Clinically Important Difference
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Author(s):  
Gershon Zinger ◽  
Alexander Bregman ◽  
Ori Safran ◽  
Shaul Beyth ◽  
Amos Peyser

Abstract Background For most patients, tennis elbow (TE) resolves within 6 months of onset. For those with persistent and painful TE, nonsurgical treatment options are limited. Thousands of studies have tried to find effective treatments for TE but have usually failed. In this study, we tested the hypothesis that injections with hyaluronic acid (HA) would be effective at reducing pain from chronic TE. Methods Patients with a minimum of six months of pain from TE and with a pain level of 50 or greater (out of 100) were included in the study. They were randomized equally into one of two treatment groups: injection with HA or injection with saline control. Follow-up was conducted at 3, 6 and 12 months from the initial injection. Both the patient and the examiner at the follow-up visits were blinded to the treatment arm. The primary outcome measure was the visual analog scale (VAS pain) score at one year. Additional outcome measures included the shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and Patient Rated Tennis Elbow Evaluation (PRTEE) scores. Results Eighteen patients were randomized into the HA injection treatment arm, and 17 (94%) completed the study. The average age was 51.9 years, and 10 of the subjects were male. Patients had an average of 28.1 months of pain before entering the study. The VAS score in the HA group decreased from a baseline of 76.4–14.3 at 12 months. All 17 patients in the HA group showed VAS score reductions above the minimal clinically important difference (MCID) of at least 18. The PRTEE score improved from 67 to 28.1. The QuickDASH score improved from 53.7 to 22.5. Follow-up in the saline group was less than 50% and was therefore not used as a comparator. Conclusions HA injections yielded significant success in pain relief by three months. Patients continued to improve for the 12-month duration of the study. This study indicates that patients with chronic lateral epicondylitis may benefit from receiving injections of hyaluronic acid rather than having to undergo surgery.


2022 ◽  
Vol 3 (2) ◽  
Author(s):  
Björn Friedrich ◽  
Enno-Edzard Steen ◽  
Sandra Hellmers ◽  
Jürgen M. Bauer ◽  
Andreas Hein

AbstractMobility is one of the key performance indicators of the health condition of older adults. One important parameter is the gait speed. The mobility is usually assessed under the supervision of a professional by standardised geriatric assessments. Using sensors in smart home environments for continuous monitoring of the gait speed enables physicians to detect early stages of functional decline and to initiate appropriate interventions. This in combination with a floor plan smart home sensors were used to calculate the distance that a person walked in the apartment and the inertial measurement unit data for estimating the actual walking time. A Gaussian kernel density estimator was applied to the computed values and the maximum of the kernel density estimator was considered as the gait speed. The proposed method was evaluated on a real-world dataset and the estimations of the gait speed had a deviation smaller than $$0.10 \, \frac{\mathrm{m}}{\mathrm{s}}$$ 0.10 m s , which is smaller than the minimal clinically important difference, compared to a baseline from a standardised geriatrics assessment.


2022 ◽  
pp. 175319342110702
Author(s):  
Alex M. Hollenberg ◽  
Jennifer Z. Mao ◽  
Warren C. Hammert

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


2022 ◽  
Vol 8 ◽  
Author(s):  
Wei-Chang Huang ◽  
Pin-Kuei Fu ◽  
Ming-Cheng Chan ◽  
Chun-Shih Chin ◽  
Wen-Nan Huang ◽  
...  

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.


Author(s):  
Ruediger B. Mueller ◽  
Hendrik Schulze-Koops ◽  
Daniel E. Furst ◽  
Stanley B.  Cohen ◽  
Kenneth Kwok ◽  
...  

Abstract 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.


2022 ◽  
Vol 10 (1) ◽  
pp. 232596712110600
Author(s):  
Wei Sheng Foong ◽  
Gerald Joseph Zeng ◽  
Graham S. Goh ◽  
Ying Hao ◽  
Denny Tjiauw Tjoen Lie ◽  
...  

Background: The literature on minimal clinically important differences (MCIDs) for patient-reported outcome measures assessing shoulder instability is limited, with none addressing the Oxford Shoulder Instability Score (OSIS). The OSIS was developed to provide a standardized method for assessing shoulder function after surgery for shoulder instability, and previous studies have demonstrated its high reliability, low interrater variability, and ease of administration. Purpose: To identify the MCID for the OSIS after arthroscopic Bankart repair for recurrent shoulder instability. Study Design: Case series; Level of evidence, 4. Methods: A longitudinally maintained institutional registry was queried for patients who underwent arthroscopic Bankart repair from 2010 to 2016 for recurrent shoulder instability secondary to a Bankart lesion without significant glenoid bone loss. The OSIS was completed preoperatively and at 1 year postoperatively. Patients were categorized into “expectations met” and “expectations unmet” groups using a questionnaire evaluating expectation fulfilment. The MCID of the OSIS at 1 year was calculated using 3 anchor-based approaches and a distribution-based approach. The 3 anchor-based approaches comprised (1) simple linear regression analysis, (2) receiver operating characteristic curve analysis, and (3) calculation of mean differences in change for the OSIS between the “expectations met” and “expectations unmet” groups. Results: The study cohort comprised 68 men and 11 women aged 29.9 ± 12.7 years (mean ± SD). Duration of follow-up for all patients exceeded 1 year. The MCIDs for the OSIS based on the 4 calculation approaches yielded a narrow range of values, ranging from 7.7 to 8.5 for the anchor-based methods and 8.6 for the distribution-based method. Conclusion: Study results indicated that patients with recurrent shoulder instability without significant bone loss who undergo primary arthroscopic Bankart repair and have at least 8.6 points of improvement on their OSIS experience a clinically significant change at 1 year postoperatively.


Neurospine ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. 854-862
Author(s):  
Conor P. Lynch ◽  
Elliot D.K. Cha ◽  
Augustus J. Rush III ◽  
Caroline N. Jadczak ◽  
Shruthi Mohan ◽  
...  

Objective: To assess the impact of bilateral versus unilateral interbody cages on outcomes for minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) procedures.Methods: A retrospective review for primary, elective, single-level MIS TLIF procedures with bilateral posterior instrumentation from 2008–2020 was performed. Patients were grouped according to unilateral or bilateral interbody cage use. Procedures performed without static interbody cages or indicated for trauma, infection, malignancy were excluded. Patient-reported outcomes (PROs) included visual analogue scale (VAS), Oswestry Disability Index, 12-item Short Form health survey physical composite score (SF-12 PCS), PatientReported Outcome Measurement Information System physical function (PROMIS-PF). PROs were collected preoperatively and postoperatively. Change in PROs (Δ) was calculated and compared between groups. Achievement of minimum clinically important difference (MCID) was calculated using established values from the literature. Achievement rates were compared between groups using logistic regression.Results: The study included 151 patients, with 111 unilateral and 40 bilateral cage placements. Charlson Comorbidity Index, diabetes, and insurance status differed between groups (p < 0.050). Prevalence of degenerative and isthmic spondylolisthesis (both p ≤ 0.002), operative level (p = 0.003), and postoperative length of stay (p = 0.022) significantly differed between groups. The unilateral group had lower 1-year arthrodesis rates (p = 0.035). Preoperative VAS leg (p = 0.017) and SF-12 PCS (p = 0.045) were worse for the unilateral group. ΔPROMIS-PF was greater for the bilateral group at 2 years (p = 0.001). Majority of patients achieved an overall MCID for all PROs, except VAS leg (bilateral group).Conclusion: While preoperative status and postoperative arthrodesis rates differed, patients achieved an MCID at similar rates regardless of use of unilateral or bilateral cages.


2021 ◽  
Author(s):  
Ori Haisraely ◽  
Yaacov Richard Lawrence ◽  
Ron Lewin ◽  
Orit Kaidar-Person ◽  
Ilana Weiss ◽  
...  

Abstract Purpose: To evaluate urinary continence and sexual potency following radical prostatectomy and adjuvant radiotherapy.Materials/Methods: Expanded Prostate Cancer Index Composite (EPIC) surveys of patients with localized prostate cancer treated with surgery followed by adjuvant/salvage pelvic radiotherapy (S+RT) were analyzed. A control cohort was primary radiotherapy (RT). Reverse "bifecta" was defined as a score less than 60 in both incontinence and sexual domains. Superior urinary function was defined as a score above 90. The clinically important difference was calculated using a distribution approach.Results: Surveys at least 1 year after treatment were available for 130 S+RT and 374 RT patients. For S+RT vs. RT, the mean urinary incontinence score was 68 [6.25 -100] versus 86.4 [CI-95 39.5-100] (p<0.001), confirming 6.5 points of clinically significant difference. The adjusted odds ratio for superior urinary function was 2.67 (1.7-4.1, p<0.001) for primary radiotherapy. The odds ratio of having both poor urinary and sexual performance (reverse " bifecta") was 0.29 in RT arm (0.14-0.58, p<0.001) when adjusted for age and Androgen Deprivation Therapy (ADT) , group risk stratification, comorbidities and smoking status.Conclusion: In this cross sectional study, Surgery with adjuvant/salvage RT was associated with significantly worse patient reported urinary continence outcomes at 1-year post treatment, lower odds of achieving perfect urinary continence and a threefold risk of reverse ‘bifecta’ with inferior urinary continence and sexual performance. Longitudinal studies of evolving toxicity are required to validate these findings. Patients referred for surgery with a high probability of requiring adjuvant or salvage radiotherapy should be informed regarding the potential composite toxicity of both surgery and radiotherapy.


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