The Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research: reference values from the Quebec Low Back Pain Study

Angarita-Fonseca, Adriana; Pagé, M. Gabrielle; Meloto, Carolina B.; Gentile, Erika Lauren; Léonard, Guillaume; Massé‐Alarie, Hugo; Tufa, Iulia; Roy, Jean‐Sébastien; Stone, Laura S.; Choinière, Manon; Fortin, Maryse; Roy, Mathieu; Sean, Monica; Tétreault, Pascal; Rainville, Pierre; Deslauriers, Simon; Lacasse, Anaïs

doi:10.1097/j.pain.0000000000002703

Cited by 6 publications

(6 citation statements)

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“…Participants are assessed using a baseline battery of questionnaires and e-diary measures over a 10-day period, which are repeated in follow-up assessments. The baseline assessment employs a modified version of the NIH minimum dataset for research in chronic low back pain (63, 64) to capture key biopsychosocial variables (e.g., pain, fatigue, affect). Furthermore, blood sample collection from this cohort will enable the creation of a chronobiological biobank to analyze the neuroimmune signatures of participants with chronic pain conditions.…”

Section: Discussionmentioning

confidence: 99%

The CircaHealth CircaPain study protocol: A longitudinal multi-site study of the chronobiological control of chronic pain

Taccardi,

Gowdy,

Singer

et al. 2024

Preprint

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IntroductionOne in five Canadians lives with chronic pain. Evidence shows that some individuals experience pain that fluctuates in intensity following a circadian (24-hour) rhythm. Endogenous molecular rhythms regulate the function of most physiological processes, neuroimmunology functions that govern pain mechanisms. Addressing chronic pain rhythmicity on a molecular and biopsychosocial level can advance understanding of the disease and identify new treatment/management strategies. Our CircaHealth CircaPain study uses an online survey combined with ecological momentary assessments and bio-sample collection to investigate the circadian control of chronic pain and identify potential biomarkers. Our primary objective is to understand inter-individual variability in pain rhythmicity, by collecting biopsychosocial measures. The secondary objective accounts for seasonal variability and the effect of latitude on rhythmicity.Methods and analysisFollowing completion of a baseline questionnaire, participants complete a series of electronic symptom-tracking diaries to rate their pain intensity, negative affect, and fatigue on a 0-10 scale at 8:00, 14:00, and 20:00 daily over 10 days. These measures are repeated at 6- and 12-months post-enrolment to account for potential seasonal changes. Infrastructure is being developed to facilitate the collection of blood samples from subgroups of participants 2 times per day over 24-48 hours to identify rhythmic expression of circulating genes and/or proteins.Ethics and disseminationEthical approval for this study was obtained by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Findings will be published in a relevant scientific journal and disseminated at national and international scientific meetings and online webinars. We maintain a website to post updated resources and engage with the community. We employ knowledge mobilization in the form of direct data sharing with participants. This study is funded by the Canadian Institutes of Health Research (CIHR) (grant PJT-497592) and the CIHR Strategy for Patient-Oriented Research (SPOR) Chronic Pain Network (CPN) (grant SCA-145102).Ethical approval date: 08 March 2024Estimated start of the study: April 2024Strengths and limitations of this studyData will be collected using self-report questionnaires only, which may lead to random or systematic misreporting.The online nature of the study might affect the diversity in our sample (e.g., the representation of rural and/or underprivileged communities).Physical distance from research laboratories with specialized equipment for analyses and biobanking storage might affect accessibility, however, this can be overcome by using mailable dried blood spot collection kits as described.Questionnaires used in our study have previously been validated in the chronic pain population and used in several languages.Uncovering distinct pain rhythmicity patterns and health outcomes associated with rhythmicity may help develop new treatments for different chronic pain conditions tailored to individual circadian rhythms.

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Section: Discussionmentioning

confidence: 99%

The CircaHealth CircaPain study protocol: A longitudinal multi-site study of the chronobiological control of chronic pain

Taccardi,

Gowdy,

Singer

et al. 2024

Preprint

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“…Nonetheless, the online recruitment allowed to recruit a diversified sample of persons living in all Quebec regions, and the QLBPS participants were found to be representative of other large random samples of adults living with chronic LBP in Canada and elsewhere in terms of proportion of women, education level, smoking, and pain intensity. 2 …”

Section: Discussionmentioning

confidence: 99%

“…The pre–COVID-19 variables were taken from the latest evaluation (between 0 and 17 months) from the QLBPS (nearest to the COVID-19 study time 0), which was based on the Canadian Minimum Dataset for Chronic LBP Research. 2 , 13 , 23 This included the following characteristics: LBP status and type; comorbid painful conditions; history of LBP surgical interventions; pain interference (PROMIS Short-Form 4a 36 ); LBP treatments (opioid use, infiltrations/injections, exercise therapy, and psychological counselling); LBP-related workplace absenteeism and compensation benefits; physical function (PROMIS Short-Form 4a 36 ); kinesiophobia (an item from the STarT Back Screening Tool 5 ); catastrophizing (an item from the STarT Back Screening Tool 5 ); LBP-related lawsuits and legal claims; substance abuse; sociodemographic profile (age, sex identity, indigenous membership, racialized groups membership, employment, and education level); cigarette use; and height/weight to calculate body mass index. Sex at birth and administrative region were also available in the QLBPS.…”

Section: Methodsmentioning

confidence: 99%

Trajectories of pain and depressive symptoms among people living with low back pain during the COVID-19 pandemic: a 24-month longitudinal study

Angarita-Fonseca,

Roy,

Lacasse

et al. 2024

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Introduction: We explored trajectories of pain intensity and depressive symptoms over the first 24 months of the pandemic in people with low back pain. Methods: This longitudinal study was conducted alongside the Quebec Low Back Pain Study. Starting in April 2020 and every 3 months until July 2022, 291 participants completed an online survey. Group-based trajectory modeling was used to identify patterns of pain intensity and depressive symptoms. Onset outbreak characteristics were then put in relation with trajectory groups using multivariate logistic regression. Results: The analysis revealed 5 trajectories of pain intensity and depressive symptoms, respectively. The pain trajectories were stable mild (n = 17, 5.8%); stable moderate (n = 103, 35.4%); stable severe (n = 81, 27.8%); U-shape (n = 24, 8.3%), and inverted U-shape (n = 66, 22.7%). The trajectories of depressive symptoms were stable none (n = 58, 19.9%); stable very mild (n = 61, 21.0%); stable mild (n = 85, 29.2%); stable moderate (n = 59, 21.7%); and severe slightly improving (n = 24, 8.3%). Pre-COVID everyday/nearly everyday pain, average pain intensity, and widespread bodily pain were predictive of pain trajectory groups. Higher pre-COVID depression, acute stress disorder, and lockdown measures-related stress were associated with moderate/severe depressive trajectories. Discussion: Our findings indicated relative stability of pain and depressive symptoms among participants during the COVID-19 pandemic but also highlighted subgroups of people who experienced temporary deterioration or improvement over the first months of the pandemic that then reverted back to baseline levels. Modifiable risk factors were identified before the onset of the pandemic, which could give preventive measures in targeted populations.

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“…This computation resulted in a PIS that ranged from 8 (least impact) to 50 (most impact). 5 Our current analysis instead used the Defense and Veterans Pain Rating Scale (DVPRS) to determine 7-day average pain intensity and the CAT versions of the PROMIS pain interference 11,12 and physical function measures. 13 The DVPRS also has a range of 0 ("no pain") to 10 ("as bad as it could be, nothing else matters"); uses a combination of numeric, color, facial expression, and word descriptors; and has been validated in military and veteran populations.…”

Section: Pain Impact Score (Pis) Componentsmentioning

confidence: 99%

“…The pain impact score (PIS)-variably referred to as the Impact Strati cation Score, [1][2][3] RTF impact score, 4 Pain Impact Strati cation Score, 5 and Pain Impact Score 6 -is a composite measure of Patient-Reported Outcomes Measurement Information System (PROMIS) measures of pain intensity, pain interference, and physical function. The National Institutes of Health (NIH) Task Force on Research Standards for Chronic Low Back Pain (RTF) has endorsed the PIS as a tool to stratify the impact of musculoskeletal pain on the lives of those who experience it.…”

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confidence: 99%

Estimating Minimal Important Change of the National Institutes of Health Research Task Force impact score using computer adaptive measures: A secondary analysis of two randomized clinical trials in a military population with chronic pain

Flynn,

Burke,

Steffen

et al. 2024

Preprint

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Background The National Institutes of Health (NIH) Research Task Force (RTF) on Research Standards for Chronic Low Back Pain impact score is a composite measure of Patient Reported Outcomes Measurement Information System (PROMIS) pain intensity, pain interference and physical function. PROMIS surveys are available in short-form and computer adaptive testing (CAT) formats. In order to calculate response rates for clinical trials in which the impact score is the primary outcome, its minimal important difference (MID) must be established. To date, four estimates of impact score MID ranging from 3 to 7.5 have been published, and all were based on data collected using PROMIS short-form surveys. None used CAT versions of PROMIS surveys. Methods Secondary analysis of data collected during the conduct of two randomized clinical trials of 6-week courses of nonpharmacological pain therapies. Research subjects were US active-duty service members referred to an interdisciplinary pain management center. Impact score was assessed at the beginning and end of treatment. The Patient Global Impression of Change (PGIC) questionnaire was administered at the end of treatment and asked respondents to report their status compared to the start of treatment using a 7-item Likert scale ranging from very much improved to very much worse. A PGIC response of “much” or “very much” improved was used as the threshold for MID. Receiver operating characteristic curve (ROC) analysis was used to determine meaningful clinical differences for the full combined sample and stratified by study sample and baseline impact score. Results A decrease of 3 points was the estimated minimal important difference for the impact score. A larger decrease in impact score was needed for participants with moderate and severe baseline pain impact to report “much” or “very much” improvement. Conclusions Using data collected with CAT surveys, we calculated an overall MID of 3 for the NIH RTF impact score, and estimates ranged from 1 to 9 depending on the study sample and baseline impact score. These findings are consistent with previous MID estimates that were based on non-adaptive short form surveys and have implications for reducing the survey burden of future impact score MID analyses.

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The Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research: reference values from the Quebec Low Back Pain Study

Abstract: Supplemental Digital Content is Available in the Text.We provide reference values and internal consistency for the Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research.

Cited by 6 publications

References 51 publications

The CircaHealth CircaPain study protocol: A longitudinal multi-site study of the chronobiological control of chronic pain

The CircaHealth CircaPain study protocol: A longitudinal multi-site study of the chronobiological control of chronic pain

Trajectories of pain and depressive symptoms among people living with low back pain during the COVID-19 pandemic: a 24-month longitudinal study

Estimating Minimal Important Change of the National Institutes of Health Research Task Force impact score using computer adaptive measures: A secondary analysis of two randomized clinical trials in a military population with chronic pain

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