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Caelers IJ, Droeghaag R, de Kunder SL, Most J, Rijkers K, Bartels RH, Kuijlen JM, Hulsbosch MH, van Hemert WL, de Bie RA, van Santbrink H. Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial. THE LANCET REGIONAL HEALTH. EUROPE 2024; 43:100964. [PMID: 39022428 PMCID: PMC11253221 DOI: 10.1016/j.lanepe.2024.100964] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/16/2024] [Revised: 05/30/2024] [Accepted: 05/31/2024] [Indexed: 07/20/2024]
Abstract
Background The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted. Methods In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. Findings Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI -12.2 to +2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P < 0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications. Interpretation For patients with single-level spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups. Funding No funding was received for this trial.
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Affiliation(s)
- Inge J.M.H. Caelers
- Department of Neurosurgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
- Department of Neurosurgery, Maastricht University Medical Center, Maastricht, the Netherlands
| | - Ruud Droeghaag
- Department of Orthopedic Surgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
| | | | - Jasper Most
- Department of Orthopedic Surgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
| | - Kim Rijkers
- Department of Neurosurgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
- Department of Neurosurgery, Maastricht University Medical Center, Maastricht, the Netherlands
- School for Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands
| | - Ronald H.M.A. Bartels
- Department of Neurosurgery, Canisius Wilhelmina Hospital Nijmegen, Nijmegen, the Netherlands
- Department of Neurosurgery, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Jos M.A. Kuijlen
- Department of Neurosurgery, University of Groningen, Groningen University Medical Center, Groningen, the Netherlands
| | | | - Wouter L.W. van Hemert
- Department of Orthopedic Surgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
| | - Rob A. de Bie
- Department of Epidemiology, Maastricht University, Maastricht, the Netherlands
- CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands
| | - Henk van Santbrink
- Department of Neurosurgery, Zuyderland Medical Center, Sittard-Geleen, Heerlen, the Netherlands
- Department of Neurosurgery, Maastricht University Medical Center, Maastricht, the Netherlands
- CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands
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Lau VI, Johnson JA, Bagshaw SM, Rewa OG, Basmaji J, Lewis KA, Wilcox ME, Barrett K, Lamontagne F, Lauzier F, Ferguson ND, Oczkowski SJW, Fiest KM, Niven DJ, Stelfox HT, Alhazzani W, Herridge M, Fowler R, Cook DJ, Rochwerg B, Xie F. Health-related quality-of-life and health-utility reporting in critical care. World J Crit Care Med 2022; 11:236-245. [PMID: 36051941 PMCID: PMC9305682 DOI: 10.5492/wjccm.v11.i4.236] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2022] [Revised: 04/16/2022] [Accepted: 05/28/2022] [Indexed: 02/06/2023] Open
Abstract
Mortality is a well-established patient-important outcome in critical care studies. In contrast, morbidity is less uniformly reported (given the myriad of critical care illnesses and complications of each) but may have a common end-impact on a patient’s functional capacity and health-related quality-of-life (HRQoL). Survival with a poor quality-of-life may not be acceptable depending on individual patient values and preferences. Hence, as mortality decreases within critical care, it becomes increasingly important to measure intensive care unit (ICU) survivor HRQoL. HRQoL measurements with a preference-based scoring algorithm can be converted into health utilities on a scale anchored at 0 (representing death) and 1 (representing full health). They can be combined with survival to calculate quality-adjusted life-years (QALY), which are one of the most widely used methods of combining morbidity and mortality into a composite outcome. Although QALYs have been use for health-technology assessment decision-making, an emerging and novel role would be to inform clinical decision-making for patients, families and healthcare providers about what expected HRQoL may be during and after ICU care. Critical care randomized control trials (RCTs) have not routinely measured or reported HRQoL (until more recently), likely due to incapacity of some patients to participate in patient-reported outcome measures. Further differences in HRQoL measurement tools can lead to non-comparable values. To this end, we propose the validation of a gold-standard HRQoL tool in critical care, specifically the EQ-5D-5L. Both combined health-utility and mortality (disaggregated) and QALYs (aggregated) can be reported, with disaggregation allowing for determination of which components are the main drivers of the QALY outcome. Increased use of HRQoL, health-utility, and QALYs in critical care RCTs has the potential to: (1) Increase the likelihood of finding important effects if they exist; (2) improve research efficiency; and (3) help inform optimal management of critically ill patients allowing for decision-making about their HRQoL, in additional to traditional health-technology assessments.
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Affiliation(s)
- Vincent Issac Lau
- Department of Critical Care Medicine, University of Alberta, Edmonton T6G 2B7, AB, Canada
| | - Jeffrey A Johnson
- School of Public Health, Inst Hlth Econ, University of Alberta, Edmonton T6G 2B7, AB, Canada
| | - Sean M Bagshaw
- Department of Critical Care Medicine, University of Alberta, Edmonton T6G 2B7, AB, Canada
| | - Oleksa G Rewa
- Department of Critical Care Medicine, University of Alberta, Edmonton T6G 2B7, AB, Canada
| | - John Basmaji
- Department of Medicine, Division of Critical Care, Western University, London N6A 5W9, Canada
| | - Kimberley A Lewis
- Division of Critical Care, McMaster University, Hamilton L8N 4A6, Canada
| | - M Elizabeth Wilcox
- Interdepartmental Division of Critical Care, University of Toronto, Toronto M5T 2S8, Canada
| | - Kali Barrett
- Interdepartmental Division of Critical Care, University of Toronto, Toronto M5T 2S8, Canada
| | | | - Francois Lauzier
- Departments of Medicine and Anesthesiology, University Laval, Laval G1V 4G2, Canada
| | - Niall D Ferguson
- Department Critical Care Medicine, University of Toronto, Toronto M5G 2C4, Canada
| | - Simon J W Oczkowski
- Department of Medicine, McMaster Clin, Hamilton Gen Hosp, McMaster University, Hamilton L8N 4A6, Canada
| | - Kirsten M Fiest
- Department of Community Health Sciences & Institute for Public Health, University of Calgary, Calgary T2N 2T9, Canada
| | - Daniel J Niven
- Department of Critical Care Medicine, University Calgary, Calgary T2N 2T9, Canada
| | - Henry T Stelfox
- Department of Community Health Sciences, University of Calgary, Calgary T2N 2T9, Canada
| | - Waleed Alhazzani
- Department of Medicine, McMaster University, Hamilton L8N 4A6, Canada
| | - Margaret Herridge
- Indepartmental Division of Critical Care, University Health Network, Toronto M5G 2C4, Canada
| | - Robert Fowler
- Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Center, Institute of Health Policy Management and Evaluation, University of Toronto, Toronto M4N 3M5, Canada
| | - Deborah J Cook
- Department of Medicine, McMaster University, Hamilton L8N 4A6, Canada
| | - Bram Rochwerg
- Department of Medicine, McMaster University, Hamilton L8N 4A6, Canada
| | - Feng Xie
- Health Research Methods, Evidence and Impact, McMaster University, Hamilton L8N 3Z5, Canada
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Klepinowski T, Sagan L. EuroQol-5 dimensions health-related quality of life questionnaire in craniovertebral instability treated with posterior fixation with or without occipital plating: A comparative study with matched datasets. JOURNAL OF CRANIOVERTEBRAL JUNCTION AND SPINE 2022; 13:72-79. [PMID: 35386241 PMCID: PMC8978853 DOI: 10.4103/jcvjs.jcvjs_125_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2021] [Accepted: 10/28/2021] [Indexed: 11/04/2022] Open
Abstract
Objective: Methods: Results: Conclusions:
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Baron JE, Parker EA, Wolf BR, Duchman KR, Westermann RW. PROMIS Versus Legacy Patient-Reported Outcome Measures for Sports Medicine Patients Undergoing Arthroscopic Knee, Shoulder, and Hip Interventions: A Systematic Review. THE IOWA ORTHOPAEDIC JOURNAL 2021; 41:58-71. [PMID: 34924871 PMCID: PMC8662933] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Indexed: 06/14/2023]
Abstract
BACKGROUND The Patient-Reported Outcomes Measurement Information System (PROMIS®) was designed to monitor the global wellbeing of patients, with the Physical Function Computer-Adaptive Test (PF-CAT) component focused specifically on functional outcome. PROMIS aims for increased item-bank accuracy, lower administrative burden, and decreased floor and ceiling effects compared to legacy patient-reported outcome measures (PROMs). Our primary research outcomes focused on sports medicine surgical populations, which may skew younger or have wide-ranging functional statuses. Specifically, for this population, we questioned if PROMIS PF-CAT was equal to legacy PROMs in (1) construct validity and (2) convergent/divergent validities; and superior to legacy PROMs with respect to (3) survey burden and (4) floor and ceiling effects. METHODS Searches were performed in April 2019 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, utilizing PubMed, Cochrane Central, and Embase databases for Level I-III evidence. This resulted in 541 records, yielding 12 studies for inclusion. PROM data was available for patients undergoing arthroscopic orthopaedic procedures of the knee, shoulder, and hip. Measures of construct validity, convergent/divergent validity, survey burden, and floor/ceiling effects were evaluated for PROMIS PF-CAT versus legacy PROMs. RESULTS PROMIS PF-CAT demonstrated excellent or excellent-good correlation with legacy PROMS for physical function and quality of life for patients undergoing arthroscopic interventions of the knee, shoulder, and hip. Compared to legacy PROM instruments, PROMIS PF-CAT demonstrated the lowest overall survey burden and had the lowest overall number of floor or ceiling effects across participants. CONCLUSION PROMIS PF-CAT is an accurate, efficient evaluation tool for sports medicine surgical patients. PROMIS PF-CAT strongly correlates with legacy physical function PROMs while having a lower test burden and less incidence of floor and ceiling effects. PROMIS PF-CAT may be an optimal alternative for traditional physical function PROMs in sports medicine patients undergoing arthroscopic procedures. Further studies are required to extend the generalizability of these findings to patients during postoperative timepoints after shoulder and hip interventionsLevel of Evidence: III.
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Affiliation(s)
- Jacqueline E. Baron
- Department of Orthopedics and Rehabilitation, University of Iowa Hospitals & Clinics, Iowa City, IA, USA
| | - Emily A. Parker
- Department of Orthopedics and Rehabilitation, University of Iowa Hospitals & Clinics, Iowa City, IA, USA
| | - Brian R. Wolf
- Department of Orthopedics and Rehabilitation, University of Iowa Hospitals & Clinics, Iowa City, IA, USA
| | - Kyle R. Duchman
- Department of Orthopedics and Rehabilitation, University of Iowa Hospitals & Clinics, Iowa City, IA, USA
| | - Robert W. Westermann
- Department of Orthopedics and Rehabilitation, University of Iowa Hospitals & Clinics, Iowa City, IA, USA
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Buckell J, Mei XW, Clarke P, Aveyard P, Jebb SA. Weight loss interventions on health-related quality of life in those with moderate to severe obesity: Findings from an individual patient data meta-analysis of randomized trials. Obes Rev 2021; 22:e13317. [PMID: 34374197 DOI: 10.1111/obr.13317] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2021] [Revised: 06/15/2021] [Accepted: 06/15/2021] [Indexed: 11/26/2022]
Abstract
The relationship between BMI and health-related quality of life (HRQoL) critically affects regulatory approval of interventions for weight loss, but evidence of the association is inconsistent. A higher standard of evidence than that available was sought with an IPD meta-analysis of 10,884 people enrolled in five randomized controlled trials of intentional weight loss interventions. Cross-sectional and longitudinal associations of BMI and HRQoL were estimated in mixed effects models specifying a latent variable for HRQoL. Spline regressions captured nonlinear associations across the range of BMI. In cross-sectional spline regressions, BMI was not associated with HRQoL for people with a BMI < 30 kg/m2 but was for those with a higher BMI. In longitudinal spline regressions, decreases in BMI were positively associated with HRQoL for people with a BMI ≥ 25 kg/m2 . The impact of change in BMI was larger for people with higher BMIs than for those with BMIs under 30 kg/m2 . Lower BMI and decreases in BMI were related to higher HRQoL for people living with obesity but not in the population without excess weight. HRQoL gains from weight loss are greater for more severe obesity. Commissioners should use these estimates for future decision making.
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Affiliation(s)
- John Buckell
- Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Xue W Mei
- Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
| | - Philip Clarke
- Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Paul Aveyard
- Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
| | - Susan A Jebb
- Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
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Abbas SS, Majeed T, Weaver N, Nair BR, Forder PM, Byles JE. Utility estimations of health states of older Australian women with atrial fibrillation using SF-6D. Qual Life Res 2021; 30:1457-1466. [PMID: 33550542 DOI: 10.1007/s11136-020-02748-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/23/2020] [Indexed: 11/27/2022]
Abstract
PURPOSE To estimate SF-6D utility scores for older women with atrial fibrillation (AF); calculate and compare mean utility scores for women with AF with various demographic, health behaviours, and clinical characteristics; and develop a multivariable regression model to determine factors associated with SF-6D utility scores. METHODS This study evaluated N = 1432 women diagnosed with AF from 2000 to 2015 of the old cohort (born 1921-26) of the Australian Longitudinal Study on Women's Health (ALSWH) who remained alive for at least 12 months post first recorded AF diagnosis. Self-reported data on demographics, health behaviours, health conditions, and SF-36 were obtained from the ALSWH surveys, corresponding to within three years of the date of the first record of AF diagnosis. Linked Pharmaceutical Benefits Scheme (PBS) data determined the use of oral anticoagulants and comorbid conditions, included in CHA2DS2-VA (Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes, Stroke or TIA, Vascular disease and Age 65-74 years) score calculation, were assessed using state-based hospital admissions data. Utility scores were calculated for every woman from their SF-36 responses using the SF-6D algorithm with Australian population norms. Mean utility scores were then calculated for women with various demographic, health behaviours, and clinical characteristics. Ordinary Least Square (OLS) regression modelling was performed to determine factors associated with these utility scores. Two different scenarios were used for the analysis: (1) complete-case, for women with complete data on all the SF-36 items required to estimate SF-6D (N = 584 women), and (2) Multiple Imputation (MI) for missing data, applied to missing values on SF-36 items (N = 1432 women). MI scenario was included to gauge the potential bias when using complete data only. RESULTS The mean health utility was estimated to be 0.638 ± 0.119 for the complete dataset and 0.642 ± 0.120 for the dataset where missing values were handled using MI. Using the MI technique, living in regional and remote areas ([Formula: see text]) and the use of oral anticoagulants ([Formula: see text] were positively associated with health utility compared to living in major cities and no use of anticoagulants, respectively. Difficulty to manage on available income [Formula: see text], no/low physical activity [Formula: see text], disability [Formula: see text], history of stroke ([Formula: see text] and history of arthritis [Formula: see text] were negatively associated with health utility. CONCLUSION This study presents health utility estimates for older women with AF. These estimates can be used in future clinical and economic research. The study also highlights better health utilities for women living in regional and remote areas, which requires further exploration.
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Affiliation(s)
- Shazia S Abbas
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.
| | - Tazeen Majeed
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
| | - Natasha Weaver
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
| | - Balakrishnan R Nair
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
| | - Peta M Forder
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
| | - Julie E Byles
- School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia
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Gum JL, Carreon LY, Glassman SD. State-of-the-art: outcome assessment in adult spinal deformity. Spine Deform 2021; 9:1-11. [PMID: 33037596 DOI: 10.1007/s43390-020-00220-3] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2020] [Accepted: 09/28/2020] [Indexed: 12/25/2022]
Abstract
Adult spinal deformity (ASD) is a diagnosis that encompasses heterogeneous disorders with an increasing prevalence. This increasing prevalence may be due to greater patient longevity or greater awareness of available treatments. Outcome assessment in ASD has evolved over the last 3 decades from physician-based assessments to a patient-centered perception of improvement. Outcome assessment that is reliable, accurate and responsive to change is especially important in ASD, as surgical treatment is known to carry a high cost and complication rate Glassman (Spine Deform 3:199-203, 2015); Glassman (Spine (Phila Pa 1976) 32: 2764-2770, 2007); Smith (J Neurosurg Spine 25:1-14, 2016). In an era of value-based care, diagnosis associated with such heterogeneity and high cost must provide sound evidence to support the cost versus outcome ratio. Numerous general health and disease specific patient-reported outcome measures (PROMs) have been utilized in ASD. We discuss these instruments in detail in the following state-of-the-art review.
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Affiliation(s)
- Jeffrey L Gum
- Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY, 40202, USA
| | - Leah Y Carreon
- Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY, 40202, USA.
| | - Steven D Glassman
- Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY, 40202, USA
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Selva-Sevilla C, Ferrara P, Gerónimo-Pardo M. Interchangeability of the EQ-5D and the SF-6D, and comparison of their psychometric properties in a spinal postoperative Spanish population. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2020; 21:649-662. [PMID: 32065301 DOI: 10.1007/s10198-020-01161-4] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/12/2019] [Accepted: 01/23/2020] [Indexed: 06/10/2023]
Abstract
OBJECTIVE EuroQol-5D (EQ-5D) and Short-Form Six-Dimensions (SF-6D) are widely used to calculate quality-adjusted life-years in cost-utility analysis. The choice of the instrument could influence the results of cost-utility analysis. Our objective was to compare the psychometric properties of the EQ-5D and SF-6D in a postoperative Spanish population, as well as assess their interchangeability in a cost-utility analysis. DESIGN Ambispective study. SETTING Tertiary public hospital. PARTICIPANTS 275 Spanish patients who had undergone surgery for lumbar disc herniation. INTERVENTION(S) Patients completed EQ-5D-3L and Short-Form 36 (SF-36v2) questionnaires. Internal consistency, floor and ceiling effects, agreement, and construct validity (convergent validity, including dimension-to-dimension correlations, and "known groups" validity) were assessed. The Spanish tariffs were applied. MAIN OUTCOME MEASURE(S) Cronbach's α coefficient, Spearman's rank correlation coefficient, Lin's concordance correlation coefficient, intraclass correlation coefficient and Bland-Altman plot. RESULTS Main findings were: (a) lack of agreement between EQ-5D and SF-6D utilities (Lin's concordance correlation coefficient: 0.664 [95% CI: 0.600-0.720]; the Bland-Altman plot showed a mean difference of 0.0835 and wide limits of agreement [- 0.2602-0.4272]). (b) Lack of correlation between domains that theoretically measure similar aspects of quality of life, with the exception of "pain" domain. CONCLUSIONS The preference-based EQ-5D and SF-6D instruments showed valid psychometric properties to assess generic outcome in a Spanish population who had undergone surgery for lumbar disc herniation; however, utility scores derived from the measures were different. Thus, these two instruments cannot be used interchangeably to perform a cost-utility analysis, and they should both be included in sensitivity analyses.
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Affiliation(s)
- Carmen Selva-Sevilla
- Department of Applied Economy, Facultad de Ciencias Económicas y Empresariales de Albacete, Universidad de Castilla La-Mancha, Pza. De la Universidad, 1, 02071, Albacete, Spain.
| | - Paula Ferrara
- Department of Neurosurgery, Complejo Hospitalario Universitario de Albacete, Albacete, Spain
| | - Manuel Gerónimo-Pardo
- Department of Anesthesiology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain
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Abstract
Abstract
Background
Various multimodal analgesic approaches have been proposed for spine surgery. The authors evaluated the effect of using a combination of four nonopioid analgesics versus placebo on Quality of Recovery, postoperative opioid consumption, and pain scores.
Methods
Adults having multilevel spine surgery who were at high risk for postoperative pain were double-blind randomized to placebos or the combination of single preoperative oral doses of acetaminophen 1,000 mg and gabapentin 600 mg, an infusion of ketamine 5 µg/kg/min throughout surgery, and an infusion of lidocaine 1.5 mg/kg/h intraoperatively and during the initial hour of recovery. Postoperative analgesia included acetaminophen, gabapentin, and opioids. The primary outcome was the Quality of Recovery 15-questionnaire (0 to 150 points, with 15% considered to be a clinically important difference) assessed on the third postoperative day. Secondary outcomes were opioid use in morphine equivalents (with 20% considered to be a clinically important change) and verbal-response pain scores (0 to 10, with a 1-point change considered important) over the initial postoperative 48 h.
Results
The trial was stopped early for futility per a priori guidelines. The average duration ± SD of surgery was 5.4 ± 2.1 h. The mean ± SD Quality of Recovery score was 109 ± 25 in the pathway patients (n = 150) versus 109 ± 23 in the placebo group (n = 149); estimated difference in means was 0 (95% CI, –6 to 6, P = 0.920). Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152) mg in the placebo group, with the difference in medians being –9 (97.5% CI, –23 to 5, P = 0.175) mg. Mean 48-h pain scores were 4.8 ± 1.8 in the analgesic pathway group versus 5.2 ± 1.9 in the placebo group, with the difference in means being –0.4 (97.5% CI; –0.8, 0.1, P = 0.094).
Conclusions
An analgesic pathway based on preoperative acetaminophen and gabapentin, combined with intraoperative infusions of lidocaine and ketamine, did not improve recovery in patients who had multilevel spine surgery.
Editor’s Perspective
What We Already Know about This Topic
What This Article Tells Us That Is New
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Andayani TM, Kristina SA, Endarti D, Haris RNH, Rahmawati A. Translation, Cultural Adaptation, and Validation of Short-Form 6D on the General Population in Indonesia. Value Health Reg Issues 2020; 21:205-210. [PMID: 32299053 DOI: 10.1016/j.vhri.2019.11.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2019] [Revised: 09/25/2019] [Accepted: 11/27/2019] [Indexed: 11/16/2022]
Abstract
OBJECTIVES This study aims to translate, culturally adapt, and validate the Short-Form 6D (SF-6D) instruments for measuring quality of life as outcome parameters in pharmacoeconomic studies. METHODS The forward-backward methods were applied to translate the SF-6D questionnaire. A preliminary Indonesian version of SF-6D questionnaire was field tested in samples of 470 adult general population. Test-retest reliability was assessed by using Spearman rank correlation coefficient and internal consistency with Cronbach α. Face validity was assessed descriptively based on the response of the respondents to all items in SF-6D. The construct validity test included internal construct validity and convergent validity, which was assessed by examining the correlation between the questionnaire and Euro-Quality of life-5D based on the scale of each domain. The known group method was used to test discriminant validity. Mann-Whitney U test was employed for comparing the utility score on dichotomous variables and Kruskal-Wallis H test was used for polychromatic variables. RESULTS The SF-6D was a valid and reliable questionnaire, indicated by the reliability coefficient of 0.725 and the value of each item ranging from 0.698 to 0.750. Construct validity indicated a strong correlation between physical functioning, role limitation, social functioning, pain, and mental health with the SF-6D utility score. Convergent validity showed a weak and moderate correlation between dimensions on SF-6D and Euro-Quality of life-5D. CONCLUSIONS The SF-6D questionnaire has been translated into Indonesian version. The SF-6D questionnaire is valid and reliable. Known group validity shows that the SF-6D could differentiate utility scores by age group and history present illness.
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Affiliation(s)
- Tri M Andayani
- Department of Pharmacology and Clinical Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia.
| | - Susi A Kristina
- Department of Pharmaceutics, Universitas Gadjah Mada, Yogyakarta, Indonesia
| | - Dwi Endarti
- Department of Pharmaceutics, Universitas Gadjah Mada, Yogyakarta, Indonesia
| | - Restu N H Haris
- Master Program in Pharmaceutical Science, Universitas Gadjah Mada, Yogyakarta, Indonesia
| | - Anindya Rahmawati
- Master Program in Clinical Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
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11
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Tjahjono R, Alvarado R, Kalish L, Sacks R, Campbell R, Marcells G, Orgain C, Harvey RJ. Health Impairment From Nasal Airway Obstruction and Changes in Health Utility Values From Septorhinoplasty. JAMA FACIAL PLAST SU 2020; 21:146-151. [PMID: 30452512 DOI: 10.1001/jamafacial.2018.1368] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
Importance The association of nasal airway obstruction with health is significant, and the health care resources utilized in open septorhinoplasty need to be included in health economic analyses. Objectives To describe the association of nasal airway obstruction and subsequent open septorhinoplasty with patient health. Design, Setting, and Participants A prospective case series study was conducted from September 30, 2009, to October 29, 2015, at 2 tertiary rhinologic centers in Sydney, Australia, among 144 consecutive adult patients (age, ≥18 years) with nasal airway obstruction from septal and nasal valve disorders. Interventions Open septorhinoplasty. Main Outcomes and Measures Patients were assessed before undergoing open septorhinoplasty and then 6 months after the procedure. Health utility values (HUVs) were derived from the 36-Item Short Form Health Survey. Nasal obstruction severity was also measured using the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire and the Sino-Nasal Outcome Test 22 questionnaires. Results A total of 144 patients (85 women and 59 men; mean [SD] age, 38 [13] years) were assessed. The baseline mean (SD) HUV for patients in this study was 0.72 (0.09), which was below the weighted mean (SD) Australian norm of 0.81 (0.22). After open septorhinoplasty, the mean (SD) HUV improved to 0.78 (0.12) (P < .001). Improvements in HUV were associated with changes in disease-specific patient-reported outcome measures, including Nasal Obstruction Symptom Evaluation scores (r = -0.48; P = .01) and Sino-Nasal Outcome Test 22 scores (r = -0.68; P = .01). Conclusions and Relevance Patients with nasal airway obstruction reported baseline HUVs that were lower than the Australian norm and similar to those in individuals with chronic diseases with significant health expenditure. There was a clinically and statistically significant improvement in HUVs after open septorhinoplasty that was associated with a reduction in Nasal Obstruction Symptom Evaluation and Sino-Nasal Outcome Test 22 scores. Outcomes from this study may be used for health economic analyses of the benefit associated with open septorhinoplasty. Level of Evidence 4.
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Affiliation(s)
- Richard Tjahjono
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia.,University of Sydney Medical School, Sydney, Australia
| | - Raquel Alvarado
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia
| | - Larry Kalish
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia.,University of Sydney Medical School, Sydney, Australia
| | - Raymond Sacks
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia.,University of Sydney Medical School, Sydney, Australia.,Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia
| | - Raewyn Campbell
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia.,University of Sydney Medical School, Sydney, Australia
| | - George Marcells
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia
| | - Carolyn Orgain
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia
| | - Richard John Harvey
- Rhinology and Skull Base Research Group, Applied Medical Research Centre, University of New South Wales, Sydney, Australia.,Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia
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12
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Vetkas A, Prans E, Kõks S, Rätsep T, Asser T. Aneurysmal subarachnoid haemorrhage: Effect of CRHR1 genotype on mental health-related quality of life. Sci Rep 2020; 10:724. [PMID: 31959877 PMCID: PMC6971041 DOI: 10.1038/s41598-020-57527-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2019] [Accepted: 12/31/2019] [Indexed: 11/09/2022] Open
Abstract
Quality of life (QoL) disturbances are common after aneurysmal subarachnoid hemorrhage (aSAH) both in physical and mental health domains and their causes are not clearly understood. Corticotropin-releasing hormone receptor 1 (CRHR1) is involved in stress reactivity and development of mental health disturbances after negative life-events. We performed a retrospective cohort study of long-term QoL outcomes among 125 surgically treated aSAH patients (2001-2013). QoL was assessed with Short Form Health Survey (SF-36) and compared to an age and gender matched general population. Genotyping of CRHR1 single nucleotide polymorphisms was performed (Rs7209436, Rs110402, Rs242924) and their effect on QoL scores was explored. aSAH patients experienced a reduced quality of life in all domains. CRHR1 minor genotype was associated with higher SF-36 mental health (OR = 1.31-1.6, p < 0.05), role-emotional (OR = 1.57, p = 0.04) and vitality scores (OR = 1.31-1.38, p < 0.05). Association of all studied SNP's with vitality and Rs242924 with mental health scores remained statistically significant after Bonferroni correction. Mental quality of life scores were associated with physical state of patients, antidepressant history and CRHR1 genotype. Predisposition to mental health disturbances after stressful life-events might be associated with reduced mental QoL after aSAH and selected patients could be provided advanced counselling in the recovery phase.
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Affiliation(s)
| | | | - Sulev Kõks
- Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Perth, WA, Australia.,The Perron Institute for Neurological and Translational Science, Perth, WA, Australia
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13
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Schmitz S, Makovski TT, Adams R, van den Akker M, Stranges S, Zeegers MP. Bayesian Hierarchical Models for Meta-Analysis of Quality-of-Life Outcomes: An Application in Multimorbidity. PHARMACOECONOMICS 2020; 38:85-95. [PMID: 31583600 DOI: 10.1007/s40273-019-00843-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/10/2023]
Abstract
BACKGROUND Health-related quality of life (HRQoL) is a key outcome in cost-utility analyses, which are commonly used to inform healthcare decisions. Different instruments exist to evaluate HRQoL, however while some jurisdictions have a preferred system, no gold standard exists. Standard meta-analysis struggles with the variety of outcome measures, which may result in the exclusion of potentially relevant evidence. OBJECTIVE Using a case study in multimorbidity, the objective of this analysis is to illustrate how a Bayesian hierarchical model can be used to combine data across different instruments. The outcome of interest is the slope relating HRQoL to the number of coexisting conditions. METHODS We propose a three-level Bayesian hierarchical model to systematically include a large number of studies evaluating HRQoL using multiple instruments. Random effects assumptions yield instrument-level estimates benefitting from borrowing strength across the evidence base. This is particularly useful where little evidence is available for the outcome of choice for further evaluation. RESULTS Our analysis estimated a reduction in quality of life of 3.8-4.1% per additional condition depending on HRQoL instrument. Uncertainty was reduced by approximately 80% for the instrument with the least evidence. CONCLUSION Bayesian hierarchical models may provide a useful modelling approach to systematically synthesize data from HRQoL studies.
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Affiliation(s)
- Susanne Schmitz
- Competence Center for Methodology and Statistics, Department of Population Health, Luxembourg Institute of Health, 1 A-B, rue Thomas Edison, 1445, Strassen, Luxembourg.
| | - Tatjana T Makovski
- Epidemiology and Public Health Research Unit, Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg
- Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
- Chairgroup of Complex Genetics and Epidemiology, Nutrition and Metabolism in Translational Research (NUTRIM), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Roisin Adams
- National Centre for Pharmacoeconomics, St James's Hospital, Dublin, Ireland
| | - Marjan van den Akker
- Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
- Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt am Main, Germany
- Academic Centre of General Practice, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
| | - Saverio Stranges
- Epidemiology and Public Health Research Unit, Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
| | - Maurice P Zeegers
- Chairgroup of Complex Genetics and Epidemiology, Nutrition and Metabolism in Translational Research (NUTRIM), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
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14
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Djurasovic M, Gum JL, Crawford CH, Owens K, Brown M, Steele P, Glassman SD, Carreon LY. Cost-effectiveness of minimally invasive midline lumbar interbody fusion versus traditional open transforaminal lumbar interbody fusion. J Neurosurg Spine 2020; 32:31-35. [PMID: 31518977 DOI: 10.3171/2019.6.spine1965] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2019] [Accepted: 06/25/2019] [Indexed: 12/25/2022]
Abstract
OBJECTIVE The midline transforaminal lumbar interbody fusion (MIDLIF) using cortical screw fixation is a novel, minimally invasive procedure that may offer enhanced recovery over traditional open transforaminal lumbar interbody fusion (TLIF). Little information is available regarding the comparative cost-effectiveness of the MIDLIF over conventional TLIF. The purpose of this study was to compare cost-effectiveness of minimally invasive MIDLIF with open TLIF. METHODS From a prospective, multisurgeon, surgical database, a consecutive series of patients undergoing 1- or 2-level MIDLIF for degenerative lumbar conditions was identified and propensity matched to patients undergoing TLIF based on age, sex, smoking status, BMI, diagnosis, American Society of Anesthesiologists Physical Status Classification System (ASA) class, and levels fused. Direct costs at 1 year were collected, including costs associated with the index surgical visit as well as costs associated with readmission. Improvement in health-related quality of life was measured using EQ-5D and SF-6D. RESULTS Of 214 and 181 patients undergoing MIDLIF and TLIF, respectively, 33 cases in each cohort were successfully propensity matched. Consistent with propensity matching, there was no difference in age, sex, BMI, diagnosis, ASA class, smoking status, or levels fused. Spondylolisthesis was the most common indication for surgery in both cohorts. Variable direct costs at 1 year were $2493 lower in the MIDLIF group than in the open TLIF group (mean $15,867 vs $17,612, p = 0.073). There was no difference in implant (p = 0.193) or biologics (p = 0.145) cost, but blood utilization (p = 0.015), operating room supplies (p < 0.001), hospital room and board (p < 0.001), pharmacy (p = 0.010), laboratory (p = 0.004), and physical therapy (p = 0.009) costs were all significantly lower in the MIDLIF group. Additionally, the mean length of stay was decreased for MIDLIF as well (3.21 vs 4.02 days, p = 0.05). The EQ-5D gain at 1 year was 0.156 for MIDLIF and 0.141 for open TLIF (p = 0.821). The SF-6D gain at 1 year was 0.071 for MIDLIF and 0.057 for open TLIF (p = 0.551). CONCLUSIONS Compared with patients undergoing traditional open TLIF, those undergoing MIDLIF have similar 1-year gains in health-related quality of life, with total direct costs that are $2493 lower. Although the findings were not statistically significant, minimally invasive MIDLIF showed improved cost-effectiveness at 1 year compared with open TLIF.
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Affiliation(s)
| | | | | | - Kirk Owens
- 2Research, Norton Leatherman Spine Center, Louisville, Kentucky
| | - Morgan Brown
- 2Research, Norton Leatherman Spine Center, Louisville, Kentucky
| | | | | | - Leah Y Carreon
- 2Research, Norton Leatherman Spine Center, Louisville, Kentucky
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15
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Joseph A, Kosmas CE, Patel C, Doll H, Asherson P. Health-Related Quality of Life and Work Productivity of Adults With ADHD: A U.K. Web-Based Cross-Sectional Survey. J Atten Disord 2019; 23:1610-1623. [PMID: 30215265 PMCID: PMC6732822 DOI: 10.1177/1087054718799367] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
OBJECTIVE The objective of this study was to assess health-related quality of life (HRQoL) in adult ADHD. METHOD U.K. residents aged 18 to 55 years with ADHD and no major mental health comorbidities completed an online survey of disorder history, the EuroQoL 5-Dimensions 5-Level (EQ-5D-5L), and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). ADHD Rating Scale-IV (ADHD-RS-IV) score was assessed by telephone. RESULTS In total, 233 participants completed the study (mean age 32.6 years; 65.2% women). Mean ( SD) ADHD-RS-IV total score, EQ-5D utility, and visual analog scale (VAS) scores were 43.5 (7.88), 0.74 (.21), and 69.8 (17.76), respectively. Mean ( SD) WPAI:GH scores indicated that health problems caused 45.7% (29.9) overall work impairment and 45.8% (28.9) impairment in regular daily activities. Greater work and activity impairment were both significantly independently associated with lower utility after adjusting for age, gender, and somatic comorbidities. CONCLUSION Adult ADHD impairs HRQoL, work productivity, and regular daily activities.
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Affiliation(s)
| | | | | | | | - Philip Asherson
- King’s College London, Greater London,
UK,Philip Asherson, Professor, Institute of
Psychiatry, Psychology and Neuroscience, King’s College London, London, SE5 8AF,
UK.
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16
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Cost-utility Analysis for Recurrent Lumbar Disc Herniation: Conservative Treatment Versus Discectomy Versus Discectomy With Fusion. Clin Spine Surg 2019; 32:E228-E234. [PMID: 30839420 DOI: 10.1097/bsd.0000000000000797] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
STUDY DESIGN This study was an ambispective long-term cost-utility analysis with retrospective chart review and included the prospective completion of health questionnaires by patients. OBJECTIVE This was a cost-utility analysis, comparing conservative treatment, discectomy, and discectomy with spinal fusion for patients with recurrent lumbar disc herniation after a previous discectomy. SUMMARY OF BACKGROUND DATA Lumbar disc herniation is an important health problem, with recurrence rates ranging from 5% to 15%. Management of recurrences is controversial due to a lack of high-level evidence. Cost-effectiveness analyses are useful when making clinical decisions. There are economic assessments for first herniations, but not in the context of recurrent lumbar disc herniations. MATERIALS AND METHODS Fifty patients with disc herniation recurrence underwent conservative treatment (n=11), discectomy (n=20), or discectomy with fusion (n=19), and they completed the Short-Form 36, EuroQol-5D, and Oswestry Disability Index.Baseline case quality-adjusted life year (QALY) values, cost-utility ratios, and incremental cost-utility ratios were calculated on the basis of the SF-36. Direct health costs were calculated by applying the health care system perspective. Both QALY and costs were discounted at a rate of 3%. One-way sensitivity analyses were conducted for uncertainty variables, such as other health surveys or 2-year follow-up. RESULTS Cost-utility analysis of conservative treatment versus discectomy showed that the former is dominant, mainly because it is significantly more economical (&OV0556;904 vs. &OV0556;6718, P<0.001), while health results were very similar (3.48 vs. 3.18, P=0.887). Cost-utility analysis of discectomy versus discectomy with fusion revealed that discectomy is dominant, showing a trend to be both more economical (&OV0556;6718 vs. &OV0556;9364, P=0.054) and more effective (3.18 vs. 1.92 QALY, P=0.061). CONCLUSIONS This cost-utility analysis showed that conservative treatment is more cost-effective than discectomy in patients with lumbar disc herniation recurrence. In cases of recurrence in which conservative treatment is not feasible, and another surgery must be performed for the patient, discectomy is a more cost-effective surgical alternative than discectomy with fusion. LEVEL OF EVIDENCE Level II.
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17
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Ye Z, Sun L, Wang Q. A head-to-head comparison of EQ-5D-5 L and SF-6D in Chinese patients with low back pain. Health Qual Life Outcomes 2019; 17:57. [PMID: 30971265 PMCID: PMC6458837 DOI: 10.1186/s12955-019-1137-6] [Citation(s) in RCA: 31] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2018] [Accepted: 04/02/2019] [Indexed: 01/08/2023] Open
Abstract
BACKGROUND The comparative performance of the 3-level EuroQol 5-dimension and Short Form 6-dimension (SF-6D) has been investigated in patients with low back pain (LBP). The aim of this study was to explore the performance including agreement, convergent validity as well as known-groups validity of the 5-level EuroQol 5-dimension (EQ-5D-5 L) and SF-6D in Chinese patients with LBP. METHODS Individuals with LBP were recruited from a large tertiary hospital in China. All subjects were interviewed using a standardized questionnaire including the EQ-5D-5 L, 36-item Short Form Health Survey (SF-36), the Oswestry questionnaire and socio-demographic questions from June 2017 to October 2017. Agreement was evaluated by intra-class correlation coefficients (ICCs) and Bland-Altman plots. Spearman's rank correlation coefficients were applied to assess convergent validity. For known-groups validity, the Mann-Whitney U test or Kruskal-Wallis H test were used, effect size (ES) and relative efficiency (RE) were also reported. The efficiency of detecting clinically relevant differences was measured by receiver operating characteristic (ROC) curves between pre-specified groups based on Oswestry disability index (ODI), ES and RE statistics were also reported. RESULTS Two hundred seventy-two LBP patients (age 38.1, 38% female) took part in the study. Agreement between the EQ-5D-5 L and the SF-6D was good (ICC 0.661) but with systematic discrepancy in the Bland-Altman plots. In terms of convergent validity, most priori assumptions were more related to EQ-5D-5 L than SF-6D, but MCS derived from SF-36 was more associated with SF-6D. EQ-5D-5 L demonstrated better performance for most groups except location and general health grouped by the general assessment of health item from SF-36. Furthermore, when we applied ODI as external indicator of health status, the area under the ROC curve for EQ-5D-5 L was larger than that for the SF-6D (0.892, 95% CI 0.853 to 0.931 versus 0.822, 95% CI 0.771 to 0.873), the effect size was 0.63 for EQ-5D-5 L and 0.44 for SF-6D, and it was proved that EQ-5D-5 L was 42% more efficient than SF-6D at detecting differences measured by ODI. CONCLUSIONS Both EQ-5D-5 L and SF-6D are valid measures for LBP patients. Even though these two measures had good agreement, they cannot be used interchangeably. The EQ-5D-5 L was superior to the SF-6D in Chinese low back pain patients in this research, with stronger correlation to ODI and better known-groups validity. Further study needs to evaluate other factors, such as responsiveness and reliability.
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Affiliation(s)
- Ziping Ye
- College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Lihua Sun
- College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Qi Wang
- Department of orthopedics, The General Hospital of Shenyang Military Area Command, Shenyang, China
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18
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Tubeuf S, Saloniki EC, Cottrell D. Parental Health Spillover in Cost-Effectiveness Analysis: Evidence from Self-Harming Adolescents in England. PHARMACOECONOMICS 2019; 37:513-530. [PMID: 30294758 DOI: 10.1007/s40273-018-0722-6] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
OBJECTIVE This article presents alternative parental health spillover quantification methods in the context of a randomised controlled trial comparing family therapy with treatment as usual as an intervention for self-harming adolescents, and discusses the practical limitations of those methods. METHODS The trial followed a sample of 754 participants aged 11-17 years. Health utilities are measured using answers to the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) for the adolescent and the Health Utility Index (HUI2) for one parent at baseline, 6 and 12 months. We use regression analyses to evaluate the association between the parent's and adolescent's health utilities as part of an explanatory regression model including health-related and demographic characteristics of both the adolescent and the parent. We then measure cost-effectiveness over a 12-month period as mean incremental cost-effectiveness ratios using various spillover quantification methods. We propose an original quantification based on the use of a household welfare function along with an equivalence scale to generate a health gain within the family to be added to the adolescent's quality-adjusted life-year gain. RESULTS We find that the parent's health utility increased over the duration of the trial and is significantly and positively associated with adolescent's health utility at 6 and 12 months but not at baseline. When considering the adolescent's health gain only, the incremental cost-effectiveness ratio is £40,453 per quality-adjusted life-year. When including the health spillover to one parent, the incremental cost-effectiveness ratio estimates range from £27,167 per quality-adjusted life-year to £40,838 per quality-adjusted life-year and can be a dominated option depending on the quantification method used. CONCLUSION According to the health spillover quantification method considered, the incremental cost-effectiveness ratios vary from within the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold range to not being cost-effective.
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Affiliation(s)
- Sandy Tubeuf
- Academic Unit of Health Economics, University of Leeds, Leeds, LS2 9NL, UK.
- Institute of Health and Society, Université Catholique de Louvain, Louvain-La-Neuve, Belgium.
| | - Eirini-Christina Saloniki
- Centre for Health Services Studies, University of Kent, Kent, UK
- Personal Social Services Research Unit, University of Kent, Kent, UK
| | - David Cottrell
- Psychological and Social Medicine, University of Leeds, Leeds, UK
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19
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Ahnemark E, Di Schiena M, Fredman AC, Medin E, Söderling JK, Ginsberg Y. Health-related quality of life and burden of illness in adults with newly diagnosed attention-deficit/hyperactivity disorder in Sweden. BMC Psychiatry 2018; 18:223. [PMID: 30005675 PMCID: PMC6044069 DOI: 10.1186/s12888-018-1803-y] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2018] [Accepted: 06/27/2018] [Indexed: 01/23/2023] Open
Abstract
BACKGROUND This observational, cross-sectional, retrospective chart review aimed to identify factors determining health-related quality of life (HRQoL) in adults with newly diagnosed attention-deficit/hyperactivity disorder (ADHD) in Sweden. METHODS Adult participants with a new clinical diagnosis of ADHD were enrolled from two specialist outpatient clinics in Stockholm, Sweden, from 2013 to 2015. Data extracted from patient records included demographics, clinical characteristics and comorbid psychiatric diagnoses identified using the Mini International Neuropsychiatric Interview (MINI). Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale - Self-reported (MADRS-S). The self-rated five-dimension EuroQol questionnaire (EQ-5D) was used to measure HRQoL. Predictors of EQ-5D index score were identified using multivariate linear regression adjusting for age, sex, education level, and main income source. RESULTS The mean age of the 189 enrolled patients was 35.2 years (standard deviation [SD], 12.3), and 107 (57%) were female. Psychiatric comorbidities were present in 92 patients (49%), with anxiety and depression being the most common diagnoses. The mean EQ-5D index score was 0.63 (SD, 0.28). Low EQ-5D index scores were significantly associated with high MADRS-S scores, multiple comorbid psychiatric disorders, low educational achievement, female sex, and not having a main income derived from employment or self-employment. CONCLUSIONS These findings suggest that adults with newly diagnosed ADHD experience low HRQoL, which may often be exacerbated by psychiatric comorbidities such as anxiety and depression. Patients presenting with ADHD and psychiatric comorbidities in adulthood may require particular care and resources in the management of their ADHD.
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Affiliation(s)
- E. Ahnemark
- Shire, Vasagatan 7, SE-111 20 Stockholm, Sweden
| | - M. Di Schiena
- Prima Child and Adult Psychiatry AB, Stockholm, Sweden
| | - A.-C. Fredman
- Prima Child and Adult Psychiatry AB, Stockholm, Sweden
- Present Address: Psychiatry Centre, Stockholm County Council, Södertälje, Sweden
| | - E. Medin
- PAREXEL International, Stockholm, Sweden
- Department of Learning, Informatics, Management and Ethics, Karolinska Institute, Stockholm, Sweden
| | | | - Y. Ginsberg
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
- Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institute, Stockholm, Sweden
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20
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Abel H, Kephart G, Packer T, Warner G. Discordance in Utility Measurement in Persons with Neurological Conditions: A Comparison of the SF-6D and the HUI3. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2017; 20:1157-1165. [PMID: 28964449 DOI: 10.1016/j.jval.2017.04.008] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/23/2016] [Revised: 03/10/2017] [Accepted: 04/12/2017] [Indexed: 06/07/2023]
Abstract
OBJECTIVES To examine the extent of disagreement in estimated utility between the six-dimensional health state short form (SF-6D) and the Health Utilities Index-Mark 3 (HUI3) in Canadians with neurological conditions and how discordance varied by participant and neurological condition attributes. METHODS The study analyzed cross-sectional survey data from the Living with and Managing the Impact of a Neurological Condition Study. Self-reported data were collected on the burden and impact of neurological conditions on participants' everyday lives. Disagreement was examined by comparing utility distributions, paired t tests of the means, Spearman ρ correlations, intraclass correlations, and Bland-Altman plots. Associations between participant and neurological condition attributes and utility differences were assessed using multiple regression models. RESULTS Disagreement between the SF-6D and the HUI3 was substantial, with a mean utility difference of 0.15 (95% confidence interval 0.13-0.17). An intraclass correlation coefficient of 0.41 suggests only marginal agreement. The Bland-Altman plot and regression analysis showed systematic variation in utility difference associated with level of utility. Depending on the level of utility, utility differences between the SF-6D and the HUI3 shift in magnitude and direction. The pattern of disagreement did not vary substantially by participant or neurological condition characteristics. CONCLUSIONS The SF-6D and the HUI3 provide inconsistent evaluations of utility in persons with neurological conditions. The magnitude and direction of differences in estimated utility are strongly associated with level of utility. Depending on the health status of the sample, the SF-6D and the HUI3 could provide widely contradictory utility estimates. A concern is that utility scores, and hence potential evaluations and health care decisions, may vary simply according to the choice of instrument.
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Affiliation(s)
- Hannah Abel
- Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada.
| | - George Kephart
- Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Tanya Packer
- School of Occupational Therapy, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Grace Warner
- School of Occupational Therapy, Dalhousie University, Halifax, Nova Scotia, Canada
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21
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Kolovos S, Bosmans JE, van Dongen JM, van Esveld B, Magai D, van Straten A, van der Feltz-Cornelis C, van Steenbergen-Weijenburg KM, Huijbregts KM, van Marwijk H, Riper H, van Tulder MW. Utility scores for different health states related to depression: individual participant data analysis. Qual Life Res 2017; 26:1649-1658. [PMID: 28260149 PMCID: PMC5486895 DOI: 10.1007/s11136-017-1536-2] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/21/2017] [Indexed: 01/30/2023]
Abstract
OBJECTIVES Depression is associated with considerable impairments in health-related quality-of-life. However, the relationship between different health states related to depression severity and utility scores is unclear. The aim of this study was to evaluate whether utility scores are different for various health states related to depression severity. METHODS We gathered individual participant data from ten randomized controlled trials evaluating depression treatments. The UK EQ-5D and SF-6D tariffs were used to generate utility scores. We defined five health states that were proposed from American Psychiatric Association and National Institute for Clinical Excellence guidelines: remission, minor depression, mild depression, moderate depression, and severe depression. We performed multilevel linear regression analysis. RESULTS We included 1629 participants in the analyses. The average EQ-5D utility scores for the five health states were 0.70 (95% CI 0.67-0.73) for remission, 0.62 (95% CI 0.58-0.65) for minor depression, 0.57 (95% CI 0.54-0.61) for mild depression, 0.52 (95%CI 0.49-0.56) for moderate depression, and 0.39 (95% CI 0.35-0.43) for severe depression. In comparison with the EQ-5D, the utility scores based on the SF-6D were similar for remission (EQ-5D = 0.70 vs. SF-6D = 0.69), but higher for severe depression (EQ-5D = 0.39 vs. SF-6D = 0.55). CONCLUSIONS We observed statistically significant differences in utility scores between depression health states. Individuals with less severe depressive symptoms had on average statistically significant higher utility scores than individuals suffering from more severe depressive symptomatology. In the present study, EQ-5D had a larger range of values as compared to SF-6D.
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Affiliation(s)
- Spyros Kolovos
- Department of Health Sciences, and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.
| | - Judith E Bosmans
- Department of Health Sciences, and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands
| | - Johanna M van Dongen
- Department of Health Sciences, and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands
| | - Birre van Esveld
- Department of Health Sciences, and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands
| | - Dorcas Magai
- Department of Clinical, Neuro and Developmental Psychology, and the EMGO Institute for Health and Care Research, Faculty of Behavioural and Movement Sciences, VU University Amsterdam, Amsterdam, The Netherlands
| | - Annemieke van Straten
- Department of Clinical, Neuro and Developmental Psychology, and the EMGO Institute for Health and Care Research, Faculty of Behavioural and Movement Sciences, VU University Amsterdam, Amsterdam, The Netherlands
| | - Christina van der Feltz-Cornelis
- Department of Social Psychiatry Tranzo, Tilburg University, Tilburg, The Netherlands
- Clinical Centre of Excellence for Body, Mind and Health, GGz Breburg, Tilburg, The Netherlands
| | | | | | - Harm van Marwijk
- Centre for Primary Care, Institute for Population Health, University of Manchester, Manchester, UK
- Department of General Practice and Elderly Care Medicine, VU University Medical Centre, Amsterdam, The Netherlands
| | - Heleen Riper
- Department of Clinical, Neuro and Developmental Psychology, and the EMGO Institute for Health and Care Research, Faculty of Behavioural and Movement Sciences, VU University Amsterdam, Amsterdam, The Netherlands
| | - Maurits W van Tulder
- Department of Health Sciences, and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands
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Nazari G, MacDermid JC, Bain J, Levis CM, Thoma A. Estimation of health-related-quality of life depends on which utility measure is selected for patients with carpal tunnel syndrome. J Hand Ther 2016; 30:299-306. [PMID: 27988154 DOI: 10.1016/j.jht.2016.11.001] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2016] [Revised: 10/25/2016] [Accepted: 11/02/2016] [Indexed: 02/09/2023]
Abstract
STUDY DESIGN Cross-sectional. INTRODUCTION Carpal tunnel syndrome (CTS) refers to the compression neuropathy of the median nerve at the wrist. PURPOSE OF THE STUDY To establish the interinstrument reliability, convergent construct validity, and the levels of agreement of health utility indexes 2 and 3 (HUI-2 and HUI-3), EuroQol 5-dimensions (EQ-5D), EuroQol-visual analog scale (EQ-VAS) and to determine the difference of these utility measures based on age and gender in patients with carpal tunnel syndrome. METHODS Seventy-four patients with a confirmed diagnosis of carpal tunnel syndrome completed the 3 questionnaires and EQ-VAS a month before surgery. Demographic characteristics were reported. Intraclass correlation coefficients were used to assess relative interinstrument reliability. Pearson correlation coefficients (r) were used to establish convergent construct validity. Bland-Altman plots and t tests were used to describe the levels of agreement between the 4 utility measures. A 2-way analysis of variance was performed to determine the effect of age and gender on the utility measures; HUI-2, HUI-3, and EQ-5D. RESULTS The intraclass correlation coefficients were 0.85 for HUI-3 vs HUI-2 and 0.80 for HUI-2 vs EQ-VAS. Pearson correlation coefficients ranged from 0.60 to 0.89; HUI-3 vs HUI-2: 0.89, and HUI-3 vs EQ-5D: 0.60. One-sample t test demonstrated significant differences between HUI-3 vs HUI-2, HUI-3 vs EQ-5D, and HUI-3 vs EQ-VAS measures, with mean differences of -0.12, -0.15, and -0.14, respectively. A 2-way analysis of variance test controlling for age and gender indicated neither as predictors of outcome scores. CONCLUSIONS The HUI-3 vs HUI-2 and HUI-2 vs EQ-VAS demonstrated excellent interinstrument relative reliability measures. The HUI-3 vs HUI-2 displayed very strong convergent construct validity measures, and strong validity measures were established between the remaining utility measures. In addition, the pair-wise utility comparisons demonstrated minimal bias between HUI-2 vs EQ-5D, HUI-2 vs EQ-VAS, and EQ-VAS vs EQ-5D measures. DISCUSSION N/A. LEVEL OF EVIDENCE N/A.
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Affiliation(s)
- Goris Nazari
- School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
| | - Joy C MacDermid
- School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
| | - James Bain
- Division of Plastic Surgery, MacHANd, McMaster Medical Centre/Hamilton Health Sciences, Hamilton, Ontario, Canada
| | - Carolyn M Levis
- Division of Plastic Surgery, St. Joseph's Healthcare, Hamilton, Ontario, Canada
| | - Achilleas Thoma
- Division of Plastic Surgery, MacHANd, Hamilton, Ontario, Canada
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Xin Y, McIntosh E. Assessment of the construct validity and responsiveness of preference-based quality of life measures in people with Parkinson’s: a systematic review. Qual Life Res 2016; 26:1-23. [DOI: 10.1007/s11136-016-1428-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/05/2016] [Indexed: 10/20/2022]
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Carreon LY, Glassman SD, Ghogawala Z, Mummaneni PV, McGirt MJ, Asher AL. Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N2QOD data. J Neurosurg Spine 2016; 24:916-21. [DOI: 10.3171/2015.10.spine15917] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
OBJECTIVE
Transforaminal lumbar interbody fusion (TLIF) has become the most commonly used fusion technique for lumbar degenerative disorders. This suggests an expectation of better clinical outcomes with this technique, but this has not been validated consistently. How surgical variables and choice of health utility measures drive the cost-effectiveness of TLIF relative to posterolateral fusion (PSF) has not been established. The authors used health utility values derived from Short Form-6D (SF-6D) and EQ-5D and different cost-effectiveness thresholds to evaluate the relative cost-effectiveness of TLIF compared with PSF.
METHODS
From the National Neurosurgery Quality and Outcomes Database (N2QOD), 101 patients with spondylolisthesis who underwent PSF were propensity matched to patients who underwent TLIF. Health-related quality of life measures and perioperative parameters were compared. Because health utility values derived from the SF-6D and EQ-5D questionnaires have been shown to vary in patients with low-back pain, quality-adjusted life years (QALYs) were derived from both measures. On the basis of these matched cases, a sensitivity analysis for the relative cost per QALY of TLIF versus PSF was performed in a series of cost-assumption models.
RESULTS
Operative time, blood loss, hospital stay, and 30-day and 90-day readmission rates were similar for the TLIF and PSF groups. Both TLIF and PSF significantly improved back and leg pain, Oswestry Disability Index (ODI) scores, and EQ-5D and SF-6D scores at 3 and 12 months postoperatively. At 12 months postoperatively, patients who had undergone TLIF had greater improvements in mean ODI scores (30.4 vs 21.1, p = 0.001) and mean SF-6D scores (0.16 vs 0.11, p = 0.001) but similar improvements in mean EQ-5D scores (0.25 vs 0.22, p = 0.415) as patients treated with PSF. At a cost per QALY threshold of $100,000 and using SF-6D–based QALYs, the authors found that TLIF would be cost-prohibitive compared with PSF at a surgical cost of $4830 above that of PSF. However, with EQ-5D–based QALYs, TLIF would become cost-prohibitive at an increased surgical cost of $2960 relative to that of PSF. With the 2014 US per capita gross domestic product of $53,042 as a more stringent cost-effectiveness threshold, TLIF would become cost-prohibitive at surgical costs $2562 above that of PSF with SF-6D–based QALYs or at a surgical cost exceeding that of PSF by $1570 with EQ-5D–derived QALYs.
CONCLUSIONS
As with all cost-effectiveness studies, cost per QALY depended on the measure of health utility selected, durability of the intervention, readmission rates, and the accuracy of the cost assumptions.
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Affiliation(s)
| | | | - Zoher Ghogawala
- 2Alan and Jacqueline Stuart Spine Center, Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts
| | - Praveen V. Mummaneni
- 3Department of Neurological Surgery, University of California, San Francisco, California; and
| | - Matthew J. McGirt
- 4Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina
| | - Anthony L. Asher
- 4Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina
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Parkin D, Devlin N, Feng Y. What Determines the Shape of an EQ-5D Index Distribution? Med Decis Making 2016; 36:941-51. [PMID: 27112934 DOI: 10.1177/0272989x16645581] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2014] [Accepted: 02/25/2016] [Indexed: 11/15/2022]
Abstract
BACKGROUND EQ-5D-3L index scores in patient and general populations typically have a nonnormal distribution, divided into 2 distinct groups. It is important to understand to what extent this is determined by the way that the EQ-5D-3L index is constructed rather than by the true distribution of ill health. OBJECTIVE This paper examines the determinants of the "2 groups" distribution pattern and the extent to which this pattern is attributable either to the EQ-5D-3L classification system used to create health state profiles or to the weights applied to profiles. METHODS Data from the English NHS PROMs program (hip and knee replacements and varicose vein and hernia repairs) and from a study of 2 chronic conditions (asthma and angina) were used to compare the distributions of EQ-5D-3L index scores with distributions from which weights have been stripped; profile data decomposed into their constituent dimensions and levels; a condition-specific index; and using weights from different countries, based on both time tradeoff and visual analogue scale. RESULTS The EQ-5D-3L classification system generates differences between patients with the same condition in respect of dimensions that are mainly observed at level 2 or 3. The weights commonly used to calculate the index exacerbate this grouping by placing a larger weight on level 3 observations, generating a noticeable gap in index scores between the groups. CONCLUSIONS Analyzing EQ-5D profile data enables a better understanding of the resulting distribution of EQ-5D scores. The distinctive shape observed for these distributions is the result of both the classification system and the weights applied to it.
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Affiliation(s)
- David Parkin
- Department of Primary Care and Public Health Sciences, King's College London, London, UK (DP)
| | | | - Yan Feng
- Office of Health Economics, London, UK (ND, YF)
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Abstract
STUDY DESIGN Systematic review. OBJECTIVE This systematic review examines validity and responsiveness of three generic preference-based measures in patients with low back pain (LBP). SUMMARY OF BACKGROUND DATA LBP is a very common incapacitating disease with a significant impact on health-related quality of life (HRQoL). Health state utility values can be derived from various preference-based HRQoL instruments, and among them the most widely ones are EuroQol 5 dimensions (EQ-5D), Short Form 6 Dimensions (SF-6D), and Health Utilities Index 3 (HUI III). The ability of these instruments to reflect HRQoL has been tested in various contexts, but never for LBP populations. METHODS A systematic search on electronic literature databases was undertaken to identify studies of patients with LBP where health state utility values were reported. Records were screened using a set of predefined eligibility criteria. Data on validity (correlations and known group methods) and responsiveness (effect sizes, standardized response means, tests of statistical significance) of instruments were extracted using a customized extraction template, and assessed using predefined criteria. RESULTS There were substantial variations in the 37 included papers identified in relation to study design and outcome measures used. EQ-5D demonstrated good convergent validity, as it was able to distinguish between known groups. EQ-5D was also able to capture changes of health states as results of different interventions. Evidence for SF-6D and HUI III was limited to allow an appropriate evaluation. CONCLUSION EQ-5D performs well in LBP population and its scores seem to be suitable for economic evaluation of LBP interventions. However, the paucity of information on the other instruments makes it impossible to determine its relative validity and responsiveness compared with them.
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Richardson J, Iezzi A, Khan MA, Chen G, Maxwell A. Measuring the Sensitivity and Construct Validity of 6 Utility Instruments in 7 Disease Areas. Med Decis Making 2015; 36:147-59. [DOI: 10.1177/0272989x15613522] [Citation(s) in RCA: 56] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2014] [Accepted: 09/20/2015] [Indexed: 01/13/2023]
Abstract
Background. Health services that affect quality of life (QoL) are increasingly evaluated using cost utility analyses (CUA). These commonly employ one of a small number of multiattribute utility instruments (MAUI) to assess the effects of the health service on utility. However, the MAUI differ significantly, and the choice of instrument may alter the outcome of an evaluation. Aims. The present article has 2 objectives: 1) to compare the results of 3 measures of the sensitivity of 6 MAUI and the results of 6 tests of construct validity in 7 disease areas and 2) to rank the MAUI by each of the test results in each disease area and by an overall composite index constructed from the tests. Methods. Patients and the general public were administered a battery of instruments, which included the 6 MAUI, disease-specific QoL instruments (DSI), and 6 other comparator instruments. In each disease area, instrument sensitivity was measured 3 ways: by the unadjusted mean difference in utility between public and patient groups, by the value of the effect size, and by the correlation between MAUI and DSI scores. Content and convergent validity were tested by comparison of MAUI utilities and scores from the 6 comparator instruments. These included 2 measures of health state preferences, measures of subjective well-being and capabilities, and generic measures of physical and mental QoL derived from the SF-36. Results. The apparent sensitivity of instruments varied significantly with the measurement method and by disease area. Validation test results varied with the comparator instruments. Notwithstanding this variability, the 15D, AQoL-8D, and the SF-6D generally achieved better test results than the QWB and EQ-5D-5L.
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Affiliation(s)
- Jeff Richardson
- Centre for Health Economics, Monash Business School, Monash University, Australia (JR, AI, MAK, AM)
- Flinders Health Economics Group, Flinders University, Australia (GC)
| | - Angelo Iezzi
- Centre for Health Economics, Monash Business School, Monash University, Australia (JR, AI, MAK, AM)
- Flinders Health Economics Group, Flinders University, Australia (GC)
| | - Munir A. Khan
- Centre for Health Economics, Monash Business School, Monash University, Australia (JR, AI, MAK, AM)
- Flinders Health Economics Group, Flinders University, Australia (GC)
| | - Gang Chen
- Centre for Health Economics, Monash Business School, Monash University, Australia (JR, AI, MAK, AM)
- Flinders Health Economics Group, Flinders University, Australia (GC)
| | - Aimee Maxwell
- Centre for Health Economics, Monash Business School, Monash University, Australia (JR, AI, MAK, AM)
- Flinders Health Economics Group, Flinders University, Australia (GC)
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Glassman SD, Carreon LY, Ghogawala Z, Foley KT, McGirt MJ, Asher AL. Benefit of Transforaminal Lumbar Interbody Fusion vs Posterolateral Spinal Fusion in Lumbar Spine Disorders. Neurosurgery 2015; 79:397-405. [DOI: 10.1227/neu.0000000000001118] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
Abstract
BACKGROUND:
Despite increasing use and potential benefits of transforaminal lumbar interbody fusion (TLIF) compared with posterolateral spinal fusion (PSF), previous studies have not documented improved clinical outcomes with TLIF vs PSF.
OBJECTIVE:
To compare the outcomes of TLIF with PSF in patients with spondylolisthesis, spinal stenosis, and adjacent level disease.
METHODS:
The National Neurosurgical Quality and Outcomes Database was queried for patients who had a lumbar fusion. Eighty-five percent (1722) of enrolled cases had 12-month follow-up data. There were 306 PSF patients and 1230 TLIF patients. PSF cases within each diagnostic subgroup were propensity-matched to patients who had TLIF. Sufficient propensity-matched controls were available for patients with spondylolisthesis (109), spinal stenosis (63), and adjacent segment disease (47).
RESULTS:
Operating room time, estimated blood loss, and length of stay were similar between PSF and TLIF in all 3 propensity-matched groups. In the spondylolisthesis group, there was a greater improvement in Oswestry Disability Index (ODI) with TLIF vs PSF at 3 months (19.4 vs 26.0, P =.009), 12 months (20.8 vs 29.3, P =.001), and in percentage reaching minimal clinically important difference at 12 months (80% vs 62%, P =.007). There were no differences in ODI improvement between PSF and TLIF in the stenosis or adjacent segment disease groups.
CONCLUSION:
TLIF generated more favorable ODI outcomes than PSF for patients with spondylolisthesis, but not for patients with spinal stenosis or adjacent segment disease. There was also equivalence in operating room time and estimated blood loss between TLIF and PSF, potentially altering the long-standing assumption that PSF is a simpler procedure.
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Affiliation(s)
| | | | - Zoher Ghogawala
- †Alan and Jacqueline Stuart Spine Center, Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts
| | - Kevin T. Foley
- §Department of Neurosurgery, University of Tennessee Health Science Center and Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee
| | - Matthew J. McGirt
- ¶Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina
| | - Anthony L. Asher
- ¶Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina
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Health-related quality-of-life outcomes after open versus endovascular abdominal aortic aneurysm repair. J Vasc Surg 2015. [DOI: 10.1016/j.jvs.2015.05.032] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
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Chotai S, Parker SL, Sivaganesan A, Godil SS, McGirt MJ, Devin CJ. Quality of Life and General Health After Elective Surgery for Cervical Spine Pathologies. Neurosurgery 2015; 77:553-60; discussion 560. [DOI: 10.1227/neu.0000000000000886] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
Abstract
BACKGROUND:
As part of the Affordable Care Act, health utility metrics are being investigated to define a cost-effective, value-based health care model. EuroQOL-5D (EQ-5D) and Short Form-6D (SF-6D) are commonly used quality-of-life instruments. Domains in the EQ-5D questionnaire are thought to be less responsive in measuring quality of life after cervical surgery.
OBJECTIVE:
To evaluate the validity and responsiveness of SF-6D and EQ-5D in determining health and quality of life after elective cervical spine surgery.
METHODS:
A total of 420 patients undergoing elective cervical spine surgery over a period of 2 years were enrolled in a prospective longitudinal registry. Patient-reported outcomes Neck Disability Index (NDI), EQ-5D, and SF-12 were recorded. Based on previously published equations, SF-6D was calculated using NDI and SF-12 scores. Patients were asked whether “surgery met their expectations” (meaningful improvement). The validity and relative responsiveness of SF-6D (NDI), SF-6D (SF-12), and EQ-5D to discriminate between meaningful and nonmeaningful improvement were calculated.
RESULTS:
Sixty-six percent of patients (277) reported a level of improvement after surgery that met their expectations (meaningful improvement). SF-6D (NDI) (area under the curve [AUC] = 0.69) was a more valid discriminator of meaningful improvement compared with the SF-6D (SF-12) (AUC = 0.65) and EQ-5D (AUC = 0.62). SF-6D (NDI) was also a more responsive measure compared with SF-6D (SF-12) and EQ-5D (standardized response mean difference: 0.66, 0.48, and 0.44, respectively).
CONCLUSION:
SF-6D is a more valid and responsive measure of general health and quality of life compared with EQ-5D. SF-6D derived from disease-specific disability scores was more valid and responsive than that derived from the generic preference-based SF-12. Cost-effective studies should use SF-6D as a measure of QALY after cervical spine surgery.
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Affiliation(s)
- Silky Chotai
- Department of Orthopedics Surgery and Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Scott L. Parker
- Department of Orthopedics Surgery and Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Ahilan Sivaganesan
- Department of Orthopedics Surgery and Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Saniya S. Godil
- Department of Orthopedics Surgery and Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Matthew J. McGirt
- Department of Neurological Surgery, Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina
| | - Clinton J. Devin
- Department of Orthopedics Surgery and Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
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Parker SL, McGirt MJ. Determination of the minimum improvement in pain, disability, and health state associated with cost-effectiveness: introduction of the concept of minimum cost-effective difference. Neurosurgery 2015; 76 Suppl 1:S64-70. [PMID: 25692370 DOI: 10.1227/01.neu.0000462079.96571.dc] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients. OBJECTIVE To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED). METHODS Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50,000/QALY and < $75,000/QALY. MCID was determined with the health transition item as the anchor. RESULTS Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42,854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43,560 vs $112,087), visual analog scale for back pain ($41,280 vs $129440), Oswestry Disability Index ($30,954 vs $121,750), and EuroQol 5D ($35800 vs $189412). CONCLUSION MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50,000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.
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Affiliation(s)
- Scott L Parker
- Department of Neurosurgery, Vanderbilt University Medical Center, and Vanderbilt Spinal Column Surgical Quality and Outcomes Research Laboratory, Nashville, Tennessee
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Lubelski D, Alvin MD, Torre-Healy A, Abdullah KG, Nowacki AS, Whitmore RG, Steinmetz MP, Benzel EC, Mroz TE. Quality-of-Life Outcomes following Thoracolumbar and Lumbar Fusion with and without the Use of Recombinant Human Bone Morphogenetic Protein-2: Does Recombinant Human Bone Morphogenetic Protein-2 Make a Difference? Global Spine J 2014; 4:245-54. [PMID: 25396105 PMCID: PMC4229380 DOI: 10.1055/s-0034-1394123] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2014] [Accepted: 08/12/2014] [Indexed: 01/22/2023] Open
Abstract
Design Retrospective study. Objectives (1) To investigate the quality-of-life (QOL) outcomes in the population undergoing lumbar spine surgery with versus without recombinant human bone morphogenetic protein-2 (rhBMP-2); (2) to determine QOL outcomes for those patients who experience postoperative complications; and (3) to identify the effect of patient characteristics on postoperative QOL outcomes. Methods A retrospective review of QOL questionnaires, including the Patient Health Questionnaire-9, Patient Disability Questionnaire (PDQ), EuroQol-5D (EQ-5D), and quality of life-year (QALY), was performed for all patients who underwent thoracolumbar and lumbar fusion surgery with versus without rhBMP-2 between March 2008 and September 2010. Individual preoperative and postoperative QOL data were compared for each patient. Demographic factors and complications were reviewed. Results We identified 266 patients, including 60 with and 206 without rhBMP-2. Questionnaires were completed an average of 10.3 ± 5 months after surgery. For all measures, average scores improved postoperatively compared with preoperatively. No differences in postoperative QOL outcomes were identified between the rhBMP-2 and the control cohorts. Median annual household income was positively associated with EQ-5D and QALY. Compared with those without, patients with postoperative complications had fewer QOL improvements. Conclusions There was no difference in QOL outcomes in the rhBMP-2 compared with the control group. Socioeconomic status and postoperative complications affected QOL outcomes following surgery. The QOL questionnaires provide the clinician with information regarding the patients' self-perceived well-being and can be helpful in the selection of surgical candidates and for understanding the effectiveness of a given surgical procedure.
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Affiliation(s)
- Daniel Lubelski
- Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States,Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, Ohio, United States,Department of Neurological Surgery, Cleveland Clinic, Cleveland, Ohio, United States
| | - Matthew D. Alvin
- Case Western Reserve University School of Medicine, Cleveland, Ohio, United States
| | - Andrew Torre-Healy
- Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, Ohio, United States,Department of Neurological Surgery, Cleveland Clinic, Cleveland, Ohio, United States
| | - Kalil G. Abdullah
- Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
| | - Amy S. Nowacki
- Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States,Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, Ohio, United States,Department of Neurological Surgery, Cleveland Clinic, Cleveland, Ohio, United States,Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, United States
| | - Robert G. Whitmore
- Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
| | - Michael P. Steinmetz
- Department of Neurological Surgery, Case Western Reserve University School of Medicine, MetroHealth Medical Center, Cleveland, Ohio, United States
| | - Edward C. Benzel
- Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States,Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, Ohio, United States,Department of Neurological Surgery, Cleveland Clinic, Cleveland, Ohio, United States
| | - Thomas E. Mroz
- Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States,Cleveland Clinic Center for Spine Health, Cleveland Clinic, Cleveland, Ohio, United States,Department of Neurological Surgery, Cleveland Clinic, Cleveland, Ohio, United States,Address for correspondence Thomas E. Mroz, MD Center for Spine Health, Department of Orthopaedic and Neurological SurgeryThe Cleveland Clinic, 9500 Euclid Avenue, S-40, Cleveland, OH 44195United States
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Richardson J, Khan MA, Iezzi A, Maxwell A. Comparing and Explaining Differences in the Magnitude, Content, and Sensitivity of Utilities Predicted by the EQ-5D, SF-6D, HUI 3, 15D, QWB, and AQoL-8D Multiattribute Utility Instruments. Med Decis Making 2014; 35:276-91. [DOI: 10.1177/0272989x14543107] [Citation(s) in RCA: 104] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Background. Cost utility analysis permits the comparison of disparate health services by measuring outcomes in comparable units, namely, quality-adjusted life-years, which equal life-years times the utility of the health state. However, comparability is compromised when different utility instruments predict different utilities for the same health state. The present paper measures the extent of, and reason for, differences between the utilities predicted by the EQ-5D-5L, SF-6D, HUI 3, 15D, QWB, and AQoL-8D. Methods. Data were obtained from patients in seven disease areas and members of the healthy public in six countries. Differences between public and patient utilities were estimated using each of the instruments. To explain discrepancies between the estimates, the measurement scales and content of the instruments were compared. The sensitivity of instruments to independently measured health dimensions was measured in pairwise comparisons of all combinations of the instruments. Results. The difference between public and patient utilities varied with the choice of instrument by more than 50% for every disease group and in four of the seven groups by more than 100%. Discrepancies were associated with differences in both the instrument content and their measurement scales. Pairwise comparisons of instruments found that variation in the sensitivity to physical and psychosocial dimensions of health closely reflected the items in the instrument's descriptive systems. Discussion. Results indicate that instruments measure related but different constructs. They imply that commonly used instruments systematically discriminate against some classes of services, most notably mental health services. Differences in the instrument scales imply the need for transformations between the instruments to increase the comparability of measurement.
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Affiliation(s)
- Jeff Richardson
- Centre for Health Economics, Monash University, Melbourne, Australia (JR, MAK, AI, AM)
| | - Munir A. Khan
- Centre for Health Economics, Monash University, Melbourne, Australia (JR, MAK, AI, AM)
| | - Angelo Iezzi
- Centre for Health Economics, Monash University, Melbourne, Australia (JR, MAK, AI, AM)
| | - Aimee Maxwell
- Centre for Health Economics, Monash University, Melbourne, Australia (JR, MAK, AI, AM)
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Carreon LY, Bratcher KR, Das N, Nienhuis JB, Glassman SD. Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain. J Neurosurg Spine 2014; 21:394-9. [PMID: 24905392 DOI: 10.3171/2014.5.spine13570] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
OBJECT The Neck Disability Index (NDI) and numeric rating scales (0 to 10) for neck pain and arm pain are widely used cervical spine disease-specific measures. Recent studies have shown that there is a strong relationship between the SF-6D and the NDI such that using a simple linear regression allows for the estimation of an SF-6D value from the NDI alone. Due to ease of administration and scoring, the EQ-5D is increasingly being used as a measure of utility in the clinical setting. The purpose of this study is to determine if the EQ-5D values can be estimated from commonly available cervical spine disease-specific health-related quality of life measures, much like the SF-6D. METHODS The EQ-5D, NDI, neck pain score, and arm pain score were prospectively collected in 3732 patients who presented to the authors' clinic with degenerative cervical spine disorders. Correlation coefficients for paired observations from multiple time points between the NDI, neck pain and arm pain scores, and EQ-5D were determined. Regression models were built to estimate the EQ-5D values from the NDI, neck pain, and arm pain scores. RESULTS The mean age of the 3732 patients was 53.3 ± 12.2 years, and 43% were male. Correlations between the EQ-5D and the NDI, neck pain score, and arm pain score were statistically significant (p < 0.0001), with correlation coefficients of -0.77, -0.62, and -0.50, respectively. The regression equation 0.98947 + (-0.00705 × NDI) + (-0.00875 × arm pain score) + (-0.00877 × neck pain score) to predict EQ-5D had an R-square of 0.62 and a root mean square error (RMSE) of 0.146. The model using NDI alone had an R-square of 0.59 and a RMSE of 0.150. The model using the individual NDI items had an R-square of 0.46 and an RMSE of 0.172. The correlation coefficient between the observed and estimated EQ-5D scores was 0.79. There was no statistically significant difference between the actual EQ-5D score (0.603 ± 0.235) and the estimated EQ-5D score (0.603 ± 0.185) using the NDI, neck pain score, and arm pain score regression model. However, rounding off the coefficients to fewer than 5 decimal places produced less accurate results. CONCLUSIONS The regression model estimating the EQ-5D from the NDI, neck pain score, and arm pain score accounted for 60% of the variability of the EQ-5D with a relatively large RMSE. This regression model may not be sufficient to accurately or reliably estimate actual EQ-5D values.
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Lubelski D, Alvin MD, Silverstein M, Senol N, Abdullah KG, Benzel EC, Mroz TE. Quality of life outcomes following surgery for patients with coexistent cervical stenosis and multiple sclerosis. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2014; 23:1699-704. [DOI: 10.1007/s00586-014-3331-x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/23/2013] [Revised: 04/23/2014] [Accepted: 04/24/2014] [Indexed: 11/28/2022]
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Estimating EQ-5D values from the Oswestry Disability Index and numeric rating scales for back and leg pain. Spine (Phila Pa 1976) 2014; 39:678-82. [PMID: 24480944 DOI: 10.1097/brs.0000000000000220] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Cross-sectional cohort. OBJECTIVE The purpose of this study is to determine whether the EuroQOL-5D (EQ-5D) can be derived from commonly available low back disease-specific health-related quality of life measures. SUMMARY OF BACKGROUND DATA The Oswestry Disability Index (ODI) and numeric rating scales (0-10) for back pain (BP) and leg pain (LP) are widely used disease-specific measures in patients with lumbar degenerative disorders. Increasingly, the EQ-5D is being used as a measure of utility due to ease of administration and scoring. METHODS The EQ-5D, ODI, BP, and LP were prospectively collected in 14,544 patients seen in clinic for lumbar degenerative disorders. Pearson correlation coefficients for paired observations from multiple time points between ODI, BP, LP, and EQ-5D were determined. Regression modeling was done to compute the EQ-5D score from the ODI, BP, and LP. RESULTS The mean age was 53.3 ± 16.4 years and 41% were male. Correlations between the EQ-5D and the ODI, BP, and LP were statistically significant (P < 0.0001) with correlation coefficients of -0.77, -0.50, and -0.57, respectively. The regression equation: [0.97711 + (-0.00687 × ODI) + (-0.01488 × LP) + (-0.01008 × BP)] to predict EQ-5D, had an R2 of 0.61 and a root mean square error of 0.149. The model using ODI alone had an R2 of 0.57 and a root mean square error of 0.156. The model using the individual ODI items had an R2 of 0.64 and a root mean square error of 0.143. The correlation coefficient between the observed and estimated EQ-5D score was 0.78. There was no statistically significant difference between the actual EQ-5D (0.553 ± 0.238) and the estimated EQ-5D score (0.553 ± 0.186) using the ODI, BP, and LP regression model. However, rounding off the coefficients to less than 5 decimal places produced less accurate results. CONCLUSION Unlike previous studies showing a robust relationship between low back-specific measures and the Short Form-6D, a similar relationship was not seen between the ODI, BP, LP, and the EQ-5D. Thus, the EQ-5D cannot be accurately estimated from the ODI, BP, and LP. LEVEL OF EVIDENCE 2.
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Chen JM, Amoodi H, Mittmann N. Cost-utility analysis of bilateral cochlear implantation in adults: a health economic assessment from the perspective of a publicly funded program. Laryngoscope 2014; 124:1452-8. [PMID: 24431194 DOI: 10.1002/lary.24537] [Citation(s) in RCA: 43] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2013] [Revised: 10/18/2013] [Accepted: 11/25/2013] [Indexed: 11/10/2022]
Abstract
OBJECTIVES/HYPOTHESIS To determine the cost-effectiveness of bilateral cochlear implantation (CI) in deaf adults. STUDY DESIGN Cost-utility analysis. METHODS Ninety patients and 52 health professionals served as proxies to estimate the benefit of bilateral cochlear implantation, utilizing the Health Utility Index. Three scenarios were created to reflect 1) deafness without intervention, 2) unilateral CI, and 3) bilateral CI. Cost evaluation reflected the burden on a publicly funded healthcare system. The base case included 25 years of service provision, processor upgrades every 5 years, 50% price reduction for second side, and 15% failure rate. Discounting and sensitivity analyses were applied. RESULTS Costs were $63,632 (unilateral CI), $111,764 (bilateral CI), and $48,132 (incremental cost of second CI). The health preference gained from no intervention to unilateral CI, and to bilateral CI were 0.270 and 0.305. Incremental utility gained by the second implant was 11.5% of total. The incremental cost-utility ratio (ICUR) was $14,658/quality-adjusted life year (QALY) for bilateral CI compared to no intervention. It was stable regardless of discounting or sensitivity analyses. ICUR was $55,020/QALY from unilateral to bilateral CI with higher uncertainties. It improved with differential discounting, further second-side price reduction, and reduced frequency of processor upgrades. ICUR worsened with reduced length of use and higher failure rates. CONCLUSIONS Sequential bilateral CI was cost-effective when compared to no intervention, although gains were made mostly by the first implant. Cost-effectiveness compared to unilateral implantation was borderline but improved through base case variations to reflect long-term gains or cost-saving measures. LEVEL OF EVIDENCE 2C.
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Affiliation(s)
- Joseph M Chen
- Department of Otolaryngology-Head and Neck Surgery, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
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Luo N, Seng BK, Thumboo J, Feeny D, Li SC. A Study of the Construct Validity of the Health Utilities Index Mark 3 (HUI3) in Patients with Schizophrenia. Qual Life Res 2013; 15:889-98. [PMID: 16721648 DOI: 10.1007/s11136-005-5745-8] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/07/2005] [Indexed: 10/24/2022]
Abstract
This study assessed the construct validity of the Health Utilities Index Mark 3 (HUI3) in patients with schizophrenia. Patients with schizophrenia recruited from a tertiary mental hospital in Singapore completed the HUI3, the Short-Form 36 Health Survey (SF-36) and the Schizophrenia Quality of Life Scale (SQLS). Patients were assessed for presence and absence of 22 common psychiatric symptoms. Construct validity was assessed using 6 a priori hypotheses. Two hundred and two patients (mean age: 37.8 years, female: 52%) completed the survey. As hypothesized, overall HUI3 utility scores were correlated with SF-36 measures (Spearman's rho: 0.19 to 0.51), SQLS scales (Spearman's rho: -0.56 to -0.36), and the number of psychiatric symptoms (Spearman's rho: -0.49). The HUI3 emotion attribute was moderately correlated with SF-36 mental health (Spearman's rho: 0.45) and SQLS psychosocial scales (Spearman's rho: -0.43), and HUI3 pain attribute was strongly correlated with SF-36 bodily pain scale (Spearman's rho: 0.58). The mean HUI3 overall, emotion, cognition, and speech scores for patients with schizophrenia were 0.07, 0.09, 0.04 and 0.04 points lower than respective age-, sex- and ethnicity-adjusted population norms (p<0.001 for all, ANCOVA). This study provides evidence for the construct validity of the HUI3 in patients with schizophrenia.
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Affiliation(s)
- Nan Luo
- Health Services Research Unit, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
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Assessment of Quality of Life After Surgery for Spinal Metastases: Position Statement of the Global Spine Tumour Study Group. World Neurosurg 2013; 80:e175-9. [DOI: 10.1016/j.wneu.2013.02.054] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2012] [Revised: 02/02/2013] [Accepted: 02/11/2013] [Indexed: 11/23/2022]
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Variation of health-related quality of life assessed by caregivers and patients affected by severe childhood infections. BMC Pediatr 2013; 13:122. [PMID: 23941314 PMCID: PMC3751113 DOI: 10.1186/1471-2431-13-122] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2013] [Accepted: 08/07/2013] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND The agreement between self-reported and proxy measures of health status in ill children is not well established. This study aimed to quantify the variation in health-related quality of life (HRQOL) derived from young patients and their carers using different instruments. METHODS A hospital-based cross-sectional survey was conducted between August 2010 and March 2011. Children with meningitis, bacteremia, pneumonia, acute otitis media, hearing loss, chronic lung disease, epilepsy, mild mental retardation, severe mental retardation, and mental retardation combined with epilepsy, aged between five to 14 years in seven tertiary hospitals were selected for participation in this study. The Health Utilities Index Mark 2 (HUI2), and Mark 3 (HUI3), and the EuroQoL Descriptive System (EQ-5D) and Visual Analogue Scale (EQ-VAS) were applied to both paediatric patients (self-assessment) and caregivers (proxy-assessment). RESULTS The EQ-5D scores were lowest for acute conditions such as meningitis, bacteremia, and pneumonia, whereas the HUI3 scores were lowest for most chronic conditions such as hearing loss and severe mental retardation. Comparing patient and proxy scores (n = 74), the EQ-5D exhibited high correlation (r = 0.77) while in the HUI2 and HUI3 patient and caregiver scores were moderately correlated (r = 0.58 and 0.67 respectively). The mean difference between self and proxy-assessment using the HUI2, HUI3, EQ-5D and EQ-VAS scores were 0.03, 0.05, -0.03 and -0.02, respectively. In hearing-impaired and chronic lung patients the self-rated HRQOL differed significantly from their caregivers. CONCLUSIONS The use of caregivers as proxies for measuring HRQOL in young patients affected by pneumococcal infection and its sequelae should be employed with caution. Given the high correlation between instruments, each of the HRQOL instruments appears acceptable apart from the EQ-VAS which exhibited low correlation with the others.
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Jutkowitz E, Pizzi L, Hess E, Suh DC, Gitlin LN. Comparison of three societally derived health-state classification values among older African Americans with depressive symptoms. Qual Life Res 2013; 22:1491-8. [PMID: 22972437 PMCID: PMC3822045 DOI: 10.1007/s11136-012-0263-y] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/30/2012] [Indexed: 11/30/2022]
Abstract
PURPOSE To compare societal values across three health-state classification systems in older African Americans with depression and to describe the association of these instruments to depression severity. METHODS We summarized baseline values for EQ-5D (US weights) and HUI2/3 (Canadian weights) and their subscales for 118 older African American participants enrolled in a randomized depression treatment trial and calculated correlations between the different instruments. We evaluated ceiling and floor effects for each instrument by comparing the proportion at the highest and lowest possible score for each tool. Also, utility scores were assessed by level of depression severity (mild, moderate, moderate severe, severe) scores as measured by the Patient Health Questionnaire (PHQ-9). RESULTS Mean utility values were 0.58 (SD = 0.21) for EQ-5D, 0.52 (SD = 0.21) for HUI2, and 0.36 (SD = 0.31) for HUI3. For the EQ-5D, 72 % of participants reported having some problems on the anxiety/depression domain. On the emotion domain for the HUI2, 23 % reported the highest level of impairment compared to only 3 % on the HUI3. No participant scored at the floor for the EQ-5D, HUI2, or HUI3 index; one participant scored at the ceiling value on the HUI3 index. Correlations ranged from 0.63 to 0.82 (all of which were significant at an alpha level of 0.05). In general, utility scores trended inversely with depression level. CONCLUSION Small differences in the three preference-weighted health-state classification systems were evident for this sample of older African Americans with depressive symptoms, with HUI scores lower than EQ-5D. For this sample, utility scores were lower (i.e., poorer) than the general United States population with depression on each utility measure.
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Affiliation(s)
- Eric Jutkowitz
- Department of Health Policy and Management, University of Minnesota School of Public Health, 420 Delaware Street SE, Minneapolis, MN 55455, USA,
| | - Laura Pizzi
- Department of Pharmacy Practice, Jefferson School of Pharmacy, 130 South 9th Street, Suite 1540, Philadelphia, PA 19107, USA,
| | - Edward Hess
- School of Medicine, Johns Hopkins University, 511 N. Washington Street, Baltimore, MD 21205, USA,
| | - Dong-Churl Suh
- College of Pharmacy, Chung-Ang University, 221 Heukseok-dong, Dongjak-gu, Seoul, South Korea,
| | - Laura N. Gitlin
- Johns Hopkins University School of Nursing Center for Innovative Care in Aging, Johns Hopkins University, 525 Wolfe Street, Suite 316, Baltimore, MD 21205, USA,
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Wong CKH, Lam ETP, Lam CLK. Comparison of direct-measured and derived short form six dimensions (SF-6D) health preference values among chronic hepatitis B patients. Qual Life Res 2013; 22:2973-81. [PMID: 23564621 DOI: 10.1007/s11136-013-0403-z] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/25/2013] [Indexed: 11/30/2022]
Abstract
PURPOSE The short form six dimensions (SF-6D) are derived from the SF-36 Health Survey with the intention that item data of the latter are often converted to a preference value, which was subsequently used in economic evaluations of interventions. The aim was to compare the equivalence and sensitivity of health preference values derived from the SF-36/SF-12 Health Surveys to that measured directly by the SF-6D for chronic hepatitis B (CHB) patients. METHODS This was a secondary analysis of the SF-6D and SF-36 data from a baseline sample of 589 patients with CHB infection with different stages of liver diseases. Degree of agreement (equivalence) between direct-measured and derived SF-6D values was determined using spearman correlation and intra-class correlation. Sensitivity and discriminative power of different SF-6D values were compared by standardized effect size and relative efficiency (RE) statistics. RESULTS Significant differences in the direct-measured or derived SF-6D preference values were found between CHB groups. Degree of agreement between SF-6D values was satisfactory. Direct-measured SF-6D was the most efficient, followed by SF-12-derived and the SF-36-derived was the least, based on the standardized effect size and the RE statistics. Sensitivity and discriminative power of direct-measured SF-6D were superior to derived SF-6D among people with different CHB health states. CONCLUSIONS Although direct-measured and derived SF-6D preference values had satisfactory sensitivity in discriminating between CHB groups, direct-measured SF-6D is the most sensitive and preferable method of obtaining health preference.
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Affiliation(s)
- Carlos K H Wong
- Department of Family Medicine and Primary Care, The University of Hong Kong, 3/F, Ap Lei Chau Clinic, 161 Ap Lei Chau Main Street, Ap Lei Chau, Hong Kong Island, Hong Kong,
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Tinelli M, Ryan M, Bond C, Scott A. Valuing benefits to inform a clinical trial in pharmacy : do differences in utility measures at baseline affect the effectiveness of the intervention? PHARMACOECONOMICS 2013; 31:163-171. [PMID: 23329427 DOI: 10.1007/s40273-012-0012-7] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/01/2023]
Abstract
BACKGROUND The generic health-related quality-of-life (HR-QOL) utility measures the EQ-5D and SF-6D are both commonly used to inform healthcare policy developments. However, their application to pharmacy practice is limited and the optimal method to inform policy developments is unknown. OBJECTIVES Our objective was to test the sensitivity of the EQ-5D and SF-6D within pharmacy when measuring whether changes in health status or other co-variates at baseline affect the effectiveness of the intervention at follow-up. A further objective was to consider the implications of the findings for pharmacy research and policy. METHODS The EQ-5D and SF-6D utility measures were employed within a randomized controlled trial (RCT) of community pharmacy-led medicines management for patients with coronary heart disease. The intervention covered a baseline visit with the potential for follow-up. Simultaneous quantile regression assessed the impact of the intervention on both EQ-5D and SF-6D measures at follow-up, controlling for baseline health, appropriateness of treatment, personal characteristics and self-reported satisfaction. RESULTS No statistically significant difference in HR-QOL across the intervention and control groups at follow-up was reported for either measure. Increased health gain was however associated with the baseline utility score (with the EQ-5D more sensitive for those in worse health) and the appropriateness of treatment, but not patient characteristics or self-reported satisfaction. CONCLUSION Neither generic measure detected a gain in HR-QOL as a result of the introduction of an innovative pharmacy-based service. This finding supports other work in the area of pharmacy, where health gains have not changed following interventions. Disease-specific utility measures should be investigated as an alternative to generic approaches such as the EQ-5D and SF-6D. Given that the RCT found an increase in self-reported satisfaction, broader measures of benefit that value patient experiences, such as contingent valuation and discrete-choice experiments, should also be considered in pharmacy.
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Affiliation(s)
- Michela Tinelli
- Health Economics Research Unit (HERU), University of Aberdeen, Aberdeen, UK.
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Cost Effectiveness of Intrathecal Drug Therapy in Management of Chronic Nonmalignant Pain. Clin J Pain 2013; 29:138-45. [DOI: 10.1097/ajp.0b013e31824b5fc9] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
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Oluboyede Y, Tubeuf S, McCabe C. Measuring health outcomes of adolescents: report from a pilot study. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2013; 14:11-19. [PMID: 21785871 DOI: 10.1007/s10198-011-0340-0] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/21/2011] [Accepted: 07/05/2011] [Indexed: 05/31/2023]
Abstract
There is a need to understand the practicality, validity and reliability of using utility measures with children and adolescents. We designed a pilot study in order to help guide the selection of an appropriate health-related quality-of-life (HRQoL) questionnaire for adolescents to be used in the context of a large randomised controlled trial (RCT) of family therapy versus standard treatment for adolescents aged 11-17 years. The pilot study was carried out on a school sample of adolescents in the same age range as the RCT. Adolescents were asked to fill in three HRQoL questionnaires: the standard EQ-5D, the licensed Health Utilities Index HUI, and the child-friendly version of the standard EQ-5D: the EQ-5D for youth (EQ-5D-Y). This report explores the problems with the language and concepts embodied within those HRQoL questionnaires and open discussion regarding how we can value the health of adolescents for cost-utility analysis in a larger study.
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Affiliation(s)
- Yemi Oluboyede
- Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah Building, Room 2.07, 101 Clarendon Road, Leeds LS2 9LJ, UK
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Consciência JADCG. Evolução psicossomática e clínica de pacientes com estenose do canal lombar operados com sistema interespinhoso. COLUNA/COLUMNA 2013. [DOI: 10.1590/s1808-18512013000300008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
OBJETIVO: Procuramos avaliar a eficácia terapêutica de estabilizadores interespinosos na doença degenerativa lombar, e a evolução do índice de depressão e somatização de sintomas preexistentes nesses pacientes. MÉTODOS: Estudamos 20 pacientes com estenose de canal lombar. Considerados diversos critérios de inclusão, os pacientes concordaram em participar do estudo assinando o consentimento livre e esclarecido. Na avaliação clínica e psicossomática utilizamos: Escore Euroqol (EQ-5D); escala visual analógica (EVA) lombar e dos membros inferiores; Oswestry Disability Index versão 2.0 e Modified Somatic Perception Questionnaire (MSPQ) e Zung Self-Rating Depression Scale (ZDS). A análise estatística foi realizada com os testes de Friedman e Wilcoxon, sendo o nível de significância 0,05. RESULTADOS: Existiu uma melhoria em EQ-5D (p<0,001), EVA lombar e dos membros inferiores (p<0,001), ODI (p<0,001), sem alterações significativas no MSPQ (p=0,197). CONCLUSÃO: Em pacientes com doença degenerativa lombar (grau 2 e 3 de Benzel e 3 e 4 de Pfirmann), estáveis em termos psicossomáticos, o uso de estabilizadores interespinosos revelou-se eficaz considerando a evolução clínica e o índice de depressão preexistente relacionado com a patologia diagnosticada.
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Parker SL, McGirt MJ. Determination of the Minimum Improvement in Pain, Disability, and Health State Associated With Cost-Effectiveness. Neurosurgery 2012; 71:1149-55. [DOI: 10.1227/neu.0b013e318271ebde] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
ABSTRACT
BACKGROUND:
Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients.
OBJECTIVE:
To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED).
METHODS:
Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50 000/QALY and < $75 000/QALY. MCID was determined with the health transition item as the anchor.
RESULTS:
Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42 854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43 560 vs $112 087), visual analog scale for back pain ($41 280 vs $129 440), Oswestry Disability Index ($30 954 vs $121 750), and EuroQol 5D ($35 800 vs $189 412).
CONCLUSION:
MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50 000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.
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Affiliation(s)
- Scott L. Parker
- Department of Neurosurgery, Vanderbilt University Medical Center, and Vanderbilt Spinal Column Surgical Quality and Outcomes Research Laboratory, Nashville, Tennessee
| | - Matthew J. McGirt
- Department of Neurosurgery, Vanderbilt University Medical Center, and Vanderbilt Spinal Column Surgical Quality and Outcomes Research Laboratory, Nashville, Tennessee
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Abstract
STUDY DESIGN Longitudinal cohort. OBJECTIVE To present Oswestry Disability Index scores and SF-6D utility values among patients with different diagnostic etiologies who underwent fusion surgery. SUMMARY OF BACKGROUND DATA Several studies have increased our understanding of health-related quality-of-life measures in patients with low back pain. With rising health care costs, cost-utility analysis is increasingly used by decision makers. Thus, clinicians and researchers need to understand the psychometrics and clinical importance of health state utility values in patients with spine disorders. METHODS A total of 1104 patients who had decompression and lumbar fusion with complete data to compute the SF-6D score at baseline and 2-year follow-up were identified. Primary surgical cases were classified as disc pathology (n = 200), spondylolisthesis (n = 288), instability (n = 43), stenosis (n = 134), or scoliosis (n = 44). Revision cases were classified as nonunion (n = 94), adjacent-level degeneration (n = 98), or postdiscectomy revision (n = 203). Baseline SF-6D and change in SF-6D scores at 2 years were compared among the groups as well as primary versus revision cases. RESULTS There were 674 women and 430 men. The mean age at surgery was 56.65 ± 12.7 years. There were 220 (19.9%) smokers. The worst mean baseline SF-6D score was in patients with nonunion (0.492), followed by disc pathology (0.493), adjacent-level degeneration (0.494), postdiscectomy revision (0.499), stenosis (0.504), instability (0.512), spondylolisthesis (0.520), and scoliosis (0.530). There was a statistically significant difference in baseline SF-6D score among the different groups (P = 0.002). The mean change in SF-6D score was greatest in patients with stenosis (0.088), followed by spondylolisthesis (0.085), scoliosis (0.076), disc pathology (0.076), instability (0.073), postdiscectomy revision (0.070), adjacent-level degeneration (0.066), and nonunion (0.050). There was no statistically significant difference in change in SF-6D score among the different groups (P = 0.096). However, revision cases had statistically significantly smaller gains in SF-6D score (0.064) than primary cases (0.082, P = 0.012). CONCLUSION Patients with lumbar degenerative disorders have health state values similar to patients with chronic renal disease, Crohn's disease, or coronary artery disease. Health state values of patients with different indications for surgery differ at baseline and after surgery. Revision cases have worse baseline SF-6D scores and less improvement in scores at 2 years after surgery than primary cases. Further studies are needed to gain a greater understanding of health state utility values in patients with lumbar degenerative disorders.
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Rajan M, Lai KC, Tseng CL, Qian S, Selim A, Kazis L, Pogach L, Sinha A. Estimating utilities for chronic kidney disease, using SF-36 and SF-12-based measures: challenges in a population of veterans with diabetes. Qual Life Res 2012; 22:53-64. [PMID: 22392523 DOI: 10.1007/s11136-012-0139-1] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/12/2012] [Indexed: 01/15/2023]
Abstract
PURPOSE Using transformations of existing quality-of-life data to estimate utilities has the potential to efficiently provide investigators with utility information. We used within-method and across-method comparisons and estimated disutilities associated with increasing chronic kidney disease (CKD) severity. METHODS In an observational cohort of veterans with diabetes (DM) and pre-existing SF-36/SF-12 responses, we used six transformation methods (SF-12 to EQ-5D, SF-36 to HUI2, SF-12 to SF-6D, SF-36 to SF-6D, SF-36 to SF-6D (Bayesian method), and SF-12 to VR-6D) to estimate unadjusted utilities. CKD severity was staged using glomerular filtration rate estimated from serum creatinines, with the modification of diet in renal disease formula. We then used multivariate regression to estimate disutilities specifically associated with CKD severity stage. RESULTS Of 67,963 patients, 22,273 patients had recent-onset DM and 45,690 patients had prevalent DM. For the recent-onset group, the adjusted disutility associated with CKD derived from the six transformation methods ranged from 0.0029 to 0.0045 for stage 2; -0.004 to -0.0009 for early stage 3; -0.017 to -0.010 for late stage 3; -0.023 to -0.012 for stage 4; -0.078 to -0.033 for stage 5; and -0.012 to -0.001 for ESRD/dialysis. CONCLUSION Disutility did not increase monotonically as CKD severity increased. Differences in disutilities estimated using the six different methods were found. Both findings have implications for using such estimates in economic analyses.
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Affiliation(s)
- Mangala Rajan
- Center for Healthcare Knowledge Management, Veterans Health Administration New Jersey, East Orange, NJ, USA
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McDonough CM, Grove MR, Elledge AD, Tosteson ANA. Predicting EQ-5D-US and SF-6D societal health state values from the Osteoporosis Assessment Questionnaire. Osteoporos Int 2012; 23:723-32. [PMID: 21484360 PMCID: PMC4017660 DOI: 10.1007/s00198-011-1619-9] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2010] [Accepted: 02/14/2011] [Indexed: 11/24/2022]
Abstract
SUMMARY Linear regression was applied to data from 275 persons with osteoporosis-related fracture to estimate EQ-5D-US and SF-6D health state values from the Osteoporosis Assessment Questionnaire. The models explained 56% and 58% of the variance in scores, respectively, and root mean square error values (0.096 and 0.085) indicated adequate prediction for use when actual values are unavailable. INTRODUCTION This study was conducted to provide models that predict EQ-5D-US and SF-6D societal health state values from the Osteoporosis Assessment Questionnaire (OPAQ). METHODS OPAQ, EQ-5D, and SF-6D data from individuals at two centers with prior osteoporosis-related fracture were used. Fractures were classified by type as hip/hip-like, spine/spine-like, or wrist/wrist-like. Spearman rank correlations between preference-based system (EQ-5D and SF-6D) dimensions and OPAQ subscales were estimated. Linear regression was used to estimate preference-based system health state values based on OPAQ subscales. We assessed models including age, sex, and fracture type and chose the model with the best performance based on the root mean square error (RMSE) estimate. RESULTS Among the 275 participants (198 women), with mean age of 68 years (range 50-94), the distribution of fracture types included 10% hip/5% hip-like, 18% spine/11% spine-like, and 24% wrist/18% wrist-like. The final regression model for EQ-5D-US included three OPAQ attributes (physical function, emotional status, and symptoms), predicted 56% of the variance in EQ-5D-US scores, and had a RMSE of 0.096. The final model for SF-6D, which included all four OPAQ dimensions, predicted 58% of the variance in SF-6D scores and had a RMSE of 0.085. CONCLUSIONS Two models were developed to estimate EQ-5D-US and SF-6D health state values from OPAQ and demonstrated adequate prediction for use when actual values are not available.
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Affiliation(s)
- C M McDonough
- The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, NH 03756, USA.
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