Physical Component Summary Research Articles

Long-term Health-related Quality of Life and Physical Function of COVID-19 Survivors with ICU-acquired Weakness.

This study examined the long-term health-related quality of life (HRQOL) and physical function of coronavirus 2019 (COVID-19) survivors diagnosed with intensive care unit-acquired weakness (ICU-AW). The correlation between muscle weakness at ICU discharge and HRQOL was assessed. A retrospective study was conducted on COVID-19 patients admitted to the ICU at Hyogo Medical University Hospital between January 2021 and November 2021. The HRQOL was evaluated using the SF-36 questionnaire, and physical function, including muscle strength assessed by the Medical Research Council Sum Score (MRC-SS), grip strength, and the 6-min walk distance (6MWD), were assessed 18 months after the onset. ICU-AW was diagnosed in patients with an MRC-SS of less than 48 at ICU discharge. We investigated the correlations between the MRC-SS at ICU discharge and the long-term clinical outcomes. We included 26 patients, with 13 having ICU-AW. In the long-term follow-up, the ICU-AW group had significantly lower scores than the no ICU-AW group in the SF-36 subscales such as Physical Functioning (PF), Role Limitation-Physical (RP), Bodily Pain (BP), Vitality (VT), Social Functioning (SF), and Role Limitation-Emotional (RE), as well as in the Physical Component Summary Score (PCS). The muscle strength was also decreased in the ICU-AW group. The MRC-SS at ICU discharge was positively correlated with PF, RP, BP, SF, RE, and PCS in SF-36 at the 18-month follow-up. COVID-19 survivors with ICU-AW experienced a long-term decline in HRQOL, and muscle weakness at ICU discharge was correlated with the long-term HRQOL.

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

ObjectiveThe objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.DesignSystematic review and network meta-analysis.Data sourcesEMBASE, MEDLINE,...

Adolescent Idiopathic Scoliosis Surgery: Postoperative Functional Outcomes at 32 Years Mean Follow-Up.

Recent clinical and radiographic studies conducted over short and medium terms have demonstrated positive results in patients undergoing surgery for adolescent idiopathic scoliosis (AIS). However, the absence of long-term data, crucial for comprehending the impact on future quality of life, especially in young patients actively involved in very intense physical activities, remains a gap. This study aims to evaluate long-term functional outcomes in patients who underwent surgery for Adolescent Idiopathic Scoliosis. Patients meeting specific criteria (diagnosis of AIS, age at surgery between 12 and 18 years, and follow-up of at least 20 years) were identified from a large spine surgery center database. A questionnaire using "Google Form" assessed various outcomes, including Visual Analog Scale (VAS) back, VAS leg, Short Form 12 score (SF-12), Scoliosis Research Society 22 score (SRS-22), incidence of spine revision surgery, postoperative high demanding activities (work and sport), and possible pregnancies was sent to the enrolled patients. The authors analyzed the results regarding all patients included and, moreover, statistical analysis categorized patients into two groups based on the surgical fusion performed: Group 1 (non-instrumented technique according to Hibbs-Risser) and Group 2 (instrumented tecnique according to Cotrel-Dubousset). A total of 63 patients (mean age 47.5 years) were included, with a mean follow-up of 31.9 years. Patients were, in mean, 47.5 years old. Group 1 comprised 42 patients, and Group 2 had 21 patients. Revision surgery was required in 19% of patients, predominantly for implant issues in Group 2 (11.9% vs. 33%, p < 0.05). Overall outcomes were favorable: VAS back = 3.5, VAS leg = 2.5, SRS-22 = 3.5, SF-12 Physical Component Summary = 41.1, SF-12 Mental Component Summary = 46.7, with no significant differences between the group 1 and group 2. At 5-years FU, the non-reoperation rate was higher in the non-instrumented group (97.6% vs. 71.4%, p < 0.001). By means of SRS-22, overall satisfaction was 3.7 ± 1.2 on a maximum scale of 5. More than half of women have successfully completed one pregnancy. Most patients (87.3%) maintained regular work activity. Among sport practioners, half returned to the similar preoperative level. This study reveals favorable long-term functional results in adolescent idiopathic scoliosis patients after surgical fusion. Mild to moderate back and leg pain were observed, but overall satisfaction, sport participation, and work activity were high. Surgical technique (non-instrumented vs. instrumented) did not significantly impact long-term results, though the instrumented fusion exhibited a higher revision rate.

An Integrated Stroke Transitional Care Intervention Improves Physical Functioning, Self-Management and Patient Experience in Older Adults with Stroke and Multimorbidity: A Multisite Pragmatic Randomized Controlled Trial

Background: The hospital-to-home transition for older adults with stroke is often fragmented, resulting in hospital readmissions and reduced quality of life, patient satisfaction and safety. There is limited evidence for strategies to improve transitions in care for older adults with stroke and multimorbidity. This study aimed to test, in real-world clinical practice, the effectiveness of the Transitional Care Stroke Intervention (TCSI) versus usual care on health outcomes, patient experience, and health and social service use costs in older adults (&gt; 55 years) with stroke and multimorbidity (&gt; 2 chronic conditions).&#x0D; Methods: This pragmatic randomized controlled trial was conducted among older adults with a stroke and multimorbidity discharged from the hospital to the community using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional team from hospital-based outpatient stroke rehabilitation clinics (Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Nurse, and Social Worker). The TCSI is a complex, integrated intervention which includes care coordination/system navigation support, phone/video visits, monthly interprofessional case conferences, and an online resource to support system navigation. Data analysis was performed by intention to treat. The primary outcome was risk of hospital readmission (all-cause) after 6 months. Secondary outcomes were mental and physical functioning, depressive symptoms, stroke self-management, patient experience, number of hospital days and readmissions, number of ED visits, survival rates to first hospital and ED visit, risk of ED visits, and health and social service use costs. Older adults with stroke were engaged as co-investigators and informed the research design, implementation, and evaluation through participation in the Patient Partner Advisory and the TCSI Steering Committees.&#x0D; &#x0D; Results: Ninety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). Most participants were men (60%), with an average of 7 comorbid conditions, and 78% had experienced their first-ever stroke. No significant group differences were seen for the baseline to six-month risk of hospital readmission (all-cause). However, stroke survivors in the intervention group reported higher levels of physical functioning (SF-12 Physical Component Summary Score mean difference: 5.10; 95% CI: 1.58-8.62, p=0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51—11.50, p=0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p=0.005) compared with the usual care group. No significant group differences were seen for the other secondary outcomes.&#x0D; Discussion: The TCSI improved physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs compared to usual care.&#x0D; Conclusion:The results provide evidence for the effectiveness of an integrated intervention to optimize transitional care outcomes for older adults with stroke and multimorbidity receiving outpatient stroke rehabilitation services.&#x0D; Suggestions for future research: Future research is needed to further evaluate this intervention in diverse settings and populations, with a larger sample size and a full economic evaluation. &#x0D; &#x0D; &#x0D;

Effect of avalglucosidase alfa on disease-specific and general patient-reported outcomes in treatment-naïve adults with late-onset Pompe disease compared with alglucosidase alfa: Meaningful change analyses from the Phase 3 COMET trial

BackgroundThe Phase 3 COMET trial (NCT02782741) comparing avalglucosidase alfa and alglucosidase alfa included health-related quality of life (HRQoL) assessments in treatment-naïve patients with late-onset Pompe disease (LOPD). Here, we further characterize results from disease-specific and general patient-reported outcome (PRO) measures. MethodsAdults who participated in the COMET trial receiving avalglucosidase alfa or alglucosidase alfa (both 20 mg/kg biweekly) during the 49-week double-blind treatment period were included in the analysis. Proportions of patients exceeding meaningful change thresholds at Week 49 were compared post hoc between treatment groups. PROs and their meaningful change thresholds included: Pompe Disease Severity Scale (PDSS; decrease 1.0–1.5 points), Pompe Disease Impact Scale (PDIS; decrease 1.0–1.5 points), Rasch-built Pompe-specific Activity Scale (R-PAct; change from unable to able to complete activity), 12-item Short Form Health Survey (SF-12; physical component summary [PCS] score: increase ≥6 points, mental component summary [MCS] score: increase ≥7 points), EuroQol 5 Dimension 5 Level (EQ-5D-5L; improvement of ≥1 category), and Patient Global Impression of Change (PGIC; any improvement). ResultsThe analysis included 99 adult patients (avalglucosidase alfa n = 50; alglucosidase alfa n = 49). Patients who received avalglucosidase alfa had significantly greater odds of achieving a meaningful change versus alglucosidase alfa for the PDSS Shortness of Breath (OR [95% CI] 11.79 [2.24; 62.18]), Fatigue/Pain (6.24 [1.20; 32.54]), Morning Headache (13.98 [1.71; 114.18]), and Overall Fatigue (5.88 [1.37; 25.11]) domains, and were significantly more likely to meet meaningful change thresholds across multiple PDSS domains (all nominal p < 0.05). A numerically greater proportion of patients in the avalglucosidase alfa group were able to complete selected activities of the R-PAct compared with the alglucosidase alfa group. Significantly greater proportions of patients who received avalglucosidase alfa achieved meaningful improvements for EQ-5D-5L usual activities dimension, EQ visual analog scale, and all four PGIC domains. The proportion of patients with improvements in SF-12 PCS and MCS was greater in the avalglucosidase alfa group versus alglucosidase alfa group, but was not significant (p > 0.05). ConclusionsThese analyses show that avalglucosidase alfa improves multiple symptoms and aspects of daily functioning, including breathing and mobility. This supports the clinical relevance of the effects of avalglucosidase alfa on HRQoL for patients with LOPD.

Relationship between physical and psychological functioning and health-related quality of life in congenital Aniridia.

Congenital aniridia is a serious eye disease characterized by absence of iris to various degrees. The aims of this study were to investigate health-related quality of life (HRQoL) in adults with aniridia and assess the relationships between HRQoL, psychological status, ocular health and obesity. Twenty-nine adults with congenital aniridia (48% male, aged 18-79 years) participated. HRQoL was measured with SF-36 and the EQ visual analogue scale (VAS). The physical (PCS) and mental (MCS) component summaries of the SF-36 were calculated with higher scores indicating better HRQoL. Symptoms of anxiety and depression were measured using the Hospital Anxiety and Depression Scale (HADS). Obesity was assessed with the Patient-Reported Outcomes in Obesity (PROS). Sociodemographic characteristics, genetic variants and ocular and medical health variables were also analysed. The participants scored significantly lower in the general health domain of the SF-36 than the general population (65.2 vs. 75.3, p = 0.017). The EQ VAS score was also lower in the aniridia group (64.9 vs. 77.9, p = 0.021). Low PCS score was correlated with presence of ocular pain (p = 0.019), high HADS score (p = 0.017) and high PROS score (p = 0.009). Low MCS score was related to higher educational level (p = 0.038) and high HADS score (p < 0.001). High HADS and PROS scores were both related to low EQ VAS scores. Adults with congenital aniridia scored worse on certain measures of HRQoL than the general population. Poorer HRQoL was associated with increased symptoms of anxiety, depression and obesity and with presence of ocular pain.

MEDICARE ADVANTAGE (MA) PLAN CHARACTERISTICS ON PHYSICAL AND MENTAL HEALTH OUTCOMES OF MA BENEFICIARIES

Abstract With growing demands for better and cost-effective care delivery by Medicare Advantage (MA) plans, comparison of self-reported health outcomes is more important because those outcomes capture patients’ experiences and perspectives. The purpose of the study is to examine the characteristics of MA plans on Medicare beneficiaries’ physical and mental health status. Methods: I used the Medicare Health Outcomes (HOS) survey, a random sample of Medicare beneficiaries surveyed from each MA plan with a minimum of 500 enrollees conducted by the CMS. The current study included 3 baseline cohorts from 2015 (n=195,800), 2016 (n=178,973), and 2017 (n=172,047). I used physical component summary (PCS) and mental component summary (MCS) scores as two outcomes which include various domains of physical (exercise, pain, activity limitation) and mental health (social functioning, emotional status, depression) status. Plan characteristics include plan ownership status (for-profit (FP) vs. not-for-profit (NFP), plan types (PPO vs. HMO/cost contract), and the number of plan members. I used the linear regression method with clustering at the plan contract level due to the correlation of multiple beneficiaries within the same plan. Results: Adjusted for beneficiary level characteristics, beneficiaries in PPO plans experienced greater physical and mental health scores than HMO or cost contract plans. MA plan with less than 5k beneficiaries is associated with a lower physical health score than plans with more than 100k beneficiaries. For-profit ownership was significantly associated with lower mental health scores. Discussion: The characteristics of MA plan insurers are important factors for beneficiaries’ enrollment decisions and quality improvement efforts.

Clinical association of health-related quality of life and mortality in an antineutrophil cytoplasmic antibody-associated vasculitis cohort

ObjectivesTo evaluate the association between health-related quality of life (HRQoL) and mortality in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). MethodsWe searched patients with AAV assessed for HRQoL at initial diagnosis using Short Form 36 (SF-36). Relationships between SF-36 physical component summary (PCS) and mental component summary (MCS) scales and variables were estimated using Pearson's correlation analysis. Contal's and O'Quigley's methods were used to determine optimal SF-36 PCS cut-off for predicting all-cause mortality. The Cox proportional hazards model and inverse probability of treatment weighting (IPTW) analysis were used to ascertain prognostic implications of SF-36 scales and mortality. ResultsThe median SF-36 PCS and MCS values of the 189 patients were 47.5 and 53.3, respectively, and 21 (11.1%) patients (microscopic polyangiitis [MPA], n=15; granulomatosis with polyangiitis [GPA], n=6) died during follow-up. SF-36 PCS was significantly but weakly associated with Birmingham Vasculitis Activity Score, Five-factor score, erythrocyte sedimentation rate (ESR), and C-reactive protein. However, SF-36 MCS was not associated with ESR. In the multivariable Cox analysis, a decrease of SF-36 PCS score by one unit indicated a higher death risk (hazard ratio [HR]: 1.030; 95% confidence interval [CI]: 1.007, 1.052; p=0.041), which was not for SF-36 MCS. IPTW analysis in a subgroup of MPA and GPA patients revealed increased patient mortality with SF-36 PCS <53.75 independently (HR: 3.249; 95% CI: 1.169, 9.033; p=0.024). ConclusionPoor baseline physical functioning associated with premature death in patients with MPA and GPA. HRQoL assessment during initial diagnosis may provide clinical insights for this population.

Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials

ObjectiveWe explored the comparative effectiveness of available therapies for chronic pain associated with temporomandibular disorders (TMD).DesignSystematic review and network meta-analysis of randomised clinical trials (RCTs).Data sourcesMEDLINE, EMBASE, CINAHL, CENTRAL, and...

Accurate Restoration of the Center of Rotation of the Hip Joint Based on Preoperative Planning Is Not Associated with Improved Clinical Outcomes

One of the main objectives of total hip arthroplasty (THA) is to recreate the center of rotation (COR). Accurate reconstruction of the COR is suggested to be within 5 mm of its anatomical location. The goal of our study was to assess whether accurate reconstruction of the COR, based on preoperative planning, is associated with improved clinical outcomes. The study population consisted of patients who underwent THA at our institution between August 2018 and May 2020. All patients underwent preoperative digital templating. The position of the predicted COR was compared to its actual postoperative position. Patients were subsequently stratified into two subgroups based on the difference between the distance of the predicted COR and the reconstructed COR, over or under 5 mm. A 12-Item Short Form Health Survey (SF-12) and visual analogue scale (VAS) were taken for each patient. 90 patients were included in this study. 60 patients (66%) had their COR reconstructed within 5 mm of preoperative planning, whereas for 30 patients (33%), reconstruction was outside of 5 mm of preoperative planning. Between the two cohorts, no significant difference existed in the physical component summary (PCS) (p = 0.33), the mental component summary (MCS = 0.16), or the visual analogue scale (VAS) (p = 0.12). The accurate restoration of COR based on preoperative planning is not associated with improved clinical outcomes. During postoperative evaluation, surgeons should feel confident if the COR is slightly greater than 5 mm of preoperative limitations.

Predictors of poor health-related quality of life among people living with HIV aged ≥60 years in the PISCIS cohort: Findings from the Vive+ project.

Advancements in and accessibility to effective antiretroviral therapy has improved the life expectancy of people living with HIV, increasing the proportion of people living with HIV reaching older age (≥60 years), making this population's health-related quality of life (HRQoL) more relevant. Our aim was to identify the determinants of poor HRQoL in people living with HIV aged ≥60 years and compare them with those of their younger counterparts. We used data from the 'Vive+' study, a cross-sectional survey conducted between October 2019 and March 2020, nested within the PISCIS cohort of people living with HIV in Catalonia and the Balearic Islands, Spain. We used the 12-item short-form survey (SF-12), divided into a physical component summary (PCS) and a mental component summary (MCS), to evaluate HRQoL. We used the least absolute shrinkage and selection operator for variable selection and used multivariable regression models to identify predictors. Of the 1060 people living with HIV (78.6% males) who participated in the study, 209 (19.7%) were aged ≥60 years. When comparing older people living with HIV (≥60 years) and their younger counterparts, older people exhibited a worse PCS (median 51.3 [interquartile range {IQR} 46.0-58.1] vs. 46.43 [IQR 42.5-52.7], p < 0.001) but a similar MCS (median 56.0 [IQR 49.34-64.7] vs. 57.0 [IQR 48.9-66.3], p = 0.476). In the multivariable analysis, cognitive function correlated with a PCS (β correlation factor [β] -0.18, p = 0.014), and depressive symptoms and satisfaction with social role correlated with an MCS (β 0.61 and β -0.97, respectively, p < 0.001) in people living with HIV aged ≥60 years. Depressive symptoms, poor cognitive function, and lower satisfaction with social roles predict poorer HRQoL in older people living with HIV. These factors need to be considered when designing targeted interventions.

Mental health status and the quality of life of infertile women receiving fertility treatment in Bangladesh: A cross-sectional study

Infertility poses significant physical and psychological challenges for women of reproductive age. In low- and middle-income countries, the prevalence of depression among infertile women is alarmingly high, reaching 44.32%. Additionally, over 50% of infertile women worldwide experience varying degrees of decline in their quality of life. Therefore, this study aimed to assess the effects of infertility on the mental health status and quality of life of infertile women in Bangladesh. Between December 2022 and March 2023, 375 infertile women in Dhaka, Bangladesh were selected using simple random sampling for this cross-sectional study. The participants’ mental health status was assessed using the Depression Anxiety and Stress Scale (DASS-21), while their quality of life was evaluated by the Short Form-12 (SF-12) scale. The prevalence of depression, anxiety, and stress were 59.7%, 55.0%, and 48.7%, respectively. Multiple logistic regression showed that infertile homemakers had 2.98 (95% CI: 1.30 to 6.80) times the odds of depression than government service holders. Aborted infertile women had 1.8 (95% CI: 1.10 to 3.26) times the odds of depression. Infertile women who married between 20 and 24 years old were 49% (95% CI: 0.27 to 0.98) less anxious than those who married earlier. Low-income infertile women (&lt;30,000 BDT) were 2.29 (95% CI: 1.02 to 5.14) times more likely to be stressed than those with higher incomes (&gt;60,000 BDT). Multiple linear regression analysis suggests that education and infertility diagnosis status significantly affect the Mental Component Summary (MCS-12) scores of the Short Form-12 (SF-12). In contrast, age, occupation, and Body Mass Index (BMI) were the significant predictors for the Physical Component Summary (PCS-12). Policymakers may use lessons learned from this study to incorporate appropriate counseling techniques, social awareness campaigns, and media involvement to control the added burden of infertility on women’s psychological health and quality of life.

Healing beyond the joint: Addressing mental health in periprosthetic joint infection in a prospective longitudinal study

ObjectivePeriprosthetic joint infection (PJI) is a devastating complication following joint replacement surgeries. While the somatic impacts of PJI have been extensively explored, the influence on mental health remains understudied. This study aimed to longitudinally assess the psychological burden, quality of life, and expectations in individuals undergoing treatment for PJI. MethodsA prospective study was conducted at a German trauma center between January 2020 and December 2022. Patients diagnosed with PJI (n = 29, mean age 71.4 ± 8.8 years) were assessed at five timepoints, within one week before revision surgery, one month, three, six, and twelve months postoperatively. Outcomes included the ICD-10 symptom-rating (ISR), German Short-Form 36 (SF-36), European Quality of Life 5 Dimensions (EQ-5D), and an expectation questionnaire. ResultsPsychological scores exhibited significant upward trends over time. The ISR score increased from 0.55 preoperatively to 0.87 at the 12-month follow-up (p = 0.002), surpassing the clinically relevant threshold. Depression and anxiety scores peaked at 6 months (1.6, p = 0.005) and 12 months (1.12, p = 0.001), respectively. Quality of life, measured by SF-36, showed stable physical component summary scores but declining mental component summary scores. Patients' expectations of returning to normal health consistently decreased (p = 0.009). ConclusionPatients undergoing treatment for PJI experience significant psychological burden, with implications for quality of life and expectations of recovery. The findings underscore the importance of addressing psychological well-being in the management of PJI and emphasize the need for comprehensive care strategies that encompass both somatic and psychological dimensions.

Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients’ frailty in parallel with their underlying heart valve disease. Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

Effect Sizes for Changes in Health and Well-Being Following Treatment With the One-To-Zero Technique in Individuals With Occipito-Atlantal Joint Dysfunction: A Repeated Measures Study

ObjectivesThe purpose of this study was to determine effect sizes (ES) for changes in self-reported measures of musculoskeletal pain and dysfunction resulting from the one-to-zero method using a repeated measures study design. MethodsTwenty participants presenting with articular dysfunction of the occipito-atlantal (C0-C1) complex were treated using the one-to-zero method, a high-velocity low-amplitude thrust administered between the C0-C1 complex before treating other restrictive segments in a cephalocaudal direction. The participants completed online questionnaires using Google Forms that assessed aspects of the biopsychosocial model of pain at baseline and within a week after treatment. The questionnaires included the following: (1) Demographic and Health Behavior Survey; (2) Neck Bournemouth Questionnaire (NBQ) or Neck Disability Index (NDI); (3) Beck Anxiety Index (BAI); (4) Insomnia Severity Index (ISI); and (5) 36-Item Short Form Health Survey (SF-36). Paired t test or Wilcoxon signed ranks test was performed, dependent on normality. Cohen's d values were calculated for each questionnaire score (0.20 indicative of small; ≥0.50 medium; and ≥0.80 large ES). ResultsThe NDI, NBQ, BAI, and ISI had a large ES (all d ≥ 0.80). In the SF-36, 4 subscales had a small to near-medium ES, 1 subscale had a medium to near-large ES, and the remaining 2 had a large ES (d ≥ 0.80). The physical and mental component summary had a large (d = 0.88) and small ES (d = 0.35), respectively. ConclusionThe effect sizes suggest the one-to-zero treatment induces change in various aspects of the biopsychosocial model.

Assessment of quality of life and its affecting factors in osteosarcopenic individuals in the Iranian older adult population: Bushehr Elderly Health (BEH) program

ObjectivesThis cross-sectional study, conducted as part of the Bushehr Elderly Health program stage II in Bushehr, Iran, aimed to evaluate health-related quality of life (HR-QoL) in individuals aged ≥ 60 with osteosarcopenia, a condition characterized by the co-occurrence of osteopenia/osteoporosis and sarcopenia. Given the increasing elderly population worldwide, understanding the HR-QoL of this demographic is crucial, with osteosarcopenia being a significant factor. MethodsThe study enrolled 2369 participants aged ≥ 60 and collected demographic and anthropometric data. Various questionnaires, including the Short Form 12, Patient Health Questionnaire-9, Activities of Daily Living, and Instrumental Activities of Daily Living, were administered. Comparisons were made between individuals with and without osteosarcopenia. Regression models were employed to identify variables associated with HR-QoL in those with osteosarcopenia. ResultsKey findings revealed that 22.5% of participants had osteosarcopenia. Significantly different HR-QoL measures were observed between the 2 groups, especially in physical functioning and physical component summary scores. Male gender, advanced age, and chronic illnesses were linked to lower physical and mental HR-QoL scores among those with osteosarcopenia. In female participants, a history of fractures and physical disability were associated with reduced quality of life. ConclusionsThis study underscores the negative impact of osteosarcopenia on HR-QoL, particularly in male participants, with a focus on physical aspects. It also highlights age and chronic disease as contributing factors to diminished HR-QoL in individuals with osteosarcopenia. These findings emphasize the importance of addressing osteosarcopenia in the elderly population to improve their overall well-being.

Whole-Body Electrostatic Pain Treatment in Adults with Chronic Pain: A Prospective Multicentric Observational Clinical Trial.

In the treatment of patients with chronic pain, whole-body electrostatic therapy using the Elosan Cabin C1 has been proposed as an adjunctive therapy. So far, data on the use of this cabin are limited. Promising results with a significant reduction in pain scores have been obtained in a small group of patients. However, treatment with Elosan Cabin C1 has not been the subject of evaluation in a larger patient population. The aim of this study was to investigate the efficacy and adverse effects of electrostatic treatment in such a population. Prospective, multi-center, observational clinical trial conducted in daily practice in a large adult ambulatory population with chronic pain. Each patient received eight weekly Elosan C1 treatment sessions for up to 9weeks. Treatment was added to an established conservative pain management. Pain scores (visual analog scale (VAS) 0-100, primary outcome) and sleep quality (seven-point Likert scale, secondary outcome) were assessed before, during, and at the end of the treatment period; quality of life (SF-12: Physical Component Summary = PCS, Mental Component Summary = MCS; secondary outcome) was assessed before and at the end of the treatment period. Subgroup analyses were performed for sex, age, duration of pain, initial pain location, pain entity, and pain medication at the start of treatment. A total of 192 patients were enrolled, 143 patients (74.5%) had a complete set of 8 treatment sessions. A reduction in pain scores from 68 ± 14 points to 47 ± 22 points was observed (p < 0.001), 65% of patients (responders) had a reduction of > 15 points. Female patients had a significantly better response than male patients with a higher number of responders (76% vs. 38%; p < 0.001). Patients with a pain history < 1year had a significantly better response than patients with a pain history > 1year. The Physical Component Summary (PCS) increased from 36 ± 11 to 41 ± 11 (+ 18%, p < 0.001) and the Mental Component Summary (MCS) from 41 ± 7 to 43 ± 7 (+ 6%, p = 0.3). Overall sleep quality improved significantly from 4.6 ± 1.7 to 3.73 ± 1.7 points (p < 0.001), with a higher proportion of responders in the female group (37 vs. 18%; p < 0.034). No serious adverse events were observed during treatment. Electrostatic therapy with Elosan Cabin C1 may be a useful and effective adjunct therapy for patients with chronic pain. The results suggest that female patients and those with a recent history of pain experience the greatest benefit. NCT04818294 (clinicaltrials.gov).

Sustained Efficacy, Safety, and Improved Quality of Life in Adult and Pediatric Patients with Transfusion-Dependent β-Thalassemia up to 9 Years Post Treatment with Betibeglogene Autotemcel (Beti-cel)

Introduction: Beti-cel gene therapy addresses the underlying cause of transfusion-dependent β-thalassemia (TDT) by adding functional copies of a modified β-globin gene to autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) via a third-generation, self-inactivating lentiviral vector (LVV), BB305, which produces functional adult hemoglobin (Hb), HbA T87Q, in red blood cells (RBCs). Here, we report efficacy, safety, and quality of life (QOL) data from adult and pediatric patients treated with beti-cel who were followed for up to 9 years after treatment. These outcomes may inform patient selection for real-world treatment with beti-cel. Methods: Patients with TDT who completed either a phase 1/2 (HGB-204 [NCT01745120]; HGB-205 [NCT02151526]) or phase 3 (HGB-207 [NCT02906202]; HGB-212 [NCT03207009]) beti-cel parent study and subsequently participated in the long-term, 13-year follow-up study LTF-303 (NCT02633943) were included in this analysis. Analyses were performed with data collected through January 30, 2023. Efficacy (including transfusion independence [TI], defined as a weighted average Hb ≥9 g/dL without packed RBC transfusions for ≥12 months) and safety are reported through last follow-up. QOL data are reported for studies HGB-204, HGB-207, and HGB-212 through month 36. Statistical analyses were conducted to examine key outcomes in subgroups based on patient age at enrollment (pediatric: &amp;lt;18 years; adult: ≥18 years). Results:As of January 30, 2023, 63 patients (median [range] age: 17 [4-35] years) had received beti-cel in a phase 1/2 or 3 study and enrolled in LTF-303, with a median (range) follow-up of 60.1 (23.8-109.5) months. Phase 3 studies used the commercial drug product manufacturing process. Ninety percent (37/41) of phase 3 patients achieved and maintained TI through last follow-up (up to 6 years; Table 1). TI rates by study, genotype, and age for phase 3 patients are also presented in Table 1. In phase 1/2 studies that used an older drug manufacturing process, 68.2% (15/22) of patients achieved TI; 14 of these patients sustained TI through last follow-up (up to 9 years). One patient no longer meets protocol-defined TI as a result of Hb level &amp;lt;9g/dL at year 6 due to acute health events unrelated to β-thalassemia, which were not attributed to loss of beti-cel treatment effect. Approximately 80% of pediatric and adult patients required only one mobilization cycle to achieve the drug product dose. The median percentage of drug product cells transduced with the BB305 LVV was comparable between adult and pediatric populations (78% and 80%, respectively), as were the month 6 median peripheral blood vector copy number (1.4 c/dg and 1.1 c/dg) and HbA T87Q (9.4 g/dL and 8.3 g/dL). Adult patients reported improvements in QOL up to month 36 as assessed by the Short Form-36 Health Survey Questionnaire mental and physical component summary scores, Functional Assessment of Cancer Therapy, and EuroQol ( Table 2). Pediatric Quality of Life Inventory scores will be reported at the time of presentation. Overall, 19% (12/63) of patients experienced ≥1 beti-cel-related adverse event (AE); the most common beti-cel-related AEs (occurring in ≥3 patients) were abdominal pain (experienced in 5/63 [7.9%] patients) and thrombocytopenia (3/63 [4.8%] patients). Five patients experienced serious veno-occlusive liver disease; all 5 received defibrotide and recovered. No malignancies, insertional oncogenesis, or vector-derived replication-competent lentivirus were reported. Age subgroup safety analysis as of last follow-up will be reported in the final presentation. Conclusion: Beti-cel is a potentially curative gene therapy for patients with TDT across ages and genotypes through achievement of TI and normal or near-normal Hb. These data will inform real-world beti-cel treatment decisions for patients with TDT and providers.

Survival and Clinical Outcomes after Unconstrained Total Knee Arthroplasty for Tibial Plateau Fractures–A Retrospective Study with Minimum 4-Year Follow-Up

This study investigated survival, complications, revisions, and patient-reported outcomes (PROs) for unconstrained total knee arthroplasty (TKA) in posttraumatic osteoarthritis (PTO) caused by intraarticular tibial plateau fractures with minimum four years follow-up. Forty-nine patients (71.4% male; 58.7 years) were included. Kaplan–Meier analysis was performed with failure defined as TKA removal. Patients without failure underwent pre- and postoperative evaluation (range of motion (ROM), Oxford Knee Score (OKS), Knee Society Score (KSS), anatomical femorotibial angle (aFTA), proximal tibial slope (PTS)) and Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) assessment at final follow-up. Fifteen (30.6%) patients had a complication, and eight (16.3%) patients underwent prosthesis removal at median 2.5 years. Cumulative survival rate of TKA was 79.6% at 20 years. A total of 32 patients with a mean follow-up of 11.8 years underwent further analyses. ROM (p = 0.028), aFTA (p = 0.044), pPS (p = 0.009), OKS (p &lt; 0.001) and KSS (p &lt; 0.001) improved significantly. SF-12 PCS was 42.3 and MCS was 54.4 at final follow-up. In general, one third of patients suffer a complication, and one in six patients has their prosthesis removed after TKA for PTO due to tibial plateau fractures. In patients who do not fail, TKA significantly improves clinical and radiographic outcomes at long-term follow-up.

The Influence of Comorbidities, General Health Status, and Self-Care Self-Efficacy on COVID-19 Symptoms During the Omicron Wave.

Background The emergence of the less virulent COVID-19 strains such as Omicron and its subvariants shifted the paradigm of COVID-19 treatment from inpatient treatment to regular outpatient care. The individual health determinants affecting COVID-19 disease severity among vulnerable adults treated in outpatient settings are an under-researched area. Methods This study conducted in an outpatient COVID-19 antibody infusion center employed a cross-sectional survey design to explore the impact of comorbidities, general health status, and self-care self-efficacy on COVID-19 symptom severity. We recruited 120 COVID-19-positive participants over 40 years of age, of which 117 completed the study with 87 providing complete data. After the screening and consenting process, the participants completed the following surveys in a secure REDCap survey software (Vanderbilt University, Nashville, USA)on an iPad (Apple Inc., Cupertino, USA): 1) sociodemographic questionnaire, 2) Charlson Comorbidity Index (CCI) to capture comorbidities, 3)Medical Outcomes Study Short-Form (SF-12) to assess general health including physical (PCS) and mental (MCS) health subscales, 4) Self-Care Self-Efficacy Scale (SCSES) to measure self-care self-efficacy, and 5) the COVID-19 Symptom rating scale (COVID-19 SRS). Statistical analysis used were Chi-square and Pearson correlations. Results As evidenced by CCI, the top five comorbidities were hypertension (42%), diabetes mellitus (31%), pulmonary disease (19%), depression (14%), and solid tumors (11%). Age was statistically significantly correlated to comorbidity burden(p<0.0001). Severe COVID-19 symptoms reported were fatigue, myalgia, cough, runny nose, and sore throat. The general health status measure (SF-12) subscales showed that the patient's mental component summary (MCS) was more statistically significant to COVID-19 symptom severity than the physical component summary (PCS). The MCS demonstrated a statistically significant correlation with fatigue and myalgia (p<0.0001), headache and breathing difficulties (p<0.001), nausea/vomiting (p<0.01), and abdominal pain/diarrhea (p<0.05). The PCS showed a lesser statistically significant correlation with fatigue, myalgia, headaches (p<0.01), fever/chills, cough, congestion/runny nose, night sweats, breathing difficulties, nausea/vomiting, and abdominal pain/diarrhea (p<0.05). Interestingly, the 'loss of smell' which is the hallmark symptom of COVID-19 was the only symptom that showed a statically significant correlation with the Charlson Comorbidity Index (p<0.05), and it did not show any association with either mental (SF-12 MCS) or physical (SF-12 PCS) health status. The SF-12 MCS also showed a statistically significant correlation with a diagnosis of depression (p< 0.01), validating it as a true measure of mental health among vulnerable adults. The SCSES was not correlated with any of the COVID-19 symptoms. Conclusions The patient's general health status, especially mental health was more statistically significant to COVID-19 symptoms. The COVID-19 hallmark symptom of 'loss of smell' was the only symptom that showed statistical significance with comorbidities. Within the limitations of a cross-sectional survey design and convenient sampling methods, this study calls to tailor general health status, especially mental health, and cumulative comorbidity burden to risk assessment/risk stratification of COVID-19 care.