Outcomes following surgical treatment of distal radial fracture: a comparison of older and younger patients using PROMIS

The purpose of this study was to assess the recovery patterns following surgery for distal radial fracture (DRF) in patients over ( n = 99) and under ( n = 273) the age of 65 using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) questionnaires. Both the older and younger cohorts showed postoperative improvement in PF and PI. The younger cohort had higher PF scores from 1 to 6 months postoperatively, however, PI scores were not significantly different between the cohorts during any period. A greater proportion of younger patients achieved the minimal clinically important difference improvement on the PROMIS PF (80% versus 66%) and PI (88% versus 75%) scales. To appropriately manage postoperative expectations, older patients should be counselled that they would likely experience most of their functional recovery by 3 months and limitations due to pain would likely be stable by 1 month. Level of evidence: II

Predictors of a Minimal Clinically Important Difference Following Omalizumab Treatment in Adult Patients With Severe Allergic Asthma

Several factors have been found to be predictors of a good response following omalizumab treatment in patients with severe allergic asthma (SAA). However, it remains unclear whether clinical characteristics can predict a minimal clinically important difference (MCID) following omalizumab treatment in this population. Therefore, the aim of this study was to investigate the features associated with an MCID following omalizumab treatment in adult patients with SAA. Of the 124 participants enrolled in this retrospective, cross-sectional study, 94, 103, 20 and 53 achieved the MCID following treatment with omalizumab and were considered to be responders of exacerbation reduction (no exacerbation during the 1-year follow-up period or ≧50% reduction in exacerbations from baseline), oral corticosteroid (OCS) sparing (no use of OCS to control asthma during the study period or a reduction of the monthly OCS maintenance dose to <50% of baseline), lung function (an increase of ≧230 ml in the forced expiratory volume in 1 s from baseline) and asthma control (an increase of ≧3 points in the asthma control test score from baseline), respectively. Normal weight [<25 vs. ≧30 kg/m2, odds ratio (OR) = 3.86, p = 0.024] was predictive of a responder of reduction in exacerbations following omalizumab treatment while subjects with a blood eosinophil level of <300 cells/μL (<300 vs. ≧300 cells/μL, OR = 5.81, p = 0.001) were more likely to exhibit an MCID in OCS sparing. No factor was found to be a predictor of lung function or asthma control. When choosing treatment for adult patients with SAA, our findings may help to select those who may benefit the most from omalizumab treatment.

Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)

Introduction/objectives We assess the impact of switching versus staying on the same tofacitinib dose on efficacy and safety in patients with rheumatoid arthritis (RA). Methods ORAL Sequel was an open-label, long-term extension study of patients with RA receiving tofacitinib 5 or 10 mg BID for up to 9.5 years. Tofacitinib doses could be switched during the study at investigator discretion. In this post hoc analysis, data from ORAL Sequel were stratified into four groups: 5 → 10 mg BID (Dose-up); 5 mg BID (Stay-on 5); 10 → 5 mg BID (Dose-down); and 10 mg BID (Stay-on 10). Efficacy assessments over 12 months included: change from baseline in 4-component Sisease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28), and DAS28 minimum clinically important difference, remission, and low disease activity (LDA) rates. Safety was assessed for the study duration. Results Generally, DAS28 improvements and minimum clinically important difference rates were significantly greater (p < 0.05) in Dose-up versus Stay-on 5 up to month 12. DAS28 remission rates were significantly greater in Dose-up versus Stay-on 5 at month 12. Change from baseline in DAS28 was similar in Dose-down and Stay-on 10. No significant differences in DAS28 LDA rates were observed between groups. Safety data were similar overall across the four groups. Conclusion In patients with RA receiving open-label tofacitinib, this analysis found that some benefited from increasing dose from 5 to 10 mg BID and did not find that reducing dose from 10 to 5 mg BID affected efficacy or that dose switching in either direction affected safety. Study registration ClinicalTrials.gov number NCT00413699. Registered December 20, 2006. https://clinicaltrials.gov/ct2/show/NCT00413699 Key Points• This post hoc analysis of data from the long-term extension study, ORAL Sequel, assessed the impact of dose switching between tofacitinib 5 and 10 mg twice daily (BID), at the investigator’s discretion, on efficacy and safety in patients with rheumatoid arthritis (RA).• Dosing up from tofacitinib 5 to 10 mg BID was associated with improved efficacy up to 12 months versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID was not generally associated with a significant loss of efficacy.• Safety outcomes were generally consistent across dose groups and did not change markedly after switching dose in either direction.• These findings can help to inform physicians on what may be expected in terms of efficacy and safety when adjusting tofacitinib dose according to clinical need. The recommended tofacitinib dosage for the treatment of RA in most jurisdictions is 5 mg BID.

Microendoscopic Decompression for Lumbar Spinal Stenosis Associated with Adjacent Segment Disease following Lumbar Fusion Surgery: 5-year Follow-up of a Retrospective Case Series

Background and Study Aims Surgical treatment options for lumbar spinal stenosis (LSS) based on adjacent segment disease (ASD) after spinal fusion typically involve decompression, with or without fusion, of the adjacent segment. The clinical benefits of microendoscopic decompression for LSS based on ASD have not yet been fully elucidated. We aimed to investigate the clinical results of microendoscopic spinal decompression surgery for LSS based on ASD. Patients and Methods From 2011 to 2014, consecutive patients who underwent microendoscopic spinal decompression without fusion for LSS based on ASD were enrolled. Data of 32 patients (17 men and 15 women, with a mean age of 70.5 years) were reviewed. Japanese Orthopaedic Association score and low back pain/leg pain visual analog scale score were utilized to measure neurologic and axial pain outcomes, respectively. Additionally, after the surgeries, we analyzed the magnetic resonance imaging (MRI), computed tomography (CT) scans, or radiographs to identify any new instabilities of the decompressed segments or progression of ASD adjacent to the decompressed segments. Results The Japanese Orthopaedic Association recovery rate at the 5-year postoperative visit was 49.2%. The visual analog scale scores for low back pain and leg pain were significantly improved. The minimum clinically important difference for leg pain (decrease by ≥24 mm) and clinically important difference for low back pain (decrease by ≥38 mm) were achieved in 84% (27/32) and 72% (23/32) of cases, respectively. Regarding new instability after microendoscopic decompression, no cases had apparent spinal instability at the decompression segment and adjacent segment to the decompressed segment. Conclusions Microendoscopic spinal decompression is an effective treatment alternative for patients with LSS caused by ASD. The ability to perform neural decompression while maintaining key stabilizing structures minimizes subsequent clinical instability. The substantial clinical and economic benefits of this approach may make it a favorable alternative to performing concurrent fusion in many patients.

No evidence of a minimal clinically important difference for the Beery-Buktenica Developmental Test of Visual-Motor Integration in children with autism spectrum disorder

The Beery Visual-Motor Integration (VMI) battery of tests are some of the most commonly used assessments in pediatric occupational therapy, often used to measure change over time. However, the minimal clinically important difference (MCID) has not been estimated for interpreting change scores. We estimated the MCID for the Beery VMI battery of tests in children with autism spectrum disorder (ASD). Four occupational therapists collected data in a public elementary school on 64 children with ASD. The Beery VMI battery was administered to children with ASD twice, approximately 11 months apart. To estimate MCID values, Beery VMI battery scores were anchored to 15-point Likert questions measuring occupational therapists’ ratings of functional change over three domains: fine motor skills, handwriting, and activities of daily living (ADLs). Using this anchor-based method, we were unable to estimate MCID values for the Beery VMI battery. Children’s Beery VMI battery scores did not change significantly over the course of the school year, and there was only one weak correlation between VMI battery change scores and therapists’ ratings of change. The inability to estimate Beery VMI battery MCID values for children with ASD adds further support for research cautioning the use of the Beery VMI as an outcome measure.

Prevalence and severity of differing dimensions of breathlessness among elderly males in the population

Breathlessness is common in the general population. Existing data were obtained primarily with the uni-dimensional modified Medical Research Council (mMRC) breathlessness scale that does not assess intensities of unpleasantness nor physical, emotional, and affective dimensions. The aim of this research was to determine the prevalence and intensity of these dimensions of breathlessness in elderly males and any associations with their duration, change over time, and mMRC grade. We conducted a population-based, cross-sectional study of 73-year-old males in a county in southern Sweden. Breathlessness was self-reported at one time-point using a postal survey including the Dyspnoea-12 (D-12), the Multidimensional Dyspnoea profile (MDP), and the mMRC. Presence of an increased dimension score was defined as a score≥minimal clinically important difference for each dimension scale. Association with mMRC, recalled change since age 65, and duration of breathlessness were analysed with linear regression. Among 907 men, an increased dimension score was present in 17% (D-12 total score), 33% (MDP A1 unpleasantness), 19% (D-12 physical), 17% (MDP immediate perception), 10% (D-12 affective), and 17% (MDP emotional response). The unpleasantness and affective dimensions were strongly associated with mMRC ≥3. Higher MDP and D-12 scores were associated with worsening of breathlessness since age 65, and higher MDP A1 unpleasantness was associated with breathlessness of less than one year duration. Increased scores of several dimensions of breathlessness are prevalent in 73-year-old males and are positively correlated with mMRC scores, worsening of breathlessness after age 65, and duration of less than one year.

The Minimal Clinically Important Difference: A Review of Clinical Significance

Background: The minimal clinically important difference (MCID) is a term synonymous with orthopaedic clinical research over the past decade. The term represents the smallest change in a patient-reported outcome measure that is of genuine clinical value to patients. It has been derived in a myriad of ways in existing orthopaedic literature. Purpose: To describe the various modalities for deriving the MCID. Study Design: Narrative review; Level of evidence, 4. Methods: The definitions of common MCID determinations were first identified. These were then evaluated by their clinical and statistical merits and limitations. Results: There are 3 primary ways for determining the MCID: anchor-based analysis, distribution-based analysis, and sensitivity- and specificity-based analysis. Each has unique strengths and weaknesses with respect to its ability to evaluate the patient’s clinical status change from baseline to posttreatment. Anchor-based analyses are inherently tied to clinical status yet lack standardization. Distribution-based analyses are the opposite, with strong foundations in statistics, yet they fail to adequately address the clinical status change. Sensitivity and specificity analyses offer a compromise of the other methodologies but still rely on a somewhat arbitrarily defined global transition question. Conclusion: This current concepts review demonstrates the need for (1) better standardization in the establishment of MCIDs for orthopaedic patient-reported outcome measures and (2) better study design—namely, until a universally accepted MCID derivation exists, studies attempting to derive the MCID should utilize the anchor-based within-cohort design based on Food and Drug Administration recommendations. Ideally, large studies reporting the MCID as an outcome will also derive the value for their populations. It is important to consider that there may be reasonable replacements for current derivations of the MCID. As such, future research should consider an alternative threshold score with a more universal method of derivation.