Pain Management
SPECIAL REPORT For reprint orders, please contact: [email protected]
PASTOR/PROMIS© pain outcomes system: what does it mean to pain specialists? Karon F Cook*,1, Chester Buckenmaier 3rd2 & Richard C Gershon1
Practice points ●●
There is growing discomfort with the current state of pain management practice, particularly with regards to opioid use and misuse.
●●
The US Army Surgeon General charged the Pain Management Task Force with
developing recommendations for improving pain management practice for soldiers and their families. ●●
Among the Taskforce’s recommendations was the development of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR).
●●
PASTOR is a system for collecting patient-reported data that is used in order to
facilitate the clinical encounter and will support data-driven evaluations of the effectiveness of different approaches to pain management, especially integrative approaches.
SUMMARY The Army Pain Management Task Force was charged with recommending pain management strategies for Army Medical Command that would optimize quality of life for patients living with acute and chronic pain. Among their recommendations was the development of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). In order to develop this tool, the Pain Management Task Force leveraged the NIH’s investment in building the Patient-Reported Outcomes Measurement Information System (PROMIS®). The two foci of PASTOR are to enhance the clinical encounter and provide data for comprehensive evaluations of treatment effectiveness. The potential of such information for the future of clinical management is described.
KEYWORDS
• chronic pain • comparative
effectiveness research • outcomes registry • pain management • patientreported outcomes
In August of 2009, Army Surgeon General, LTG Eric Shoomaker (retired) chartered the Army Pain Management Task Force (PMTF). The PMTF’s charge was “to provide recommendations for an Army Medical Command comprehensive pain management strategy that is holistic, multidisciplinary and multimodal in approach, utilizes state of the art/science modalities and technologies and provides optimal quality of life for soldiers and other patients with acute and chronic pain” [1] . From the beginning, the mission encompassed not only pain management of soldiers, but also of soldiers’ families and other populations. The concerns and needs of soldiers Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA Defense & Veterans Center for Integrative Pain Management, Uniformed Services University of the Health Sciences, Bethesda, MD, USA *Author for correspondence: Tel.: +1 713 291 3918; [email protected] 1 2
10.2217/PMT.14.25 © 2014 Future Medicine Ltd
Pain Manage. (2014) 4(4), 277–283
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Special Report Cook, Buckenmaier & Gershon were addressed, but the effort is relevant to other pain populations. In order to achieve this mission, the PMTF visited 28 clinical sites representing a broad range of care facilities servicing active military, veterans and civilians. Interviews with clinical experts and medical staff elicited opinions regarding pain management capacity, resources and best practices. The findings of this study were published in PMTF’s final report [1] . The lack of consistency in pain management practice was highlighted, not only within civilian, veteran and active military settings, but across all medical services. The report hypothesized several causes for this variability of service, including the lack of standard pain curricula in medical schools, the influence of mentors on practice patterns, clinicians’ own beliefs about pain and their experiences treating patients who have pain and the relative paucity of data supporting established practice patterns. The transient nature of both patients and providers in military medical systems accentuates the impact of practice variability on individual patients. The lack of empirical evidence regarding the best treatments for pain management, especially when choosing from among integrative approaches, is another barrier to consistency in the pain management service provided. Without empirical evidence that documents both patients’ concerns and the relative effectiveness of different treatment options, clinicians are likely to rely on what they have learned in medical school or from mentors, perpetuating unwarranted variability in pain management practice. Informed both by clinical interviews and the results of an extensive literature review, the PMTF derived a number of specific recommendations [1] . Among these was the development of a tool that would standardize pain assessment within the military health system and provide a system-wide source of pain-related, patient-reported outcomes (PROs) data. The Pain Assessment Screening Tool and Outcomes Registry (PASTOR) addresses this need. This article describes how the PMTF leveraged the Patient-Reported Outcomes Measurement Information System (PROMIS®), a large-scale measurement initiative of the NIH [2] , in order to build PASTOR. We describe the unique characteristics of PROMIS that made it attractive as the source for PASTOR measures of painrelated PROs. The development and initiation of PASTOR are discussed, including the two
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PASTOR foci: enhancing the clinical encounter and comprehensive documentation of patient characteristics and treatment effectiveness. The potential of such information for the future of clinical management is described. NIH PROMIS: a unique tool for measuring PROs Pain service and pain assessment have the following in common: both are bedeviled by ‘practice variability’ [1,3–5] . There has been inconsistency in the instruments selected for quantifying patients’ pain-related symptoms and concerns. For any given patient-relevant outcome, there is often a myriad of available measures. This situation has been described as health outcome’s ‘Tower of Babel’, a confusion of instruments that cannot ‘talk to each other’ because each has its own scoring metric [2] . This situation renders comparisons between healthcare systems exceedingly difficult and greatly hinders the development and implementation of systemwide, evidence-based ‘best’ practices. This lack of standardization motivated NIH’s PROMIS initiative [2] . To date, the NIH has invested more than US$100 million in developing and maintaining an extensive library of health outcomes measures and an electronic platform for administering them – the PROMIS Assessment Center (IL, USA) [6] . The PROMIS measures have unique features that are relevant to addressing the goals set forth by the PMTF. The measures are based on ‘item banks’ rather than traditional, static forms. Item banks are collections of items that span the entire content range of the domain being measured and target all relevant levels of that domain. A typical PROMIS item bank includes between 40 and 70 items. Item banks can be used to generate short forms that accommodate different measurement needs and contexts (e.g., greater precision, less response burden or more symptomatic patients). Item banks also provide the foundation for dynamic assessment via computer adaptive testing (CAT) [7–10] . When items are administered using CAT, a computer algorithm selects items for individuals based on their answers to previous items. This tailoring of the assessment results in measurement precision with significantly less response burden. Whether a symptom or outcome is measured using a PROMIS short form or a PROMIS CAT, the scores are directly comparable because they are scaled to a common mathematical metric.
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PASTOR/PROMIS® pain outcomes system: what does it mean to pain specialists? Also unique to PROMIS is that its measures target domains rather than diseases or conditions. A domain includes the perceptions, functions, activities and concerns specific to what is being measured. PROMIS’s domain framework includes physical, mental and social health domains [11–16] . The PROMIS measures have proven to have equal or superior psychometric properties compared with legacy measures, as evidenced in 250 peer-reviewed articles published through 2013 (for a complete list of publications, see [17]). In addition, the precision of legacy measures can be achieved with substantially fewer items using CAT administrations.
comparisons among systems because of lack of standardization in what was collected.
Leveraging NIH measurement efforts When the PMTF released its 2010 report and the accompanying recommendation for a standard pain assessment tool, NIH-funded investigators had been working on PROMIS for 7 years. An extensive instrument library and the PROMIS Assessment Center were already in place. This convergence of needs and resources created the opportunity for a natural partnership between the US Department of Defense (DoD) and the NIH. The DoD was able to leverage the financial and scientific resources that were expended in developing PROMIS. In September 2011, the PMTF convened a meeting of clinical pain experts, health outcomes researchers, military medical leaders and PROMIS scientists in order to draft the content specifications for PASTOR. The panel discussed the range of pain domains and pain correlates (e.g., fatigue, sleep impairment and anxiety) that they believed would facilitate provider–patient interactions and increase understanding of the impact of pain on patients’ lives. The panel identified clinical, demographic and other variables for a pain outcomes registry that could be used to evaluate empirical questions related to pain management strategies (e.g., patients’ reports on the impact of different integrative medicine treatments and personally relevant ‘important activities’ that are limited by their painful condition). In later work, the list of measures was winnowed down in order to reduce response burden and focus on clinical priorities. Box 1 summarizes the contents of PASTOR 1.0. Traditionally, the patient information gathered in PASTOR would have been collected using inefficient, paper-based surveys, imposing excessive administrative burden both on patients and clinic staff. Furthermore, the data collected would often defy
●●A clinical report for pain clinicians
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The two foci of PASTOR PASTOR was developed for both clinical and research purposes. The initial focus has been on using the data collected in order to improve the clinical encounter, alerting clinicians to emerging and potential pain-related health problems and enhancing communication between patients and their clinicians. The PASTOR tool also serves as the basis for a pain registry that will be a rich resource for future research and clinical resource management. The clinical focus of the PASTOR effort stimulated the development of a provider’s summary report designed to enhance the clinical management of patients with pain. This report is a summary of an individual patient’s status based on the patient’s self-report. A draft of the PASTOR Pain Report was developed and refined based on several rounds of input from pain experts and other clinicians. The report extracts data elements from PASTOR that clinicians believed would be valuable for interviewing patients, understanding outcomes relevant to patients and managing care plans. For example, when completing PASTOR, patients enter three personally relevant activities that are currently limited by pain and rate their current ability to perform each activity. The goals are entered in free text in order to allow maximum choice for patients. These goals and the self-rated progress towards them are included in the pain report. The report tracks trends over the course of follow-up clinical visits in other relevant outcomes (e.g., changes in pain, sleep and social function), providing a graphic representation of treatments, symptoms, outcomes and progression towards patient-defined goals over time. The report is a powerful tool to efficiently focus the limited clinical encounter time on specific treatment issues that the patient has identified as relevant. Some of the elements included in the report are a body pain map that indicates areas of pain (including worst pain), results of screens for clinically relevant parameters (e.g., alcohol and opioid misuse/abuse, depression and post-traumatic stress disorder), symptoms and outcomes over time and a history of activities that the patients report to be affected by their pain.
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Special Report Cook, Buckenmaier & Gershon ●●A registry to inform pain policy & pain
management
The PASTOR registry will be a repository of demographics, interventions, symptoms, outcomes and patient progress towards pain-related goals. The registry will be populated with data from multiple time points, supporting sophisticated statistical evaluations of the magnitude and trajectory of changes over time. Because of the large number of patients treated within the military health system, the PASTOR registry will be well powered (using big data) for subgroup comparisons, which are critical to understanding individual variations in responses to pain management approaches. One of the attractive aspects of PROMIS is the fact that measures are standardized to the T-score metric and allow direct comparisons to a reference population (e.g., the US general population). With the PROMIS data registry, additional normative comparisons will be available based on other relevant comparative populations (e.g., the military health system population and active duty soldiers). These comparisons provide interpretative contexts for understanding and comparing outcome levels. PASTOR status In 2012, the US Army Medical Research and Material Command (USAMR A A) awarded a contract to Northwestern University (IL, USA) to operationalize PASTOR (Richard Gershon, PI). The PROMIS Statistical Center and the PROMIS Assessment Center are located within the Department of Medical Social Sciences, Feinberg Medical School at Northwestern University. In the fall of 2013, a PASTOR prototype was completed and submitted for alpha testing. Roll-out at the Walter Reed National Military Medical Center (MD, USA) began in January 2014. Patients are introduced to PASTOR by study team members who explain its purpose and assist any patient who is not technologically comfortable. This person-to-person introduction has proven to be important both in terms of patient comfort with using PASTOR and their buy-in. Prior to clinic visits, patients are sent an email with login information asking them to complete the PASTOR assessment using the Internet-enabled device of their choice. Patients who fail to complete their assessments prior to arrival for their clinic visits are directed to a clinic-based kiosk or
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tablet that is enabled to access the PASTOR assessment. The ability of patients to complete the PASTOR assessment at a time and under conditions of their choosing is a particular strength of this tool. Additional funding from USAMRAA is supporting work by the Madigan Army Medical Center (WA, USA) Clinical Informatics program to embed the PASTOR system ‘behind the wire’ (Richard Barnhill, PI). When completed, PASTOR data will be created, stored, delivered and maintained within the electronic medical records system. The system also will allow staff to view the patient data using dashboards, visual representations, trends reports and summaries. The work at Madigan also includes a pilot rollout of the PASTOR system at Naval Medical Center San Diego (CA, USA). Conclusion The US Department of Health and Human Services published a framework for improving health outcomes and quality of life in individuals living with multiple chronic conditions (MCCs) [18] . Among the recommended strategies were two that parallel the goals and functions of PASTOR: “implement and effectively use health information technology” and “innovate and strengthen methods for researchers to improve measurement of patient-centered outcomes of treatments and other interventions for individuals with MCC” [18] . PASTOR is not the first effort to identify a core outcome dataset in order to standardize research and improve the generalizability of research findings (e.g., see [19–21] ). What is unique about PASTOR is its dual purpose as a research resource and as a tool for enhancing patients’ encounters with healthcare providers. PASTOR enables clinicians and patients within the military to meaningfully share relevant health information in real time. The system provides insight into both present and historical pain. This valuable information directly addresses the PMTF’s charge to provide a holistic, state-of-the-art, multidisciplinary approach to address chronic pain management across all military medical services. PASTOR’s robust platform will enable military health providers to respond with consistent and proven methodologies that can continuality be monitored, measured and improved in order to enhance the quality of life for patients suffering from acute and chronic pain.
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PASTOR/PROMIS® pain outcomes system: what does it mean to pain specialists?
Special Report
Box 1. Nonexhaustive summary of measures included as part of the Pain Assessment Screening Tool and Outcomes Registry. Registration, demographic and other information ●● Pain measures ●● Pain intensity, quality and impact ●● Defense and Veterans Pain Rating Scale ●● Graphic pain map ●● Patient-Reported Outcomes Measurement Information System (PROMIS®) Bank v1.0 – pain interference (computer adaptive) ●● PROMIS pain quality (short form) ●● PROMIS headache (computer adaptive) ●● Patient activities limited by pain ●● What are your three most important activities that are limited by pain? ●● How well are you currently able to perform (each) activity? ●● Problem screening ●● Opioid abuse/misuse ●● Post-traumatic stress disorder ●● PROMIS anxiety (computer adaptive) ●● PROMIS depression (computer adaptive) ●● PROMIS alcohol (computer adaptive) ●● Alcohol Use Disorders Identification Test C ●● PROMIS measures of additional pain correlates ●● PROMIS SF v1.0 – global health (short form) ●● PROMIS fatigue (computer adaptive) ●● PROMIS social sat role (computer adaptive) ●● PROMIS anger (computer adaptive) ●● PROMIS sleep-related impairment (computer adaptive) ●● PROMIS Bank v1.0 – physical function (computer adaptive) ●● Health utilization ●● Providers seen by type (e.g.,) ●● Self-reported treatment history and effectiveness evaluations
Future perspective The PASTOR system will provide a template for registries that support both clinical management and research into other conditions and diseases. There is substantial overlap in the domains that are important to patients with chronic pain and the domains that are relevant to persons with other chronic conditions. Furthermore, because individuals often suffer from MCCs, the ‘silo’ strategy of treating single chronic conditions has been increasingly challenged [18] . The development of PASTOR comes at a time in health research when ‘new frontiers’ are emerging for the use of PROs in general and pain management in particular [22] . Important to the military healthcare system is the ability to conduct comparative effectiveness evaluations. Because many clinical and laboratory measures do not directly relate to the matters of greatest relevance to patients, it is critical that patients’ perspectives are systematically included [22] . Furthermore, the
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PASTOR tool comes at a dramatic time in the evolution of pain management. In recent years, alarms regarding opioid use and misuse have sounded in news outlets [23–26] , government agencies [27–30] and the scientific literature [31– 34] . The CDC reported that opioid pain relievers were responsible for 73.8% of the 20,044 prescription drug overdose deaths in the USA in 2008 [29] . In addition to concerns regarding opioid overdoses, there is a growing realization that as many as a third of chronic patients cannot tolerate strong opioids [35] . As has been observed, there are not well-validated algorithms for identifying individuals who are the best candidates for opioid therapy [36] . The same can be said for identifying the patients who are most likely to benefit from complementary and nontraditional pain interventions. A potential approach is the application of ‘personalized medicine’, defined as “optimizing medication types and dosages
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Special Report Cook, Buckenmaier & Gershon for individual patients based upon genetic, biomarker, and other patient-related factors” [36] . PROs may be among the predictors that could help identify the treatments that are best suited for individualized patient care. For example, negative or depressed affect in patients has been associated with low responsiveness to opioid treatment [37–39] . The development of algorithms in order to inform personalized medicine, however, will require large, longitudinal databases. Registries, including the data produced by PASTOR, will provide the critical data needed to achieve the full benefits of this approach. Copyright protection Our team is comprised partly of military service members and employees of the US Government. This work was prepared as part of our official duties. Title 17 U.S.C. 105 provides that “Copyright protection under this title is not available for any work of the US Government.” Title 17 U.S.C. 101 defines a US Government work as a work
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prepared by a military service member or employee of the US Government as part of that person’s official duties.
Disclaimer The views expressed in this article are those of the authors and do not necessarily reflect the official policy of the Department of the Army, the Department of Defense, the US Government.
Financial & competing interests disclosure This work was supported by institutional funding and the Defense and Veterans Center for Integrative Pain Management. The work discussed was supported by funding from the US Army Medical Research Acquisition Activity ( U S A M R A A ) , W 81 X W H -12 -2 - 013 3 ( P I : C Buckenmaier). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
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SPECIAL REPORT For reprint orders, please contact: [email protected]
PASTOR/PROMIS© pain outcomes system: what does it mean to pain specialists? Karon F Cook*,1, Chester Buckenmaier 3rd2 & Richard C Gershon1
Practice points ●●
There is growing discomfort with the current state of pain management practice, particularly with regards to opioid use and misuse.
●●
The US Army Surgeon General charged the Pain Management Task Force with
developing recommendations for improving pain management practice for soldiers and their families. ●●
Among the Taskforce’s recommendations was the development of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR).
●●
PASTOR is a system for collecting patient-reported data that is used in order to
facilitate the clinical encounter and will support data-driven evaluations of the effectiveness of different approaches to pain management, especially integrative approaches.
SUMMARY The Army Pain Management Task Force was charged with recommending pain management strategies for Army Medical Command that would optimize quality of life for patients living with acute and chronic pain. Among their recommendations was the development of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). In order to develop this tool, the Pain Management Task Force leveraged the NIH’s investment in building the Patient-Reported Outcomes Measurement Information System (PROMIS®). The two foci of PASTOR are to enhance the clinical encounter and provide data for comprehensive evaluations of treatment effectiveness. The potential of such information for the future of clinical management is described.
KEYWORDS
• chronic pain • comparative
effectiveness research • outcomes registry • pain management • patientreported outcomes
In August of 2009, Army Surgeon General, LTG Eric Shoomaker (retired) chartered the Army Pain Management Task Force (PMTF). The PMTF’s charge was “to provide recommendations for an Army Medical Command comprehensive pain management strategy that is holistic, multidisciplinary and multimodal in approach, utilizes state of the art/science modalities and technologies and provides optimal quality of life for soldiers and other patients with acute and chronic pain” [1] . From the beginning, the mission encompassed not only pain management of soldiers, but also of soldiers’ families and other populations. The concerns and needs of soldiers Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA Defense & Veterans Center for Integrative Pain Management, Uniformed Services University of the Health Sciences, Bethesda, MD, USA *Author for correspondence: Tel.: +1 713 291 3918; [email protected] 1 2
10.2217/PMT.14.25 © 2014 Future Medicine Ltd
Pain Manage. (2014) 4(4), 277–283
part of
ISSN 1758-1869
277
Special Report Cook, Buckenmaier & Gershon were addressed, but the effort is relevant to other pain populations. In order to achieve this mission, the PMTF visited 28 clinical sites representing a broad range of care facilities servicing active military, veterans and civilians. Interviews with clinical experts and medical staff elicited opinions regarding pain management capacity, resources and best practices. The findings of this study were published in PMTF’s final report [1] . The lack of consistency in pain management practice was highlighted, not only within civilian, veteran and active military settings, but across all medical services. The report hypothesized several causes for this variability of service, including the lack of standard pain curricula in medical schools, the influence of mentors on practice patterns, clinicians’ own beliefs about pain and their experiences treating patients who have pain and the relative paucity of data supporting established practice patterns. The transient nature of both patients and providers in military medical systems accentuates the impact of practice variability on individual patients. The lack of empirical evidence regarding the best treatments for pain management, especially when choosing from among integrative approaches, is another barrier to consistency in the pain management service provided. Without empirical evidence that documents both patients’ concerns and the relative effectiveness of different treatment options, clinicians are likely to rely on what they have learned in medical school or from mentors, perpetuating unwarranted variability in pain management practice. Informed both by clinical interviews and the results of an extensive literature review, the PMTF derived a number of specific recommendations [1] . Among these was the development of a tool that would standardize pain assessment within the military health system and provide a system-wide source of pain-related, patient-reported outcomes (PROs) data. The Pain Assessment Screening Tool and Outcomes Registry (PASTOR) addresses this need. This article describes how the PMTF leveraged the Patient-Reported Outcomes Measurement Information System (PROMIS®), a large-scale measurement initiative of the NIH [2] , in order to build PASTOR. We describe the unique characteristics of PROMIS that made it attractive as the source for PASTOR measures of painrelated PROs. The development and initiation of PASTOR are discussed, including the two
278
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PASTOR foci: enhancing the clinical encounter and comprehensive documentation of patient characteristics and treatment effectiveness. The potential of such information for the future of clinical management is described. NIH PROMIS: a unique tool for measuring PROs Pain service and pain assessment have the following in common: both are bedeviled by ‘practice variability’ [1,3–5] . There has been inconsistency in the instruments selected for quantifying patients’ pain-related symptoms and concerns. For any given patient-relevant outcome, there is often a myriad of available measures. This situation has been described as health outcome’s ‘Tower of Babel’, a confusion of instruments that cannot ‘talk to each other’ because each has its own scoring metric [2] . This situation renders comparisons between healthcare systems exceedingly difficult and greatly hinders the development and implementation of systemwide, evidence-based ‘best’ practices. This lack of standardization motivated NIH’s PROMIS initiative [2] . To date, the NIH has invested more than US$100 million in developing and maintaining an extensive library of health outcomes measures and an electronic platform for administering them – the PROMIS Assessment Center (IL, USA) [6] . The PROMIS measures have unique features that are relevant to addressing the goals set forth by the PMTF. The measures are based on ‘item banks’ rather than traditional, static forms. Item banks are collections of items that span the entire content range of the domain being measured and target all relevant levels of that domain. A typical PROMIS item bank includes between 40 and 70 items. Item banks can be used to generate short forms that accommodate different measurement needs and contexts (e.g., greater precision, less response burden or more symptomatic patients). Item banks also provide the foundation for dynamic assessment via computer adaptive testing (CAT) [7–10] . When items are administered using CAT, a computer algorithm selects items for individuals based on their answers to previous items. This tailoring of the assessment results in measurement precision with significantly less response burden. Whether a symptom or outcome is measured using a PROMIS short form or a PROMIS CAT, the scores are directly comparable because they are scaled to a common mathematical metric.
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PASTOR/PROMIS® pain outcomes system: what does it mean to pain specialists? Also unique to PROMIS is that its measures target domains rather than diseases or conditions. A domain includes the perceptions, functions, activities and concerns specific to what is being measured. PROMIS’s domain framework includes physical, mental and social health domains [11–16] . The PROMIS measures have proven to have equal or superior psychometric properties compared with legacy measures, as evidenced in 250 peer-reviewed articles published through 2013 (for a complete list of publications, see [17]). In addition, the precision of legacy measures can be achieved with substantially fewer items using CAT administrations.
comparisons among systems because of lack of standardization in what was collected.
Leveraging NIH measurement efforts When the PMTF released its 2010 report and the accompanying recommendation for a standard pain assessment tool, NIH-funded investigators had been working on PROMIS for 7 years. An extensive instrument library and the PROMIS Assessment Center were already in place. This convergence of needs and resources created the opportunity for a natural partnership between the US Department of Defense (DoD) and the NIH. The DoD was able to leverage the financial and scientific resources that were expended in developing PROMIS. In September 2011, the PMTF convened a meeting of clinical pain experts, health outcomes researchers, military medical leaders and PROMIS scientists in order to draft the content specifications for PASTOR. The panel discussed the range of pain domains and pain correlates (e.g., fatigue, sleep impairment and anxiety) that they believed would facilitate provider–patient interactions and increase understanding of the impact of pain on patients’ lives. The panel identified clinical, demographic and other variables for a pain outcomes registry that could be used to evaluate empirical questions related to pain management strategies (e.g., patients’ reports on the impact of different integrative medicine treatments and personally relevant ‘important activities’ that are limited by their painful condition). In later work, the list of measures was winnowed down in order to reduce response burden and focus on clinical priorities. Box 1 summarizes the contents of PASTOR 1.0. Traditionally, the patient information gathered in PASTOR would have been collected using inefficient, paper-based surveys, imposing excessive administrative burden both on patients and clinic staff. Furthermore, the data collected would often defy
●●A clinical report for pain clinicians
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The two foci of PASTOR PASTOR was developed for both clinical and research purposes. The initial focus has been on using the data collected in order to improve the clinical encounter, alerting clinicians to emerging and potential pain-related health problems and enhancing communication between patients and their clinicians. The PASTOR tool also serves as the basis for a pain registry that will be a rich resource for future research and clinical resource management. The clinical focus of the PASTOR effort stimulated the development of a provider’s summary report designed to enhance the clinical management of patients with pain. This report is a summary of an individual patient’s status based on the patient’s self-report. A draft of the PASTOR Pain Report was developed and refined based on several rounds of input from pain experts and other clinicians. The report extracts data elements from PASTOR that clinicians believed would be valuable for interviewing patients, understanding outcomes relevant to patients and managing care plans. For example, when completing PASTOR, patients enter three personally relevant activities that are currently limited by pain and rate their current ability to perform each activity. The goals are entered in free text in order to allow maximum choice for patients. These goals and the self-rated progress towards them are included in the pain report. The report tracks trends over the course of follow-up clinical visits in other relevant outcomes (e.g., changes in pain, sleep and social function), providing a graphic representation of treatments, symptoms, outcomes and progression towards patient-defined goals over time. The report is a powerful tool to efficiently focus the limited clinical encounter time on specific treatment issues that the patient has identified as relevant. Some of the elements included in the report are a body pain map that indicates areas of pain (including worst pain), results of screens for clinically relevant parameters (e.g., alcohol and opioid misuse/abuse, depression and post-traumatic stress disorder), symptoms and outcomes over time and a history of activities that the patients report to be affected by their pain.
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Special Report Cook, Buckenmaier & Gershon ●●A registry to inform pain policy & pain
management
The PASTOR registry will be a repository of demographics, interventions, symptoms, outcomes and patient progress towards pain-related goals. The registry will be populated with data from multiple time points, supporting sophisticated statistical evaluations of the magnitude and trajectory of changes over time. Because of the large number of patients treated within the military health system, the PASTOR registry will be well powered (using big data) for subgroup comparisons, which are critical to understanding individual variations in responses to pain management approaches. One of the attractive aspects of PROMIS is the fact that measures are standardized to the T-score metric and allow direct comparisons to a reference population (e.g., the US general population). With the PROMIS data registry, additional normative comparisons will be available based on other relevant comparative populations (e.g., the military health system population and active duty soldiers). These comparisons provide interpretative contexts for understanding and comparing outcome levels. PASTOR status In 2012, the US Army Medical Research and Material Command (USAMR A A) awarded a contract to Northwestern University (IL, USA) to operationalize PASTOR (Richard Gershon, PI). The PROMIS Statistical Center and the PROMIS Assessment Center are located within the Department of Medical Social Sciences, Feinberg Medical School at Northwestern University. In the fall of 2013, a PASTOR prototype was completed and submitted for alpha testing. Roll-out at the Walter Reed National Military Medical Center (MD, USA) began in January 2014. Patients are introduced to PASTOR by study team members who explain its purpose and assist any patient who is not technologically comfortable. This person-to-person introduction has proven to be important both in terms of patient comfort with using PASTOR and their buy-in. Prior to clinic visits, patients are sent an email with login information asking them to complete the PASTOR assessment using the Internet-enabled device of their choice. Patients who fail to complete their assessments prior to arrival for their clinic visits are directed to a clinic-based kiosk or
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tablet that is enabled to access the PASTOR assessment. The ability of patients to complete the PASTOR assessment at a time and under conditions of their choosing is a particular strength of this tool. Additional funding from USAMRAA is supporting work by the Madigan Army Medical Center (WA, USA) Clinical Informatics program to embed the PASTOR system ‘behind the wire’ (Richard Barnhill, PI). When completed, PASTOR data will be created, stored, delivered and maintained within the electronic medical records system. The system also will allow staff to view the patient data using dashboards, visual representations, trends reports and summaries. The work at Madigan also includes a pilot rollout of the PASTOR system at Naval Medical Center San Diego (CA, USA). Conclusion The US Department of Health and Human Services published a framework for improving health outcomes and quality of life in individuals living with multiple chronic conditions (MCCs) [18] . Among the recommended strategies were two that parallel the goals and functions of PASTOR: “implement and effectively use health information technology” and “innovate and strengthen methods for researchers to improve measurement of patient-centered outcomes of treatments and other interventions for individuals with MCC” [18] . PASTOR is not the first effort to identify a core outcome dataset in order to standardize research and improve the generalizability of research findings (e.g., see [19–21] ). What is unique about PASTOR is its dual purpose as a research resource and as a tool for enhancing patients’ encounters with healthcare providers. PASTOR enables clinicians and patients within the military to meaningfully share relevant health information in real time. The system provides insight into both present and historical pain. This valuable information directly addresses the PMTF’s charge to provide a holistic, state-of-the-art, multidisciplinary approach to address chronic pain management across all military medical services. PASTOR’s robust platform will enable military health providers to respond with consistent and proven methodologies that can continuality be monitored, measured and improved in order to enhance the quality of life for patients suffering from acute and chronic pain.
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PASTOR/PROMIS® pain outcomes system: what does it mean to pain specialists?
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Box 1. Nonexhaustive summary of measures included as part of the Pain Assessment Screening Tool and Outcomes Registry. Registration, demographic and other information ●● Pain measures ●● Pain intensity, quality and impact ●● Defense and Veterans Pain Rating Scale ●● Graphic pain map ●● Patient-Reported Outcomes Measurement Information System (PROMIS®) Bank v1.0 – pain interference (computer adaptive) ●● PROMIS pain quality (short form) ●● PROMIS headache (computer adaptive) ●● Patient activities limited by pain ●● What are your three most important activities that are limited by pain? ●● How well are you currently able to perform (each) activity? ●● Problem screening ●● Opioid abuse/misuse ●● Post-traumatic stress disorder ●● PROMIS anxiety (computer adaptive) ●● PROMIS depression (computer adaptive) ●● PROMIS alcohol (computer adaptive) ●● Alcohol Use Disorders Identification Test C ●● PROMIS measures of additional pain correlates ●● PROMIS SF v1.0 – global health (short form) ●● PROMIS fatigue (computer adaptive) ●● PROMIS social sat role (computer adaptive) ●● PROMIS anger (computer adaptive) ●● PROMIS sleep-related impairment (computer adaptive) ●● PROMIS Bank v1.0 – physical function (computer adaptive) ●● Health utilization ●● Providers seen by type (e.g.,) ●● Self-reported treatment history and effectiveness evaluations
Future perspective The PASTOR system will provide a template for registries that support both clinical management and research into other conditions and diseases. There is substantial overlap in the domains that are important to patients with chronic pain and the domains that are relevant to persons with other chronic conditions. Furthermore, because individuals often suffer from MCCs, the ‘silo’ strategy of treating single chronic conditions has been increasingly challenged [18] . The development of PASTOR comes at a time in health research when ‘new frontiers’ are emerging for the use of PROs in general and pain management in particular [22] . Important to the military healthcare system is the ability to conduct comparative effectiveness evaluations. Because many clinical and laboratory measures do not directly relate to the matters of greatest relevance to patients, it is critical that patients’ perspectives are systematically included [22] . Furthermore, the
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PASTOR tool comes at a dramatic time in the evolution of pain management. In recent years, alarms regarding opioid use and misuse have sounded in news outlets [23–26] , government agencies [27–30] and the scientific literature [31– 34] . The CDC reported that opioid pain relievers were responsible for 73.8% of the 20,044 prescription drug overdose deaths in the USA in 2008 [29] . In addition to concerns regarding opioid overdoses, there is a growing realization that as many as a third of chronic patients cannot tolerate strong opioids [35] . As has been observed, there are not well-validated algorithms for identifying individuals who are the best candidates for opioid therapy [36] . The same can be said for identifying the patients who are most likely to benefit from complementary and nontraditional pain interventions. A potential approach is the application of ‘personalized medicine’, defined as “optimizing medication types and dosages
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Special Report Cook, Buckenmaier & Gershon for individual patients based upon genetic, biomarker, and other patient-related factors” [36] . PROs may be among the predictors that could help identify the treatments that are best suited for individualized patient care. For example, negative or depressed affect in patients has been associated with low responsiveness to opioid treatment [37–39] . The development of algorithms in order to inform personalized medicine, however, will require large, longitudinal databases. Registries, including the data produced by PASTOR, will provide the critical data needed to achieve the full benefits of this approach. Copyright protection Our team is comprised partly of military service members and employees of the US Government. This work was prepared as part of our official duties. Title 17 U.S.C. 105 provides that “Copyright protection under this title is not available for any work of the US Government.” Title 17 U.S.C. 101 defines a US Government work as a work
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prepared by a military service member or employee of the US Government as part of that person’s official duties.
Disclaimer The views expressed in this article are those of the authors and do not necessarily reflect the official policy of the Department of the Army, the Department of Defense, the US Government.
Financial & competing interests disclosure This work was supported by institutional funding and the Defense and Veterans Center for Integrative Pain Management. The work discussed was supported by funding from the US Army Medical Research Acquisition Activity ( U S A M R A A ) , W 81 X W H -12 -2 - 013 3 ( P I : C Buckenmaier). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
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