2022 Oct 17;46(5):497-502. doi: 10.5993/AJHB.46.5.1.</citation>
    <PMID>36333833</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodriguez A, Edelen MO, Herman PM, Hays RD. Unpacking the impact of chronic pain as measured by the impact stratification score. BMC Musculoskelet Disord. 2022 Sep 23;23(1):884. doi: 10.1186/s12891-022-05834-4.</citation>
    <PMID>36151555</PMID>
  </results_reference>
  <results_reference>
    <citation>Herman PM, Qureshi N, Arick SD, Edelen MO, Hays RD, Rodriguez A, Weir RL, Coulter ID. Definitions of Chronic Low Back Pain From a Scoping Review, and Analyses of Narratives and Self-Reported Health of Adults With Low Back Pain. J Pain. 2023 Mar;24(3):403-412. doi: 10.1016/j.jpain.2022.10.012. Epub 2022 Oct 23.</citation>
    <PMID>36283654</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We have 3 types of data in this study. The first is using data from existing datasets gathered in other studies. We don't know whether we will be able to get permission to share those data. The second source is the MTurk sample. We hope to share those data and those of the third source KnowledgePanel. However, in each case we are limited by the regulations of those data collection platforms.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426812
org study id: RHINO ID 2019-0651
secondary id: 1R01AT010402-01A1
nct id: NCT04426812
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many complementary and integrative health approaches have been shown to be effective for
      chronic pain and included in guidelines. This evidence of effectiveness is built on hundreds
      of studies representing millions of research dollars, and the ability to analyze and better
      compare results across these studies is essential to obtain the full value of this
      investment. However, useful across-study comparisons which would allow better understanding
      and targeting of these interventions are hampered by at least two challenges: the lack of
      common outcome measures and the inability to meaningfully stratify or classify patients.

      The first two Aims of this study each address one of these two challenges. The last Aim takes
      advantage of this study to further test the viability of MTurk as a data collection platform.

      Specific Aim 1 addresses the lack of common outcome measures. This Aim is to develop and
      evaluate links or crosswalks between the PROMIS-29 and other common (legacy) measures used
      for chronic pain so that the results of studies using different measures can be compared. Our
      hypothesis here is that we will be able to create some sort of linkage between PROMIS and
      legacy measures that will allow for each pair estimates of one to be made from the other.

      Specific Aim 2 addresses the inability to meaningfully stratify or subclassify chronic pain
      patients. This Aim is to evaluate and refine the chronic pain impact stratification scheme
      (ISS) proposes by the NIH Research Task Force on chronic low back pain, which is based on 9
      PROMIS-29 items. Our hypothesis here is that the ISS can be refined so that it can identify
      subgroups of chronic pain patients with different levels of morbidity and different needs for
      treatment.

      Specific Aim 3 addresses the potential for more efficient data collection using the MTurk
      platform. This Aim is to evaluate MTurk as a cost- and time-efficient method to collect
      quality data on individuals with chronic pain. Our hypothesis here is that we find that MTurk
      produces data of sufficient quality to be of use to future research projects.
While there is an extensive literature on the effectiveness of pharmaceutical and
      nonpharmacologic interventions for chronic low back pain (CLBP), it is challenging to
      synthesize the findings because of differences in the CLBP samples and in the outcome
      measures used. The NIH Research Task Force (RTF) on CLBP noted that these differences make it
      "difficult to compare epidemiologic data and studies of similar or competing interventions,
      replicate findings, pool data from multiple studies, resolve conflicting conclusions, develop
      multidisciplinary consensus, or even achieve consensus within a discipline regarding
      interpretation of findings." To this list we would add that these differences also prevent
      the use of the results to answer questions such as 'Which therapies work best? And for whom?'
      This project tackles two things that are needed to address these differences and allow for
      better cross-study comparisons: we will develop empirical links between different outcome
      measures to allow their expression in similar units (Aim 1), and we will refine the RTF's
      proposed stratification (subgrouping) of patients by the impact of their CLBP (Aim 2).

      To address the first challenge, in Aim 1 this study will develop and evaluate crosswalks or
      links between components of the 29-item Patient-Reported Outcomes Measurement Information
      System (PROMIS®) short form (PROMIS-29) and common legacy measures used for chronic pain. The
      purpose of these crosswalks or links is to allow researchers who measured outcomes using one
      instrument to estimate what the outcome would be if it had been measured using the other
      instrument. In particular, we will create crosswalks/links for the two most commonly used
      instruments used to measure outcomes for CLBP: the Roland-Morris Disability Questionnaire
      (RMDQ) and the Oswestry Disability Index (ODI). In addition, depending on data availability
      and input from our Advisory Council we will create at least two other crosswalks/links
      between the PROMIS-29 and other legacy measures for CLBP (e.g., the Back Pain Functional
      Scale) or legacy measures for other types of chronic pain (e.g., the Neck Disability Index
      for chronic neck pain).

      To address the second challenge, in Aim 2 we will evaluate and refine the chronic pain impact
      stratification scheme proposed by the NIH Research Task Force on chronic low back pain. The
      proposed scheme uses the Impact Stratification Score (ISS) which is calculated using 9 items
      from the PROMIS-29. This ISS was intended to identify and categorize patients with chronic
      pain into groups based on the severity of their condition so that treatment can be better
      targeted. We will first evaluate the ISS and its properties to determine whether they are
      stable across different samples and determine whether they can be improved. After we have
      finalized the components and calculation of the ISS, we will examine its effect on the
      impacts of chronic pain (e.g., health-related quality of life, healthcare utilization, worker
      productivity) to identify meaningful cut-points to use to stratify chronic pain patients into
      subgroups who exhibit different levels of chronic pain impact.

      Three types of data will be used in the analyses to address Aims 1 and 2: data from existing
      datasets built during other studies, data collected from an anonymous national convenience
      sample using Amazon's Mechanical Turk (MTurk) crowdsourcing platform, and data from members
      of the probability-based nationally representative KnowledgePanel. Aim 3 will evaluate
      whether MTurk is a reliable, efficient method to collect data on individuals with chronic
      pain. One part of this evaluation will involve comparison of the results from MTurk to what
      was found using KnowledgePanel.
observational model: Cohort
time perspective: Prospective
measure: Oswestry Disability Index (ODI)
time frame: Baseline only
description: Measure of function for those with chronic back pain; range 0-100; higher is worse
measure: Roland-Morris Disability Questionnaire (RMDQ)
time frame: Baseline only
description: Measure of function for those with chronic back pain; range 0-100; higher is worse
measure: Impact Stratification Score (ISS)
time frame: Baseline only
description: Measure of the level of impact chronic pain has on individual's lives; range 8-50; higher is worse
measure: PROMIS pain intensity
time frame: Baseline only
description: Measure of pain intensity; range 0-10; higher is worse
measure: PROMIS pain interference
time frame: Baseline only
description: Measure of the amount of interference pain causes in life; range 4-20; higher is worse
measure: PROMIS physical function
time frame: Baseline only
description: Measure of the impact of a condition on physical function; range 4-20; higher is worse
measure: Change in Impact Stratification Score (ISS)
time frame: Baseline and 3 months
description: Measure of the change in the level of impact chronic pain has on individual's lives; range -42 to +42; positive values are a worsening of impact
arm group label: MTurk sample
description: Data collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain.
arm group label: KnowledgePanel
description: Data collected from a sample of panel members in an online representative panel called KnowledgePanel who self-identify as having chronic pain.
intervention type: Other
intervention name: No intervention; just data collection
description: No intervention; just data collection
arm group label: KnowledgePanel
arm group label: MTurk sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patricia M Herman, ND, PhD
role: Principal Investigator
affiliation: RAND
facility: 
country: United States
citation: Herman PM, Edelen MO, Rodriguez A, Hilton LG, Hays RD. A protocol for chronic pain outcome measurement enhancement by linking PROMIS-29 scale to legacy measures and improving chronic pain stratification. BMC Musculoskelet Disord. 2020 Oct 10;21(1):671. doi: 10.1186/s12891-020-03696-2.
PMID: 33038933
citation: Edelen MO, Rodriguez A, Herman P, Hays RD. Crosswalking the Patient-Reported Outcomes Measurement Information System Physical Function, Pain Interference, and Pain Intensity Scores to the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. Arch Phys Med Rehabil. 2021 Jul;102(7):1317-1323. doi: 10.1016/j.apmr.2021.02.014. Epub 2021 Mar 5.
PMID: 33684368
citation: Dunbar MS, Rodriguez A, Edelen MO, Hays RD, Coulter ID, Siconolfi D, Herman PM. Longitudinal Associations of PROMIS-29 Anxiety and Depression Symptoms With Low Back Pain Impact in a Sample of U.S. Military Service Members. Mil Med. 2023 Mar 20;188(3-4):e630-e636. doi: 10.1093/milmed/usab339.
PMID: 34417805
citation: PROMIS(R) Health Organization (PHO) 2021 Conference Abstracts. J Patient Rep Outcomes. 2021 Oct 1;5(Suppl 1):90. doi: 10.1186/s41687-021-00349-3. No abstract available.
PMID: 34595566
citation: Hays RD, Orlando Edelen M, Rodriguez A, Herman P. Support for the Reliability and Validity of the National Institutes of Health Impact Stratification Score in a Sample of Active-Duty U.S. Military Personnel with Low Back Pain. Pain Med. 2021 Oct 8;22(10):2185-2190. doi: 10.1093/pm/pnab175.
PMID: 34022052
citation: Hays RD, Shannon ZK, Long CR, Spritzer KL, Vining RD, Coulter ID, Pohlman KA, Walter JA, Goertz CM. Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial. Pain Med. 2022 Aug 31;23(9):1550-1559. doi: 10.1093/pm/pnac009. Erratum In: Pain Med. 2022 May 30;23(6):1198.
PMID: 35060609
citation: Hilton LG, Coulter ID, Ryan GW, Hays RD. Comparing the Recruitment of Research Participants With Chronic Low Back Pain Using Amazon Mechanical Turk With the Recruitment of Patients From Chiropractic Clinics: A Quasi-Experimental Study. J Manipulative Physiol Ther. 2021 Oct;44(8):601-611. doi: 10.1016/j.jmpt.2022.02.004. Epub 2022 Jun 18.
PMID: 35728997
citation: Hays RD, Slaughter ME, Spritzer KL, Herman PM. Assessing the Significance of Individual Change in 2 Samples of Patients in Treatment for Low Back Pain Using 5 Different Statistical Indicators. J Manipulative Physiol Ther. 2021 Nov-Dec;44(9):699-706. doi: 10.1016/j.jmpt.2022.03.002. Epub 2022 Jun 23.
PMID: 35753878
citation: Herman PM, Coulter ID, Hays RD, Rodriguez A, Edelen MO. A Scoping Review of Chronic Low Back Pain Classification Schemes Based on Patient-Reported Outcomes. Pain Physician. 2022 Sep;25(6):471-482.
PMID: 36122256
citation: Hays RD, Slaughter M, Rodriguez A, Edelen MO, Herman PM. Analyses of Cross-Sectional Data to Link the PEG With the Patient Reported Outcomes Measurement and Information System (PROMIS) Global Physical Health Scale. J Pain. 2022 Nov;23(11):1904-1911. doi: 10.1016/j.jpain.2022.06.006. Epub 2022 Jun 26.
PMID: 35768043
citation: Hays RD, Qureshi N, Edelen M, Rodriguez A, Slaughter M, Herman PM. Crosswalking the National Institutes of Health Impact Stratification Score to the PEG. Arch Phys Med Rehabil. 2023 Mar;104(3):425-429. doi: 10.1016/j.apmr.2022.08.006. Epub 2022 Aug 27.
PMID: 36030893
citation: Qureshi N, Edelen M, Hilton L, Rodriguez A, Hays RD, Herman PM. Comparing Data Collected on Amazon's Mechanical Turk to National Surveys. Am J Health Behav. 2022 Oct 17;46(5):497-502. doi: 10.5993/AJHB.46.5.1.
PMID: 36333833
citation: Rodriguez A, Edelen MO, Herman PM, Hays RD. Unpacking the impact of chronic pain as measured by the impact stratification score. BMC Musculoskelet Disord. 2022 Sep 23;23(1):884. doi: 10.1186/s12891-022-05834-4.
PMID: 36151555
citation: Herman PM, Qureshi N, Arick SD, Edelen MO, Hays RD, Rodriguez A, Weir RL, Coulter ID. Definitions of Chronic Low Back Pain From a Scoping Review, and Analyses of Narratives and Self-Reported Health of Adults With Low Back Pain. J Pain. 2023 Mar;24(3):403-412. doi: 10.1016/j.jpain.2022.10.012. Epub 2022 Oct 23.
PMID: 36283654
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Undecided
ipd description: We have 3 types of data in this study. The first is using data from existing datasets gathered in other studies. We don't know whether we will be able to get permission to share those data. The second source is the MTurk sample. We hope to share those data and those of the third source KnowledgePanel. However, in each case we are limited by the regulations of those data collection platforms.