How should minimally important change (MIC) scores for the Patient Oriented Eczema Measure (POEM) be interpreted?: a validation using varied methods

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the MIC of the POEM is 3 points. Further assessment of the minimally important change (MIC) of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. Objectives To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate to severe atopic eczema. Methods This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate to severe eczema. Results Data was collected from 300 children. The smallest detectable change was 2.12. The MIC estimates were 1.07 (0.2 SD) and 2.68 (0.5 SD) based on distribution-based methods, were 3.09 to 6.13 based on patient-reported anchor-based methods, and were 3.23 to 5.38 based on investigator-reported anchor-based methods. Conclusions We recommend the following thresholds are used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2.1 to 2.9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3 to 3.9, probably a clinically important change; 4+, very likely to be a clinically important change

Anterior Lumbar Interbody Implants: Importance of the Interdevice Distance

Object. The implantation of interbody fusion cages allows for the restoration of disc height and the enlargement of the neuroforaminal space. The purpose of this study was to compare the extent of subsidence occurring after conventional cage placement compared to a novel wider cage placement technique. Methods. This study is a retrospective evaluation of radiographs of patients who underwent stand-alone single level anterior lumbar interbody fusion with lordotic titanium cages and rhBMP-2. Fifty-three patients were evaluated: 39 patients had wide cage placement (6 mm interdevice distance) and 14 had narrow cage placement (2 mm interdevice distance). Anterior and posterior intervertebral disc space heights were measured post-operatively and at follow-up imaging. Results. The decrease in anterior intervertebral disc space height was 2.05 mm versus 3.92 mm (P < .005) and 1.08 mm versus 3.06 mm in posterior disc space height for the wide cage placement and the narrow cage placement respectively. The proportion of patients with subsidence greater than 2 mm was 41.0% in the wide cage patients and 85.7% for the narrow cage patients (P < .005). Conclusions. The wider cage placement significantly reduced the amount of subsidence while allowing for a greater exposed surface area for interbody fusion

Patterns of change and stability in caregiver burden and life satisfaction from 1 to 2 years after severe traumatic brain injury : a Norwegian longitudinal study

Objectives: To assess burden and life satisfaction in caregivers of patients with severe traumatic brain injury (sTBI) at 1 and 2 years post-injury, to examine if change in burden can be predicted by caregiver and patient demographics, patient’s functional status, caregiver’s social network or caregiver’s level of burden at 1 year. Design: Prospective national multicenter study. Self-report from caregivers, patient data collected from a national cohort study on patients with sTBI. Participants: 80 caregivers. Main outcome measure: The Caregiver Burden Scale (CBS), life satisfaction. Results: The total caregiver burden increased significantly between years 1 and 2 post-injury (p=0.04). Life Satisfaction was significantly lower at 2 years follow-up (p=0.03) than at 1 year. Thirty percent of the caregivers reported an increased burden, 55% were stable, and 15% had a decrease in burden between the two follow-up times. Logistic regression analyses revealed that experiencing loneliness was an independent predictor of increased burden from 1 to 2 years post-injury (OR=4.35, p<0.05). Conclusions: The results demonstrate a need for long-term follow-up of patients and caregivers that particularly focuses on professional support to relieve caregiver burden and risk of loneliness or social isolation. This group may benefit from additional follow-up interventions tailored to their needs

Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears

Background Knowledge about Minimal Important Differences (MIDs) is essential for the interpretation of continuous outcomes, especially patient-reported outcome measures (PROMS). Objective The aim of this study was to estimate the MID for the Western Ontario Rotator Cuff Index (WORC: score 0 (best) to 2100 (worst disability)) in adults with shoulder pain associated with partial-thickness rotator cuff tears, ‘symptomatic PTTs’, undergoing conservative treatment with physiotherapy. Design A prospectively-designed anchor-based MID analysis using data from a prospective prognostic study with a three-month follow-up conducted within an outpatient care setting in Germany. Methods The MID was estimated using data from 64 adults with atraumatic symptomatic PTTs who underwent three months of conservative treatment with physiotherapy. The anchor was a seven-point Global Perceived Change (GPC) scale. Results Based on a definition of the MID being the threshold of “being (at least slightly) improved” with a probability nearest to 0.90 (i.e. 9 of 10 patients achieving the MID), the MID for the WORC was estimated as −300 for ‘improved’ shoulder-related disability in 9 out of 10 patients (95% CI 8 out of 10 patients to everyone) undergoing three months of exercise-based physiotherapy for symptomatic PTTs. Conclusions This is the first published MID estimate for the WORC in adults with symptomatic PTTs of the rotator cuff undergoing typical treatment comprising conservative treatment with physiotherapy. The conceptual framework for interpretation facilitates its use in similar clinical contexts

Effective Dose 50 method as the Minimal Clinically Important Difference:Evidence from depression trials

OBJECTIVE: Previous research on the minimal clinically important difference (MCID) for depression and anxiety is based on population averages. The present study aimed to identify the MCID across the spectrum of baseline severity. STUDY DESIGN AND SETTINGS: The present analysis used secondary data from two randomised controlled trials for depression (n=1,122) to calibrate the Global Rating of Change with the PHQ-9 and GAD-7. The MCID was defined as a change in scores corresponding to a 50% probability of patients "feeling better", given their baseline severity, referred to as Effective Dose 50 (ED50). RESULTS: MCID estimates depended on baseline severity and ranged from no change for very mild up to 14 points (52%) on the PHQ-9 and up to 10 points (48%) on the GAD-7 for very high severity. The average MCID estimates were 3.7 points (23%) and 3.3 (28%) for the PHQ-9 and GAD-7 respectively. CONCLUSION: The ED50 method generates MCID estimates across the spectrum of baseline severity, offering greater precision but at the cost of greater complexity relative to population average estimates. This has important implications for evaluations of treatments and clinical practice where users can employ these results to tailor the MCID to specific populations according to baseline severities

Estimation of minimum clinically important difference for pain in fibromyalgia

Objective To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia. Methods Data were pooled across 12‐week treatment periods from 4 randomized, double‐blind, placebo‐controlled studies designed to evaluate the safety and efficacy of duloxetine for the treatment of fibromyalgia. Each study enrolled subjects with American College of Rheumatology–defined fibromyalgia who presented with moderate to severe pain. The MCIDs for the BPI average pain item score and the BPI severity score (the mean of the BPI pain scale values: right now, average, least, and worst) were estimated by anchoring against the Patient's Global Impressions of Improvement scale. Results The anchor‐based MCIDs for the BPI average pain item and severity scores were 2.1 and 2.2 points, respectively. These MCIDs correspond to 32.3% and 34.2% reductions from baseline in scores. Conclusion In these analyses, the MCIDs for several pain measures obtained from the BPI were similar (∼2 points) and corresponded to a 30–35% improvement from baseline to end point. These findings may be beneficial for use in designing clinical trials in which the BPI is used to evaluate improvements in pain severity.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/87063/1/20449_ftp.pd

Estimates of success in patients with sciatica due to lumbar disc herniation depend upon outcome measure

The objectives were to estimate the cut-off points for success on different sciatica outcome measures and to determine the success rate after an episode of sciatica by using these cut-offs. A 12-month multicenter observational study was conducted on 466 patients with sciatica and lumbar disc herniation. The cut-off values were estimated by ROC curve analyses using Completely recovered or Much better on a 7-point global change scale as external criterion for success. The cut-off values (references in brackets) at 12 months were leg pain VAS 17.5 (0–100), back pain VAS 22.5 (0–100), Sciatica Bothersomeness Index 6.5 (0–24), Maine-Seattle Back Questionnaire 4.5 (0–12), and the SF-36 subscales bodily pain 51.5, and physical functioning 81.7 (0–100, higher values indicate better health). In conclusion, the success rates at 12 months varied from 49 to 58% depending on the measure used. The proposed cut-offs may facilitate the comparison of success rates across studies

How do validated measures of functional outcome compare with commonly used outcomes in administrative database research for lumbar spinal surgery?

Clinical interpretation of health services research based on administrative databases is limited by the lack of patient-reported functional outcome measures. Reoperation, as a surrogate measure for poor outcome, may be biased by preferences of patients and surgeons and may even be planned a priori. Other available administrative data outcomes, such as postoperative cross sectional imaging (PCSI), may better reflect changes in functional outcome. The purpose was to determine if postoperative events captured from administrative databases, namely reoperation and PCSI, reflect outcomes as derived by validated functional outcome measures (short form 36 scores, Oswestry disability index) for patients who underwent discretionary surgery for specific degenerative conditions of the lumbar spine such as disc herniation, spinal stenosis, degenerative spondylolisthesis, and isthmic spondylolisthesis. After reviewing the records of all patients surgically treated for disc herniation, spinal stenosis, degenerative spondylolisthesis, and isthmic spondylolisthesis at our institution, we recorded the occurrence of PCSI (MRI or CT-myelograms) and reoperations, as well as demographic, surgical, and functional outcome data. We determined how early (within 6 months) and intermediate (within 18 months) term events (PCSI and reoperations) were associated with changes in intermediate (minimum 1 year) and late (minimum 2 years) term functional outcome, respectively. We further evaluated how early (6–12 months) and intermediate (12–24 months) term changes in functional outcome were associated with the subsequent occurrence of intermediate (12–24 months) and late (beyond 24 months) term adverse events, respectively. From 148 surgically treated patients, we found no significant relationship between the occurrence of PCSI or reoperation and subsequent changes in functional outcome at intermediate or late term. Similarly, earlier changes in functional outcome did not have any significant relationship with subsequent occurrences of adverse events at intermediate or late term. Although it may be tempting to consider administrative database outcome measures as proxies for poor functional outcome, we cannot conclude that a significant relationship exists between the occurrence of PCSI or reoperation and changes in functional outcome

Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits.</p> <p>Methods/Design</p> <p>The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").</p> <p>Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.</p> <p>Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided.</p> <p>Discussion</p> <p>New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01224379">NCT01224379</a></p