Minimal Important Difference Research Articles

The Oswestry Disability Index in Elective Single level Lumbar Fusion: Is 3 month follow up enough?

BackgroundProspective, longitudinal collection of patient reported outcomes (PRO) has become an essential metric in orthopedics. Despite the utility of PROs, data collection presents a significant challenge to the healthcare system. There is a need to better understand if serial data collection over a 1 to 2 year postoperative period is truly warranted. The purpose of this study was to determine if continued PRO collection after 3 months postop is needed in patients that underwent lumbar fusion. MethodsThis retrospective study utilized 239 patients that underwent an elective single level lumbar fusion between April 1, 2020 and February 1, 2023. Changes in the Oswestry Disability Index (ODI) scores over a one year period were assessed for all patients. Patients were placed into one of three study groups, those that improved by 10 points, those that worsened by 10 points, and those that did not change (score change less than 10 points in either direction). Movement between study groups, the minimal clinical important difference (MCID), and patient satisfaction were analyzed for each patient. ResultsImprovement between preoperative and the 3 month postoperative evaluations was noted for most patients. There was limited change in scores after 3 months. Patients in the improved group continued to improve through 1 year post-operative. Patients in the worsened group continued to decline by 1 year postoperative. Patients in the no change group demonstrated the highest potential to change groups. ConclusionsPatients with substantial improvement or worsening at 3 months have a low likelihood of substantial clinical change thereafter. This subset of patients may not need further evaluation with PROs, but those in the worsened group may benefit from other interventions to potentially alter their course.

Synthetic medial meniscus implant demonstrates high reoperation rates: Patients who retain implant or require implant exchange show improvement in post meniscectomy knee pain and clinical function

PurposeThe purpose of this study was to evaluate the clinical outcomes in the use of a synthetic medial meniscus implant in patients symptomatic after medial meniscectomy and not responsive to other treatment methods. and not responded to non-operative treatment. MethodsThis single-arm, multicenter, prospective study enrolled subjects between ages 30-75 with post-meniscectomy pain. Changes from baseline to 24-months were measured in the pain subscale of the knee injury and osteoarthritis outcome score (KOOS) and in KOOS overall (average of all five subscales) in patients that had received a medial meniscus implant. Success was a 20-point improvement at 24-months, reoperation rates, and implant failures were recorded. VAS, IKDC, and WOMET scores were also measured. ResultsOf the 115 treated patients 3 (2.6%) were either lost to follow-up or missed the 24-month visit, 48 (43%) patients had at least one subsequent surgery, 12 (10.7%) had the implant permanently removed. Of the remaining 100 patients, the mean KOOS pain improved 28.4 points at 24 months (P <0.001), and mean KOOS overall improved 28.3 points (P < 0.001). Seventy-six percent of subjects had mean scores for KOOS pain above the minimal clinically important difference (MCID) threshold, and 72% of subjects met or exceeded this threshold for KOOS overall. There were 29 patients (25.9%) who underwent implant exchange. The 24-month clinical outcomes were similar between subjects who had an implant exchange and patients who did not have any subsequent implant procedure (P < 0.2). ConclusionThe synthetic medial meniscus demonstrates high reoperation and failure rates. Patients who retained the implant or required implant exchange showed significantly improved pain, function, and quality of life at 24-month follow-up in patients symptomatic following partial medial meniscectomy and failed non-operative management. The high reoperation rate is a concern, and further evaluation is needed to determine any contributing factors.

Persistence of Labral Tears and Resolution of Paralabral Cysts with 2-year MRI analysis after Periacetabular Osteotomy (PAO) for Hip Dysplasia

To evaluate the labrum status and paralabral cysts on preoperative and postoperative magnetic resonance imaging (MRI) in patients with developmental dysplasia of the hip (DDH) who underwent periacetabular osteotomy (PAO). A retrospective review was conducted using prospectively collected data from patients who had undergone primary PAO between June 1, 2021 and May 30, 2022. Inclusion criteria were an age range of 16 to 55 years and a minimum follow-up of two years. MRI was utilized to evaluate the preoperative and postoperative conditions of the labrum and the presence of paralabral cysts. Furthermore, the correlations between the presence of paralabral cysts and demographic and radiographic variables were investigated. Additionally, patient-reported outcomes (PROs), minimal clinically important difference (MCID), and complications were reported during the final follow-up evaluation. A total of 23 patients were included in the final analysis, with an average follow-up of 26.6 ± 3.4 months (range, 24-32 months). All patients diagnosed with symptomatic DDH exhibited labrum tears. MRI scans revealed paralabral cysts in ten out of twenty-four (41.6%) patients, with a significant correlation noted between the presence of cysts and preoperative LCEA (ρ=-0.649; P=0.001), ACEA (ρ=-0.637; P=0.001), Tönnis angle (ρ=0.593; P=0.002) and age (ρ=-0.444; P=0.034). Postoperative MRI scans at one year showed resolution of all paralabral cysts, while labral tears were found to persist. At the end of the follow-up period, most patients improved considerably in PROs compared to preoperative values. The probabilities of achieving the MCID were 91.3% on the HOS-ADL, 78.2% on the HOS-SSS, 91.3% on the mHHS, 73.9% on the iHOT-12, and 69.6% on the VAS pain scale. All symptomatic patients with DDH had labral tears and a high prevalence of paralabral cysts, which were corrected with reduced acetabular coverage. After PAO surgery, patients experienced notable enhancements in PROs, with resolution of paralabral cysts but persistence of labral tears.

Effect of Telerehabilitation-Based Motor Imagery Training on Pain and Related Factors in People with Multiple Sclerosis: Randomized Controlled Pilot Trial

ObjectivesTo investigate the effect of telerehabilitation-based graded motor imagery (MI,GMI) training on pain and pain-related factors in people with multiple sclerosis (MS). DesignRandomized controlled, assessor-blind pilot trial with repeated measure design. SettingNeurology outpatient clinic. ParticipantsThirty-two people with MS were randomly allocated to intervention (n=16) and control (n=16) groups. InterventionsDuring 8-week GMI training period, the first 2-weeks involved implicit MI training while 6-weeks explicit MI training were conducted. Main OutcomeThe primary outcome was the general pain intensity over the past two days, assessed with Visual Analogue Scale, with a minimum clinically important difference (MCID) of 23 mm. Secondary outcomes included general pain and specific body parts' pain intensity over the past seven days, neuropathic pain intensity, MI ability, fatigue, depression, anxiety, quality of life, sleep quality, daytime sleepiness and cognitive functions scores. Assessments were conducted at baseline, at weeks 8 (post-treatment) and 12 (follow-up). ResultsThe intervention group demonstrated a significant reduction in pain intensity over the past two days compared to control group (p<0.05). Furthermore, at the 8-week assessment, the intervention group surpassed the MCID in pain intensity over the past 2 and 7 days (p<0.05), whereas no significant change was observed in the control group (p>0.05). Significant effects were observed post-treatment on general pain over the past seven days, neuropathic pain, MI ability, fatigue, depression, quality of life, processing speed, and visuospatial memory within intervention group compared to control group (p<0.05). However, the impact on anxiety, sleep quality, daytime sleepiness, and verbal memory between groups were not significant (p>0.05). ConclusionTelerehabilitation-based GMI training stands out as viable for management of chronic pain and pain-related psychosocial symptoms for people with MS.

Anatomic Total Shoulder Arthroplasty Revised to Reverse Total Shoulder Arthroplasty: Clinical and Radiographic Outcomes Compared to Primary Reverse Total Shoulder Arthroplasty

Reverse total shoulder arthroplasty (rTSA) has become the procedure of choice for a failed aTSA. Little data exists regarding outcomes; the few studies published to date have small numbers, short follow-up, and most do not have a control group or use first generation implants. The purpose of this study is to compare the clinical and radiographic outcomes of failed aTSA revised to rTSA to primary rTSA. A prospective multicenter shoulder registry was used to conduct a retrospective review of patients that received a primary rTSA for osteoarthritis and rotator cuff disease and compare them to those that had an aTSA revised to a rTSA using the same implant between 2007 and 2021 with a minimum follow-up of two years. Cohorts were matched 3:1 (primary:revision) by age, gender, body mass index and length of follow-up. Those that underwent revision for humeral fracture, infection, or an unknown reason were excluded. Preoperative and postoperative range of motion (ROM) and patient reported outcome measures (PROMs) were compared. Outcomes included rates of scapular notching, complications, revision, and patient satisfaction. There were 88 aTSA revised to rTSA compared to 264 matched primary rTSA. In both cohorts, the mean age was 68 years, 59% were female, and the mean follow-up was 56 months. The most common reason for revision was rotator cuff tearing (53%), followed by aseptic glenoid loosening (34%), instability (9%), aseptic humeral loosening (6%) and glenoid component dissociation (3%). At latest follow-up, patients in both groups had statistically significant improvements in all outcome scores, exceeding the minimal clinically important difference (MCID) and the substantial clinical benefit (SCB). The revision cohort had significantly less postoperative abduction (P<0.001) and forward elevation (P=0.001) compared to the primary rTSA cohort. All PROMs in the revision cohort were significantly worse than those in the primary rTSA cohort. Patient satisfaction rate in the revision cohort was significantly lower than the primary cohort (P<0.001). Complication (P=0.005) and revision rates (P=0.013) were significantly higher in the revision cohort, while scapular notching was similar. Patients undergoing revision of a failed aTSA to rTSA have worse clinical outcomes compared to those undergoing primary rTSA, including all PROMs, abduction, elevation, pain relief and patient satisfaction, with higher complication and revision rates. While patients in the revision group had significant improvements that exceeded the MCID and SCB, they do not achieve the same outcomes as patients who undergo primary rTSA.

Pain Remission Following Delayed Targeted Muscle Reinnervation in Amputees.

Targeted muscle reinnervation (TMR) has demonstrated efficacy for treatment of neuropathic pain. This study aims to identify patients for whom delayed TMR may be most effective and to identify associated factors for favorable pain outcomes in this patient population. An analysis was conducted on prospectively enrolled amputee patients who underwent delayed TMR at a tertiary care center from 2017 to 2024. Data on demographics, comorbidities, surgical details, and pain outcomes were collected. Patient reported pain severity on a 0-10 scale was prospectively collected. The main pain outcome was pain remission (achieving the minimally clinically important difference (MCID)). Additionally, sustained mild pain (pain score ≤ 3/10 for ≥ 3 months), and pain disappearance (pain score 0/10 for ≥ 3 months) were assessed. Multivariable regression analyses identified factors influencing pain outcomes. Out of 101 patients included in this study, 64 patients (63.4%) achieved pain remission within a two-year post-operative period, and 37 patients (36.6%) did not. Sustained mild pain, which could be achieved in addition to pain remission, was achieved by 45.8% of patients, with 17.8% of these achieving complete pain disappearance. Patients achieving pain remission demonstrated lower pain over the entire post-operative trajectory (p < 0.001). Lower pre-operative pain scores, absence of depression, no pre-operative opioid use, lower Elixhauser Comorbidity Index, and distal amputation levels were correlated with favorable outcomes following delayed TMR (p < 0.05). Pre-operative pain severity, psychiatric comorbidities, and opioid use significantly influenced pain outcomes, emphasizing the need for comprehensive patient assessment. These findings will help with patient stratification and pre-operative counseling to support patients who are best suitable for delayed TMR surgery.

Inferior Clinical Outcomes Following Endoscopic Proximal Hamstring Repair in Patients with Chronic Degenerative Tears Despite the use of Dermal Allograft Augmentation

PurposeTo compare clinical outcomes in patients undergoing endoscopic proximal hamstring repair with and without dermal allograft augmentation. MethodsA retrospective review of prospectively collected data was performed on patients undergoing endoscopic proximal hamstring repair (PHR) and proximal hamstring repair with dermal allograft augmentation (PHR-A) by a single surgeon between 2016 and 2023. Augmentation was utilized for cases of chronic degenerative tears (> 6 weeks from the time of initial injury) where hamstring tissue quality was deemed poor intraoperatively. A survey of patient-reported outcome measures (PROMs) was completed at a minimum of 1 year postoperatively. PROMs included a Visual Analogue Scale (VAS) for pain; University of California, Los Angeles (UCLA) Activity Scale; modified Harris Hip Score (mHHS); Hip Outcome Score-Sports-Specific Subscale (HOS-SSS); and a Single Assessment Numeric Evaluation (SANE). The proportion of patients achieving the minimal clinically important difference (MCID), patient acceptable symptom state (PASS), and substantial clinical benefit (SCB) for PROMs were compared between groups. ResultsSixty-four patients were included (42 PHR, 22 PHR-A). No differences were seen between the PHR and PHR-A groups in terms of age at surgery (49 ± 12 vs. 54 ± 9, p=0.08), sex, or body-mass index (BMI). There was a significantly longer time to follow-up (41.5±23.4 vs. 20.1±10.2 months, p<0.001) in the PHR group. There were significantly greater postoperative mHHS (82.7±15.1 vs. 72.0±18.0, p=0.02) and SANE (89.6±9.9 vs. 73.6±22.5, p=0.002) scores in the PHR group. There were no significant differences in postoperative VAS, UCLA, or HOS-SSS between groups. A greater proportion of patients in the PHR group achieved a SCB for mHHS (71% vs. 36%, p=0.008). ConclusionsOur study demonstrates inferior clinical outcomes in patients undergoing endoscopic proximal hamstring repair with dermal allograft augmentation compared to patients undergoing endoscopic proximal hamstring repair without augmentation. Level of EvidenceIII, retrospective comparative case series

Early NRS Leg and Back Thresholds Predict Clinical Recovery after MIS Transforaminal Lumbar Interbody Fusion for Degenerative Spine Disease.

This retrospective study included patients who underwent primary one-level minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spine conditions. To identify early predictors of failing to achieve the Oswestry Disability Index (ODI) minimum clinically important difference (MCID) one-year post-surgery. Early identification of patients at risk of failing to achieve ODI-MCID is crucial for early intervention and improved postoperative counseling. Currently, no specific thresholds guide patient follow-up for optimal recovery. The assessment included demographic information, surgical details, and patient-reported outcome measures (PROMs). PROMs were collected postoperatively at 2-, 6-, and 12-week time points, as well as at 6- and 12-months. The study included 166 patients, with 34% failing to achieve ODI-MCID at one year. Early VAS back and leg scores were found to be significant predictors of ODI-MCID achievement. The optimal thresholds identified were 2.25 for early VAS back and 4.25 for early VAS leg. A rerun regression identified the thresholds as independent predictors of ODI-MCID, with odds ratios of 0.31 for both measures. VAS back and leg score thresholds at 6-12 weeks can predict ODI-MCID achievement one year after MIS TLIF. Patients exceeding the identified thresholds may be at risk of failing ODI-MCID and should be monitored closely. Level 3.

Cough in pulmonary rehabilitation: a retrospective analysis of responders/non-responders

Pulmonary rehabilitation (PR) is essential for people with chronic respiratory diseases (CRD), yet its impact on cough-related quality of life (CR-QoL) remains unexplored. We assessed the PR effects on CR-QoL, described the characteristics of responders and non-responders to PR and explored determinants of responsiveness in this health domain in individuals with CRD.A retrospective study was conducted. We assessed CR-QoL using the Leicester Cough Questionnaire (LCQ) and the impact of the disease with the COPD Assessment Test (CAT), before and after PR. Cut-offs of &lt;17.05 in LCQ total score and ≥10 in CAT were used to detect low CR-QoL and medium impact of the disease. Responders were defined as achieving a minimal clinically important difference (MCID) of ≥1.3 on the LCQ total score. Pre-post PR analysis involved t-test/Wilcoxon/McNemar tests and comparisons between groups included independent t /Mann-Whitney U/Fisher's exact tests. Logistic regression was employed to investigate factors influencing MCID achievement.135 participants with CRD (39%♀; 68±10 years old; 61% COPD; FEV1%predicted 62.6±23.0) were included. After PR, significant improvements were observed in all LCQ domains and CAT. 31% of participants were identified as responders in the LCQ (36%♀; 66±10 years; 62% COPD; FEV1%predicted 60.0±22.3) showcasing significant differences in LCQ and CAT compared to non-responders. People with low CR-QoL and/or medium/high impact of the disease at baseline were 11 and 4 times, more likely to respond to PR in CR-QoL, respectively.PR enhances CR-QoL. Identification of CR-QoL and disease impact traits at baseline offers insights to optimize this outcome responsiveness to PR.

Minimal Clinically Important Difference of Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI).

To calculate the minimal clinically important difference (MCID) for the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI). Prospective cohort study. A single tertiary care balance and falls center. Fifty-three subjects meeting Barany Society criteria for vestibular migraine (VM) or probable VM were included and divided into 3 treatment groups. Treatment was not standardized, instead, management was decided individually between each patient and their provider. All subjects completed VM-PATHI before and after intervention. A Global Rating of Change (GRoC) questionnaire was also completed following intervention. Anchor-based methods, using a GRoC questionnaire, were utilized to estimate the MCID that produced the highest sensitivity and specificity on a receiver operating characteristic (ROC) curve. Forty-three subjects were classified as responders and 10 were classified as nonresponders. The mean VM-PATHI pretreatment score minus the posttreatment score between the responders (mean = 14, SD 13) and nonresponders (mean = 4 SD = 12) was statistically significant (mean difference = 10, 95% confidence interval, CI [1, 20], P = .03). The VM-PATHI score change cutoff that best differentiated between responders and nonresponders was a VM-PATHI change of 6. Thus, the MCID was defined as a change of 6 points (sensitivity = 72%, specificity = 70%). The area under the ROC curve was 0.89, 95% CI [0.80, 0.98], which demonstrates an excellent ability for the VM-PATHI score change to discriminate between responders and nonresponders. The average change in VM-PATHI scores was 9 points (SD 11) for those with "a little better" rating on the GRoC, 14 points (SD 14) for those with a "moderately better" rating, and 20 points (SD 13) for those with a "very much better" rating. Patients with VM are likely to demonstrate clinical improvement if their VM-PATHI score decreases by 6 or more.

The effectiveness of sacral lateral branch radiofrequency neurotomy for posterior sacroiliac joint complex pain in patients selected by dual sacral lateral branch blocks; A real-world cohort study

BackgroundPrevious study of spinal neurotomy procedures indicates that stringent block selection improves outcomes. However, this pattern is not established for sacral lateral branch radiofrequency neurotomy (SLBRFN). Few SLBRFN studies have used stringent block selection criteria such as ≥80 % pain reduction following dual sacral lateral branch blocks (SLBB). ObjectiveEvaluate the effectiveness of SLBRFN in patients with ≥80 % pain relief following dual SLBBs. MethodsRetrospective single-arm cohort study of consecutive patients from two Canadian musculoskeletal and pain clinics who underwent first-time SLBRFN after report of ≥80 % pain relief following dual diagnostic SLBBs. Patients were identified by electronic medical record query between 2016 and 2022. The primary outcome was the proportion of individuals with a ≥50 % reduction in the numeric pain rating scale (NPRS) score three months after SLBRFN. Secondary outcomes included the proportion of responders achieving the minimal clinically important difference (MCID) on the pain disability quality-of-life questionnaire (PDQQ), and the duration and mean percentage of pain relief among those with recurrent symptoms after a successful SLBRFN. ResultsOf the 70 participants included, 32 (45.7 %; 95 % CI = 34.6–57.3) reported a ≥50 % reduction in NPRS, and 35 (50.0 %; 95 % CI = 38.6–61.4) achieved the MCID on the PDQQ at 3-months. Among the 17 patients who reported a return of symptoms, the mean duration of relief was 8.0 ± 3.5 months, and the mean percentage of pain relief was 77.9 % ± 16.4 %. Logistic regression models revealed that the use of multi-tined RF probes and lower patient BMI were associated with treatment success. Discussion/conclusionSLBRFN reduced pain and disability in approximately 50 % of patients at 3 months when selected using relatively restrictive selection criteria. Treatment success was associated with multi-tined RF probe type and lower patient BMI. Larger prospective studies assessing long-term outcomes are needed to further evaluate the impact of different selection criteria and techniques on SLBRFN effectiveness.

A Bayesian reanalysis of the CULPRIT-SHOCK trial.

The optimal revascularization strategy for patients with acute myocardial infarction (AMI), cardiogenic shock (CS), and multivessel disease remains controversial. The CULPRIT-SHOCK trial compared culprit lesion-only vs. immediate multivessel percutaneous coronary intervention (PCI), providing important data but leaving efficacy questions unresolved. To address lingering uncertainties and gain deeper insights, we performed a Bayesian reanalysis of the CULPRIT-SHOCK trial data. We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, sceptical, and enthusiastic priors. Relative risks (RRs) with 95% highest posterior density (HPD) intervals were calculated. We defined the minimal clinically important difference (MCID) as RR < 0.84. We performed subgroup analyses for key patient characteristics and assessed secondary outcomes and safety endpoints. Probabilities of benefit, achieving MCID, and harm were computed. Results are presented as median RR with probabilities of effect sizes. Bayesian reanalysis showed a median RR of 0.82 (95% HPD 0.66-1.04) with a non-informative prior, indicating a 95% probability of benefit and 59% probability of achieving MCID. Subgroup analyses revealed potentially stronger effects in males (RR 0.78, 73% probability of MCID), patients without diabetes (RR 0.76, 79% probability of MCID), and those with non-anterior ST-segment elevation MI (STEMI; RR 0.74, 76% probability of MCID). Secondary outcomes suggested potential benefits in mortality (RR 0.85) and need for renal replacement therapy (RR 0.72) but increased risks of recurrent MI (RR 2.84) and urgent revascularization (RR 2.88). Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favouring the culprit lesion-only PCI strategy in AMI patients with CS and multivessel disease. The analysis demonstrates a high probability of overall benefit, with a notable chance of achieving a minimally clinically important difference, particularly in specific subgroups. These findings not only support the consideration of culprit lesion-only PCI in certain patient populations but also underscore the need for careful risk-benefit assessment. Furthermore, our hypothesis-generating subgroup analyses, which show varying probabilities of achieving MCID, illuminate promising avenues for future targeted investigations in this critical patient population.

A systematic review and meta-analysis of health-related quality of life (HRQoL) outcomes in randomised controlled trials for pulmonary arterial hypertension (PAH)

Abstract Introduction ESC guidelines recognise the under use of disease-specific health-related quality of life (HRQoL) instruments. These include CAMPHOR, PAH-SYMPACT, Emphasis-10 and Living with Pulmonary Hypertension (LPH). Patients highly value HRQoL as a treatment outcome in PAH. This is the first meta-analysis to evaluate HRQoL instruments and outcomes in RCTs in pulmonary arterial hypertension (PAH). Purpose To evaluate which PAH-RCT interventions improve HRQoL outcomes and compare the suitability of HRQoL instruments used. Method We searched MEDLINE (Jan 1970 to Dec 2023) and Cochrane Library from Jan 1990 to Dec 2023 (EMBASE, CT.gov, ICTRP, CINAHL) for RCTs in PAH. Abstracts and unpublished studies were excluded and PRISMA reporting structure followed. Trials meeting final selection criteria included HRQoL instruments sufficiently powered to detect a minimal clinically important difference (MCID). Effective sample sizes were calculated in GPower3.1 from a two independent means model for 80% power, 5% significance, one-tailed test. Meta-analysis was performed in SPSSv28.1. Full search criteria are registered on PROSPERO (ID: CRD42024484021). Results After removal of duplicates, 896 records were screened, 43 studies included a HRQoL endpoint. 8 studies were included in the meta-analysis after exclusion for insufficient data (n=10) or power (n=25). 3 of these did not meet the MCID (&amp;gt;33m) for six-minute walk distance (6MWD) and evaluated separately to discriminate accuracy of HRQoL instrument. Instruments available for comparison were Short Form-36(SF-36), EuroQol (EQ-5D-5L) and Living with Pulmonary Hypertension (LPH). Studies not reaching MCID for 6MWD also showed no change in HRQoL (figure 1). Ambrisentan and exercise training demonstrate a significant improvement (p&amp;lt;0.05) in SF-36 physical(P) component (figure 2). This component was anchored to determine 6MWD MCID; other HRQoL values responded variably. Utility weighting to account for geographical variation was not reported with EQ-5D-5L and SF-36 in multicentre studies however AIR 2002 (Iloprost) was significant for both EQ-5D-5L instruments. The total component score of the disease-specific LPH was more sensitive to functional improvements and overall change in HRQoL compared to EQ-5D-5L (p&amp;lt;0.05). Conclusion Fewer than 10% of all RCTs in PAH have adequately considered a HRQoL outcome measure. 8 RCTs were powered to assess HRQoL. Iloprost, ambrisentan, riociguat and exercise training interventions demonstrate significant improvement in HRQoL. LPH was the only PAH-instrument powered to detect change. LPH was more sensitive to HRQoL than generic instruments and is multidimensional. Geographical indexing should be considered for generic instruments such as EQ-5D-5L and SF-36 in multicentre trials. As a highly valued outcome for patients, future studies should prioritise HRQoL as an endpoint.Figure 1Figure 2

Inhaled Reliever Therapies for Asthma

The optimal inhaled reliever therapy for asthma remains unclear. To compare short-acting β agonists (SABA) alone with SABA combined with inhaled corticosteroids (ICS) and with the fast-onset, long-acting β agonist formoterol combined with ICS for asthma. The MEDLINE, Embase, and CENTRAL databases were searched from January 1, 2020, to September 27, 2024, without language restrictions. Pairs of reviewers independently selected randomized clinical trials evaluating (1) SABA alone, (2) ICS with formoterol, and (3) ICS with SABA (combined or separate inhalers). Two reviewers independently extracted data and assessed risk of bias. Random-effects meta-analyses synthesized outcomes. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to evaluate the certainty of evidence. Asthma symptom control (5-item Asthma Control Questionnaire; range, 0-6, lower scores indicate better asthma control; minimum important difference [MID], 0.5 points), asthma-related quality of life (Asthma Quality of Life Questionnaire; range, 1-7, higher scores indicate better quality of life; MID, 0.5 points), risk of severe exacerbations, and risk of serious adverse events. A total of 27 randomized clinical trials (N = 50 496 adult and pediatric patients; mean age, 41.0 years; 20 288 male [40%]) were included. Compared with SABA alone, both ICS-containing relievers were associated with fewer severe exacerbations (ICS-formoterol risk ratio [RR], 0.65 [95% CI, 0.60-0.72]; risk difference [RD], -10.3% [95% CI, -11.8% to -8.3%]; ICS-SABA RR, 0.84 [95% CI, 0.73-0.95]; RD, -4.7% [95% CI, -8.0% to -1.5%]) with high certainty. Compared with SABA alone, both ICS-containing relievers were associated with improved asthma control (ICS-formoterol RR improvement [MID] in total score, 1.07 [95% CI, 1.04-1.10]; RD, 4.1% [95% CI, 2.3%-5.9%]; ICS-SABA RR, 1.09 [95% CI, 1.03-1.15]; RD, 5.4% [95% CI, 1.8%-8.5%]) with high certainty. In an indirect comparison with ICS-SABA, ICS-formoterol was associated with fewer severe exacerbations (RR, 0.78 [95% CI, 0.66-0.92]; RD, -5.5% [95% CI, -8.4% to -2.0%]) with moderate certainty. Compared with SABA alone, ICS-formoterol (RD, -0.6% [95% CI, -1.3% to 0%]) was not associated with increased risk of serious adverse events (high certainty) and ICS-SABA (RD, 0% [95% CI, -1.1% to 1.2%]) was not associated with increased risk of serious adverse events (moderate certainty). In this network meta-analysis of patients with asthma, ICS combined with formoterol and ICS combined with SABA were each associated with reduced asthma exacerbations and improved asthma control compared with SABA alone.

Minimally Invasive Transforaminal Versus Lateral Lumbar Interbody Fusion for Degenerative Spinal Pathology: Clinical Outcome Comparison in Patients With Predominant Back Pain.

Retrospective review. To compare perioperative and postoperative clinical outcomes between minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and lateral lumbar interbody fusion (LLIF) in patients presenting with predominant back pain. Two popular techniques utilized for lumbar arthrodesis are MIS-TLIF and LLIF. Both techniques have reported high fusion rates and suitable postoperative clinical outcomes. Scarce literature exists, however, comparing these 2 common fusion techniques in a subset population of patients presenting with predominant back pain preoperatively. A retrospective review of lumbar procedures performed between November 2005 and December 2021 was conducted using a prospectively maintained single-surgeon database. Inclusion criteria were set as primary, elective, single, or multilevel MIS-TLIF or LLIF procedures for degenerative spinal pathology in patients with predominant preoperative back pain [visual analog scale (VAS) back pain preoperative score > VAS leg preoperative score]. Patients undergoing a revision procedure, single-level procedure at L5-S1, or surgery indicated for infectious, malignant, or traumatic etiologies were excluded. In addition, patients with VAS leg preoperative scores ≥ to VAS back preoperative scores were excluded. Patient demographics, perioperative characteristics, postoperative complications, and patient-reported outcome measures (PROMs) were collected. PROMs included VAS for back and leg pain, Oswestry Disability Index (ODI), and Short Form-12 (SF-12) Item Survey Mental (MCS) and Physical (PCS) Composite Scores with all values collected at the preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year follow-up time point. Patients were grouped into 2 cohorts, depending on whether a patient underwent a MIS-TLIF or LLIF. Demographic and perioperative characteristics were compared between groups using χ2 and Student t test for categorical and continuous variables, respectively. Mean PROM scores were compared between cohorts at each time point utilizing an unpaired Student t test. Postoperative improvement from preoperative baseline within each cohort was assessed with paired samples t test. Achievement of minimum clinical important difference (MCID) was determined by comparing ΔPROM scores to previously established threshold values. MCID achievement rates were compared between groups with χ2 analysis. Statistical significance was noted as a P value <0.05. Eligible study cohort included 153 patients, split into 106 patients in the MIS-TLIF cohort and 47 patients in the LLIF cohort. The mean age was 55.9 years, the majority (57.5%) of patients were males, the mean body mass index was 30.8kg/m2, and the majority of the included cohort were nondiabetic and nonhypertensive. No significant demographic differences were noted between cohorts. The MIS-TLIF cohort had a significantly greater proportion of patients with preoperative spinal pathology of recurrent herniated nucleus pulposus, whereas a significantly greater proportion of patients in the LLIF cohort demonstrated isthmic spondylolisthesis (P < 0.046, all). No significant differences were noted between cohorts for operative duration, estimated blood loss, 1-year rate of arthrodesis, postoperative length of stay, postoperative VAS pain scores on postoperative day 0 or 1, and postoperative narcotic consumption on postoperative day 0 or 1. Patients in the LLIF cohort showed greater rates of postoperative ileus (4.3% vs 0.0%). No other significant differences were noted between cohorts for postoperative complications. Between cohorts, preoperative PROM scores did not significantly differ. The following significant postoperative mean PROM scores were demonstrated: VAS back at 12 weeks and ODI at 12 weeks with both mean scores favoring the LLIF cohort. The MIS-TLIF cohort reported significant improvement from preoperative baseline to the 2-year time point for all PROMs collected at all individual postoperative time points except SF-12 MCS at 6 weeks (P < 0.0, all). LLIF cohort reported significant improvement from preoperative baseline to the 1-year time point for all PROMs collected at all individual postoperative time points except for ODI at 6 weeks, 1 year, and 2 years, SF-12 MCS at 6 weeks and 2 years, and SF-12 PCS at 2 years(P < 0.042, all). The majority of patients in both cohorts achieved overall MCID for VAS back, VAS leg, ODI, and SF-12 PCS. A significantly greater proportion of patients in the LLIF cohort achieved MCID for SF-12 PCS at 12 weeks (94.4% vs 61.1%; P < 0.008). Patients with predominant back pain undergoing MIS-TLIF or LLIF for degenerative spinal pathology demonstrated similar 2-year mean clinical outcomes for physical function, disability, leg pain, and back pain. At the 12-week time point, mean outcome scores for back pain and disability favored the lateral approach with concurrent higher rates of MCID achievement for physical function at that time point.

Progress Toward Estimating the Minimal Clinically Important Difference of Intelligibility: A Crowdsourced Perceptual Experiment.

The purpose of the current study was to estimate the minimal clinically important difference (MCID) of sentence intelligibility in control speakers and in speakers with dysarthria due to multiple sclerosis (MS) and Parkinson's disease (PD). Sixteen control speakers, 16 speakers with MS, and 16 speakers with PD were audio-recorded reading aloud sentences in habitual, clear, fast, loud, and slow speaking conditions. Two hundred forty nonexpert crowdsourced listeners heard paired conditions of the same sentence content from a speaker and indicated if one condition was more understandable than another. Listeners then used the Global Ratings of Change (GROC) Scale to indicate how much more understandable that condition was than the other. Listener ratings were compared with objective intelligibility scores obtained previously via orthographic transcriptions from nonexpert listeners. Receiver operating characteristic (ROC) curves and average magnitude of intelligibility difference per level of the GROC Scale were evaluated to determine the sensitivity, specificity, and accuracy of potential cutoff scores in intelligibility for establishing thresholds of important change. MCIDs derived from the ROC curves were invalid. However, the average magnitude of intelligibility difference derived valid and useful thresholds. The MCID of intelligibility was determined to be about 7% for a small amount of difference and about 15% for a large amount of difference. This work demonstrates the feasibility of the novel experimental paradigm for collecting crowdsourced perceptual data to estimate MCIDs. Results provide empirical evidence that clinical tools for the perception of intelligibility by nonexpert listeners could consist of three categories, which emerged from the data ("no difference," "a little bit of difference," "a lot of difference"). The current work is a critical step toward development of a universal language with which to evaluate changes in intelligibility as a result of neurological injury, disease progression, and speech-language therapy.

Predictors of time to achieve clinically significant improvements following lateral lumbar interbody fusion

BackgroundAs lateral lumbar interbody fusions (LLIF) are increasingly performed, our understanding of postoperative clinical trajectories is important in informing preoperative patient expectations. While minimum clinically important difference (MCID) rates are widely utilized in spine surgery literature, there is less published on how long it takes for patients to achieve MCID following LLIF. ObjectiveTo evaluate the length of time it takes for patients to report MCID achievement for back pain, leg pain, disability, and physical function and evaluate predictors of time to achieve MCID. MethodsPatients undergoing elective LLIF by the senior author with baseline and postoperative patient-reported outcomes (PROs) recorded were retrospectively identified. Data on potential predictors of time to MCID achievement were gathered including demographics, comorbidities, diagnostic information, and baseline PROs. MCID achievement rates for Oswestry Disability Index (ODI), Visual Analog Scale-Back (VAS-Back), VAS-Leg, and Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF) were calculated at six-, twelve, 6 month- 1 year- and 2-year postoperative timepoints. A Kaplan-Meier survival analysis was conducted to determine the proportion of patients achieving MCID at each time point. A multivariate Cox regression determined predictors of time to MCID achievement. ResultsOne hundred-five patients were included in the analysis. The mean time to achieve MCID for PROMIS-PF was 44.7 weeks, for VAS-Back was 38.5 weeks, for VAS-Leg was 36.7 weeks, and for ODI was 38.3 weeks. Worse baseline VAS-Back significantly predicted earlier MCID achievement for VAS-Back (HR: 1.55), while diabetes was predictive of later MCID achievement (HR: 0.21). Higher body mass index and worse preoperative ODI predicted earlier MCID achievement for ODI (HR: 1.04–1.08), and higher VAS-Leg score and two-level fusion were predictive of later MCID achievement for ODI, (HR:0.26–0.81). Worse preoperative VAS-Leg, isthmic spondylolisthesis, and three-level fusion were predictors of earlier achievement of MCID for VAS-Leg (HR: 1.27–6.47). Herniated nucleus pulposus and foraminal stenosis were early predictors (HR: 2.92–3.23) and workers’ compensation was a late predictor of MCID attainment for PROMIS-PF (HR: 0.13). ConclusionSelect demographic variables, comorbidities, spinal pathology, and preoperative PROs influenced the time it took for patients to report clinically significant improvements in pain, disability, and physical function scores. These findings can be used to prognosticate outcomes for patients undergoing LLIF and inform patient expectations of postoperative recovery.

Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: A CRUSE® mobile health study.

CRUSE® is an app that allows patients with chronic spontaneous urticaria (CSU) to monitor their daily disease activity through the use of visual analogue scales (VASs). We aimed to determine the concurrent validity, reliability, responsiveness and minimal important difference (MID) of CRUSE® VASs. We evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU ('VAS urticaria'), VAS for the impact of urticaria on work/school productivity ('VAS productivity') and the VAS of EQ-5D. Concurrent validity was assessed by measuring the association between each VAS and the Urticaria Activity Score (UAS). Intra-rater reliability was determined based on the data of users providing multiple daily questionnaires within the same day. Test-retest reliability and responsiveness (ability to change), respectively, were tested in clinically stable and clinically unstable users. MIDs were determined using distribution-based methods. We included 5938 patients (67,380 days). Concurrent validity was high, with VAS urticaria being more strongly associated with the UAS score than the remaining VASs. Intra-rater reliability was also high, with intraclass correlation coefficients (ICC) being above 0.950 for all VASs. Moderate-high test-retest reliability and responsiveness were observed, with reliability ICC being highest for VAS EQ-5D and responsiveness being highest for VAS urticaria. The MID for VAS urticaria was 17 (out of 100) units, compared to 15 units for VAS productivity and 11 units for VAS EQ-5D. Daily VASs for CSU available in the CRUSE® app display high concurrent validity and intra-rater reliability and moderate-high test-retest reliability and responsiveness.

Comparative Study on Postoperative Immobilization in Reverse Total Shoulder Arthroplasty: 4 Weeks vs. 6 Weeks of Immobilization Yields Similar Clinical and Functional Outcomes.

Background/Objectives: To investigate clinical and functional outcomes of patients undergoing reverse total shoulder arthroplasty (RTSA) using a rehabilitation protocol of either 4 or 6 weeks of immobilization. Methods: This comparative study analyzed a consecutive patient cohort that underwent RTSA in a single institute from January 2021-February 2023. Patients were assigned to groups according to the duration of postoperative immobilization and were followed up for a minimum of one year. Patient demographics, range of motion (ROM), functional outcomes using the Simple Shoulder Test (SST) and the American Shoulder and Elbow Score (ASES) as well as postoperative complications were recorded. The minimum clinically important difference (MCID) was used to assess whether the differences between the groups in SST, ASES, SWB, and VAS were clinically relevant. Results: Sixty patients met the inclusion criteria (35 patients in the 6-week immobilization group (6 WG) and 25 patients in the 4-week immobilization group (4 WG)) and were available for the total follow-up period. Similar baseline demographics were observed between the groups. Active ROM significantly improved for both groups, with abduction and forward flexion improving the most. In terms of functional outcomes, significant improvement (p < 0.001) was demonstrated for both groups (ASES, SST, VAS, and SWB). However, patients in the 4 WG reached significantly better results in VAS and SWB at 6 weeks and 3 months, as well as in ASES 3 months postoperatively, whereas both groups leveled off at the end of the follow-up period after 1 year. Taking into account the MCID, these differences for ASES at 3 months, as well as VAS and SWB at 6 weeks and 3 months postoperatively, were significant. Surprisingly, there were no differences between the groups over the entire follow-up period in terms of the SST. Conclusions: The author's findings suggest faster clinical recovery at 6 weeks and 3 months in patients undergoing postoperative immobilization of 4 weeks compared to 6 weeks following RTSA. However, clinical and functional outcomes were equal for 4 WG and 6 WG at one year follow up.

Short-term effects on physical activity level with web-based self-management support in people with COPD: a randomised controlled trial

We aimed to evaluate short-term effects of a web-based self-management support on objectively measured physical activity (PA) compared to usual care in people with chronic obstructive pulmonary disease (COPD). We conducted a pragmatic randomised controlled trial including people with stable COPD within primary healthcare. Participants were randomised to intervention group, IG (access to the COPD Web, an interactive website to support self-management with focus on PA), or to control group, CG (usual care). Primary outcome at 3 months was change in accelerometry-measured daily steps analysed with ANCOVA, and secondary outcomes were self-reported PA, disease-related symptoms, and quality of life. Missing data in intention-to-treat (ITT) analyses were multiply imputed. One hundred and forty-six participants (n = 73/group), mean (SD) age 69.5 (6.7) years, FEV1pred 60.7 (19.1)% were included. The ITT analysis showed no significant difference in steps between the groups: 1295 steps (95% CI: [−365, 2955], p = 0.12), while the complete case analysis (n = 98) revealed a significant difference of 1492 steps (95% CI: [374, 2609], p = 0.01) in favour of IG. A significant increase in self-reported PA was seen in IG in both the ITT and complete case analysis. In summary, access to the COPD Web was insufficient to increase short-term PA level compared to usual care. However, among participants with complete step data, a clinically relevant effect on daily steps exceeding the minimal important difference was observed, partly explained by higher baseline PA than among dropouts. This indicates that access to the COPD Web may increase PA levels for some people with COPD.