scholarly journals EVOLVE: A prospective and multicenter evaluation of outcomes for quality of life, pain and activities of daily living for balloon kyphoplasty in the treatment of Medicare-eligible subjects with vertebral compression fractures

2017 ◽  
Vol 28 (2) ◽  
pp. S25 ◽  
Author(s):  
D Beall ◽  
M Chambers ◽  
S Thomas ◽  
J Webb ◽  
B Goodman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Compression Fractures

173 EVOLVE - Significant Improvements in Pain, Disability, Quality of Life and Overall Health with Use of Balloon Kyphoplasty for Vertebral Compression Fractures in Medicare-Eligible Patients Despite Minimal Improvements in Vertebral Body Height an

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 244-245
Author(s):  
John Amburgy ◽  
Douglas Beall ◽  
Richard Easton ◽  
Douglas Linville ◽  
Sanjay Talati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vertebral Body ◽  
Body Height ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Vertebral Body Height ◽  
Compression Fractures ◽  
Time Points ◽  
Pain Disability

Abstract INTRODUCTION Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful. In the U.S., there are more than 1.5 million vertebral fractures annually and 40% of those over the age of 80 will experience this pathology, threatening quality of life and increasing morbidity and mortality. Kyphoplasty is a minimally invasive surgery to stabilize the fracture and recent EVOLVE analysis demonstrated minimal improvement in kypohotic angulation or vertebral body height, however, patients demonstrated significant improvements in pain, disability, quality of life and overall health. METHODS Prospective, multicenter 12-month clinical study of outcomes pertaining to activities of daily living, pain, quality of life, and safety parameters in a Medicare-eligible population treated with kyphoplasty for painful acute or subacute VCFs associated with osteoporosis or cancer. RESULTS >NRS back pain improved from 8.7 (scale 0–10) by 5.2, 5.4, 6.0, 6.2 and 6.3 points, at the 7-day, and the 1, 3, 6 and 12-month time points, respectively. ODI improved from 63.4 (scale 0–100) by 30.5, 35.3, 36.3 and 36.2 points, at the 1, 3, 6 and 12-month time points, respectively. The SF-36 PCS was 24.2 at baseline (scale 0–100) and improved 10.7, 12.4, 13.4 and 13.8 points, at 1, 3, 6 and 12 months. The EQ-5D was 0.383 points (scale 0–1) and improved 0.316, 0.351, 0.356 and 0.358 points, at 1, 3, 6 and 12 months. All measures were statistically significant with P < 0.001 at every time point. Despite these significant improvements in pain, disability, qulity of life and overall health, there were only modest, but significant improvements in kyphotic angulation (1.1° improvement) and vertebral body height (4% improvement). CONCLUSION This large, prospective, multicenter study trial demonstrates that utilization of kyphoplasty for vertebral compression fractures provides significant improvements in pain, disability, quality of life, and overall health despite modest improvements in kyphotic angulation and vertebral body height in Medicare-eligible patients.

Final Results of the First Randomized Trial Comparing Balloon Kyphoplasty (BKP) to Non-Surgical Management Among Cancer Patients with Vertebral Compression Fractures: Marked Improvement in Back Function, Quality of Life and Pain in the BKP Arm.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2873-2873 ◽  
Author(s):  
James R Berenson ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
Jeffrey A Zonder ◽  
John B Tillman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Back Pain ◽  
Pain Relief ◽  
Randomized Trial ◽  
Cancer Patients ◽  
Research Funding ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Compression Fractures

Abstract Abstract 2873 Poster Board II-849 Destructive vertebral lesions are a common source of morbidity for patients with cancer. Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability. We report the final results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of BKP. Twenty-two multinational sites enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with cancer and ' 3 painful VCFs were randomly assigned to BKP or nonsurgical management (NSM) and followed for 12 months. Patients were excluded with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site, or spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire (RMDQ), a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Following this assessment, cross-over to BKP was allowed in the NSM arm. Patients were randomized to BKP (N=70) or NSM (N=64). Five patients withdrew early from the study without significant baseline data; the 3 patients assigned to BKP did not undergo the procedure. Thus, 68 BKP and 61 control patients were evaluable. Mean patient age was 64 years, 58% were female, and tumor types included multiple myeloma (38%), cancers of the breast (22%), lung (8.5%), prostate (6.2%) and other sites (26%). At baseline, 35% of patients were currently on daily corticosteroids, 50% had received bisphosphonates within 12 months of study entry, 49% had received prior radiation (52 % to the spine), and 67% of patients were previously treated with chemo/hormonal therapies. VCFs were identified in a single (34%), two (26%) or three (40%) sites. Mean baseline RMDQ scores were similar between the groups; 17.6 and 18.2 points for BKP and NSM patients, respectively. However, at one month, there was an improvement for patients randomized to BKP of −8.3 points (95% CI −6.4 to −10.2) whereas those receiving NSM showed no significant change (0.1 points, 95% CI 1.0 to −0.8; p<0.0001). At one week, BKP-treated patients also showed significant improvement in their back pain (−3.8 points, 95%CI, −3.1 to −4.6) whereas those patients treated with NSM had no change (−0.3 points, 95%CI, 0.1 to −0.7; p<0.0001). Similar results for pain were obtained at one month (BKP: −3.9 [95%CI, −3.1 to −4.7]; NSM: −0.6 [95%CI, −0.1 to −1.1]; p<0.0001). The greater pain relief observed in the BKP group was accompanied by a greater reduction in the usage of any analgesics to control pain relief within one month (p=0.002). BKP patients also reported fewer days (compared to NSM) within two weeks where their activity was limited due to back pain (6.3 fewer days per 2 weeks; 95%CI, 5.8 to 6.8; p<0.0001) and greater improvements in quality of life as measured by the SF-36 physical component summary score (8.4 points higher; 95%CI, 7.7 to 9.1; p<0.0001). Thirty-eight of the 61 patients in the NSM group crossed over and underwent BKP with 21 (58%) occurring within 1 week of the 1-month visit. These cross-over patients were also assessed for safety and efficacy at 1 month following the procedure and through the study period. They showed similar benefits in regards to back disability, back pain relief, analgesic use, activity level, and quality of life as those originally assigned to BKP. Among all patients treated with BKP, these improvements were sustained throughout the 12-month study period. Adverse events were similar between the two groups. One serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. One patient with a cement leakage to the disc had an adjacent fracture occur 1 day after the index procedure; the local investigator judged this to be device-related. This randomized study demonstrates that cancer patients with VCFs treated with BKP have a superior outcome compared to NSM as measured by the primary endpoint, the RMDQ score. BKP also resulted in a marked reduction in back pain, improved quality of life and fewer days with limitation of daily activities; these outcomes were both clinically and statistically significant and these effects were maintained throughout the 12 month study period. This study supports the benefits of BKP in the management of cancer patients with VCFs. Disclosures: Berenson: Medtronic Spine LLC: Consultancy, Research Funding. Pflugmacher:Medtronic Spine LLC: Research Funding. Jarzem:Medtronic Spine LLC: Research Funding. Zonder:Medtronic Spine LLC: Research Funding. Tillman:Medtronic Spine LLC: Employment. Ashraf:Medtronic Spine LLC: Employment. Vrionis:Medtronic Spine LLC: Research Funding.

scholarly journals PSU25 Balloon Kyphoplasty Increases Quality of Life in Cancer Patients With Vertebral Compression Fractures

2012 ◽  
Vol 15 (7) ◽  
pp. A406 ◽  
Author(s):  
G. Olafsson ◽  
J. Mesterton ◽  
J.R. Berenson ◽  
F. Vrionis ◽  
L. Alvares
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Compression Fractures

scholarly journals Analysis of Medication Adherence and Its Influencing Factors in Patients with Schizophrenia in the Chinese Institutional Environment

2021 ◽  
Vol 18 (9) ◽  
pp. 4746
Author(s):  
Wei Yu ◽  
Jie Tong ◽  
Xirong Sun ◽  
Fazhan Chen ◽  
Jie Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Medication Adherence ◽  
Activities Of Daily Living ◽  
Influencing Factors ◽  
Self Efficacy ◽  
Daily Living ◽  
Institutional Environment ◽  
Factors Influencing ◽  
Quality Of Life Scale

Background: Factors related to medication adherence in patients with schizophrenia have always been key to the treatment and rehabilitation of these patients. However, the treatment modes in different countries are not the same, and there is no research on the factors influencing medication adherence under different mental health service modes. Objectives: The purpose of this study was to explore medication adherence and its influencing factors in patients with schizophrenia in the Chinese institutional environment. Methods: We conducted a cross-sectional study of hospitalized persons living with schizophrenia from November 2018 to January 2019. A systematic sampling method was used to select 217 hospitalized persons living with schizophrenia. The Medication Adherence Rating Scale (MARS), Positive and Negative Syndrome Scale (PANSS), General Self-Efficacy Scale (GSES), Schizophrenia Quality of Life Scale (SQLS), and Scale of Social Skills for Psychiatric Inpatients (SSPI) were used to explore medication compliance and its influencing factors in the Chinese institutional environment. Results: The descriptive analysis and ANOVA showed that there were no significant differences in medication adherence when assessed by demographic characteristics such as sex, marital status, and education level (p > 0.05). A correlation analysis showed that there was no significant correlation between medication adherence and mental symptoms (p > 0.05) but that there was a positive correlation with self-efficacy, quality of life, and activities of daily living (p < 0.01). The linear regression analysis showed that self-efficacy, psychosocial factors, symptoms/side effects, and activities of daily living had significant effects on medication adherence (F = 30.210, p < 0.001). Conclusions: Our findings show that the self-efficacy, quality of life, and social function of patients with schizophrenia are important self-factors influencing medication adherence in the Chinese institutional environment.

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