Browsing by Subject "Patient Reported Outcome Measures"
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Item Open Access Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients.(Spine, 2016-11) Chapman, Todd M; Baldus, Christine R; Lurie, Jon D; Glassman, Steven D; Schwab, Frank J; Shaffrey, Christopher I; Lafage, Virginie; Boachie-Adjei, Oheneba; Kim, Han J; Smith, Justin S; Crawford, Charles H; Lenke, Lawrence G; Buchowski, Jacob M; Edwards, Charles; Koski, Tyler; Parent, Stefan; Lewis, Stephen; Kang, Daniel G; McClendon, Jamal; Metz, Lionel; Zebala, Lukas P; Kelly, Michael P; Spratt, Kevin F; Bridwell, Keith HStudy design
Prospective, cross-sectional study.Objective
The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).Summary of background data
Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.Methods
Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.Inclusion criteria
40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.Results
Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.Conclusion
In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.Level of evidence
2.Item Open Access Comparing and Contrasting the Clinical Utility of Sagittal Spine Alignment Classification Frameworks: Roussouly Versus SRS-Schwab.(Spine, 2022-03) Passias, Peter G; Bortz, Cole; Pierce, Katherine E; Passfall, Lara; Kummer, Nicholas A; Krol, Oscar; Lafage, Renaud; Diebo, Bassel G; Lafage, Virginie; Ames, Christopher P; Burton, Douglas C; Gupta, Munish C; Sciubba, Daniel M; Schoenfeld, Andrew J; Bess, Shay; Hostin, Richard; Shaffrey, Christopher I; Line, Breton G; Klineberg, Eric O; Smith, Justin S; Schwab, Frank J; International Spine Study GroupStudy design
Retrospective cohort study of a prospectively collected database.Objective
To compare clinical utility of two common classification systems for adult spinal deformity (ASD) and determine whether both should be considered in surgical planning to improve patient outcomes.Summary of background data
Surgical restoration of appropriate Roussouly classification shape or SRS-Schwab ASD classification may improve outcomes.Methods
ASD patients with pre- and 2-year postop (2Y) radiographic/health-related quality of life (HRQL) data were grouped by "theoretical" and "current" Roussouly type. Univariate analyses assessed outcomes of patients who mismatched Roussouly types at both pre- and 2Y intervals (Mismatched) and those of preoperative mismatched patients who matched at 2-years (Matched). Subanalysis assessed outcomes of patients who improved in Schwab modifiers, and patients who both improved in both Schwab modifiers and matched Roussouly type by 2Y.Results
Included: 515 ASD patients (59 ± 14 yrs, 80% F). Preoperative breakdown of "current" Roussouly types: Type 1 (10%), 2 (54%), 3 (24%), and 4 (12%). Matched and Mismatched groups did not differ in rates of reaching MCID for any HRQL metrics by 2Y (all P > 0.10). Reoperation, PJK, and complications did not differ between Matched and Mismatched (all P > 0.10), but Roussouly Matched patients had toward lower rates of instrumentation failure (17.2% vs. 24.8%, P = 0.038). By 2Y, 28% of patients improved in PT Schwab modifier, 37% in SVA, and 46% in PI-LL. Patients who both Matched Roussouly at 2Y and improved in all Schwab modifiers met MCID for Oswestry Disability Index (ODI) and Scoliosis Research Society (SRS) activity at higher rates than patients who did not.Conclusion
Isolated restoration per the Roussouly system was not associated with superior outcomes. Patients who both matched Roussouly type and improved in Schwab modifiers had superior patient-reported outcomes at 2-years. Concurrent consideration of both systems may offer utility in establishing optimal realignment goals.Level of Evidence: 3.Item Open Access Comparison of Outcomes Following Anterior vs Posterior Fusion Surgery for Patients With Degenerative Cervical Myelopathy: An Analysis From Quality Outcomes Database.(Neurosurgery, 2019-04) Asher, Anthony L; Devin, Clinton J; Kerezoudis, Panagiotis; Chotai, Silky; Nian, Hui; Harrell, Frank E; Sivaganesan, Ahilan; McGirt, Matthew J; Archer, Kristin R; Foley, Kevin T; Mummaneni, Praveen V; Bisson, Erica F; Knightly, John J; Shaffrey, Christopher I; Bydon, MohamadBACKGROUND:The choice of anterior vs posterior approach for degenerative cervical myelopathy that spans multiple segments remains controversial. OBJECTIVE:To compare the outcomes following the 2 approaches using multicenter prospectively collected data. METHODS:Quality Outcomes Database (QOD) for patients undergoing surgery for 3 to 5 level degenerative cervical myelopathy was analyzed. The anterior group (anterior cervical discectomy [ACDF] or corpectomy [ACCF] with fusion) was compared with posterior cervical fusion. Outcomes included: patient reported outcomes (PROs): neck disability index (NDI), numeric rating scale (NRS) of neck pain and arm pain, EQ-5D, modified Japanese Orthopedic Association score for myelopathy (mJOA), and NASS satisfaction questionnaire; hospital length of stay (LOS), 90-d readmission, and return to work (RTW). Multivariable regression models were fitted for outcomes. RESULTS:Of total 245 patients analyzed, 163 patients underwent anterior surgery (ACDF-116, ACCF-47) and 82 underwent posterior surgery. Patients undergoing an anterior approach had lower odds of having higher LOS (P < .001, odds ratio 0.16, 95% confidence interval 0.08-0.30). The 12-mo NDI, EQ-5D, NRS, mJOA, and satisfaction scores as well as 90-d readmission and RTW did not differ significantly between anterior and posterior groups. CONCLUSION:Patients undergoing anterior approaches for 3 to 5 level degenerative cervical myelopathy had shorter hospital LOS compared to those undergoing posterior decompression and fusion. Also, patients in both groups exhibited similar long-term PROs, readmission, and RTW rates. Further investigations are needed to compare the differences in longer term reoperation rates and functional outcomes before the clinical superiority of one approach over the other can be established.Item Open Access Consistent improvement with eculizumab across muscle groups in myasthenia gravis.(Annals of clinical and translational neurology, 2020-08) Mantegazza, Renato; O'Brien, Fanny L; Yountz, Marcus; Howard, James F; REGAIN study groupObjective
To assess whether eculizumab, a terminal complement inhibitor, improves patient- and physician-reported outcomes (evaluated using the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale, respectively) in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis across four domains, representing ocular, bulbar, respiratory, and limb/gross motor muscle groups.Methods
Patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis were randomized 1:1 to receive either placebo or eculizumab during the REGAIN study (NCT01997229). Patients who completed REGAIN were eligible to continue into the open-label extension trial (NCT02301624) for up to 4 years. The four domain scores of each of the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale recorded throughout REGAIN and through 130 weeks of the open-label extension were analyzed.Results
Of the 125 patients who participated in REGAIN, 117 enrolled in the open-label extension; 61 had received placebo and 56 had received eculizumab during REGAIN. Patients experienced rapid improvements in total scores and all four domain scores of both the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale with eculizumab treatment. These improvements were sustained through 130 weeks of the open-label extension.Interpretation
Eculizumab treatment elicits rapid and sustained improvements in muscle strength across ocular, bulbar, respiratory, and limb/gross motor muscle groups and in associated daily activities in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.Item Open Access Determinants of Patient Satisfaction 2 Years After Spinal Deformity Surgery: A Latent Class Analysis.(Spine, 2019-01) Yang, Jingyan; Lafage, Virginie; Lafage, Renaud; Smith, Justin; Klineberg, Eric O; Shaffrey, Christopher I; Mundis, Gregory; Hostin, Richard; Burton, Douglas; Ames, Christopher P; Bess, Shay; Kim, Han Jo; Schwab, Frank; International Spine Study Group (ISSG)Study design
Retrospective review of prospective multicenter database.Objective
To investigate the determinants of patient satisfaction with respect to changes in functional limitations 2 years after spinal deformity surgery.Summary of background data
For operatively treated adult spine deformity (ASD), patient satisfaction has become an important component of evaluating quality of care.Methods
A total of 430 operative patients with ASD with 2-year follow-up were analyzed. Patient satisfaction was assessed using the Scoliosis Research Society 22-item. Latent class analysis was performed to assign individuals to classes based on the changes in pre- and 2-year postoperative functions, assessed using the Oswestry Disability Index (ODI). An ordered logistic regression was conducted to assess the association of class membership and satisfaction.Results
Latent class analysis identified four classes. The worsened-condition class (WC: 1.4%) consisted of patients who were likely to experience worsened function, particularly in lifting and pain intensity. The remained-same class (RS: 13.0%) included patients who remained the same, because the majority reported approximately no change in walking, standing, and sitting. The mild-improved class (mild-I: 40.2%) included patients with mildly enhanced conditions, specifically, in standing, social life, and employment. The most-improved class (most-I: 45.3%) included patients with great improvement after surgery mainly in standing, followed by social life and employment. The odds of being satisfied were significantly increased by 3.91- (P < 0.001) and 16.99-fold (P < 0.001), comparing patients in mild-I and most-I to the RS/WC class, respectively, after controlling for confounders.Conclusion
Improvement in standing, social life, and employment are the most important determinants of patient satisfaction postsurgery. Reduced pain intensity and enhanced walking ability also help to elevate patient satisfaction. However, lifting, personal care, sitting, sleeping, and travelling may be of less importance. Examining the heterogeneity of patient-reported outcome in patients with ASD allows the identification of classes with different patient characteristics and satisfaction, and thus, help to guide tailored provision of care.Level of evidence
4.Item Open Access Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy.(Spine, 2020-11) Archer, Kristin R; Bydon, Mohamad; Khan, Inamullah; Nian, Hui; Pennings, Jacquelyn S; Harrell, Frank E; Sivaganesan, Ahilan; Chotai, Silky; McGirt, Matthew J; Foley, Kevin T; Glassman, Steven D; Mummaneni, Praveen V; Bisson, Erica F; Knightly, John J; Shaffrey, Christopher I; Asher, Anthony L; Devin, Clinton J; QOD Vanguard sitesStudy design
Retrospective analysis of prospectively collected registry data.Objective
To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery.Summary of background data
Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care.Methods
This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients.Results
Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725.Conclusions
These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling.Level of evidence
2.Item Open Access Development of an Item Bank to Measure Medication Adherence: Systematic Review.(Journal of medical Internet research, 2020-10) Kwan, Yu Heng; Oo, Livia Jia Yi; Loh, Dionne Hui Fang; Phang, Jie Kie; Weng, Si Dun; Blalock, Dan V; Chew, Eng Hui; Yap, Kai Zhen; Tan, Corrinne Yong Koon; Yoon, Sungwon; Fong, Warren; Østbye, Truls; Low, Lian Leng; Bosworth, Hayden Barry; Thumboo, JulianBackground
Medication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer-adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress.Objective
We aim to develop an item bank to measure general medication adherence.Methods
Using the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected ("binned" and "winnowed") according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group.Results
A total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence).Conclusions
We developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs.Item Open Access Differences in Patient-Reported Outcomes Between Anterior and Posterior Approaches for Treatment of Cervical Spondylotic Myelopathy: A Quality Outcomes Database Analysis.(World neurosurgery, 2022-04) Wilkerson, Christopher G; Sherrod, Brandon A; Alvi, Mohammed Ali; Asher, Anthony L; Coric, Domagoj; Virk, Michael S; Fu, Kai-Ming; Foley, Kevin T; Park, Paul; Upadhyaya, Cheerag D; Knightly, John J; Shaffrey, Mark E; Potts, Eric A; Shaffrey, Christopher; Wang, Michael Y; Mummaneni, Praveen V; Chan, Andrew K; Bydon, Mohamad; Tumialán, Luis M; Bisson, Erica FObjective
Surgery for cervical spondylotic myelopathy (CSM) may use anterior or posterior approaches. Our objective was to compare baseline differences and validated postoperative patient-reported outcome measures between anterior and posterior approaches.Methods
The NeuroPoint Quality Outcomes Database was queried retrospectively to identify patients with symptomatic CSM treated at 14 high-volume sites. Demographic, comorbidity, socioeconomic, and outcome measures were compared between treatment groups at baseline and 3 and 12 months postoperatively.Results
Of the 1151 patients with CSM in the cervical registry, 791 (68.7%) underwent anterior surgery and 360 (31.3%) underwent posterior surgery. Significant baseline differences were observed in age, comorbidities, myelopathy severity, unemployment, and length of hospital stay. After adjusting for these differences, anterior surgery patients had significantly lower Neck Disability Index score (NDI) and a higher proportion reaching a minimal clinically important difference (MCID) in NDI (P = 0.005 at 3 months; P = 0.003 at 12 months). Although modified Japanese Orthopaedic Association scores were lower in anterior surgery patients at 3 and 12 months (P < 0.001 and P = 0.022, respectively), no differences were seen in MCID or change from baseline. Greater EuroQol-5D improvement at 3 months after anterior versus posterior surgery (P = 0.024) was not sustained at 12 months and was insignificant on multivariate analysis.Conclusions
In the largest analysis to date of CSM surgery data, significant baseline differences existed for patients undergoing anterior versus posterior surgery for CSM. After adjusting for these differences, patients undergoing anterior surgery were more likely to achieve clinically significant improvement in NDI at short- and long-term follow-up.Item Open Access Early Patient-Reported Outcomes Predict 3-Year Outcomes in Operatively Treated Patients with Adult Spinal Deformity.(World neurosurgery, 2017-06) Jain, Amit; Kebaish, Khaled M; Sciubba, Daniel M; Hassanzadeh, Hamid; Scheer, Justin K; Neuman, Brian J; Lafage, Virginie; Bess, Shay; Protopsaltis, Themistocles S; Burton, Douglas C; Smith, Justin S; Shaffrey, Christopher I; Hostin, Richard A; Ames, Christopher P; International Spine Study GroupBackground
For patients with adult spinal deformity (ASD), surgical treatment may improve their health-related quality of life. This study investigates when the greatest improvement in outcomes occurs and whether incremental improvements in patient-reported outcomes during the first postoperative year predict outcomes at 3 years.Methods
Using a multicenter registry, we identified 84 adults with ASD treated surgically from 2008 to 2012 with complete 3-year follow-up. Pairwise t tests and multivariate regression were used for analysis. Significance was set at P < 0.01.Results
Mean Oswestry Disability Index (ODI) and Scoliosis Research Society-22r total (SRS-22r) scores improved by 13 and 0.8 points, respectively, from preoperatively to 3 years (both P < 0.001). From preoperatively to 6 weeks postoperatively, ODI scores worsened by 5 points (P = 0.049) and SRS-22r scores improved by 0.3 points (P < 0.001). Between 6 weeks and 1 year, ODI and SRS-22r scores improved by 19 and 0.5 points, respectively (both P < 0.001). Incremental improvements during the first postoperative year predicted 3-year outcomes in ODI and SRS-22r scores (adjusted R2 = 0.52 and 0.42, respectively). There were no significant differences in the measured or predicted 3-year ODI (P = 0.991) or SRS-22r scores (P = 0.986).Conclusions
In surgically treated patients with ASD, the greatest improvements in outcomes occurred between 6 weeks and 1 year postoperatively. A model with incremental improvements from baseline to 6 weeks and from 6 weeks to 1 year can be used to predict ODI and SRS-22r scores at 3 years.Item Open Access Hip Osteoarthritis in Patients Undergoing Surgery for Severe Adult Spinal Deformity: Prevalence and Impact on Spine Surgery Outcomes.(The Journal of bone and joint surgery. American volume, 2024-07) Diebo, Bassel G; Alsoof, Daniel; Balmaceno-Criss, Mariah; Daher, Mohammad; Lafage, Renaud; Passias, Peter G; Ames, Christopher P; Shaffrey, Christopher I; Burton, Douglas C; Deviren, Vedat; Line, Breton G; Soroceanu, Alex; Hamilton, D Kojo; Klineberg, Eric O; Mundis, Gregory M; Kim, Han Jo; Gum, Jeffrey L; Smith, Justin S; Uribe, Juan S; Kebaish, Khaled M; Gupta, Munish C; Nunley, Pierce D; Eastlack, Robert K; Hostin, Richard; Protopsaltis, Themistocles S; Lenke, Lawrence G; Hart, Robert A; Schwab, Frank J; Bess, Shay; Lafage, Virginie; Daniels, Alan H; International Spine Study GroupBackground
Hip osteoarthritis (OA) is common in patients with adult spinal deformity (ASD). Limited data exist on the prevalence of hip OA in patients with ASD, or on its impact on baseline and postoperative alignment and patient-reported outcome measures (PROMs). Therefore, this paper will assess the prevalence and impact of hip OA on alignment and PROMs.Methods
Patients with ASD who underwent L1-pelvis or longer fusions were included. Two independent reviewers graded hip OA with the Kellgren-Lawrence (KL) classification and stratified it by severity into non-severe (KL grade 1 or 2) and severe (KL grade 3 or 4). Radiographic parameters and PROMs were compared among 3 patient groups: Hip-Spine (hip KL grade 3 or 4 bilaterally), Unilateral (UL)-Hip (hip KL grade 3 or 4 unilaterally), or Spine (hip KL grade 1 or 2 bilaterally).Results
Of 520 patients with ASD who met inclusion criteria for an OA prevalence analysis, 34% (177 of 520) had severe bilateral hip OA and unilateral or bilateral hip arthroplasty had been performed in 8.7% (45 of 520). A subset of 165 patients had all data components and were examined: 68 Hip-Spine, 32 UL-Hip, and 65 Spine. Hip-Spine patients were older (67.9 ± 9.5 years, versus 59.6 ± 10.1 years for Spine and 65.8 ± 7.5 years for UL-Hip; p < 0.001) and had a higher frailty index (4.3 ± 2.6, versus 2.7 ± 2.0 for UL-Hip and 2.9 ± 2.0 for Spine; p < 0.001). At 1 year, the groups had similar lumbar lordosis, yet the Hip-Spine patients had a worse sagittal vertebral axis (SVA) measurement (45.9 ± 45.5 mm, versus 25.1 ± 37.1 mm for UL-Hip and 19.0 ± 39.3 mm for Spine; p = 0.001). Hip-Spine patients also had worse Veterans RAND-12 Physical Component Summary scores at baseline (25.7 ± 9.3, versus 28.7 ± 9.8 for UL-Hip and 31.3 ± 10.5 for Spine; p = 0.005) and 1 year postoperatively (34.5 ± 11.4, versus 40.3 ± 10.4 for UL-Hip and 40.1 ± 10.9 for Spine; p = 0.006).Conclusions
This study of operatively treated ASD revealed that 1 in 3 patients had severe hip OA bilaterally. Such patients with severe bilateral hip OA had worse baseline SVA and PROMs that persisted 1 year following ASD surgery, despite correction of lordosis.Level of evidence
Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.Item Open Access Impact of Dominant Symptom on 12-Month Patient-Reported Outcomes for Patients Undergoing Lumbar Spine Surgery.(Neurosurgery, 2020-10) Devin, Clinton J; Asher, Anthony L; Archer, Kristin R; Goyal, Anshit; Khan, Inamullah; Kerezoudis, Panagiotis; Alvi, Mohammed Ali; Pennings, Jacquelyn S; Karacay, Bernes; Shaffrey, Christopher I; Bisson, Erica F; Knightly, John J; Mummaneni, Praveen V; Foley, Kevin T; Bydon, MohamadBackground
The impact of symptom characteristics on outcomes of spine surgery remains elusive.Objective
To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery.Methods
We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ2 penalized by degrees of freedom.Results
A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied (P < .0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) (P = .002), and return to work (P = .03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) (P = .09) [ref = predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied (P < .0001), but showed no significant difference in achieving MCID (P = .22) or return to work (P = .07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work.Conclusion
Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.Item Open Access Impact of predominant symptom location among patients undergoing cervical spine surgery on 12-month outcomes: an analysis from the Quality Outcomes Database.(Journal of neurosurgery. Spine, 2021-07) Devin, Clinton J; Asher, Anthony L; Alvi, Mohammed Ali; Yolcu, Yagiz U; Kerezoudis, Panagiotis; Shaffrey, Christopher I; Bisson, Erica F; Knightly, John J; Mummaneni, Praveen V; Foley, Kevin T; Bydon, MohamadObjective
The impact of the type of pain presentation on outcomes of spine surgery remains elusive. The aim of this study was to assess the impact of predominant symptom location (predominant arm pain vs predominant neck pain vs equal neck and arm pain) on postoperative improvement in patient-reported outcomes.Methods
The Quality Outcomes Database cervical spine module was queried for patients undergoing 1- or 2-level anterior cervical discectomy and fusion (ACDF) for degenerative spine disease.Results
A total of 9277 patients were included in the final analysis. Of these patients, 18.4% presented with predominant arm pain, 32.3% presented with predominant neck pain, and 49.3% presented with equal neck and arm pain. Patients with predominant neck pain were found to have higher (worse) 12-month Neck Disability Index (NDI) scores (coefficient 0.24, 95% CI 0.15-0.33; p < 0.0001). The three groups did not differ significantly in odds of return to work and achieving minimal clinically important difference in NDI score at the 12-month follow-up.Conclusions
Analysis from a national spine registry showed significantly lower odds of patient satisfaction and worse NDI score at 1 year after surgery for patients with predominant neck pain when compared with patients with predominant arm pain and those with equal neck and arm pain after 1- or 2-level ACDF. With regard to return to work, all three groups (arm pain, neck pain, and equal arm and neck pain) were found to be similar after multivariable analysis. The authors' results suggest that predominant pain location, especially predominant neck pain, might be a significant determinant of improvement in functional outcomes and patient satisfaction after ACDF for degenerative spine disease. In addition to confirmation of the common experience that patients with predominant neck pain have worse outcomes, the authors' findings provide potential targets for improvement in patient management for these specific populations.Item Open Access Improvement in SRS-22R Self-Image Correlate Most with Patient Satisfaction after 3-Column Osteotomy.(Spine, 2021-06) Gum, Jeffrey L; Shasti, Mark; Yeramaneni, Samrat; Carreon, Leah Y; Hostin, Richard A; Kelly, Michael P; Lafage, Virginie; Smith, Justin S; Passias, Peter G; Kebaish, Khaled; Shaffrey, Christopher I; Burton, Douglas L; Ames, Christopher P; Schwab, Frank J; Protopsaltis, Themistocles; Bess, R Shay; ISSGStudy design
Longitudinal cohort.Objectives
The aim of this study was to examine the relationship between patient satisfaction, patient-reported outcome measures (PROMs) and radiographic parameters in adult spine deformity (ASD) patients undergoing three-column osteotomies (3CO).Summary of background data
Identifying factors that influence patient satisfaction in ASD is important. Evidence suggests Scoliosis Research Society-22R (SRS-22R) Self-Image domain correlates with patient satisfaction in patients with ASD.Methods
This is a retrospective review of ASD patients enrolled in a prospective, multicenter database undergoing a 3CO with complete SRS-22R pre-op and minimum 2-years postop. Spearman correlations were used to evaluate associations between the 2-year SRS Satisfaction score and changes in SRS-22R domain scores, Oswestry Disability Index (ODI), and radiographic parameters.Results
Of 135 patients eligible for 2-year follow-up, 98 patients (73%) had complete pre- and 2-year postop data. The cohort was mostly female (69%) with mean BMI of 29.7 kg/m2 and age of 61.0 years. Mean levels fused was 12.9 with estimated blood loss of 2695 cc and OR time of 407 minutes; 27% were revision surgeries. There was a statistically significant improvement between pre- and 2-year post-op PROMs and all radiographic parameters except Coronal Vertical Axis. The majority of patients had an SRS Satisfaction score of ≥3.0 (90%) or ≥4.0 (68%), consistent with a moderate ceiling effect. Correlations of patient satisfaction was significant for Pain (0.43, P < 0.001), Activity (0.39, P < 0.001), Mental (0.38, P = 0.001) Self-Image (0.52, P < 0.001). ODI and Short-Form-36 Physical component summary had a moderate correlation as well, with mental component summary being weak. There was no statistically significant correlation between any radiographic or operative parameters and patient satisfaction.Conclusion
There was statistically significant improvement in all PROMs and radiographic parameters, except coronal vertical axis at 2 years in ASD patients undergoing 3CO. Improvement in SRS Self-Image domain has the strongest correlation with patient satisfaction.Level of Evidence: 3.Item Open Access Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.(Journal of neurosurgery. Spine, 2018-11) Chan, Andrew K; Bisson, Erica F; Bydon, Mohamad; Glassman, Steven D; Foley, Kevin T; Potts, Eric A; Shaffrey, Christopher I; Shaffrey, Mark E; Coric, Domagoj; Knightly, John J; Park, Paul; Wang, Michael Y; Fu, Kai-Ming; Slotkin, Jonathan R; Asher, Anthony L; Virk, Michael S; Kerezoudis, Panagiotis; Chotai, Silky; DiGiorgio, Anthony M; Haid, Regis W; Mummaneni, Praveen VOBJECTIVEThe AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.Item Open Access Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review.(Journal of medical Internet research, 2020-10) Kwan, Yu Heng; Weng, Si Dun; Loh, Dionne Hui Fang; Phang, Jie Kie; Oo, Livia Jia Yi; Blalock, Dan V; Chew, Eng Hui; Yap, Kai Zhen; Tan, Corrinne Yong Koon; Yoon, Sungwon; Fong, Warren; Østbye, Truls; Low, Lian Leng; Bosworth, Hayden Barry; Thumboo, JulianBackground
Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research.Objective
This study aims to evaluate the quality of the PROMs used to measure medication adherence.Methods
This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines.Results
A total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically.Conclusions
This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.Item Open Access Measurement-based care using DSM-5 for opioid use disorder: can we make opioid medication treatment more effective?(Addiction (Abingdon, England), 2019-08) Marsden, John; Tai, Betty; Ali, Robert; Hu, Lian; Rush, A John; Volkow, NoraContext and purpose
Measurement-based care (MBC) is an evidence-based health-care practice in which indicators of disease are tracked to inform clinical actions, provide feedback to patients and improve outcomes. The current opioid crisis in multiple countries provides a pressing rationale for adopting a basic MBC approach for opioid use disorder (OUD) using DSM-5 to increase treatment retention and effectiveness.Proposal
To stimulate debate, we propose a basic MBC approach using the 11 symptoms of OUD (DSM-5) to inform the delivery of medications for opioid use disorder (MOUD; including methadone, buprenorphine and naltrexone) and their evaluation in office-based primary care and specialist clinics. Key features of a basic MBC approach for OUD using DSM-5 are described, with an illustration of how clinical actions are guided and outcomes communicated. For core treatment tasks, we propose that craving and drug use response to MOUD should be assessed after 2 weeks, and OUD remission status should be evaluated at 3, 6 and 12 months (and exit from MOUD treatment) and beyond. Each of the 11 DSM-5 symptoms of OUD should be discussed with the patient to develop a case formulation and guide selection of adjunctive psychological interventions, supplemented with information on substance use, and optionally extended with information from other clinical instruments. A patient-reported outcome measure should be recorded and discussed at each remission assessment.Conclusions
MBC can be used to tailor and adapt MOUD treatment to increase engagement, retention and effectiveness. MBC practice principles can help promote patient-centred care in OUD, personalized addiction therapeutics and facilitate communication of outcomes.Item Open Access 'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.(Journal of neurology, 2020-07) Vissing, John; Jacob, Saiju; Fujita, Kenji P; O'Brien, Fanny; Howard, James F; REGAIN study groupBackground
The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension.Methods
Attainment of 'minimal symptom expression' was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. 'Minimal symptom expression' was defined as MG-ADL total score of 0-1 or MG-QOL15 total score of 0-3.Results
At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved 'minimal symptom expression' increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved 'minimal symptom expression' (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports.Conclusions
Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained 'minimal symptom expression' based on patient-reported outcomes. 'Minimal symptom expression' may be a useful tool in measuring therapy effectiveness in gMG.Trial registration
ClinicalTrials.gov NCT01997229, NCT02301624.Item Open Access Outcome at 1 year in patients with femoral shaft fractures treated with intramedullary nailing or skeletal traction in a low-income country: a prospective observational study of 187 patients in Malawi.(Acta orthopaedica, 2020-12) Chokotho, Linda; Wu, Hao-Hua; Shearer, David; Lau, Brian C; Mkandawire, Nyengo; Gjertsen, Jan-Erik; Hallan, Geir; Young, SvenBackground and purpose - Intramedullary nailing (IMN) is underutilized in low-income countries (LICs) where skeletal traction (ST) remains the standard of care for femoral shaft fractures. This prospective study compared patient-reported quality of life and functional status after femoral shaft fractures treated with IMN or ST in Malawi. Patients and methods - Adult patients with femoral shaft fractures managed by IMN or ST were enrolled prospectively from 6 hospitals. Quality of life and functional status were assessed using EQ-5D-3L, and the Short Musculoskeletal Function Assessment (SMFA) respectively. Patients were followed up at 6 weeks, 3, 6, and 12 months post-injury. Results - Of 248 patients enrolled (85 IMN, 163 ST), 187 (75%) completed 1-year follow-up (55 IMN, 132 ST). 1 of 55 IMN cases had nonunion compared with 40 of 132 ST cases that failed treatment and converted to IMN (p < 0.001). Quality of life and SMFA Functional Index Scores were better for IMN than ST at 6 weeks, 3 and 6 months, but not at 1 year. At 6 months, 24 of 51 patients in the ST group had returned to work, compared with 26 of 37 in the IMN group (p = 0.02). Interpretation - Treatment with IMN improved early quality of life and function and allowed patients to return to work earlier compared with treatment with ST. Approximately one-third of patients treated with ST failed treatment and were converted to IMN.Item Open Access Patients with a depressive and/or anxiety disorder can achieve optimum Long term outcomes after surgery for grade 1 spondylolisthesis: Analysis from the quality outcomes database (QOD).(Clinical neurology and neurosurgery, 2020-10) Kashlan, Osama; Swong, Kevin; Alvi, Mohammed Ali; Bisson, Erica F; Mummaneni, Praveen V; Knightly, John; Chan, Andrew; Yolcu, Yagiz U; Glassman, Steven; Foley, Kevin; Slotkin, Jonathan R; Potts, Eric; Shaffrey, Mark; Shaffrey, Christopher I; Haid, Regis W; Fu, Kai-Ming; Wang, Michael Y; Asher, Anthony L; Bydon, Mohamad; Park, PaulIntroduction
In the current study, we sought to compare baseline demographic, clinical, and operative characteristics, as well as baseline and follow-up patient reported outcomes (PROs) of patients with any depressive and/or anxiety disorder undergoing surgery for low-grade spondylolisthesis using a national spine registry.Patients and methods
The Quality Outcomes Database (QOD) was queried for patients undergoing surgery for Meyerding grade 1 lumbar spondylolisthesis undergoing 1-2 level decompression or 1 level fusion at 12 sites with the highest number of patients enrolled in QOD with 2-year follow-up data.Results
Of the 608 patients identified, 25.6 % (n = 156) had any depressive and/or anxiety disorder. Patients with a depressive/anxiety disorder were less likely to be discharged home (p < 0.001). At 3=months, patients with a depressive/anxiety disorder had higher back pain (p < 0.001), lower quality of life (p < 0.001) and higher disability (p = 0.013); at 2 year patients with depression and/or anxiety had lower quality of life compared to those without (p < 0.001). On multivariable regression, depression was associated with significantly lower odds of achieving 20 % or less ODI (OR 0.44, 95 % CI 0.21-0.94,p = 0.03). Presence of an anxiety disorder was not associated with decreased odds of achieving that milestone at 3 months. The presence of depressive-disorder, anxiety-disorder or both did not have an impact on ODI at 2 years. Finally, patient satisfaction at 2-years did not differ between the two groups (79.8 % vs 82.7 %,p = 0.503).Conclusion
We found that presence of a depressive-disorder may impact short-term outcomes among patients undergoing surgery for low grade spondylolisthesis but longer term outcomes are not affected by either a depressive or anxiety disorder.Item Open Access Patients' Experiences With Staphylococcus aureus and Gram-negative Bacterial Bloodstream Infections: A Qualitative Descriptive Study and Concept Elicitation Phase To Inform Measurement of Patient-reported Quality of Life.(Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-07) King, Heather A; Doernberg, Sarah B; Miller, Julie; Grover, Kiran; Oakes, Megan; Ruffin, Felicia; Gonzales, Sarah; Rader, Abigail; Neuss, Michael J; Bosworth, Hayden B; Sund, Zoë; Drennan, Caitlin; Hill-Rorie, Jonathan M; Shah, Pratik; Winn, Laura; Fowler, Vance G; Holland, Thomas LBackground
Although Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) cause substantial morbidity, little is known regarding patient perceptions' of their impact on quality of life (QOL). Guidance for assessing QOL and disease-specific measures are lacking. We conducted a descriptive qualitative study to gain an in-depth understanding of patients' experiences with SAB/GNB and concept elicitation phase to inform a patient-reported QOL outcome measure.Methods
We conducted prospective one-time, in-depth, semi-structured, individual, qualitative telephone interviews 6- 8 weeks following bloodstream infection with either SAB or GNB. Patients were enrolled in an institutional registry (tertiary academic medical center) for SAB or GNB. Interviews were audio-recorded, transcribed, and coded. Directed content analysis identified a priori and emergent themes. Theme matrix techniques were used to facilitate analysis and presentation.Results
Interviews were completed with 30 patients with SAB and 31 patients with GNB. Most patients were at or near the end of intravenous antibiotic treatment when interviewed. We identified 3 primary high-level concepts: impact on QOL domains, time as a critical index, and sources of variability across patients. Across both types of bloodstream infection, the QOL domains most impacted were physical and functional, which was particularly evident among patients with SAB.Conclusions
SAB/GNB impact QOL among survivors. In particular, SAB had major impacts on multiple QOL domains. A combination of existing, generic measures that are purposefully selected and disease-specific items, if necessary, could best capture these impacts. Engaging patients as stakeholders and obtaining their feedback is crucial to conducting patient-centered clinical trials and providing patient-centered care.