SF-36 Mental Component Score Research Articles

Calculation of Minimally Clinically Important Difference in VAS, SF-36, and LSA Scores for Hallux Rigidus Correction Via MTP Fusion

Category:Bunion; Midfoot/Forefoot; OtherIntroduction/Purpose:Hallux rigidus is a mobility limiting disease commonly seen in elderly patient populations. Correction via metatarsophalangeal (MTP) fusion has been shown to be a safe and effective means of treatment in these populations relative to younger cohorts. An increasingly important measure of surgical efficacy is the establishment of patient-reported outcomes for achieving meaningful change through a procedure. Calculation of a minimally clinically important difference (MCID) has been established to illuminate these thresholds. The objective of this study was to calculate MCID thresholds for visual analogue pain (VAS), Short Form 26 Health survey (SF-36), and LifeSpace Mobility Assessment (LSA) following first MTP fusion.Methods:A prospective study of all patients undergoing MTP fusion between August 1, 2015 and July 1, 2018 by a single surgeon was conducted following IRB approval. A total of 143 patients were included in the study. Demographics and surgical data were collected from review of the electronic medical record. Patient reported VAS, SF-36, and LSA scores were collected at routine 6- month and 12-month follow-up clinic appointments, as well as preoperatively. This study utilized a distribution-based approach for calculation of MCID for each of the patient reported outcomes. The MCID was defined as 0.5 times the standard deviation of the pre-operative score, 95% bootstrap confidence intervals were creating using the bias corrected and accelerated method.Results:The average age of patients undergoing first MTP fusion was 63.4 years (SD 10.6). Patient demographics were recorded, 25.9% of patients were current or former smokers, 60.8% had clinically managed hypertension, 9.8% had diabetes, and 31.5% carried a diagnosis of osteoarthritis. The average patient had 1.9 (SD 1.1) toes operated on during the procedure, including their MTP fusion. Mean tourniquet time was 65.6 (SD 24.8) minutes and mean operative time was 89.9 (SD 31.4) minutes. Mean (SD): VAS, 4.7 (2.8); LSA, 86.4 (35.1); SF-36 physical component score, 63.00 (19.9); SF-36 component score, 77.4 (19.8). MCID: VAS, 1.4 (95% CI 1.3 to 1.5); LSA, 17.6 (95% CI 14.4 to 21.4); SF-36 physical component score, 9.9 (95% CI 9.1 to 11.0); SF-36 mental component score, 9.8 (95% CI 8.7 to 11.4).Conclusion:This study identifies the MCID for VAS, SF-36, and LSA following first MTP fusion. The MCID of VAS reveals minimal improvements in pain (>1.5) are clinically significant. Both SF-36 physical and mental component scores reveal narrow 10- point differences have clinically significant changes. In contrast, LSA appears to have a relatively wide MCID value for patients undergoing first MTP fusion, highlighting the need for a large increase in mobility for significant improvement.

Improvement of Depressive Symptoms Following Surgical Correction of Hallux Valgus and Hallux Rigidus via 1st MTP Fusion

Category:Bunion; Midfoot/ForefootIntroduction/Purpose:Psychiatric comorbidity has been shown to significantly impact postoperative course, leading to increasingly complicated hospitalizations, increased pain, and worse overall patient outcomes. Achieving adequate pain management is paramount in restoring mobility and ultimately reaching treatment goals, making an understanding of the interplay between psychiatric conditions and orthopedics vitally important. Specifically, deformity of the first MTP joint has been associated with increased psychiatric symptoms preoperatively. However, despite this particular population's vulnerability to depressive symptoms, the effects of surgical correction on mental function outcomes have not been well observed. The purpose of this study was to assess the association of psychotropic medication use in patients with diagnoses of hallux rigidus and hallux valgus undergoing first MTP fusion and differences in patient-reported pain and functionality scores.Methods:A retrospective analysis of prospectively collected patient outcomes for those undergoing MTP fusion for hallux valgus and hallux rigidus between August 1, 2015, and July 1, 2018, was conducted. A total of 95 patients were included in the study.Demographics and surgical data were collected from a review of the electronic medical record, and patients were grouped based on chronic use of psychotropic medications at the time of surgery. Patient-reported VAS, SF-36 Mental Component Scores (MCS), and Physical Component Scores (PCS) scores were collected at preoperative and routine 6-month and 12-month postoperative follow-up clinic appointments. Categorical variables were compared using Pearson's chi-squared test. For normally distributed data outcome scores were compared using the independent sample t-test while non-normal data comparisons were made with the Mann-Whitney U test. For all statistical tests, assumptions of α <.05 and β =.8 were made.Results:The average age of the patients in our cohort was 63.3 (range, 39 - 83), with 42 patients in the psychotropic medication (MED) and 53 patients non-psychotropic medication (NO MED) cohorts. Mean time to final follow-up was similar between NO MED and MED groups (p=.987). No differences in mean VAS scores were detected at preoperative (p=.455), 6-month (p=.505), nor 1-year (p=.269) visits. Similarly, no differences in SF-36 PCS were detected at preoperative (p=.087), 6-month (p=.314), nor 1- year (p=.103) postoperative visits. Patients taking psychotropic medications had significantly lower mean SF-36 MCS at preoperative and 6-month postoperative visits (p=.004, p=.033, respectively). No difference in mean mental component score was detected at the 1-year postoperative visit (p=.184).Conclusion:This study is the first to examine the surgical outcomes of patients undergoing 1st MTP fusion for hallux rigidus and hallux valgus while concurrently taking psychotropic medications. SF-36 mental component scores were depressed at preoperative baseline in the psychotropic medication cohort and improved postoperatively to a level similar to that of their non- psychotropically medicated peers. These findings suggest that psychiatric diagnoses should be considered in the discussion of conservative vs. surgical management of hallux valgus and rigidus, as a secondary benefit of surgical correction may be partial relief of depressive symptoms.

Intramedullary Nailing vs Plating of the Fibula for Ankle Fractures in the Young Active Patient

Category:Ankle; TraumaIntroduction/Purpose:The use of fibular nailing (FN) for fixation of lateral malleolar fractures has been rising in recent years. Currently, it has been validated as an effective minimally invasive approach to ankle fractures specially in patients with high risk of wound dehiscence, diabetics and elderly low-demand patients. While most of the studies comparing the use of a fibula nail versus plating (PL) are carried out in this population at risk, the use of FN in younger patients with higher functional demands has been hardly studied. The aim of this study is to compare the functional and quality of life outcomes of patients treated with FN and PL in an active population.Methods:We performed an IRB-approved retrospective study including ankle fractures treated in our hospital from January 2017 to February 2020, with a minimum followup of one year. We included only patients between 18 and 55 years old treated by five fellowship-trained foot and ankle surgeons and divided into two groups according to the method of fixation of the fibula: intramedullary nailing (FN) or plating (PL). Demographics, medical comorbidities, type of fracture, reoperations and complications were collected. Functional and clinical evaluation included the Lower Extremity Functional Score (LEFS) and Short form 12 (SF 12) were obtained at an average of 28 months follow-up (range 14-50).Results:Eighty-five patients were included in this study with a mean age of 36.9 years old (range 16-55). The FN group was conformed by 31 patients (18 men) while the PL group consisted of 54 patients (32 men). Both groups were comparable in terms of age, sex, type of fracture, open fractures, number of malleoli compromised (P>0.05). Union was achieved in all patients. The complication rate was 3.2% (1 patient) in the FN group versus 5,5% (3 patients) in the PL group (p=0.66). Two patients (6.5%) in the FN group and 7 patients (13%) in the PL group required hardware removal (p=0.36). There were no significant differences in SF-12 physical component (p=0.30), SF-12 Mental component (p=0.52) and LEFS Score (p=0.88).Conclusion:In this comparative study, there were no differences between the FN and PL groups for fixation of the fibula in terms of functional results and quality of life at an average of 28 months follow-up. Complications and hardware removal rates had no statistical differences between both groups. This is the first report on the literature comparing both fixation strategies on an active high-demand population.

Validation of a European Spanish-version of the Self-Evaluation of Negative Symptoms (SNS) in patients with schizophrenia

IntroductionNegative symptoms can be grouped into five domains: apathy/avolition, anhedonia, asociality, alogia, and affective flattening. There are few validate self-rated measures that assess these five dimensions. Therefore, this study aimed to validate the Self-Evaluation of Negative Symptoms (SNS) in Spanish patients with schizophrenia. Material and methodsCross-sectional, validation study in 104 outpatients with schizophrenia evaluated using the Spanish version of the following scales: Clinical Assessment Interview for Negative Symptoms (CAINS), Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale for Schizophrenia (CGI-SCH), Personal and Social Performance (PSP), Motivation and Pleasure Scale – Self-Report (MAP-SR), 36-item Short-Form Health Survey (SF-36) and the Self-Evaluation of Negative Symptoms (SNS). Results ReliabilityInternal consistency (Cronbach's alpha) was 0.915. Convergent validity: The Pearson correlation coefficient between MAP-SR and SNS Total scores was 0.660 (p<0.001). For PANSS-N, the correlation was 0.437 (p<0.005) and with the CAINS-Total was 0.478 (p<0.005). Divergent validity: The Pearson correlation coefficient between SNS and PSP was r=−0.372 (p≤0.001), and with SF-36 Physical and Mental Summary Component scores were r=−0.213 (p=0.066) and r=−0.144 (p=0.219), respectively. Discriminant validity: SNS Total scores were significantly statistically different according to the severity of the negative symptomatology rated by the CGI-SCH negative scale (p<0.001). ConclusionThe SNS is a reliable and valid instrument to self-rate the five domains of negative symptoms in patients with schizophrenia and seems to be appropriate for use in everyday clinical practice as a complementary measure to the evaluation performed by the clinician.

Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on health-related quality of life among post-acute coronary syndrome patients: A randomized controlled trial.

Objectives:To determine the effectiveness of Mobile health augmented Cardiac rehabilitation (MCard) on health-related quality of life (HRQoL) among post-acute coronary syndrome (post-ACS) patients.Methods:At the Armed Forces Institute of Cardiology (AFIC), a tertiary care hospital in Rawalpindi, Pakistan, a two-arm randomised controlled trial was conducted in which mobile health augmented cardiac rehabilitation (MCard) was developed and implemented on post-ACS patients from January 2019 until March 2021. The trial conforms to the CONSORT statement 2010. The post-ACS patients were randomly allocated (1:1) to an intervention group (received MCard; counselling, empowering with self-monitoring devices, short text messages, in addition to standard post-ACS care) or control group (standard post-ACS care). HRQoL was assessed by generic Short Form-12 and MacNew quality of life myocardial infarction (QLMI) tools. Participants were followed for 24 weeks with data collection and analysis at three time points (baseline, 12 weeks and 24 weeks).Results:At baseline, 160 patients (80 in each group; mean age 52.66±8.46 years; 126 male, 78.75%) were recruited, of which 121(75.62%) continued and were analysed at 12-weeks and 119(74.37%) at 24-weeks. The mean SF-12 physical component score significantly improved in the MCard group at 12 weeks follow-up (48.93 vs control 43.87, p<.001) and 24 weeks (53.52 vs 46.82 p<.001). The mean SF-12 mental component scores also improved significantly in the MCard group at 12 weeks follow-up (44.84 vs control 41.40, p<.001) and 24 weeks follow-up (48.95 vs 40.12, p<.001). At 12-and 24-week follow-up, all domains of MacNew QLMI (social, emotional, physical and global) were also statistically significant (p<.001) improved in the MCard group, unlike the control group.Conclusion:MCard is an effective and acceptable intervention at improving all domains of HRQoL. There was an improvement in physical, mental, social, emotional and global domains among the MCard group in comparison to the control group. The addition of MCard programs to post-ACS standard care may improve patient outcomes and reduce the burden on the health care setting.

Health-related quality of life is dynamic in alcoholic hepatitis and responds to improvement in liver disease and reduced alcohol consumption.

The impact of alcoholic hepatitis (AH) on health-related quality of life (HRQOL) remains inadequately described. We aimed to characterize HRQOL in AH and heavy drinkers (HD), and its associations with clinical variables and outcomes. This is a post hoc analysis of participants in the Translational Research and Evolving Alcoholic Hepatitis Treatment 001 study (NCT02172898). HRQOL was measured using Short Form Health Survey (SF-36). Mean SF-36 scores were compared in AH and HD with two-sample t-tests. Associations among clinical characteristics, 30-day mortality, and SF-36 mental and physical component scores (MC, PC) were investigated with generalized linear and logistic multivariate regression models. Trends of MC and PC scores were analyzed using one-way ANOVA. Participants with AH (n=258) and HD (n=181) were similar demographically. AH cases had a mean Model for End-stage Liver Disease (MELD) score of 23 (7). AH cases had lower PC scores [37 (10) vs. 48 (11), p<0.001] but higher MC scores [37 (13) vs. 32 (13), p<0.001]. MC scores were independently associated with age, male gender, and daily alcohol consumption; PC scores were independently associated with age, BMI, alanine aminotransferase concentration, alkaline phosphatase concentration, white blood cell counts, and the presence of ascites. With each 5-point decrease in the baseline PC score, the adjusted odds of dying within 30days increased by 26.7% (95% CI 1% to 46%). Over time, HRQOL in AH improved (day 0 to day 180 delta PC score: 4.5±1.7, p=0.008; delta MC score: 9.8±2.0, p<0.001). Participants with a MELD score <15 by day 180 had greater increases in PC scores than those with MELD score ≥15 (delta PC score 7.1±1.8 vs. -0.7±2.3, p=0.009), while those abstinent by day 180 had greater increases in MC scores than those who were not abstinent (delta MC score 9.1±1.8 vs. 2.8±2.4, p=0.044). HRQOL is poor in AH and HD in a domain-specific pattern. Independent of MELD score, lower baseline HRQOL is associated with higher 30-day mortality. Over time, HRQOL improves with greater gains seen in individuals with improved MELD scores and those who were abstinent.

Full-Endoscopic Posterior Lumbar Interbody Fusion with Epidural Anesthesia: Technical Note and Initial Clinical Experience with One-Year Follow-Up.

ObjectiveThe purpose of this study was to introduce and evaluate the early clinical outcomes of the full-endoscopic posterior lumbar interbody fusion (Endo-PLIF) technique with epidural anesthesia (EA) for single-segment lumbar degenerative diseases.MethodsIn this retrospective case series study, we explored the feasibility and effectiveness of the Endo-PLIF with EA for single-segment lumbar degenerative diseases. Between March 2018 and January 2019, a series of 24 patients with single-segment lumbar degenerative diseases underwent Endo-PLIF surgery and were followed up for a minimum of 12 months (15.21±2.27 months). Clinical outcomes including visual analog scale (VAS) scores for back and leg pain, Oswestry Disability Index (ODI) scores, and the Short Form-36 health survey questionnaire (SF-36) were evaluated preoperatively, and postoperatively at 3 days and at 3, 6, and 12-months.ResultsAll patients underwent successful single-segment Endo-PLIF surgery. The mean operation time was 209.17±39.49 min, and average amount of bleeding was 43.33±14.87 mL. The VAS for lower extremity pain and back pain significantly improved at 3 days, and at 3, 6, 12 months compared with preoperative, respectively. The ODI scores decreased from 42.04±3.96 to 12.75±2.71 (P<0.001) at preoperative and 12 months postoperatively, respectively. The SF-36 Physical Component Scores (PCS) improved from 34.96±4.63 preoperatively to 52.08±6.05 (P<0.001) at 12 months postoperatively. Additionally, the SF-36 Mental Component Scores (MCS) improved from 39.38±5.70 at preoperative to 53.13±5.97 (P<0.001) at 12 months postoperatively. Two patients experienced dysesthesia, and one patient had a wound infection.ConclusionEndo-PLIF with EA is a feasible and valuable technique for the treatment of single-segment lumbar degenerative diseases in selected patients.

Abstract 11147: Associations of Physical and Mental-Health Related Quality of Life and Sleep Disturbance with Cardiovascular Disease Risk in Post-Menopausal Breast Cancer Survivors

Introduction: Lower health-related quality of life (HRQoL) and greater sleep disturbance (SD) are associated with an increased risk of cardiovascular disease (CVD) in the general population. However, these associations may differ in breast cancer (BC) survivors who experience competing risks from cancer and its associated treatment. We examined whether physical or mental HRQoL (including individual subscales) or SD were associated with CVD risk in BC survivors. Methods: We conducted a longitudinal analysis in the Women’s Health Initiative (WHI) of post-menopausal women free of prevalent CVD at baseline and diagnosed with invasive BC during study follow-up from 1993 - 2010. CVD was defined as physician-adjudicated coronary heart disease or stroke. Physical and mental HRQoL, measured by the SF-36 Physical and Mental Component Scores (PCS and MCS, respectively), and SD, measured by the WHI Insomnia Rating Scale (IRS), were recorded post-BC diagnosis. Higher PCS and MCS scores indicate better HRQoL while higher IRS scores indicate worse SD. Time-dependent Cox proportional hazards models were used starting at BC diagnosis until 2010 or censoring adjusted for relevant confounders most proximal to or at BC diagnosis. Results: In 2,884 BC survivors, 157 developed CVD during a median follow-up of 9.5 years. After adjustment, higher PCS scores were significantly associated with a lower risk of CVD (Table). For a 5-unit difference, the risk of CVD was 9% lower for those with higher PCS scores (95% CI: 0.83, 0.99). Of the SF-36 sub-scales, higher scores on vitality, physical functioning, and general health were significantly associated with a lower risk of CVD (Table). Conclusions: In BC survivors, we found that better physical HRQoL was associated with lower CVD risk. While further research is needed to replicate these findings, our results support existing recommendations that women with breast cancer adopt health behaviors that promote physical health.

Exercise-based cardiac rehabilitation for coronary heart disease.

Exercise-based cardiac rehabilitation for coronary heart disease.

Retinal Venular Tortuosity Jointly with Retinal Amyloid Burden Correlates with Verbal Memory Loss: A Pilot Study.

Introduction: Retinal imaging is a non-invasive tool to study both retinal vasculature and neurodegeneration. In this exploratory retinal curcumin-fluorescence imaging (RFI) study, we sought to determine whether retinal vascular features combined with retinal amyloid burden correlate with the neurocognitive status. Methods: We used quantitative RFI in a cohort of patients with cognitive impairment to automatically compute retinal amyloid burden. Retinal blood vessels were segmented, and the vessel tortuosity index (VTI), inflection index, and branching angle were quantified. We assessed the correlations between retinal vascular and amyloid parameters, and cognitive domain Z-scores using linear regression models. Results: Thirty-four subjects were enrolled and twenty-nine (55% female, mean age 64 ± 6 years) were included in the combined retinal amyloid and vascular analysis. Eleven subjects had normal cognition and 18 had impaired cognition. Retinal VTI was discriminated among cognitive scores. The combined proximal mid-periphery amyloid count and venous VTI index exhibited significant differences between cognitively impaired and cognitively normal subjects (0.49 ± 1.1 vs. 0.91 ± 1.4, p = 0.006), and correlated with both the Wechsler Memory Scale-IV and SF-36 mental component score Z-scores (p < 0.05). Conclusion: This pilot study showed that retinal venular VTI combined with the proximal mid-periphery amyloid count could predict verbal memory loss. Future research is needed to finesse the clinical application of this retinal imaging-based technology.

Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial

Integrating primary prevention into care pathways for older adults is a core strategy of healthy ageing, but evidence remains limited. We aimed to determine whether incorporating a multidomain intervention into primary health care could improve standard value-based health outcomes and quality of life. For this Taiwan Integrated Geriatric Care (TIGER) study, a pragmatic randomised controlled trial, we recruited community-dwelling outpatients aged 65 years or older with at least three chronic medical conditions. We excluded people with malignancies undergoing chemotherapy, people with a life expectancy of less than 12 months, or people who were insufficiently able to communicate with study staff. Participants were randomly assigned (1:1) to usual care or to the integrated multidomain intervention using block randomisation. The integrated multidomain intervention entailed 16 2-h sessions per year, comprising communal physical exercise, cognitive training, nutrition and disease education, plus individualised treatment by specialists in integrated geriatric care. The primary outcome was changes from baseline quality of life, based on 36-item Short Form Health Survey (SF-36) scores, at 3, 6, 9, and 12 months. Intervention effects were analysed per protocol using a generalised linear mixed model. This trial is registered with ClinicalTrials.gov, NCT03528005. Between June 25, 2018, and Feb 15, 2019, 628 participants were screened, of whom 398 were assigned to the integrated multidomain intervention (n=199) or to usual care (n=199). 335 (84%) participants completed the 12-month follow-up. Compared with the usual care group, the integrated multidomain intervention group had significantly higher mean SF-36 physical component scores across all timepoints (overall difference 0·8, 95% CI 0·2-1·5; p=0·010), but differences at 3, 6, 9, and 12 months did not reach statistical significance. The SF-36 mental component scores did not differ significantly overall, but were significantly higher in the integrated multidomain intervention group at the 12-month follow-up (55·3 [SD 7·6] vs 57·2 [7·0]; p=0·019). No serious adverse events occurred. Incorporating multidomain interventions into integrated health care improved quality of life. Our standardised protocol is amenable to inclusion in policies to promote value-based care and healthy ageing. National Health Research Institutes, Taiwan, and Ministry of Science and Technology, Taiwan.

Factors associated with objectively-derived physical activity and sedentary behavior in older adults

Abstract Background Identification of factors associated with older adults' physical activity (PA) and sedentary behavior (SB) is essential to inform effective targeted prevention strategies to prevent the impact of lack of PA and high sedentary time on health in older adults. While most previous studies examined factors associated activity levels separately, this study investigated factors associated with the activity distribution using the continuum of acceleration, avoiding loss of information that could arise from categorization of activity levels. Methods This study included 3896 participants (25.3% women, mean [range] age: 69.4 [60-83] years) from the Whitehall II accelerometer sub-study. The association of socio-demographic, lifestyle and cardiometabolic factors with the whole activity intensity distribution and time in SB, light PA and moderate-to-vigorous PA was examined using functional data analysis and linear regressions, respectively. The consistency of the associated factors over time was examined using factors assessed at the time of the activity measure, and 9 and 18 years prior this measure. Results Cross-sectional analyses showed participants who were older, current smokers, obese, with chronic conditions, and those reporting poor SF36 physical component score spent more time in the lowest acceleration intensities at the expense of less time in higher intensities. Occupational position in men and SF36-mental component score in women were additionally associated with activity distribution. In both men and women, the pattern of factors associated with PA and SB were generally similar in prospective and cross-sectional analyses. Conclusions This study confirms socio-demographic disparities in PA and SB and identify several modifiable factors which are eligible to health promotion interventions. Factors associated with activity intensity distribution at older age were consistent in the 20 years before physical activity measure. Key messages Factors associated with activity intensity distribution at older age slightly differ between men and women. Factors associated with activity intensity distribution at older age were consistent whether they were assessed in mid-life or at older age suggesting promotion of PA shall start as early as possible.

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.

Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed. We undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of -0.50 PHQ-9 points (95% CI -2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI -0.51 to 1.06) and at 3 months -0.87 (95% CI -1.56 to -0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (-1.33, 1.73) and at 3 months 0.31 (-1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (-4.17, 4.85) and at 3 months 0.11 (-4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (-2.64, 5.15) and at 3 months 1.26 (-2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness. In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT). ISRCTN94091479.

Third-Generation Minimally Invasive Chevron-Akin Osteotomy for Hallux Valgus Produces Similar Clinical and Radiological Outcomes as Scarf-Akin Osteotomy at 2 Years: A Matched Cohort Study.

The minimally invasive chevron-Akin (MICA) osteotomy is an increasingly popular technique for the correction of hallux valgus. However, there is a paucity of literature comparing it with traditional open techniques. The purpose of this study was to compare the clinical and radiological outcomes of the MICA osteotomy using a new-generation MICA screw and scarf-Akin osteotomy for hallux valgus correction. Thirty cases of MICA osteotomy were propensity score matched 1:1 with a control group of 30 scarf-Akin osteotomy cases. The groups were matched for age, sex, body mass index, preoperative visual analog scale (VAS) score, American Orthopaedic Foot & Ankle Society (AOFAS) metatarsophalangeal-interphalangeal (MTP-IP) score, 36-Item Short-Form Health Survey (SF-36) physical component score (PCS) and mental component score (MCS), preoperative hallux valgus angle (HVA) and intermetatarsal angle (IMA), and concomitant procedures. Outcomes were compared at 6 and 24 months postoperatively. Early postoperative VAS scores were also compared. Both groups demonstrated significant improvements in VAS score, AOFAS score, and SF-36 PCS and MCS at 6 and 24 months postoperatively. For the MICA group, HVA improved from 23.5 to 7.7 degrees, and IMA improved from 13.5 to 7.5 degrees. For the scarf-Akin osteotomy group, HVA improved from 23.7 to 9.3 degrees, and IMA improved from 13.6 to 7.8 degrees. The first 24-hour postoperative VAS score was significantly lower in the MICA group compared with the scarf-Akin group (2.0 ± 2.0 vs 3.4 ± 2.6, P = .029). However, there was no significant difference in clinical or radiological outcomes between the groups at 6 and 24 months. The MICA procedure with the new-generation MICA screw is an attractive option for the correction of hallux valgus, yielding similar midterm radiological and clinical outcomes compared with the well-established scarf-Akin osteotomy. The first 24-hour postoperative VAS score in the MICA group was also statistically lower, although its clinical significance remains to be determined. Level III, retrospective comparative study.

Discordance in patient and physician global assessment in relapsing polychondritis.

Relapsing polychondritis (RP) is a rare, heterogeneous, systemic inflammatory disease that targets cartilage. Patient-reported outcome measures may differ from physician assessment. This study compared patient global assessment (PtGA) and physician global assessment (PhGA) scores in a prospective cohort of patients with RP. Adult patients with RP underwent a standardized comprehensive evaluation at ∼6 month intervals. At each visit, three physicians scored PhGA by consensus. The patient independently completed four patient-reported outcomes: PtGA, 36-item Short Form Health Survey (SF-36), Brief Illness Perception Questionnaire (BIPQ) and Multidimensional Fatigue Inventory (MFI). Patient-physician discordance was defined as a difference between PtGA and PhGA of ≥3 on a 0-10 scale. A total of 76 patients were evaluated over 154 visits. The median PhGA was 3 [interquartile range (IQR) 2-3] and the median PtGA was 5 (IQR 4-7). PtGA and PhGA were concordant in 66 visits (42.9%) and patients scored disease severity ≥3 points higher than physicians scored disease activity (positive discordance) in 84 visits (54.5%). Compared with visits with concordance, visits with positive discordance were associated with significantly worse scores on the MFI, BIPQ, SF-36 physical component score and SF-36 mental component score. Patients with RP typically self-report high PtGA that does not align with PhGA. Discordance is likely driven by the high physical and psychological burden of illness experienced by patients. Multifaceted treatment approaches that address the burden of disease in RP from the patient perspective are needed.

Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms

Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001). In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. ClinicalTrials.gov number: NCT01803438.

Two-year use of flash glucose monitoring is associated with sustained improvement of glycemic control and quality of life (FLARE-NL-6)

IntroductionThe FreeStyle Libre (FSL) is a flash glucose monitoring (FGM) system. The Flash Monitor Register in the Netherlands (FLARE-NL-4) study previously demonstrated the positive effects of FSL-FGM use during 1...

Change in psoriatic arthritis outcome measures impacts SF-36 physical and mental component scores differently: an observational cohort study.

ObjectiveThe objective was to investigate interplay and physical and mental component scores between change (Δ) in health-related quality of life (HRQoL) quantified by the physical component score (PCS) and mental component score (MCS) retrieved from short-form health survey (SF-36), change in disease activity (ΔDAS28CRP) and manifestations of PsA.MethodsPsA patients initiating new medical therapy were enrolled. Independent disease measures evaluating disease activity, enthesitis, psoriasis, pain and fatigue were collected at treatment initiation and after 4 months. Interplay between independent disease measures and dependent outcome measures, ΔPCS and ΔMCS, was described with univariate regression analyses. Multivariate regression analyses were applied to assess the impact of independent variables, such as individual disease outcome measures vs ΔDAS28CRP on ΔPCS and ΔMCS.ResultsOne hundred and eight PsA patients were included. In the univariate regression analyses, improvement in fatigue, pain and disability were associated with improvement in ΔPCS (β; −2.08, −0.18 and −13.00, respectively; all P < 0.001) and ΔMCS (β; −1.59, −0.12 and −6.07, respectively; P < 0.001, P < 0.001 and P = 0.003, respectively). When patient-reported outcomes were included in the final multivariate models, improvements in ΔPCS and ΔMCS were associated with improvements in pain, fatigue and disability (P < 0.001). Improvement in enthesitis impacted ΔPCS positively (β −0.31, P < 0.001). No association was found between change in skin psoriasis, ΔPCS and ΔMCS (β 0.15, P = 0.056 and β 0.05, P = 0.561, respectively).ConclusionIn this PsA patient cohort, diminishing pain, disability and fatigue improved PCS and MCS significantly. Changes in enthesitis and psoriasis did not grossly impact HRQoL compared with DAS28CRP. Individual PsA manifestations influence HRQoL differently, which is important clinically when targeting treatment.Trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT02572700.

P112. Cervical disc replacement for radiculopathy versus myeloradiculopathy: An MCID analysis

<h3>BACKGROUND CONTEXT</h3> Several previous randomized controlled trials have documented the success of cervical disc replacement (CDR) in treating radiculopathy and/or myelopathy, but many did not systematically compare outcomes of patients with radiculopathy versus those with myelopathy. Currently, there is still controversy about whether CDR utilization in patients with components of myelopathy can result in equivalent outcomes when compared to its use in patients with only radiculopathy. <h3>PURPOSE</h3> The purpose of the present study was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing CDR for cervical spondylotic radiculopathy versus myeloradiculopathy. <h3>STUDY DESIGN/SETTING</h3> Retrospective review of prospectively collected data. <h3>PATIENT SAMPLE</h3> Patients who underwent one or two-level CDR with radiculopathy versus myeloradiculopathy. <h3>OUTCOME MEASURES</h3> Neck Disability Index (NDI), 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). <h3>METHODS</h3> Demographic variables and operative characteristics were analyzed for differences between patients with radiculopathy versus myeloradiculopathy. PROs were assessed for differences between the two diagnosis groups as well as improvements within each group following surgery. 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. <h3>RESULTS</h3> A total of 85 patients were included in the present study, of which 48 (56%) had radiculopathy and 37 (44%) had myeloradiculopathy. Average follow-up was 13.4 months. There were no significant differences in preoperative demographic variables, or the number and distribution of cervical levels treated between the two diagnosis groups. There were no significant differences in preoperative NDI, Neck-VAS, Arm-VAS, SF-12 PCS, SF-12 MCS, and PROMIS PF scores between the two groups. At the final postoperative visit, there was no significant difference in each PRO assessed between the radiculopathy and myeloradiculopathy groups and both groups demonstrated statistically significant improvement in each PRO compared to preoperative values (P<0.02).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. <h3>CONCLUSIONS</h3> This is the first study to compare the MCID across various PROs in patients with radiculopathy versus myelopathy undergoing CDR. The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups. 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. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

271. Increasing frailty is negatively correlated with long term functional outcomes after surgery for degenerative cervical myelopathy: 757 patients from the CSM-NA and CSM-I multicenter observational studies

<h3>BACKGROUND CONTEXT</h3> The effect of frailty on the long-term outcomes after surgery for degenerative cervical myelopathy (DCM) patients has not been reported. <h3>PURPOSE</h3> The objective of the current study was to define the effect of frailty on the long term functional and quality of life outcomes on surgical DCM patients. <h3>STUDY DESIGN/SETTING</h3> Retrospective analysis of prospectively collected observational data. <h3>PATIENT SAMPLE</h3> Patients enrolled to the CSM-International and CSM-North America multicenter, prospective cohort studies. <h3>OUTCOME MEASURES</h3> Functional outcome (modified Japanese Orthopedic Association score; MJOA), quality of life outcomes (SF-36 mental component and physical component scores; MCS, PCS) at 2-years postsurgery. <h3>METHODS</h3> Patients enrolled into the CSM-NA/CSM-I studies with functional and quality of life assessments at baseline and 2 years after surgery were included. The modified frailty index 5-point score (MFI-5) was calculated for all patients. "Prefrail," "Frail" and "Severely Frail" were compared to "Not Frail" patients on univariate analysis for all outcome measures, and the odds of achieving the minimum clinical important difference (MCID) for each. <h3>RESULTS</h3> A total of 757 patients were included, with a mean age of 56 [55-57] years (37% female). Increasing frailty was associated with increasing age (p<0.001), worse baseline MJOA score (p<0.001) and worse baseline PCS and MCS scores (p<0.001, p=0.001). Frailty did not affect the mean difference of MJOA scores after 2 years (2.43[2.15-2.71] vs 2.6[2.04-3.16]; p=0.605) or the change in PCS/MCS scores (p=0.899, p=0.138). The odds of achieving MCID for the MJOA is significantly reduced with increasing frailty (OR=3.1[2.4-3.9], p<0.001 for "Not Frail" vs OR=1.1[0.8-1.6]; p=0.5 for "Frail/Severely Frail" patients), but frailty did not affect the odds of achieving MCID for PCS/MCS. <h3>CONCLUSIONS</h3> Increasing frailty is associated with worse baseline functional and quality of life impairment for DCM patients, but this does not affect the mean difference in MJOA or PCS/MCS scores after 2 years. Frailty has a significant effect on the odds of achieving the MCID for functional outcomes, but not quality of life outcomes. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.