A Retrospective, Multicenter, Quantitative Analysis of Patients’ Baseline Pain Quality (PROMIS-29) Entering into Pain and Spine Practices in the United States (ALIGN)

Pope, Jason E.; Fishman, Michael; Chakravarthy, Krishnan; Hanes, Michael; Gerling, Michael C.; Heros, Robert; Falowski, Steven; Shah, Jay M.; Orhurhu, Vwaire; Urits, Ivan; Deer, Timothy R.

doi:10.1007/s40122-021-00238-z

Cited by 22 publications

(19 citation statements)

References 14 publications

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“…Consistent with our previously published population profile of chronic pain patients, subjects in this cohort reflected chronic pain profiles of baseline PROMIS-29 subdomain values significantly worse than the general population, which has a mean T-score of 50. 17 On average, subjects displayed moderate-severe pain (7/10) and moderate-high impact pain (36.4/50). Further, subjects displayed severe pain interference and physical dysfunction, with an average T-score of 67, which is 1.7 standard deviations worse than that of the US general population.…”

Section: Resultsmentioning

confidence: 97%

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Pope¹,

Fishman

Gunn³

et al. 2021

JPR

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Purpose Discovery and validation of pragmatic biomarkers represent significant advancements in the field of pain management. Evaluating relationships between objective biomarkers and patient-reported outcomes (PROs) is an effective way to gain mechanistic insight into the potential role of biochemistry in chronic pain. The aim of this study was to validate the Foundation Pain Index (FPI) by evaluating associations between deranged biochemical function and PROMIS-29 domains in individuals living with chronic pain. Patients and Methods PROMIS-29 scores and FPI test results were obtained from 298 patients with chronic pain in this retrospective, observational study. Statistical analysis was performed using clinical test data to evaluate relationships between deranged biochemical function and quality of life measures across 8 universal domains. Results FPI scores significantly associated with multiple PROMIS-29 domains including physical function, impact score, fatigue, pain interference, and depression (P < 0.05). Moreover, specific analytes that comprise the FPI significantly correlated with PROMIS-29 domains, including 5-hydroxyindolacetic acid (pain interference, physical function, and pain impact scores), hydroxymethylglutarate (physical function), homocysteine (pain impact scores), kynurenic acid (pain interference and physical function), and quinolinic acid (physical function) (P < 0.05). Conclusion Cross-validation of the FPI with PROMIS-29 domains further supports the role of deranged biochemical function in the etiology of chronic pain. Objective identification of atypical biochemical function and subsequent correction holds tremendous promise for the non-opioid management of pain. Continued research efforts will aim to determine the impact of biochemical optimization in pre-surgical periods and post-surgical outcomes in patients with chronic pain.

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Section: Resultsmentioning

confidence: 97%

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Pope¹,

Fishman

Gunn³

et al. 2021

JPR

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“…The PROMIS-29 is generalized to the entire US population, and as such, can serve as a common measurement language that is universally relevant across disease states. The creation of a normative data set for the chronic pain population at multiple sites was performed in a previous work [ 17 ]; this study serves to evaluate the influence of the site of patient instrument completion (remote versus in person) on PROMIS-29 baseline presentation in the chronic pain and spine population presenting for care.…”

Section: Discussionmentioning

confidence: 99%

“…For most PROMIS-29 instruments, the average T-score for the US general population is 50, with a standard deviation of 10 [ 16 , 17 ]. A greater T-score signifies a larger measurement on the domain.…”

Section: Discussionmentioning

confidence: 99%

“…This study presents the effect of the site of the assessment of the PROMIS-29 v2.1 on the scoring, and did not discern the reason the patient elected to be assessed remotely or in person. Clearly, during this time, in response to the COVID 19 pandemic [17][18][19][20], the Centers for Medicare and Medicaid Services (CMS) relaxed regulations to expand telehealth to allow for telehealth strategies to be administered directly in the patient's home. On March 18, 2020, CMS recommended limiting nonessential care [18].…”

Section: Discussionmentioning

confidence: 99%

“…home). Clearly, this validation is not only necessary for ongoing clinical research investigations, but is also clinically relevant during the COVID pandemic transition to telehealth, with the use of the emergency 1135 waiver [ 17 ]. To date, there are no studies or data published on whether the initial intake data among the chronic pain population are influenced by the clinical environment, and if so, what contextual information plays a key role in data integrity.…”

Section: Introductionmentioning

confidence: 99%

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The Impact of Clinical Setting on Evaluating Patients Using the PROMIS-29 Baseline Measures in the COVID Era: A Retrospective Multicenter Quantitative Analysis

et al. 2021

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Background Multidimensional patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The PROMIS-29 assessment tool is utilized as a component of assessing multidimensional pain scales. It includes patient-reported measures of pain, mood, sleep, social participation, and function. Currently, there are no data on whether a patient’s immediate environment (remote versus in person) influences the reported patient outcomes measurement of a multidimensional tool represented as PROMIS-29 data. Methods Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into a chronic pain or spine center in the United States. The PROMIS-29 v2.1 was recorded. Statistical differences were assessed among age groups and across the seven domains of the assessment. Results A total of 25,187 distinct patients were enrolled in the study from August 2018 to December 2020 with a presenting baseline measurement of PROMIS-29. The PROMIS-29 v2.1 was evaluated across the seven domains, and subgroup age analysis was performed for patients completing surveys in the clinical setting (non-remote group) and those completing the survey in the remote setting (remote group) during entry into spine and pain practices across the United States. For mental health scores, those less than 40 years of age and those over 80 years of age showed significant differences in ratings of anxiety and depression in the remote versus non-remote setting. Regarding physical health scores, those aged 60–79 showed a significant difference in the remote versus non-remote ratings for pain interference ( p = 0.005; 63.9 vs. 64.4), physical function ( p = 0.000; 36.4 vs. 35.7), and fatigue ( p = 0.020; 57.2 vs. 57.7), while subjects over 80 years of age showed a statistical difference between the remote versus non-remote setting only in rating physical function ( p = 0.025; 33.0 vs. 34). Notably, the rating of sleep disturbance in the remote versus non-remote setting was the only significant variable in the 40–59 age category ( p = 0.000; 60.0 vs. 59.1). Those less than 40 years of age also reported a significant difference in the remote versus non-remote setting when rating sleep disturbance ( p = 0.000; 60.5 vs. 58.9). With regard to social function, only those older than 80 years showed a significant difference in rating of ability in the remote compared to the non-remote setting ( p = 0.031; 39.6 vs. 40.7). Conclusions This data set is the first published data describing the influence of environment (remote versus in person) on PROMIS-29 outcome measurements in the chronic pain population.

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Outcomes after selective nerve root blockade for lumbar radicular pain from lumbar disc hernia or lumbar spinal stenosis assessed by the PROMIS-29 – a prospective observational cohort study

Karlsson,

Carlsson,

Åkerstedt

et al. 2024

Acta Neurochir

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Purpose Selective nerve root blocks (SNRB) are used both as a therapeutic and diagnostic tool for lumbar radicular pain. Most studies evaluate the effect of SNRB simply by its relation to pain reduction. It is well known that pain is associated with other factors such as depression, anxiety, inactivity and sleeping disorders, but these patient-related outcomes are seldom evaluated. This study evaluated the influence of SNRB on pain-related outcomes including depression, anxiety, fatigue, pain interference, activity and sleep. Methods One hundred three patients with lumbar radicular pain were treated with a SNRB. Patient-reported outcome measures (PROMs) were assessed with the PROMIS-29 for 12 weeks (84 days) following the SNRB. Patients were stratified based on their pain reduction at the 14-day follow up as responders (≥ 30% pain reduction) and non-responders (< 30% pain reduction). Post-treatment duration was estimated with the Kaplan–Meier analysis with return to baseline as an event. A paired t-test was used to compare pre- and post-treatment responses at specific time intervals. Results Forty-four percent (n = 45) of the patients were responders and showed significant improvement in all parameters throughout the 84-days follow-up, the exception was sleep that lost significance at day 70. The mean post-treatment duration among responders was 59 (52–67) days. Non-responders showed significant improvements in pain interference and pain intensity until day 35 and in ability for social participation until 21-day. Conclusion SNRB can improve pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance and the ability to participate in social roles.

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A Retrospective, Multicenter, Quantitative Analysis of Patients’ Baseline Pain Quality (PROMIS-29) Entering into Pain and Spine Practices in the United States (ALIGN)

Cited by 22 publications

References 14 publications

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

Cross-Validation of the Foundation Pain Index with PROMIS-29 in Chronic Pain Patients

The Impact of Clinical Setting on Evaluating Patients Using the PROMIS-29 Baseline Measures in the COVID Era: A Retrospective Multicenter Quantitative Analysis

Outcomes after selective nerve root blockade for lumbar radicular pain from lumbar disc hernia or lumbar spinal stenosis assessed by the PROMIS-29 – a prospective observational cohort study

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