Patient-reported Outcomes Research Articles

Benefits and Harms of Coronary Revascularization in Non-Dialysis-Dependent Chronic Kidney Disease and Ischemic Heart Disease: A Systematic Review and Meta-Analysis.

Key Points In people with non–dialysis-dependent CKD, revascularization may lower all-cause mortality and risk of cardiovascular events.Adverse kidney events, which are often cited as a reason to avoid revascularization, were uncommon.Additional research on the effect of revascularization on patient-reported outcomes in people with non–dialysis-dependent CKD is needed. Background Cardiovascular disease is the leading cause of death in people with CKD. Coronary revascularization can improve cardiac function and prognosis in people with ischemic heart disease; however, in people with CKD, there is concern that potential harms could outweigh benefits of revascularization. Evidence on the balance of these risks and benefits, specifically in people with non–dialysis-dependent CKD, is lacking. Methods We conducted a systematic review of randomized controlled trials to assess the risks and benefits of revascularization, compared with medical management, among adults or children with ischemic heart disease and CKD not requiring KRT (dialysis or transplantation). We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials through December 12, 2023. Two people independently screened titles and abstracts followed by full-text review, serially extracted data using standardized forms, independently assessed risk of bias, and graded the certainty of evidence (COE). Results Evaluating data from nine randomized controlled trials, we found that people with CKD and ischemic heart disease treated with revascularization may experience lower all-cause mortality compared with people receiving medical management (risk ratio [RR], 0.80; 95% confidence interval [CI], 0.64 to 0.98; COE, low). Revascularization may reduce incidence of myocardial infarction (RR, 0.81; 95% CI, 0.64 to 1.04; COE, low) and heart failure (RR, 0.80; 95% CI, 0.52 to 1.23; COE, low). The effect on cardiovascular mortality is uncertain (hazard ratio, 0.67; 95% CI, 0.37 to 1.20; COE, very low). Evidence was insufficient for patient-reported outcomes and adverse kidney events. Data were limited by heterogeneity of patient populations and the limited number of trials. Conclusions In people with non–dialysis-dependent CKD, revascularization may be associated with lower all-cause mortality compared with medical management and may also lower the risk of cardiovascular events. Additional data surrounding kidney and patient-reported outcomes are needed to comprehensively engage in shared decision making and determine optimal treatment strategies for people with CKD and ischemic heart disease. Clinical Trial registry name and registration number: CRD42022349820 (PROSPERO).

No difference in osteoarthritis, but less graft failures after 5 years, comparing anatomic double-bundle to anatomic single-bundle ACL reconstruction.

The purpose of this study was to compare the incidence of knee osteoarthritis (OA) between the anatomic single-bundle (SB) and anatomic double-bundle (DB) anterior cruciate ligament (ACL) reconstruction technique after 5-year follow-up (FU). Secondary objectives were to compare patient-reported outcome measures (PROMs), clinical examination, activity level, functional tests and graft failures between the two groups. The study was a secondary analysis after 5-year FU of a randomized controlled trial (RCT) (Clinical Trials NCT01033188). One hundred and twenty patients between 18 and 40 years were randomized to either anatomic SB or anatomic DB reconstruction. The Kellgren-Lawrence (KL) classification grade ≥2 and the Osteoarthritis Research Society International (OARSI) atlas criteria score ≥2 were used for defining OA. Additionally, PROMs were obtained and clinical examinations of the knees were performed. Finally, the number of patients experiencing graft failure in each group was recorded. Radiographic imaging was performed in 39 patients in the SB group and in 37 patients in the DB group. Four patients (10%) in the SB group and two (5%) in the DB group developed osteoarthritis according to the KL classification (p = 0.28). Five (13%) in the SB group and three (8%) in the DB group developed osteoarthritis according to the OARSI atlas criteria (p = 0.59; difference 5.0% [95% confidence interval, CI: -0.10 to 0.20]). There were no significant differences in the PROMs, clinical examinations, activity levels, or functional tests when comparing the two groups. Of initially 62 SB patients, 14 (23%) experienced graft failure compared to 4 (7%) of the 58 DB patients (p = 0.015; difference 0.016 [95% CI: 0.03-0.29]). At 5-year FU, there were no significant differences in the incidence of OA, PROMS, or other clinical findings comparing the anatomic DB to anatomic SB ACL reconstructed patients. There were fewer graft failures among patients treated with anatomic DB ACL reconstruction. II.

Meniscal allograft transplantation in patients with substantial cartilage disease led to a sustained long-term improvement in patient-reported outcome measures.

Due to a lack of consensus regarding effective treatment options in young patients, the indications of meniscal allograft transplantation (MAT) have widened to include those with substantial cartilage disease. The aim of this study was to report the long-term patient-reported outcome measures (PROMs) and allograft survival rates for patients with substantial cartilage disease. A review of the prospectively maintained database was performed. Patients with International Cartilage Repair Society 3b or above cartilage grading in either their femur or tibia were classified as having substantial cartilage disease. Postoperative International Knee Documentation Committee, Tegner, Knee Injury and Osteoarthritis Outcome Score and Lysholm were compared between those with and without substantial cartilage disease. Kaplan-Meir analysis was used to assess the survival rates. Survival was defined as revision or removal of allograft or conversion to arthroplasty. Data from 422 patients were included in the analysis with 129 patients found to have full-thickness chondral lesions and 281 patients without full-thickness chondral lesions. The mean follow-up was 6.33 (SD 3.48) years for the cohort. The mean age for the entire cohort was 30 (SD 9.23). Patients in substantial cartilage disease group underwent meniscal transplantation at an older age (32 [standard deviation {SD} 8.47] years vs. 29 [SD 9.35] years [p < 0.001]). There was no significant difference in PROMs between the two groups up to 10 years postoperatively (p > 0.05). The substantial cartilage disease group had significantly lower survival rates compared to those without (80.62% vs. 94.32%). MAT in the context of substantial cartilage disease was associated with an improvement in PROMs up to 10 years with no difference to the group without substantial cartilage disease. The PROMs in combination with the long-term survival rates in this study can be used to counsel patients preoperatively. Level IV.

Zygomatic Implant Perforated Flap vs Fibula Osseous Flap Maxillary Reconstruction

This cohort study assesses the potential differences in facial contour and patient-reported outcomes in zygomatic implant perforated flap compared to fibula free flap maxillary reconstruction.

Measurement of acute postoperative pain intensity in orthopedic trials: a qualitative concept elicitation study.

Pain intensity is an important outcome in clinical trials of surgery because pain relief is important to patients. Currently, recommended scales are the numeric rating scale 0-10 and visual analogue scale. However, these scales allow for considerable influence of individual imagination, previous experience, and coping skills, limiting proficiency in comparative clinical trials. We aimed to explore postoperative expressions of "how much it hurts"-the first step to improve pain intensity measurement. This was a qualitative study using inductive content analysis: words and visual cues describing pain intensity were collected from (i) existing pain intensity measures by search of COSMIN, PubMed, and Google, (ii) patient interviews recorded and transcribed word-for-word, (iii) clinician interviews transcribed likewise, and (iv) 100 patient telephone interviews with notes taken. After familiarization, the collected expressions were labelled inductively in categories and assembled in tables (case and theme-based matrices). Descriptors fell into 12 categories: intensity (slight/strong), evaluative (negligible/unbearable), cognitive impact (distracting/can be ignored), activity impact (limits some/all activity), sleep impact (can/cannot sleep), examples (like stubbing a toe), physical signs (crying/writhing), associated symptoms (nauseating/tiring), treatment (ice helps/need morphine), affective (annoying/dreadful), discriminative (aching/piercing), and general recovery (hindering recovery/functional interference). Many visual cues were also identified. Literature and recorded interviews gave rise to the categories, and telephone interviews found saturation, providing no further categories. Pain intensity is expressed by terms that fall into 12 categories and by a variety of graphic elements. This advances development of a patient-reported outcome measure of pain intensity for orthopedic trials.

Social Pain Minimization Mediates Discrimination’s Effect on Sleep Health

ABSTRACT Objective Discrimination disrupts sleep and contributes to race-based health inequities for Black Americans, but less is known about the psychological mechanisms underlying this relation. The current work tests whether emotion invalidation, termed Social Pain Minimization (SPM), mediates discrimination’s negative effects on sleep quality. We focus on the experiences of Black Americans because of racism’s disproportionate effect on the health outcomes of Black individuals in the U.S. Methods Four studies with cross-sectional (Studies 1a-1b) and cross-lagged panel designs (Studies 2–3; N total = 1,176) were used. Discrimination and SPM were assessed with established measures and self-reported sleep quality was assessed with three different operationalizations including the short form Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) subscale and composites of the Insomnia Severity Index (ISI). Results Cross-sectional (Studies 1a-1b) and longitudinal mediation analyses (Studies 2–3) indicated discrimination’s negative effect on sleep quality partially operated through SPM (Study 1a, 95% CI = [−.24, −.016]); Study 1b, 95% CI = [−.22, −.03]; Study 2, 95% CI = [−.268, −.007]]; Study 3, 95% CI = [−0.043, −.002]). Conclusion Beyond its direct negative effect on sleep, discrimination also operates through SPM to reduce sleep quality. Emotion invalidation stemming from discrimination damages sleep.

Impact of Knee Osteoarthritis and Arthroplasty on Full Body Sagittal Alignment in Adult Spinal Deformity Patients.

Retrospective analysis of prospectively collected data. This study evaluates the impact of knee osteoarthritis (OA) and knee arthroplasty on alignments and patient-reported outcomes measures (PROMS) of patients undergoing adult spinal deformity (ASD) corrective surgery. The relationship between knee OA and spinal alignment in patients with ASD is incompletely understood. It is also unknown how patients with knee arthroplasty and ASD compare to ASD patients with native knees. Baseline full-body radiographs were used, and hip and knee OA were graded by two independent reviewers using the KL classification. Spinopelvic parameters and PROMs were compared across the different knee OA groups and compared between patients with knee replacement and native knees. 199 patients with bilateral non severe OA (G1), 31 patients with unilateral severe knee OA (G2), and 60 patients with bilateral severe knee OA (G3). Patients with severe knee OA presented with worse spinopelvic parameters. However, after multivariable regression analysis controlling for age, frailty, PI, T1PA, knee OA was an independent predictor of knee flexion (G1:-0.02±7.3, G2: 7.8±9.4, G3: 4.5±8.7, P<0.001), and ankle dorsiflexion (G1: 2.3±4.0, G2: 6.6±4.5, G3: 5.1±4.1, P<0.001). There was no difference in PROMs (P>0.05). Secondary analysis included 96 patients: 48 patients (50%) with non-severe knee OA, and 48 patients (50%) with knee replacement. There was no difference in radiographic parameters or PROMs between the groups. In this study of complex ASD patients, patients with worse spinal deformity were more likely to have concomitant knee OA. Knee OA was shown to be a predictor of knee flexion and ankle dorsiflexion angles, but was not associated with worse PROMs in this study population. Patients with knee arthroplasty, however, had comparable spinal alignment and PROMs relative to those with mild OA.

Determining Maximal Outcome Improvement Thresholds for Patient-Reported Outcome Measures After Primary ACL Reconstruction: A Mid-Term Follow-up Study Using the Anchor Method.

The clinical interpretation of patient-reported outcome measures (PROMs) after anterior cruciate ligament (ACL) reconstruction (ACLR) can be challenging. This study aimed to establish the clinical relevance of PROMs by determining maximal outcome improvement (MOI) thresholds at mid-term follow-up after primary ACLR. A total of 343 patients who underwent primary single-bundle ACLR using hamstring tendon autograft at our institute were included. Patients were queried with a 2-option anchor question regarding satisfaction with their current knee symptom state. The MOI of a PROM was calculated for each patient as the percentage of improvement normalized by the maximal possible improvement. The MOI threshold for each PROM was determined as the optimal cutoff value for predicting patient satisfaction based on receiver operating characteristic curve analysis. Multivariable logistic regression analyses were performed to identify predictors of achieving these thresholds. Subgroup analyses that stratified the time from injury to surgery within the cohort were performed, and MOI thresholds were recalculated within each of these subgroups. The PROMs evaluated in this study were the modified Lysholm Knee Score and the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score. The calculated MOI threshold was 35.1% for the Lysholm score and 46.7% for the IKDC score. A longer time from injury to surgery reduced the odds of achieving the MOI threshold for the Lysholm score (odds ratio [OR] per time bracket = 0.7114, p < 0.0001) and IKDC score (OR = 0.8038, p = 0.0003). Male sex was associated with higher odds of achieving the MOI threshold for the IKDC score (OR = 1.9645, p = 0.0143). For patients with chronicity of ≤6 months, the MOI threshold was 35.1% for the Lysholm score and 57.9% for the IKDC score, and for patients with chronicity of >6 months, the thresholds were 24.5% and 27.1%, respectively. The calculated MOI thresholds for the Lysholm and IKDC scores at mid-term follow-up after primary ACLR were 35.1% and 46.7%, respectively. Greater chronicity of the ACL injury was associated with lower odds of achieving the MOI thresholds for the PROMs at mid-term follow-up. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Longitudinal validation of the PROMIS-16 in a sample of adults in the United States with back pain.

This longitudinal study evaluates whether the Patient-Reported Outcomes Measurement and Information System (PROMIS)-16 domains capture average change over time comparable to the PROMIS-29 + 2 and have similar associations with change in overall health rating and two disability indices. Data were collected using Amazon's Mechanical Turk at baseline, 3 months, and 6 months among individuals reporting chronic low back pain. The analytic sample includes respondents who completed baseline and at least one follow-up assessment (N = 1137). We estimated latent growth models for eight PROMIS domains and compared growth parameters between the PROMIS-16 and PROMIS 29 + 2 with a z-test. Additionally, for each domain, random intercept and slope scores for individuals were computed for the PROMIS-29 + 2 and PROMIS-16 and correlated to estimate concordance. Using growth parameters for physical function and pain interference, we predicted average change in the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ), the overall health rating, and compared regression coefficients between the PROMIS-16 and PROMIS 29 + 2. All growth models fit the data well. Intercept and slope parameters were statistically comparable (p's > 0.05) in magnitude across all domains between the PROMIS-16 and PROMIS-29 + 2. Correlations between random intercept and slope scores for individuals across domains were high. Additionally, the regression coefficients between slopes for pain interference and physical function and ODI, RMDQ, and overall health rating were statistically comparable (p's > 0.05) between the PROMIS-16 and PROMIS 29 + 2. Results provide between-level support for the longitudinal and predictive validity of the PROMIS-16. Similar average baseline scores and changes over time were observed between PROMIS-16 and PROMIS-29 + 2. Further, average change estimates comparably predicted average change in distal outcomes. This work provides evidence supporting the utility of the PROMIS-16 as a viable, short-profile option for use in clinical and research settings.

Surgical Treatments for Facial Aberrant Reinnervation Syndrome: A Systematic Review.

Background: Facial aberrant reinnervation syndrome is characterized by aberrant facial muscle reinnervation after facial nerve injury producing facial synkinesis, hypertonicity, and muscle spasm. Objective: To systematically review the surgical treatments for facial aberrant reinnervation syndrome and assess their effectiveness as measured by patient-reported outcomes, physician-graded outcomes, or computer-automated grading systems. Methods: We conducted a systematic review using PubMed, Embase, and Cochrane CENTRAL in accordance with PRISMA guidelines. Texts reporting outcomes of any surgical treatment for facial aberrant reinnervation syndrome from 2003 to 2023 were included. Results: After screening, 25 studies with 731 patients were included. Surgical procedures included selective neurectomy (SN), selective myectomy (SM), cross-facial nerve graft, masseter nerve transfer, and gracilis muscle transfer. All surgical techniques and combinations showed significant improvement in at least one clinical outcome measure from baseline (p < 0.05), although one study found no significant improvement. Thirty different outcome measures were used, the most common being the FaCE and eFACE scales (seven studies each). Conclusions: All surgical procedures in this review yield improved clinical outcome measures for facial aberrant reinnervation syndrome, with SN and SM being the dominant surgical treatments. Standardized outcome assessment and more nuanced patient evaluation are necessary to determine the most effective surgical treatments.

Functional Outcome and Patient Satisfaction After Primary vs Secondary Arthrodesis for Lisfranc Injuries: Toward a Single-Surgery Approach.

The choice between primary arthrodesis (PA) and open reduction and internal fixation (ORIF) for acute Lisfranc injuries remains contentious. Apart from primary treatment, arthrodesis is often used for treating chronic Lisfranc injuries, including patients in whom initial ORIF or nonoperative treatment failed. The aim of this study was to compare PA and secondary arthrodesis (SA) in terms of complications and functional outcome. A retrospective cohort study was conducted on trauma patients with Lisfranc injuries treated at a level 1 trauma center between July 1, 2010, and July 1, 2020. Selected patients were evaluated at the outpatient clinic and received a survey. Demographics, injury characteristics, management, complications, and patient-reported outcomes (American Orthopaedic Foot & Ankle Society midfoot score, Foot Function Index) were analyzed. Twenty-nine of 37 potential patients (78.4%; PA n = 11, SA n = 18) completed the survey with a median follow-up of 7.1 (PA) to 9.3 (SA) years (P = .01). The majority were female (n = 18, 62.1%); the mean age of PA patients was 57.1 years (SD 14.2) compared with 43.5 years (SD 17.1) in SA patients (P = .04). In the PA group, there was no infection, 100% union, and implants were removed in 5 of 11 patients. In the SA group, 11.1% (n = 2) developed infection, malunion rate was 11.1%, implants were removed in 33.3% (n = 6), and 22.2% required revision surgery. AOFAS was "good" in PA (77.7, SD 17.3) compared with rated "fair" in SA (67.1, SD 21.3, P = .19). FFI was better in PA (26.0, SD 26.2) than SA (37.6, SD 30.8, P = .32), which exceeded the minimally important clinical difference. Although this study was limited by sample size, the overall results suggest equivalent functional outcome, pain and treatment satisfaction in primary arthrodesis compared with secondary arthrodesis patients for treatment of Lisfranc injury.

What Is the Best Way to Treat Focal Articular Cartilage Lesions of the Knee? Perhaps No Treatment at All: Commentary on an article by Thomas Birkenes, MD, et al.: "Long-Term Outcomes of Arthroscopically Verified Focal Cartilage Lesions in the Knee. A 19-Year Multicenter Follow-up with Patient-Reported Outcomes".

What Is the Best Way to Treat Focal Articular Cartilage Lesions of the Knee? Perhaps No Treatment at All: Commentary on an article by Thomas Birkenes, MD, et al.: "Long-Term Outcomes of Arthroscopically Verified Focal Cartilage Lesions in the Knee. A 19-Year Multicenter Follow-up with Patient-Reported Outcomes".

Psychometric Testing of the Cross-Culturally Adapted Thai Version of the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale in Caregivers of Patients With Chronic Illnesses.

To evaluate the psychometric properties of the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC). The CSE-CSC scale was developed congruently with the Caregiver Contribution to Self-Care of Patient with Chronic Illness Inventory (CC-SC-CII) to assess caregiver self-efficacy (CSE), the motivation factor of caregiving. Its applicability in Asian populations, including Thailand, was limited. Psychometric tests were guided by COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) principles. This included translating the English version into Thai, following the principles of good practice for the translation and cultural adaptation process for patient-reported outcome (PRO) measures. Nine nursing experts evaluated the content validity. The analysis included caregivers of patients with chronic conditions from 16 primary care centres in Thailand. We tested the structural validity using exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and concurrent validity for CC-SC-CII-v2. We tested the scale's reliability with methods for multidimensional and unidimensional constructs, the intraclass correlation coefficients (ICCs) and measurement error variance. Kappa coefficient (k = 1.00) indicated the scale's excellent content validity. The final analysis included a total of 407 samples. The EFA with the first split-half subsample (n = 194) extracted a two-dimensional structure. One reflected CSE in Maintenance and Monitoring behaviour and another captured CSE in Management behaviour. CFA with the second split-half subsample (n = 213) and the overall sample (n = 407) supported the scale's bidimensional model with high factor loadings. Each dimension and the overall CSE-CSC scale positively correlated with each scale and the overall CC-SC-CII-v2. McDonald's ω and Cronbach's α (both ranged from 0.91-0.94) indicated excellent internal reliability. Test-retest reliability showed ICCs between 0.95 and 0.96. Measurement error yielded satisfactory results. Testing of the Thai CSE-CSC scale supported validity and reliability, indicating that the scale can apply to Thai caregivers. This scale can be used in clinical practice and research to evaluate CSE in contribution to patient self-care.

Nonsurgical Interventions for Gender-Affirming Facial Feminization: A Scoping Review.

Importance: Systematic review will improve understanding of nonsurgical facial feminization techniques, which are useful alternatives or adjuncts to surgical gender affirmation. Objective: To determine the effectiveness of nonsurgical facial feminization techniques in patients seeking gender-affirming feminization by reviewing the literature for patient-reported, subjective, and objective outcomes of feminization. Evidence Review: A comprehensive database search was conducted through July 28, 2022. A total of 264 titles and abstracts were screened by two independent reviewers in Covidence. Of all, 48 met the inclusion criteria for full-text review, and 20 articles were included in the final data extraction. Findings: The most described nonsurgical facial feminization techniques were neurotoxins, fillers, and hair removal. Techniques were derived from cisgender cosmetic procedures to achieve feminine qualities. The most common study type was expert opinion or literature reviews. There were only two studies that analyzed measurable nonsurgical facial feminization techniques. Conclusions and Relevance: There is a lack of high-quality prospective research and randomized, controlled trials specific to the transgender patient population that evaluate outcomes, patient satisfaction, or complications. Such studies are needed to inform evidence-based practices.

Follow-up Trends in Patients Undergoing Modified Wendler Glottoplasty.

After modified Wendler glottoplasty (mWG), close follow-up with laryngologist and speech-language pathologist (SLP) is thought to be essential to achieve best outcomes. This study presents a case series of patients undergoing mWG at a single institution to identify factors associated with trends in post-operative follow-up. Retrospective review of trans women patients who underwent mWG between March 2018 and July 2023 was performed. Demographic data, pre-operative care, and post-operative course were reviewed. Lost to follow-up (LTFU) was defined as a failure to return to the office or schedule a follow-up appointment as recommended, for ≥2 months after last visit. Logistic regressions were utilized to identify possible factors associated with being LTFU. Eight (50%) of 16 patients met LTFU criteria. Patients were considered not LTFU if they completed care (n = 3, 19%) or were still undergoing care (n = 5, 31%). Patients with chronic diseases were less likely to become LTFU (p = 0.03). Those lost to follow-up had more no-show visits (p = 0.04). Total number of gender-affirming surgeries, distance from hospital, socioeconomic status of residential zip code, race/ethnicity, other psychological history, and patient-reported outcome measure scores did not affect LTFU rates. Fifty percent of patients were LTFU after modified Wendler glottoplasty. Even one no-show visit increased risk of being LTFU, whereas the presence of chronic diseases was protective against this. This study illustrates that increased efforts are needed following mWG to better understand the factors associated with being LTFU and to facilitate patients' ability to complete post-operative care successfully. 4 Laryngoscope, 2024.

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®).

We derived meaningful individual-level change thresholds for worsening in selected patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) items and their composite scores. We used two data sources, the PRO-TECT trial (Alliance AFT-39) that collected PRO-CTCAE data from adults with advanced cancer at 26 United States (U.S.) community oncology practices and the PRO-CTCAE validation study that collected PRO-CTCAE data from adults undergoing chemotherapy or radiation therapy at nine U.S. cancer centers or community oncology practices. Both studies administered selected PRO-CTCAE items and EORTC QLQ-C30 scales. Conceptually, relevant QLQ-C30 domains were used as anchors to estimate meaningful change thresholds for deterioration in corresponding PRO-CTCAE items and their composite scores. Items or composites with ǀρǀ ≥ 0.30 correlation with QLQ-C30 scales were included. Changes in PRO-CTCAE scores and composites were estimated for patients who met or exceeded a 10-point deterioration on the corresponding QLQ-C30 scale. Change scores were computed between baseline and the 3-month timepoint in PRO-TECT, and in the PRO-CTCAE validation study between baseline and a single follow-up visit that occurred between 1 and 7weeks later. For each PRO-CTCAE item, change scores could range from - 4 to 4; for a composite, change scores could range from - 3 to 3. Change scores in QLQ-C30 and PRO-CTCAE were available in 406 and 792 patients in PRO-TECT and the validation study, respectively. Across QLQ-C30 scales, the proportion of patients with a 10-point or greater worsening on QLQ-C30 ranged from 15 to 30% in the PRO-TECT data and 13% to 34% in the validation data. Across PRO-CTCAE items, anchor-based meaningful change estimates for deterioration ranged from 0.05 to 0.30 (mean 0.19) in the PRO-TECT data and from 0.19 to 0.53 (mean 0.36) in the validation data. For composites, they ranged from 0.06 to 0.27 (mean 0.17) in the PRO-TECT data and 0.22 to 0.51 (mean 0.37) in the validation data. In both datasets, the minimal meaningful individual-level change threshold for worsening was one point for all items and composite scores. gov: NCT03249090 (AFT-39), NCT02158637 (MC1091).

Patient‐reported outcome measures following individualised TKA are not affected by the degree of preoperative coronal varus or valgus laxity

AbstractPurposeTo determine whether there is a correlation between preoperative coronal varus or valgus laxity and patient‐reported outcome measures (PROMs) 2 years after individualised total knee arthroplasty (TKA).MethodsRecords of 150 consecutive patients who received individualised TKA were retrospectively analysed, and 126 with complete pre‐ and postoperative data were included. Preoperative coronal varus and valgus stress radiographs (15 N load) were taken using a telos stress device with the knee in 5°–10° of flexion. Varus stress angles were positive if the joint opened on the lateral side, and valgus stress angles were positive if the joint opened on the medial side. The sum of varus and valgus stress angles indicated total joint laxity. During surgery, cases that required tibial recuts to balance the joint were recorded. Patients completed three PROMs and rated their satisfaction. Correlations between laxity and PROMs were evaluated using Pearson's correlation.ResultsStress radiographs revealed varus stress angles of 6.3° ± 3.5° (range, −4.5° to 14.1°), valgus stress angles of 0.1° ± 3.7° (range, −8.0° to 10.9°), and the sum of the varus and valgus stress angle of 6.4° ± 3.3° (range, 0.1° to 17.1°). There were no correlations between laxity and PROMs: r &lt; 0.160 for varus stress angle, r &lt; 0.180 for valgus stress angle and r &lt; 0.160 for the sum of stress angles. There were no statistically significant or clinically relevant differences in PROMs between knees without and those with tibial recuts.ConclusionPreoperative coronal varus or valgus laxity was not correlated with PROMs following individualised TKA at a minimum 2‐year follow‐up. Individualised TKA with personalised alignment enables adequate accommodation of a broad spectrum of preoperative coronal varus–valgus laxities.Level of EvidenceIV

Effect of neuromuscular control on the shoulder function of patients with healed rotator cuff and those with retear after arthroscopic rotator cuff repair.

To compare functional outcomes such as muscle strength, neuromuscular control and patient-reported outcomes (PROs) between patients with healed rotator cuffs and those with retears after arthroscopic rotator cuff repair (RCR). One hundred and nine patients who underwent arthroscopic RCR were included (85 in the healed group, 24 in the retear group). Shoulder muscle strength and neuromuscular control index (acceleration time [AT]) were evaluated using an isokinetic device. PROs were assessed using the pain visual analogue scale (VAS), Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES) and University of California at Los Angeles (UCLA) scores. Continuous variables were compared using independent t tests. Multiple linear regression analysis was used to identify the influence of the predictor variables on the dependent variable. The muscle strength and ATs for external rotators (ERs), internal rotators (IRs) and forward flexors as well as PROs including VAS, SST and ASES scores, were not significantly different between the two groups pre- and postoperatively (n.s.). Multiple linear regression analysis revealed that postoperative ATs for the IRs (p = 0.006) and ERs (p = 0.028) in the operated shoulders were closely associated with the postoperative UCLA score. Compared with the healed group after arthroscopic RCR, the retear group had no clinically relevant differences in muscle strength, ATs and PROs, including VAS, SST, ASES and UCLA scores. However, postoperative ATs for IRs and ERs in the operated shoulders were a significant predictor of postoperative UCLA scores. Therefore, clinicians and therapists need to be aware of the importance of neuromuscular control in patients who have undergone arthroscopic RCR and prioritize therapeutic exercises to restore neuromuscular control. Level III.

Outpatient versus inpatient total shoulder arthroplasty: A meta-analysis of clinical outcomes and adverse events.

In recent years, orthopaedic procedures have increasingly shifted from inpatient to outpatient settings. This trend includes total shoulder arthroplasty (TSA), which is being performed more frequently in outpatient facilities and ambulatory surgical centres. The purpose of this study was to compare the clinical outcomes and rates of adverse events between outpatient and inpatient TSA. PubMed, Cochrane, and Google Scholar (pages 1-20) databases were screened for articles comparing outpatient to inpatient TSA through June 2024, using relevant and holistic search terms. Non-comparative articles and those utilizing national databases were excluded from our study. Data on complications, myocardial infarction (MI), thromboembolic events, anaemia/transfusions, infections, readmissions, emergency department (ED) visits, revision surgery, and patient reported outcome measures at one year (Visual Analog Scale [VAS] and American Shoulder and Elbow Surgeons [ASES] score) were extracted. A total of 14 articles were included in our study, involving 1070 outpatient and 1330 inpatient TSA patients. Patients in the inpatient group were older and had a higher ASA compared to the patients in the outpatient group. The outpatient TSA group was found to have significantly lower rates of overall complications (odds ratio [OR] = 0.59, p = 0.001), medical complications (OR = 0.43, p < 0.001), and readmissions (OR = 0.47, p = 0.008), as well as higher mean ASES scores (81.4 vs. 78.5, p = 0.01) when compared to the inpatient TSA group. There were no significant differences in rates of ED visits (p = 0.27), revisions (p = 0.06), and VAS scores (p = 0.15) between inpatient and outpatient TSA groups. TSAs performed in the outpatient setting had a lower rate of overall adverse events, medical complications, readmissions, and a higher ASES score compared to inpatient TSAs. However, since patients in the inpatient group had higher ASA and were older, our results support the safety of the outpatient TSA based on the current selection criteria.

Impact of Age in Single-Level Versus Multilevel Airway Compromise: A Multi-Institutional Review.

Examine the association between age and treatment outcomes in conditions causing single- versus multilevel airway restriction. Multi-institutional retrospective cohort study. Tertiary laryngology centers. Participants included younger (18-64 years) and geriatric (≥65 years) adults with posterior glottic stenosis (PGS), multilevel airway stenosis (MLAS), and bilateral vocal fold paralysis (BVFP). Subgroup demographics, comorbidities, type, and etiology of airway compromise were described. Associations between age and primary outcome variables (i.e., tracheostomy and decannulation rates, number of surgeries performed, time between surgeries, and change in quality-of-life patient-reported outcome measures [PROMs]) were evaluated. Statistical analyses included independent t tests, χ2, Fisher's exact, or Mann-Whitney tests. In 158 patients [96 younger (30 PGS, 29 MLAS, 37 BVFP) and 62 geriatric (24 PGS, 9 MLAS, 29 BVFP)], age differences were not significant for gender (P = .990), tracheostomy placement (70% vs 66%, P = .629), or decannulation success (40% vs 24%, P = .091) in younger versus geriatric groups, respectively. In younger patients, MLAS was more common (30.2% vs 14.5%, P = .024), and BVFP patients were more likely to decannulate (50% vs 12%, P = .017). Geriatric patients were more likely to have a history of prior radiation (26% vs 10%, P = .016), stenosis due to malignancy (23% vs 9%, P = .022), and fewer overall surgeries (median 1 vs 3, P = .003). Median PROMs were comparable between age subgroups (P > .05). Younger adults underwent more surgeries, but overall comorbidities, tracheostomy decannulation rates, and PROMs were comparable between groups. Age does not negatively impact treatment outcomes and should not be a deterrent in treatment decision-making.