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1.
Spine J ; 19(7): 1154-1161, 2019 07.
Article in English | MEDLINE | ID: mdl-30849533

ABSTRACT

BACKGROUND: The internal validity of long-term studies is significantly affected by the high loss to follow-up in the spine surgery population (>20%). Phone and email-based administration of patient-reported outcomes instruments is a less cumbersome approach for increasing response rates and assessment frequency while potentially decreasing follow-up burden on patients and physicians. PURPOSE: This study sought to validate simultaneous administration of the Neck Disability Index (NDI) and Japanese Orthopedic Association (JOA) questionnaires in patients with either cervical myelopathy and/or radiculopathy. STUDY DESIGN/SETTING: This is a single-center, randomized crossover phone and email validation of legacy outcome measures for cervical myelopathy and/or radiculopathy patients. PATIENT SAMPLE: The study included nonsurgical along with pre- and postsurgical cervical myelopathy and/or radiculopathy patients presenting to a tertiary spine care center. OUTCOME MEASURES: NDI and JOA. METHODS: Two-hundred and six patients (mean age: 58.5 years) were randomized in a 1:4 ratio to either email completion of the NDI and JOA before or after in-office completion, or to phone completion before or after in-office completion. An interval of 1 to 4 weeks was established between the administration of questionnaires. The difference between written in-office and corresponding email and phone versions was assessed with a paired t test. Homogeneity was assessed using intraclass correlation coefficients. Test-retest reliabilities were independently examined for postoperative patients (n=145). Recall bias was assessed in postoperative patients by calculating intraclass correlation coefficients for those with days between assessments lesser than the mean and for those greater. Differences in response rates between phone and email versions were assessed with McNemar's and Cochran-Mantel-Haenszel tests. RESULTS: There was no significant difference between email and in-office versions (n=85) of the NDI (p=.17, Mean Paired Difference=1.34) and JOA (p=.64, Mean Paired Difference=0.11). No significant difference was seen between phone followed by in-office administration (n=32) of the NDI (p=.88, Mean Paired Difference=0.22) and JOA (p=.38, Mean Paired Difference=-0.22), nor between in-office administration followed by phone (n=44) for the NDI (p=.10, Mean Paired Difference=2.79) and JOA (p=.37, Mean Paired Difference=0.27). Intraclass coefficients (ICCs) of the email versions of the NDI and JOA were 0.88 and 0.78, respectively; of the phone-before-office versions of the NDI and JOA were 0.91 and 0.82; of the office-before-phone versions were 0.86 and 0.78. Similarly, strong intraclass correlation coefficients indicative of a lack of recall bias were found for "In-Office" and external assessments completed by postsurgical patients with days between assessments lesser and greater than the mean (ICC range 0.63-0.92). No significant difference was seen in completion rates between email and in-office questionnaire completion (p=.13) and phone-before-office and in-office questionnaire completion (p=.31). However, a significant difference was found in completion rates for phone-after-office questionnaires (p<.001). CONCLUSIONS: Administration of the NDI and JOA over phone and email in patients with cervical myelopathy or radiculopathy is valid with strong test-retest reliability and internal consistency. Phone and email administration of the NDI and JOA can reduce nonresponse rates and decrease the burden of follow-up and data acquisition. Follow-up phone reminders increase the response rate for administration of these patient-reported outcomes (PROs) via email.


Subject(s)
Disability Evaluation , Radiculopathy/diagnosis , Spinal Cord Diseases/diagnosis , Surveys and Questionnaires/standards , Adult , Cervical Vertebrae/pathology , Female , Humans , Internet , Male , Middle Aged , Orthopedics/organization & administration , Random Allocation , Societies, Medical , Telephone
2.
Spine J ; 18(3): 439-446, 2018 03.
Article in English | MEDLINE | ID: mdl-28822825

ABSTRACT

BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein 2 (rhBMP-2) plays a pivotal role in complex spine surgery. Despite its limited approval, the off-label use of rhBMP-2 is prevalent, particularly in transforaminal lumbar interbody fusions (TLIFs). PURPOSE: To determine the effectiveness and safety of rhBMP-2 use in TLIF procedures versus autograft. STUDY DESIGN: Retrospective cohort study. PATIENT SAMPLE: Patients older than 18 years undergoing spine surgery for lumbar degenerative spine disease at a single academic institution. OUTCOME MEASURES: Clinical outcome was determined according to patient records. Radiographic outcome was determined according to plain X-rays and computed tomography (CT). METHODS: A retrospective study from 1997 to 2014 was conducted on 191 adults undergoing anterior-posterior instrumented spinal fusion with TLIF at a single academic institution. Patient data were gathered from operative notes, follow-up clinic notes, and imaging studies to determine complications and fusion rates. One hundred eighty-seven patients fit the criteria, which included patients with a minimum of one TLIF, and had a minimum 2-year radiographic and clinical follow-up. Patients were further classified into a BMP group (n=83) or non-BMP group (n=104). Three logistic regression models were run using rhBMP-2 exposure as the independent variable. The respective outcome variables were TLIF-related complications (radiculitis, seroma, osteolysis, and ectopic bone), surgical complications, and all complications. RESULTS: Bone morphogenetic protein (n=83) and non-BMP (n=104) groups had similar baseline demographics (sex, diabetes, pre-existing cancer). On average, the BMP and non-BMP groups were similarly aged (51.9 vs. 47.9 years, p>.05), but the BMP group had a shorter follow-up time (3.03 vs. 4.06 years; p<.001) and fewer smokers (8 vs. 21 patients; p<.048). The fusion rate for the BMP and non-BMP groups was 92.7% and 92.3%, respectively. The pseudoarthrosis rate was 7.5% (14 of 187 patients). Radiculitis was observed in seven patients in the BMP group (8.4%) and two patients in the non-BMP group (1.9%). Seroma was observed in two patients in the BMP group (2.4%) and none in the non-BMP group. No deep infections were observed in the BMP group, and in one patient in the non-BMP group (0.96%). Although patients exposed to BMP were at a significantlygreater risk of developing radiculitis and seroma (odds ratio [OR]=4.53, confidence interval [CI]=1.42-14.5), BMP exposure was not a significant predictor of surgical complications (OR=0.32, CI=0.10-1.00) or overall complications (OR=1.11, CI=0.53-2.34). The outcome of TLIF-related complications was too rare and the confidence interval too wide for practical significance of the first model. CONCLUSION: Evidence supports the hypothesis that off-label use of rhBMP-2 in TLIF procedures is relatively effective for achieving bone fusion at rates similar to patients receiving autograft. Patients exhibited similar complication rates between the two groups, with the BMP group exhibiting slightly higher rates of radiculitis and seroma.


Subject(s)
Bone Morphogenetic Protein 2/therapeutic use , Lumbosacral Region/surgery , Postoperative Complications/epidemiology , Spinal Fusion/methods , Transforming Growth Factor beta/therapeutic use , Adult , Aged , Bone Morphogenetic Protein 2/administration & dosage , Bone Morphogenetic Protein 2/adverse effects , Female , Humans , Male , Middle Aged , Postoperative Complications/diagnostic imaging , Radiography , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Spinal Fusion/adverse effects , Transforming Growth Factor beta/administration & dosage , Transforming Growth Factor beta/adverse effects , Transplantation, Autologous/adverse effects , Transplantation, Autologous/methods
3.
Global Spine J ; 7(1 Suppl): 28S-36S, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28451488

ABSTRACT

STUDY DESIGN: Multicenter retrospective case series and review of the literature. OBJECTIVE: To determine the rate of esophageal perforations following anterior cervical spine surgery. METHODS: As part of an AOSpine series on rare complications, a retrospective cohort study was conducted among 21 high-volume surgical centers to identify esophageal perforations following anterior cervical spine surgery. Staff at each center abstracted data from patients' charts and created case report forms for each event identified. Case report forms were then sent to the AOSpine North America Clinical Research Network Methodological Core for data processing and analysis. RESULTS: The records of 9591 patients who underwent anterior cervical spine surgery were reviewed. Two (0.02%) were found to have esophageal perforations following anterior cervical spine surgery. Both cases were detected and treated in the acute postoperative period. One patient was successfully treated with primary repair and debridement. One patient underwent multiple debridement attempts and expired. CONCLUSIONS: Esophageal perforation following anterior cervical spine surgery is a relatively rare occurrence. Prompt recognition and treatment of these injuries is critical to minimizing morbidity and mortality.

4.
Am J Ophthalmol ; 154(3): 452-459.e2, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22789564

ABSTRACT

PURPOSE: To characterize the costs of caring for patients with open-angle glaucoma (OAG) in the United States over time and to identify factors that influence these costs. DESIGN: Longitudinal cohort study. METHODS: Claims data from 19 927 newly diagnosed OAG patients enrolled in a large United States managed care network were reviewed to identify glaucoma-related charges for all incident OAG patients from 2001 through 2009. Average glaucoma-related charges for enrollees with OAG were characterized in 6-month blocks from the date of initial OAG diagnosis through the ensuing 5 years. Factors associated with being an enrollee in the costliest 5% for glaucoma-related charges (accruing $5810 or more in charges in the first 2 years) were identified using logistic regression. RESULTS: The costliest 5% of enrollees were responsible for $10 202 871 (24%) of all glaucoma-related charges. By comparison, those whose costs fell within the lower 50% of the cost distribution collectively amassed only $7 986 582 (19%) of all glaucoma-related charges. A spike in glaucoma-related charges occurred in the 6-month period around the time of OAG diagnosis, stabilized by 1 year after diagnosis, and remained relatively constant over time. Risk factors associated with being in the costliest 5% for glaucoma-related care included younger age, Northeastern United States state residence, undergoing cataract surgery, and possessing ocular comorbidities (P < .006 for all comparisons). CONCLUSIONS: A small subset of enrollees account for a large proportion of all glaucoma-related charges. Understanding the characteristics of these individuals and finding ways to reduce disease burden and costs associated with their care can result in substantial cost savings.


Subject(s)
Glaucoma, Open-Angle/economics , Health Care Costs/trends , Health Resources/statistics & numerical data , Adult , Aged , Aged, 80 and over , Comorbidity , Databases, Factual , Delivery of Health Care/economics , Fees and Charges , Female , Glaucoma, Open-Angle/diagnosis , Health Services Research , Humans , Longitudinal Studies , Male , Middle Aged , Risk Factors , United States
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