Evidence map›Paper›PMID 29432327›Full record

ArticlePain2018

Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 1-the Patient Assessment for Low Back Pain - Symptoms (PAL-S).

Mona L Martin, Steven I Blum, Hiltrud Liedgens, Donald M Bushnell, Kelly P McCarrier, Noël V Hatley, Abhilasha Ramasamy, Rainer Freynhagen, Mark Wallace, Charles Argoff and 3 more

Open access · hybridAbstract read
In one paragraph

Article in Pain, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Mona L MartinHealth Research Associates, Inc, Mountlake Terrace, WA, USA.
Steven I BlumHealth Economics and Outcomes Research, Forest Research Institute, Jersey City, NJ, USA. Mr. Blum is now with the GlaxoSmithKline, Collegeville, PA, USA. Ms. Ramasamy is now with the Novo Nordisk, Plainsboro, NJ, USA.
Hiltrud LiedgensGrünenthal GmbH, Aachen, Germany.
Donald M BushnellHealth Research Associates, Inc, Mountlake Terrace, WA, USA.
Kelly P McCarrierHealth Research Associates, Inc, Mountlake Terrace, WA, USA.
Noël V HatleyHealth Research Associates, Inc, Mountlake Terrace, WA, USA.
Abhilasha RamasamyHealth Economics and Outcomes Research, Forest Research Institute, Jersey City, NJ, USA. Mr. Blum is now with the GlaxoSmithKline, Collegeville, PA, USA. Ms. Ramasamy is now with the Novo Nordisk, Plainsboro, NJ, USA.
Rainer FreynhagenZentrum für Anästhesiologie, Intensivmedizin, Schmerztherapie & Palliativmedizin, Benedictus Krankenhaus Tutzing and Technische Universität, München, Germany.
Mark WallaceDepartment of Anesthesiology, University of California San Diego, San Diego, CA, USA.
Charles ArgoffDepartment of Neurology, Albany Medical College, Albany, NY, USA.
Mariёlle EerdekensGrünenthal GmbH, Aachen, Germany.
Maurits KokGrünenthal GmbH, Aachen, Germany.
Donald L PatrickDepartment of Health Sciences, University of Washington, Seattle, WA, USA.
Grünenthal Group (Germany) · DEAlbany Medical Center Hospital · USGlaxoSmithKline (United States) · USNovo Nordisk (United States) · USTechnical University of Munich · DEUniversity of California San Diego · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We describe the mixed-methods (qualitative and quantitative) development and preliminary validation of the Patient Assessment for Low Back Pain-Symptoms (PAL-S), a patient-reported outcome measure for use in chronic low back pain (cLBP) clinical trials. Qualitative methods (concept elicitation and cognitive interviews) were used to identify and refine symptom concepts and quantitative methods (classical test theory and Rasch measurement theory) were used to evaluate item- and scale-level performance of the measure using an iterative approach. Patients with cLBP participated in concept elicitation interviews (N = 43), cognitive interviews (N = 38), and interview-based assessment of paper-to-electronic mode equivalence (N = 8). A web-based sample of patients with self-reported cLBP participated in quantitative studies to evaluate preliminary (N = 598) and revised (n = 401) drafts and a physician-diagnosed cohort of patients with cLBP (N = 45) participated in preliminary validation of the measure. The PAL-S contained 14 items describing symptoms (overall pain, sharp, prickling, sensitive, tender, radiating, shocking, shooting, burning, squeezing, muscle spasms, throbbing, aching, and stiffness). Item-level performance, scale structure, and scoring seemed to be appropriate. One-week test-retest reproducibility was acceptable (intraclass correlation coefficient 0.81 [95% confidence interval, 0.61-0.91]). Convergent validity was demonstrated with total score and MOS-36 Bodily Pain (Pearson correlation -0.79), Neuropathic Pain Symptom Inventory (0.73), Roland-Morris Disability Questionnaire (0.67), and MOS-36 Physical Functioning (-0.65). Individual item scores and total score discriminated between numeric rating scale tertile groups and painDETECT categories. Respondent interpretation of paper and electronic administration modes was equivalent. The PAL-S has demonstrated content validity and is potentially useful to assess treatment benefit in cLBP clinical trials.

Indexed as

Patient Reported Outcome MeasuresSelf ReportAdolescentAdultAgedAged, 80 and overCognitionCohort StudiesFemaleHumansLow Back PainMaleMiddle AgedPain MeasurementPsychometricsReproducibility of Results

Identifiers

PMID29432327
PMCPMC5965933
OpenAlexW2791256983

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.