357 Comparative Effectiveness between Primary and Revision Foraminotomy for the Treatment of Lumbar Foraminal Stenosis

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 282-282
Author(s):  
Emily Hu ◽  
Jianning Shao ◽  
Heath P Gould ◽  
Roy Xiao ◽  
Colin Haines ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Retrospective Cohort ◽  
Minimum Clinically Important Difference ◽  
Functional Score ◽  
Foraminal Stenosis ◽  
Lumbar Foraminal Stenosis ◽  
Clinically Important Difference ◽  
Significant Difference ◽  
Functional Scores

Abstract INTRODUCTION Foraminotomy has demonstrated clinical benefit for the management of lumbar foraminal stenosis (LFS). Although many patients undergo multiple foraminotomies, there is little data comparing primary foraminotomy (PF) and revision foraminotomy (RF) in terms of cost and quality of life (QOL) outcomes. METHODS A retrospective cohort study was conducted among patients undergoing foraminotomy for LFS. QOL instruments (EQ-5D, PDQ, and PHQ-9) were prospectively collected between 2008 and 2016. Outcome measures included improvement in postoperative QOL, perioperative cost, and QOL minimum clinically important difference (MCID). RESULTS >579 procedures were eligible 476 (82%) PF and 103 (18%) RF. A significantly higher proportion of males underwent RF than PF (71% vs. 59%, P = 0.03) and PF was done on a significantly higher number of vertebral levels (2.2 vs. 2.0, P = 0.04). There were no other significant differences in demographics. Preoperatively, mean PDQ-Functional scores (50 vs. 54, P = 0.04), demonstrated significantly poorer QOL in the RF cohort. Postoperatively, EQ-5D index showed significant improvement in both the PF (0.547?0.648, P < 0.0001) and the RF (0.507?0.648, P < 0.0001) cohorts. Similarly, total PHQ-9 improved significantly in the PF cohort (7.84?5.91, P < 0.001) and in the RF cohort (8.55?5.53, P = 0.02), as did total PDQ (PF: 77?63, P < 0.0001; RF: 85?70, P = 0.04). QOL scores were also compared between groups preoperatively and postoperatively. The only significant difference between PF and RF was observed in preoperative PDQ-Functional score (50 vs. 54, P = 0.04). The proportion of patients achieving an MCID was not significantly associated with cohort. Finally, perioperative cost did not differ significantly between cohorts (PF: $13,383 vs. RF: $13,595, P = 0.82). CONCLUSION RF patients had poorer preoperative PDQ-Functional scores, but both PF and RF produce significant improvement in all measures. There was no difference in QOL outcomes or cost between PF and RF. Therefore, while one procedure does not clearly have superior cost effectiveness than the other, both achieved significant effectiveness.

Minimum clinically important difference in pain, disability, and quality of life after neural decompression and fusion for same-level recurrent lumbar stenosis: understanding clinical versus statistical significance

2012 ◽  
Vol 16 (5) ◽  
pp. 471-478 ◽  
Author(s):  
Scott L. Parker ◽  
Stephen K. Mendenhall ◽  
David N. Shau ◽  
Owoicho Adogwa ◽  
William N. Anderson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Minimum Clinically Important Difference ◽  
Leg Pain ◽  
Lumbar Stenosis ◽  
Detectable Change ◽  
Calculation Methods ◽  
Recurrent Stenosis ◽  
Minimum Detectable Change ◽  
Clinically Important Difference

Object Spine surgery outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect, but the extent of improvement in the numerical scores of these questionnaires lacks a direct clinical meaning. Because of this, the concept of a minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of same-level recurrent stenosis following index lumbar fusion, which commonly requires revision decompression and fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for this pathology. Methods In 53 consecutive patients undergoing revision surgery for same-level recurrent lumbar stenosis–associated back and leg pain, PRO measures of back and leg pain were assessed preoperatively and 2 years postoperatively, using the visual analog scale for back pain (VAS-BP) and leg pain (VAS-LP), Oswestry Disability Index (ODI), Physical and Mental Component Summary categories of the 12-Item Short Form Health Survey (SF-12 PCS and MCS) for quality of life, Zung Depression Scale (ZDS), and EuroQol-5D health survey (EQ-5D). Four established anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for 2 separate anchors (health transition index of the SF-36 and the satisfaction index). Results All patients were available for 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs assessed. The 4 MCID calculation methods generated a range of MCID values for each of the PROs (VAS-BP 2.2–6.0, VAS-LP 3.9–7.5, ODI 8.2–19.9, SF-12 PCS 2.5–12.1, SF-12 MCS 7.0–15.9, ZDS 3.0–18.6, and EQ-5D 0.29–0.52). Each patient answered synchronously for the 2 anchors, suggesting both of these anchors are equally appropriate and valid for this patient population. Conclusions The same-level recurrent stenosis surgery-specific MCID is highly variable based on calculation technique. The “minimum detectable change” approach is the most appropriate method for calculation of MCIDs in this population because it was the only method to reliably provide a threshold above the 95% confidence interval of the unimproved cohort (greater than the measurement error). Based on this method, the MCID thresholds following neural decompression and fusion for symptomatic same-level recurrent stenosis are 2.2 points for VAS-BP, 5.0 points for VAS-LP, 8.2 points for ODI, 2.5 points for SF-12 PCS, 10.1 points for SF-12 MCS, 4.9 points for ZDS, and 0.39 QALYs for EQ-5D.

scholarly journals CORRELATION OF LUMBAR FORAMINAL STENOSIS DEGREE ON SAGITTAL MRI WITH JOABPEQ (JAPANESE ORTHOPAEDIC ASSOCIATION BACKPAIN QUESTIONNAIRE) AND ODI (OSWESTRY DISABILITY INDEX) ON LUMBAR FORAMINAL STENOSIS L5-S1 PATIENTS

Biomedika ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 68-73
Author(s):  
Bagas Widhiarso ◽  
Anggita Tri Yurisworo ◽  
Andhi Prijosedjati ◽  
Pamudji Utomo ◽  
Handry Tri Handojo
Keyword(s):  
Quality Of Life ◽  
Magnetic Resonance Imaging ◽  
Oswestry Disability Index ◽  
Japanese Orthopaedic Association ◽  
Foraminal Stenosis ◽  
Resonance Imaging ◽  
Lumbar Foraminal Stenosis ◽  
Pain Evaluation ◽  
Magnetic Resonance Imaging Mri

Lumbar Foraminal Stenosis (LFS) dapat secara signifikan mengurangi fungsi dan kualitas hidup pasien dan Magnetic Resonance Imaging (MRI) adalah alat pendukung yang umum digunakan untuk mengukur beratnya stenosis. Lee score umumnya digunakan untuk mengukur derajat LFS pada MRI sagital. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) dan Oswestry Disability Index (ODI) digunakan untuk menilai disabilitas dan skor fungsional pada pasien LFS. Penelitian ini bertujuan untuk mengetahui korelasi antara derajat LFS pada MRI sagital dengan kualitas hidup pada pasien dengan LFS. Penelitian ini merupakan penelitian analitik observasional yang melibatkan 25 pasien dengan gejala klinis LFS di RS. X Surakarta. Pasien dinilai dengan mengisi kuesioner JOABPEQ dan ODI, kemudian dilakukan evaluasi MRI sagittal lumbar untuk menentukan derajat Lee score, kemudian melakukan uji korelasi pada data yang diperoleh. Penelitian ini menunjukkan korelasi yang signifikan antara Skor Lee dengan JOABPEQ dan ODI. Tingkat LFS berdasarkan Lee Score memiliki korelasi yang signifikan dengan tingkat disabilitas menggunakan JOABPEQ dan ODI. JOABPEQ memiliki korelasi yang lebih signifikan dengan Skor Lee dibandingkan dengan ODI. Kata Kunci : Lumbar Foraminal Stenosis, Lee Score, JOABPEQ, ODI Lumbar Foraminal Stenosis (LFS) can significantly reduce the patient’s function and quality of life and Magnetic Resonance Imaging (MRI) is commonly used supporting tool to measure the degree of stenosis. Lee Score is commonly used to measure the degree of LFS on sagittal MRI. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and Oswestry Disability Index (ODI) to assess disability and functional scores in LFS patients. This study was conducted to determine the correlation between the degree of LFS on sagittal MRI images with quality of life in patients with LFS.This study is an observational analytics study involving 25 patients with clinical symptoms of LFS in X Hospital Surakarta. Patients were assessed by filling JOABPEQ dan ODI questionnaires, then performed sagittal lumbar MRI evaluation to determine the degree of Lee Score, then performed correlation test on the data obtained.This study shows a significant correlation between Lee Score with JOABPEQ and ODI. The degree of LFS based on Lee Score has a significant correlation with the degree of disability using JOABPEQ and ODI. JOABPEQ has a more significant correlation to Lee Score compared with ODI. Keywords:Lumbar Foraminal Stenosis, Lee Score, JOABPEQ, ODI

scholarly journals Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036498 ◽  
Author(s):  
Maja-Marie Grønfeldt Højer ◽  
Marie Louise De Bruin ◽  
Arnela Boskovic ◽  
Christine Erikstrup Hallgreen
Keyword(s):  
Clinical Practice ◽  
Healthcare Professional ◽  
Retrospective Cohort ◽  
European Medicines Agency ◽  
Quality Of Information ◽  
Honestly Significant Difference ◽  
Significant Difference ◽  
Post Hoc ◽  
Different Characteristics

ObjectiveTo assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.DesignRetrospective cohort study.SettingDHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.InterventionQuality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey’s honestly significant difference if significant.ResultsIn total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0–6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a ‘adequate instruction’ which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001).ConclusionsMonitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.

Heterogeneity of treatment response in bronchiectasis clinical trials

2021 ◽  
pp. 2100777
Author(s):  
Oriol Sibila ◽  
Elena Laserna ◽  
Amelia Shoemark ◽  
Lidia Perea ◽  
Diana Bilton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lung Function ◽  
Treatment Response ◽  
Minimum Clinically Important Difference ◽  
Clinical Parameters ◽  
Clinically Important Difference ◽  
Primary Endpoints ◽  
The Relationship

IntroductionRecent randomised clinical trials (RCTs) in Bronchiectasis have failed to reach their primary endpoints, suggesting a need to reassess how we measure treatment response. Exacerbations, quality of life (QOL) and lung function are the most common endpoints evaluated in bronchiectasis clinical trials. We aimed to determine the relationship between responses in terms of reduced exacerbations, improved symptoms and lung function in bronchiectasis.MethodsWe evaluated treatment response in 3 RCTs that evaluated mucoactive therapy (inhaled Mannitol), an oral anti-inflammatory/antibiotic (Azithromycin) and an inhaled antibiotic (Aztreonam). Treatment response was defined by absence of exacerbations during follow-up, an improvement of QOL above the minimum clinically important difference (MCID) and an improvement in FEV1 of ≥100 mL from baseline.Measurements and main resultsCumulatively the three trials included 984 patients. Changes in FEV1, QOL and exacerbations were heterogeneous in all trials analysed. Improvements in QOL were not correlated to changes in FEV1 in the azithromycin and aztreonam trials (r=−0.17, p=0.1 and r=0.04, p=0.4) and weakly correlated in the mannitol trial (r=0.22, p<0.0001). An important placebo effect was observed in all trials, especially regarding improvements in QOL. Clinical meaningful lung function improvements were rare across all trials evaluated, suggesting that FEV1 is not a responsive measure in bronchiectasis.ConclusionsImprovements in lung function, symptoms and exacerbation frequency are dissociated in bronchiectasis. FEV1 is poorly responsive and poorly correlated with other key outcome measures. Clinical parameters are poorly predictive of treatment response suggesting the need to develop biomarkers to identify responders

Abstract NS13: Road to Recovery after Stroke: Understanding Predictors of Discharge Destination, Functional Independence, and Quality of Life after Hospital Discharge

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Laurie Paletz ◽  
Pamela Roberts ◽  
Harriet Aronow ◽  
Sonia Guerra ◽  
Tingjian Yan
Keyword(s):  
Quality Of Life ◽  
Comparative Effectiveness ◽  
Functional Independence Measure ◽  
Functional Independence ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Functional Scores ◽  
Brain Involvement

Introduction: Stroke is the leading cause of long-term disability and affects 795,000 people in the U.S. each year. This study was conducted to enhance knowledge of outcomes during recovery and the options for participating in rehabilitation and preventive care during patients’ transitions to the community. Comprehensive Stroke Certification charges hospitals with the task of expanding knowledge of functional and quality of life outcomes for all stroke patients through the continuum examining effects of stroke severity, functional impairment, and patient characteristics on discharge destinations, functional independence, and quality of life after discharge. Methods: Retrospective analysis of an acute stroke quality improvement database which includes measures collected by MedTel Outcomes LLC on all stroke patients one month after discharge. Included, is the Functional Independence Measure and standardized quality of life and participation measures. In the database are standardized measures from the medical record such stroke type, Modified Rankin score, and acute functional independence measure score for 719 patients with a 30-day follow-up phone assessment for functional and quality of life measures from January 1, 2011 to December 31, 2012. Preliminary Findings: Over 75% of patients had hemiparesis, & over 90% survived 30-days post discharge and were living in the community. At follow-up, mostwere independent in self-care, and half were independent in mobility excluding stairs. Those with right brain involvement had a complicated, slower recovery. Those with left brain involvement,had lower functional scores and a higher percentage of them were not living in the community, rather, living in institutions. Conclusions: All patients experiencing a stroke should have evidence-based information on their options & what to expect during their recovery during their transitions into the community. The data base is useful as a source of outcome data for comparative effectiveness and to build a regional collaborative outcomes database for Comparative Effectiveness Research and quality benchmarking. Findings can be used to understand the functional trajectory of recovery based on severity of stroke and other factors.

Comprehensive Assessment of 1-Year Outcomes and Determination of Minimum Clinically Important Difference in Pain, Disability, and Quality of Life After Suboccipital Decompression for Chiari Malformation I in Adults

Neurosurgery ◽  
2013 ◽  
Vol 73 (4) ◽  
pp. 569-581 ◽  
Author(s):  
Scott L. Parker ◽  
Saniya S. Godil ◽  
Scott L. Zuckerman ◽  
Stephen K. Mendenhall ◽  
John A. Wells ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Short Form ◽  
Minimum Clinically Important Difference ◽  
Numeric Rating Scale ◽  
Pain Disability ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Difference Thresholds

Abstract BACKGROUND: To date, there has been no study to comprehensively assess the effectiveness of suboccipital craniectomy (SOC) for Chiari malformation I (CMI) using validated patient-reported outcome measures. OBJECTIVE: To determine the effectiveness and minimum clinically important difference thresholds of SOC for the treatment of adult patients with CMI using patient-reported outcome metrics. METHODS: Fifty patients undergoing first-time SOC and C1 laminectomy for CMI at a single institution were followed up for 1 year. Baseline and 1-year postoperative pain, disability, quality of life, patient satisfaction, and return to work were assessed. Minimum clinically important difference thresholds were calculated with 2 anchors: the Health Transition Index and North American Spine Society satisfaction questionnaire. RESULTS: The severity of headaches improved in 37 patients (74%). Improvement in syrinx size was seen in 12 patients (63%) and myelopathy in 12 patients (60%). All patient-reported outcomes showed significant improvement 1 year postoperatively (P &lt; .05). Of the 38 patients (76%) employed preoperatively, 29 (76%) returned to work postoperatively at a median time of 6 weeks (interquartile range, 4-12 weeks). Minimum clinically important difference thresholds after SOC for CMI were 4.4 points for numeric rating scale for headache, 0.7 points for numeric rating scale for neck pain, 13.8 percentage points for Headache Disability Index, 14.2 percentage points for Neck Disability Index, 7.0 points for Short Form-12 Physical Component Summary, 6.1 points for Short Form-12 Mental Component Summary, 4.5 points for Zung depression, 1.7 points for modified Japanese Orthopaedic Association, and 0.34 quality-adjusted life-years for Euro-Qol-5D. CONCLUSION: Surgical management of CMI in adults via SOC provides significant and sustained improvement in pain, disability, general health, and quality of life as assessed by patient-reported outcomes. This patient-centered assessment suggests that suboccipital decompression for CMI in adults is an effective treatment strategy.

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