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1.
Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.  相似文献   

2.
BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.  相似文献   

3.

BACKGROUND CONTEXT

Health-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant.

PURPOSE

To calculate MCID and minimum detectable change (MDC) values of total scores of the Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI), Physical Component Summary (PCS), Mental Component Summary (MCS) of the Short Form 36 (SF-36), and Scoliosis Research Society 22R (SRS-22R) in surgically and nonsurgically treated ASD patients who have completed an anchor question at pretreatment and 1-year follow-up.

STUDY DESIGN/SETTING

Prospective cohort.

PATIENT SAMPLE

Surgical and nonsurgical patients from a multicenter ASD database.

OUTCOME MEASURES

Self-reported HRQOL measures (COMI, ODI, SF-36, SRS-22R, and anchor question).

METHODS

A total of 185 surgical and 86 nonsurgical patients from a multicenter ASD database who completed pretreatment and 1-year follow-up HRQOL scales and the anchor question at the first year follow-up were included. The anchor question was used to determine MCID for each HRQOL measure. MCIDs were calculated by an anchor-based method using latent class analysis (LCA) and MDCs by a distribution-based method.

RESULTS

All differences between means of baseline and first year postoperative total score measures for all scales demonstrated statistically significant improvements in the overall population as well as the surgically treated patients but not in the nonsurgical group. The calculated MDC and MCID values of HRQOL parameters in the entire study population were 1.34 and 2.62 for COMI, 10.65 and 14.31 for ODI, 6.09 and 7.33 for SF-36 PCS, 6.14 and 4.37 for SF-36 MCS, and 0.42 and 0.71 for SRS-22R. The calculated MCID values for surgical and non-surgical treatment groups were 2.76 versus 1.20 for COMI, 14.96 versus 2.45 for ODI, 7.83 versus 2.15 for SF-36 PCS, 5.14 versus 2.03 for SF-36 MCS, and 0.94 versus 0.11 for SRS-22R; the MDC values for surgical and nonsurgical treatment groups were 1.22 versus 1.51 for COMI, 10.27 versus 9.45 for ODI, 5.16 versus 6.77 for SF-36 PCS, 6.05 versus 5.67 for SF-36 MCS, and 0.38 versus 0.43 for SRS-22R.

CONCLUSIONS

This study has demonstrated that MCID calculations for the HRQOL scales in ASD using LCA yield values comparable to other studies that had used different methodologies. The most important finding was the significantly different MCIDs for COMI, ODI, SF-36 PCS and SRS-22 in the surgically and nonsurgically treated cohorts. This finding suggests that a universal MCID value, inherent to a specific HRQOL for an entire cohort of ASD may not exist. Use of different MCIDs for surgical and nonsurgical patients may be warranted.  相似文献   

4.

Introduction

Early results have indicated that the Bryan cervical total disc replacement (TDR) favorably compares to anterior cervical decompression and fusion, while it is associated with fewer complications and higher levels of satisfaction. In this study, we sought to prospectively report the midterm outcomes of the Bryan TDR.

Patients and methods

A total of 20 patients had performed their 4-year follow-up visit and had been assessed clinically and radiologically. Clinical outcomes (JOA, VAS, NDI, SF-36) and ROM measurements were investigated preoperatively and at 1 and 6 months, and 1, 2 and 4 years after operation. Complications were also investigated. Occurrences of heterotopic ossifications (HOs) and adjacent-level degeneration (ALD) radiographic changes were detected from 4-year follow-up X-rays.

Results

The mean JOA score, VAS score for arm and neck, NDI score and SF-36 score for PCS and MCS were reduced significantly at each postoperative time point when compared with the preoperative condition. The range of movement of the cervical spine, functional spinal unit, treated segment and the adjacent segment temporarily decreased at the early assessment, but all recovered to preoperative levels over a 6-month to 4-year time period. HO was evident in 6 of the 23 operated segments, which did not restrict the movement of the prosthesis. No obvious ALD was found on MRI. There were no cases of prosthesis migration, subsidence, loosening or wear.

Conclusion

The midterm outcomes demonstrated that the Bryan TDR maintains favorable clinical and radiological results, with preservation of movement and satisfactory clinical outcome. There were no serious complications or cases of prosthetic wear or failure. The long-term benefits are yet to be examined.  相似文献   

5.

Introduction

This study clarified individual associations of joint space narrowing (JSN) and radiographic features (RF) of hip osteoarthritis (HOA), i.e., cyst and osteophyte formation and subchondral sclerosis, with quality of life (QOL) in Japanese HOA patients.

Methods

This cross-sectional study comprised 117 Japanese HOA patients (98 women, 17 men; mean age, 61.2 years). We recorded locations and the size of each RF and measured JSN on the acetabular side (Ace) or femoral head (FH). We evaluated pain with the Visual Analog Scale (VAS) and assessed QOL with the physical component summary (PCS) and mental component summary (MCS) of the Medical Outcomes Study Short Form-36. We compared QOL with/without the RF on the Ace, FH or both and analyzed relationships between each RF and VAS, PCS and MCS with linear regression analysis. We assessed independent associations of each RF with PCS and MCS with multiple regression analysis using various independent variables.

Results

VAS values with the cyst on the Ace only were significantly lower than those with the cyst at both locations. PCS values with the cyst on the Ace only were significantly higher than those for both locations. Independent associations existed for maximum cyst length on the Ace and FH with VAS and for JSN with PCS, but none existed for MCS.

Conclusions

Our study suggested that the location and the size of the cyst formation were associated with both VAS and QOL in Japanese HOA patients. The JSN was independently associated with the PCS.  相似文献   

6.
BackgroundMental health has been demonstrated to affect postoperative outcomes. No prior literature has reported the relationship between preoperative mental health on outcomes following anterior cervical discectomy and fusion (ACDF) in the Workers Compensation (WC) population.MethodsWC claimants who underwent primary ACDF were identified from a single-surgeon retrospective database. Patients were separated by SF-12 MCS score into Depressed (<45.6) or Not Depressed (ND) (≥45.6) cohorts. Patient-reported Outcome Measurement Information System Physical Function (PROMIS PF), SF-12 Physical Component Score (SF-12 PCS), SF-12 MCS, visual analog scale (VAS) neck/arm pain, and Neck Disability Index (NDI) were collected and compared within and between groups. Minimum clinically important difference (MCID) achievement rates were compared between groups.ResultsDepressed patients had greater length of stay (p = 0.007) and postoperative narcotic consumption (p = 0.026). Depressed patients improved at 12-week to 2-year PROMIS PF, 6-month SF-12 PCS, 6-week to 6-month SF-12 MCS, 6-week to 6-month and 2-year VAS neck, all VAS arm, and 6-month NDI (p ≤ 0.045, all). ND patients improved at 12-week to 1-year PROMIS PF, 6-month to 2-year SF-12 PCS, 12-week to 1-year VAS neck, 6-week to 1-year VAS arm, and 12-week to 1-year NDI (p ≤ 0.044, all). Between groups, ND patients reported superior PROMIS PF, SF-12 MCS, VAS neck, VAS arm, and NDI scores at two or more periods (p ≤ 0.045, all). MCID achievement rate regarding SF-12 MCS was greater in the Depressed cohort at all postoperative points up to 1 year (p ≤ 0.020, all).ConclusionDepressed patients tended to have a greater length of stay and postoperative narcotic consumption immediately after surgery. Not depressed patients reported more favorable physical and mental function, pain, and disability scores preoperatively and postoperatively. Depressed patients reported greater MCID achievement in mental function following surgery. Depressed patients with WC have a greater likelihood of reporting tangible improvement in mental health scores following ACDF.  相似文献   

7.
Background ContextThe Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB).PurposeThis study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders.Study Design/SettingThe study setting is a longitudinal cohort in a multisurgeon spine specialty clinic.Patient sampleThe sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up.Outcome MeasuresThe outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain.MethodsThe MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient “Compared to one year ago, how would you rate your health in general now?” with answers ranging from “Much Better,” “Somewhat Better,” “About the Same,” “Somewhat Worse,” to “Much Worse.” An ROC curve was constructed for each measure. The ROC curve–derived MCID was the change score with equal sensitivity and specificity to distinguish the “Somewhat Better” from the “About the Same” patients. The ROC curve–derived SCB was the change score with equal sensitivity and specificity to distinguish the “Much Better” from the “Somewhat Better” patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID.ResultsThe calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain.ConclusionsPatients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion.  相似文献   

8.

Background

Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing.

Methods

This study is a secondary analysis of data collected in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator Characteristics (ROC) curves was used to evaluate responsiveness of the clinical tests. The Neck Disability Index was used to discriminate between those who had improved and those who were unchanged at the 4-month follow-up. Minimum Clinically Important Difference (MCID), together with sensitivity, specificity, positive and negative predictive values, in addition to positive and negative likelihood ratios were calculated.

Results

In total, 164 participants completed the 4 month follow up. One-hundred forty four participants were classified as unchanged whereas 20 patients were considered to be improved. Twenty-six participants didn’t complete all of the clinical tests, leaving a total of 138 to be included for analyses. Area Under Curve (AUC) ranged from 0.50-0.62 for the clinical tests, and were all below an acceptable level. MCID was generally large, and the corresponding sensitivity and specificity was low with sensitivity ranging from 20 to 60%, and specificity from 54 to 86%. LR+ (0.8-2.07) and LR- (0.7-1.1) showed low diagnostic value for all variables, with PPV ranging from 12.1 to 26.1 and NPV ranging from 84.7 to 89.2.

Conclusion

Responsiveness of the included clinical tests was generally low when using change in NDI score as the anchor from baseline to the 4-month follow up. Further investigations of responsiveness are warranted, possibly using other anchors, which to a higher degree resemble similar dimensions as the clinical tests.
  相似文献   

9.

Purpose

Little data are available regarding the influence of psychiatric factors on chronic dysphagia after anterior cervical spine surgery. The purpose of this study was to identify associations between psychiatric factors and the development of chronic dysphagia in patients after anterior cervical spine surgery.

Methods

The authors prospectively examined 72 patients with degenerative disc disease of the cervical spine who were treated by single-level anterior cervical discectomy and fusion. Demographic data including age, gender, body mass index, and smoking status were collected. Short form-36, mental component scores (MCS), physical component scores (PCS), Neck Disability Indices (NDI), and the Neck Pain and Disability Scale (NPDS) were assessed before surgery and at final follow-up. Psychiatric conditions were evaluated using the Zung depression scale and the Zung anxiety scale. At 1 year postoperatively, patients were contacted by telephone to determine the presence and severity of dysphagia. For statistical analyses, patients were divided into two groups: group I, those with No or Mild dysphagia; and group II, those with Moderate or Severe dysphagia at 1 year after surgery. Potential risk factors of chronic dysphagia were evaluated by multivariate logistic regression analysis.

Results

The patients included 22 women and 50 men of overall average age 47.1 ± 7.8 years. The prevalences of No/Mild (group I) and Moderate/Severe (group II) dysphagia were 69.4 % (50 patients) and 30.6 % (22 patients), respectively. Mean preoperative NDI, NPDS, PCS, and MCS scores of 34.2, 44.8, 33.7, and 46.2 in the 72 study subject improved to 9.9, 16.1, 55.1, and 56.2, respectively, at 1 year after surgery. The mean preoperative ZDS and ZAS scores were 35.2 and 34.2, respectively. The two study groups were significantly different in terms of the presence of a psychiatric problem, preoperative NDIs, and MCS scores. However, multivariate logistic regression showed that the presence of a psychiatric problem prior to surgery (P = 0.005) was the only significant predictor of chronic dysphagia.

Conclusions

The presence of a psychiatric problem seems to be an important risk factor of chronic dysphagia in patients with cervical disc herniation. The study shows that psychiatric factors should be evaluated prior to surgery to determine the risk of chronic dysphagia.  相似文献   

10.

Introduction and hypothesis

Although the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ) is widely used to assess sexual function in women, the minimum important difference (MID) (defined as the smallest difference in scores of a patient-reported outcome measure that is perceived by patients as beneficial or harmful and which would lead the clinician to consider a change in treatment) is not known. The objective was to estimate the MID for the PISQ.

Methods

Two study populations, one of women with overactive bladder (OAB) and urgency UI (UUI) treated with tolterodine in a placebo-controlled trial (cohort I), and one of women treated surgically for prolapse and/or UI (cohort II) were used. Cohort I anchors were the Overactive Bladder Questionnaire (OAB-q), the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Treatment Benefit Questionnaire (PPTBQ), and the change in number of UUI episodes in bladder diaries. Distribution MIDs were also calculated.

Results

In the anchor-based analysis, the MID values for changes in PISQ total scores at 3 months in cohort I were 5 points using the UUI anchor (diary-dry women), 5 points using the PPBC anchor, 5 points with the PPTBQ, and 9 points with the OAB-q. In cohort II, the MID at week 12 in PISQ total scores was 7 points in women with improved IIQ-7 scores. The distribution-based MID in PISQ total scores was 5.3 points in cohort I and 5.8 points in cohort II.

Conclusion

A reasonable estimate of MID for the PISQ total score is 6 points. Improvements that meet these thresholds may be considered clinically important.  相似文献   

11.

Background

The acetabular labrum is critical to hip function. Surgical options for treatment of a damaged labrum include removal, debridement, and refixation using suture anchors.

Questions/Purposes

The purpose of this study is to determine if certain patient demographic and osseous morphological factors result in increased labral damage requiring refixation.

Methods

Data was collected prospectively from a consecutive series of 334 procedures performed from August 2010 to June 2011 for femoroacetabular impingement. Demographic data, including age, sex, and race, was collected from patient charts. Three-dimensional (3D) CT scans were reviewed to retrieve alpha angles, acetabular version, femoral version, and lateral center edge angle on the symptomatic hip.

Results

In 238 (71.3%) of the procedures, the labrum required refixation using suture anchors with a mean of 2.74 anchors being used. Of males, 78.8% required suture anchors and 62.3% of females required suture anchors. Among procedures requiring suture anchors, significantly more suture anchors were used in males (2.92) than females (2.47). Regression analysis showed a positive association between alpha angle, acetabular retroversion at 1 and 2 o’clock, and the number of suture anchors used. The mean alpha angle in the cohort that required suture anchors (63.1°) was significantly greater than the cohort that did not (59.4°).

Conclusion

This study found femoral deformities to contribute more to labral damage than acetabular deformities and highlighted the importance of preoperative 3D CT scans. This study provides demographic and morphologic factors to review preoperatively to evaluate if extensive labral damage is present and if suture anchor refixation will be required.  相似文献   

12.

Purpose

Little information is available regarding the use of patient-controlled sédation (PCS) among the elderly. This study evaluated the safety and efficacy of propofol PCS among elderly patients undergoing hip or knee arthroplasty.

Methods

Forty patients, aged 65–78 yr, undergoing hip or knee arthroplasty under regional anaesthesia were randomized to receive propofol PCS (dose = 0.3 mg·kg?1. delay=three min: n = 20) or anaesthetist-administered midazolam-fentanyl sédation (n = 20). Sedation, anxiety and discomfort visual analogue scores (VAS) were mea sured, by an independent observer, preoperatively, immediately at the end of surgery and one hour following admission to the postanaesthetic care unit (PACU). Cognition was evaluated, using an abbreviated Mini Mental Status Examination, preoperatively and in the PACU. Patient satisfaction, based on VAS and a brief questionnaire, was measured in the PACU. The incidence of intraoperative complications was also compared.

Results

Patient satisfaction was high in each group. Sedation and anxiety VAS were similar m each group. A high incidence of pain with drug injection was noted among patients receiving propofol (80%) Transient deeper levels of sédation (6 vs 1;P = 0.05) were observed more commonly in the propofol PCS group.

Conclusion

Propofol PCS provides effective sédation. Using a propofol dose of 0.3 mg·kg?1, transient episodes of deeper sédation were noted more frequently among patients receiving PCS. These episodes did not require intervention but. suggest that this propofol PCS dose approaches the limit of safety and should be further reduced for some elderly patients.  相似文献   

13.

Purpose

To investigate the clinical and radiological results of total disc replacement (TDR) in the cervical spine with preoperative reducible kyphosis, and discuss when TDR is indicated for the patients with preoperative kyphosis.

Methods

Fifty-two patients who underwent single-level cervical TDR from June 2008 to May 2010 were included in this study. TDR was indicated for patients with preoperative lordosis or reducible kyphosis, and the patients were divided into a lordotic group (preoperative global angle of ≥0°) and kyphotic group (preoperative global angle of <0°). Clinical results were evaluated using the Japanese Orthopaedic Association (JOA) score, visual analog scale (VAS) score and Neck Disablity Index (NDI). For radiological evaluation, the global and functional spinal unit (FSU) angles and the global and FSU range of motion were measured preoperatively and postoperatively.

Results

The mean NDI in the kyphotic group was significantly higher than that in the lordotic group preoperatively and at six months postoperatively, but the groups showed no significant differences in JOA score, VAS score and NDI at the two year follow-up. The mean global and FSU angles in the kyphotic group were significantly lower than those in the lordotic group preoperatively and at six months postoperatively, but they gradually improved postoperatively. The differences lost significance at the two year follow-up.

Conclusions

Postoperative cervical kyphosis had adverse effects on the NDI after TDR. Artificial discs, symptom relief, and neck functional exercises may contribute to correction of preoperative reducible kyphosis at different stages after cervical TDR. Preoperative reducible kyphosis should not be an independent contraindication for cervical TDR.  相似文献   

14.
BackgroundEffective pain management is paramount for outpatient surgical success. This study aims to report a case series of patients undergoing cervical disc replacement (CDR) in an ambulatory surgery center (ASC) with the use of an enhanced multimodal analgesic (MMA) protocol.MethodsPrimary, single-/2-level CDR procedures at an ASC with an enhanced MMA protocol were included. ASC patients were discharged day of surgery. Patient-reported outcome measures (PROMs) were administered at preoperative/6-week/12-week/6-month/1-year/2-year timepoints and included Visual Analogue Scale (VAS) neck, VAS arm, Neck Disability Index (NDI), Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), and 12-Item Short-Form Physical and Mental Composite Score (SF-12 PCS/SF-12 MCS). A t-test assessed postoperative PROM improvement from baseline. MCID achievement was determined by comparing ΔPROM scores to previously established thresholds.Results106 patients were included, 76 single-level and 30 2-level. Most single-levels occurred at C5–C6, most 2-levels at C5–C7. One 2-level patient developed a hematoma 5 days postoperatively and underwent revision for evacuation. Five patients reported postoperative dysphagia; all were quickly resolved. One patient had an episode of seizure secondary to serotonin syndrome from concealed drug use. Patient was reintubated, transferred, and treated for serotonin syndrome. Two patients experienced postoperative nausea/vomiting. Cohort significantly improved from baseline for all PROMS at all timepoints except SF-12 MCS at 1-year/2-years and SF-12 PCS at 2 years (p < 0.047, all). Overall MCID achievement rates were: VAS arm (48.7%), VAS neck (69.1%), NDI (98.9%), SF-12 MCS (50.0%), SF-12 PCS (54.6%), and PROMIS-PF (73.4%).ConclusionOutpatient CDR, incorporating an enhanced MMA protocol, can be safely and effectively performed with proper patient selection and surgical technique. Patients saw timely discharge, well-controlled postoperative pain, and favorable long-term outcomes.  相似文献   

15.

Purpose

Little information is available regarding the use of patient-controlled sedation (PCS) among elderly patients undergoing operative procedures under local or regional anaesthesia. This prospective, randomized study evaluated the safety of propofol PCS, and the attitude among elderly patients toward self-administration of sedation during cataract surgery.

Methods

Prospective, randomized study conducted in a University affiliated, tertiary-care hospital. Fifty-five elderly patients (aged 65–79 yr) were randomized to receive propofol patient-controlled sedation (PCS) (n = 28) or no intraoperative sedation (n = 27) during cataract surgery performed under peribulbar block. The PCS parameters consisted of a lockout interval of three minutes and a PCS dose of 0.3 mg · kg?1. Study groups were compared with respect to sedation, anxiety and discomfort visual analogue scores (VAS), cognitive functioning, patient satisfaction and the incidence of intraoperative complications.

Results

Patients in the PCS group administered a mean propofol dose of 65 ±49 mg during procedures with a mean duration of 46 min. The incidence of intraoperative complications and sedation, anxiety and discomfort VAS were similar between groups. Patient satisfaction with PCS was high. In the PCS group, 10 (35%) of the 28 patients did not use the device because they were comfortable and did not feel they needed sedation. Satisfaction was higher in the PCS group (P = 0.02), whether or not they used the PCS device, compared with patients who did not receive a PCS device.

Conclusions

Propofol PCS represents a safe sedation technique among elderly patients in a monitored care setting. Elderly patients appear to prefer the option of receiving some form of intraoperative sedation and respond favourably to the opportunity to control administration.  相似文献   

16.
17.

Background

The objectives of this study were to evaluate, in mild primary hyperparathyroidism (pHPT) patients, the quality of life (QoL) using the SF-36 questionnaire before and after parathyroidectomy and to detect preoperatively patients who benefit the most from surgery. Most pHPT patients present a mild pHPT defined by calcemia ≤11.4 mg/dL. For these patients, there is debate about whether they should be managed with surveillance, medical therapy, or surgery.

Methods

A prospective multicenter study investigated QoL (SF-36) in patients with mild pHPT before and after parathyroidectomy in four university hospitals. Laboratory results and SF-36 scores were obtained preoperatively and postoperatively (3, 6, and 12 months).

Results

One hundred sixteen patients were included. After surgery, the biochemical cure rate was 98%. Preoperatively, the mental component summary and the physical component summary (PCS) were 38.69 of 100 and 39.53 of 100, respectively. At 1 year, the MCS and the PCS were 41.29 of 100 and 42.03 of 100. The subgroup analysis showed a more significant improvement in patients < 70 years and with calcemia ≥10.4 mg/dL. Postoperative PCS was correlated with age and preoperative PCS: variation = 32.11 ? 0.21 × age ? 0.4 × preoperative PCS. Men did not improve their MCS postoperatively. Only women with a preoperative MCS <43.6 of 100 showed postoperative improvement.

Conclusions

This study showed, in patients with mild pHPT, an improvement of QoL 1 year after parathyroidectomy. Patients <70 years and with calcemia ≥10.4 mg/dL had a more significant improvement.  相似文献   

18.

Background Context

Predictors of outcome after surgery for degenerative cervical myelopathy (DCM) have been determined previously through hypothesis-driven multivariate statistical models that rely on a priori knowledge of potential confounders, exclude potentially important variables because of restrictions in model building, cannot include highly collinear variables in the same model, and ignore intrinsic correlations among variables.

Purpose

The present study aimed to apply a data-driven approach to identify patient phenotypes that may predict outcomes after surgery for mild DCM.

Study Design

This is a principal component analysis of data from two related prospective, multicenter cohort studies.

Patient Sample

The study included patients with mild DCM, defined by a modified Japanese Orthopaedic Association score of 15–17, undergoing surgical decompression as part of the AOSpine CSM-NA or CSM-I trials.

Outcome Measures

Patient outcomes were evaluated preoperatively at baseline and at 6 months, 1 year, and 2 years after surgery. Quality of life (QOL) was evaluated by the Neck Disability Index (NDI) and Short Form-36 version 2 (SF-36v2). These are both patient self-reported measures that evaluate health-related QOL, with NDI being specific to neck conditions and SF-36v2 being a generic instrument.

Materials and Methods

The analysis included 154 patients. A heterogeneous correlation matrix was created using a combination of Pearson, polyserial, and polychoric regressions among 67 variables, which then underwent eigen decomposition. Scores of significant principal components (PCs) (with eigenvalues>1) were included in multivariate logistic regression analyses for three dichotomous outcomes of interest: achievement of the minimum clinically important difference [MCID] in (1) NDI (≤?7.5), (2) SF-36v2 Physical Component Summary (PCS) score (≥5), and (3) SF-36v2 Mental Component Summary (MCS) score (≥5).

Results

Twenty-four significant PCs accounting for 75% of the variance in the data were identified. Two PCs were associated with achievement of the MCID in NDI. The first (PC 1) was dominated by variables related to surgical approach and number of operated levels; the second (PC 21) consisted of variables related to patient demographics, severity and etiology of DCM, comorbid status, and surgical approach. Both PC 1 and PC 21 also correlated with SF-36v2 PCS score, in addition to PC 4, which described patients' physical profile, including gender, height, and weight, as well as comorbid renal disease; PC 6, which received large loadings from variables related to cardiac disease, impaired mobility, and length of surgery and recovery; and PC 9, which harbored large contributions from features of upper limb dysfunction, cardiorespiratory disease, surgical approach, and region. In addition to PC 21, a component profiling patients' socioeconomic status and support systems and degree of physical disability (PC 24) was associated with achievement of the MCID in SF-36 MCS score.

Conclusions

Through a data-driven approach, we identified several phenotypes associated with disability and physical and mental health-related QOL. Such data reduction methods may separate patient-, disease-, and treatment-related variables more accurately into clinically meaningful phenotypes that may inform patient care and recruitment into clinical trials.  相似文献   

19.
《The spine journal》2022,22(9):1481-1489
BACKGROUND CONTEXTAlthough anterior cervical discectomy and fusion is believed to positively impact a patient's radicular symptoms as well as axial neck pain, the outcomes of cervical disc replacement (CDR) with regards to neck pain specifically have not been established.PURPOSEPrimary: to assess clinical improvement following CDR in patients with neck pain greater than arm pain. Secondary: to compare the clinical outcomes between patients undergoing CDR for predominant neck pain (pNP), predominant arm pain (pAP), and equal neck and arm pain (ENAP).STUDY DESIGNRetrospective review of prospectively collected data.PATIENT SAMPLEPatients who had undergone one- or two-level CDR for the treatment of degenerative cervical pathology and had a minimum of 6-month follow-up were included and stratified into three cohorts based on their predominant location of pain: pNP, pAP, and ENAP.OUTCOME MEASURESPatient-reported outcomes: Neck Disability Index (NDI), Visual Analog Scale (VAS) neck and arm, Short Form 12-Item Physical Health Score (SF12-PHS), Short Form 12-Item Mental Health Score (SF12-MHS), minimal clinically important difference (MCID).METHODSChanges in Patient-reported outcomes from preoperative values to early (<6 months) and late (≥6 months) postoperative timepoints were analyzed within each of the three groups. The percentage of patients achieving MCID was also evaluated.RESULTSOne hundred twenty-five patients (52 pNP, 30 pAP, 43 ENAP) were included. The pNP cohort demonstrated significant improvements in early and late NDI and VAS-Neck, early SF-12 MCS, and late SF-12 PCS. The pAP and ENAP cohorts demonstrated significant improvements in all PROMs, including NDI, VAS-Neck, VAS-Arm, SF-12 PCS, and SF-12 MCS, at both the early and late timepoints. No statistically significant differences were found in the MCID achievement rates for NDI, VAS-Neck, SF-12 PCS, and SF-12 MCS at the late timepoint amongst the three groups.CONCLUSIONSCDR leads to comparable improvement in neck pain and disability in patients presenting with neck pain greater than arm pain and meeting specific clinical and radiographic criteria.  相似文献   

20.

Objective

Arthroscopic stabilization surgery has become the gold standard for the treatment of acute and chronic shoulder instability over recent years. The present study was aimed to retrospectively examine the outcome of a knotless anchor system with regard to the risk of relaxation and the required number of anchors.

Patients and methods

A total of 120 patients with anteroinferior instability of the shoulder were surgically treated between 2005 and 2009. Almost all cases (91%) showed a type II (77%) or type III (14%) instability according to the classification by Gerber; 90 patients were followed up after an average of 36 months.

Results

There was a significant improvement in the Rowe score, i.e., 33 points presurgery to 92 points postsurgery. Relaxation was observed in only 3 cases (3%). A 2-anchor system was used in all cases.

Conclusion

The knotless anchor system is a safe method for the treatment of type II and III acute and chronic instabilities. It was shown that the principle of fixation (the puncture technique, and the anchor technique) minimized the risk of relaxation and reduced the number of anchors required to that described in the literature.  相似文献   

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