Lumbar MR imaging and reporting epidemiology: do epidemiologic data in reports affect clinical management?
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ABSTRACT:
SUBMITTER: McCullough BJ
PROVIDER: S-EPMC3285226 | biostudies-other | 2012 Mar
REPOSITORIES: biostudies-other
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Project description:Background and purposeSeveral studies have examined clinician preferences regarding the style of body sonography and CT reports. Our study is the first to examine clinicians' and radiologists' preferences in lumbar spine CT and MR imaging reports with respect to content and format and specific components such as management suggestions by the radiologist.Materials and methodsA spine report survey, which consisted of 3 case scenarios, each with 6 different reports varying in content and format, was mailed to clinicians and radiologists. Their preferences regarding content, format, and management suggestions were gathered.ResultsA total of 89 clinicians (49%) and 31 radiologists (53%) responded. Both clinicians and radiologists preferred reports with moderate or detailed instead of limited content (P < .01). Itemized and prose formats were equally acceptable to clinicians and radiologists. Although both groups identified moderate CT technique description as ideal, more clinicians valued the inclusion of the quality of a CT study (P < .001). Specialists preferred reports with greater detail but no recommendations, whereas family physicians preferred less detail but wanted specific management suggestions (P < .01). Neuroradiologists (75%-100%) were more likely to provide management suggestions than non-neuroradiologists (23%-59%).ConclusionsClinicians favored lumbar spine CT and MR imaging reports with detailed content in either itemized or structured prose formats, irrespective of the modality or the extent of abnormalities reported. Family physicians preferred management suggestions from the radiologists. Specialists, however, preferred a review of the radiologic findings and an opinion without specific recommendations. To optimize patient care, radiologists should be mindful of these preferences and consider tailoring their reports to their audiences.
| S-EPMC7964006 | biostudies-literature
Project description:Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions.We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging.If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.
| S-EPMC4674321 | biostudies-literature
Project description:PurposeTo characterize the inter- and intraobserver variability of qualitative, non-disk contour degenerative findings of the lumbar spine at magnetic resonance (MR) imaging.Materials and methodsThe case accrual method used to perform this institutional review board-approved, HIPAA-compliant retrospective study was the random selection of 111 interpretable MR examination cases of subjects from the Spine Patient Outcomes Research Trial. The subjects were aged 18-87 years (mean, 53 years +/- 16 [standard deviation]). Four independent readers rated the cases according to defined criteria. A subsample of 40 MR examination cases was selected for reevaluation at least 1 month later. The following findings were assessed: spondylolisthesis, disk degeneration, marrow endplate abnormality (Modic changes), posterior anular hyperintense zone (HIZ), and facet arthropathy. Inter- and intraobserver agreement in rating the data was summarized by using weighted kappa statistics.ResultsInterobserver agreement was good (kappa = 0.66) in rating disk degeneration and moderate in rating spondylolisthesis (kappa = 0.55), Modic changes (kappa = 0.59), facet arthropathy (kappa = 0.54), and posterior HIZ (kappa = 0.44). Interobserver agreement in rating the extent of Modic changes was moderate: kappa Values were 0.43 for determining superior anteroposterior extent, 0.47 for determining superior craniocaudal extent, 0.57 for determining inferior anteroposterior extent, and 0.48 for determining inferior craniocaudal extent. Intraobserver agreement was good in rating spondylolisthesis (kappa = 0.66), disk degeneration (kappa = 0.74), Modic changes (kappa = 0.64), facet arthropathy (kappa = 0.69), and posterior HIZ (kappa = 0.67). Intraobserver agreement in rating the extent of Modic changes was moderate, with kappa values of 0.54 for superior anteroposterior, 0.60 for inferior anteroposterior, 0.50 for superior craniocaudal, and 0.60 for inferior craniocaudal extent determinations.ConclusionThe interpretation of general lumbar spine MR characteristics has sufficient reliability to warrant the further evaluation of these features as potential prognostic indicators.
| S-EPMC2657480 | biostudies-literature
Project description:BACKGROUND:Clinicians, patients, and policy-makers rely on published evidence from clinical trials to help inform decision-making. A lack of complete and transparent reporting of the investigated trial outcomes limits reproducibility of results and knowledge synthesis efforts, and contributes to outcome switching and other reporting biases. Outcome-specific extensions for the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT-Outcomes) and Consolidated Standards of Reporting Trials (CONSORT-Outcomes) reporting guidelines are under development to facilitate harmonized reporting of outcomes in trial protocols and reports. The aim of this review was to identify and synthesize existing guidance for trial outcome reporting to inform extension development. METHODS:We searched for documents published in the last 10 years that provided guidance on trial outcome reporting using: an electronic bibliographic database search (MEDLINE and the Cochrane Methodology Register); a grey literature search; and solicitation of colleagues using a snowballing approach. Two reviewers completed title and abstract screening, full-text screening, and data charting after training. Extracted trial outcome reporting guidance was compared with candidate reporting items to support, refute, or refine the items and to assess the need for the development of additional items. RESULTS:In total, 1758 trial outcome reporting recommendations were identified within 244 eligible documents. The majority of documents were published by academic journals (72%). Comparison of each recommendation with the initial list of 70 candidate items led to the development of an additional 62 items, producing 132 candidate items. The items encompassed outcome selection, definition, measurement, analysis, interpretation, and reporting of modifications between trial documents. The total number of documents supporting each candidate item ranged widely (median 5, range 0-84 documents per item), illustrating heterogeneity in the recommendations currently available for outcome reporting across a large and diverse sample of sources. CONCLUSIONS:Outcome reporting guidance for clinical trial protocols and reports lacks consistency and is spread across a large number of sources that may be challenging to access and implement in practice. Evidence and consensus-based guidance, currently in development (SPIRIT-Outcomes and CONSORT-Outcomes), may help authors adequately describe trial outcomes in protocols and reports transparently and completely to help reduce avoidable research waste.
| S-EPMC7341657 | biostudies-literature
Project description: Not available
| S-EPMC8546498 | biostudies-literature
Project description:BACKGROUND:Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines. METHODS:The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. DISCUSSION:InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.
| S-EPMC6404348 | biostudies-other
Project description:Nontuberculous Mycobacteria (NTM) are environmental microorganisms that can affect human health. A 2009-2010 occurrence survey of NTM in potable tap water samples indicated an increased recovery rate for many clinically significant species such as M. avium (30%) and M. abscessus (12%). To determine if these trends by species were mirrored in human infections, isolation rates of NTM species identified in clinical laboratory reports from four states were evaluated.Clinical laboratory reports from the Mississippi, Missouri, Ohio, and Wisconsin Health Departments were used to investigate the species of NTM isolated from human specimens in 2014. The NTM positive specimen reports were tabulated for each species and complex/group. The number of reports by month were used to investigate seasonal trends. The 2014 isolation rates were compared to historic values to examine longitudinal trends.The positive rate of NTM specimens increased from 8.2 per 100,000 persons in 1994 to 16 per 100,000 persons in 2014 (or 13.3 per 100,000 after excluding Mycobacterium gordonae). Changes in NTM diversity were observed in complex/groups known to be clinically significant. Between 1994 and 2014 the rate implicating M. abscesses-chelonae group and M. avium complex increased by 322 and 149%, respectively.Based on public health data supplied by the four State's Health Departments and the 2014 U.S. population, 50,976 positive NTM specimen reports per year were projected for the nation; serving as an indicator for the national potential disease burden that year.
| S-EPMC5891905 | biostudies-other
Project description:To investigate if the clinical outcome of intra-articular lumbar facet joint injections is affected by the therapist's attitude.A total of 40 patients with facet joint-associated chronic low back pain were randomly divided into two groups. All patients received computed tomography-guided, monosegmental intra-articular facet joint injections. Following the therapeutic procedure, the patients of the experimental group (EG) held a conversation with the radiologist in a comfortable atmosphere. During the dialog, the patients were encouraged to ask questions and were shown four images. The patients of the control group (CG) left the clinic without any further contact with the radiologist. Outcome was assessed using a pain-based Verbal Numeric Scale at baseline, at 1 wk and at 1, 3, and 6 mo after first treatment.The patient demographics showed no differences between the groups. The patients of the EG received 57 interventional procedures in total, while the patients of the CG received 70 interventional procedures. In both groups, the pain scores decreased significantly over the entire observation period. Compared to the CG, the EG showed a statistically significant reduction of pain at 1 wk and 1 mo post-treatment, while at 3 and 6 mo after treatment, there were no significant differences between both groups.Our results show a significant effect on pain relief during the early post-interventional period in the EG as compared to the CG. The basic principle behind the higher efficacy might be the phenomenon of hetero-suggestion.
| S-EPMC4919763 | biostudies-other
Project description:Study Design?Systematic review. Objectives?(1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive information when making treatment decisions. Methods?A systematic search of PubMed, the Cochrane collaboration database, and the National Guideline Clearinghouse through May 2015 was conducted. Randomized controlled trials with at least 2 years of follow-up comparing lumbar artificial disk replacement with lumbar fusion were included. Patients were required to have axial or mechanical low back pain of ?3 months' duration due to degenerative joint disease defined as degenerative disk disease, facet joint disease, or spondylosis. Outcomes included the quality of AE acquisition methodology and results reporting, and AEs were defined as those secondary to the procedure and reoperations. Individual and pooled relative risks and their 95% confidence intervals comparing lumbar TDR with fusion were calculated. Results?RCTs demonstrated a generally poor description of methods for assessing AEs. There was a consistent lack of clear definition or grading for these events. Furthermore, there was a high degree of variation in reporting of surgery-related AEs. Most studies lacked adequate reporting of the timing of AEs, and there were no clear distinctions between acute or chronic AEs. Meta-analysis of the pooled data demonstrated a twofold increased risk of AEs in patients having lumbar fusion compared with patients having lumbar TDR at 2-year follow-up, and this relative risk was maintained at 5 years. Furthermore, the pooled data demonstrated a 1.7 times greater relative risk of reoperation in the fusion group compared with lumbar TDR, although this risk decreased to 1.1 at 5-year follow-up. However, given the lack of quality and consistency in the methods of recording and reporting of AEs, we are unable to make a clear recommendation of one treatment over the other. Conclusions?Based on the currently available literature, lumbar TDR appears to be comparable in safety to lumbar fusion. However, due to lack of consistency in reporting of AEs, it is difficult to make conclusions regarding the true safety profile of lumbar TDR. Standardization in AE reporting will significantly improve the reliability of the current literature.
| S-EPMC4671900 | biostudies-other
Project description:Background and purposeIn MS, the relation between clinical and MR imaging measures is still suboptimal. We assessed the correlation of disability and specific impairment of the clinical functional system with overall and regional CNS damage in a large cohort of patients with MS with different clinical phenotypes by using a random forest approach.Materials and methodsBrain conventional MR imaging and DTI were performed in 172 patients with MS and 46 controls. Cervical cord MR imaging was performed in a subgroup of subjects. To evaluate whether MR imaging measures were able to correctly classify impairment in specific clinical domains, we performed a random forest analysis.ResultsBetween-group differences were found for most of the MR imaging variables, which correlated significantly with clinical measures (r ranging from -0.57 to 0.55). The random forest analysis showed a high performance in identifying impaired versus unimpaired patients, with a global error between 7% (pyramidal functional system) and 31% (Ambulation Index) in the different outcomes considered. When considering the performance in the unimpaired and impaired groups, the random forest analysis showed a high performance in identifying patients with impaired sensory, cerebellar, and brain stem functions (error below 10%), while it performed poorly in defining impairment of visual and mental systems (error of 91% and 70%, respectively). In analyses with a good level of classification, for most functional systems, damage of the WM fiber bundles subserving their function, measured by using DTI tractography, had the highest classification power.ConclusionsRandom forest analysis, especially if applied to DTI tractography data, is a valuable approach, which might contribute to overcoming the MS clinical-MR imaging paradox.
| S-EPMC7964386 | biostudies-literature