Dataset Information

Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

ABSTRACT: INTRODUCTION:Inadequate validation, floor/ceiling effects, and time constraints limit utilization of standardized patient-reported outcome measures. We aimed to validate Patient-reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) for patients treated surgically for a lumbar disk herniation. METHODS:PROMIS, CATs, Oswestry Disability Index, and Short Form-12 measures were administered to 78 patients treated with lumbar microdiskectomy for symptomatic disk herniation with radiculopathy. RESULTS:PROMIS CATs demonstrated convergent validity with legacy measures; PROMIS scores were moderately to highly correlated with the Oswestry Disability Index and Short Form-12 physical component scores (r = 0.41 and 0.78, respectively). PROMIS CATs demonstrated similar responsiveness to change compared with legacy measures. On average, the PROMIS CATs were completed in 2.3 minutes compared with 5.7 minutes for legacy measures. DISCUSSION:The PROMIS CATs demonstrate convergent and known groups' validity and are comparable in responsiveness to legacy measures. These results suggest similar utility and improved efficiency of PROMIS CATs compared with legacy measures. LEVELS OF EVIDENCE:Level II.

SUBMITTER: Bhatt S

PROVIDER: S-EPMC7315643 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

Bhatt Surabhi S Boody Barrett S BS Savage Jason W JW Hsu Wellington K WK Rothrock Nan E NE Patel Alpesh A AA

The Journal of the American Academy of Orthopaedic Surgeons 20190201 3

<h4>Introduction</h4>Inadequate validation, floor/ceiling effects, and time constraints limit utilization of standardized patient-reported outcome measures. We aimed to validate Patient-reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) for patients treated surgically for a lumbar disk herniation.<h4>Methods</h4>PROMIS, CATs, Oswestry Disability Index, and Short Form-12 measures were administered to 78 patients treated with lumbar microdiskectomy for symptom ...[more]

PMID: 30247310

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Project description:BackgroundMinimal clinically important difference (MCID) estimates are useful for gauging clinical relevance when interpreting changes or differences in patient-reported outcomes scores. These values are lacking in the setting of elbow trauma. Our primary purpose was to estimate the MCID of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) computer adaptive test (CAT), the PROMIS upper extremity (UE) CAT, and the QuickDASH using an anchor-based approach for patients recovering from elbow trauma and related surgeries. Secondarily, we aimed to estimate the MCID using the 1/2 standard deviation method.Materials & methodsAdult patients undergoing treatment for isolated elbow injuries between July 2014 and April 2020 were identified at a single tertiary academic medical center. Outcomes, including the PROMIS PF CAT v1.2/2.0, PROMIS UE CAT v1.2, and QuickDASH, were collected via a tablet computer. For inclusion, baseline (6 months before injury up to 11 days postoperatively or after injury) and follow-up (11 to 150 days postoperative or after injury) PF or UE CAT scores were required, as well as a response to an anchor question querying improvement in physical function. The MCID was calculated using (1) an anchor-based approach using the difference in mean score change between anchor groups reporting "No change" and "Slightly Improved/Improved" and (2) the 1/2 standard deviation method.ResultsOf the 146 included patients, the mean age was 46 ± 18 years and 67 (46%) were women. Most patients (129 of 146 or 88%) were recovering from surgery, and the remaining 12% were recovering from nonoperatively managed fractures and/or dislocations. The mean follow-up was 157 ± 192 days. Scores for each instrument improved significantly between baseline and follow-up. Anchor-based MCID values were calculated as follows: 5.7, 4.6, and 5.3 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively. MCID values estimated using the 1/2 standard deviation method were 4.3, 4.8, and 11.7 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively.ConclusionsIn the setting of elbow trauma, we propose MCID ranges of 4.3 to 5.7 for the PROMIS PF CAT, 4.6 to 4.8 for the PROMIS UE CAT, and 5.3 to 11.7 for the QuickDASH. These values will provide a framework for clinical relevance when interpreting clinical outcomes studies, or powering clinical trials, for populations recovering from trauma.

Project description:BackgroundDisk herniation and disk bulge are two common disorders of lumbar intervertebral disks (IVDs) that often result in numbness, pain in the lower limbs, and lower back pain. Magnetic resonance (MR) imaging is one of the most efficient techniques for detecting lumbar diseases and is widely used for making clinical diagnoses at hospitals. However, there is a lack of efficient tools for effectively interpreting massive amounts of MR images to meet the requirements of many radiologists.ObjectiveThe aim of this study was to present an automatic system for diagnosing disk bulge and herniation that saves time and can effectively and significantly reduce the workload of radiologists.MethodsThe diagnosis of lumbar vertebral disorders is highly dependent on medical images. Therefore, we chose the two most common diseases-disk bulge and herniation-as research subjects. This study is mainly about identifying the position of IVDs (lumbar vertebra [L] 1 to L2, L2-L3, L3-L4, L4-L5, and L5 to sacral vertebra [S] 1) by analyzing the geometrical relationship between sagittal and axial images and classifying axial lumbar disk MR images via deep convolutional neural networks.ResultsThis system involved 4 steps. In the first step, it automatically located vertebral bodies (including the L1, L2, L3, L4, L5, and S1) in sagittal images by using the faster region-based convolutional neural network, and our fourfold cross-validation showed 100% accuracy. In the second step, it spontaneously identified the corresponding disk in each axial lumbar disk MR image with 100% accuracy. In the third step, the accuracy for automatically locating the intervertebral disk region of interest in axial MR images was 100%. In the fourth step, the 3-class classification (normal disk, disk bulge, and disk herniation) accuracies for the L1-L2, L2-L3, L3-L4, L4-L5, and L5-S1 IVDs were 92.7%, 84.4%, 92.1%, 90.4%, and 84.2%, respectively.ConclusionsThe automatic diagnosis system was successfully built, and it could classify images of normal disks, disk bulge, and disk herniation. This system provided a web-based test for interpreting lumbar disk MR images that could significantly improve diagnostic efficiency and standardized diagnosis reports. This system can also be used to detect other lumbar abnormalities and cervical spondylosis.

Project description:ContextFor patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.ObjectiveTo compare the treatment effects of diskectomy and usual care.Design, setting, and patientsProspective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.InterventionsStandard open diskectomy vs usual nonoperative care.Main outcome measuresChanges from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).ResultsOf the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7).ConclusionsPatients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.Trial registrationclinicaltrials.gov Identifier: NCT00000410.

Dataset Information

Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

Publications

Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

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