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Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

ABSTRACT: Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM method) from the Fracture Reduction Evaluation (FREE) trial.The FREE trial was a randomised, non-blinded study comparing balloon kyphoplasty with non-surgical care for the treatment of patients with acute painful vertebral fractures. Patients were randomised to treatment (1:1 ratio), and stratified for gender, fracture aetiology, use of bisphosphonates and use of systemic steroids at the time of enrolment. Six outcome measures - Short-form 36 physical component summary (SF-36 PCS) scale, EuroQol 5-Dimension Questionnaire (EQ-5D), Roland-Morris Disability (RMD) score, back pain, number of days with restricted activity in last 2 weeks, and number of days in bed in last 2 weeks - were analysed using four methods for dealing with missing data: CC, LOCF, MM and MI analyses.There were no missing data in baseline covariates values, and only a few missing baseline values in outcome variables. The overall missing-response level increased during follow-up (1 month: 14.5%; 24 months: 28%), corresponding to a mean of 19% missing data during the entire period. Overall patterns of missing response across time were similar for each treatment group. Almost half of all randomised patients were not available for a CC analysis, a maximum of 4% were not included in the LOCF analysis, and all randomised patients were included in the MM and MI analyses. Improved estimates of treatment effect were observed with LOCF, MM and MI compared with CC; only MM provided improved estimates across all six outcomes considered.The FREE trial results are robust as the alternative methods used for substituting missing data produced similar results. The MM method showed the highest statistical precision suggesting it is the most appropriate method to use for analysing the FREE trial data.This trial is registered with ClinicalTrials.gov (number NCT00211211).

SUBMITTER: Ranstam J

PROVIDER: S-EPMC3323461 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

Ranstam Jonas J Turkiewicz Aleksandra A Boonen Steven S Van Meirhaeghe Jan J Bastian Leonard L Wardlaw Douglas D

BMC medical research methodology 20120324

<h4>Background</h4>Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM metho ...[more]

PMID: 22443312

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Project description:This retrospective analysis of insurance claims evaluated real-world trends in prescription fills among patients treated with balloon kyphoplasty (N = 6,656) or vertebroplasty (N = 2,189) following diagnosis of vertebral compression fracture. Among those with evidence of opioid use, nearly half of patients discontinued or reduced prescription fills relative to pre-operative levels.IntroductionVertebral compression fractures (VCF) are associated with debilitating pain, spinal misalignment, increased mortality, and increased healthcare-resource utilization in elderly patients. This study evaluated the effect of balloon kyphoplasty (BKP) or vertebroplasty (VP) on post-procedure opioid prescription fills and payer costs in patients with VCF.MethodsThis was a retrospective analysis of a large, nationally representative insurance-claims database. Clinical characteristics, opioid prescription patterns, and payer costs for subjects who underwent either BKP or VP to treat VCF were evaluated beginning 6 months prior to surgery through 7-month follow-up that included a 30-day, postoperative medication washout. Patient demographics, changes in opioid utilization, and payer costs were analyzed.ResultsA total of 8,845 patients met eligibility criteria (75.3% BKP and 24.7% VP) with a mean of age 77 and 74% female. Among the 75% of patients who used opioids, 48.7% of patients discontinued opioid medication and 8.4% reduced prescription fills versus preoperative baseline. Patients who reduced or discontinued prescriptions exhibited a decrease in all-cause payer costs relative to pre-intervention levels, which was a significantly greater change relative to patients with no change, increase, or new start of opioids.ConclusionsInterventional treatment for VCF was associated with decreased or discontinued opioid prescription fills and reduced payer costs in follow-up in a significant proportion of the study population. Reduction of opioid-based harms may represent a previously unrecognized benefit of vertebral augmentation for VCF, especially in this elderly and medically fragile population.

Project description:Background contextOsteoporotic vertebral fractures (OVFs) can lead to severe pain and reduced function and quality-of-life, but the strength of evidence for treatments remains low, particularly in younger populations.PurposeTo determine whether patients with OVFs who received kyphoplasty had different patterns of healthcare utilization compared to propensity-matched patients who did not receive vertebral augmentation.DesignObservational cohort study.Patient sampleWe identified patients with OVFs from 2007 to 2018 in the IBM MarketScan Commercial Claims and Encounters Databases who received kyphoplasty and compared them to propensity-matched controls who did not receive vertebral augmentation (either kyphoplasty or vertebroplasty).Outcome measuresMajor medical complications within 30 days, fills of opioids from 1-week through 1-month postaugmentation, and spine-related gross covered payments from 3-days postkyphoplasty through 1-year post-OVF.MethodsWe used logistic regression to obtain odds ratios (ORs) and 95% confidence intervals (95% CIs) to compare binary outcomes and median analysis to compare continuous outcomes.ResultsOf the 15,197 OVF patients identified, 1,969 (13%) received kyphoplasty and 1,928 (98%) of these were propensity matched to nonaugmented controls. We did not observe differences in the odds of major medical complications within 30 days (adjusted OR [95% CI]: 1.0 [0.6, 1.8]) but patients who received kyphoplasty were more likely to have filled opioid medications within 30 days (adjusted OR [95% CI]: 1.3 [1.1, 1.5]) and had greater spine-related gross covered payments (kyphoplasty median [95% CI]: $1,340 [$240, $4,850]; nonaugmented: $7,870 [$7,480, $8,270]; adjusted difference in medians [95% CI]: $260 [$190, $2,050]).ConclusionsIn this cohort of patients <65 years, receipt of kyphoplasty was associated with greater likelihood of opioid fills and somewhat greater spine-related gross covered payments, but no difference in major medical complications. In this retrospective study of administrative data, we did not detect advantages of treatment with kyphoplasty compared with nonaugmentation for any of our outcomes.

Project description:BackgroundTo date, few reports have evaluated the long-term outcome of percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fractures (OVCFs) and the factors influencing the long-term outcome of this procedure are uncertain.MethodsA total of 91 patients underwent PKP for thoracolumbar OVCFs from June 2012 to December 2012. Pain Visual Analogue Scores (VAS) and Oswestry Disability Index (ODI) were recorded preoperatively and after 10-year follow-up. Factors that may affect surgical outcome, such as gender, age, height, weight, hypertension, diabetes, cause of injury, fracture segment, length of hospitalization, history of previous spinal surgery, preoperative bone mineral density (BMD), preoperative VAS and ODI scores, length of surgery, bone cement dosage, postoperative standardized anti-osteoporosis treatment, and other new vertebral fractures, were analyzed by multiple linear regression with VAS and ODI scores at the last follow-up. The correlation factors affecting the efficacy were analyzed.ResultsThe preoperative and final follow-up pain VAS was 7.9 ± 1.1 and 2.2 ± 1.1. ODI scores were 30.4 ± 4.2 and 10.7 ± 2.6. The difference was statistically significant (P < 0.05). Most of the patients were females aged 65-75 years who suffered low-energy injuries, with most of the fracture segments in the thoracolumbar region (T11-L2). At the final follow-up visit, 12 cases (13.19%) developed other new vertebral fractures, and 33 cases (36.26%) continued to adhere to anti-osteoporosis treatment after discharge. Multiple linear regression analysis showed that there was a statistical difference between gender and VAS score at the last follow-up (P < 0.05), and between age, cause of injury and postoperative standardized anti-osteoporosis treatment and ODI at the last follow-up (P < 0.05). There were no statistically significant differences between the other factors and the final follow-up VAS and ODI scores (P > 0.05).ConclusionThe long-term outcome after PKP is satisfactory. Age, gender, cause of injury, and standardized postoperative anti-osteoporosis treatment may be factors affecting the long-term outcome.

Project description:Osteoporosis vertebral compression fractures (OVCF) are common with the aging process. This study aimed to compare the effects of unilateral transverse process extrapedicular (UEPKP) and bilateral transpedicular percutaneous kyphoplasty (BTPKP) for patients with thoracolumbar OVCF. Data from 136 patients with OVCF treated with single-level PKP in our hospital between May 2019 and April 2021 were studied. Patients were grouped based on surgical procedure: there were 62 patients in the UEPKP group and 74 in the BTPKP group. All clinical and radiological data were collected from medical records. Clinical outcomes, including visual analog scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores of the lumbar spine, were evaluated preoperatively, postoperatively, and at the follow-up visit. The radiological evaluations (anterior vertebral height rate and local kyphosis angle) and complications were also collected. All patients had successfully improved after surgery. In the UEPKP group, patients showed a significantly shorter operating time and lower fluoroscopy frequency than patients in the BTPKP group (p < 0.05). However, a significantly better distribution score and cement volume were found in the BTPKP group (p < 0.05). The UEPKP group achieved a significantly better VAS score (0.6 ± 0.5 vs. 0.9 ± 0.8) and ODI (24.7 ± 3.1 vs. 27.5 ± 1.8) at the final follow-up visit than the BTPKP group (p < 0.05). The UEPKP group showed significantly worse radiological outcomes (anterior height rate and local kyphosis angle) at the 6- and 12-month follow-ups (p < 0.05). As for complications, the UEPKP group showed significantly fewer facet joint violations and intraspinal leakages (p < 0.05). UEPKP could be a safe and effective alternative procedure for patients with thoracolumbar osteoporotic vertebral compression fracture, which possesses an apparent advantage in reducing intraspinal leakage and facet joint violation over BTPKP.

Dataset Information

Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

Publications

Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

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