SF-36 Mental Scores Research Articles

Economic hardship resulting from the late 2000s Great Recession and long-term changes in mental health: a prospective analysis from the Moli-sani study.

Economic downturns may have detrimental effects on mental health. We investigated the association of economic hardship resulting from the late 2000s Great Recession with long-term changes in mental health. We analysed data from 1,647 participants to the larger Moli-sani cohort (2005-2010, Italy), who were re-examined between 2017 and 2020. To evaluate economic hardship, we performed a Latent Class Analysis on nine items linked to change in employment status and financial hardship. Depression symptoms were measured by the Patients' Health Questionnaire (PHQ-2; higher values indicate more depressive symptoms; data available in N = 941 individuals) and health perception as assessed by the 36-Item Short Form Health Survey (decreased values indicate worsening of health perception). Economic hardship was categorized into three classes: "None", "Average" and "High", the latter reflecting increasing economic hardship. Mean (standard deviation) changes in PHQ-2, SF-36 mental and physical after 12.8 years (median) were - 0.1 (1.3), 0.5 (9.9) and - 2.2 (6.2) units, respectively. Changes in SF-36 mental score decreased by 1.0 unit (0.3) monotonically across "none" to "average" to "high" category in a multivariable-adjusted model analysis; the SF-36 physical score decreased by 0.4 (0.2) unit and PHQ-2 increased by 0.1 (0.1). In comparison with participants in the "none", those in the "high" class had 84% (95%CI: 26%-170%) higher odds to report an increment in PHQ-2 values from baseline to re-examination. Economic hardship resulting from the Great Recession in late 2000s was associated with deterioration of mental health, as reflected by increased depression symptoms and reduced perceived mental health.

Analysis of disease burden in patients with hereditary angioedema from Japan by patient-reported outcomes.

Hereditary angioedema (HAE) symptoms can vary greatly. Disease burden evaluation is essential for providing adequate treatments for patients. Patient-reported outcome measures (PROMs), including the 12-Item Short Form Health Survey (SF-12), the Angioedema Quality of Life (AE-QoL), the Hospital Anxiety and Depression Scale (HADS), and the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaires, were collected in 2021, before modern medications for long-term prophylaxis (LTP) of HAE were licensed in Japan. Patients also reported their HAE attack frequency as "annual" (several attacks annually), "monthly" (several attacks monthly) or "weekly" (several attacks weekly). Multiple linear regression analyses were conducted on the relationship between independent parameters (sex, age, attack frequency, HAE type, and HADS scores) and dependent parameters (AE-QoL and SF-12 scores). Fifty-four patients reported PROMs. All PROMs showed substantial health-related quality of life (HRQoL) impairment. Overall, the higher the attack frequencies, the greater the reported impairment in the PROMs tended to be. In multiple linear regression analyses, higher AE-QoL Fatigue/Mood and Fears/Shame domain scores (greater impairment) were associated with higher HADS anxiety subscale scores; higher AE-QoL total scores (greater HRQoL impairment) and lower SF-12 Physical and Mental Health Composite scores (greater general health impairment) were associated with higher HADS depression subscale scores. Patients with monthly or weekly HAE attacks reported numerically low absenteeism and numerically high presenteeism and work productivity loss as measured by the WPAI:SHP questionnaire. In this study, conducted before modern LTP options were available in Japan, patients with HAE reported notable impairment in HRQoL and work productivity. Weekly or monthly HAE attack frequencies were associated with a high disease burden. Furthermore, a substantial number of patients reported notable fatigue/mood impairment as measured by the AE-QoL and depression as measured by the HADS regardless of attack frequency. These results provide a basis for future studies evaluating the effect of LTP on the clinical manifestations and HRQoL in patients with HAE.

Total hip arthroplasty with porous tantalum trabecular metal pads in patients with Crowe IV developmental dysplasia of the hip: a midterm followup study

PurposeCrowe IV developmental dysplasia of the hip (DDH) is a catastrophic hip disease. Moreover, obtaining ideal clinical efficacy in conventional total hip arthroplasty (THA) is often difficult. In this study, we aimed to assess the mid-term clinical results of THA with porous tantalum trabecular metal (TM) pads for acetabular reconstruction in the treatment of Crowe IV DDH.MethodsA cohort of 28 patients (32 hips) diagnosed with Crowe type IV DDH who underwent acetabular reconstruction during THA using TM pads with scheduled follow-up between 2011 and 2018, were included in this study. Eight cases were men and 24 were women, with a mean age of 48.4 years (range, 36–72 years) and a mean follow-up was 74.3 months (range, 42–132 months). All patients underwent acetabular reconstruction using TM pads and total hip replacement with subtrochanteric osteotomy.ResultsAt the final follow-up, 28 hips (87.5%) demonstrated mild or no postoperative limping. The Harris Hip Score improved from 58.4 ± 10.6 preoperatively to 85.6 ± 8.9. The mean pain, stiffness, and function scores on the Western Ontario and McMaster University Osteoarthritis index were 86.5 ± 10.2, 87.3 ± 12.4 and 85.4 ± 11.6 respectively. The mean score of patient satisfaction was 90.4 ± 7.6. Additionally, the SF-12 physical summary score was 41.8 ± 5.6 and the SF-12 mental summary score was 51.6 ± 5.4. TM construct survivorship due to all-cause failure was 90.6% at 5 years with 3 hips at risk, 87.5% at 10 years with 4 hips at risk. The survivorship due to failure from aseptic loosening was 96.9% at 5 years with 1hips at risk and 93.75% at 10 years with 2 hips at risk.ConclusionThis study demonstrated satisfactory mid-term clinical and radiological results with the application of TM pads for acetabular reconstruction combined with THA in patients with Crowe IV DDH.Trial registration numberChiCTR1800014526, Date: 18/01/2018.

Patient outcomes of conventional versus robot assisted total hip arthroplasty

Background: Robotic assisted (RA) total hip arthroplasty (THA) may provide improved precision and accuracy; however, contention remains on whether RA THA provides better patient outcomes than conventional THA. This study compares short-term clinical outcomes, complication rates, and operative times between these two groups. Methods: We retrospectively reviewed charts for demographic data, comorbidities, operating time, revisions, and complications of patients who underwent RA and conventional THA. Patient-reported outcomes were collected via OBERD database at the following timepoints: preoperatively, 6-month, 1-year, and 2-year postoperatively. Descriptive statistics and mixed multivariate regression analyses were used to analyze data. Results: Two hundred ten patients were included (n=149 conventional, n=61 RA). Patients with RA THAs were younger than those with conventional THAs (59 years, IQR: 53-66 and 64 years, IQR: 58-71; P=.002). The operative time was longer for the RA compared to the conventional group (106 minutes, IQR: 92-120 and 92 minutes, IQR: 82-109, respectively, P=< .001). There was no statistically significant difference in SF-12 mental scores, SF-12 physical scores, or OHS between RA and conventional THA at different timepoints. Additionally, there was no statistically significant difference in complication and revision rates between the two groups. Conclusion: Our findings demonstrated that there were no statistically significant differences in patient-reported outcomes between the RA versus conventional THA groups. Furthermore, our findings suggest a lack of significant differences in complication or revision rates. Surgeons performing robot-assisted surgeries for hip replacements can reasonably expect patient outcomes that are, at a minimum, as successful as the conventional counterparts.

The Clinical Impact of the Extension of Acute Type A Aortic Surgery on Long-Term Outcomes: Should We Tend to Be Conservative?

Background and Objectives: Despite advances in surgical techniques, industry adjuncts, and cerebral perfusion techniques, the in-hospital mortality rate of type A acute dissection (TAAD) remains at 15-30%. This study aimed to investigate the influence of different extents of aortic resection on survival and quality of life (QoL) after long-term follow-up. Materials and Methods: A retrospective observational trial was performed, including 165 patients operated upon for TAAD. Patients were divided into two groups according to the extent of their aortic repair: the first group comprised patients who had ascending aorta replacement and the second included patients who had hemiarch or total arch replacement. The groups were compared with regard to their baseline characteristics, operative characteristics, survival, complications, and QoL during nine years of follow-up. Results: The mean follow-up time was 75.6 months (1-108 months). The mean survival in the ascending aorta repair group was 89.651 (81.242-98.061) months and was 54.801 (40.053-69.548) months in the hemiarch and arch group; the difference between the groups was significant (log-rank p < 0.001). The rate of new postoperative neurological deficits was statistically higher in the hemiarch and arch group (17.5% vs. 8.4%, p = 0.045), the most common being stroke, and was also more frequent in the hemiarch and arch group than in the ascending aorta group (with statistical significance (15.7% vs. 6.5%)). The mean SF-12 physical score from the QoL questionnaire was higher in the ascending aorta replacement group than in the hemiarch and arch group (50.1 ± 7.3 vs. 44.0 ± 11.9, p = 0.017). Additionally, the mean SF-12 mental score was higher in the ascending aorta replacement group (52.3 ± 7.3 vs. 47.1 ± 12.8, p = 0.032). Conclusions: A more aggressive approach involving aortic arch repair means a lower survival rate and lesser quality of life after long-term follow-up in comparison with the replacement of the ascending aorta. If clinically applicable, a more defensive strategy may be considered.

Adherence to Clotting Factor Treatment and Association with Bleeding and Health-Related Quality of Life in Persons with Hemophilia

Introduction: Measuring patient adherence to prophylactic treatment with clotting factor in persons with hemophilia includes both subjective and objective measurements. There are limited studies conducted in adherence research using objective measures and a few studies revealed lack of correlation between subjective and objective adherence measurement. The study objectives are 1) to develop an objective adherent measurement; and 2) to assess it's association with bleeding and health-related quality of life (HRQoL) using the data collected from the Hemophilia Utilization Group Study Part VI (HUGS VI), which was an observational, non-interventional study investigating adherence to factor replacement therapy among persons with hemophilia A or B. Methods: HUGS VI enrolled participants from eight U.S. federally-supported hemophilia treatment centers in seven states (California, Colorado, Georgia, Indiana, Pennsylvania, Texas, and Washington) from 2015 to 2017. We enrolled eligible participants who either used standard half-life (SHL) products or used extended half-life (EHL) products for less than six weeks. We collected data on socio-demographics, bleeds, joint problems, and pain via surveys, as well as HRQoL, as measured by SF-12 at enrollment and at each three-month follow-up. We collected monthly factor prescription data from the clinical chart, and monthly factor dispensing records from the participants' pharmacy. We calculated factor treatment for the proportion of days covered (PDC) as the sum of the days of treatment available based on dispensing records, divided by the sum of the days of treatment prescribed based on prescription records for nine months post-enrollment. PDC ≥0.8 was considered an objective measure of adherence to factor treatment. The number of bleeds was summed from each of three quarterly follow-up surveys. We defined EHL users as participants who started an EHL product during the study period, either six weeks prior to enrollment or anytime during the nine months follow up. Association of PDC with nine months bleeds, ratings of chronic pain, and SF-12 scores in the nine-month follow-up were analyzed using Pearson correlation and Student T-Tests. Results: We analyzed a sample of 69 adults (age ≥18 years) with moderate or severe hemophilia using prophylactic treatment who completed at least baseline and nine-month follow-up surveys and had both prescription and dispensing records. Mean age was 28.9±10.3 (standard deviation) years, 91.3% were hemophilia A, and 65.2% were adherent to clotting factor treatment with PDC ≥0.8. EHL users were less likely to be adherent to the treatment than non-EHL users (adherence rate was 47.4% vs. 72.0%, p=0.06). PDC was significantly and negatively correlated with nine months of joint bleeds (correlation coefficient r=-0.30, p=0.01), and total bleeds (r=-0.33, p=0.026), but positively correlated with SF-12 physical composite score (r=0.32, p=0.009). PDC was not correlated with chronic pain (r=0.08, p=0.51) or SF-12 mental composite score (r=0.03, p=0.79). The participants who were adherent to factor treatment had fewer mean joint and total bleeds (2.6±4.1 vs. 1.3±2.1, p=0.08, and 4.9±5.6 vs. 2.9±3.8, p=0.07, respectively) than those non-adherent to treatment, although the differences did not reach statistical significance. Compared to participants who were adherent to treatment, non-adherent participants had a lower SF-12 physical composite score, with an approximately 5-point difference (43.4±10.6 vs. 48.0±9.1, p=0.07). Conclusions: As the data collection period occurred when EHL products became commercially available, treatment adherence may have led to treatment selection as participants switched from SHL to EHL products. Our data showed that participants who were non-adherent to treatment were more likely to be EHL users. Better adherence with higher PDC was moderately correlated with fewer bleeds, but higher HRQoL physical health composite score. The objective adherence measurement developed in this study should be further studied to investigate whether switching from SHL to EHL improves treatment adherence and its association with clinical outcomes.

Social gradient in quality of life according to microscale neighbourhood features, Limassol, Cyprus

Abstract Background Beyond indices of socio-economic disadvantage (SED), not standard practice in Cyprus, neighbourhood audits provide information about environmental inequity not captured by other methods. Lack of spatial thinking often leads to attributing geographical differences to socio-demographic composition. Methods A random sample of 45 neighbourhoods along the SED continuum were audited using the Cyprus Neighborhood Observational Tool (CyNOTes). SED was defined according to a purposefully developed postcode level index (N = 124), by factor analyzing a set of census indicators. A sample of 10 residents aged 45-64 per neighborhood responded to a door-to-door SF-36 quality of life (QoL) survey (N = 450). Associations of QoL with SED and audit scores, organized in 9 domains, were explored in random-effect regression models adjusting for gender, age, education and income. Results The SED index captured a stepwise decrease across tertiles with increasing disadvantage in both Physical (-1.79 95% CI -2.84, -0.73; p &amp;lt; 0.001) and Mental (-1.42 95%CI -2.46, -0.59; p = 0.008) SF-36 Component Scores. Associations attenuated but remained statistically significant after adjusting for person-based social position. Re-classifying neighbourhoods according to audit ratings also revealed a social gradient for most CyNOTes domains. The domain with the strongest association with both Physical (-1.84 95%CI -2.88, -0.80; p &amp;lt; 0.001) and Mental SF-36 Scores (-1.88 95%CI -2.83, -0.93; p &amp;lt; 0.001) was “Pedestrian and Cycling Environment”. Associations persisted in adjusted models and appeared similar, if not stronger, to associations with the SED index. Conclusions The study depicted the social gradient in quality of life among late working-life residents across Limassol neighbourhoods. Other than the expected patterning according to SED, audit indicators of environmental inequity also captured a social gradient, linking micro-scale neighborhood features to the residents’ quality of life. Key messages • A social gradient in quality of life was demonstrated along the socio-economic and environmental disadvantage in Limassol. • Depicting neighborhood microenvironment inequity can trigger and contextualize conversations about health and place among the local Public Health research and policy community.

Diz Osteoartritli Bireylerde Osteoartrit Şiddeti, Ağrı, Alt Ekstremite Kas Kuvveti, Kinezyofobi ve Yaşam Kalitesi Arasındaki İlişkinin İncelenmesi

Objective: Osteoarthritis (OA) is among the primary causes of chronic disability. Pain and other symptoms of OA may have an effect on function and quality of life. The study aims to investigate the relationship between osteoarthritis severity, pain, muscle strength, kinesiophobia, and quality of life in individuals with knee OA. &#x0D; Material and Method: 100 patients with knee OA were enrolled in this study. The mean age of the patients was 65.50±2.74 years and the mean body mass index was 27.89±1.21 kg/m2. The severity of OA was evaluated with the Lequesne Algofunctional Index (LAI). Pain levels and their effect on function were evaluated with the Visual Analog Scale (VAS) and WOMAC Osteoarthritis Index; functional muscle strength with the Sit-to- Stand Test (5-STS) and Stair Test (ST); kinesiophobia with the Tampa Kinesiophobia Scale; quality of life with the SF-12 Scale. &#x0D; Results: There was a weak correlation between LAI and VAS rest (r=0.34), VAS night (r=0.30), and SF-12 mental score (r=-0.20) (p

Surgical treatment of specific Unified Classification System B fractures: potentially destabilising lesser trochanter periprosthetic fractures

To investigate the clinical effects of specific Unified Classification System B (UCS B)-lesser trochanter periprosthetic fractures and determine whether they occur only with non-cemented stems. A retrospective analysis of 28 patients with specific UCS B2 fractures who underwent two surgical treatments, longer stem revision and internal fixation (LSRIF) and open reduction and internal fixation (ORIF), was performed. The patients were assessed at 1, 3, 6, 12, and 24 months and annually thereafter. Fracture healing, complications, Harris Hip Score (HHS), and the Short Form Health Survey questionnaire (SF-36) quality of life score were assessed at each follow-up. At the time of the last follow-up, seven patients had been lost: three were lost to contact, two died, and two were hospitalised elsewhere and unavailable for follow-up. The remaining 21 patients were followed for an average of 49.3 ± 15.4 (range: 24–74.4) months. Their average fracture healing time was 13.5 ± 1.1 (12–15.4) weeks. Complications included three cases (10.71%) of thrombus, one (3.57%) of heart failure, and one (3.57%) of pulmonary infection. There were no revisions due to prosthesis loosening, subsidence, or infection. At the last follow-up, the HHS, SF-36 mental score, and SF-36 physical score were recorded, LSRIF vs. ORIF (82.9 ± 6.6 vs. 74.7 ± 3.9, p = 0.059; 50.9 ± 7.6 vs. 38 ± 1.4, p = 0.012, and 51.7 ± 8.4 vs. 39.7 ± 3.4, p = 0.032, respectively). Specific UCS B2 fractures mostly occur with non-cemented stems. LSRIF with cables is the main treatment, while ORIF is an option for those elderly in poor condition.

Evaluation of Outcomes of Percutaneous Endoscopic Discectomy in the Treatment of Patients with Lumbar Degenerative Disc Herniation

Background Lumbar discectomy is one of the most common operations performed worldwide for lumbarrelated symptoms. During the latter half of the 19th century, more techniques were developed to remove the herniated disc with minimal invasiveness. Aim and objectives The aim of this study was to analyze the safety and efficacy of percutaneous endoscopic discectomy in the treatment of lumbar degenerative disc herniation for adult patients. Subjects and methods A systematic review was conducted, including adult patients (&amp;gt; 18 years and less than 80 years old) with surgical treatment of lumbar radiculopathy secondary to degenerative herniated discs. Results results revealed that mean preoperative VAS was 6.05 which improved post operation to 1.35. Mean preoperative ODI score was 56.5 which decreased to 14.2 post operation, and SF-36 physical was used by four studies and mean preoperative score was 42.07 which increased to 76.2 post operation. SF-36 mental score used by three studies with mean preoperative score was 41.08 which increased post operation to 65.5. Conclusion PELD appears to be an effective intervention for LDH, as it has a small amount of intraoperative blood loss, short postoperative hospital stay, and good clinical and functional outcomes. It needs more training, as it has a long learning curve.

Duplex ultrasound for surveillance of lower limb revascularisation.

Duplex ultrasound for surveillance of lower limb revascularisation.

Sexual function in Chinese women with different clinical phenotypes of polycystic ovary syndrome

Objective: To investigate sexual function stratified according to four clinical phenotypes of polycystic ovary syndrome (PCOS) and its association with clinical and quality of life parameters, and to compare these with healthy controls in Chinese women with PCOS. Methods: A cross-sectional study was designed in 1000 PCOS women and 500 control women aged 18–45 years. PCOS women were grouped into four clinical phenotypes according to the Rotterdam Criteria. FSFI (Female Sexual Function Index), SF-12 (the 12-item short form health survey) and clinical and hormonal characteristics likely to affect sexual function were determined. Results: 809 PCOS women and 385 control women with complete parameters were evaluated after screening. Phenotype A had a lower total FSFI mean score (23.14 ± 3.22) compared with phenotype D and control group (p < 0.05). The control group had the highest total FSFI mean score (24.98 ± 3.78). For the percentage at risk of sexual dysfunction, phenotype A (87.5%) and phenotype B (82.46%) had a higher risk of female sexual dysfunction (FSD) than that in phenotype C (75.34%), phenotype D (70.56%) and control group (61.30%) (p < 0.05). SF-12 mental domain scores were significantly lower in phenotypes A and B compared with phenotypes C and control group (p < 0.05). Infertility treatment, bioavailable testosterone, psychological factors, age and waist circumference presented negative correlation with female sexual function. Conclusions: The risk of FSD in PCOS women seemed to be associated with PCOS clinical phenotypes. The classical PCOS phenotype with oligo-ovulation and hyperandrogenism had a higher risk of sexual dysfunction.

The outcome of a multicomponent lifestyle intervention in patients with obesity: A cohort study

Persons with obesity are at risk of developing diseases. Furthermore, people with obesity are often stigmatized and struggle with how to improve their lifestyle despite perhaps already knowing what healthy habits consist of. Hence, there is a need for lifestyle interventions aimed at improving mental well-being in patients with obesity in order to induce lifestyle change. The aim of the study was to investigate the outcome of a multicomponent lifestyle intervention in a group of Danish patients with obesity (Body Mass Index (BMI) ≥30). The study was a cohort study for patients referred for a multicomponent lifestyle intervention (3 times/6 months) at a lifestyle rehabilitation center from 2016 to 2019 with a BMI ≥30. Patients completed questionnaires at baseline, 6 and 18 months regarding diet, physical activity, body weight, the Short-Form 12-Item Health Survey (SF-12) (minimal important change ≥5 points) and a question regarding satisfaction with treatment. A total of 1336 patients (mean age (standard deviation) 51(14) years, 25% men) were included. Median weight change (25th;75th quartile) was -5% (-2;-8%), p<0.001 from baseline to 6 months and -4% (0;-9%), p<0.001 at 18 months. After the intervention, only 8% patients had an unhealthy diet and patients reported increased participation in physical activities (+1 day/week) (p<0.001). Patients changed their mean [95%confidence interval] SF-12 physical score 4.0 [3.4;4.5] points (p<0.001) at 6 months follow up and 3.2 [2.4;3.8] points (p<0.001) at 18 months. Their SF-12 mental scores were changed 2.8 [2.2;3.4] points (p<0.001) at 6 months and 2.3 [1.5;3.1] points (p<0.001) at 18 months. 40–45% patients had a minimal important change in their SF-12 scores. 91% of the patients were highly satisfied with the treatment. Patients participating in a multicomponent lifestyle intervention focusing on improving mental factors had improved outcomes at 6 and 18 months follow up.

Injury-related emergency department visits and unplanned readmissions are associated with worse long-term mental and physical health

BackgroundThe risk factors for unplanned emergency department (ED) visits and readmission after injury and the impact of these unplanned visits on long-term outcomes are not well understood. We aim to: 1) describe the incidence of and risk factors for injury-related ED visits and unplanned readmissions following injury and, 2) explore the relationship between these unplanned visits and mental and physical health outcomes 6–12 months post-injury. MethodsTrauma patients with moderate-to-severe injury admitted to one of three Level-I trauma centers were asked to complete a phone survey to assess mental and physical health outcomes at 6–12 months. Patient reported data on injury-related ED visits and readmissions was collected. Multivariable regression analyses were performed controlling for sociodemographic and clinical variables to compare subgroups. ResultsOf 7,781 eligible patients, 4675 were contacted and 3,147 completed the survey and were included in the analysis. 194 (6.2%) reported an unplanned injury-related ED visit and 239 (7.6%) reported an injury-related readmission. Risk factors for injury-related ED visits included: younger age, Black race, a lower level of education, Medicaid insurance, baseline psychiatric or substance abuse disorder and penetrating mechanism. Risk factors for unplanned injury-related readmission included younger age, male sex, Medicaid insurance, substance abuse disorder, greater injury severity and penetrating mechanism of injury. Injury-related ED visits and readmissions were associated with significantly higher rates of PTSD, chronic pain and new injury-related functional limitations in addition to lower SF-12 mental and physical composite scores. ConclusionsInjury-related ED visits and unplanned readmissions are common after hospital discharge following treatment of moderate-severe injury and are associated with worse mental and physical health outcomes.

Does Baseline Severity of Arm Pain Influence Outcomes Following Single-Level Anterior Cervical Discectomy and Fusion?

Retrospective cohort. To assess preoperative arm pain severity influence on postoperative patient-reported outcomes measures (PROMs) and minimal clinically important difference (MCID) achievement following single-level anterior cervical discectomy and fusion (ACDF). There is evidence that preoperative symptom severity can affect postoperative outcomes. Few have evaluated this association between preoperative arm pain severity and postoperative PROMs and MCID achievement following ACDF. Individuals undergoing single-level ACDF were identified. Patients were grouped by preoperative Visual Analog Scale (VAS) arm ≤8 vs. >8. PROMs collected preoperatively and postoperatively included VAS-arm/VAS-neck/Neck Disability Index (NDI)/12-item Short Form (SF-12) Physical Composite Score (PCS)/SF-12 mental composite score (MCS)/Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF). Demographics, PROMs, and MCID rates were compared between cohorts. A total of 128 patients were included. The VAS arm ≤8 cohort significantly improved for all PROMs excepting VAS arm at 1-year/2-years, SF-12 MCS at 12-weeks/1-year/2-years, and SF-12 PCS/PROMIS-PF at 6-weeks, only (p ≤0.021, all). The VAS arm >8 cohort significantly improved for VAS neck at all timepoints, VAS arm from 6-weeks to 1-year, NDI from 6-weeks to 6-months, and SF-12 MCS/PROMIS-PF at 6-months (p ≤0.038, all). Postoperatively, the VAS arm >8 cohort had higher VAS-neck (6 weeks/6 months), VAS-arm (12 weeks/6 months), NDI (6 weeks/6 months), lower SF-12 MCS (6 weeks/6 months), SF-12 PCS (6 months), and PROMISPF (12 weeks/6 months) (p ≤0.038, all). MCID achievement rates were higher among the VAS arm >8 cohort for the VAS-arm at 6-weeks/12-weeks/1-year/overall and NDI at 2 years (p ≤0.038, all). Significance in PROM score differences between VAS arm ≤8 vs. >8 generally dissipated at the 1-year and 2-year timepoint, although higher preoperative arm pain patients suffered from worse pain, disability, and mental/physical function scores. Furthermore, clinically meaningful rates of improvement were similar throughout the vast majority of timepoints for all PROMs studied.

The Spanish Version of the International Index of Erectile Function: Adaptation and Validation.

The International Index of Erectile Function (IIEF) is a widely employed questionnaire in urology to assess erectile dysfunction (ED) in both clinical research and practice. To translate and culturally adapt the Spanish version of the International Index of Erectile Function (IIEF) and to analyze its psychometric properties in Spanish men with erectile dysfunction (ED). Firstly, direct and reverse translations were performed. Secondly, a pilot study was carried out on 23 patients with the lowest possible education level without being illiterate. Finally, 170 participants completed the IIEF. Test-retest reliability, internal consistency and construct validity (exploratory factor analysis) were assessed. Concurrent and divergent validity were evaluated with the Hospital Anxiety and Depression Scale (HADS) and the 12-item Short-Form Health Survey (SF-12), respectively. Discriminant validity (with and without anxiety or depression) was calculated using a receiver-operating characteristic curve analysis. High internal consistency (Cronbach's alpha = 0.968, total score) and moderate-to-excellent test-retest reliability were found. The factor analysis showed a two-factor structure (explained variance of 77.34%). Significant correlations of the IIEF total score (p < 0.01) and domains (p < 0.05) with HADS anxiety and depression scores were observed (concurrent validity), while non-significant correlations with SF-12 physical and mental summary scores were found (divergent validity). The IIEF total score could discriminate between participants with and without anxiety (p < 0.05) and depression (p < 0.01), with an optimal cut-off point of <39.50 for both anxiety (48.30% sensitivity and 78.75% specificity) and depression (50.00% sensitivity and 81.01% specificity). The psychometric properties of the IIEF have not been analyzed in Spanish people to date. Strengths and Limitations: The Spanish version of the IIEF was shown to be capable of discriminating between men with erectile dysfunction with and without depression or anxiety. There are some limitations to this study that should be noted. It was conducted on Spanish participants, and, thus, it should be employed with caution in other Spanish-speaking countries. This study was carried out on a selected population, and, therefore, the generalizability of its results to other populations might be limited. Moreover, a large majority of the participants (89.41%) had secondary or higher education. Future studies should be performed on a more general population with a varied geographical and educational background. The Spanish IIEF is a valid and reliable instrument for assessing erectile function among Spanish men with ED.

Outcome Analysis of En-bloc Excision and Endoprosthetic Replacement among the Cases Operated for Distal Femoral and Proximal Tibial Giant Cell Tumour around the Knee: A Retrospective Study

Introduction: Giant Cell Tumour (GCT) around the knee joint is the most common site for this locally malignant bone tumour and, in advanced stages, requires excision of the tumour mass. Current recommendations promote joint salvage procedures in allograft or mega prosthetic replacement. Patients undergoing this surgery need massive changes in their lifestyle to cope with their activities of daily living. The psychological and social impact following these procedures has not been extensively studied. Aim: To observe the long term functional results as well as the impact on quality of life in patients undergoing endoprosthetic replacements in GCT around the knee with emphasis on any difference in results among the cases operated for distal femoral and proximal tibial GCT. Materials and Methods: This retrospective study was conducted at Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow from June 2015 to June 2019 with a total sample size of 21 cases. The two groups formed were; one having GCT of distal end femur and the other group with GCT of proximal end tibia. The evaluation was done for outcome measures by Oxford Knee Score (OKS) and Musculo Skeletal Tumour Society score (MSTS) for their functional outcome and Short Form Health Survey (SF12) for their quality of life effect at two years postoperatively. Students unpaired t-test was performed for intergroup analysis and Analysis of Variance (ANOVA) was done for within the group analysis for subsequent follow-up visits. Data was analysed using Statistical Package for Social Sciences (SPSS) version 21. Results: The mean age of study population was 33.67±8.674 years. The male-female distribution was insignificant (p=0.673), providing us with a homogenous study group. Recurrent GCT was found significantly more commonly in the proximal tibia group than in the distal femur group (p=0.031). Comparison of OKS and MSTS preoperatively, at six months, at one year, and two years showed statistically significant improvement in successive follow-ups in both the distal femur and proximal tibia groups (p&lt;0.001 in both groups). Intergroup analysis also showed significantly better scores in the distal femur group compared to the proximal tibia group in the preoperative period and all successive follow-ups. On intergroup analysis at 2 years, both the OKS (p=0.020*) and MSTS score (p&lt;0.0001) were found to be statistically significant. SF-12 mental and physical scores preoperatively also showed statistically significant improvement in all cases (p&lt;0.001 for mental and physical components. Conclusion: Early functional outcomes of en-bloc excision and reconstruction with modular endoprosthesis are good in terms of joint function and the patient’s overall mental and physical well-being.

Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial

ObjectiveThe WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. MethodsThe dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. ResultsA total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, −2.43; 95% confidence interval, −3.73 to −1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, −0.02; 95% confidence interval, −0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. ConclusionsWIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.

S1093 Assessment of Physical and Mental Health Before and After Protocolized Endoscopic Necrosectomy for Walled-Off Pancreatic Necrosis in a Prospective Multi-Center Trial

Introduction: A regulatory FDA IDE prospective multi-center clinical trial (G170261-NCT03525808) was performed to evaluate rigorous protocolized management of walled off necrosis (WON) ≥ 6 cm in size with > 30% necrotic material using endoscopic ultrasound (EUS) guided lumen apposing metal stent (LAMS) placement with/without endoscopic necrosectomy. Few studies have examined changes in health related quality of life (HRQOL) before and after endoscopic management for WON. The SF-12 is a validated measure of HRQOL containing 12 items which yield a Mental Components Score (MCS) and a Physical Components Score (PCS). Higher scores correspond to a greater perceived quality of life. Methods: The pre-specified target sample of 40 consecutive eligible patients was enrolled by multiple centers from September 2018 to March 2020. Patients with radiographic WON resolution (as demonstrated by size ≤ 3 cm on CT or MRI) and/or 60 days LAMS indwell time had stent removal followed by an end of study visit 6 months later. SF-12 quality of life questionnaires were completed by patients at baseline, stent removal and at the end of study visit. Results: Mean SF-12 Physical Components Score (PCS) was 27.5±21.1 at baseline, 54.4±19.5 at the time of LAMS removal, and 77.9±22.3 at end of study. Mean SF-12 Mental Components Score (MCS) was 44.9±20.1 at baseline, 64.7±16.5 at the time of LAMS removal, and 79.0±17.2 at end of study. The mean improvement in PCS score from baseline to LAMS removal was 26.0±24.8 (p< 0.0001), with the mean improvement in score from baseline to end of the study being 49.1±29.6 (p< 0.0001). The mean improvement in MCS was 19.6±20.1 from baseline to LAMS removal (p< 0.0001) and 32.0±22.3 from baseline to the end of study (p< 0.0001). The mean improvement from the time of stent removal to the end of study was 25.2±18.0 (PCS, p< 0.0001) and 15.5±18.5 (MCS, p=0.0002) (Figure). Conclusion: These data suggest that patients undergoing protocolized endoscopic necrosectomy for walled-off pancreatic necrosis experience significant improvement in both physical and mental HRQOL. Improvement in the physical score domain appeared to be greater than for the mental score domain. HRQOL indicators continued to improve over a mean follow-up of 180 days.Figure 1.: SF-12 Physical and Mental Components Score.

Cryoneurolysis Is a Safe, Effective Modality to Improve Rehabilitation after Total Knee Arthroplasty.

Although long term pain and mobility outcomes in total knee arthroplasties (TKA) are successful, many patients experience significant amount of debilitating pain during the immediate post-operative period that necessitates narcotic use. Percutaneous cryoneurolysis to the infrapatellar saphenous and anterior femoral cutaneous nerves may help to better restore function and rehabilitation after surgery while limiting narcotic consumption. A retrospective chart review of primary TKA patients receiving pre-operative cryoneurolysis from 2019 to 2020 was performed to assess total opioid morphine milligram equivalents (MME) consumed inpatient and at interval follow-up. Demographics and medical comorbidities were compared between cryoneurolysis and age-matched control patients to assess baseline characteristics. Functional rehabilitation outcomes, including knee range of motion (ROM), ambulation distance, and Boston AM-PAC scores, as well as patient reported outcomes using the KOOS JR and SF-12 scores were analyzed using STATA 17 Software. The analysis included 29 cryoneurolysis and 28 age-matched control TKA patients. Baseline demographics and operative technique were not significant between groups. Although not statistically significant, cryoneurolysis patients had a shorter length of stay (2.5 vs. 3.5 days) and overall less inpatient and outpatient MME requirements. Cryoneurolysis patients had statistically significant improved 6-week ROM and 1-year follow-up KOOS JR and SF-12 mental scores compared to the control. There were no differences in complication rates. Cryoneurolysis is a safe, effective treatment modality to improve active functional recovery and patient satisfaction after TKA by reducing MME requirements. Patients who underwent cryoneurolysis had on average fewer MME prescribed during the perioperative period, improved active ROM, and improved patient-reported outcomes with no associated increased risk of infections, deep vein thrombosis, or neurologic complications.