RESUMO
The threshold for statistical significance is determined by the maximum allowable probability of Type I error (α). For studies that test multiple hypotheses or make multiple comparisons, the probability of at least 1 Type I error (family-wise error rate; FWER) increases as the number of hypotheses/comparisons increase. It is generally best practice to set the acceptable threshold for FWER to be less than or equal to α. Bonferroni correction and Tukey honestly significant difference test are 2 of the more common methods to control for FWER. When doing exploratory analysis or evaluating secondary outcomes of a study, it may not be necessary or desirable to control for FWER, which reduces the power of the study. However, deciding to control for FWER should be decided during the design of the study.
Assuntos
Probabilidade , HumanosRESUMO
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The aim was to investigate the clinical relevance of preoperative caudal adjacent segment degeneration (ASD) in patients undergoing isolated L4-5 fusion to determine a threshold of degeneration at which a primary L4-S1 fusion would be warranted. SUMMARY OF BACKGROUND DATA: Increased motion and biomechanical forces across the adjacent caudal segment in isolated L4-L5 fusion leads to concerns regarding the increased incidence of revision surgery because of the development of ASD. METHODS: Patients who underwent isolated L4-L5 fusion between 2014 and 2019 were reviewed. Pfirrmann grading and the disc heights of the caudal level relative to the rostral level were used to quantify preoperative adjacent degenerative disc disease. To assess the influence of preoperative caudal degenerative disc disease, preoperative disc height ratios (DHRs) were compared for patients who reported minimal, moderate, and severe Oswestry disability index (ODI) sores on postoperative assessment. For each patient-reported outcome measure (PROM), adjacent DDD was compared for those who did and did not meet MCID. An area under curve analysis was used to identify a threshold of degeneration impacting outcomes from the preoperative DHR. RESULTS: A total of 123 patients were studied with an average follow-up of 2.11 years. All patients demonstrated a significant improvement in all PROMs after surgery. When categorizing patients based on the severity of postoperative ODI scores, there were no preoperative differences in the L5-S1 Pfirrmann grading or DHRs. There was a significant association between greater preoperative anterior DHR and an increased number patients who met MCID for visual analog scale back. There were no radiographic differences in preoperative L5-S1 Pfirrmann grade or DHR for ODI, visual analog scale leg, MCS-12, or PCS-12. area under curve analysis was not able to identify a preoperative DHR threshold that reflected worse MCID for any PROM. CONCLUSION: No preoperative radiographic indicators of caudal ASD were predictive of worse clinical outcomes after isolated L4-5 fusion. LEVEL OF EVIDENCE: Level III.
Assuntos
Degeneração do Disco Intervertebral , Fusão Vertebral , Humanos , Degeneração do Disco Intervertebral/complicações , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Estudos Retrospectivos , Fusão Vertebral/efeitos adversos , Resultado do TratamentoRESUMO
STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to determine the effect of a statewide, government-mandated prescription drug monitoring program (PDMP) on patient-initiated phone calls after lumbar and cervical spinal surgery. SUMMARY OF BACKGROUND DATA: Prior studies have examined the most common reasons for a postoperative phone calls, most of which pertain to pain or prescription medications. However, no studies have investigated the effects of mandatory opioid prescription reporting on these calls. METHODS: Patients who underwent lumbar decompression, lumbar fusion, or posterior cervical fusion were retrospectively identified. Patients were sorted into 1 of 2 cohorts based on their procedure date's relation to the initiation of the state's PDMP: "pre-PDMP" and "post-PDMP." All clinical and demographic data were obtained from electronic health records. Telephone communications from or on behalf of patients were retrospectively reviewed. Multivariable logistic regression was performed to determine independent factors associated with a postoperative phone call. RESULTS: Five hundred and twenty-five patients (2689 phone calls) were included in the study. Average number of phone calls per patient increased significantly after PDMP implementation among lumbar (3.27 vs. 5.18, P<0.001), cervical (5.08 vs. 11.67, P<0.001), and all (3.59 vs. 6.30, P<0.001) procedures. Age [odds ratio (OR): 1.05 (1.01, 1.09), P=0.02], cervical procedure [OR: 4.65 (1.93, 11.21), P=0.001], and a post-PDMP date of surgery [OR: 6.35 (3.55, 11.35), P<0.001] were independently associated with an increased likelihood of a postoperative phone call. A higher percentage of calls were in reference to postoperative care (4.6% vs. 2.4%, P=0.01) and wound care (4.3% vs. 1.4%, P<0.001) in the post-PDMP cohort compared with the pre-PDMP cohort. CONCLUSIONS: Patient-initiated telephone calls increased significantly after implementation of a mandatory statewide PDMP. Increasing age, operation involving the cervical spine, and surgery occurring after implementation of the state's PDMP were independently associated with an increased likelihood of postoperative phone call to health care providers.
Assuntos
Programas de Monitoramento de Prescrição de Medicamentos , Analgésicos Opioides/uso terapêutico , Humanos , Cuidados Pós-Operatórios , Período Pós-Operatório , Estudos RetrospectivosRESUMO
OBJECTIVE: Spinal decompression with or without fusion is one of the most commonly performed procedures in spine surgery. However, there is limited evidence on the effect of discharge environment on outcomes after surgery. The purpose of this study is to identify the effects of discharge disposition setting on clinical outcomes after spine surgery. METHODS: Patients who underwent lumbar decompression, lumbar decompression and fusion, or posterior cervical decompression and fusion surgery were retrospectively identified. All clinical and demographic data were obtained from electronic health records. Surgical outcomes included wound complications, revision surgery, "30-day" readmission (0-30 d), and "90-day" readmission (31-90 d). Discharge disposition was stratified into home/self-care, acute inpatient rehabilitation, and subacute rehabilitation. Patient-reported outcome measures including VAS Back, VAS Leg, VAS Neck, VAS Arm, PCS-12 and MCS-12, ODI, and NDI were compared between patient discharge disposition settings using the Mann-Whitney U test. Pearson's chi-square analysis was used to assess for differences in wound complications, revision surgery, 30-day readmission, or 90-day readmission rates. Multivariate logistic regression incorporating age, sex, body mass index (BMI), Charlson Comorbidity Index (CCI), and discharge disposition was used to determine independent predictors of wound complications. RESULTS: A total of 637 patients were included in the study. A significant difference (P = 0.03) was found in wound complication based on discharge disposition, with subacute disposition having the highest proportion of wound complications (6.1%) and home disposition having the lowest (1.5%). There were no significant differences in the rates of revision surgery, 30-day readmission, or 90-day readmission between groups. Subacute rehabilitation (odds ratio: 3.67, P = 0.047) and CCI (odds ratio 1.49, P = 0.01) were independent predictors of wound complications. Significant improvement in PROMs was seen across all postacute discharge dispositions. Baseline (P = 0.02) and postoperative (P = 0.02) ODI were significantly higher among patients discharged to an acute facility (49.4 and 32.0, respectively) compared to home (42.2 and 20.0) or subacute (47.4 and 28.4) environments. CONCLUSION: Subacute rehabilitation disposition and CCI are independent predictors of wound complications after spinal decompression surgery. Patients undergoing spine surgery have similar readmission and revision rates and experience similar clinical improvement across all postacute discharge dispositions.
Assuntos
Alta do Paciente , Readmissão do Paciente , Índice de Massa Corporal , Descompressão Cirúrgica/efeitos adversos , Humanos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos RetrospectivosRESUMO
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The aim of this study was to investigate the differences in Medicare reimbursement for one- to three-level lumbar decompression procedures performed at a tertiary referral center versus an orthopedic specialty hospital (OSH). SUMMARY OF BACKGROUND DATA: Lumbar decompression surgery is one of the most commonly performed spinal procedures. Lumbar decompression also comprises the largest proportion of spinal surgery that has transitioned to the outpatient setting. METHODS: Patients who underwent a primary one- to three- level lumbar decompression were retrospectively identified. Reimbursement data for a tertiary referral center and an OSH were compiled through Centers for Medicare and Medicaid Services. Demographic data, surgical characteristics, and time cost data were collected through chart review. Multivariate regression models were used to determine independent factors associated with total episode of care cost, operating room (OR) time, procedure time, and length of stay (LOS), and to determine independent predictors of having the decompression performed at the OSH. RESULTS: Total episode of care, facility, and non-facility payments were significantly greater at the tertiary referral center than the OSH, as were OR time for one- to three-level procedures, procedure time of all pooled levels, and LOS for one- and two-level procedures. Three-level procedure was independently associated with increased OR time, procedure time, and LOS. Age and two-level procedure were also associated with increased LOS. Procedure at the OSH was associated with decreased OR time and LOS. Charlson Comorbidity Index was a negative predictor of decompression being performed in the OSH setting. CONCLUSION: Significant financial savings to health systems can be expected when performing lumbar decompression surgery at a specialty hospital as opposed to a tertiary referral center. Patients who are appropriate candidates for surgery in an OSH can in turn expect faster perioperative times and shorter LOS.Level of Evidence: 3.
Assuntos
Descompressão Cirúrgica , Medicare , Idoso , Humanos , Tempo de Internação , Vértebras Lombares/cirurgia , Estudos Retrospectivos , Centros de Atenção Terciária , Estados UnidosRESUMO
INTRODUCTION: Posterior cervical decompression and fusion (PCDF) is a procedure commonly performed to help alleviate symptoms and improve quality of life in patients experiencing cervical spondylotic myelopathy, multilevel stenosis, and cervical deformity. Although various risk factors have been linked to adverse outcomes in patients after PCDF, this is the first study that specifically explores postoperative glycemic variability and its association with adverse outcomes. METHODS: A retrospective cohort study was conducted with a total of 264 patients after PCDF procedures that had available postoperative blood glucose measurements. Patients were divided into tertiles based on their coefficient of variation as an indicator of glycemic variability. Outcomes measured included inpatient complications, length of stay (LOS), 90-day readmission, revision, and surgical site infection rates. RESULTS: Results showed a significant difference in glycemic variability among tertiles with respect to LOS (P = 0.01). The average LOS for the first, second, and third tertiles was 3.90 (3.20, 4.59), 5.73 (4.45, 7.00), and 6.06 (4.89, 7.22), respectively. Logistic regression analysis showed significantly higher odds of readmission (odds ratio: 4.77; P = 0.03) and surgical site infections (odds ratio: 4.35; P = 0.04) in the high glycemic variability group compared with the low glycemic variability group within 90 days of surgery. No significant difference was noted among tertiles with respect to inpatient complications. DISCUSSION: This study establishes a relationship between postoperative glycemic variability and LOS, as well as 90-day readmission and surgical site infection rates after PCDF. Our results suggest that limiting fluctuations in blood glucose levels may curtail inpatient healthcare costs related to in-hospital stay. Although immediate postoperative glycemic variability is ultimately acceptable, before discharge, proper glucose management plans should be in place to help prevent adverse patient outcomes.
Assuntos
Glicemia , Fusão Vertebral , Vértebras Cervicais/cirurgia , Humanos , Tempo de Internação , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Qualidade de Vida , Estudos Retrospectivos , Fusão Vertebral/efeitos adversosRESUMO
STUDY DESIGN: A retrospective cohort study. OBJECTIVE: The goal of this study was to determine the effect of smoking on patient-reported outcome measurements (PROMs) after lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: Although smoking is known to decrease fusion rates after lumbar fusion, there is less evidence regarding the influence of smoking on PROMs after surgery. METHODS: Patients undergoing between 1 and 3 levels of lumbar fusion were divided into 3 groups on the basis of preoperative smoking status: never smokers (NS); current smokers (CS); and former smokers (FS). PROMs collected for analysis include the Physical Component Score (PCS-12), Mental Component Score (MCS-12), Oswestry Disability Index (ODI), and Visual Analogue Scale back (VAS back) and leg (VAS leg) pain scores. Preoperative and postoperative PROMs were compared between groups. A multiple linear regression analysis was performed to determine whether preoperative smoking status was a predictor of change in PROM scores. RESULTS: A total of 220 (60.1%) NS, 52 (14.2%) CS, and 94 (25.7%) FS patients were included. Patients in most groups improved within each of the PROMs analyzed (P<0.05). VAS leg pain (P=0.001) was found to significantly differ between groups, with NS and FS having less disability than CS (3.6 vs. 2.0, P=0.010; and 3.6 vs. 2.4, P=0.022; respectively). Being a CS significantly predicted less improvement in ODI (P=0.035), VAS back (P=0.034), and VAS leg (P<0.001) compared with NS. In addition, NS had a significantly lower 30-day readmission rate than CS or FS (3.2% vs. 5.8% and 10.6%, respectively, P=0.029). CONCLUSION: CS exhibited worse postoperative VAS leg pain and a lower recovery ratio than never smokers. In addition, being in the CS group was a significant predictor of decreased improvement in ODI, VAS back, and VAS leg scores. LEVEL OF EVIDENCE: Level III.
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Fumar , Fusão Vertebral , Humanos , Vértebras Lombares/cirurgia , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos , Fumar/efeitos adversos , Fusão Vertebral/efeitos adversos , Resultado do TratamentoRESUMO
STUDY DESIGN: Retrospective study. OBJECTIVE: The aim of this study was to determine risk factors for prolonged opioid use and to investigate whether opioid-tolerance affects patient-reported outcomes following anterior cervical discectomy and fusion (ACDF) surgery. SUMMARY OF BACKGROUND DATA: There is a lack of consensus on risk factors that can affect continued opioid use after cervical spine surgery and the influence of opioid use on patient-reported outcomes. METHODS: Ninety-two patients who underwent ACDF for degenerative cervical pathologies were retrospectively identified and their opioid usage before surgery was investigated using a state-sponsored prescription drug monitoring registry. Opioid-naïve and opioid tolerant groups were defined using criteria most consistent with the Federal Drug Administration (FDA) definition. Patient-reported outcomes were then collected, including the Short Form-12 (SF-12) Physical Component (PCS-12) and Mental Component (MCS-12), the Neck Disability Index (NDI), the Visual Analogue Scale Neck (VAS neck) and the Visual Analogue Scale Arm (VAS Arm) pain scores. Logistic regression was used to determine predictors for prolonged opioid use following ACDF. Univariate and multivariate analyses were conducted to compare change in outcomes over time between the two groups. RESULTS: Logistic regression analysis demonstrated that opioid tolerance was a significant predictor for prolonged opioid use after ACDF (odds ratio [OR]: 18.2 [1.46, 226.4], Pâ=â0.02). Duration of usage was also found to be a significant predictor for continued opioid use after surgery (OR: 1.10 [1.0, 1.03], Pâ=â0.03). No other risk factors were found to be significant predictors. Both groups overall experienced improvements in patient-reported outcomes after surgery. Multiple linear regression analysis, controlling for patient demographics, demonstrated that opioid-tolerant user status positively affected change in outcomes over time for NDI (ßâ=â-13.7 [-21.8,-5.55], Pâ=â0.002) and PCS-12 (ßâ=â6.99 [2.59, 11.4], Pâ=â0.003) but no other outcomes measured. CONCLUSION: Opioid tolerance was found to be a significant predictor for prolonged opioid use after ACDF. Additionally, opioid-naïve and opioid-tolerant users experienced overall improvements across PROMs following ACDF. Opioid-tolerance was associated with NDI and PCS-12 improvements over time compared to opioid-naïve users. LEVEL OF EVIDENCE: 4.
Assuntos
Analgésicos Opioides , Tolerância a Medicamentos/fisiologia , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/uso terapêutico , Humanos , Dor Pós-Operatória/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos , Fatores de Risco , Fusão Vertebral/efeitos adversosRESUMO
STUDY DESIGN: This is a retrospective comparative review. OBJECTIVE: The objective of this study was to identify the influence of body mass index (BMI) on postsurgical complications and patient reported outcomes measures (PROMs) following lumbar decompression surgery. SUMMARY OF BACKGROUND DATA: Current literature does not accurately identify the impact of BMI on postsurgical complications or outcomes. MATERIALS AND METHODS: Records from a single-center, academic hospital were used to identify patients undergoing 1 to 3-level lumbar decompression surgery. Patients under 18 years of age, those undergoing surgery for infection, trauma, tumor, or revision, and those with <1-year follow-up were excluded. Patients were split into groups based on preoperative BMI: class I: BMI <25.0 kg/m; class II: BMI 25.0-29.9 kg/m; class III: BMI 30.0-34.9 kg/m; and class IV: BMI >35.0 kg/m. Absolute PROM scores, the recovery ratio and the percent of patients achieving minimum clinically important difference between groups were compared and a multiple linear regression analysis was performed. RESULTS: A total of 195 patients were included with 34 (17.4%) patients in group I, 80 (41.0%) in group II, 49 (25.1%) in group III, and 32 (16.5%) in group IV. Average age was 60.0 (58.0, 62.0) years and average follow-up was 13.0 (12.6, 13.4) months. All patients improved significantly within each group, except for class III and class IV patients, who did not demonstrate significant improvements in terms of Mental Component Score (MCS-12) scores (P=0.546 and 0.702, respectively). There were no significant differences between BMI groups for baseline or postoperative PROM values, recovery ratio, or the percent of patients reaching minimum clinically important difference. Multiple linear regression analysis revealed that BMI was not a significant predictor for change in outcomes for any measure. The 30-day readmission rate was 6.2% and overall revision rate at final follow-up was 5.1%, with no significant differences between groups. CONCLUSION: This study's results suggest that BMI may not significantly affect complications or patient outcomes at 1-year in those undergoing lumbar decompression surgery. LEVEL OF EVIDENCE: Level III.
Assuntos
Região Lombossacral , Medidas de Resultados Relatados pelo Paciente , Adolescente , Índice de Massa Corporal , Descompressão , Humanos , Região Lombossacral/cirurgia , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
STUDY DESIGN: Retrospective cohort review. OBJECTIVE: The objective of this study was to identify depression using the Mental Component Score (MCS-12) of the Short Form-12 (SF-12) survey and to correlate with patient outcomes. SUMMARY OF BACKGROUND DATA: The impact of preexisting depressive symptoms on health-care related quality of life (HRQOL) outcomes following lumbar spine fusion is not well understood. METHODS: Patients undergoing lumbar fusion between one to three levels at a single center, academic hospital were retrospectively identified. Patients under the age of 18 years and those undergoing surgery for infection, trauma, tumor, or revision, and less than 1-year follow-up were excluded. Patients with depressive symptoms were identified using an existing clinical diagnosis or a score of MCS-12 less than or equal to 45.6 on the preoperative SF-12 survey. Absolute HRQOL scores, the recovery ratio (RR) and the percent of patients achieving minimum clinically important difference (MCID) between groups were compared, and a multiple linear regression analysis was performed. RESULTS: A total of 391 patients were included in the total cohort, with 123 (31.5%) patients reporting symptoms of depression based on MCS-12 and 268 (68.5%) without these symptoms. The low MCS-12 group was found to have significantly worse preoperative Oswestry disability index (ODI), visual analogue scale back pain (VAS Back) and visual analogue scale leg pain (VAS Leg) scores, and postoperative SF-12 physical component score (PCS-12), ODI, VAS Back, and VAS Leg pain scores (Pâ<â0.05) than the non-depressed group. Finally, multiple linear regression analysis revealed preoperative depression to be a significant predictor of worse outcomes after lumbar fusion. CONCLUSION: Patients with depressive symptoms, identified with an MCS-12 cutoff below 45.6, were found to have significantly greater disability in a variety of HRQOL domains at baseline and postoperative measurement, and demonstrated less improvement in all outcome domains included in the analysis compared with patients without depression. However, while the improvement was less, even the low MCS-12 cohort demonstrated statistically significant improvement in all HRQOL outcome measures after surgery. LEVEL OF EVIDENCE: 3.