Clinical Important Difference Research Articles

THE SMALLEST WORTHWHILE EFFECT OF EXERCISE THERAPY FOR PEOPLE WITH CHRONIC LOW BACK PAIN: A DISCRETE CHOICE EXPERIMENT STUDY

INTRODUCTION Understanding the magnitude of treatment effect patients need to see to consider a treatment worthwhile is of clear clinical and research importance. Current measures of clinical importance, such as the minimum clinical important difference, are limited as they are not determined by patients, and do not reflect specific costs, risks or inconveniences of individual treatments, i.e. you could have the same MCID for surgery as for exercise. We aimed to identify the smallest worthwhile effect (SWE), a new measure of clinical importance, of exercise therapy for people with non-specific chronic low back pain (CLBP) using discrete choice experiment. METHODS The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS 213 participants completed the survey. Mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. This means, for a baseline pain of 5, the SWE would be a 1/10 between-group reduction in pain. CONCLUSION This patient-informed threshold of clinical importance should guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise.

Minimal Important Clinical Difference Values Are Not Uniformly Valid in the Active Duty Military Population Recovering from Shoulder Surgery

There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of two different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operator curve (ROC) -based MCIDs and baseline-adjusted ROC MCIDs. All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROMs battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons score (ASES), Patient Reported Outcome Management Information System (PROMIS) Physical Function (PF), PROMIS Pain Interference (PI), and the Warfighter Readiness survey. Standard anchor-based and baseline-adjusted ROC MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval either completely negative or positive). There were 117 patients (136 operations) identified, comprised of 83% males with a mean age of 35.7 ± 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC MCID calculation, the MCID estimates for SANE, ASES, and PROMIS PI were both statistically and theoretically valid if the baseline score was less than 70.5, 69, and 65.7. When MCIDs were calculated and anchored to the results of standard, anchor-based MCID, a standard ROC analysis did not yield statistically or theoretically valid results across a battery of PROMs commonly used to assess outcomes after shoulder surgery in the active duty military population. Conversely, a baseline-adjusted ROC method was more effective at discerning changes across a battery of PROMs among the same cohort.

Clinical outcomes after hip arthroscopy in acetabular dysplastic patients, previously treated with periacetabular osteotomy: a minimum of two-year follow-up data from the Danish Hip Arthroscopy Registry

ABSTRACT Periacetabular osteotomy (PAO) is the treatment of choice in dysplastic acetabulum. Due to continued symptoms, 2–11% of these patients require an additional hip arthroscopy. The purpose of this study was to report clinical outcome after a minimum of 2-year follow-up of additional hip arthroscopy after PAO with data from Danish Hip Arthroscopy Registry. Inclusion criteria in the study cohort were PAO surgery resulting in an additional hip arthroscopy procedure. The cohort was evaluated according to the surgical findings and patient-related outcome measures (PROMs) pre-operatively and at 2-year follow-up. A total of 287 patients were included in the study cohort. PROMs improved significantly in all subscales from pre-operatively to 2-year follow-up in the study cohort. According to PROM subscales, 47.8–57.6% and 25.2–38.2% achieved Minimal Clinical Important Difference and Patient Acceptable Symptom State, respectively. This study demonstrates, in PAO-treated patients, significant PROM improvements after additional hip arthroscopy. Unfortunately, only ∼50% and 30% achieved Minimal Clinical Important Difference and Patient Acceptable Symptom State, respectively.

225 SpineTrak: The First Randomized Controlled Trial Using the Apple Watch to Objectively Track Spine Surgical Patients

INTRODUCTION: Early mobilization after surgery is associated with reduced complications, shorter hospitalization, and improved psychological well-being. Current methods for evaluating spine surgery outcomes rely on subjective, patient-reported outcome measures (PROMs). Wearable activity monitors, including the Apple Watch (AW), allow for real-time tracking of objective activity metrics. METHODS: Eligibility: Adult patients undergoing elective spine surgery. Patients are randomized 1:1 to the intervention vs control group. All patients complete PROMs pre-operatively and at 6-weeks, 3-months, 6-months, and 1-year post-operatively. Only intervention patients receive AW and download a study-specific app to collect AW data. AW health measures are visualized in reports provided to patients and surgeons. RESULTS: To date, we have enrolled 200 patients (n=100 intervention; n=100 control). Among patients past 1-year post-operation (n=129), 74% reached the minimal clinically-important difference in improvement for ODI/NDI, SF-36 PCS, and/or EQ-VAS relative to pre-operation. Intervention patients (n=95) have worn AW 81.3%±21.1% of the days for 14.6±4.7 hours/day. At 6-weeks post-operation, 73% of patients responded that they were very satisfied with using the AW in their spine care. 61% found seeing their AW activity data helpful. 96% of neurosurgeons agreed that AW reports help them understand their patients’ recovery. Preliminary analyses of patient recovery profiles have predicted the requirement for revision surgery in some participants. CONCLUSIONS: Preliminary results indicate patients are compliant with wearing the AW, and both patients and surgeons are satisfied with its use in their spine care. Initial analyses show poor correlation between AW measures and PROMs, emphasizing the need for a metric that combines objective and subjective measures to better track spine surgery recovery.

The feasibility, repeatability, validity and responsiveness of the EQ-5D-3L in Krio for patients with stroke in Sierra Leone

ObjectivesTo assess the feasibility, repeatability, validity and responsiveness of the EQ-5D-3L in Krio for patients with stroke in Sierra Leone, the first psychometric assessment of the EQ-5D-3L to be conducted in patients with stroke in Sub Saharan Africa.MethodsA prospective stroke register at two tertiary government hospitals recruited all patients with the WHO definition of stroke and followed patients up at seven days, 90 days and one year post stroke. The newly translated EQ-5D-3L, Barthel Index (BI), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), a measure of stroke severity, were collected by trained researchers, face to face during admission and via phone at follow up. Feasibility was assessed by completion rate and proportion of floor/ceiling effects. Internal consistency was assessed by inter item correlations (IIC) and Cronbach’s alpha. Repeatability of the EQ-5D-3L was examined using test–retest, EQ-5D-3L utility scores at 90 days were compared to EQ-5D-3L utility scores at one year in the same individuals, whose Barthel Index had remained within the minimally clinical important difference. Known group validity was assessed by stroke severity. Convergent validity was assessed against the BI, using Spearman’s rho. Responsiveness was assessed in patients whose BI improved or deteriorated from seven to 90 days. Sensitivity analyses were conducted using the UK and Zimbabwe value sets, to evaluate the effect of value set, in a subgroup of patients with no formal education to evaluate the influence of patient educational attainment, and using the mRS instead of the BI to evaluate the influence of utilising an alternative functional scale.ResultsThe EQ-5D-3L was completed in 373/460 (81.1%), 360/367 (98.1%) and 299/308 (97.1%) eligible patients at seven days, 90 days and one year post stroke. Missing item data was low overall, but was highest in the anxiety/depression dimension 1.3% (5/373). Alpha was 0.81, 0.88 and 0.86 at seven days, 90 days and one year post stroke and IIC were within pre-specified ranges. Repeatability of the EQ-5D-3L was moderate to poor, weighted Kappa 0.23–0.49. EQ-5D-3L utility was significantly associated with stroke severity at all timepoints. Convergent validity with BI was strong overall and for shared subscales. EQ-5D-3L was moderately responsive to both improvement Cohen’s D 0.55 (95% CI:0.15—0.94) and deterioration 0.92 (95% CI:0.29—1.55). Completion rates were similar in patients with no formal education 148/185 (80.0%) vs those with any formal education 225/275 (81.8%), and known group validity for stroke severity in patients with no formal education was strong. Using the Zimbabwe value set instead of the UK value set, and using the mRS instead of the BI did not change the direction or significance of results.ConclusionsThe EQ-5D-3L for stroke in Sierra Leone was feasible, and responsive including in patients with no formal education. However, repeatability was moderate to poor, which may be due to the study design, but should add a degree of caution in the analysis of repeated measures of EQ-5D-3L over time in this population. Known group validity and convergent validity with BI and mRS were strong. Further research should assess the EQ-5D in the general population, examine test–retest reliability over a shorter time period and assess the acceptability and validity of the anxiety/depression dimension against other validated mental health instruments. Development of an EQ-5D value set for West Africa should be a research priority.

A multidisciplinary approach to identifying and managing heterotopic gastric inlet patches.

Gastric inlet patches are often incidental, but can also be a treatable cause of laryngo-esophageal symptoms. We retrospectively reviewed all patients whose gastric inlet patches were diagnosed following assessment for laryngopharyngeal and swallowing symptoms. Improvement following Argon Plasma Coagulation (APC) was assessed using Minimum Clinically-Important Difference methodology combining voice, throat, and swallowing domains. Correlations between APC response and measures of reflux and mucosal barrier integrity, measured during 24-h pH-impedance manometry, were obtained. Proximal and Distal Mean Nocturnal Baseline Impedance (MNBI) values were separately calculated and the novel variable of Mucosal Impedance Gradient was derived as [((Distal MNBI-Proximal MNBI)/((Distal MNBI + Proximal MMBI)/2)) x 100]. Inlet patches were detected in 57 of 651 patients who had Transnasal Panendoscopy (8.7 ± 2.2%). There were 34 males. Mean age was 58 years. Mean duration of symptoms was 2 years. The commonest symptoms were hoarseness (n = 33), throat symptoms (n = 24), and dysphagia (n = 21), respectively. APC was used to ablate patches in 34 patients. Treatment response was 71% at a mean followup of 5.5 months. MIG > - 25% predicted response to APC, with area under the receiver operating characteristic curve of 0.875 (Sensitivity = 81%; Specificity = 100%; p < 0.0001). Gastric inlet patches are common and under-recognized. They can cause protracted pharyngo-esophageal symptoms. Patch ablation is an effective treatment for carefully selected patients. Optimal patient selection requires multidisciplinary teamwork. Mucosal Impedance Gradient could further refine patient selection.

Dry eye symptoms and health-related quality of life among Chinese individuals: a national-based study

AimsTo assess the impact of dry eye symptoms (DESs) on health-related quality of life (HRQOL) among Chinese residents.MethodsA total of 21 916 participants were involved in this nationwide cross-sectional study....

(030) Hand Held, Self-Applicable Radio Frequency Device for the Treatment of Erectile Dysfunction. A Pilot Study with 6 Months Follow-Up

Abstract Introduction Collagen is an essential component of the structures involved in the erectile mechanism. Radiofrequency (RF) energy has been shown to renew and restore the spatial structural arrangement of collagen fibers and may improve erectile function of men suffering from erectile dysfunction (ED). Objective To assess the feasibility, safety, and efficacy of low-intensity radiofrequency (RF) therapy in men with ED. Methods Men with moderate &amp; mild to moderate ED, with or without the use of PDE5-inhibitors were included. After instructions, each patient treated himself with the radiofrequency device (Vertica®), applying his selected individual RF intensity. Patients underwent, according to the protocol, 12 sessions of 30-minute treatments over 2 months. Patients were evaluated at baseline, 1, 3 and 6 months after treatment using validated questionnaires; International Index of Erectile Function (Full IIEF), IIEF-EF, and erection Hardness score (EHS), satisfaction (EDITS, BSW), and disease-specific quality and quality of life (QEQ, SQOL). In each session, patients filled safety and side-effect questions (pain, fever, burning, discomfort, urinary disorders). The Wilcoxon signed ranks test and the Marginal Homogeneity test were used for statistical processing. Results Twenty-seven out of 28 men treated, were available for 6 months follow-up, mean age 59.2±9.7. The mean ED duration was 41.2±29 months. Mean baseline IIEF-EF was 16.8±1 and improved significantly to 24.8±1.6, 24.3±1.8, and 24.2±2.08 at 1, 3 and 6 months respectively (p&amp;lt;0.001). The Minimal Clinical Important Difference (MCID) criteria were met by 25/28 (89%) at 1-month follow-up and 20/27(74%) at 6-month follow-up (p&amp;lt;0.001). A statistically and clinically significant improvement was demonstrated in the Full IIEF and EHS scores at baseline and during follow-up. No correlation was found between IIEF improvement and the age of the patients. Borderline significance (p=0.05) was found between the duration of ED and IIEF-EF improvement. No side effects were reported and participants rated the device as very comfortable and easy to operate. Conclusions The novel radiofrequency, home-use device for the treatment of ED shows promising results and the potential to improve erectile function. In this study, it was feasible and safe. Further high-quality randomized controlled trials are needed to determine the long-term efficacy of the treatment. Disclosure Yes, this is sponsored by industry/sponsor: Ohhmed, Israel. Clarification: No industry support in study design or execution. Any of the authors act as a consultant, employee or shareholder of an industry for: Ohhmed, Freya, Besins, Verility.

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.

Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS). Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups. Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient. This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS. Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

Clinical outcomes of functional endoscopic sinus surgery in cystic fibrosis patients - a single centre experience.

Endoscopic sinus surgery (ESS) is an established surgical option for cystic fibrosis (CF) patients with chronic rhinosinusitis that is refractory to conventional medical management. Objective and subjective evidence of benefit of ESS in this cohort of patients is currently conflicting in the literature. A single center retrospective study was undertaken of all CF patients (transplanted and non-transplanted) over the age of 16 who underwent an ESS over a six-year period from 2015 to 2021. Patients on triple-therapy CFTR modulators were excluded. Data was collected on demographics, clinical management, and outcome measures. The objective outcome measures were lung function (%predicted FEV1), pulmonary exacerbations (total number of days of IV antibiotics- both ambulatory and in hospital). The subjective outcome measure was SNOT-22 scores preand 6 months post-operatively. A minimally clinical important difference (MCID) in SNOT-22 scores of 9 points was used. 55 patients were included in our study, with a median age of 31 and 53% females. Median Lund-Mackay scores for the cohort was 13 (3- 24). There was a significant improvement in lung function at 1-year post-surgery, and a significant MCID reduction in SNOT-22 scores at 6 months post-surgery across the cohort. Sub-group analysis revealed a sustained MCID reduction in SNOT-22 scores in both lung-transplanted and native lung groups, and in patients with primary ESS or previous ESS. However, there was no post-operative pulmonary function improvement in lung transplanted patients and patients with previous ESS. There was no impact on the rate of pulmonary exacerbations across the cohort. 2 patients in the cohort died secondary to pulmonary disease. There was a demonstrated clinical and symptomatic benefit of ESS in CF patients in this study. Stricter guidelines for indications for ESS need to be established with regards to CF patients who will undergo ESS in the future.

Primary and revision reverse total shoulder arthroplasty using a patient-matched glenoid implant for severe glenoid bone deficiency

BackgroundSevere glenoid bone loss in the setting of both primary and revision reverse total shoulder arthroplasty (rTSA) continues to remain a significant challenge. The purpose of this study was to report on radiographic and clinical outcomes of primary and revision rTSA using a patient-matched, 3-dimensionally printed metal glenoid implant to address severe glenoid bone deficiency. This is a follow-up study to previously reported preliminary results. MethodsA retrospective review was performed on 62 patients with severe glenoid bone deficiency underwent either primary or revision rTSA using the Comprehensive Vault Reconstruction System (VRS) (Zimmer Biomet, Warsaw, IN, USA) at a single institution. Preoperative and postoperative values for the Disabilities of the Arm, Shoulder and Hand (DASH), Constant, American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test (SST), Single Assessment Numeric Evaluation (SANE), and Visual Analog Scale (VAS) pain scores as well as active range of motion (ROM) were collected and compared using the Wilcoxon signed rank test with the level of statistical significance set at P < 0.05. Percentage of patients achieving minimal clinical important difference (MCID) and substantial clinical benefit (SCB) was also calculated. ResultsFifty-five of 62 (88.7%) shoulders were able to be contacted at a minimum of 2-years postoperatively, with 47/62 (75.8%), having complete clinical and radiographic follow-up with a mean age of 67.5 years (range, 48-85 years) and follow-up of 39.2 months (range, 25-56 months). There were 19 primary and 28 revision rTSAs. Significant improvements were seen in mean active forward flexion (63.1° ± 30.3° to 116.8° ± 35°), abduction (48.1° ± 16.1 to 76.2° ± 13.4°) (P < 0.001), external rotation (16° ± 23.7° to 32.1° ± 24.5°) (P < 0.005), DASH (59.9 ± 17.7 to 35.7 ± 24.3), Constant (23.4 ± 13.1 to 53.1 ± 17.4), ASES (27.8 ± 16.2 to 69.1 ± 25.2), SST (3.3 ± 2.5 to 7.6 ± 3.5), SANE (28.9 ± 18.3 to 66.7 ± 21.2), and VAS pain (7.1 ± 2.4 to 1.8 ± 2.6) scores (P < 0.001). MCID and SCB was achieved in a majority of patients postoperatively. Overall complication rate was 29.1% with only 1 baseplate failure. ConclusionThis study demonstrates promising evidence that the VRS implant can be used as a viable option to achieve clinically important improvement in a majority of patients treated for severe glenoid bone deficiency with rTSA in both the primary and revision setting.

Global health status and fatigue score in isocitrate dehydrogenase-mutant diffuse glioma grades 2 and 3: A longitudinal population-based study from surgery to 12-month follow-up.

At the group level, health-related quality of life (HRQoL) in patients with IDH-mutant diffuse glioma grades 2 and 3 seems to remain stable over time. However, clinical experience indicates that there are patients with unfavorable outcomes on key HRQoL subdomains. The aim of this longitudinal population-based study, following patients over a period of 12 months from surgery, was to describe individual-level data on global health status and fatigue score and explore possible predictors of deterioration. All patients undergoing surgery for presumed glioma grades 2 or 3 at the Sahlgrenska University Hospital during 2017-2022, were screened for the study. Patients were invited to complete the European Organization of Research and Treatment of Cancer core questionnaires and brain module at baseline, 3 and 12 months postoperatively. Data is reported with respect to minimal clinical important difference (MCID). We included 51 patients with IDH-mutant diffuse glioma grades 2 or 3. There was no difference in group-level data of either global health status or fatigue score from baseline to the 12-month follow-up (P-value > .05). Unfavorable individual changes (beyond MCID) in global health status and fatigue score were observed in 12 and in 17 patients, respectively (23.5% and 33.3%). A lower proportion of proton radiotherapy was found in patients with unfavorable changes in fatigue (10/15, 66.7%) compared to all other patients undergoing radiotherapy (22/23, 95.7%, P-value .03). Deterioration beyond MCID was seen in approximately one-third of patients. Changes in global health status could not be predicted, but changes in fatigue may be influenced by tumor-targeted and symptomatic treatment.

Limited Improvement with Minimally Invasive Lumbar Decompression Alone for Degenerative Scoliosis with Cobb Angle over 20 Degrees: The Impact of Decompression Location.

Retrospective review of a prospectively collected multi-surgeon registry. To evaluate the outcomes of minimally invasive (MI) decompression in patients with severe degenerative scoliosis (DS) and identify factors associated with poorer outcomes. MI decompression has gained widespread acceptance as a treatment option for patients with lumbar canal stenosis and DS. However, there is a lack of research regarding the clinical outcomes and the impact of MI decompression location in patients with severe DS exhibiting a Cobb angle exceeding 20 degrees. Patients who underwent MI decompression alone were included and categorized into the DS or control groups based on Cobb angle (>20 degrees). Decompression location was labeled as "scoliosis-related" when the decompression levels were across or between end vertebrae, and "outside" when the operative levels did not include the end vertebrae. The outcomes including Oswestry Disability Index (ODI) were compared between the propensity score-matched groups for improvement and minimal clinical importance difference (MCID) achievement at ≥1 year postoperatively. Multivariable regression analysis was conducted to identify factors contributing to the non-achievement of MCID in ODI of the DS group at the ≥1 year timepoint. A total of 253 patients (41 DS) were included in the study. Following matching for age, gender, osteoporosis status, psoas muscle area, and preoperative ODI, the DS groups exhibited a significantly lower rate of MCID achievement in ODI (DS: 45.5% vs. control 69.0%, P=0.047). The "scoliosis-related" decompression (Odds ratio: 9.9, P=0.028) was an independent factor of non-achievement of MCID in ODI within the DS group. In patients with a Cobb angle>20 degrees, lumbar decompression surgery, even in the MI approach, may result in limited improvement of disability and physical function. Caution should be exercised when determining a surgical plan, especially when decompression involves the level between or across the end vertebrae. 3.

Let's Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study.

Distal radius fractures are the most frequently encountered fractures in Western societies, typically affecting patients aged 50 years and older. Although this is a common injury, the best treatment for these fractures in older patients is still under debate. This prospective study aims to compare the outcome of operatively and nonoperatively treated distal radius fractures in the older population. Only patients with distal radius fractures for which equipoise regarding the optimal treatment exists will be included. This prospective international multicenter observational cohort study will be designed as a natural experiment. Natural experiments are observational studies in which treatment allocation is determined by factors outside the control of the investigators but also (largely) independent of patient characteristics. Patients aged 65 years and older with an acute distal radius fracture will be considered for inclusion. Treatment allocation (operative vs nonoperative) will be based on the local preferences of the treating hospital either in Switzerland or the Netherlands. Hence, the process governing treatment allocation resembles that of randomization. Patients will be identified after treatment has been initiated. Based on the radiographs and baseline information of the patient, an expert panel of 6 certified trauma surgeons from 2 regions will provide their treatment recommendation. Only patients for whom the experts disagree on treatment recommendations will ultimately be included in the study (ie, for whom there is a clinical equipoise). For these patients, both operative and nonoperative treatment of distal radius fractures are viable, and treatment choice is predominantly determined by personal or local preference. The primary outcome will be the Patient-Rated Wrist Evaluation score at 12 weeks. Secondary outcomes will include the Physical Activity Score for the Elderly, the EQ questionnaire, pain, the living situation, range of motion, complications, and radiological outcomes. By including outcomes such as living situation and the Physical Activity Score for the Elderly, which are not relevant for younger cohorts, valuable information to tailor treatment to the needs of the older population can be gained. According to the sample size collection, which was based on the minimal important clinical difference of the Patient-Rated Wrist Evaluation, 92 patients will have to be included, with at least 46 patients in each treatment group. Enrollment began in July 2023 and is expected to continue until summer 2024. The final follow-up will be 2 years after the last patient is included. Although many trials on this topic have previously been published, there remains an ongoing debate regarding the optimal treatment for distal radius fractures in older patients. This observational study, which will use a fairly new methodological study design, will provide further information on treatment outcomes for older patients with distal radius fractures for which to date equipoise exists regarding the optimal treatment. DERR1-10.2196/52917.

Monitoring outcome measures for cardiometabolic disease during rehabilitation and follow-up in people with spinal cord injury.

Controlled pragmatic intervention with follow-up. To describe cardiometabolic risk outcomes after a pragmatic intervention implemented into standard spinal cord injury (SCI) rehabilitation. Inpatient SCI rehabilitation in East-Denmark. Inpatients, >18 years, having sustained a SCI within the last 12 months at admission to rehabilitation, regardless of etiology, neurological level or completeness of the lesion or mobility status. Patient education on health promotion was guided by evidence and included feedback on peak oxygen uptake (VO2peak) (primary outcome measure), body mass index (BMI), Dual energy X-ray absorptiometry and metabolic profile (secondary outcome measures). Paired t-tests, non-parametric tests and Analysis of Variance (ANOVA) were used for analyzes. VO2peak and BMI were compared to historical data. VO2peak increased significantly from admission to discharge but did not exceed historical data despite a minimal clinical important difference. BMI decreased significantly during rehabilitation (p < 0.001) followed by a significant increase after discharge (p = 0.006). There was a trend that people with American Spinal Injury Association Impairment Scale (AIS) D SCI increased lean mass to nearly normal values. Criteria for pre-diabetes or diabetes were present in 28.5% and dyslipidemia in 45% of the participants 44.2 days after time of injury. Despite improvements during rehabilitation, outcome measures were worse than recommended, and most outcome measures worsened at follow up, even in people with an AIS D SCI. Meaningful support regarding exercise and diet when tackling altered life circumstances is needed after discharge.

TECH preserves global cognition of older adults with MCI compared with a control group: a randomized controlled trial

BackgroundCognitive training using touchscreen tablet casual game applications (apps) has potential to be an effective treatment method for people with mild cognitive impairment (MCI).AimsThis study aimed to establish the effectiveness of ‘Tablet Enhancement of Cognition and Health’ (TECH), a novel cognitive intervention for improving/preserving cognition in older adults with MCI.MethodsA single-blind randomized controlled trial with assessments pre-, post-, and at 6-month follow-up was conducted. TECH entailed 5 weeks of daily self-training utilizing tablet apps, facilitated by weekly group sessions. Global cognition was assessed by the Montreal Cognitive Assessment (MoCA), and specific cognitive components were assessed using WebNeuro computerized battery. Short Form Health Survey (SF-12) assessed health-related quality of life (HRQoL). Intention-to-treat analysis was conducted and the %change was calculated between pre–post and between pre–follow-up. Cohen’s d effect size was also calculated.ResultsSixty-one participants aged 65–89 years were randomly allocated to TECH (N = 31, 14 women) or to standard care (N = 30, 14 women). Pre–post and pre–follow-up MoCA %change scores were significantly higher in TECH than control (U = 329.5, p < .05; U = 294.5, p < .05) with intermediate effect size values (Cohen’s d = .52, Cohen’s d = .66). Forty percent of TECH participants versus 6.5% of control participants achieved a minimal clinical important difference in MoCA. Pre–post between-group differences for specific cognitive components were not found and HRQoL did not change.Discussion and conclusionsTECH encouraged daily self-training and showed to preserve global cognition of older adults with MCI. The implementation of TECH is recommended for older adults with MCI, who are at risk for further cognitive decline.

Exercise-Induced Functional Changes in People with Parkinson's Disease following External Cueing and Task-Based Intervention.

The purpose of this study was to evaluate change in motor function, gait speed, dynamic balance, balance confidence, and quality of life (QoL) in nine participants with Parkinson's disease (PwPD) completing Lee Silverman Voice Treatment BIG (LSVT-BIG), an external cueing and task-based intervention. Although supported as an efficacious treatment in PwPD, there is limited research examining clinically meaningful change in outcome measures related to external cueing and task-based interventions. This was a case series of nine PwPD (age range 64-76 years, 55% male) who completed the LSVT-BIG protocol. Disease duration ranged from 1 to 17 years and was classified as moderate in all participants (Hoehn and Yahr = 2 or 3). Outcome measures included motor function (MDS-UPDRS Part III Motor), gait speed, dynamic balance (MiniBEST), Activities-specific Balance Confidence (ABC), and Summary Index for PD Quality of Life 39 (PDQ-SI). Assessments were completed at baseline (BASE), end of treatment (EOT), and 4 weeks after EOT (EOT+4). Minimal detectable change (MDC) or minimal clinical important difference (MCID) was observed in one or more outcome measures in 8 of 9 participants at EOT and EOT+4 across domains of motor function (67%, 78%), gait speed (78%, 67%), balance confidence (44%, 33%), quality of life (44%, 78%), and dynamic balance (22%, 22%). Discussion. In this case series, 8 of 9 participants showed MDC or MCID changes across multiple functional domains. Improvements were observed immediately post (EOT) and 4-week post-treatment (EOT+4) suggesting a temporal component of the LSVT-BIG impact on functional change. Future research should include clinical trials to examine additional external cueing and task-based intervention efficacy with consideration of intensity, frequency, and mode of delivery across disease severity.

Effect of revision sacroiliac joint fusion on unresolved pain and disability: a retrospective cohort study.

The sacroiliac (SI) joint is recognized as a source of low back pain in 15-30% of patients. Though randomized controlled trials have shown clinical improvement following SI joint fusion in 83.1% of patients, revision rates of 2.9% within 2years have been reported. There is a paucity of literature reviewing this small yet significant population of patients requiring revision surgery. Following IRB approval, retrospective review of patients, who underwent a revision SI joint fusion from 2009 to 2021 was completed. Patient-reported outcomes were measured before and at each clinic visit after surgery with visual analoge scale (VAS) for back pain and Oswestry Disability Index (ODI). Patient characteristics (chronic opiate use and prior lumbar fusion) and surgical factors (operative approach, type/number of implants and use of bone graft) were recorded. Patient-reported outcomes were evaluated with Paired t and Wilcoxon signed rank tests. Univariate and multivariate logistic regression determined if patients met the minimally clinical important differences (MCID) for VAS-back pain and ODI scores at 1year. Fifty-two patients (77% female) with an average age of 49.1 (SD ± 11.1) years met inclusion criteria. Forty-four had single sided revisions and eight bilateral revisions. At 1year follow-up there was no significant improvement in VAS-Back (p = 0.06) or ODI (p = 0.06). Patients with chronic opioid use were 8.5 times less likely to achieve the MDC for ODI scores (OR 0.118, p = 0.029). There was no difference in outcomes when comparing the different surgical approaches (p = 0.41). Our study demonstrates patients undergoing revision surgery have moderate improvement in low back pain, however, few have complete resolution of their symptoms. Specific patient factors, such as chronic opiate use and female sex may decrease the expected improvement in patient-reported outcomes following surgery. Failure to obtain relief may be due to incorrect indications, lack of biologic fusion and/or presence of co-pathologies. Further clinical examination and consistent long-term follow-up, clarify the role revision surgery plays in long-term patient outcomes.

Urinary Symptoms Change and Quality of Life After Robotic Radical Prostatectomy: A Secondary Analysis of a Randomized Controlled Trial

ObjectiveTo present the patient-reported QoL outcomes from a prospective, randomized controlled trial comparing the use of pelvic floor muscle training (PFMT) and duloxetine after robot-assisted radical prostatectomy (RARP). MethodsWe identified 213 men with organ-confined disease having post-RARP urinary incontinence who were randomly assigned to received PFMT, duloxetine, combined PFMT-duloxetine and pelvic floor muscle home exercises. Urinary symptoms burden was measured by marked clinical important difference improvement (MCID) defined by using the International Prostate Symptom Score(IPSS) difference of -8 points(ΔIPSS ≤ -8). QoL was assessed according to Visual Analog Scale(VAS), King’s Health Questionnaire(KQH), and International Index of Erectile Function(IIEF-5). Multivariable regression analyses aimed to predict MCID, burden of urinary symptoms (IPSS ≥8), and patients reporting to be satisfied (IPSS QoL ≤2) or comfortable (VAS ≤1) post-RARP. ResultsModerate to severe urinary symptoms decreased from 48% pre-operatively to 40%, 34% and 23% at 3mo, 6mo and 12mo post-RARP. After surgery, MCID improvement was observed in 19% of patients, and deterioration in 3.3%. Large prostate was the only factor associated to MCID (OR 1.03 [95%CI 1.01-1.05], p=0.005). At 6mo, patients reached the same degree of preoperative satisfaction. NVB preservation was the only predictor of being comfortable regarding urinary symptoms postoperatively (OR12.8 [CI95% 1.47-111.7],P=0.02 at 3mo) and was also associated to higher median postoperative IIEF-5. ConclusionDespite UI following RARP, patients with larger prostates experience a reduction of lower urinary tract symptoms (LUTS) within a year, which subsequently elevates QoL. Furthermore, nerve-sparing surgery augments erectile function and urinary outcomes, shaping postoperative QoL.

WALKING CADENCE AS A MEASURE OF ACTIVITY INTENSITY AND THE IMPACT ON FUNCTIONAL CAPACITY FOR OLDER ADULTS WITH FRAILTY

Abstract Background Walking cadence has been suggested as a measure of activity intensity; however, it remains uncertain if prefrail and frail older adults can increase their walking cadence and if doing so leads to improvements in functional capacity. We aimed to determine if cadence can be increased and if this leads to improvement in functional capacity in prefrail and frail older adults. Methods We performed a secondary data analysis of a walking intervention in prefrail and frail older adults living in retirement communities. Patients were randomized to Casual Speed Walking (CSW) and High-Intensity Walking (HIW) groups. Our primary outcome was improvement in 6-minute walk test (6MWT) distance above the minimally clinical important difference (MCID). We performed linear and logistic mixed-effects regressions to analyze our aims. Results 102 participants were included in the final analysis with 56 in the CSW group and 46 in the HIW group. Participants in the HIW group increased their walking cadence as compared to the CSW group during the intervention (HIW 100[88, 111] steps/min vs. CSW 77[65, 86] steps/min; P &amp;lt; 0.001). Participants that increased their walking cadence demonstrated an increased odds of improvement in their 6MWT MCID (OR: 0.11, 95% CI: 0.033, 0.18; p=0.005). Conclusions Older adults can increase their walking cadence and walking cadence can serve as a surrogate measure of activity intensity during walking interventions. An increase of 14 steps/minute from their comfortable walking cadence increased the odds of improvement in 6MWT MCID.