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OBJECTIVES: To assess the use of a co-designed patient-reported outcome (PRO) clinical dashboard and estimate its impact on shared decision-making (SDM) and symptomatology in adults with advanced cancer or chronic kidney disease (CKD). MATERIALS AND METHODS: We developed a clinical PRO dashboard within the Northwestern Medicine Patient-Reported Outcomes system, enhanced through co-design involving 20 diverse constituents. Using a single-group, pretest-posttest design, we evaluated the dashboard's use among patients with advanced cancer or CKD between June 2020 and January 2022. Eligible patients had a visit with a participating clinician, completed at least two dashboard-eligible visits, and consented to follow-up surveys. PROs were collected 72 h prior to visits, including measures for chronic condition management self-efficacy, health-related quality of life (PROMIS measures), and SDM (collaboRATE). Responses were integrated into the EHR dashboard and accessible to clinicians and patients. RESULTS: We recruited 157 participants: 66 with advanced cancer and 91 with CKD. There were significant improvements in SDM from baseline, as assessed by collaboRATE scores. The proportion of participants reporting the highest level of SDM on every collaboRATE item increased by 15 percentage points from baseline to 3 months, and 17 points between baseline and 6-month follow-up. Additionally, there was a clinically meaningful decrease in anxiety levels over study period (T-score baseline: 53; 3-month: 52; 6-month: 50; P < .001), with a standardized response mean (SRM) of -0.38 at 6 months. DISCUSSION: PRO clinical dashboards, developed and shared with patients, may enhance SDM and reduce anxiety among patients with advanced cancer and CKD.
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BACKGROUND: The purpose of this study was to compare outcomes between patients undergoing same-day discharge (SDD) total knee arthroplasty (TKA) at an ambulatory surgery center (ASC) versus a tertiary care university hospital setting. METHODS: A single tertiary academic center's institutional database was reviewed for patients that underwent primary TKA and were discharged the same day from August 2021 to January 2024. Patients who did not have at least one year of follow-up were excluded. Patient demographics, comorbidities, patient-reported outcome measures (PROMs), emergency department (ED) visits, admissions, reoperations, and revisions were collected. Patients were stratified by the location of their surgery: ASC versus hospital. Specific criteria had to be met prior to surgery at the ASC, and the final decision regarding the location of surgery was made via shared decision-making between the patient and their surgeon. Patients who did not meet ASC criteria underwent TKA at the main hospital. Univariable analyses were used to compare groups, and multivariable logistic regression was used to determine if surgical location was a significant factor. Of the 449 TKAs meeting inclusion criteria, 63.3% (284) were performed at the ASC and 36.7% (165) at the university hospital at a mean follow-up of 1.51 years (range, 1.00 to 2.40). Of those 165 whose surgery was done at the hospital, 93.9% met at least one ASC exclusion criteria. RESULTS: Patients whose TKA was done at the hospital had significantly higher weight (P = 0.003), body mass index (BMI) (P < 0.001), Elixhauser comorbidity index (ECI) (P < 0.001), proportion of patients who had an American Society of Anesthesiologists (ASA) classification of 3 (P = 0.023), and proportion of patients who required general anesthesia (P < 0.001). Additionally, patients whose TKA was done at the hospital had higher preoperative patient-reported outcome measurement information system (PROMIS) pain interference (PI) (62.0 [59.0, 66.0] versus 63.0 [61.8, 67.0]; P = 0.006), and lower physical function (PF) (39.0 [36.0, 43.0] versus 38.0 [34.0, 41.0]; P = 0.001). At 1 year, however, patients in both groups had similar PROMIS PI (53.0 [49.0, 59.0] versus 54.0 [44.0, 59.0]; P = 0.785) and PROMIS PF (47.0 [42.0, 51.0] versus 47.0 [41.0, 50.0]; P = 0422) scores as well as similar rates of achieving minimum clinically important difference (MCID) for PROMIS PI (64.4 versus 71.4%; P = 0.336) and PROMIS PF (60.5 versus 71.4%; P = 0.124). They also had a similar number of ED visits and admissions at 30 and 90 days, as well as similar reoperation-free (92.0 versus 93.3%; P = 0.79) and revision-free (95.5 versus 99.4%; P = 0.59) survival at 2 years. CONCLUSION: Although ASCs have strict patient criteria for SDD TKA, complex patients at a tertiary university hospital can be sent home the same day with equivalent outcomes. Therefore, unhealthier patients can safely achieve SDD without compromising outcomes if done in the appropriate setting.
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INTRODUCTION: Though Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (P-UE) has been validated in upper extremity orthopedics, it's ability to capture a patient's functional recovery after arthroscopic rotator cuff repair (aRCR), as measured by its responsiveness, is minimal in the early postoperative period. The primary purpose of this study is to determine if addition of PROMIS Pain Intensity (P-Intensity) or Pain Interference (P-Interference) scores to PROMIS UE improves the responsiveness throughout the one-year postoperative period after aRCR. METHODS: This prospective, longitudinal study included 100 patients who underwent aRCR. Patients completed P-UE, P-Interference, P-Intensity, American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff Index (WORC) scores preoperatively and at 2-weeks, 6-weeks, 3 months, 6-months and 12-months after surgery. Responsiveness at each time-point relative to preoperative baseline and one-way analysis of variance with post-hoc analysis was conducted for each PROM. Responsiveness of the outcome score was determined using the effect size (ES), graded as small (0.2), medium (0.5), or large (0.8). The Pearson correlation coefficient (r) was determined between these instruments at each time-point. RESULTS: In isolation, P-UE, P-Interference, and P-Intensity showed a medium-large ability to detect change (positive and negative) throughout the one-year postoperative period. The addition of PROMIS pain scores to P-UE improved the responsiveness of the instrument (from medium to a large effect size) starting at 3 months and continued throughout the 12 month follow-up period. Though the addition of pain scores increases the response burden for PROMIS, this was still lower when compared to the response burden for the legacy outcome scores (p<0.05). CONCLUSION: The addition of PROMIS pain instruments improves the responsiveness of the P-UE function score in patients undergoing aRCR.
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Purpose: Despite improvements in survival, adolescent and young adult (AYA) oncology patients are at high risk for experiencing negative health-related quality of life (HRQOL) outcomes. AYA cancer programs have attempted to develop assessment tools to identify areas of need. We aimed to demonstrate the feasibility/utility of the Patient-Reported Outcome Measurement Information System®-29 (PROMIS®-29) within an AYA oncology program clinic. Methods: AYA patients were referred by oncologists to the AYA oncology program at Prisma Health. The PROMIS-29 v2.0 survey was administered to AYAs at point of care. Feasibility of distribution and completion rate of surveys were determined. PROMIS surveys were self-reported and subsequently scored using standardized methods. The domains assessed included physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles/activities, pain interference, and pain intensity. Qualitative descriptions of AYA care delivery based on survey responses at the patient level and programmatic level are also presented. Results: Between May 2017 and 2019, 134 AYAs who were newly diagnosed or in treatment completed the survey. Distribution and completion rates for the PROMIS-29 were both 100%, and meaningful changes in program-level services were implemented as a result of PROMIS-29 score patterns. Within the entire cohort, T-scores for anxiety, fatigue, and physical function reached clinically relevant thresholds. Conclusion: PROMIS offers a feasible opportunity for AYA programs to measure clinically useful HRQOL outcomes in AYAs. The survey can be used to deliver real-time AYA care to recently diagnosed and in-treatment AYAs and make programmatic changes within AYA oncology programs.
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AIM: To describe the impact of the COVID-19 on the psychosocial health of patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and systemic lupus erythematosus (SLE). DESIGN: Longitudinal observational study of a series of patients with rheumatic disease. METHODS: The main outcome measure was impairment of the ability to participate in social activities, as measured using the PROMIS-APS instrument Short Form-8a. We evaluated social activities in various settings and performed a multivariate analysis to study the association between worsening of social participation during the COVID-19 pandemic and implicated factors. RESULTS: One hundred and twenty-five patients had completed the prospective follow-up: 40 with AR (32%), 42 with SpA (33.6%), and 43 with SLE (34.4%). Overall, poorer mean PROMIS scores were recorded after the COVID-19 pandemic for: satisfaction with social roles (p=0.029), depression (p=0.039), and ability to participate in social activities (p=0.024). The factors associated with ability to participate in social activities after the COVID-19 pandemic were older age (ß=-0.215; p=0.012), diagnosis of SLE (ß=-0.203; p=0.015), depression (ß=-0.295; p=0.003) and satisfaction with social roles (ß=0.211; p=0.037). CONCLUSION: The ability to participate in social activities after the COVID-19 pandemic is affected in patients with rheumatic disease, especially in SLE.
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COVID-19 , Enfermedades Reumáticas , Humanos , COVID-19/psicología , COVID-19/epidemiología , Femenino , Masculino , Persona de Mediana Edad , Estudios Longitudinales , Adulto , Enfermedades Reumáticas/psicología , Artritis Reumatoide/psicología , Lupus Eritematoso Sistémico/psicología , Anciano , Participación Social , Estudios Prospectivos , Espondiloartritis/psicología , Depresión/epidemiología , Depresión/etiología , PandemiasRESUMEN
BACKGROUND: In contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies. METHODS: We administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population. RESULTS: The correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr. CONCLUSION: Despite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.
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Medición de Resultados Informados por el Paciente , Calidad de Vida , Humanos , Estados Unidos , Masculino , Femenino , Persona de Mediana Edad , Estudios Transversales , Adulto , Estudios Longitudinales , Anciano , Encuestas y Cuestionarios , Prioridad del Paciente/estadística & datos numéricos , Dolor de Espalda/psicología , Adulto Joven , Adolescente , Encuestas EpidemiológicasRESUMEN
Background: The role of biceps tenodesis (BT) during open reduction internal fixation (ORIF) of proximal humerus fractures (PHFs) remains unclear. A subset of patients undergoing ORIF have persistent pain with unclear etiology. The purpose of our study was to compare outcomes of ORIF of PHFs with and without concomitant BT. We hypothesize patients undergoing BT at the time of ORIF will have improved patient-reported outcome scores with fewer secondary procedures related to treatment of the biceps. Methods: In this retrospective cohort study, all patients undergoing ORIF for a PHF at a single level one trauma center from January 2019 to June 2022 were reviewed. Patients under the age of 18 were excluded. Primary outcomes were patient-reported outcomes measurement information system physical function, depression, and pain interference scores at 5 time points up to final follow-up. Secondary outcomes included total operative time, complications, subsequent procedures, steroid injections, and range of motion. Chi-square tests were performed for categorical values and paired t-tests for continuous variables. Results: 71 patients met inclusion criteria: 41 undergoing ORIF without BT and 30 undergoing ORIF with BT. Average follow-up was 11 months. There were no statistically significant differences in patient demographics between groups. There were no differences in patient-reported outcomes measurement information system scores at any time point postoperatively. At final follow-up patients in the ORIF with BT group had higher forward flexion than those who did not undergo BT (142 vs. 123 degrees, respectively, P < .02). There were no differences in surgical time, revision rates, postsurgical complications, or postoperative injections between groups. Conclusion: BT performed during ORIF of PHFs did not result in significantly different functional or patient-reported outcomes between groups, except for greater forward flexion at final follow-up. Although BT was done more commonly in severe PHFs, patients in both groups had similar rates of subsequent biceps-related procedures and revision surgery.
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PURPOSE: Quality of life (QoL) is identified as a clinical and research priority by the autistic community. Researchers have the responsibility to ensure that instruments used to measure QoL do so reliably and accurately among autistic participants. METHODS: Our study evaluated measurement invariance of Emotional Distress (Depression, Anxiety, Anger, Psychological Stress) and Subjective Well-Being (Life Satisfaction, Positive Affect, and Meaning & Purpose) scales of the Patient-Reported Outcomes Measurement Information System (PROMIS) among groups of autistic (N=140, n per scale=132-140) and general population (N=1,224, n per scale=406-411) teenagers (14-17 years). These scales were included in the PROMIS Autism Battery-Lifespan, which uses PROMIS scales to measure QoL domains most relevant for autistic people. RESULTS: Multi-group confirmatory factor analyses using permutation tests demonstrated that Depression and Positive Affect scales exhibited scalar invariance between groups, indicating that scores can be meaningfully compared across autistic and general population teens. Anger and Psychological Stress scales demonstrated metric invariance between groups, indicating that these scales measure the same latent trait in both groups, but group comparisons are not supported. CONCLUSION: We provide guidance as to how these scales can be used in psychometrically supported ways to capture constructs relevant for understanding QoL among autistic teens.
Quality of life is an important outcome for autistic people and their families. However, many quality of life scales have not been tested to make sure they accurately measure quality of life among autistic people. It is important to make sure that quality of life measures works similarly among the autistic population. The goal of our study is to test whether scales on a common quality of life measure the Patient-Reported Outcomes Measurement Information System (PROMIS) measures quality of life in the same way between autistic and general population adolescents. We found that some of the PROMIS scales worked the same way for autistic and general population adolescents and others did not. These results help researchers confidently use the PROMIS scales to measure different aspects of quality of life among autistic youth.
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OBJECTIVES: To evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials. METHODS: Content validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn's disease (Crohn's disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn's disease (N = 360) and UC (N = 518). RESULTS: Common (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain. CONCLUSIONS: PROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.
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OBJECTIVE: The objective of this study was to examine the psychometric properties of the EQ-5D-Y-3 L, Patient Reported Outcomes Measurement System 25-item version profile v2.0 (PROMIS-25), and Pediatric Quality of Life Inventory™ version 4.0 Generic Core Scale (PedsQL 4.0) in Chinese pediatric patients with spinal muscular atrophy (SMA). METHODS: The data used in this study were obtained via a web-based cross-sectional survey. Parents of pediatric patients with SMA completed the proxy-reported EQ-5D-Y-3 L, PedsQL 4.0, and PROMIS-25 measures. Information about socioeconomic and health status was also obtained. The ceiling and floor effects, factorial structure, convergent validity, and known-group validity of the three measures were assessed. RESULTS: Three hundred and sixty-three parents of children aged from 5 to 12 completed the questionnaires. Strong floor effects were observed for the physical function components of the PROMIS-25 (41.3%) and PedsQL 4.0 (67.8%). For EQ-5D-Y-3 L, 84.6% of the respondents reported having "a lot of" problems with the dimensions "walking" and "looking after myself." Minimal ceiling or floor effects were observed for the EQ-5D-Y-3 L index value. The confirmatory factor analysis supported a six-factor structure for the PROMIS-25, but did not support a four-factor structure for the PedsQL 4.0. All hypothesized correlations of the dimensions among the three measures were confirmed, with coefficients ranging from 0.28 to 0.68. Analysis of variance showed that EQ-5D-Y-3 L demonstrated better known-group validity than the other two measures in 14 out of 16 comparisons. CONCLUSIONS: The EQ-5D-Y-3 L showed better discriminant power than the other two measures. The physical health dimensions of all three measures showed the significant floor effects. These findings provide valuable insights into the effectiveness of these measures at capturing and quantifying the impact of SMA on patients' health-related quality of life.
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Atrofia Muscular Espinal , Psicometría , Calidad de Vida , Humanos , Masculino , Femenino , Niño , Calidad de Vida/psicología , Estudios Transversales , Encuestas y Cuestionarios/normas , Preescolar , Atrofia Muscular Espinal/psicología , Reproducibilidad de los Resultados , Medición de Resultados Informados por el Paciente , ChinaRESUMEN
INTRODUCTION: An area of rehabilitation research in burns is the impact of co-morbidities on disease trajectory. Obesity is a comorbidity of increasing public health concern, but its role remains controversial regarding burn injury and physical recovery. Our aim was to evaluate the association between body mass index (BMI) categories as a measure of obesity at discharge and self-reported physical function (PF) during recovery of adult burn survivors. METHODS: This is a retrospective study on data collected by four major US burn centers, which contribute to the Burn Model System National Database. The data included BMI obtained at hospital discharge and self-reported PF-mobility, using the PROMIS measures assessed at 6, 12, and 24 months after burn. Subjects were classified into weight status categories based on BMI: underweight (BMI <18.5), normal weight (18.5 ≤ BMI <25), overweight (25 ≤ BMI <30), obesity class 1 (30 ≤ BMI <35), obesity class 2 (35 ≤ BMI <40), and obesity class 3 (BMI ≥40). Mixed-effects linear regression models were used to assess the association between BMI categories and PF scores over time, adjusted for patient and injury characteristics. RESULTS: A total of 496 adult burn patients aged 47 ± 16 years were included, with mean total body surface area (TBSA) burned of 18 ± 19 % and mean BMI at discharge of 28 ± 7 kg/m2. PROMIS PF scores significantly improved over time in the recovery phase after burn (time effect, p < 0.001). Compared to overweight burn patients, normal-underweights exhibited lower PF score by an average of 4.06 units (p = 0.001) but scores increased linearly by an estimated 0.17 units per month (p = 0.01) over the 24 months after discharge. Similarly, compared to overweight burn patients, class 1 obese reported lower PF score by a mean 2.67 units (p = 0.07) but PF increased linearly by 0.15 units per month (p = 0.07) over the 24 months after discharge. These findings were independent of the effects of age at discharge, sex, TBSA burned, and hand and leg burn. CONCLUSION: Being overweight was associated with improved and faster recovery of PF scores compared to normal, underweight, and obese burn patients during long-term recovery. Hence, our data suggests that long-term recovery and restoration of PF in adult burn survivors is not compromised by a small excess in body weight.
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Introduction: Depression and anxiety are the most commonly reported mental health conditions. The Patient-Reported Outcomes Measurement Information System Short Form v1.0-Depression 8a (PROMIS-D-8a), Anxiety 8a (PROMIS-Anx8a), and Pain Anxiety Symptoms Scale-20 (PASS-20) measures were designed to assess depression, general anxiety, and pain-related anxiety, respectively. Objectives: To examine the responsiveness and estimate the clinically important differences (CIDs) of the Thai version of these measures in individuals with chronic low back pain (CLBP). Methods: The study sample comprised 144 participants with CLBP. Responsiveness was evaluated by calculating the change scores, effect sizes (ESs), standardized response means (SRMs), area under the curve (AUC), and correlations between the change scores and associated Global Perceived Effect (GPE). We also estimated CIDs by the difference in mean change score between improved and unchanged groups and standard error of measurement (SEM) for each measure. Results: Statistically significant differences in the mean change scores, ESs, and SRMs supported the responsiveness of all measures. The AUCs achieved acceptable discriminatory ability (0.71-0.72) for moderate improvement but not for any improvement (0.65-0.68). The correlations between GPE and change scores on all measures were low (r ranging 0.28-0.33). The estimated CIDs for the PROMIS-D-8a, PROMIS-Anx8a, and PASS-20 were 3.64, 4.20, and 8.80, respectively. Conclusion: The PROMIS-D-8a, PROMIS-Anx8a, and PASS-20 measures were sensitive for detecting clinical changes over time in individuals with CLBP. The CID values can be used as reference points for assessing meaningful improvements in the domains assessed by these scales in clinical and research practice.
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Background: The relationship between oral and overall health is of interest to health care professionals and patients alike. This study investigated the correlation between oral health-related quality of life (OHRQoL) and health-related quality of life (HRQoL) in a general adult population. Methods: This cross-sectional study used a convenience sample of adult participants (N = 607) attending the 2022 Minnesota County and State fairs in USA, the 5-item Oral Health Impact Profile (OHIP-5) assessed OHRQoL, and the 10-item PROMIS v.1.2 Global Health Instrument assessed HRQoL. Spearman and Pearson correlations were used to summarize the bivariable relationship between OHRQoL and HRQoL (both physical and mental health dimensions). A structural equation model determined OHRQoL-HRQoL correlations (r). Correlations' magnitude was interpreted according to Cohen's guidelines (r = 0.10, 0.30, and 0.50 to demarcate "small," "medium," and "large" effects, respectively). Results: OHRQoL and HRQoL correlated with r = 0.52 (95% confidence interval, CI: [0.50-0.55]), indicating that the two constructs shared 27% of their information. According to Cohen, this was a "large" effect. OHRQoL, and the physical and mental HRQoL dimensions correlated with r = 0.55 (95% CI: [0.50-0.59]) and r = 0.43 (95% CI: [0.40-0.46]), respectively, indicating a "large" and a "medium" effect. OHRQoL and HRQoL were substantially correlated in an adult population. Conclusion: Using OHIP-5 to assess their dental patients' oral health impact allows dental professionals to gain insights into patients' overall health-related wellbeing.
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Salud Bucal , Calidad de Vida , Humanos , Calidad de Vida/psicología , Salud Bucal/estadística & datos numéricos , Masculino , Femenino , Estudios Transversales , Adulto , Persona de Mediana Edad , Minnesota , Estado de Salud , Anciano , Medición de Resultados Informados por el Paciente , Encuestas y Cuestionarios , Adulto JovenRESUMEN
Purpose: Distal radius fractures (DRFs) indicated for operative intervention are most commonly treated with volar-locked plating (VLP); however, dorsal bridge plating (DBP) has been used as an alternative fixation method. The purpose of this study was to use a propensity score to match and compare the radiographic and clinical outcomes of patients undergoing isolated VLP or DBP for DRFs. Methods: We performed a retrospective, propensity score-matched analysis of patients undergoing isolated VLP or DBP treatment for isolated DRFs from 2015 to 2022 at a single level-1 trauma center. Patients were propensity score-matched by a total of eight demographic and comorbidity factors, AO Foundation/Orthopedic Trauma Association classification, and preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Our primary outcomes included postoperative complications, wrist and forearm range of motion (ROM), grip strength, and radiographic measurements, including radial height, radial inclination, volar tilt, and articular step-off. Results: Overall, 415 DBP and 2075 VLP were successfully propensity score-matched and included in this study. Grip strength and ROM measurements at the 6-month follow-up, including wrist flexion, wrist extension, forearm pronation, forearm supination, radial deviation, and ulnar deviation, were increased in the VLP compared with DBP (P < .05). Complication rates among both the groups were relatively low; however, the rates of malunion and nonunion were significantly higher among the DBP group (P < .05). Radial height, radial inclination, and articular step-off were improved in the VLP group compared with the DBP group (P < .05); however, volar tilt was similar between groups. PROMIS upper extremity and physical function were significantly higher among the VLP group (P < .05). No significant difference was noted in PROMIS pain interference between the groups. Conclusions: When compared with DBP, patients undergoing VLP are more likely to have improved clinical and radiographic outcomes. Although improvement in wrist and forearm ROM and radiographic parameters is statistically significant, it may not be clinically relevant. Type of study/level of evidence: Therapeutic III.
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BACKGROUND: International focus groups with patients with idiopathic inflammatory myopathies (IIM) conducted by the OMERACT Myositis Working Group over the years demonstrated the pain as an important symptom experienced by these patients. In this study, we aimed to examine the frequency and degree of pain interference, the aspects of daily life impacted by pain, and the factors associated with pain interference in adults with IIM. METHODS: This was a prospective observational study with two visits. The patients who fulfilled the probable/definite IIM (ACR/EULAR Myositis Classification Criteria) were enrolled. Pain interference was assessed with PROMIS pain interference form (6a). Myositis core set measures and PROMIS fatigue (7a) and physical function (8b) were obtained at both visits. Logistic regression and linear mixed models were performed to assess the association between pain interference and other parameters. RESULTS: A total of 129 patients with IIM (60 % females) were recruited from U.S., South Korea, Netherlands, Sweden, and Australia. Approximately 71 % reported pain interference. The patients in the greater pain interference group were more likely to be female, had significantly worse patient/physician global disease activity, fatigue, and physical function than those in the lower pain interference group. The most commonly impacted life aspect was household chores. Manual muscle testing, patient/physician global disease activity, fatigue, and physical function were all significantly associated with pain interference score >60. CONCLUSION: The majority of the patients with IIM experience the impact of pain on their daily activities, particularly household chores. Myositis disease activity, duration, and subtype could be associated with greater pain interference.
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Actividades Cotidianas , Miositis , Humanos , Miositis/fisiopatología , Miositis/complicaciones , Miositis/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto , Dolor/etiología , Dolor/fisiopatología , Anciano , Dimensión del DolorRESUMEN
PURPOSE: The Patient-Reported Outcome Measurement Information System (PROMIS®) was developed to provide reliable, valid, and normed item banks to measure health. The item banks provide standardized scores on a common metric allowing for individualized, brief assessment (computerized adaptive tests), short forms (e.g. heart failure specific), or profile assessments (e.g. PROMIS-29). The objective of this study was to translate and linguistically validate 24 PROMIS adult item banks into French and highlight cultural nuances arising during the translation process. METHODS: We used the FACIT translation methodology. Forward translation into French by two native French-speaking translators was followed by reconciliation by a third native French-speaking translator. A native English-speaking translator fluent in French then completed a back translation of the reconciled version from French into English. Three independent reviews by bilingual translators were completed to assess the clarity and consistency of terminology and equivalency across the English source and French translations. Reconciled versions were evaluated in cognitive interviews for conceptual and linguistic equivalence. RESULTS: Twenty-four adult item banks were translated: 12 mental health, 10 physical health, and two social health. Interview data revealed that 577 items of the 590 items translated required no revisions. Conceptual and linguistic differences were evident for 11 items that required iterations to improve conceptual equivalence and two items were revised to accurately reflect the English source. CONCLUSION: French translations of 24 item banks were created for routine clinical use and research. Initial translation supported conceptual equivalence and comprehensibility. Next steps will include validation of the item banks.
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Medición de Resultados Informados por el Paciente , Psicometría , Traducción , Traducciones , Humanos , Adulto , Femenino , Masculino , Encuestas y Cuestionarios/normas , Reproducibilidad de los Resultados , Calidad de Vida , Lingüística , Lenguaje , Persona de Mediana EdadRESUMEN
Introduction Anterior cruciate ligament (ACL) tears occur frequently in young athletes, and ligament repair and reconstruction are surgical treatments. Although there are suggested benefits for both approaches, there is a lack of direct comparisons between ACL repair and reconstruction.This study aims to compare the mid-term functional outcomes and quality of life measures between patients that have undergone ACL repair versus reconstruction. Methods A retrospective review was conducted for demographic and operative report data of patients who underwent an ACL repair or reconstruction between 2012 and 2018. Patients were contacted over the phone and underwent a Patient-Reported Outcomes Measurement Information System (PROMIS) survey evaluating pain interference, mobility, and function. Patients were excluded from the study if there was an incomplete operative note, missing contact information, or failure to answer phone calls. Results A total of 74 eligible patients were included, with n = 54 in the ACL reconstruction group (73.0%) and n = 20 in the ACL repair group (27.0%). Reconstruction patients had a PROMIS (median (IQR)) physical function score of 22.50 (16.00-59.00), as compared to repair patients' physical function score of 60.00 (21.50-60.00). There was a significant difference favoring repair (p = 0.040). In addition, ACL reconstruction patients had a significantly higher rate of additional procedures, with 63.0% of reconstruction patients receiving an additional operation as compared to 30.0% of repair patients (p = 0.017). The surgery type did not show a significant effect on physical function scores, while additional procedures remained significant in the linear regression analysis. Conclusion Although ACL repair is associated with improved physical function scores as compared to reconstruction in the univariate analysis, surgery type did not show significance when controlling for other variables. Further studies are necessary to compare patients with similar injuries to account for differences in additional procedures, but the results remain promising in assisting with patient-driven treatment decisions.
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Objective To explore how socioeconomic status and patient characteristics may be associated with initial self-reports of pain and determine if there was an increased association with undergoing spine surgery. Methods Patients at an academic center between 2015 and 2021 who completed the Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) questionnaire were included. Multivariable linear regression models were used to determine the association between insurance type and patient factors with initial reports of pain. Multivariable logistic regression models were used to determine the association between PI and the likelihood of surgery in two time periods, three and 12 months. Results The study included 9,587 patients. The mean PROMIS-PI scores were 61.93 (SD 7.82) and 63.74 (SD 6.93) in the cervical and lumbar cohorts, respectively. Medicaid and Workers' Compensation insurance patients reported higher pain scores compared to those with private insurance: Medicaid (cervical: 2.77, CI (1.76-3.79), p<0.001; lumbar (2.05, CI (1.52-2.59), p<0.001); Workers' Compensation (cervical: 2.12, CI (0.96-3.27), p<0.001; lumbar: 1.51, CI (0.79-2.23), p<0.001). Black patients reported higher pain compared to White patients (cervical: 1.50, CI (0.44-2.55), p=0.01; lumbar: 1.51, CI (0.94-2.08), p<0.001). Higher PROMIS-PI scores were associated with a higher likelihood of surgery. There was no increased association of likelihood of surgery in Black, Medicaid, or Workers' Compensation patients when controlling for pain severity. Conclusion Black patients and patients with Medicaid and Workers' compensation insurance were likely to report higher pain scores. Higher initial pain scores were associated with an increased likelihood of surgery. However, despite increased pain scores, Black patients and those with Medicaid and Workers' Compensation insurance did not have a higher likelihood of undergoing surgery.
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OBJECTIVES: To analyse the effect of fezolinetant on patient-reported sleep disturbance and impairment in individuals with vasomotor symptoms (VMS) using pooled data from the SKYLIGHT 1 and 2 studies. STUDY DESIGN: The SKYLIGHT studies were phase-3, double-blind investigations. Individuals (≥40-≤65 years) who were assigned female at birth and seeking treatment of/relief from moderate-to-severe VMS were enrolled. Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period. MAIN OUTCOME MEASURES: Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment - Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12. RESULTS: Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: -0.6 [95 % confidence interval [CI]: -1.7, 0.4] for 30 mg and -1.5 [-2.5, -0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: -1.1 [95 % CI: -2.1, -0.1] for 30 mg and -1.3 [-2.3, -0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period. CONCLUSIONS: Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treatment for VMS.