SF-36 Mental Component Score Research Articles

S304: SUTIMLIMAB, A COMPLEMENT C1S INHIBITOR, PROVIDES SUSTAINED IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES IN PATIENTS WITH COLD AGGLUTININ DISEASE (CAD): 2 YEAR FOLLOW-UP FROM THE CARDINAL STUDY

Background: CAD is a rare chronic autoimmune hemolytic anemia characterized by classical complement pathway (CP)-mediated hemolysis, anemia, fatigue, and poor quality of life (QOL). Sutimlimab is a first-in-class humanized monoclonal antibody that selectively inhibits C1s of the C1 complex, preventing CP activation, while leaving the alternative and lectin pathways intact. One-year interim follow-up from the CARDINAL study (NCT03347396) have previously demonstrated continuous classical CP inhibition with sutimlimab resulted in rapid, sustained improvements in all patient-reported outcomes (PROs) measures evaluated. Aims: To report sutimlimab effect on PROs at 2 years, from the CARDINAL Part B extension. Methods: CARDINAL was a Phase 3, open-label, single-arm study with a 26-week treatment period (Part A) and a 2-year extension (Part B) after the last patient finishes Part A. Sutimlimab was administered through intravenous infusions on Days 0 and 7, followed by biweekly dosing. PRO data through Week 135, the last data recording within the 2-year Part B time period, are reported here. Efficacy endpoints included hemolytic markers and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) as a measure of QOL. Exploratory QOL endpoints included mean change from baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) scores, 12-Item Short Form Health Survey (SF-12), Patient Global Impression of Change (PGIC) and Patient Global Impression of Fatigue Severity (PGIS). PRO measures were evaluated every 3 months and conducted in the following order: FACIT-Fatigue, PGIS, PGIC, SF-12 and EQ-5D-5L. Descriptive statistics, frequency, or percentage were used to analyze outcomes. Results: Overall, 24 patients enrolled and 22 finished Part A and entered Part B, with 19 (86.4%) patients completing Part B. The mean (SD) FACIT-Fatigue score at baseline was 32 (11) and improved by 7 (8) within 1 week of sutimlimab treatment; the mean change score from baseline remained ≥5 from Week 1 to Week 135 (minimum score of 38 (9) at Week 123, maximum score of 44 (5) at Week 7), consistent with a clinically meaningful improvement. Efficacy for the EQ-5D-5L visual analogue scale (VAS) was sustained over 2 years; the mean (SD) change from baseline in EQ-5D-5L visual analogue scale (VAS) score (n=15/22) at Week 135 was 17.1 (21.6) (Figure A). The majority of evaluable patients (n=13/15) indicated an improved disease state compared to baseline on the PGIC at Week 135. No or mild fatigue was reported in patients (80%, n=12/15) on completing PGIS at Week 135, compared with one-third at baseline (n=2/6). The mean increase in SF-12 physical and mental component scores (n=6/22) from baseline to Week 123 were 4.7 (6.9) and 3.8 (14.1) (Figure B), consistent with the clinically important changes of 3.9 and 2.8 respectively. Image:Summary/Conclusion: From this CARDINAL follow-up extension study, sutimlimab has shown to produce rapid and sustained improvements in FACIT-Fatigue and other PRO measures evaluated up to 2 years, demonstrating the continued meaningful impact of sutimlimab on patient QOL.

PB2233: SYSTEMATIC LITERATURE REVIEW OF HEALTH-RELATED QUALITY OF LIFE BURDEN IN PATIENTS ACROSS THE SPECTRUM OF THALASSEMIA

Background: Recent systematic literature reviews (SLRs) have highlighted the health-related quality of life (HRQoL) burden in transfusion-dependent thalassemia (TDT), particularly β-thalassemia (β-thal). However, less is known about HRQoL in non–transfusion-dependent thalassemia (NTDT) and alpha-thalassemia (α-thal). Aims: To conduct an SLR on the real-world HRQoL burden across the entire spectrum of thalassemia and report evidence gaps. Methods: Searches (2010 to September 2021) were conducted in MEDLINE, Embase, Cochrane Database of Systematic Reviews, Health Technology Assessment Database, NHS Economic Evaluation Database, and EconLit for real-world studies reporting on HRQoL, utilities, and patient-reported outcomes in adult and pediatric patients with thalassemia. Conference abstracts from 2017 to September 2021 were also searched. References were screened at title/abstract and then full text by two independent reviewers. Data extraction was undertaken by one reviewer and validated by a second independent reviewer. Results were grouped by genotype (β-thal/α-thal) and transfusion phenotype (TDT/NTDT) to support comparisons. Results: A total of 2,541 records were screened at title/abstract, 441 at full-text and 7 references were identified through other sources. A total of 126 publications reporting on 116 study populations were included. Most evidence was published since 2015 (n=95) and sample sizes ranged from 22 to 1240. The number of publications by transfusion phenotype (TDT/NTDT) and thalassemia genotype (β-thal/α-thal) is shown in Table 1. Overall, most TDT/NTDT studies were conducted in β-thal or did not report genotype. Four studies included patients with α-thal but did not report HRQoL results separately for this subgroup. Across 52 studies reporting on TD β-thal, most showed that both adult and pediatric patients have reduced HRQoL. One study found EQ-VAS utility values to be poorer in adults than in children with TDT (mean [SD]: 75.04 [17.86] for >18 years vs. 84.97 [15.16] for ≤18 years; P<0.001). Four studies in pediatric patients noted the negative impact of TDT on caregivers’ HRQoL. Very few studies assessed HRQoL for NTDT patients vs healthy controls, and none were in adult population. One pediatric study found NTDT patients had worse total and domain PedsQOL scores (all P<=0.05) than healthy controls. Several studies compared NTDT and TDT patients. Using the SF-36, one study found significantly poorer HRQoL in NTDT than in TDT adults (mean total score [SD]: 66.5 [16.1] vs. 75.8 [18.8]; P=0.021). A prospective, non-interventional study found significantly lower SF-36 mental component scores at baseline in NTDT compared to TDT adults (mean [SD]: 47.4 [8.4] vs. 51.6 [7.2]; P <0.01), and NTDT patients had worse HRQoL change from baseline at 24 weeks than TDT patients. In pediatric patients, one study found poorer HRQoL in TDT compared to NTDT (mean PedsQL total score [SD]: 42.25 [20.61] vs. 67.76 [18.31]; P=0.0001). However, both NTDT and TDT patients had poorer HRQoL than healthy controls (83.45 [15.6]); P<0.0001). Image:Summary/Conclusion: This SLR highlights the negative impact of thalassemia on HRQoL. Adding to previously published SLRs, it shows limited evidence is available for NTDT patients; however, studies suggest that HRQoL burden may be worse in NTDT than TDT patients, particularly in adults. Characterizing the HRQoL burden of α-thal is a clear evidence gap. High-quality, real-world studies in NTDT and α-thal are needed to better understand the HRQoL burden and the potential impact of new treatments on HRQoL.

A head-to-head comparison of EQ-5D-5L and SF-6D in Dutch patients with fractures visiting a Fracture Liaison Service

Aims This study compared the psychometric properties of EQ-5D-5L and SF-6D to assess the interchangeability of both instruments in patients with a recent fracture presenting at a Fracture Liaison Service (FLS). Materials and methods Data from a prospective observational study in a Dutch FLS clinic were used. Over 3 years, subjects were interviewed at several time points using EQ-5D-5L and SF-36. Floor and ceiling effects were evaluated. Agreement was evaluated by intra-class correlation coefficients and visualized in Bland–Altman plots. Spearman’s rank correlation coefficients were applied to assess convergent validity. Mann–Whitney U test or Kruskal–Wallis H test as well as effect size (ES) were used to explore known-groups validity. Responsiveness was explored using standardized response mean (SRM) and ES. For each measurement property, hypotheses on direction and magnitude of effects were formulated. Results A total of 499 patients were included. EQ-5D-5L had a considerable ceiling effect in comparison to SF-6D (21 vs. 1.2%). Moderate agreement between the (UK and Dutch) EQ-5D-5L and SF-6D was identified with intra-class correlation coefficients of 0.625 and 0.654, respectively. Bland–Altman plots revealed proportional bias as the differences in utilities between two instruments were highly dependent on the health states. High correlation between instruments was found (UK: rho = 0.758; Dutch: rho = 0.763). EQ-5D-5L and SF-6D utilities showed high correlation with physical component score but low correlation with mental component score of SF-36. Both instruments showed moderate discrimination (ES > 0.5) for subgroup by baseline fracture type, and moderate responsiveness (SRM > 0.5) in patients that sustained a subsequent fracture. Conclusion Both EQ-5D-5L and SF-6D appeared to be valid utility instruments in patients with fractures attending the FLS. However, they cannot be used interchangeably given only moderate agreement was identified, and differences in utilities and ceiling effect were revealed. Comparable construct validity and responsiveness were indicated, and neither instrument was found to be clearly superior.

Commencement of flash glucose monitoring is associated with a decreased rate of depressive disorders among persons with diabetes (FLARE-NL7)

IntroductionDepressive disorders are more common among persons with diabetes, as compared with persons without diabetes. The burden of glucose management is known to associate with depressive symptoms. This study aims...

Long-Term Trajectory of Recovery Following Pilon Fracture Fixation.

To describe the trajectory of recovery following fixation of pilon fractures from baseline to 5-year follow-up. Prospective cohort study. Level-1 trauma center. Patients with pilon fractures (OTA/AO 43.C) treated with open reduction and internal fixation. None. Patient-reported outcome measures were measured at baseline, 6 months, 1 year, and 5 years using the Short-Form 36 Health Survey (SF-36) Physical Component Score and Mental Component Score, Short Musculoskeletal Functional Assessment, and the Foot and Ankle Outcome Score. One hundred two patients were enrolled: mean age was 42.6 years; 69% were males; 88% had an injury severity score of 9; 74 patients (73%) completed 1-year follow-up; 40 patients (39%) completed 5-year follow-up. Trajectory of recovery of physical function showed a significant decline between baseline and 6 months, with significant improvement between 6 months and 1 year and then ongoing but slower improvement between 1 year and 5 years. Sixty-four patients returned to baseline SF-36 Physical Component Score at 5 years. Pain was a persistent issue and remained significantly worse at 5 years when compared with baseline. Psychological well-being (SF-36 Mental Component Score) did not significantly change from baseline at 5 years. Functional recovery following open reduction and internal fixation for pilon fractures was characterized by an initial decrease in function from baseline, followed by an increase between 6 months and 1 year, and then slower but continued increases from 1 year to 5 years. Function did not return to baseline levels, pain was a persistent issue, and mental well-being showed no change from baseline at 5 years. This information may be useful when counselling patients. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Incorporating patient-reported outcome data into a hematopoietic cell transplant survival calculator.

7045 Background: The Center for International Blood and Marrow Transplant Research (CIBMTR) provides a validated 1-year Overall Survival (OS) calculator to estimate outcomes for individual patients prior to allogeneic Hematopoietic Cell Transplant (HCT) to inform risk. The calculator considers pre-HCT clinical and demographic characteristics, but not patient-reported outcome (PRO)s. Pre-HCT PRO scores have been associated with OS. We hypothesized that adding the baseline PRO score to the calculator will enhance its performance in predicting OS. Methods: In addition to established covariates,we considered pre-HCT PRO scores, collected on five (published) prospective randomized clinical trials performed through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). Measures used were the SF36 physical component score (PCS) and mental component score (MCS), and the FACT-BMT Trial outcome index (TOI). We also investigated inclusion of a single question from the SF36: In general, would you say your health is: excellent/very good/good vs fair/poor. Patients were ≥18. Results: 1,033 patients were included, 341 (33%) completed only the SF36, 339 (33%) only the FACT-BMT and 353 (34%) both, per study design. HCT occurred 2004-2014, and the population was diverse with respect to disease, stage, demographics, and transplant characteristics. When adjusted for clinical characteristics, the PCS was significantly predictive of mortality (HR=0.88, 95%CI 0.81-0.96, p=0.0021), while the MCS and TOI were not. The single general health question was also significantly associated with mortality (HR=0.52, 95%CI 0.35-0.74, p=0.0004). Addition of PRO scores to the calculator did not result in a significant change in the model’s predictive ability as measured by Harrell’s concordance statistic (Table). Conclusions: In this large analysis, we confirmed the significant, independent association of pre-HCT PRO scores with OS. We showed, for the first time in this setting, that a single general health question is as accurate as the full SF36 measure for predicting survival, but we did not find support for the hypothesis that adding PROs to the calculator improved its performance. Estimates of baseline PRO measure effect on mortality and model concordance statistics at 1-year post-HCT. [Table: see text]

Association Between Patient Reported Outcomes Measurement Information System Physical Function With Postoperative Pain, Narcotics Consumption, and Patient-Reported Outcome Measures Following Lumbar Microdiscectomy.

Retrospective cohort study. To determine association between preoperative Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) scores with postoperative pain, narcotics consumption, and patient-reported outcome measures (PROMs) following single-level lumbar microdiscectomy. Consecutive patients who underwent single-level lumbar microdiscectomy were identified from May 2017-May 2020. Patients were grouped by their preoperative PROMIS-PF scores: mild disability (score≥40), moderate disability (score 30-39.9), and severe disability (score<30). Preoperative PROMIS-PF subgroups were tested for association with inpatient postoperative pain, total inpatient narcotics consumption, time to narcotic use cessation as well as improvements in postoperative PROMIS-PF, ODI, VAS-Leg Pain, VAS-Back Pain, SF-12 Physical Component Score (PCS), SF-12 Mental Component Score (MCS) at 2-, 6-, 12-weeks, 6-month, 1-year, 2-year follow-up. A total of 127 patients were included. Patients with greater disability reported higher inpatient maximum Visual Analog Scale (VAS) pain scores (P = .023) and total inpatient narcotics consumption (P = .008) but no difference in time to narcotic cessation after surgery (P = .373). However, patients with greater preoperative disability also demonstrated greater improvement from baseline in PROMIS-PF, ODI, SF-12 PCS, and SF-12 MCS at 2-week follow-up (P < .05). These higher improvements from baseline for patients with greater preoperative disability were sustained for PROMIS-PF, ODI, and VAS-Leg Pain at 2-year follow-up (P < .05). Patients with greater preoperative disability, as measured by PROMIS-PF, had increased inpatient postoperative pain and narcotics consumption, but also higher improvement from baseline in long-term PROMs. This data can be utilized for patient counseling and setting expectations.

0048 The Association Between Sleep Health and Work- and Health-Related Quality of Life in Desk Workers and Differences in Associations Pre- and Post-COVID-19 Emergence

Abstract Introduction COVID-19 resulted in many office workers switching to remote work. Emerging studies report working from home has negatively affected sleep health (SH) and psychological well-being. Our aim was to evaluate the relationship between SH and health- and work-related quality of life and explore whether these associations differed pre- and post-COVID-19 emergence. Methods Baseline data from 125 adults enrolled pre- (n=59) and post-COVID-19 emergence (n=66) in a clinical trial with desk jobs were included in this analysis (86.4% White; 49.6% female; 43.9±10.7 y). Health-related quality of life (HRQoL) was assessed using the SF-36 questionnaire, which addresses eight health concepts (physical, social, and role functioning; mental health; health perceptions; energy or fatigue; pain; general health) and yields 2 summary scales (mental component summary, physical component summary). Workplace productivity and worker health was measured using the Health and Work Questionnaire (HWQ). Six SH dimensions were assessed using questionnaires (satisfaction, alertness) and 7 nights of actigraphy (regularity, timing, efficiency, duration). Each dimension was categorized as “good” or “poor”; a composite score was created based on the sum of good SH dimensions. Multiple linear regression models were adjusted for gender and age and stratified by enrollment pre- or post-COVID-19 emergence. Data are presented as standardized coefficients (β) and p-values (p). Results Compared to participants enrolled prior to COVID-19, those enrolled post-COVID-19 had worse SF-36 emotional, social, and general health and greater HWQ-assessed impatience (all p&amp;lt;0.05); however, SH did not differ between those enrolled pre- and post-COVID. Prior to COVID-19, greater SH was associated with higher SF-36 physical component scores (β=.389, p=.003); however, no association was observed post-COVID (β=.137, p=.271). In contrast, no association was observed pre-COVID between SH and SF-36 mental component scores (β=.181, p=.160), but greater SH was associated with greater mental component scores post-COVID (β =.308, p=.004). Furthermore, better SH was associated with lower stress post-COVID (β =-.423, p&amp;lt;.001). Conclusion SH was associated with HRQoL and workplace and worker health, though these associations sometimes differed between pre- and post-COVID emergence. Research should explore whether promoting SH in employees impacts their personal and workplace-related quality of life. Support (If Any) This study was funded by National Institutes of Health (NIH) grants R01HL134809 and R01HL147610.

Midterm follow-up outcomes of total hip arthroplasty in treatment for patients with juvenile-onset ankylosing spondylitis

To assess the midterm follow-up outcomes of total hip arthroplasty (THA) for the treatment of patients with juvenile-onset ankylosing spondylitis (JAS). The clinical data of 81 patients (127 hips) with JAS (age≤16 years, JAS group) and 267 patients (391 hips) with adult onset ankylosing spondylitis (AAS) (age>16 years, AAS group) between January 2004 and March 2018 were retrospectively analysed. The baseline demographics, clinical, radiographic, and laboratory parameters were collected. Before operation and at last follow-up, the overall disease activity [Bath ankylosing spondylitis disease activity index (BASDAI)] and function status [Bath ankylosing spondylitis functional index (BASFI)], hip subjective score [Harris hip score (HHS)] and objective score [12-item short form health survey (SF-12), including physical component score (PCS) and mental component score (MCS)], and patient satisfaction for THA were reviewed. The major orthopedic complications, including periprosthetic infection, dislocation, periprosthetic fractures, and poor incision healing, were also recorded during the follow-up period. The comparison of preoperative baseline parameters showed that the body mass, body mass index, age of onset, age of surgery, disease duration, and the proportion of combined smoking history in the JAS group were significantly lower than those in the AAS group ( P<0.05), the proportion of bilateral surgeries, proportion of uveitis, proportion of combined family history, C-reactive protein, albumin, and preoperative BASFI were significantly higher than those in the AAS group ( P<0.05). Both groups were followed up. The follow-up time in the JAS group was 29-199 months, with an average of 113 months; in the AAS group was 35-199 months, with an average of 98 months. Incisions in both groups healed by first intention. During the follow-up period, there were 1 case of periprosthetic fracture, 1 case of dislocation, and 1 case of ceramic fragmentation in the JAS group, 1 case of periprosthetic infection and 6 cases of periprosthetic fracture in the AAS group. There was no significant difference in the incidence of complications between the two groups ( P>0.05). At last follow-up, the BASDAI, BASFI, SF-12 MCS, SF-12 PCS, and HHS score of the two groups were significantly improved when compared with those before operation ( P<0.05); but there was no significan difference in the difference of the above parameters before and after operation and the patient satisfaction between the two groups ( P>0.05). The midterm follow-up outcomes of THA for the treatment of JAS patients were reliable. A low age at disease onset did not exert a significant negative effect on THA reconstruction for the treatment of ankylosing spondylitis.

MO017: The Impact of Pre-Transplantation Nephrectomy on Quality of Life in Patients With Autosomal Dominant Polycystic Kidney Disease

Abstract BACKGROUND AND AIMS In autosomal dominant polycystic kidney disease (ADPKD), the enlarged kidneys can cause clinical problems, for instance pain or gastro-intestinal complaints, recurrent infections, or cause a lack of space for a kidney transplant. In selected ADPKD patients, a nephrectomy is required in the work-up for a kidney transplantation. Currently, it is unknown how this procedure affects quality of life (QoL), nor how leaving both kidneys in situ influences wellbeing. The aim of this study was to investigate the impact of pretransplantation nephrectomy on quality of life in APDKD patients. METHOD In this retrospective cohort study all ADPKD patients, ≥18 years, who received a kidney transplantation in 2 ADPKD expertise centers in the Netherlands (UMC Groningen and UMC Leiden) between January 2000 and January 2016, were asked to participate. Of these two centers, one has a restrictive approach, wherein a unilateral procedure is only performed when strict indications are met, and one a proactive approach, wherein a bilateral procedure is performed routinely in the work-up for transplantation. Data were collected on patients characteristics, date of nephrectomy, date of kidney transplantation and QoL. QoL was assessed using validated questionnaires (the SF-36, PHQ-9 and ADPKD-Impact Score) on three different time points (12 months before transplantation, 12 months after transplantation and date of filling out the questionnaire). Patients were followed for at least 24 months after transplantation. RESULTS 321 ADPKD (61 ± 9 years, 57.9% male) patients were included. The minority of patients (n = 99, 30.8%) underwent native nephrectomy in preparation for transplantation, of which 43 patients (13.4%) underwent bilateral nephrectomy. Lack of space was the most common indication for nephrectomy (68.7%), followed by recurrent cyst infection (18.2%) and refractory pain complaints (9.1%). Age, sex and comorbidities did not differ before transplantation between patients who would later undergo a pretransplantation nephrectomy when compared to those who would not undergo this procedure, except for QoL. The SF-36 physical component score (PCS) and mental component score (MCS) were lower in the nephrectomy group vs. no nephrectomy group (33.8 versus 38.4, P = 0.003; 48.7 versus 51.7, P = 0.04, respectively). In addition, the PHQ-9 and ADPKD-IS were significantly lower in patients who would later undergo a pre-transplantation nephrectomy compared to patients who would not undergo this procedure (P = 0.01, P = 0.01, respectively). After transplantation the PCS and MCS improved significantly in both groups, with this improvement in PCS and MCS being significantly more in patients who had a pretransplant nephrectomy compared with those who did not have a nephrectomy (change in PCS 17.3, P &amp;lt; 0.001 versus 13.4, P &amp;lt; 0.001; change in MCS 9.7, P &amp;lt; 0.001 versus 4.5, P &amp;lt; 0.001). Similar findings were noted for the PHQ-9 and APDKD-IS. At the end of follow-up, 7.9 ± 4.6 years after transplantation, PCS and MCS were still better in both groups (PCS 45.9, P &amp;lt; 0.001 versus 49.7, P &amp;lt; 0.001; MCS 57.4, P &amp;lt; 0.001 versus 55.1, P &amp;lt; 0.001, respectively). No differences in the PCS, MCS, PHQ-9 and ADPKD impact scores were observed between both expertise centers as well as in patients who underwent unilateral versus bilateral nephrectomy. CONCLUSION This study shows that ADPKD patients who underwent a pretransplantation nephrectomy experienced more complaints compared with patients without nephrectomy. After nephrectomy and transplantation, QoL significantly improved in these patients, resulting in a similar QoL level in all transplanted ADPKD patients on short as well as long-term follow-up. Bilateral nephrectomy had no additional benefit on QoL compared with unilateral nephrectomy. Together, this indicates that a restrictive approach, wherein a unilateral procedure is performed only when strict indications are met, may improve QoL in these patients and is therefore justified.

Assessing the Burden of Illness Associated with Acquired Generalized Hypoactive Sexual Desire Disorder.

Background:Hypoactive sexual desire disorder (HSDD), which affects ∼10% of women in the United States, is defined as the persistent or recurrent deficiency/absence of sexual desire accompanied by personal distress. Although HSDD impacts patient quality of life and interpersonal relationships, the disorder often goes unaddressed or untreated. Recent studies of the burden of illness in women with HSDD, especially premenopausal women, are limited.Materials and Methods:A 45-minute web-based survey was designed to investigate the experience of women seeking treatment for HSDD and the impact of this disorder on several psychosocial aspects of women's lives. Women were recruited from an online panel of patients who participated in research studies for compensation. Validated questionnaires assessed sexual function (Female Sexual Function Index) and health-related quality of life (12-Item Short Form Survey [SF-12]), including mental and physical component scores.Results:A total of 530 women, aged ≥18 years, diagnosed with acquired generalized HSDD were included in the study. Premenopausal women indicated greater overall HSDD symptom burden compared with postmenopausal women. Patients with HSDD reported lower SF-12 scores compared with the general population. A multivariable regression analysis demonstrated that psychosocial factors influencing the burden of HSDD, including interference with their relationship with their partner (β = −0.18; p < 0.005), mental and emotional well-being (β = −0.23; p < 0.005), and household and personal activities (β = −0.23; p = 0.02), negatively affected SF-12 mental component scores.Conclusions:HSDD symptom burden was found to be negatively and statistically significantly associated with patients' mental health; the impact was greater among premenopausal women compared with postmenopausal women.

Cervical Disc Replacement for Radiculopathy Versus Myeloradiculopathy: An MCID Analysis.

Retrospective cohort study. The aim was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing cervical disc replacement (CDR) for cervical spondylotic radiculopathy versus myeloradiculopathy. To date, a limited number of studies have demonstrated mostly similar results in patients with cervical spondylotic radiculopathy or myeloradiculopathy undergoing CDR. However, each of these previous studies have focused on statistically significant differences, which may not correlate with patient perceived improvements in outcomes or success. Patients who underwent 1 or 2-level CDR with radiculopathy versus myeloradiculopathy were identified, and prospectively collected data was retrospectively reviewed. Demographic variables, preoperative diagnosis, and operative variables were collected for each patient. The following PROs were prospectively collected: Neck Disability Index (NDI), visual analog scale (VAS)-Neck, VAS-Arm, Short Form-12 Health Survey (SF-12) Physical Component Score (PCS), SF-12 Mental Component Score (MCS), PROMIS Physical Function (PF). An MCID analysis of PROs for each diagnosis group was performed and the percentage of patients achieving the MCID was compared between the two diagnosis groups. Eight-five patients, of which 56% had radiculopathy and 44% had myeloradiculopathy. MCID analysis demonstrated that at 6-week, 12-week, and final postoperative follow-up there was no significant difference in the percentage of patients with radiculopathy or myeloradiculopathy achieving the MCID for each PRO assessed. In both diagnosis groups the percentage of patients achieving the MCID for each PRO continued to increase from the 6-week to final postoperative follow-up except for the SF-12 MCS in patients with myeloradiculopathy. The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups treated with CDR. In addition, the percentage of patients achieving the MCID continued to increase from 6 weeks to final follow-up in both groups for almost all PROs assessed.

Comparison of Fusion Rate and Functional Outcome Between Local Cancellous Bone Plus Demineralized Bone Matrix and Local Bone in 1-Level Posterior Lumbar Interbody Fusion.

Study Design:Retrospective study with prospectively collected data.Objective:The purpose of this study is to investigate the difference in fusion rate and clinical outcome of patients with local bone as filler for the graft and demineralized bone matrix (DBM) plus only the cancellous bone from local bone as a filler for cage in 1-level posterior lumbar interbody fusion (PLIF) with cage.Summary of Background Data:Cancellous bone is more advantageous than cortical bone in the local bone for improving bone formation in spine fusion surgery. There are little studies on the difference in fusion rate and reduction of fusion time using only these cancellous bones.Methods:Of the 40 patients who underwent 1-level PLIF using cage, 20 patients in group A used local bone and 20 patients in group B used mixture of cancellous bone extracted separately from local bone and commercially available DBM as filler for cage. Changes in fusion rate and intervertebral spacing were measured using lateral radiography, and fusion was determined as nonunion using the Brantigan-Steffee classification. The clinical outcome was evaluated.Results:There was no difference in height change over time between the two groups. Regarding union grade, group B showed better union grade than group A. However, no difference in union grade change over time was observed between the 2 groups. In group B, Oswestry Disability Index (ODI), Rolland-Morris Disability Questionnaire (RMDQ), and SF-36 mental component score (MCS) significantly decreased, but there was no difference in change over time.Conclusions:In 1-level PLIF for degenerative lumbar disease, better fusion rate was observed in the group that used only cancellous bone from local bone plus DBM than that in the group that used local bone; however, there was no difference in fusion grade change over time in the 2 groups.

Impact of biologics on health-related quality of life in patients with Ankylosing spondylitis: A systematic review and meta-analysis of randomized controlled trials

ObjectiveTo examine the impact of novel biologic disease-modifying antirheumatic drugs (bDMARDs) with tumor necrosis factor (TNF) inhibitors or Interleukin-17A (IL-17A) antibody agents on health-related quality of life (HRQoL) outcomes in patients with radiographic axial spondyloarthritis (r-axSpA). MethodsA literature search on PubMed, Embase, and Clinicaltrials.gov databases was performed through February 2022 to identify randomized controlled trials (RCTs) reporting HRQoL outcomes of bDMARDs for treatment of r-axSpA. Approved bDMARD therapy for r-axSpA included five TNF-inhibitors (infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol) and two IL-17A antibody agents (secukinumab, and ixekizumab). Heterogeneity (I2) was used to determine the variability between studies. ResultsSixteen RCTs, involving 3481 participants, were included. The placebo-controlled and treatment blinded durations ranged from 12 to 24 weeks. Compared with the placebo, bDMARD therapy was associated with significant improvement in HRQoL measures with the 36-item Short Form Survey (SF-36), European Quality of Life–5 Dimensions (EQ-5D), and Ankylosing Spondylitis Quality of Life (ASQoL). The pooled mean differences of changes from baseline for the SF-36 Physical Component Score (PCS), SF-36 Mental Component Score (MCS), EQ-5D, and ASQoL were 4.39 [95% Confidence Interval (CI): 3.24 to 5.54, P < 0.001]; 2.37 (95%-CI: 1.25 to 3.49, P = 0.003); 0.11 (95%-CI: 0.07 to 0.14, P < 0.001); and -2.45 (95%-CI: -3.21 to -1.70, P < 0.001), respectively. Heterogeneity was high (I2 = 79%) among studies reporting SF-36 PCS, and moderate (I2 = 61%, 34%, and 49%) among studies reporting SF-36 MCS, EQ-5D, and ASQoL, respectively. ConclusionsBiologic therapy was associated with a significant improvement in quality of life in patients with r-axSpA. The results were consistent among all three measures of HRQoL outcomes.

Effects of a Supplement Containing a Cranberry Extract on Recurrent Urinary Tract Infections and Intestinal Microbiota: A Prospective, Uncontrolled Exploratory Study.

Aim:Cranberries (Vaccinium macrocarpon) are traditionally used in prevention of urinary tract infections (UTIs). The authors' aim was to evaluate effects of a supplement containing cranberry extract, pumpkin seed extract, vitamin C, and vitamin B2 on recurrent uncomplicated UTIs in women and their intestinal microbiota.Methods:A prospective, uncontrolled exploratory study was conducted in women with recurrent uncomplicated UTIs. The primary exploratory outcome was the number of UTIs in a 6-month prospective observation period compared with a 6-month retrospective period. Further outcomes included number of antibiotics, quality of life (SF-36), intestinal microbiota (assessed by 16S rRNA amplicon sequencing), and evaluation questions. Parameters were assessed at baseline and after 1, 2, and 7 months (start of intake of cranberry supplement after 1 month for 6 months). p-Values were calculated with the pairwise Wilcoxon signed-rank test for α diversity and permutational multivariate analysis of variance.Results:Twenty-three women (aged 52.7 ± 12.4 years) were included in the study. Participants reported 2.2 ± 0.8 UTIs (at baseline) in the previous 6 months. After 6 months of cranberry intake, participants reported a significant decrease to 0.5 ± 0.9 UTIs (p < 0.001). Number of antibiotic therapies was also significantly (p < 0.001) reduced by 68% during 6 months of cranberry intake (0.14 ± 0.35) when compared with 6 months retrospectively (1.14 ± 0.71). The SF-36 physical component score increased from 44.9 ± 5.5 at baseline to 45.7 ± 4.6 at 7 months (p = 0.16). The SF-36 mental component score decreased slightly from the baseline value of 46.5 ± 6.5 to 46.2 ± 6.4 at 7 months (p = 0.74). No significant intragroup mean changes at genus, family, or species level for α and β diversity within the intestinal microbiota were found. In the evaluation questions, participants rated the cranberry extract positively and considered it beneficial. The supplement intake was safe.Conclusions:This study shows that women with recurrent uncomplicated UTIs benefit from cranberry intake. Future larger clinical studies with further investigation of the mechanisms of action are required to determine the effects of cranberries on participants with uncomplicated UTIs.

Worse pre-admission quality of life is a strong predictor of mortality in critically ill patients

Objectives In this study, we aimed to investigate whether quality of life (QoL) before intensive care unit (ICU) admission could predict ICU mortality in critically ill patients. Patients and methods Between January 2019 and April 2019, a total of 105 ICU patients (54 males, 51 females; mean age: 58 years; range, 18 to 91 years) from two ICUs of a tertiary care hospital were included in this cross-sectional, prospective study. Pre-admission QoL was measured by the Short Form (SF)-12- Physical Component Scores (PCS) and Mental Component Scores (MCS) and EuroQoL five-dimension, five-level scale (EQ-5D-5L) within 24 h of ICU admission and mortality rates were estimated. Results The overall mortality rate was 28.5%. Pre-admission QoL was worse in the non-survivors independent from age, sex, socioeconomic and education status, and comorbidities. During the hospitalization, the rate of sepsis and ventilator/hospital-acquired pneumonia were similar among the two groups (p>0.05). Logistic regression analysis adjusted for sex, age, education status, and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores showed that pre-admission functional status as assessed by the SF-12 MCS (odds ratio [OR]: 14,2; 95% confidence interval [CI]: 2.5-79.0), SF-12 PCS (OR: 10.6; 95% CI: 1.8-62.7), and EQ-5D-5L (OR: 8.0; 95% CI: 1.5-44.5) were found to be independently associated with mortality. Conclusion Worse pre-admission QoL is a strong predictor of mortality in critically ill patients. The SF-12 and EQ-5D-5L scores are both valuable tools for this assessment. Not only the physical status, but also the mental status before ICU admission should be evaluated in terms of QoL to better utilize ICU resources.

The association of comorbidity indices and minimal clinically important difference in a population undergoing shoulder arthroplasty

BackgroundShoulder arthroplasty (SA) procedures are increasingly common. The Charlson and Elixhauser indices are ICD-10 based measures used in large databases to describe the patient case mix in terms of secondary medical conditions. There is a paucity of data on the relationship between these indices and patient-reported outcome measures (PROMs) after shoulder arthroplasty. MethodsPatients undergoing SA from 2016-2018 were identified in the electronic medical records. Charlson and Elixhauser comorbidities were used to calculate comorbidity scores according to established algorithms (eg Elixhauser-Walraven). Patient shoulder-specific (American Shoulder and Elbow Surgeons (ASES) score and Shoulder Activity Scale (SAS)) and general health scales (SF-12 Mental Component Score (MCS) and Physical Component Score (PCS) and Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI)) PROMs were obtained from our institution’s shoulder registry. Linear regression models adjusting for age and sex evaluated associations between comorbidity scores and PROMs. Receiver operating characteristic (ROC) curves determined optimal cutoffs, maximizing sensitivity and specificity to identify patients likely to fail to meet minimal clinically important difference (MCID) values. ResultsA total of 1817 SA procedures were identified. Higher Charlson and Elixhauser-Walraven scores were significantly associated with lower baseline SAS and SF-12 PCS. Patients with higher Charlson scores had lower baseline ASES (P = .003) and lower baseline (P = .0002) and 2-year (P = .02) SF-12 MCS. No significant associations were found for PROMIS-PI with either index. The Charlson score better predicted the failure to meet MCID for SF-12 PCS with an AUC of 0.64, compared to 0.55 for Elixhauser-Walraven. Conversely, Elixhauser-Walraven better predicted PROMIS-PI with an AUC of 0.66, compared to 0.53 for Charlson. Moderate AUCs were observed for the remaining PROMs, ranging from 0.57-0.64, with little difference between index scores. ConclusionHigher Charlson and Elixhauser-Walraven scores were associated with lower baseline scores on most PROMs. Generally, the Charlson score performed better than the Elixhauser-Walraven score in predicting worse outcomes at 2 years. Comorbidity indices may be useful as a decision aid to provide appropriate expectations of outcomes for patients undergoing SA.

Mental Health as a Predictor of Preoperative Expectations for Pain and Disability Following Lumbar Fusion

To evaluate impact of preoperative mental health on expectations in patients undergoing transforaminal, anterior, or lateral lumbar interbody fusion. Demographics, perioperative characteristics, duration of preoperative symptoms, and preoperative mental health scores were collected. Pain and disability were recorded using preoperative visual analog scale (VAS) for back and leg pain and Oswestry Disability Index scores. Patients' expectations were recorded. Preoperative mental health was recorded using Patient Health Questionnaire-9 (PHQ-9), 12-Item Short Form Health Survey (SF-12) mental component score (MCS), and Veterans RAND 12-Item Health Survey (VR-12) MCS. PHQ-9 scores were categorized by severity of depressive symptoms. Simple linear regression evaluated impact of preoperative mental health on patient expectations for pain and disability; multiple linear regression evaluated the same while accounting for preoperative scores. In 181 patients, PHQ-9 and increasing severity of depressive symptoms significantly predicted VAS back pain expectations (P ≤ 0.006); significance was lost after accounting for preoperative VAS back pain. All mental health outcomes significantly predicted VAS leg pain expectations (P ≤ 0.040); only PHQ-9 retained significance after accounting for preoperative VAS leg pain. All mental health scores significantly predicted ODI expectations (P < 0.001); none retained significance after accounting for preoperative ODI. PHQ-9, SF-12, and VR-12 significantly predicted all ODI domains except personal care and pain intensity (P ≤ 0.045). PHQ-9 significantly predicted patient expectations for lifting, walking, standing, sleeping, sex life, and social life. SF-12 MCS significantly predicted expectations for lifting, walking, standing, sleeping, and social life after accounting for preoperative domain scores. VR-12 MCS significantly predicted expectations for lifting, walking, standing, sleeping, sex life, and social life (P ≤0.050, all), even after accounting for preoperative scores. Mental health scores impact expectations regarding improvement in more active areas of a patient's life. Poor mental health scores may be associated with lower expectations for preoperative symptom improvement.

Coresidence of Older Parents and Adult Children Increases Older Adults' Self-Reported Psychological Well-Being.

A multigenerational household is no longer a rare phenomenon in contemporary society. However, relevant literature has focused on elderly parents receiving support from their adult child, thereby coresiding. This is potentially problematic, as both generations could benefit from living together, and little is known about the benefit of living with adult children from older adults' perspectives compared to the risk of this living situation. Previous research suggests a significant negative effect of living alone, e.g., low psychological well-being, and it becomes more salient among single parents, such as widowed or divorced. The current paper utilizes the National Health Measurement Study with a sample of age 55 and over. Their SF-36 Mental Health and Physical Health Component and self-acceptance scores were measured. Path analysis reveals that both physical and mental health and self-acceptance scores are lower among single older adults at the time of the survey (e.g., divorced and widowed) than among those who are nonsingle and living with their adult child. A complete mediation effect of living with an adult child on older adults' mental health and self-acceptance was observed in both White and non-White minority older adults. This suggests that living with an adult child possibly serves as a protective factor for the negative relationship between living alone and their well-being. The current study seeks to stimulate ideas that might generate the following answer to community-based care in our contemporary aging society.

Impact on Quality of Life of Seton Placing in Perianal Crohn's Disease

IntroductionOften, in perineal Crohn's disease (CD), a seton is placed to guarantee a constant drainage and prevent septic complication while biologic therapy is ongoing. This study aimed to assess the long-term quality of life after surgery for perineal CD in relation to seton placing.Patients and MethodsData of 65 consecutive patients with CD and non-CD operated on from 2014 to 2019 for perianal fistula or abscess were retrieved. Forty-three had CD and 14 of them had a seton placed during surgery and they kept it on while they had anti-TNF-alpha therapy. Patients were interviewed with the Cleveland Global Quality of Life (CGQL) and SF-12 quality of life questionnaires. Disease activity was defined as Harvey-Bradshaw Index (HBI) and Perianal Disease Activity Index (PDAI). Comparisons between groups were carried out with the nonparametric tests, and multiple regression models were used to assess predictors of quality of life.ResultsThe total CGQL score and SF-12 mental component score (MCS) were significantly higher (and thus better) in the seton group than in patients treated without seton. On the contrary, SF-12 physical component score (PCS) was not different between the two groups. HBI was significantly better in patients in the seton group. At multivariate analysis, seton placement and HBI were confirmed to be independent predictors of long-term SF-12 MCS whereas only HBI confirmed to be a predictor of total CGQL score.ConclusionsSeton placing during anti-TNF-alpha therapy is independently associated with a better MCS. Unexpectedly, this device, instead of to cause psychological distress, seems to assure patients during their biologic therapy providing psychological benefit beyond the mere medical effect.