Trends in the use of patient-reported outcome instruments in neurosurgical adult thoracolumbar deformity and degenerative disease literature.
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ABSTRACT:
SUBMITTER: Algattas H
PROVIDER: S-EPMC5490342 | biostudies-other | 2017 Apr-Jun
REPOSITORIES: biostudies-other
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Project description:Study Design Bibliometric analysis. Objective To determine trends, frequency, and distribution of patient-reported outcome instruments (PROIs) in degenerative cervical spine surgery literature over the past decade. Methods A search was conducted via PubMed from 2004 to 2013 on five journals (The Journal of Bone and Joint Surgery, The Bone and Joint Journal, The Spine Journal, European Spine Journal, and Spine), which were chosen based on their impact factors and authors' consensus. All abstracts were screened and articles addressing degenerative cervical spine surgery using PROIs were included. Articles were then analyzed for publication date, study design, journal, level of evidence, and PROI trends. Prevalence of PROIs and level of evidence of included articles were analyzed. Results From 19,736 articles published, 241 articles fulfilled our study criteria. Overall, 53 distinct PROIs appeared. The top seven most frequently used PROIs were: Japanese Orthopaedic Association score (104 studies), visual analog scale for pain (100), Neck Disability Index (72), Short Form-36 (38), Nurick score (25), Odom criteria (21), and Oswestry Disability Index (15). Only 11 PROIs were used in 5 or more articles. Thirty-three of the PROIs were appeared in only 1 article. Among the included articles, 16% were of level 1 evidence and 32% were of level 4 evidence. Conclusion Numerous PROIs are currently used in degenerative cervical spine surgery. A consensus on which instruments to use for a given diagnosis or procedure is lacking and may be necessary for better communication and comparison, as well as for the accumulation and analysis of vast clinical data across multiple studies.
| S-EPMC4836929 | biostudies-other
Project description:Adult spinal deformity (ASD) is a complex condition that combines scoliosis, kyphosis, pain, and postoperative range of motion limitation. The lack of a scale that can successfully capture this complex condition is a clinical challenge. We aimed to develop a disease-specific scale for ASD. The study included 106 patients (mean age; 68 years, 89 women) with ASD. We selected 29 questions that could be useful in assessing ASD and asked the patients to answer them. The factor analysis found two factors: the main symptom and the collateral symptom. The main symptom consisted of 10 questions and assessed activity of daily living (ADL), pain, and appearance. The collateral symptom consisted of five questions to assess ADL due to range of motion limitation. Cronbach's alpha was 0.90 and 0.84, respectively. The Spearman's correlation coefficient between the change of main symptom and satisfaction was 0.48 (p < 0.001). The effect size of Cohen's d for comparison between preoperative and postoperative scores was 1.09 in the main symptom and 0.65 in the collateral symptom. In conclusion, we have developed a validated disease-specific scale for ASD that can simultaneously evaluate the benefits and limitations of ASD surgery with enough responsiveness in clinical practice.
| S-EPMC10787822 | biostudies-literature
Project description:Study Design Retrospective cross-sectional study. Clinical Question What is the prevalence of cervical spondylosis (CS) and thoracolumbar (TL) spinal deformity in an administrative database during a 4-year study period? Is the prevalence of CS or TL deformity higher in patients who have the other spine diagnosis compared with the overall study population? Are patients with both diagnoses more likely to have undergone spine surgery? Patients and Methods An administrative claims database containing 53 million patients with either Medicare (2005-2008) or private payer (2007-2010) insurance was used to identify patients with diagnoses of CS and/or TL deformity. Disease prevalence between groups was compared using a χ (2) test and reported using prevalence ratios (PR). Results The prevalence of CS was higher in patients with TL deformity than without TL deformity, for both Medicare (PR = 2.81) and private payer (PR = 1.79). Similarly, the prevalence of TL deformity was higher in patients with CS than without CS for both Medicare (PR = 3.19) and private payer (PR = 2.05). Patients with both diagnoses were more likely to have undergone both cervical (Medicare, PR = 1.44; private payer, PR = 2.03) and TL (Medicare, PR = 1.68; private payer, PR = 1.74) spine fusion. All comparisons were significant with p < 0.0001. Conclusions Patients with either CS or TL deformity had a higher prevalence of the other spinal diagnosis compared with the overall disease prevalence in the study population. Patients with both diagnoses had a higher prevalence of having spine surgery compared with patients with only one diagnosis. More studies to identify a causal mechanism for this relationship are warranted.
| S-EPMC3969428 | biostudies-literature
Project description:BackgroundSickle cell disease (SCD) is a chronic condition associated with high mortality and morbidity. It is characterized by acute clinical symptoms such as painful vaso-occlusive crises, which can impair health-related quality of life (HRQL). This study was conducted to identify validated patient-reported outcome (PRO) instruments for use in future trials of potential treatments for SCD.MethodsA systematic literature review (SLR) was performed using MEDLINE and EMBASE to identify United States (US)-based studies published in English between 1997 and 2017 that reported on validated PRO instruments used in randomized controlled trials and real-world settings. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to assess the quality of PRO instruments.ResultsThe SLR included 21 studies assessing the psychometric properties of 24 PRO instruments. Fifteen of those instruments were developed and validated for adults and 10 for children (one instrument was used in both children and young adults aged up to 21 years). Only five of the 15 adult instruments and three of the 10 pediatric instruments were developed specifically for SCD. For most instruments, there were few or no data on validation conducted in SCD development cohorts. Of the 24 PRO instruments identified, 16 had strong internal reliability (Cronbach's α ≥0.80). There was often insufficient information to assess the content validity, construct validity, responsiveness, or test-retest reliability of the instruments identified for both child and adult populations. No validated PRO instruments measuring caregiver burden in SCD were identified.ConclusionsThe evidence on the psychometric properties of PRO instruments was limited. However, the results of this SLR provide key information on such tools to help inform the design of future clinical trials for patients with SCD in the US.
| S-EPMC5963009 | biostudies-literature
Project description:ObjectiveAdult cervical deformity (ACD) is a debilitating spinal condition that causes significant pain, neurologic dysfunction, and functional impairment. Surgery is often performed to correct cervical alignment, but the optimal amount of correction required to improve patient-reported outcomes (PROs) are not yet well-defined.MethodsA review of the literature was performed and Fisher z-transformation (Zr) was used to pool the correlation coefficients between alignment parameters and PROs. The strength of correlation was defined according to the following: poor (0 < r ≤ 0.3), fair (0.3 < r ≤ 0.5), moderate (0.5 < r ≤ 0.8), and strong (0.8 < r ≤ 1).ResultsIncreased C2-7 sagittal vertical axis was fairly associated with increased Neck Disability Index (NDI) (pooled Zr = 0.31; 95% confidence interval [CI], -0.03 to 0.58). Changes in T1 slope minus cervical lordosis poorly correlated with NDI (pooled Zr = -0.04; 95% CI, -0.23 to 0.30). Increased C7-S1 was poorly associated with worse EuroQoL 5-Dimension (pooled Zr = -0.22; 95% CI, -0.36 to -0.06). Correction of horizontal gaze did not correlate with legacy metrics. Modified Japanese Orthopedic Association correlated with C2-slope, C7-S1, and C2-S1.ConclusionSpinal alignment parameters variably correlated with improved health-related quality of life and myelopathy after corrective surgery for ACD. Further studies evaluating legacy PROs, Patient-Reported Outcomes Measurement System, and ACD specific instruments are needed for further validation.
| S-EPMC8497234 | biostudies-literature
Project description:IntroductionAdult spinal deformity (ASD) surgery patients are at higher risk for surgical site infections (SSIs) due to large incisions, high blood loss, long surgical duration, and extensive instrumentation. The use of vancomycin powder has demonstrated inconsistent results in ASD surgery. Antibiotic-impregnated calcium sulfate beads have been used in arthroplasty and foot and ankle surgery with promising results. The purpose of this study was to provide preliminary data on the use of vancomycin-impregnated calcium sulfate beads in the prevention of SSI following ASD surgery and provide comparisons to the use of vancomycin powder.MethodsA retrospective chart review was performed for 95 consecutive surgical ASD patients at a tertiary care center from January 2017 until March 2020. Patients received either vancomycin powder (powder group) or vancomycin-impregnated calcium sulfate beads (bead group) intrawound prior to closure. Patient demographics, operative course, and incidence of postoperative infections were recorded. A two-tailed chi-squared test was performed to compare infection rates.ResultsNinety-five patients were included for review. Forty-two patients were in the powder group and 53 patients were in the bead group. The bead group was older (59.8 vs 67.8 years, p < 0.01) with similar BMI and rates of diabetes, smoking, and length of surgery. There were four postoperative SSI in the powder group requiring operative irrigation and debridement and one SSI in the bead group (9.5% vs 1.9%, p = 0.09). All infections occurred in the first 90 days of the postoperative period.ConclusionPreliminary examination of the use of vancomycin-impregnated calcium sulfate beads demonstrated a 1.9% surgical site infection rate in adult spinal deformity surgical patients, which was not significantly different compared with the 9.5% infection rate in patients who received vancomycin powder. Prospective study is needed to determine if the differences found are significant in a larger number of patients.
| S-EPMC8819864 | biostudies-literature
Project description:Patient-reported outcome instruments provide valuable insight into disease-related morbidity known only to the patient and complement more objective outcome tools in the clinical trial setting. They are of particular importance in systemic sclerosis owing to the challenges around defining disease activity, the episodic nature of many disease-specific manifestations and the paucity of validated objective surrogate outcome measures for use in clinical trials. Early clinical trials of systemic sclerosis often incorporated legacy patient-reported outcome instruments, but the last 20 years has witnessed the emergence of several scleroderma-specific instruments that are now being routinely used alongside other outcomes in systemic sclerosis clinical trials. More recently, the value of patient-reported outcomes has been highlighted by their prominence in the American College of Rheumatology Combined Response Index for Systemic Sclerosis that has been utilized as the primary endpoint of recent clinical trials of early diffuse systemic sclerosis. This review considers the role and performance of the various patient-reported outcome instruments utilized in systemic sclerosis clinical trials, the current positioning of patient-reported outcome instruments within clinical trial endpoint models across the range of systemic sclerosis disease manifestations and, where applicable, we shall highlight areas for future research.
| S-EPMC8922614 | biostudies-literature
Project description:PurposeSymptomatic adult spinal deformity (ASD) with an extremely variable presentation with pain, with and without neurogenic leg pain, and/or disturbed sagittal and coronal balance, causes a significant societal burden of disease. It is an important consequence of the aging adult population, generating a plethora of spine-related interventions with variable treatment efficacy and consistently high costs. Recent years have witnessed more than a threefold increase in the prevalence and treatment of ASD, and further increases over the coming decades are expected with the growing elderly population worldwide. The ability to monitor and assess clinical outcomes has not kept pace with these developments. This paper addresses the pressing need to provide a set of common outcome metrics for this growing group of patients with back pain and other disabilities due to an adult spinal deformity.MethodsThe standard outcome set was created by a panel with global representation, using a thorough modified Delphi procedure. The three-tiered outcome hierarchy (Porter) was used as a framework to capture full cycle of care. The standardized language of the International Classification of Functioning, Disability and Health (WHO-ICF) was used.ResultsConsensus was reached on a core set of 25 WHO-ICF outcome domains ('What to measure'); on the accompanying globally available clinician and patient reported measurement instruments and definitions ('How to measure'), and on the timing of the measurements ('When to measure'). The current work has brought to light domains not routinely reported in the spinal literature (such as pulmonary function, return to work, social participation), and domains for which no adequate instruments have yet been identified (such as how to clinically quantify in routine practice lumbar spinal stenosis, neurogenic claudication, radicular pain, and loss of lower extremity motor function).ConclusionA standard outcome set was developed for patients undergoing treatment for adult spinal deformity using globally available outcome metrics. The current framework can be considered a reference for further work, and may provide a starting point for routine methodical and systematic monitoring of outcomes. Post-COVID e-health may accelerate the routine capture of these types of data.
| S-EPMC8363534 | biostudies-literature
Project description:ObjectiveDegenerative cervical myelopathy [DCM] is a disabling and increasingly prevalent group of diseases. Heterogeneous reporting of trial outcomes limits effective inter-study comparison and optimisation of treatment. This is recognised in many fields of healthcare research. The present study aims to assess the heterogeneity of outcome reporting in DCM as the premise for the development of a standardised reporting set.MethodsA systematic review of MEDLINE and EMBASE databases, registered with PROSPERO (CRD42015025497) was conducted in accordance with PRISMA guidelines. Full text articles in English, with >50 patients (prospective) or >200 patients (retrospective), reporting outcomes of DCM were eligible.Results108 studies, assessing 23,876 patients, conducted world-wide, were identified. Reported outcome themes included function (reported by 97, 90% of studies), complications (reported by 56, 52% of studies), quality of life (reported by 31, 29% of studies), pain (reported by 29, 27% of studies) and imaging (reported by 59, 55% of studies). Only 7 (6%) studies considered all of domains in a single publication. All domains showed variability in reporting.ConclusionsSignificant heterogeneity exists in the reporting of outcomes in DCM. The development of a consensus minimum dataset will facilitate future research synthesis.
| S-EPMC4970758 | biostudies-literature
Project description:Study designA post hoc analysis.ObjectiveAdvances in machine learning (ML) have led to tools offering individualized outcome predictions for adult spinal deformity (ASD). Our objective is to examine the properties of these ASD models in a cohort of adult symptomatic lumbar scoliosis (ASLS) patients.Summary of background dataML algorithms produce patient-specific probabilities of outcomes, including major complication (MC), reoperation (RO), and readmission (RA) in ASD. External validation of these models is needed.MethodsThirty-nine predictive factors (12 demographic, 9 radiographic, 4 health-related quality of life, 14 surgical) were retrieved and entered into web-based prediction models for MC, unplanned RO, and hospital RA. Calculated probabilities were compared with actual event rates. Discrimination and calibration were analyzed using receiver operative characteristic area under the curve (where 0.5=chance, 1=perfect) and calibration curves (Brier scores, where 0.25=chance, 0=perfect). Ninety-five percent confidence intervals are reported.ResultsA total of 169 of 187 (90%) surgical patients completed 2-year follow up. The observed rate of MCs was 41.4% with model predictions ranging from 13% to 68% (mean: 38.7%). RO was 20.7% with model predictions ranging from 9% to 54% (mean: 30.1%). Hospital RA was 17.2% with model predictions ranging from 13% to 50% (mean: 28.5%). Model classification for all three outcome measures was better than chance for all [area under the curve=MC 0.6 (0.5-0.7), RA 0.6 (0.5-0.7), RO 0.6 (0.5-0.7)]. Calibration was better than chance for all, though best for RA and RO (Brier Score=MC 0.22, RA 0.16, RO 0.17).ConclusionsASD prediction models for MC, RA, and RO performed better than chance in a cohort of adult lumbar scoliosis patients, though the homogeneity of ASLS affected calibration and accuracy. Optimization of models require samples with the breadth of outcomes (0%-100%), supporting the need for continued data collection as personalized prediction models may improve decision-making for the patient and surgeon alike.
| S-EPMC9771887 | biostudies-literature