Multiple Patient-reported Outcomes Research Articles

Ceramic-on-Ceramic Total Hip Arthroplasty Using a Double Tapered, Proximally Coated Stem: 15 to 24-year Clinical and Radiologic Follow-Up

BackgroundTotal hip arthroplasty implant choice profoundly affects survivorship, complications, and failure modes. This study evaluates the long-term (average 18 year) outcomes of ceramic-on-ceramic hip arthroplasty using uncemented shells and stems. Despite an impressive 20-year cumulative percent revision of 5.9%, the hydroxyapatite proximally coated femoral components evaluated in this study have seen declining use since 2003. MethodsA review of 349 consecutive total hip arthroplasties from 1999 to 2007 was matched to 272 cases with registry data. A survivorship analysis included 274 hips (Group A) after excluding patients lost to follow-up and navigated cases. Group B comprised 135 patients who had complete datasets spanning a minimum of 15 years. ResultsKaplan-Meier analysis identified a 95.6% survivorship plateau at 16 to 24 years, with no significant impact from age, sex, component size, or original pathology. In Group B, EuroQol-5 Dimensions-5 Levels (EQ5D5L) scores indicated favorable outcomes in mobility, self-care, activities, pain/discomfort, and anxiety/depression, with an EQ5D visual analog score mean of 79.24. Functional scores, including the Harris Hip Score, Oxford Hip Score, and Forgotten Joint Score, showed positive outcomes. Radiologic assessments revealed no osteolysis or loose components, with a mean Engh score of 21.69. Dorr classification identified bone quality variations. Better Engh scores corresponded to higher levels of patient satisfaction. Age at surgery was correlated with better functional scores, while sex influenced various outcomes. ConclusionsThis comprehensive study, spanning an average of 18.23 years, combined multiple patient-reported outcome measures with extensive clinical and radiologic follow-up. It reported a notably high survivorship rate for this implant combination but highlighted the declining use of the hydroxyapatite proximally coated femoral stem used in this study, potentially facing withdrawal risks in Australia. Level of evidenceTherapeutic Level IV.

Activating cancer communities through an exercise strategy for survivors: an effectiveness-implementation trial

IntroductionStrong evidence supports the recommendation that individuals living with or beyond cancer (LWBC) should be physically active and engage in physical exercise to enhance health and improve cancer-related outcomes. Many individuals LWBC are not achieving these benefits, partly due to a lack of resources. To address this, Activating Cancer Communities through an Exercise Strategy for Survivors (ACCESS) was developed to provide exercise programming and investigate exercise strategies and barriers for those LWBC.MethodsUsing an effectiveness-implementation design, adults LWBC joined ACCESS by healthcare provider or self-referral. A clinical exercise physiologist triaged participants to either a hospital-based site or one of two community-based sites to complete a 12-week, 24-session multimodal individualized exercise program. Physical fitness and multiple patient-reported outcomes were measured pre- and post-intervention.ResultsBetween January 2018 and March 2020, there were 332 referrals. Of these, 122 participants consented and completed the study. Completing ACCESS was associated with improvements in physical fitness and participant-reported outcomes, including general wellbeing, fatigue, negative emotional states, sleep quality, and exercise self-efficacy. The program was well-received by participants and was deemed feasible and acceptable from an implementation perspective.DiscussionThe ACCESS program demonstrably improved several health outcomes for individuals LWBC. Implementation outcomes have and continue to guide ongoing efforts to improve accessibility to ACCESS and work with the regional health authority and cancer care program to support the adoption of exercise into standard oncology care.Clinical trial registrationclinicaltrials.gov, identifier [NCT03599843].

Preoperative predictors of two-year satisfaction in hand and wrist surgery patients

PurposeAs stakeholders seek to improve patient outcomes while maintaining cost-effectiveness in an increasingly expensive healthcare system, metrics such as patient satisfaction are becoming more important. This present study sought to identify factors associated with and independently predictive of better surgical satisfaction two years following hand and wrist surgery. MethodsPatients undergoing hand and wrist surgery at an urban outpatient institution were enrolled preoperatively into a surgical registry and assessed two years postoperatively. Patient satisfaction with surgery was measured at two years postoperatively with the Surgical Satisfaction Questionnaire (SSQ-8). Bivariate analysis determined associations between postoperative satisfaction and patient demographics, injury specifiers, medical history, and multiple patient-reported outcomes (PROs). Multivariable analysis determined independent predictors of two-year postoperative satisfaction following hand and wrist surgery. ResultsBetter surgical satisfaction was associated with having never smoked, no preoperative opioid use, lack of an accompanying legal claim, lack of a workers compensation claim, no clinical history of depression/anxiety, less comorbidities, and higher preoperative expectations.Various PROs relating to function, pain, activity, and general health at both baseline and two years demonstrated associations with postoperative satisfaction. Multivariable analysis confirmed that never smoking, lack of a legal claim, and better preoperative Brief Michigan Hand Questionnaire scores were independently predictive of better surgical satisfaction two years following hand and wrist surgery. ConclusionAt two years following hand and wrist surgery, better patient satisfaction was best predicted by never smoking, no related legal claim, and better baseline Brief Michigan Hand Questionnaire scores. Level of evidenceIII.

High survivorship and low complication rate in a single-centre series of 651 medial opening wedge high tibial osteotomy cases with a mean follow-up of 13 years.

This study aimed to report the early to midterm results of medial opening wedge high tibial osteotomy (MOWHTO) from the largest single-centre osteotomy database. The primary outcomes were reporting the radiological corrections and the functional outcomes represented by multiple patient-reported outcome measures (PROMs). The secondary outcomes were to report the complications, revisionsand survivorship up to 10 years postoperatively. A prospectively maintained single-centre database of 1138 knee osteotomies was retrospectively reviewed. Patients who underwent MOWHTO and met the inclusion criteria were included. Those inclusion criteria were moderate to severe knee pain that failed conservative management;varus knee malalignment; and isolated medial osteoarthritis of the knee. A total of 651 cases, with a mean age of 46.7 ± 9 years and a mean body mass indexof 29.6 ± 5.2 kg/m2 , were included. This comprised 71% males (n = 462) and 29% females (n = 189). The mean follow-up was 158.1 ± 45.4 months. Multiple PROMs were recorded preoperatively and serially postoperatively. This included the Knee injury andOsteoarthritisOutcome Scores, the Oxford Knee Score, the Oxford Knee Score-Activity and Participation Questionnaire, the Western Ontario and McMaster University Scores, the Visual Analogue Scale for health and pain, and the EQ-5D, which is a standardised measure of health-related quality of life. All lower limb alignment measurements were recorded pre- and postoperatively. The rates of osteotomy revision, conversion to arthroplasty, complications, and 5- and 10-year survivorship were recorded. A total of 651 cases were followed up to a mean of 158.1 ± 45.4 months. The mean planned correction angle was 7.6° ± 2.9°. The mean planned opening wedge distance was 8.1 ± 3.1 mm. The mean intraoperative anterior and posterior osteotomy gaps opening were 7.7 ± 3.4and 8.9 ± 3.8 mm, respectively. Postoperatively, the mean mechanical tibiofemoral angle improved from -5.7° ± 2.9° varus to 1.3° ± 2.5° valgus, the mean medial proximal tibial angle improved from preoperative 85.5° ± 2.3° to postoperative 91.6° ± 2.7°and the mean Mikulicz point improved from 21.7 ± 12.6% to 54.8 ± 11% (all p values < 0.001). All PROMs significantly improved at 24 months follow-up (all p values < 0.001). The rate of osteotomy revision was 1.1% at a mean of 2 ± 2.5 years postoperatively. The overall rate of arthroplasty conversion was 9.1%. This comprised 5.8% total knee arthroplasty conversion at a mean of 6.9 ± 3.5 years postoperatively and 3.2% unicompartmental knee arthroplasty conversion at a mean of 5.7 ± 2.5 years postoperatively. An overall 10.3% complication rate was recorded. The 5 and 10-year survivorship was 97.2%and 91.9%, respectively. MOWHTOis a radiologically and clinically rewarding procedure with a high survival rate at 5 and 10 years and a low complication rate in experienced hands. MOWHTO should be considered in patients presenting with medial unicompartmental knee pain with an evidence of overload and a varus mechanical coronal plane axis. Level IV, retrospective cohort study.

ASES and UCLA Are Responsive Patient-Reported Outcome Measures After Rotator Cuff Repair: A Systematic Review and Meta-analysis.

Multiple patient-reported outcome measures (PROMs) have been used to assess shoulder function, but it is unknown which are the most effective. The purpose of this study was to report the multiple PROMs used after rotator cuff repair (RCR) and to compare the responsiveness between them. It was hypothesized that the Western Ontario Rotator Cuff PROM would be the most responsive and commonly used in patients undergoing RCR. Meta-analysis; Level of evidence, 4. A systematic review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PRISMA-Searching extension guidelines via PubMed/MEDLINE, Embase (Elsevier), and Web of Science (Clarivate). Patient and study characteristics were extracted. From the studies that met inclusion criteria for responsiveness analysis (≥2 PROMs reported, 1-year minimum follow-up, and pre- and postoperative PROM means and standard deviations reported), the authors compared the responsiveness between PROM instruments using effect size and relative efficiency (RE) if a PROM could be compared with another in ≥10 articles. A total of 252 studies met inclusion criteria (32,072 patients; mean age, 59.6 years; mean body mass index, 28.7; mean follow-up time, 27.8 months). Range of motion was reported in 131 (52%) studies and imaging findings were reported in 123 (49%) studies. There were 67 PROM instruments identified; the most commonly used were the American Shoulder and Elbow Surgeon (ASES) (n = 183; 73%), Visual Analog Scale (VAS) (n = 163; 65%), and Constant (n = 118; 47%) scores. The 3 PROMs with the highest effect sizes were the University of California, Los Angeles (UCLA) (2.51), Western Ontario Rotator Cuff (2.42), and ASES (2.00) scores. Overall, UCLA and ASES scores were the most responsive PROMs. The ASES PROM was more responsive than the VAS (RE, 1.70), Constant (RE, 2.76), Simple Shoulder Test (RE, 1.67), and Single Assessment Numeric Evaluation (RE, 2.14) scores. The UCLA PROM was more responsive than the ASES (RE, 1.03), VAS (RE, 3.66), Constant (RE, 1.72), and Simple Shoulder Test (RE, 1.66) scores. ASES and UCLA scores were the most responsive PROMs after RCR. The authors recommend widespread adoption of ASES and UCLA scores for clinical and research standardization; however, the UCLA PROM requires in-person range of motion and strength testing, which is a practical limitation and barrier to long-term follow-up.

Surgical management of recurrent instability following Latarjet procedure - A systematic review of salvage procedures.

Failed Latarjet procedures pose a surgical challenge due to complex anatomical issues. This systematic review investigates salvage techniques for recurrent instability following a Latarjet procedure. A search was conducted on MEDLINE and PubMed Central following the methodology registered to International Prospective Register of Systematic Reviews. Inclusion criteria focused on identifying revision procedures following a Latarjet procedure. Exclusion criteria filtered out irrelevant studies, such as those focused on Bankart procedures. After a multistage selection process, 10 eligible studies were included for data extraction. The most frequently utilized technique for salvage was variations of the Eden-Hybinette procedure. Complications associated with these salvage procedures include graft-related problems and donor site morbidity. Patients reported significant improvements in multiple patient-reported outcome scores, and multiple studies indicated high rates of return to sports activities. However, it is noteworthy that there remains an average recurrence rate of 7%. The review emphasizes the limited therapeutic options available largely due to shoulder anatomy alterations. Despite promising trends in patient-reported outcomes, recurrence remains possible post-salvage surgeries. Addressing recurrent instability after a Latarjet procedure continues to be a unique surgical challenge. However, this systematic review highlights encouraging indications, with positive trends evident in patient-reported outcomes.

Association Between Proximal Hamstring Tear Characteristics and Achievement of Clinically Significant Outcomes After Endoscopic and Open Repair at Minimum 2-Year Follow-up

Background: The effect of preoperative tear characteristics and the relative efficacy of open versus endoscopic surgical techniques have not been elucidated for the surgical treatment of proximal hamstring tendon injuries. Purpose: (1) To report on achievement rates of clinically significant outcomes at a minimum 2-year follow-up for multiple patient-reported outcomes (PROs) after surgical treatment of proximal hamstring injuries, stratified according to severity of proximal hamstring injury, and (2) to compare clinical outcomes associated with endoscopic versus open surgical repair for a subset of similarly classified tears. Study Design: Cohort study; Level of evidence, 3 Methods: A single-surgeon clinical registry was queried for patients who underwent surgical repair for proximal hamstring ruptures between January 2012 and March 2021. Injuries were classified by magnetic resonance imaging as follows: grade 1, incomplete tear with the involvement of 1 or 2 tendons; grade 2, complete tear with the involvement of 3 tendons and ≤2-cm retraction; and grade 3, complete tear with the involvement of 3 tendons and >2-cm retraction. The Patient Acceptable Symptom State (PASS) for multiple PROs was calculated and compared among injury grades and between surgical techniques. Results: Among 75 patients with a mean follow-up of 30.5 ± 5.1 months, 20 had grade 1 tears, 24 had grade 2 tears, and 31 had grade 3 tears. Favorable 2-year postoperative PROs were demonstrated by each grade for all measured PROs. Patients with grade 3 tears were noted to have significantly lower rates of 2-year PASS achievement for the Hip Outcome Score–Activities of Daily Living (HOS-ADL) and Hip Outcome Score–Sports Specific (HOS-SS) scales (P≤ .032). Among grade 2 tears, patients treated endoscopically demonstrated significantly greater HOS-SS (endoscopic, 91.7%; open, 58.3%; P = .045) and Patient-Reported Outcomes Measurement Information System for Physical Function (endoscopic, 80.0%; open, 50.0%; P = .033) PASS achievement rates compared with those treated with the open technique. Complication rates were highest in patients with grade 3 tears (45.2%, P = .043). Conclusion: Surgical repair of proximal hamstring tendon tears with varying extents of tendon retraction resulted in high rates of achieving PASS at the 2-year follow-up. Among complete tears with <2 cm of retraction, endoscopic repairs exhibited equal or higher rates of achieving PASS compared with open repairs across multiple PROs at 2 years postoperatively. However, patients with complete tears and retraction >2 cm achieved lower rates of PASS on the HOS-ADL and HOS-SS scales and had a higher rate of complications.

Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase3 Trials in Adults with Mild to Severe Plaque Psoriasis.

Patients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING1 (NCT03956355) and PSOARING2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials. Outcomes included a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 0 or 1 (itch-free state); Dermatology Life Quality Index (DLQI) itch item scores; and Psoriasis Symptom Diary (PSD) itch item scores. Analyses included 683 tapinarof- and 342 vehicle-treated patients. At baseline, mean pruritus scores were similar across trials with only 7-11% of patients reporting an itch-free state. At week12, the proportion of tapinarof-treated patients achieving an itch-free state was 50% in both trials compared with 32% (P = 0.0007) and 27% (P < 0.0001) in the vehicle groups. Improvements were apparent at the earliest assessments with continued improvement over the course of the trials. There were rapid and statistically significant improvements in the proportion of patients with a ≥ 4-point improvement in PP-NRS for tapinarof-treated patients versus vehicle from week2 with 68% vs 46% (P = 0.0004) and 60% vs 31% (P = 0.0001) at week12 achieving a response in each trial. Significantly greater reductions in itch with tapinarof versus vehicle were also demonstrated at week12 for DLQI itch item1 (P = 0.0026 and P < 0.0001), PSD item1 (both P < 0.0001), and PSD item2 (both P < 0.0001). Tapinarof was highly efficacious in reducing pruritus across multiple patient-reported outcome measures, with rapid, statistically significant, and clinically meaningful improvements. The high proportion of patients achieving the treatment target of an itch-free state at week12 (50%) is a noteworthy clinical outcome for a non-steroidal topical cream in the treatment of mild to severe plaque psoriasis. Clinical trial registration information: NCT03956355, NCT03983980.

Abstract B044: Avanzando Caminos (Leading Pathways): The Hispanic/Latino cancer survivorship cohort study

Abstract Background: Advances in prevention, early detection, and treatment have resulted in a 29% reduction in cancer mortality since 1990 and unprecedented increases in the number of cancer survivors. There are more than 16.9M survivors living in the US today and 22.1M are expected by 2030. Cancer survivorship outcomes vary by race/ethnicity, socioeconomic status (SES), and more. Cancer is the leading cause of deaths in Hispanics/Latinos (H/Ls), a critical issue given that H/Ls are the largest ethnic minority group in the US and will account for 30% of the US population by 2060. H/Ls are disproportionately impacted by cancer due to inequities in SES and healthcare access, which leads to differences in risk factors/exposures and barriers to high-quality cancer prevention, early detection, and treatment. Although H/Ls have lower incidence rates for most common cancer types, significant disparities exist in prevalence, invasiveness, and mortality in specific cancers and across multiple patient-reported outcomes, such as quality of life and symptom burden. However, there is limited work documenting survivorship experiences among H/Ls. Purpose: The Avanzando Caminos multisite cohort study was established to address critical gaps in the science of H/L survivorship. It aims to examine the influence of sociocultural, medical, stress, psychosocial, lifestyle, behavioral, and biological factors on symptom burden, health-related quality of life, and clinical outcomes among H/Ls who have been previously treated for cancer. Methods: Avanzando Caminos, a collaboration between the Sylvester Comprehensive Cancer Center at the University of Miami and the Mays Cancer Center at UT Health San Antonio, is a 6-year prospective, cohort-based study of 3,000 H/Ls (1,500 in South Florida and 1,500 in South Texas) who completed primary cancer treatment within the past five years for stomach, liver, cervical, colorectal, lung, breast, kidney, or prostate cancers. Participants will complete self-report measures at baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Blood draws to assess leukocyte gene expression, cardiometabolic markers, and genetic admixture will be collected at baseline, 1 year, 3 years, and 5 years. Medical and cancer characteristics and clinical outcomes will be extracted from the electronic medical record and/or state cancer registry at each time point. Data analysis will include general latent variable modeling with maximum likelihood robust variance estimation. Results: So far, we have recruited 398 H/L participants with a mean age of 59.49 years, 62% are female, 35% are Mexican, 57% Cuban, 24% Central/South American, 78% Puerto Rican, and 7% other. Preliminary results will include sociocultural, quality of life, stress, and other factors impacting H/Ls survivors. Conclusions: Avanzando Caminos is expected to fill critical gaps in knowledge to guide future secondary and tertiary prevention efforts to mitigate cancer disparities and optimize health-related quality of life among Hispanic/Latino cancer survivors. Citation Format: Amelie G. Ramirez, Patricia Chalela, Stephanie Rowan, Ysabel R. Lew, Victoria C. Garza, Natalie Rodriguez, Myriam N. Gonzalez, Britney E. Ortiz, Dorothy Long Parma, Edgar Muñoz, Yidong Chen, Chen-Pin Wang, Adolfo E. Diaz Duque, Luz M. Garcini, Dolores M. Perdomo, Stefanie V. Beltran, Gabrielle Montes de Oca, Maria Baraya, Akina Natori, Madeline H. Krause, Paulo S. Pinheiro, Patricia I. Moreno, Michael H. Antoni, Carmen Calfa, Olveen Carrasquillo, Gilberto Lopes, Steve Cole, Frank J. Penedo. Avanzando Caminos (Leading Pathways): The Hispanic/Latino cancer survivorship cohort study [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B044.

Title: The Impact of Recent Vaso-Occlusive Crisis on Health-Related Quality of Life in Adults with Sickle Cell Disease

Introduction: Sickle cell disease (SCD) is characterized by vaso-occlusive crises (VOCs) and a progressive clinical course, often leading to end organ damage and mortality. Individuals living with SCD with recurrent VOCs experience daily life disruptions due to recurrent pain crises, debilitating chronic pain and fatigue, which substantially impair health-related quality of life (HRQoL). The impact of a recent VOC on HRQoL has not been quantified. We investigated HRQoL impacts in adults with SCD who experienced a recent VOC (&amp;lt; 1 week) in comparison to overall adults with SCD with recurrent VOCs. Methods: A mixed-methods study was conducted to quantify the HRQoL, work impacts, and perceived health inequalities of individuals with SCD with recurrent VOCs. The study consisted of qualitative interviews and an online longitudinal survey administered at 3 timepoints (month 0, 3, and 6) in the US, UK, France, Germany, and Italy. Patient advocacy groups used multi-channel outreach to invite participants, who were required to meet the eligibility criteria and provide consent. Key eligibility criteria included recurrent VOCs defined as ≥ 2 VOCs/year in each of the 2 years prior to enrollment requiring a medical facility interaction and administration of pain medication or red blood cell transfusion. The survey included multiple patient-reported outcome (PROs) measures: the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) inclusive of the FACT-General (FACT-G), EuroQol- 5 Dimension 5-Level (EQ-5D-5L), 11-point pain numerical rating scale (NRS), Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me), and the Work Productivity and Activity Impairment (WPAI) questionnaire. In this post-hoc analysis study participants with a current or recent VOC (&amp;lt; 1 week ago) were identified based on ASCQ-Me responses (herein referred to as recent VOC). The HRQoL impact of a recent VOC was assessed by descriptively comparing PRO scores between those with a recent VOC and the overall population of adults with SCD with recurrent VOCs (herein referred to as overall population). Results: The survey was completed by 142 participants with SCD (≥ 18 years) with 139 providing time since last VOC living in the US (n=82) and UK, Germany, France, and Italy (n=57). Fifty-six (40.3%) reported a recent VOC and had a similar mean age (35.7 vs. 35.3 years) and hydroxyurea use in the past month (58.9% vs. 61.9%) compared with the overall population. A higher proportion of those with a recent VOC were unemployed or unable to work due to SCD (76.8% vs. 64.7%). The mean EQ-5D VAS (0-100 scale, 100=best health) among those with a recent VOC was 49.2 (SD: 14.2), which was 16.2% and 38.8% lower relative to the overall study population (58.7 [SD: 19.4]) and the US general population (80.4 [SD: 15.6]), respectively. The overall mean EQ-5D health utility US index score (0.59 [SD: 0.27]) was much lower than the US general population (0.85 [SD: 0.21]) and further reduced among those with a recent VOC by 0.11 (0.48 [SD: 0.25]). The FACT-G total mean score was 53.6 (SD: 14.3) (0-108 scale, 108=best HRQoL) among those with a recent VOC representing a clinically meaningful reduction compared with the overall population (62.5 [SD:18.1]); with all FACT-G domain scores negatively impacted by a recent VOC. Based on the WPAI, those employed with a recent VOC (n=15) reported a mean of 35.4% (SD: 35.8%) absenteeism and 62.5% (SD: 21.8%) presenteeism, which were higher than the overall study population (24.7% [SD: 27.1%] and 42.0% [SD: 27.8%)], respectively). In the past 12 months, those with a recent VOC had a greater mean number of emergency room visits (9.6 [SD: 12.6] vs 6.2 [SD: 8.8]), hospitalizations with overnight stays (6.0 [SD: 5.7] vs. 4.0 [SD: 4.5]), and days overnight in the hospital (21.8 days [SD: 32.9] vs. 14.7 [SD: 24.7]) compared to the overall population. Conclusions: Despite current treatments, nearly 40% of adults with SCD in the surveyed population experienced a recent VOC (&amp;lt; 1 week), which has significant negative impacts on HRQoL and functional status, including the ability to work. These results demonstrate the substantial humanistic burden of those living with SCD with recurrent VOCs and the additional impairment of a recent VOC. Novel treatments that reduce or eliminate VOCs may provide an opportunity to improve health inequalities, HRQoL, and address unmet needs in this patient population.

Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study

BackgroundPostsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy. MethodsPatient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1–d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries. ResultsOf 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07–0.31, scale: 0–10); all changes were independent of baseline data or patient characteristics and similar between different procedures. ConclusionsPain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

The placebo effect in randomized-controlled trials of medical treatments for chronic rhinosinusitis: A systematic review and meta-analysis.

The placebo effect observed in clinical trials evaluating medical treatments for chronic rhinosinusitis (CRS) is not well understood. This systematic review and meta-analysis sought to characterize the placebo effect present within CRS outcomes. A systematic review of PubMed, Scopus, and Cumulated Index in Nursing and Allied Health Nursing (CINAHL) was performed. Randomized controlled trials (RCTs) evaluating medical treatments for CRS versus placebo were included. We assessed patient-reported (sino-nasal outcome test 22 [SNOT-22], nasal obstruction, sense of smell, nasal obstruction visual analogue score [VAS], sense of smell VAS, anterior rhinorrhea, and postnasal drip) and objective (Lund-Mackay Computed tomography (CT) score, peak nasal inspiratory flow [PNIF], nasal polyp scores, 40-item Smell Identification Test, serum IgE, and blood eosinophil levels) outcomes. Twenty-one RCTs were included, comprising 1437 patients (mean age 49.2 years). Biologics were the most common treatment investigated (n=9). Eleven studies administered background steroids along with placebo. Following placebo administration, multiple patient-reported outcomes significantly decreased, including SNOT-22 (mean difference -9.49, 95% confidence interval [CI] [-11.26, -7.73]), nasal obstruction (-0.33 [-0.54, -0.13]), sense of smell (-0.22 [-0.33, -0.11]), nasal obstruction VAS (-2.47 [-2.87, -2.06]), and loss of smell VAS (-2.31 [-4.14, -0.47]) scores. For objective measures, significant changes occurred in Lund-Mackay CT score (-0.82, [-1.48, -0.16]) and PNIF (4.70, [4.76, 24.64]) with placebo. Placebo arms had the greatest impact when no background medications were used. Placebo treatments have a statistically and potentially clinically significant effect on patient-reported and some objective CRS outcomes. Further investigation is required to fully understand placebo effect, which could improve assessment of RCTs and impact patient care.

Clinical Outcomes After Open and Endoscopic Repair of Proximal Hamstring Tendon Tears at a Minimum Follow-up of 5 Years.

Current evidence supports favorable short-term clinical outcomes with few complications after surgical management of proximal hamstring injuries; however, the durability of clinical benefits beyond approximately 2 years after surgery is unknown. To evaluate patient-reported clinical outcomes and complication rates associated with open and endoscopic repair of proximal hamstring tears at minimum 5-year follow-up. Case series; Level of evidence, 4. A single-surgeon registry of patients was queried between October 1, 2014, and December 31, 2017, to identify patients who underwent open or endoscopic repair of a proximal hamstring tear. Patients who reported minimum 5-year follow-up data were included. Multiple patient-reported outcome measures, including the Hip Outcome Score Activities of Daily Living (HOS-ADL) and Sports-Specific (HOS-SS) subscales, 12-Item International Hip Outcome Tool (iHOT-12), and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain domains, along with surgical complications, were analyzed. Among 35 eligible patients (65.7% female; mean age, 52.3 ± 8.4 years), 24 had full-thickness tears and 11 had partial-thickness tears. There were 23 open repairs and 12 endoscopic repairs. Mean duration from symptom onset to surgical intervention was 37.9 weeks (range, 1.3-306.9 weeks). At a mean follow-up of 69.0 months (range, 60.0-95.0 months), mean postoperative outcome scores were as follows: HOS-ADL, 86.8 ± 12.7; HOS-SS, 83.1 ± 19.5; iHOT-12, 86.3 ± 14.9; PROMIS-PF, 50.0 ± 11.8; and PROMIS-Pain, 50.2 ± 7.9. Regarding complications, 28.6% of patients had a complication including persistent peri-incisional numbness (11.4%), wound infection (11.4%), postoperative neuropathy (8.6%), and revision surgery (2.9%). Both open and endoscopic surgical techniques for repair of proximal hamstring injuries produced favorable patient-reported clinical outcomes at a minimum 5-year follow-up.

Cancer Pain Management in Patients Receiving Inpatient Specialized Palliative Care Services

ContextCancer pain is a common complication that is frequently undertreated in patients with cancer. ObjectivesThis study is aimed at assessing the time needed to achieve cancer pain management goals through specialized palliative care (SPC). MethodsThis was a multicenter, prospective, longitudinal study of inpatients with cancer pain who received SPC. Patients were continuously followed up until they considered cancer pain management successful, and we estimated this duration using the Kaplan–Meier method. We investigated the effectiveness of pain management using multiple patient-reported outcomes (PROs) and quantitative measures, including pain intensity change in the Brief Pain Inventory. A paired-sample t-test was used to compare the pain intensity at the beginning and end of the observation period. ResultsCancer pain management based on the PROs was achieved in 87.9% (385/438) of all cases. In 94.5% (364/385) of these cases, cancer pain management was achieved within 1 week, and the median time to pain management was 3 days (95% confidence interval [CI], 2–3). The mean worst pain intensity in the last 24 h at the start and end of observation were 6.9 ± 2.2 and 4.0 ± 2.3, respectively, with a difference of −2.9 (95% CI, −3.2 to −2.6; p < 0.01). Overall, 81.6% of the patients reported satisfaction with cancer pain management, and 62 adverse events occurred. ConclusionSPC achieved cancer pain management over a short period with a high level of patient satisfaction resulting in significant pain reduction and few documented adverse events.

Image-free handheld robotic-assisted technology improved the accuracy of implant positioning compared to conventional instrumentation in patients undergoing simultaneous bilateral total knee arthroplasty, without additional benefits in improvement of clinical outcomes

PurposeThe purpose of this study was to compare the clinical and radiological outcomes in patients who underwent simultaneous bilateral total knee arthroplasty (SB-TKA) using either robotic-assisted TKA (RA-TKA) or conventional TKA (C-TKA).MethodsIncluded were the patients who underwent SB-TKA between January 2018 and January 2020 and had a minimum follow-up of 2 years. Of 151 patients included, 117 patients were operated using an image-free handheld robotic sculpting system (RA-TKA group) and 34 patients operated using conventional instrumentation (C-TKA group). The key outcomes noted were multiple patient-reported outcomes (PROs), adverse events, and radiological outcomes. Two investigators independently measured the radiological outcomes on pre- and post-operative radiographs in coronal plane (medial proximal tibial angle [MPTA] and anatomic lateral distal femoral angle [aLDFA]) and sagittal plane (posterior tibial slope [PTS] and posterior condylar offset [PCO]). The chi-square test was used to examine categorical variables. Student’s t test was used to analyze the continuous variables.ResultsPatients in both groups were similar in baseline characteristics (gender, body mass index, incidence of comorbidities, and length of hospital stay) except that RA-TKA group patients younger (66.7 ± 8.9 vs 70.4 ± 10.5, P = 0.037) than C-TKA group. The operative time was longer in RA-TKA group as compared to C-TKA (189.3 ± 37.1 vs 175.0 ± 28.2, P = 0.040). The final PROs at each were similar between the two groups (P > 0.05). The values of PROs at final follow-up in RA-TKA compared to C-TKA were VAS pain (0.4 ± 0.9 vs 0.4 ± 0.5), KOOS-JR (89.3 ± 5.8 vs 87.1 ± 5.3), and physical (55.9 ± 2.8 vs 55.4 ± 3.2), mental (61.1 ± 4.4 vs 60.2 ± 4.7) component of VR-12 scores, and KSS satisfaction (37.5 ± 1.1 vs 37.1 ± 2.2) (all P > 0.50 or non-significant [n.s.]). While one patient in RA-TKA required revision of femoral component for peri-prosthetic fracture, none of the patient in conventional group were revised (0.85% vs 0%, P = n.s.). The proportion of patients with outliers in RA-TKA group was lower for aLDFA (2.6% vs 22.1%, P < 0.01) and PTS (0% vs 35%, P < 0.01).ConclusionThis comparative study in patients undergoing SB-TKA found reduction of outliers in femoral and tibial implant positioning with RA-TKA as compared to C-TKA. There were no differences in both groups for pain, function, and satisfaction at a minimum of 2 years of follow-up.Level of evidenceIII Therapeutic Study.

Impairment in Functioning and Quality of Life in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE).

Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by excessive daytime sleepiness, sleep inertia, and prolonged sleep. Its impact on patients' quality of life and daily functioning has not been fully elucidated. The Real World Idiopathic Hypersomnia Outcomes Study (ARISE) evaluated the daily functioning, relationships, cognition, emotional well-being, and productivity/employment of participants with idiopathic hypersomnia. ARISE was a US-based virtual cross-sectional survey comprising multiple patient-reported outcome measures (Functional Outcomes of Sleep Questionnaire, short version [FOSQ-10], Quality of Life in Neurological Disorders [Neuro-QoL] Social Roles and Stigma domains, British Columbia Cognitive Complaints Inventory [BC-CCI], Patient Health Questionnaire [PHQ-9], and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [WPAI:SHP]). Participants were adults 21-65 years of age with idiopathic hypersomnia. Data were analyzed for all participants and for subgroups with/without long sleep time (LST; self-reported sleep ≥11 hours in 24 hours). Of 75 participants enrolled, most were female (81.3%) and the mean (SD) age was 34.1 (10.7) years. Participants' scores on the FOSQ-10 (mean [SD] score: 10.7 [2.8]) and the Neuro-QoL Social Roles (43.4 [4.2]) and Stigma (57.3 [5.9]) domains reflected impairments in daily functioning and quality of life. More than half of participants reported moderate to severe cognitive complaints (BC-CCI; 62.7%) and moderate to severe depressive symptoms (PHQ-9; 66.7%). Scores on the WPAI:SHP showed substantial impairments in absenteeism, presenteeism, overall work productivity, and overall regular daily activity (mean percent [SD]: 12.3 [23.6], 47.6 [22.7], 51.4 [24.7], and 64.0 [21.9], respectively). These considerable impairments were found in participants with and without LST. ARISE participants with idiopathic hypersomnia demonstrated poor quality of life and impaired functioning across multiple symptom domains.

Poster 338: Analysis of Patient Reported Outcomes and Subsequent Surgery Rate following Quadriceps Tendon Anterior Cruciate Ligament Reconstruction and Lateral Extra-articular Tenodesis in Skeletally Immature Patients: Two Year Follow-Up

Objectives: The incidence of anterior cruciate ligament reconstruction (ACLR) in pediatric and adolescent patients is increasing significantly and many patients possess risk factors that predispose to ACL re-tear. Lateral extra-articular tenodesis (LET) may be performed in conjunction with ACLR to reduce the risk of ACL re-tear. The purpose of this study is to evaluate the 2-year clinical outcomes of ACLR with soft tissue quadriceps tendon (QUAD) autograft and a lateral extra-articular tenodesis (LET) using a modified Lemaire technique in skeletally immature patients. Methods: A consecutive series of patients who underwent QUAD tendon autograft ACLR and LET with a minimum of 2-year follow-up data was analyzed retrospectively. ACLR techniques included all- epiphyseal (AE) and complete transphyseal (CT) and were indicated based on skeletal age. Outcome measures included participants’ return to sports (RTS), concomitant or subsequent surgical procedures and multiple patient-reported outcome measures, including Single Assessment Numeric Evaluation (SANE), Pediatric International Knee Documentation Committee (Pedi-IKDC) and HSS Functional Activity Brief Scale (HSS Pedi-FABS) scores. Results: The final cohort included 50 consecutive adolescent patients aged 11 to 16 years (mean 14.2 ± 1 years) with a minimum follow-up of 2 years. Two patients were lost to follow-up. Of the patients included in the study (n=48), 98% participated in high-risk competitive sports (Table 1). Two patients (4%) were revision ACLR. Ten (21%) patients underwent AE and 38 (79%) underwent CT ACLR. Sixteen patients (33%) had subsequent surgical procedures, including 5 contralateral ACLR, 4 meniscus surgeries, 4 QUAD autograft scar revision, 4 irrigation and debridement (2 patients, 2 each) and 3 hardware removal procedures (2 for hemi-epiphysiodesis and 1 tibial socket button removal). The rate of graft failure was 0%. At two-year follow-up, mean SANE score was 93, mean Pedi-IKDC score was 90, and mean HSS-Pedi-FABS score was 23. RTS rate was 100%. Conclusions: A LET when performing an ACLR is safe and should be considered as a concomitant procedure for adolescent patients that are at high risk of re-tear. [Table: see text]

Short-Term Outcomes of Concomitant Patellofemoral Arthroplasty and Medial Patellofemoral Ligament Reconstruction to Treat Concurrent Patellofemoral Arthritis and Patellar Instability.

The purpose of this study was to evaluate the efficacy of combined patellofemoral arthroplasty (PFA) and medial patellofemoral ligament (MPFL) reconstruction in patients with patellofemoral arthritis in the setting of concomitant patellar instability. Patients who underwent single-stage, combined PFA and MPFL reconstruction by a single surgeon at a tertiary-care orthopaedic center between 2016 and 2021 were identified. Postoperative radiographic and clinical outcomes at a minimum of 6 months were recorded using patient-reported outcome measures, including International Knee Documentation Committee (IKDC), Kujala, and VR-12. Early complications and rates of recurrent instability were also recorded. Of the 16 patients who met inclusion and exclusion criteria, 13 patients were available for final follow-up (81%; 51.7 ± 7.2 years, 11 females, 2 males) with a mean clinical follow-up of 1.3 ± 0.5 years (range: 0.5-2.3 years). Patients experienced significant improvements in patellar tilt and multiple patient-reported outcome metrics postoperatively, including IKDC, Kujala, VR-12 Mental Health, and VR-12 Physical Health. At the time of the most recent follow-up, no patient had experienced a postoperative dislocation or subluxation event. The findings suggest that concurrent PFA and MPFL reconstruction are associated with significant improvements in multiple patient-reported outcomes. Further studies are needed to evaluate the duration of clinical benefits achieved with this combined intervention.

Association of Open Reduction and Internal Fixation With Volar Locking Plate for Distal Radius Fractures With Patient-Reported Outcomes in Older Adults

ImportanceRandomized clinical trials (RCTs) and meta-analyses have reported inconsistent conclusions regarding optimal distal radius fracture (DRF) treatment in older adults and are limited due to the inclusion of cohort studies with small sample sizes. A network meta-analysis (NMA) addresses these limitations by only synthesizing direct and indirect evidence from RCTs and may clarify optimal DRF treatment in older adults.ObjectiveTo examine DRF treatment results in optimal short-term and intermediate-term patient-reported outcomes.Data SourcesSearches of MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials were conducted for RCTs that investigated DRF treatment outcomes in older adults between January 1, 2000, and January 1, 2022.Study SelectionRandomized clinical trials including patients with a mean age of 50 years or older that compared the following DRF treatments were eligible for inclusion: casting, open reduction and internal fixation with volar lock plating (ORIF), external fixation, percutaneous pinning, and nail fixation.Data Extraction and SynthesisTwo reviewers independently completed all data extraction. An NMA aggregated all direct and indirect evidence among DRF treatments. Treatments were ranked by surface under the cumulative ranking curve score. Data are reported as standard mean differences (SMDs) and 95% CIs.Main Outcomes and MeasuresThe primary outcome was short-term (≤3 months) and intermediate-term (&amp;amp;gt;3 months to 1 year) Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire scores. Secondary outcomes included Patient-Rated Wrist Evaluation (PRWE) scores and 1-year complication rates.ResultsIn this NMA, 23 RCTs consisting of 3054 participants (2495 women [81.7%]) with a mean (SD) age of 66 (7.8) years were included. At 3 months, DASH scores were significantly lower for nail fixation (SMD, −18.28; 95% CI, −29.93 to −6.63) and ORIF (SMD, −9.28; 95% CI, −13.90 to −4.66) compared with casting. The PRWE scores were also significantly lower for ORIF (SMD, −9.55; 95% CI, −15.31 to −3.79) at 3 months. In the intermediate term, ORIF was associated with lowered DASH (SMD, −3.35; 95% CI, −5.90 to −0.80) and PRWE (SMD, −2.90; 95% CI, −4.86 to −0.94) scores. One-year complication rates were comparable among all treatments.Conclusions and RelevanceThe findings of this NMA suggest that ORIF may be associated with clinically significant improvements in short-term recovery compared with casting for multiple patient-reported outcomes measures with no increase in 1-year complication rates. Shared decision-making with patients may be useful to identify patient preferences regarding recovery to determine optimal treatment.

ID: 211963 Identifying Core Patient-Reported Outcomes for Chronic Pain Patients Treated With Spinal Cord Stimulation

Pain perception is complex and involves both sensory and psychological components of the brain. Multiple patient-reported outcomes (PROs) are usually required to capture different aspects of pain to characterize the experience. However, the burden of collecting full-length PROs at each clinical visit is demanding. The objective of this work is to investigate the feasibility of using a limited set of outcome questions from multiple PROs to accurately reflect the subject’s response to spinal cord stimulation (SCS) therapy for pain management.