Browsing by Subject "Quality of Life"
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Item Open Access A comparative analysis of the prevalence and characteristics of cervical malalignment in adults presenting with thoracolumbar spine deformity based on variations in treatment approach over 2 years.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2016-08) Jalai, Cyrus M; Passias, Peter G; Lafage, Virginie; Smith, Justin S; Lafage, Renaud; Poorman, Gregory W; Diebo, Bassel; Liabaud, Barthélemy; Neuman, Brian J; Scheer, Justin K; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P; International Spine Study Group (ISSG)Purpose
Characteristics specific to cervical deformity (CD) concomitant with adult thoracolumbar deformity (TLD) remains uncertain, particularly regarding treatment. This study identifies cervical malalignment prevalence following surgical and conservative TLD treatment through 2 years.Methods
Retrospective analysis of a prospective, multicenter adult spinal deformity (ASD) database. CD was defined in operative and non-operative ASD patients according to the following criteria: T1 Slope minus Cervical Lordosis (T1S-CL) ≥20°, C2-C7 Cervical Sagittal Vertical Axis (cSVA) ≥40 mm, C2-C7 kyphosis >10°. Differences in rates, demographics, health-related quality of life (HRQoL) scores for Oswestry Disability Index (ODI) and Scoliosis Research Society Questionnaire (SRS-22r), and radiographic variables were assessed between treatment groups (Op vs. Non-Op) and follow-up periods (baseline, 1-year, 2-year).Results
Three hundred and nineteen (200 Op, 199 Non-Op) ASD patients were analyzed. Op patients' CD rates at 1 and 2 years were 78.9, and 63.0 %, respectively. Non-Op CD rates were 21.1 and 37.0 % at 1 and 2 years, respectively. T1S-CL mismatch and cSVA malalignment characterized Op CD at 1 and 2 years (p < 0.05). Op and Non-Op CD groups had similar cervical/global alignment at 1 year (p > 0.05 for all), but at 2 years, Op CD patients had worse thoracic kyphosis (TK), T1S-CL, CL, cSVA, C2-T3 SVA, and global SVA compared to Non-Ops (p < 0.05). Op CD patients had worse ODI, and SRS Activity at 1 and 2 years post-operative (p < 0.05), but had greater 2-year SRS Satisfaction scores (p = 0.019).Conclusions
In the first study to compare cervical malalignment at extended follow-up between ASD treatments, CD rates rose overall through 2 years. TLD surgery, resulting in higher CD rates characterized by T1S-CL and cSVA malalignment, produced poorer HRQoL. This information can aid in treatment method decision-making when cervical deformity is present concomitant with TLD.Item Open Access A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database.(Neurosurgery, 2020-09) Chan, Andrew K; Bisson, Erica F; Bydon, Mohamad; Foley, Kevin T; Glassman, Steven D; Shaffrey, Christopher I; Wang, Michael Y; Park, Paul; Potts, Eric A; Shaffrey, Mark E; Coric, Domagoj; Knightly, John J; Fu, Kai-Ming; Slotkin, Jonathan R; Asher, Anthony L; Virk, Michael S; Kerezoudis, Panagiotis; Alvi, Mohammed A; Guan, Jian; Haid, Regis W; Mummaneni, Praveen VBackground
It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness.Objective
To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size.Methods
We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively.Results
A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P < .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P < .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P < .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P > .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = -4.7; 95% CI = -9.3 to -0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance.Conclusion
For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.Item Open Access A cost-effectiveness comparisons of adult spinal deformity surgery in the United States and Japan.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018-03) Yagi, Mitsuru; Ames, Christopher P; Keefe, Malla; Hosogane, Naobumi; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Shay Bess, R; Matsumoto, Morio; Watanabe, Kota; International Spine Study Group (ISSG)Purpose
Information about the cost-effectiveness of surgical procedures for adult spinal deformity (ASD) is critical for providing appropriate treatments for these patients. The purposes of this study were to compare the direct cost and cost-effectiveness of surgery for ASD in the United States (US) and Japan (JP).Methods
Retrospective analysis of 76 US and 76 JP patients receiving surgery for ASD with ≥2-year follow-up was identified. Data analysis included preoperative and postoperative demographic, radiographic, health-related quality of life (HRQOL), and direct cost for surgery. An incremental cost-effectiveness ratio (ICER) was determined using cost/quality-adjusted life years (QALY). The cost/QALY was calculated from the 2-year cost and HRQOL data.Results
JP exhibited worse baseline spinopelvic alignment than the US (pelvic incidence and lumbar lordosis: 35.4° vs 22.7°, p < 0.01). The US had more three-column osteotomies (50 vs 16%), and shorter hospital stay (7.9 vs 22.7 days) (p < 0.05). The US demonstrated worse postoperative ODI (41.3 vs. 33.9%) and greater revision surgery rate (40 vs 10%) (p < 0.05). Due to the high initial cost and revision frequency, the US had greater total cost ($92,133 vs. $49,647) and cost/QALY ($511,840 vs. $225,668) at 2-year follow-up (p < 0.05).Conclusion
Retrospective analysis comparing the direct costs and cost-effectiveness of ASD surgery in the US vs JP demonstrated that the total direct costs and cost/QALY were substantially higher in the US than JP. Variations in patient cohort, healthcare costs, revision frequencies, and HRQOL improvement influenced the cost/QALY differential between these countries.Item Open Access A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.(Health Qual Life Outcomes, 2004-05-06) Samsa, Greg; Matchar, David B; Dolor, Rowena J; Wiklund, Ingela; Hedner, Ewa; Wygant, Gail; Hauch, Ole; Marple, Cheryl Beadle; Edwards, RogerBACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.Item Open Access A Risk-Benefit Analysis of Increasing Surgical Invasiveness Relative to Frailty Status in Adult Spinal Deformity Surgery.(Spine, 2021-08) Passias, Peter G; Brown, Avery E; Bortz, Cole; Pierce, Katherine; Alas, Haddy; Ahmad, Waleed; Passfall, Lara; Kummer, Nicholas; Krol, Oscar; Lafage, Renaud; Lafage, Virginie; Burton, Douglas; Hart, Robert; Anand, Neel; Mundis, Gregory; Neuman, Brian; Line, Breton; Shaffrey, Christopher; Klineberg, Eric; Smith, Justin; Ames, Christopher; Schwab, Frank J; Bess, Shay; International Spine Study GroupStudy design
Retrospective review of a prospectively enrolled multicenter Adult Spinal Deformity (ASD) database.Objective
Investigate invasiveness and outcomes of ASD surgery by frailty state.Summary of background data
The ASD Invasiveness Index incorporates deformity-specific components to assess correction magnitude. Intersections of invasiveness, surgical outcomes, and frailty state are understudied.Methods
ASD patients with baseline and 3-year (3Y) data were included. Logistic regression analyzed the relationship between increasing invasiveness and major complications or reoperations and meeting minimal clinically important differences (MCID) for health-related quality-of-life measures at 3Y. Decision tree analysis assessed invasiveness risk-benefit cutoff points, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to P < 0.05.Results
Overall, 195 of 322 patients were included. Baseline demographics: age 59.9 ± 14.4, 75% female, BMI 27.8 ± 6.2, mean Charlson Comorbidity Index: 1.7 ± 1.7. Surgical information: 61% osteotomy, 52% decompression, 11.0 ± 4.1 levels fused. There were 98 not frail (NF), 65 frail (F), and 30 severely frail (SF) patients. Relationships were found between increasing invasiveness and experiencing a major complication or reoperation for the entire cohort and by frailty group (all P < 0.05). Defining a favorable outcome as no major complications or reoperation and meeting MCID in any health-related quality of life at 3Y established an invasiveness cutoff of 63.9. Patients below this threshold were 1.8[1.38-2.35] (P < 0.001) times more likely to achieve favorable outcome. For NF patients, the cutoff was 79.3 (2.11[1.39-3.20] (P < 0.001), 111 for F (2.62 [1.70-4.06] (P < 0.001), and 53.3 for SF (2.35[0.78-7.13] (P = 0.13).Conclusion
Increasing invasiveness is associated with increased odds of major complications and reoperations. Risk-benefit cutoffs for successful outcomes were 79.3 for NF, 111 for F, and 53.3 for SF patients. Above these, increasing invasiveness has increasing risk of major complications or reoperations and not meeting MCID at 3Y.Level of Evidence: 3.Item Open Access A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life.(Clinical obesity, 2017-10) Kolotkin, RL; Andersen, JRThis is the first systematic review of reviews to assess the effect of obesity and weight loss on health-related quality of life (HRQoL). We identified 12 meta-analyses/systematic reviews published between January 2001 and July 2016. They addressed the following themes: (i) the relationship between weight/body mass index and HRQoL (baseline/pre-intervention; n = 2). (ii) HRQoL after weight loss (varied interventions and/or study design; n = 2). (iii) HRQoL after weight loss (randomized controlled trials only; n = 2). (iv) HRQoL after bariatric surgery (n = 6). We found that in all populations, obesity was associated with significantly lower generic and obesity-specific HRQoL. The relationship between weight loss and improved HRQoL was consistently demonstrated after bariatric surgery, perhaps due to a greater than average weight loss compared with other treatments. Improved HRQoL was evident after non-surgical weight loss, but was not consistently demonstrated, even in randomized controlled trials. This inconsistency may be attributed to variation in quality of reporting, assessment measures, study populations and weight-loss interventions. We recommend longer-term studies, using both generic and obesity-specific measures, which go beyond HRQoL in isolation to exploring mediators of HRQoL changes and interactions with other variables, such as comorbidities, fitness level and body image.Item Open Access Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.(Spine, 2022-02) Durand, Wesley M; Babu, Jacob M; Hamilton, David K; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Study design
Retrospective cohort study.Objective
We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism.Summary of background data
ASD patients experience markedly decreased health-related quality of life along many dimensions.Methods
Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP).Results
In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type.Conclusion
ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.Item Open Access An analysis from the Quality Outcomes Database, Part 1. Disability, quality of life, and pain outcomes following lumbar spine surgery: predicting likely individual patient outcomes for shared decision-making.(Journal of neurosurgery. Spine, 2017-10) McGirt, Matthew J; Bydon, Mohamad; Archer, Kristin R; Devin, Clinton J; Chotai, Silky; Parker, Scott L; Nian, Hui; Harrell, Frank E; Speroff, Theodore; Dittus, Robert S; Philips, Sharon E; Shaffrey, Christopher I; Foley, Kevin T; Asher, Anthony LOBJECTIVE Quality and outcomes registry platforms lie at the center of many emerging evidence-driven reform models. Specifically, clinical registry data are progressively informing health care decision-making. In this analysis, the authors used data from a national prospective outcomes registry (the Quality Outcomes Database) to develop a predictive model for 12-month postoperative pain, disability, and quality of life (QOL) in patients undergoing elective lumbar spine surgery. METHODS Included in this analysis were 7618 patients who had completed 12 months of follow-up. The authors prospectively assessed baseline and 12-month patient-reported outcomes (PROs) via telephone interviews. The PROs assessed were those ascertained using the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for back pain (BP) and leg pain (LP). Variables analyzed for the predictive model included age, gender, body mass index, race, education level, history of prior surgery, smoking status, comorbid conditions, American Society of Anesthesiologists (ASA) score, symptom duration, indication for surgery, number of levels surgically treated, history of fusion surgery, surgical approach, receipt of workers' compensation, liability insurance, insurance status, and ambulatory ability. To create a predictive model, each 12-month PRO was treated as an ordinal dependent variable and a separate proportional-odds ordinal logistic regression model was fitted for each PRO. RESULTS There was a significant improvement in all PROs (p < 0.0001) at 12 months following lumbar spine surgery. The most important predictors of overall disability, QOL, and pain outcomes following lumbar spine surgery were employment status, baseline NRS-BP scores, psychological distress, baseline ODI scores, level of education, workers' compensation status, symptom duration, race, baseline NRS-LP scores, ASA score, age, predominant symptom, smoking status, and insurance status. The prediction discrimination of the 4 separate novel predictive models was good, with a c-index of 0.69 for ODI, 0.69 for EQ-5D, 0.67 for NRS-BP, and 0.64 for NRS-LP (i.e., good concordance between predicted outcomes and observed outcomes). CONCLUSIONS This study found that preoperative patient-specific factors derived from a prospective national outcomes registry significantly influence PRO measures of treatment effectiveness at 12 months after lumbar surgery. Novel predictive models constructed with these data hold the potential to improve surgical effectiveness and the overall value of spine surgery by optimizing patient selection and identifying important modifiable factors before a surgery even takes place. Furthermore, these models can advance patient-focused care when used as shared decision-making tools during preoperative patient counseling.Item Open Access Artificial Intelligence Models Predict Operative Versus Nonoperative Management of Patients with Adult Spinal Deformity with 86% Accuracy.(World neurosurgery, 2020-09) Durand, Wesley M; Daniels, Alan H; Hamilton, David K; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert; International Spine Study GroupObjective
Patients with ASD show complex and highly variable disease. The decision to manage patients operatively is largely subjective and varies based on surgeon training and experience. We sought to develop models capable of accurately discriminating between patients receiving operative versus nonoperative treatment based only on baseline radiographic and clinical data at enrollment.Methods
This study was a retrospective analysis of a multicenter consecutive cohort of patients with ASD. A total of 1503 patients were included, divided in a 70:30 split for training and testing. Patients receiving operative treatment were defined as those undergoing surgery up to 1 year after their baseline visit. Potential predictors included available demographics, past medical history, patient-reported outcome measures, and premeasured radiographic parameters from anteroposterior and lateral films. In total, 321 potential predictors were included. Random forest, elastic net regression, logistic regression, and support vector machines (SVMs) with radial and linear kernels were trained.Results
Of patients in the training and testing sets, 69.0% (n = 727) and 69.1% (n = 311), respectively, received operative management. On evaluation with the testing dataset, performance for SVM linear (area under the curve =0.910), elastic net (0.913), and SVM radial (0.914) models was excellent, and the logistic regression (0.896) and random forest (0.830) models performed very well for predicting operative management of patients with ASD. The SVM linear model showed 86% accuracy.Conclusions
This study developed models showing excellent discrimination (area under the curve >0.9) between patients receiving operative versus nonoperative management, based solely on baseline study enrollment values. Future investigations may evaluate the implementation of such models for decision support in the clinical setting.Item Open Access Assessment of Adult Spinal Deformity Complication Timing and Impact on 2-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System.(Spine, 2022-03) Wick, Joseph B; Le, Hai V; Lafage, Renaud; Gupta, Munish C; Hart, Robert A; Mundis, Gregory M; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O; International Spine Study GroupStudy design
Retrospective review of prospectively collected multicenter registry data.Objective
To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance.Summary of background data
ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system).Methods
The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed.Results
Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90.Conclusion
Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.Item Open Access Assessment of the psychometric properties of an English version of the cancer dyspnea scale in people with advanced lung cancer.(Journal of pain and symptom management, 2012-11) Uronis, Hope E; Shelby, Rebecca A; Currow, David C; Ahmedzai, Sam H; Bosworth, Hayden B; Coan, April; Abernethy, Amy PContext
Dyspnea is a poorly understood subjective sensation. Existing dyspnea measures fail to adequately address its multidimensionality. A Japanese group developed and validated the Cancer Dyspnea Scale (CDS) for assessing dyspnea in patients with advanced lung cancer.Objectives
We evaluated the validity and reliability of the English version of the CDS (CDS-E) that has 12 items and takes, on average, 140 seconds for individuals to complete.Methods
Eligible patients had advanced lung cancer, consented, and were fluent in English. Participants completed a 100 mm visual analogue scale (VAS), the modified Borg scale, the CDS-E, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy--Lung quality-of-life scale. Demographic, radiographic, and treatment information were obtained from patients' medical records.Results
One hundred twelve participants were enrolled at three sites in the U.S., Australia, and the U.K. Mean age was 64.5 years (SD 11.5); 90% were Caucasian, 68% had Eastern Cooperative Oncology Group performance status 0-1, and 50% had non-small cell carcinoma. All completed the CDS-E independently, without difficulty. The CDS-E had reasonable internal consistency overall (Cronbach's α = 0.71) and for each of the three factors (effort, anxiety, discomfort Cronbach's α = 0.80-0.84). CDS-E scores were significantly correlated with the 100mm VAS (r = 0.82; P < 0.001) and the modified Borg (r = 0.87; P < 0.001). After factor analysis, the CDS-E was revised by removing three items (r-CDS-E).Conclusion
The CDS-E and r-CDS-E are reliable and valid measures of the sensation and the psychological components of dyspnea, with the shorter version having similar psychometric properties.Item Open Access Association between preoperative cervical sagittal deformity and inferior outcomes at 2-year follow-up in patients with adult thoracolumbar deformity: analysis of 182 patients.(Journal of neurosurgery. Spine, 2016-01) Scheer, Justin K; Passias, Peter G; Sorocean, Alexandra M; Boniello, Anthony J; Mundis, Gregory M; Klineberg, Eric; Kim, Han Jo; Protopsaltis, Themistocles S; Gupta, Munish; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Smith, Justin S; Ames, Christopher P; International Spine Study GroupObjective
A high prevalence of cervical deformity (CD) has been identified among adult patients with thoracolumbar spinal deformity undergoing surgical treatment. The clinical impact of this is uncertain. This study aimed to quantify the differences in patient-reported outcomes among patients with adult spinal deformity (ASD) based on presence of CD prior to treatment.Methods
A retrospective review was conducted of a multicenter prospective database of patients with ASD who underwent surgical treatment with 2-year follow-up. Patients were grouped by the presence of preoperative CD: 1) cervical positive sagittal malalignment (CPSM) C2-7 sagittal vertical axis ≥ 4 cm; 2) cervical kyphosis (CK) C2-7 angle > 0; 3) CPSM and CK (BOTH); and 4) no baseline CD (NONE). Health-related quality of life (HRQOL) scores included the Physical Component Summary and Mental Component Summary (PCS and MCS) scores of the 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), Scoliosis Research Society-22 questionnaire (SRS-22), and minimum clinically important difference (MCID) of these scores at 2 years. Standard radiographic measurements were conducted for cervical, thoracic, and thoracolumbar parameters.Results
One hundred eighty-two patients were included in this study: CPSM, 45; CK, 37; BOTH, 16; and NONE, 84. Patients with preoperative CD and those without had similar baseline thoracolumbar radiographic measurements and similar correction rates at 2 years. Patients with and without preoperative CD had similar baseline HRQOL and on average both groups experienced some HRQOL improvement. However, those with preoperative CPSM had significantly worse postoperative ODI, PCS, SRS-22 Activity, SRS-22 Appearance, SRS-22 Pain, SRS-22 Satisfaction, and SRS-22 Total score, and were less likely to meet MCID for ODI, PCS, SRS-22 Activity, and SRS-22 Pain scores with the following ORs and 95% CIs: ODI 0.19 (0.07-0.58), PCS 0.17 (0.06-0.47), SRS-22 Activity 0.23 (0.09-0.62), SRS-22 Pain 0.20 (0.08-0.53), and SRS-22 Appearance 0.34 (0.12-0.94). Preoperative CK did not have an effect on outcomes. Interestingly, despite correction of the thoracolumbar deformity, 53.3% and 51.4% of patients had persistent CPSM and persistent CK, respectively.Conclusions
Patients with thoracolumbar deformity without preoperative CD are likely to have greater improvements in HRQOL after surgery than patients with concomitant preoperative CD. Cervical positive sagittal alignment in adult patients with thoracolumbar deformity is strongly associated with inferior outcomes and failure to reach MCID at 2-year follow-up despite having similar baseline HRQOL to patients without CD. This was the first study to assess the impact of concomitant preoperative cervical malalignment in adult patients with thoracolumbar deformity. These results can help surgeons educate patients at risk for inferior outcomes and direct future research to identify an etiology and improve patient outcomes. Investigation into the etiology of the baseline cervical malalignment may be warranted in patients who present with thoracolumbar deformity.Item Open Access Association of myelopathy scores with cervical sagittal balance and normalized spinal cord volume: analysis of 56 preoperative cases from the AOSpine North America Myelopathy study.(Spine, 2013-10) Smith, Justin S; Lafage, Virginie; Ryan, Devon J; Shaffrey, Christopher I; Schwab, Frank J; Patel, Alpesh A; Brodke, Darrel S; Arnold, Paul M; Riew, K Daniel; Traynelis, Vincent C; Radcliff, Kris; Vaccaro, Alexander R; Fehlings, Michael G; Ames, Christopher PStudy design
Post hoc analysis of prospectively collected data.Objective
Development of methods to determine in vivo spinal cord dimensions and application to correlate preoperative alignment, myelopathy, and health-related quality-of-life scores in patients with cervical spondylotic myelopathy (CSM).Summary of background data
CSM is the leading cause of spinal cord dysfunction. The association between cervical alignment, sagittal balance, and myelopathy has not been well characterized.Methods
This was a post hoc analysis of the prospective, multicenter AOSpine North America CSM study. Inclusion criteria for this study required preoperative cervical magnetic resonance imaging (MRI) and neutral sagittal cervical radiography. Techniques for MRI assessment of spinal cord dimensions were developed. Correlations between imaging and health-related quality-of-life scores were assessed.Results
Fifty-six patients met inclusion criteria (mean age = 55.4 yr). The modified Japanese Orthopedic Association (mJOA) scores correlated with C2-C7 sagittal vertical axis (SVA) (r = -0.282, P = 0.035). Spinal cord volume correlated with cord length (r = 0.472, P < 0.001) and cord average cross-sectional area (r = 0.957, P < 0.001). For all patients, no correlations were found between MRI measurements of spinal cord length, volume, mean cross-sectional area or surface area, and outcomes. For patients with cervical lordosis, mJOA scores correlated positively with cord volume (r = 0.366, P = 0.022), external cord area (r = 0.399, P = 0.012), and mean cross-sectional cord area (r = 0.345, P = 0.031). In contrast, for patients with cervical kyphosis, mJOA scores correlated negatively with cord volume (r = -0.496, P = 0.043) and mean cross-sectional cord area (r = -0.535, P = 0.027).Conclusion
This study is the first to correlate cervical sagittal balance (C2-C7 SVA) to myelopathy severity. We found a moderate negative correlation in kyphotic patients of cord volume and cross-sectional area to mJOA scores. The opposite (positive correlation) was found for lordotic patients, suggesting a relationship of cord volume to myelopathy that differs on the basis of sagittal alignment. It is interesting to note that sagittal balance but not kyphosis is tied to myelopathy score. Future work will correlate alignment changes to cord morphology changes and myelopathy outcomes. SUMMARY STATEMENTS: This is the first study to correlate sagittal balance (C2-C7 SVA) to myelopathy severity. We found a moderate negative correlation in kyphotic patients of cord volume and cross-sectional area to mJOA scores. The opposite (positive correlation) was found for lordotic patients, suggesting a relationship of cord volume to myelopathy that differs on the basis of sagittal alignment.Item Open Access Asthma, Airflow Obstruction, and Eosinophilic Airway Inflammation Prevalence in Western Kenya: A Population-Based Cross-Sectional Study.(International journal of public health, 2023-01) Navuluri, Neelima; Lagat, David; Egger, Joseph R; Birgen, Elcy; Diero, Lameck; Murdoch, David M; Thielman, Nathan; Kussin, Peter S; Que, Loretta G; Paul, DevonObjectives: Determine the prevalence of airway disease (e.g., asthma, airflow obstruction, and eosinophilic airway inflammation) in Kenya, as well as related correlates of airway disease and health-related quality of life. Methods: A three-stage, cluster-randomized cross-sectional study in Uasin Gishu County, Kenya was conducted. Individuals 12 years and older completed questionnaires (including St. George's Respiratory Questionnaire for COPD, SGRQ-C), spirometry, and fractional exhaled nitric oxide (FeNO) testing. Prevalence ratios with 95% confidence intervals (CIs) were calculated. Multivariable models were used to assess correlates of airflow obstruction and high FeNO. Results: Three hundred ninety-two participants completed questionnaires, 369 completed FeNO testing, and 305 completed spirometry. Mean age was 37.5 years; 64% were women. The prevalence of asthma, airflow obstruction on spirometry, and eosinophilic airway inflammation was 21.7%, 12.3% and 15.7% respectively in the population. Women had significantly higher SGRQ-C scores compared to men (15.0 vs. 7.7). Wheezing or whistling in the last year and SGRQ-C scores were strongly associated with FeNO levels >50 ppb after adjusting for age, gender, BMI, and tobacco use. Conclusion: Airway disease is a significant health problem in Kenya affecting a young population who lack a significant tobacco use history.Item Open Access Baseline Frailty Status Influences Recovery Patterns and Outcomes Following Alignment Correction of Cervical Deformity.(Neurosurgery, 2021-05) Pierce, Katherine E; Passias, Peter G; Daniels, Alan H; Lafage, Renaud; Ahmad, Waleed; Naessig, Sara; Lafage, Virginie; Protopsaltis, Themistocles; Eastlack, Robert; Hart, Robert; Burton, Douglas; Bess, Shay; Schwab, Frank; Shaffrey, Christopher; Smith, Justin S; Ames, ChristopherBackground
Frailty severity may be an important determinant for impaired recovery after cervical spine deformity (CD) corrective surgery.Objective
To evaluate postop clinical recovery among CD patients between frailty states undergoing primary procedures.Methods
Patients >18 yr old undergoing surgery for CD with health-related quality of life (HRQL) data at baseline, 3-mo, and 1-yr postoperative were identified. Patients were stratified by the modified CD frailty index scale from 0 to 1 (no frailty [NF] <0.3, mild/severe fraily [F] >0.3). Patients in NF and F groups were propensity score matched for TS-CL (T1 slope [TS] minus angle between the C2 inferior end plate and the C7 inferior end plate [CL]) to control for baseline deformity. Area under the curve was calculated for follow-up time intervals determining overall normalized, time-adjusted HRQL outcomes; Integrated Health State (IHS) was compared between NF and F groups.Results
A total of 106 CD patients were included (61.7 yr, 66% F, 27.7 kg/m2)-by frailty group: 52.8% NF, 47.2% F. After propensity score matching for TS-CL (mean: 38.1°), 38 patients remained in each of the NF and F groups. IHS-adjusted HRQL outcomes from baseline to 1 yr showed a significant difference in Euro-Qol 5 Dimension scores (NF: 1.02, F: 1.07, P = .016). No significant differences were found in the IHS Neck Disability Index (NDI) and modified Japanese Orthopedic Association between frailty groups (P > .05). F patients had more postop major complications (31.3%) compared to the NF (8.9%), P = .004, though DJK occurrence and reoperation between the groups was not significant.Conclusion
While all groups exhibited improved postop disability and pain scores, frail patients experienced greater amount of improvement in overall health state compared to baseline disability. This signifies that with frailty severity, patients have more room for improvement postop compared to baseline quality of life.Item Open Access Breast cancer oral anti-cancer medication adherence: a systematic review of psychosocial motivators and barriers.(Breast cancer research and treatment, 2017-09) Lin, Cheryl; Clark, Rachel; Tu, Pikuei; Bosworth, Hayden B; Zullig, Leah LPurpose
In the past decade, there has been an increase in the development and use of oral anti-cancer medications (OAMs), especially for breast cancer-the most prevalent cancer in women. However, adherence rates for OAMs are often suboptimal, leading to lower survival rate, increased risk of recurrence, and higher healthcare costs. Our goal was to identify potentially modifiable psychosocial facilitators and barriers that may be targeted to increase OAM adherence for breast cancer patients.Methods
We systematically searched PubMed for studies published in the U.S. by June 15, 2016 that addressed the following: (1) OAMs for breast cancer; (2) medication adherence; and (3) at least one psychosocial aspect of adherence.Results
Of the 1752 papers screened, 21 articles were included and analyzed. The most commonly reported motivators for adherence are patient-provider relationships (n = 11 studied, 82% reported significant association) and positive views and beliefs of medication (n = 9 studied, 89% reported significant association). We also identified consistent evidence of the impact of depression and emotions, perception of illness, concern of side effects, self-efficacy in medication management and decision making, knowledge of medication, and social support on OAM adherence.Conclusions
Compared to traditional demographic, system, and clinical-related factors that have been well documented in the literature but are not easily changed, these cognitive, psychological, and interpersonal factors are more amendable via intervention and therefore could generate greater benefit in improving patient compliance and health outcomes. As OAMs shift treatment administration responsibility onto patients, continuous provider communication and education on illness and regimen are the keys to supporting patients' medication behavior.Item Open Access Can acute clinical outcomes predict health-related quality of life after stroke: a one-year prospective study of stroke survivors.(Health and quality of life outcomes, 2018-11-21) Yeoh, Yen Shing; Koh, Gerald Choon-Huat; Tan, Chuen Seng; Lee, Kim En; Tu, Tian Ming; Singh, Rajinder; Chang, Hui Meng; De Silva, Deidre A; Ng, Yee Sien; Ang, Yan Hoon; Yap, Philip; Chew, Effie; Merchant, Reshma Aziz; Yeo, Tseng Tsai; Chou, Ning; Venketasubramanian, N; Young, Sherry H; Hoenig, Helen; Matchar, David Bruce; Luo, NanBackground
Health-related quality of life (HRQoL) is a key metric to understand the impact of stroke from patients' perspective. Yet HRQoL is not readily measured in clinical practice. This study aims to investigate the extent to which clinical outcomes during admission predict HRQoL at 3 months and 1 year post-stroke.Methods
Stroke patients admitted to five tertiary hospitals in Singapore were assessed with Shah-modified Barthel Index (Shah-mBI), National Institute of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Mini-Mental State Examination (MMSE), and Frontal Assessment Battery (FAB) before discharge, and the EQ-5D questionnaire at 3 months and 12 months post-stroke. Association of clinical measures with the EQ index at both time points was examined using multiple linear regression models. Forward stepwise selection was applied and consistently significant clinical measures were analyzed for their association with individual dimensions of EQ-5D in multiple logistic regressions.Results
All five clinical measures at baseline were significant predictors of the EQ index at 3 months and 12 months, except that MMSE was not significantly associated with the EQ index at 12 months. NIHSS (3-month standardized β = - 0.111; 12-month standardized β = - 0.109) and mRS (3-month standardized β = - 0.122; 12-month standardized β = - 0.080) were shown to have a larger effect size than other measures. The contribution of NIHSS and mRS as significant predictors of HRQoL was mostly explained by their association with the mobility, self-care, and usual activities dimensions of EQ-5D.Conclusions
HRQoL at 3 months and 12 months post-stroke can be predicted by clinical outcomes in the acute phase. NIHSS and mRS are better predictors than BI, MMSE, and FAB.Item Open Access Can unsupervised cluster analysis identify patterns of complex adult spinal deformity with distinct perioperative outcomes?(Journal of neurosurgery. Spine, 2023-05) Lafage, Renaud; Fourman, Mitchell S; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; Kebaish, Khaled M; Burton, Douglas C; Hostin, Richard; Passias, Peter G; Protopsaltis, Themistocles S; Daniels, Alan H; Klineberg, Eric O; Gupta, Munish C; Kelly, Michael P; Lenke, Lawrence G; Schwab, Frank J; Lafage, Virginie; International Spine Study GroupObjective
The objective of this study was to use an unsupervised cluster approach to identify patterns of operative adult spinal deformity (ASD) and compare the perioperative outcomes of these groups.Methods
A multicenter data set included patients with complex surgical ASD, including those with severe deformities, significant surgical complexity, or advanced age who underwent a multilevel fusion. An unsupervised cluster analysis allowing for 10% outliers was used to identify different deformity patterns. The perioperative outcomes of these clusters were then compared using ANOVA, Kruskal-Wallis, and chi-square tests, with p values < 0.05 considered significant.Results
Two hundred eighty-six patients were classified into four clusters of deformity patterns: hyper-thoracic kyphosis (hyper-TK), severe coronal, severe sagittal, and moderate sagittal. Hyper-TK patients had the lowest disability (mean Oswestry Disability Index [ODI] 32.9 ± 17.1) and pain scores (median numeric rating scale [NRS] back score 6, leg score 1). The severe coronal cluster had moderate functional impairment (mean physical component score 34.4 ± 12.3) and pain (median NRS back score 7, leg score 4) scores. The severe sagittal cluster had the highest levels of disability (mean ODI 49.3 ± 15.6) and low appearance scores (mean 2.3 ± 0.7). The moderate cluster (mean 68.8 ± 7.8 years) had the highest pain interference subscores on the Patient-Reported Outcomes Measurement Information System (mean 65.2 ± 5.8). Overall 30-day adverse events were equivalent among the four groups. Fusion to the pelvis was most common in the moderate sagittal (89.4%) and severe sagittal (97.5%) clusters. The severe coronal cluster had more osteotomies per case (median 11, IQR 6.5-14) and a higher rate of 30-day implant-related complications (5.5%). The severe sagittal and hyper-TK clusters had more three-column osteotomies (43% and 32.3%, respectively). Hyper-TK patients had shorter hospital stays.Conclusions
This cohort of patients with complex ASD surgeries contained four natural clusters of deformity, each with distinct perioperative outcomes.Item Open Access Cervical radiographical alignment: comprehensive assessment techniques and potential importance in cervical myelopathy.(Spine, 2013-10) Ames, Christopher P; Blondel, Benjamin; Scheer, Justin K; Schwab, Frank J; Le Huec, Jean-Charles; Massicotte, Eric M; Patel, Alpesh A; Traynelis, Vincent C; Kim, Han Jo; Shaffrey, Christopher I; Smith, Justin S; Lafage, VirginieStudy design
Narrative review.Objective
To provide a comprehensive narrative review of cervical alignment parameters, the methods for quantifying cervical alignment, normal cervical alignment values, and how alignment is associated with cervical deformity and myelopathy with discussions of health-related quality of life.Summary of background data
Indications for surgery to correct cervical alignment are not well-defined and there is no set standard to address the amount of correction to be achieved. In addition, classifications of cervical deformity have yet to be fully established and treatment options defined and clarified.Methods
A survey of the cervical spine literature was conducted.Results
New normative cervical alignment values from an asymptomatic volunteer population are introduced, updated methods for quantifying cervical alignment are discussed, and describing the relationship between cervical alignment, disability, and myelopathy are outlined. Specifically, methods used to quantify cervical alignment include cervical lordosis, cervical sagittal vertical axis, and horizontal gaze with the chin-brow vertical angle. Updated methods include T1 slope. Evidence from a few recent studies suggests correlations between radiographical parameters in the cervical spine and health-related quality of life. Analysis of the cervical regional alignment with respect to overall spinal pelvic alignment is emerging and critical. Cervical myelopathy and sagittal alignment of the cervical spine are closely related as cervical deformity can lead to spinal cord compression and tension.Conclusion
Cervical deformity correction should take on a comprehensive approach in assessing global cervical-pelvic relationships and the radiographical parameters that effect health-related quality of life scores are not well-defined. Cervical alignment may be important in assessment and treatment of cervical myelopathy. Future work should concentrate on correlation of cervical alignment parameters to disability scores and myelopathy outcomes. SUMMARY STATEMENTS: STATEMENT 1: Cervical sagittal alignment (cervical SVA and kyphosis) is related to thoracolumbar spinal pelvic alignment and to T1 slope. STATEMENT 2: When significant deformity is clinically or radiographically suspected, regional cervical and relative global spinal alignment should be evaluated preoperatively via standing 3-foot scoliosis X-rays for appropriate operative planning. STATEMENT 3: Cervical sagittal alignment (C2-C7 SVA) is correlated to regional disability, general health scores and to myelopathy severity. STATEMENT 4: When performing decompressive surgery for CSM, consideration should be given to correction of cervical kyphosis and cervical sagittal imbalance (C2-C7 SVA) when present.Item Open Access Cervical spondylotic myelopathy with severe axial neck pain: is anterior or posterior approach better?(Journal of neurosurgery. Spine, 2023-01) Chan, Andrew K; Shaffrey, Christopher I; Gottfried, Oren N; Park, Christine; Than, Khoi D; Bisson, Erica F; Bydon, Mohamad; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Michalopoulos, Giorgos D; Sherrod, Brandon A; Agarwal, Nitin; Chou, Dean; Haid, Regis W; Mummaneni, Praveen VObjective
The aim of this study was to determine whether multilevel anterior cervical discectomy and fusion (ACDF) or posterior cervical laminectomy and fusion (PCLF) is superior for patients with cervical spondylotic myelopathy (CSM) and high preoperative neck pain.Methods
This was a retrospective study of prospectively collected data using the Quality Outcomes Database (QOD) CSM module. Patients who received a subaxial fusion of 3 or 4 segments and had a visual analog scale (VAS) neck pain score of 7 or greater at baseline were included. The 3-, 12-, and 24-month outcomes were compared for patients undergoing ACDF with those undergoing PCLF.Results
Overall, 1141 patients with CSM were included in the database. Of these, 495 (43.4%) presented with severe neck pain (VAS score > 6). After applying inclusion and exclusion criteria, we compared 65 patients (54.6%) undergoing 3- and 4-level ACDF and 54 patients (45.4%) undergoing 3- and 4-level PCLF. Patients undergoing ACDF had worse Neck Disability Index scores at baseline (52.5 ± 15.9 vs 45.9 ± 16.8, p = 0.03) but similar neck pain (p > 0.05). Otherwise, the groups were well matched for the remaining baseline patient-reported outcomes. The rates of 24-month follow-up for ACDF and PCLF were similar (86.2% and 83.3%, respectively). At the 24-month follow-up, both groups demonstrated mean improvements in all outcomes, including neck pain (p < 0.05). In multivariable analyses, there was no significant difference in the degree of neck pain change, rate of neck pain improvement, rate of pain-free achievement, and rate of reaching minimal clinically important difference (MCID) in neck pain between the two groups (adjusted p > 0.05). However, ACDF was associated with a higher 24-month modified Japanese Orthopaedic Association scale (mJOA) score (β = 1.5 [95% CI 0.5-2.6], adjusted p = 0.01), higher EQ-5D score (β = 0.1 [95% CI 0.01-0.2], adjusted p = 0.04), and higher likelihood for return to baseline activities (OR 1.2 [95% CI 1.1-1.4], adjusted p = 0.002).Conclusions
Severe neck pain is prevalent among patients undergoing surgery for CSM, affecting more than 40% of patients. Both ACDF and PCLF achieved comparable postoperative neck pain improvement 3, 12, and 24 months following 3- or 4-segment surgery for patients with CSM and severe neck pain. However, multilevel ACDF was associated with superior functional status, quality of life, and return to baseline activities at 24 months in multivariable adjusted analyses.