scholarly journals A prospective study of the relation of patient-reported outcome measures with lumbar disc surgery for herniated lumbar disc

2021 ◽  
Vol 18 (3) ◽  
pp. 10-19
Author(s):  
Hitendra S Naik ◽  
Samarendra Nath Ghosh ◽  
Pradeep Saha ◽  
Parthasarathy Biswas

Introduction: The aim of this 6-month prospective study was to seek out the factors affecting surgical outcome, predictors of treatment response and their correlates in open discectomy for herniated lumbar disc. Methods and Materials: Eighty patients who fulfilled the required criteria were chosen. Socio-demographic, clinical data proforma, Visual Analogue Scale for pain (VAS), Japanese Orthopedic Association (JOA) Scale for subjective and objective pain related QoL, General Health Questionnaire-12 (GHQ-12) for screening mental health, Short Form-36 (SF-36) Health Survey for assessing Health-related Quality of Life (HRQOL) and Montgomery Asberg Depression Rating Scale (MADRS) for measurement of clinical depression were used at the preoperative stage and reassessed again at 1 month, 3 months and 6 months post-discectomy. Results: Postoperatively, VAS and JOA Scale scores continued to show improvement at each follow up (p<0.001). Majority of the SF-36 subscales showed significant improvement at 3-months and 6-months of the postoperative period. A significant correlation was seen between the duration of pain symptoms and depression scores at 6 months (rho 0.301 p<0.01). Baseline VAS score had a significant negative correlation with baseline Physical Functioning and General Health scores at 6 months. The duration and severity of pain symptoms before surgery predicted the depression scores at 6 months (adjusted R square 0.056 p<0.001) postoperatively. Conclusion: The discectomy procedure resulted in significant improvement in baseline subjective pain symptoms and overall HRQOL. Greater the duration and intensity of pain symptoms at baseline, greater was the depression scores and lesser was the SF-36 physical functioning and general health at 6-month postoperative period.

2013 ◽  
Vol 74 (1) ◽  
pp. 104-107 ◽  
Author(s):  
Ron D Hays ◽  
Karen L Spritzer ◽  
James F Fries ◽  
Eswar Krishnan

ObjectiveTo estimate responsiveness (sensitivity to change) and minimally important difference (MID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning scale (PROMIS PF-20).MethodsThe PROMIS PF-20, short form 36 (SF-36) physical functioning scale, and Health Assessment Questionnaire (HAQ) were administered at baseline, and 6 and 12 months later to a sample of 451 persons with rheumatoid arthritis. A retrospective change (anchor) item was administered at the 12-month follow-up. We estimated responsiveness between 12 months and baseline, and between 12 months and 6 months using one-way analysis of variance F-statistics. We estimated the MID for the PROMIS PF-20 using prospective change for people reporting getting ‘a little better’ or ‘a little worse’ on the anchor item.ResultsF-statistics for prospective change on the PROMIS PF-20, SF-36 and HAQ by the anchor item over 12 and 6 months (in parentheses) were 16.64 (14.98), 12.20 (7.92) and 10.36 (12.90), respectively. The MID for the PROMIS PF-20 was 2 points (about 0.20 of an SD).ConclusionsThe PROMIS PF-20 is more responsive than two widely used (‘legacy’) measures. The MID is a small effect size. The measure can be useful for assessing physical functioning in clinical trials and observational studies.


2012 ◽  
Vol 39 (6) ◽  
pp. 1185-1191 ◽  
Author(s):  
MARK C. GENOVESE ◽  
CHENGLONG HAN ◽  
EDWARD C. KEYSTONE ◽  
ELIZABETH C. HSIA ◽  
JACQUELINE BUCHANAN ◽  
...  

Objective.To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.Methods.In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.Results.Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.Conclusion.Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550)


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Chi Heon Kim ◽  
Yunhee Choi ◽  
Chun Kee Chung ◽  
Ki-Jeong Kim ◽  
Dong Ah Shin ◽  
...  

AbstractPhysicians often encounter surgical candidates with lumbar disc herniation (LDH) who request non-surgical management even though surgery is recommended. However, second opinions may differ among doctors. Therefore, a prospective comprehensive cohort study (CCS) was designed to assess outcomes of nonsurgical treatment for surgical candidates who were recommended to undergo surgery for LDH but requested a second opinion. The CCS includes both randomized and observational cohorts, comprising a nonsurgery cohort and surgery cohort, in a parallel fashion. Crossover between the nonsurgery and surgery cohorts was allowed at any time. The present study was an as-treated interim analysis of 128 cases (nonsurgery cohort, n = 71; surgery cohort, n = 57). Patient-reported outcomes included visual analogue scores for the back (VAS-B) and leg (VAS-L), the Oswestry Disability Index, the EuroQol 5-Dimension instrument, and the 36-Item Short-Form Health Survey (SF-36), which were evaluated at baseline and at 1, 3, 6, 12, and 24 months. At baseline, age and SF-36 physical function were significantly lower in the surgery cohort than in the nonsurgery cohort (p < 0.05). All adjusted outcomes significantly improved after both nonsurgical and surgical treatment (p < 0.05). The nonsurgery cohort showed less improvement of VAS-B and VAS-L scores at 1 month (p < 0.01), but no difference between cohorts was observed thereafter for 24 months (p > 0.01). Nonsurgical management may be a negotiable option even for surgical candidates in the shared decision-making process.


RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001707
Author(s):  
Ayşe A Küçükdeveci ◽  
Atilla H Elhan ◽  
Beyza D Erdoğan ◽  
Şehim Kutlay ◽  
Derya Gökmen ◽  
...  

IntroductionThe importance of patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA) clinical studies has been recognised for many years. The current study aims to describe the RA PROMs used over the past 20 years, and their performance metrics, to underpin appropriate tool selection.MethodsThe study included a systematic search for PROMs that have been in use over the period 2000–2019, with detailed documentation of their psychometric properties, and a user-friendly presentation of the extensive evidence base.Results125 PROMs were identified with psychometric evidence available. The domains of pain, fatigue, emotional functions, mobility, physical functioning and work dominated, with self-efficacy and coping as personal factors. Domains such as stiffness and sleep were poorly served. The most frequently used PROMs included the Health Assessment Questionnaire Disability Index (HAQ), the Short Form 36 (SF-36), the EuroQoL and the Modified HAQ which, between them, appeared in more than 3500 papers. Strong psychometric evidence was found for the HAQ, and the SF-36 Physical Functioning and Vitality (fatigue) domains. Otherwise, all domains except stiffness, sleep, education and health utility, had at least one PROM with moderate level of psychometric evidence.ConclusionThere is a broad range of PROMs for measuring RA outcomes, but the quality of psychometric evidence varies widely. This work identifies gaps in key RA domains according to the biopsychosocial model.


2021 ◽  
Vol 37 (S1) ◽  
pp. 17-17
Author(s):  
Eduardo Pinar ◽  
Juan García de Lara ◽  
José Hurtado ◽  
Miguel Robles ◽  
Gunnar Leithold ◽  
...  

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.


2011 ◽  
Vol 33 (2) ◽  
pp. 103-108 ◽  
Author(s):  
Mariane Ricardo Acosta Lopez ◽  
Juliane Portella Ribeiro ◽  
Liliane da Costa Ores ◽  
Karen Jansen ◽  
Luciano Dias de Mattos Souza ◽  
...  

OBJETIVO: Investigar a associação entre depressão e qualidade de vida em jovens de 18 a 24 anos de idade. MÉTODO: Estudo transversal de base populacional, composto por 1.560 jovens de 18 a 24 anos residentes na zona urbana de Pelotas (RS). A seleção amostral foi realizada por conglomerados: da divisão censitária de 448 setores, 97 foram sorteados aleatoriamente. A avaliação da depressão foi realizada através do Mini-International Neuropsychiatric Interview (MINI), e a qualidade de vida foi mensurada pela Medical Outcomes Study Short-Form General Health Survey (SF-36), ambos validados para uso em língua portuguesa. RESULTADOS: A prevalência de depressão foi de 12,6%. A média dos escores de qualidade de vida entre os oito domínios do SF-36 foi menor entre os jovens com depressão, apresentando associação significativa no teste t para todos os domínios (p = 0,000). CONCLUSÃO: Jovens com indicativo de depressão apresentaram menores níveis de qualidade de vida nos domínios explorados.


2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.


2018 ◽  
Vol 8 (7) ◽  
pp. 703-708 ◽  
Author(s):  
Andreas Kiilerich Andresen ◽  
Rune Tendal Paulsen ◽  
Frederik Busch ◽  
Alexander Isenberg-Jørgensen ◽  
Leah Y. Carreon ◽  
...  

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.


2015 ◽  
Vol 86 (11) ◽  
pp. e4.32-e4
Author(s):  
Neil Scolding ◽  
Hongwei Wang ◽  
Yan Liu ◽  
Lawrence Steinman

In the 2-year, phase 3 CARE-MS II study (NCT00548405), alemtuzumab demonstrated superior clinical and patient-reported outcomes (PROs) over subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis patients who had inadequate efficacy response to prior therapy. To further evaluate the relationship between PROs and disability, Short-Form 36-Item (SF-36) survey physical component summary (PCS) and mental component summary (MCS), and Functional Assessment of Multiple Sclerosis (FAMS) scores were analysed against Expanded Disability Status Scale (EDSS) outcomes, adjusted for baseline characteristics and randomisation arm. A 1.0-point difference in baseline EDSS score was associated with 2.0-point PCS, 0.8-point MCS, and 4.0-point FAMS worsening over 12 months (all P<0.001). A 1.0-point annualised EDSS score worsening corresponded to a 2.2-point PCS, 1.6-point MCS, and 6.0-point FAMS worsening (all P<0.001). For baseline EDSS score <4.0, 1.0-point annualised worsening was associated with 7.2-point FAMS and 2.0-point MCS worsening (both P<0.001). For baseline EDSS score ≥4.0, 1.0-point worsening corresponded to worsening on FAMS (2.4 points; P=0.04), but not MCS (P=0.82). Given that a half-point EDSS change is considered the minimum reliably measurable clinical difference, a 1.0-point change in SF-36 PCS and MCS or 3.0-point change in FAMS may represent a minimum important difference in PRO for multiple sclerosis patients.


2020 ◽  
Author(s):  
Ines Buchholz ◽  
You-Shan Feng ◽  
Maresa Buchholz ◽  
Lewis E. Kazis ◽  
Thomas Kohlmann

Abstract BackgroundThe translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.MethodsThe instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, confirmatory factor analysis (CFA) and effect size measures.ResultsItem non-response varied between 1.8%/1.1% (SFVR−36/RESF−36) and 6.5%/8.6% (GHVR−36/GHSF−36). PCS was normally distributed (Kolmogorov-Smirnov Tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7[13.8–66.1]) and VR-36 (38.5 ± 10.1[11.7–67.8]), SF-12 (36.9 ± 10.9[15.5–61.6]) and VR-12 (36.2 ± 11.5[12.7–59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR−36: 36.2 ± 14.2[12.9–66.6], MCSSF−36: 39.0 ± 15.6[2.0-73.2], MCSVR−12: 37.2 ± 13.8[8.4–70.2], MCSSF−12: 39.0 ± 12.3[17.6–65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (0.4–0.7) to high (> 0.7) correlations with convergent (PCSVR: 0.55–0.76, MCSVR: 0.60–0.78) and small correlations (< 0.3) with divergence (PCSVR: <0.12, MCSVR: <0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation.ConclusionsThe psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations.


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