Significant Improvement In Health-related Quality Of Life Research Articles

Bariatric Surgery: An Opportunity to Improve Quality of Life and Healthy Habits

Bariatric surgery therapy (BST) is an effective treatment for obesity; however, little is known about its impacts on health-related quality of life (HRQoL) and related factors. This study aimed to evaluate changes in HRQoL and its relationship with weight loss, depression status, physical activity (PA), and nutritional habits after BST. Data were obtained before and 18 months postprocedure from 56 obese patients who underwent BST. We administered four questionnaires: Short Form-36 health survey for HRQoL, 14-item MedDiet adherence questionnaire, Rapid Assessment of PA (RAPA) questionnaire, and Beck’s Depression Inventory-II. Multivariable linear regression analysis was used to identify factors associated with improvement in HRQoL. After the surgery, MedDiet adherence and HRQoL improved significantly, especially in the physical component. No changes in PA were found. Patients without previous depression have better mental quality of life, and patients who lost more than 25% of %TBWL have better results in physical and mental quality of life. In the multivariable analysis, we found that %TBWL and initial PCS (inversely) were related to the improvement in PCS and initial MCS (inversely) with the MCS change. In conclusion, BST is an effective intervention for obesity, resulting in significant weight loss and improvements in HRQoL and nutritional habits.

ACUTE AND LONG-TERM EFFECTS OF APP-DELIVERED HEARTFULNESS MEDITATION ON PSYCHOLOGICAL OUTCOMES AND THE ENDOCANNABINOID SIGNALING SYSTEM IN CYCLIC VOMITING SYNDROME.

Cyclic vomiting syndrome (CVS) is a disorder of gut brain interaction (DGBI) often triggered by stress. Interventions like meditation may improve psychological outcomes and Health-Related Quality of Life (HRQoL), but their efficacy and the underlying mechanism are unknown. We conducted a 6-week single-arm pilot study to assess the effects of Heartfulness meditation (HFM) in CVS using a custom-designed meditation app. Primary outcomes included state and trait anxiety and mood state changes pre- vs. post-meditation, and secondary outcomes were psychological distress, coping, sleep quality and HRQoL at baseline and weeks 3 and 6. Serum concentrations of endocannabinoids N-arachidonylethanolamine (AEA) and 2-arachidonoylglycerol (2-AG) and related lipids were measured pre-and-post HFM at baseline and week 6. In 30 treatment completers, there was a significant improvement in state anxiety (p<0.001), total mood disturbance (p<0.001), and other mood states (all p values <0.05) across the three time points. Trait anxiety was also improved at week 6. There was a significant improvement in psychological distress (global severity index), sleep quality (daytime dysfunction), coping (using religion/spirituality) and HRQoL (mental and physical) across the three time points (all p <0.05). Significant increases in AEA and related lipids N-oleoylethanolamine and palmitoylethanolamide post-vs.-pre HFM were observed at week 6 (p<0.001, 0.002, 0.003, respectively). No adverse effects were noted. App-delivered HFM is feasible, safe and effective and improves psychological outcomes and augments endocannabinoids. This provides insight into the mechanism underlying HFM and has potential for widespread use as a digital therapeutic in CVS and other DGBI.Study Highlights.

Abstract PS02-09: Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial

Abstract Background: Follow-up after breast cancer with regular specialist-led visits has failed to prove superiority over other strategies in terms of recurrence detection and survival, but it is still a cornerstone in breast cancer follow-up in many healthcare systems. Follow-up provided by the general practitioner or a specialist nurse has been reported more cost-effective and non-inferior in terms of patient-reported health-related quality of life (HRQoL) and in meeting the needs of breast cancer survivors. However, no follow-up strategies have demonstrated indisputable superiority over other strategies. Methods: In this randomized controlled trial (MyHealth), patients who recently completed surgery, and chemo-/radiotherapy if indicated, for stage I–II breast cancer were randomly assigned to intervention or control follow-up at Zealand University Hospital, Denmark. The nurse-led intervention comprised three to five individual self-management sessions during the first six months, and regular reporting of symptoms with nurse navigation to relevant healthcare services during three years of follow-up. The control comprised outpatient visits with oncologist every six months for three years. The primary outcome was breast cancer-specific HRQoL measured by the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) summary score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) two years after randomization. Secondary outcomes were fear of recurrence, anxiety, depression, and healthcare utilization. Results: From January 2017 to January 2019, 503 patients were randomly assigned to intervention (n=251) or control (n=252) follow-up. At two years, patients in the intervention group reported a significantly higher HRQoL (mean 75·69 (SD 12·27)) than patients in the control group (mean 71·26 (SD 14·08)), a mean difference of 5·05 (95% CI; 3·30–6·79), which is considered clinically relevant. The intervention group also reported significantly less fear of recurrence, anxiety, and depression as shown in Table 1. Furthermore, patients in the intervention group had fewer physician consultations but more nurse contacts, and an unchanged diagnostic imaging pattern as shown in Table 2. The effect on all outcomes was stable through three years of follow up. Conclusions: The MyHealth study suggests a new strategy for follow-up after early breast cancer providing significant improvements in HRQoL, fear of recurrence, anxiety, and depression without inflicting extra expenses to the healthcare system. (Funded by the Danish Cancer Society, Region Zealand and Copenhagen University Hospital; Clinicaltrials.gov number; NCT02949167.) Table 1: Outcome findings by study group at baseline, 6, 12, 24, and 36 months Data are mean (SD) unless otherwise stated. The effect estimates are based on the mixed model assuming no difference between groups at baseline. The QoL and fear of recurrence variables are continuous, and the estimates describe the mean difference in score between patients in the two groups. For anxiety and depression, data were zero-inflated. These estimates describe the exponential coefficients of anxiety and depression scores in the intervention group compared to the control group. Cohen’s d is a measure of effect size, and interpreted as small for Cohen’s d = 0·2, medium for Cohen’s d = 0·5, and large for Cohen’s d = 0·8 Table 2: Number of contacts and diagnostic imaging examinations during the first three years of follow-up by study group Data are numbers and mean (SD) per patient during the first three years of follow-up. 1 Most telephone consultations were scheduled as outpatient visits according to the protocol, but changed to telephone consultations due to the COVID-19 pandemic Citation Format: Lena Saltbæk, Pernille Bidstrup, Randi Karlsen, Beverley Høeg, Trine Horsboel, Federica Belmonte, Elisabeth Andersen, Vibeke Zoffmann, Anne Friberg, Mads Svendsen, Helle Christensen, Vesna Glavicic, Dorte Nielsen, Susanne Dalton, Christoffer Johansen. Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-09.

Quality of Life Outcomes After Pediatric Otitis Media Surgery: A Systematic Review and Meta-Analysis.

Systematically review of literature characterizing health-related quality of life (HRQoL) impact of surgery in pediatric otitis media (OM) patients, and meta-analysis of studies using the OM-6 questionnaire. Pubmed, EMBASE, Cochrane Library, Scopus. A systematic review of literature of studies evaluating HRQoL outcomes for OM patients managed by surgery. Two investigators independently reviewed abstracts and full-length articles. Risk of bias was assessed using the MINORS criteria and Cochrane Risk of Bias 2 tool. The search yielded 1272 studies, 50 underwent full-text review and 23 met inclusion criteria. Non-randomized studies were of moderate to good quality, while randomized trials had a high risk of bias. Age ranged from 6 months to 15 years. Race and socioeconomic factors were inconsistently reported. There were 11 HRQoL outcome measure instruments of which four were disease-specific. Eleven studies used OM-6 and nine were included in the meta-analysis. Pooled analysis of five studies showed a mean OM-6 change of 1.79 (95% CI: 1.53-2.06; 95% PI: 0.92-2.67; I2 = 68%) 4-6 weeks after surgery; a mean change of 1.87 (95% CI: 1.15-2.58; 98%) after 6 months across two studies; and a mean change of 1.64 (1.02 to 2.27; -6.35 to 9.64; 98%) after 9-13 months across three studies. There is no consistency in HRQoL instruments used to evaluate pediatric OM surgery outcomes in current literature with few RCTs. Meta-analysis showed a clinically significant large improvement in HRQoL 4-6 weeks after tympanostomy tube placement. N/A Laryngoscope, 2024.

Predictors of Health-Related Quality of Life Among Women Participating in an Appointment-Based Cardiac Rehabilitation Program.

An alternative patient-centered appointment-based cardiac rehabilitation (CR) program has led to significant improvements in health outcomes for patients with cardiovascular disease. However, less is known about the effects of this approach on health-related quality of life (HRQoL), particularly for women. We examined the effects of a patient-centered appointment-based CR program on HRQoL by sex and examined predictors of HRQoL improvements specifically for women. Data were used from an urban single-center CR program at Yale New Haven Health (2012-2017). We collected information on patient demographics, socioeconomic status, and clinical characteristics. The Outcome Short-Form General Health Survey (SF-36) was used to measure HRQoL. We evaluated sex differences in SF-36 scores using t tests and used a multivariate linear regression model to examine predictors of improvements in HRQoL (total SF-36 score) for women. A total of 1530 patients with cardiovascular disease (23.7% women, 4.8% Black; mean age, 64 ± 10.8 years) were enrolled in the CR program. Women were more likely to be older, Black, and separated, divorced, or widowed. Although women had lower total SF-36 scores on CR entry, there was no statistically significant difference in CR adherence or total SF-36 score improvements between sexes. Women who were employed and those with chronic obstructive pulmonary disease were more likely to have improvements in total SF-36 scores. Both men and women participating in an appointment-based CR program achieved significant improvements in HRQoL. This approach could be a viable alternative to conventional CR to optimize secondary outcomes for patients.

Impact of Spinal CSF Leaks on Quality of Life and Mental Health and Long-Term Reversal by Surgical Closure.

Spontaneous intracranial hypotension (SIH) caused by a spinal CSF leak is a multisymptom syndrome, which can dramatically affect physical and mental health. However, systematic data on health-related quality of life (HRQoL) and mental health are scarce. We hypothesized that surgical treatment leads to significant and sustained improvements in HRQoL and mental health in patients with SIH. In this single-center cohort study, we prospectively collected HRQoL and mental health data in patients undergoing surgical closure of a spinal CSF leak from September 2020 to November 2022. EuroQoL (EQ-5D-5L), including the health state index (EQ-Index) and the visual analog scale (EQ-VAS), measured HRQoL. The 21-item version of the Depression Anxiety Stress Scales (DASS-21) measured symptoms of mental health. Follow-ups were performed 3 and 6 months postoperatively. Primary outcome was the change in EQ-Index, EQ-VAS, and DASS-21 subscales. Secondary outcome was the impact of baseline depression symptoms on HRQoL outcomes following surgery. Seventy-four patients were included. EQ-VAS improved from 40 (interquartile range [IQR] 30-60) preoperatively to 70 (IQR 55-85) at 3 months and to 72 (IQR 60-88) at 6 months postoperatively (p < 0.001, respectively). EQ-Index increased from 0.683 (IQR 0.374-0.799) to 0.877 (0.740-0.943) at 3 months and to 0.907 (0.780-0.956) at 6 months postoperatively (p < 0.001, respectively). Depression, anxiety, and stress significantly improved after surgery. Preoperative depressive symptoms did not affect the HRQoL outcome. The severe impact of a spinal CSF leak on HRQoL and mental health significantly improved after closure of the leak. Higher levels of depressive symptoms do not predict worse outcomes and should not discourage invasive treatment. Further systematic evaluation of outcomes, with special regard to quality of life, is needed, as it allows a comparison of symptom burden between SIH and more familiar diseases as well as a comparison of different treatment modalities in future studies.

Effect of pulmonary rehabilitation on functional status dyspnea and quality of life among post COVID-19 patients

Objectives To determine the Effect of pulmonary rehabilitation on functional status dyspnea and quality of life among post-COVID-19 patients. Methods The study utilized an experimental study designwith a total of 120 participantsto examine the effects of pulmonary rehabilitation. The participants were divided into two groups: Group A (experimental group) and Group B (control group). Demographic variables such as age, weight, and height were collected. Health-related quality of life (HRQL), post-COVID-19 functional status, and perceived exertion were assessed before and after the intervention. Results Group A demonstrated a higher mean age than Group B, indicating a significant age difference between the two groups, with no significant difference observed in weight and height. Following the intervention, Group A exhibited significant improvement in HRQL, post-COVID-19 functional status, and perceived exertion compared to Group B. Conclusion Pulmonary rehabilitation had positive effects on health-related quality of life, post-COVID-19 functional status, and perceived exertion. The experimental group benefited from improved HRQL, suggesting an overall enhancement in their well-being. The study provides preliminary evidence supporting the effectiveness of pulmonary rehabilitation as an intervention for improving outcomes in individuals post-COVID-19.

Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). Single-center retrospective cohort study. Large general teaching hospital. A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Minimally invasive sacroiliac joint fusion using triangular titanium implants versus nonsurgical management for sacroiliac joint dysfunction: a systematic review and meta-analysis.

Minimally invasive sacroiliac joint (MISIJ) fusion is a surgical option to relieve SIJ pain. The aim of this systematic review and meta-analysis was to compare MISIJ fusion with triangular titanium implants (TTI) to nonoperative management of SIJ dysfunction. We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. We included prospective clinical trials that compared MISIJ fusion to nonoperative management in individuals with chronic low back pain attributed to SIJ dysfunction. We evaluated pain on visual analogue scale, Oswestry Disability Index (ODI) score, health-related quality of life (HRQoL) using the 36-Item Short Form Health Survey (SF-36) physical component (PCS) and mental component summary (MCS) scores, patient satisfaction, and adverse events. A total of 8 articles representing 3 trials that enrolled 423 participants were deemed eligible. There was a significant reduction in pain score with MISIJ fusion compared with nonoperative management (standardized mean difference [SMD] -1.71, 95% confidence interval [CI] -2.03 to -1.39). Similarly, ODI scores (SMD -1.03, 95% CI -1.24 to -0.81), SF-36 PCS scores (SMD 1.01, 95% CI 0.83 to 1.19), SF-36 MCS scores (SMD 0.72, 95% CI 0.54 to 0.9), and patient satisfaction (odds ratio 6.87, 95% CI 3.73 to 12.64) were significantly improved with MISIJ fusion. No significant difference was found between the 2 groups with respect to adverse events (SMD -0.03, 95% CI -0.28 to 0.23). Our analysis showed that MISIJ fusion with TTI shows a clinically important and statistically significant improvement in pain, disability score, HRQoL, and patient satisfaction with a similar adverse event profile to nonoperative management in patients with chronic low back pain attributed to SIJ dysfunction.

P854 Tofacitinib demonstrates preliminary efficacy in induction of remission in chronic pouchitis

Abstract Background Pouchitis is common following total proctocolectomy for ulcerative colitis (UC) and ileal pouch-anal anastomosis (IPAA) and generally responds to antibiotics. However, up to 20% of patients develop either antibiotic-dependent or antibiotic-refractory pouchitis, collectively referred to as chronic pouchitis. Methods We report our preliminary induction results from a multi-center open label induction with randomized withdrawal trial to assess the efficacy of tofacitinib in chronic pouchitis. All eligible participants received 10mg tofacitinib twice daily for 8 weeks, with an additional 8 weeks of therapy given to patients with an inadequate initial clinical response. The primary endpoint was clinical response (a reduction of clinical PDAI≥2) at week 8. Secondary endpoints included endoscopic response (a reduction of endoscopic PDAI≥2), mPDAI remission (modified pouchitis disease activity index (mPDAI)≤ 4 and a reduction of mPDAI≥2), mPDAI response (a reduction of mPDAI≥2) and improvement in health-related quality of life (HRQoL) using the short inflammatory bowel disease questionnaire (SIBDQ). Serum cytokine levels was analyzed using LEGENDplex human inflammation panel 1. Univariate analysis was performed to identify clinical and biochemical predictors of response to tofacitinib. Results A total of 33 patients with chronic pouchitis (Table 1) were included in the preliminary analysis. The clinical and endoscopic response rates at week 8 were 55% and 58% respectively, with a median improvement of 1 (p&amp;lt;0.05) and 3 (p&amp;lt;0.05) respectively (Figure 1). The mPDAI remission rate was 49% at week 8 with an mPDAI response rate of 73%. Endoscopic responders exhibited significant improvements in endoscopic oedema, granularity, friability, and mucous exudate (p&amp;lt;0.05). There was significant improvement in HRQoL, with the median SIBDQ score increasing from 35 at baseline to 54 at week 8 (p&amp;lt;0.05). Eleven patients received a further 8 weeks of therapy with a clinical response rate of 36%, yielding an overall response rate including extended induction of 67%. Univariate analysis did not reveal significant differences in baseline characteristics, clinical, or biochemical markers between responders and non-responders. However, a history of corticosteroid use (p=0.08) and high baseline levels of faecal calprotectin (p=0.15) demonstrated a non-significant association with treatment response. Elevated baseline serum levels of IL-1b, IFN-a and IL-33 were associated with a treatment response at week 8 (p&amp;lt;0.05). Conclusion Tofacitinib demonstrated preliminary efficacy in inducing both clinical and endoscopic response in patients with chronic pouchitis who have undergone IPAA for UC.

Elderly Patients Show Substantial Improvement in Health-Related Quality of Life After Surgery for Degenerative Cervical Myelopathy Despite Medical Frailty: An Ambispective Analysis of a Multicenter, International Data Set.

We assessed the relationship between Modified Frailty Index-5 (mFI-5) and neurological outcomes, as well as health-related quality of life (HRQoL) measures, in elderly patients with degenerative cervical myelopathy (DCM) after surgery. Data from 3 major DCM trials (the Arbeitsgemeinschaft für Osteosynthesefragen Spine Cervical Spondylotic Myelopathy-North America, Cervical Spondylotic Myelopathy-International, and CSM-PROTECT studies) were combined, involving 1047 subjects with moderate to severe myelopathy. Patients older than 60 years with 6-month and 1-year postoperative data were analyzed. Neurological outcome was assessed using the modified Japanese Orthopaedic Association score, while HRQoL was measured using the 36-Item Short Form Health Survey (SF-36) (both Physical Component Summary [SF-36 PCS] and Mental Component Summary [SF-36 MCS] scores) and the Neck Disability Index. Frail (mFI ≥2) and nonfrail (mFI = 0-1) cohorts were compared using univariate paired statistics. The final analysis included 261 patients (62.5% male), with a mean age of 71 years (95% CI 70.7-72). Frail patients (mFI ≥2) had lower baseline modified Japanese Orthopaedic Association scores (10.45 vs 11.96, P < .001), SF-36 PCS scores (32.01 vs 36.51, P < .001), and SF-36 MCS scores (39.32 vs 45.24, P < .001). At 6-month follow-up, SF-36 MCS improved by a mean (SD) of 7.19 (12.89) points in frail vs 2.91 (11.11) points in the nonfrail group (P = .016). At 1 year after surgery, frail patients showed greater improvement in both SF-36 PCS and SF-36 MCS composite scores compared with nonfrail patients (7.81 vs 4.49, P = .038, and 7.93 vs 3.01, P = .007, respectively). Bivariate regression analysis revealed that higher mFI-5 scores correlated with more substantial improvement in overall mental status at 6 months and 1 year (P = .024 and P = .009, respectively). mFI-5 is a clinically helpful signature to reflect the HRQoL status among elderly patients with DCM. Despite preoperative medical frailty, elderly patients with DCM experience significant HRQoL improvement after surgery. These findings enable clinicians to identify elderly patients with modifiable comorbidities and provide informed counseling on anticipated outcomes. II.

Changes in activities-specific balance confidence of active unilateral transtibial prosthesis users after provision of a self-aligning ankle foot.

Self-aligning ankle feet have an increased range of motion and are marketed to improve compliance over uneven terrain and increase function and balance; however, much of the existing literature focuses on the biomechanical aspect of these prostheses as opposed to patient-reported measures. To compare activities-specific balance confidence (ABC), health-related quality of life (HR-QoL), perceived mobility, gait speed, and step length before and after provision of a self-aligning ankle foot in the active unilateral transtibial prosthesis user. Retrospective analysis of prospectively collected data. Patient-reported and functional measures were captured for 85 users who were provided with a self-aligning ankle foot. Measures were recorded immediately before self-aligning ankle foot provision and again at 6 months afterward. The primary outcome was the ABC Score, along with the following secondary measures; HR-QoL using EQ-5D-5L Health Index Prosthetic Limb User Survey of Mobility and 10-meter timed walk test. The median age of the cohort was 55.2 years old and 71% were males, with the majority having their transtibial amputation due to trauma. There was a statistically significant improvement in ABC from 76 to 86% (p < 0.001) with a medium effect size. There was no statistically significant improvement in HR-QoL (p = 0.051), Prosthetic Limb User Survey of Mobility (p = 0.043), time taken to walk 10 m (p = 0.15) and step length (p = 0.003). Self aligning ankle feet increased ABC and step length with no detrimental effect on HR-QoL, perceived mobility or walking speed in those with a unilateral trans-tibial amputation.

Cardiac Rehabilitation Program Effect on Health-Related Quality of Life Among Patients With Coronary Artery Bypass Grafts.

Coronary artery bypass graft (CABG) necessitates modification in patients' lifestyle after discharge, which leads to a decrease in their health-related quality of life (HRQOL). Hence, cardiac rehabilitation programs (CRPs) are needed. This study aimed to explore the effect of a CRP on HRQOL and physiological factors on CABG patients after discharge. The study used a quasiexperimental pre-/posttest design. Two experimental and control groups tested with 30 patients with CABG surgery participated in a rehabilitation center after discharge. The Arabic version of the Nottingham Health Profile for measuring HRQOL was used. In addition to several sociodemographic and physiological variables, findings indicated a significant improvement in HRQOL and its domains for the experimental group after CRP (mean = 2.06, SD = 1.7) when compared with the control group (mean = 19.9, SD = 3.1; P = .01), as well as some physiological variables 3 months after surgery. The CRP is an important intervention that administrators and cardiologists should take into consideration for CABG patients. It improves not just their HRQOL but also many physiological indicators.

Older Adults with Acute Myeloid Leukemia (AML) Experience Improvement in Health-Related Quality of Life (HRQoL) Scores with Intensive Therapy: Prospective Study from ECOG-ACRIN (EA) E2906 Phase 3 Trial

Background There is limited prospective or comparative data evaluating the HRQoL impact of intensive chemotherapy (IC) in older adults (age ≥60 years) with AML. In the recent EA E2906 phase 3 study of '7&amp;3' (daunorubicin &amp; cytarabine) vs. clofarabine (CLO), a putative lower intensity therapy, we incorporated a prospective patient-reported outcomes (PRO) assessment of HRQoL and fatigue to understand treatment impact from the patients' (pts) perspective. Methods E2906 study design and results have been presented previously [n=727, med. age 68 years (range 60-86), randomized 1:1 to ‘standard’ ‘7&amp;3‘ &amp; high dose cytarabine (Arm A) vs. single agent CLO (Arm B), as remission induction (Step 1) and consolidation (Step 2), respectively]. There was no difference in composite complete remission (CCR, 50%) or 30-day mortality rates (8.5%), and in primary analysis CLO was inferior for Overall Survival. HRQoL was a key secondary protocol endpoint. PROs assessed HRQoL and leukemia-specific symptoms and concerns using Functional Assessment of Cancer Therapy-Leukemia scale (FACT-Leu), &amp; Fatigue using FACT-Fatigue subscale. PROs were administered at prespecified time points: (1) Baseline; (2) Cycle 1 at nadir (approx. Day 15); (3) End of Step 1 restaging (approx. D 40); (4) Beginning of Step 2 (1 st consolidation, approx. D 45); and (5) 2 nd cycle consolidation/End Step 2 (approx. D 60). The FACT-Leu Trial Outcome Index ( TOI) was calculated by summing physical well-being, functional well-being, and leukemia-specific concerns subscales to create a single composite score. Higher TOI scores correspond to better HRQoL. The primary endpoint was to evaluate TOI difference from randomization to day 30 after induction therapy between arms, evaluated using Wilcoxon rank sum test. We also compared Clinically Meaningful differences (CMiD) in TOI (defined as patient change ≥½ standard deviation from baseline TOI) between arms, using the X2 test. Pts not completing at least 2 assessment forms (including baseline) were excluded. Testing of constructs of Physical Well-being (PWB), Functional, Leukemia &amp; Fatigue scales demonstrated high Cronbach's a values (a &amp;gt;0.7) except for PWB (a=0.672) at a single time point (End of Step 2). Results Baseline TOI was available for n=489, and 364 pts (n=182 each Arm) were evaluable in this planned analysis. Evaluating CMiD during Cycle 1 induction, pts in Arm B were less likely to experience ‘Worse’ TOI score (32% vs. 40.7%, Arm A), more likely to maintain stable TOI scores (49.1% vs. 39%, Arm A), and had a similar proportion of ‘Better’ TOI scores (20.3%, A vs. 18.9%, B) although differences were not significant (p=0.1389). Conversely in cycle 1 consolidation, more patients in Arm A experienced Better TOI (45.1% vs. 29.2%, Arm B), fewer had stable TOI (45.1% vs. 58.3%, Arm B), and rates of ‘Worse’ TOI were similar (9.8%, A vs 12.5%, Arm B), again differences were not significant (p=0.2616). There was no difference in Fatigue scores between Arms (p=0.49). We evaluated whether TOI and Fatigue scores could predict the ability to complete protocol therapy. In univariate analysis baseline TOI (p=0.0059) and Fatigue (p=0.0057) were associated with Step 1 completion, however on multivariate analysis (adjusting for age, sex, and Arm) were no longer significant [TOI, Odds Ratio (OR) 1.03 (0.98-1.08, p=0.27); Fatigue, OR 1.03 (0.96-1.11, p=0.42)]. There was a borderline association of TOI with Step 2 completion [TOI OR 1.10 (1.00-1.23, p=0.06)]. Using a multivariable linear mixed effects model, we observed similar and significant changes in TOI scores in both Arms, demonstrating the effect of IC &amp; CLO on HRQoL (Figure). Comparing to baseline, TOI scores decreased significantly at C1 induction nadir (-4.0873, p&amp;lt;0.0001), and increased by 5.0762 (p=0.0004) at end Step 1, by 6.9047 at cycle 1 consolidation (p&amp;lt;0.0001), and by 11.4601 (p&amp;lt;0.0001) at end Step 2. Differences were mainly apparent in those who achieved CCR, and there was significant attrition in PRO responses in non-CCR pts. Conclusions Older adults experienced significant improvement in HRQoL after nadir regardless of therapy, and those achieving CCR report significantly higher scores. We did not observe differences in leukemia specific HRQoL or fatigue between treatment Arms (7&amp;3 vs. CLO). Patient-reported HRQoL &amp; Fatigue was not predictive of completion of protocol therapy. These results serve as a benchmark for expectations with IC in older adults.

Real-World Outcomes and Digitally Monitored Quality of Life in Voxelotor-Treated Patients with Sickle Cell Disease

Background Voxelotor is a haemoglobin oxygen-affinity modulator that leads to inhibited red blood cell sickling, has demonstrated reduced markers of haemolysis and anaemia improvement, and is one of a small number of novel disease-modifiers approved in the US for sickle cell disease (SCD) treatment. It has marketing authorisation in the UK and is currently undergoing reimbursement appraisal. The modelled impact of voxelotor on health-related quality of life (HRQoL)remains a key issue in current trial evidence. Therefore, the need for real-world data and understanding of patient-reported outcomes and experiences following treatment remains critical. Aims This work sought to characterise the side effects, HRQoL, and wearable-captured sleep and activity metrics of SCD patients in the UK, before and after treatment initiation. Methods Feedback from 19 SCD patients who had received voxelotor was captured through an online survey (Aug 2022-Mar 2023). 15 of these patients were also consented and enrolled within an artificial intelligence (AI) platform of over 600 SCD patients that combined genomic, medical record, real-time wearable biometric, and patient-reported outcomes data into a single platform. This included a mobile phone app for day-to-day QoL questionnaire (EQ-5D-5L) entry and an FDA-cleared smartwatch to capture sleep quality and physical activity. Convenience sampling selected data for a 17-patient (89%) subcohort with available pre- and post-voxelotor initiation EQ-5D-5L scores, either through the platform or follow-up survey snapshots. For each patient, this was analysed up to the date on which they completed the survey. EQ-5D-5L was also analysed in comparison to platform patients who had hydroxyurea (HU) in the past (n=19) or were receiving HU at the time of analysis (n=60), in addition to those with no recorded HU use (n=116). Additional analysis compared pre- and post-initiation activity levels (n=6), 4 of whom also had sleep quality data. Results The 19 surveyed patients had received voxelotor for a mean ± SD (range) of 194 ± 415 (17-1,826) days. 11 (58%) had also received HU and 1 (5%) received crizanlizumab. The mean age was 33 ± 13 (14-52) years, 12 (63%) were male, and 16 (84%) had HbSS. Side effects were reported in 8 (42%) patients, mostly diarrhea (6, 32%), stomach pains (2, 11%), and nausea/vomiting (2, 11%). Comparison of the 17-patient pre- to post-voxelotor cohort showed a statistically significant (p&amp;lt;0.001) increase in pooled EQ-5D-5L scores, from 0.558 ± 0.314 to 0.761 ± 0.262 (Figure 1). Post-initiation EQ-5D-5L for these 17 patients was significantly higher than for those receiving HU at 0.731 ± 0.232 (p=0.023) or who had previously received HU at 0.704 ± 0.256 (p=0.040) (Figure 2). Analysis of pre- and post-initiation wearables data saw increased deep sleep in 50% (2/4) and decreased nightly wakeups in 50% (2/4) of patients. Pooled pre- and post-initiation data showed a significant difference in deep sleep (43% vs. 47%, p=0.011). The mean number of steps and distance increased for 50% (3/6) of patients. While soft activity (Metabolic Equivalent of Task (METs): &amp;lt;3, e.g., sleeping, sitting quietly, slow walk) decreased for 67% (4/6) of patients, moderate activity (MET: 3-6, e.g., fast walk, cleaning, gardening) increased in 67% (4/6) and intense activity (MET: &amp;gt;6, e.g., running, hiking) increased in 60% (3/5). Conclusions Our data present a different lens to the voxelotor treatment experience of patients in the UK, with a side effect profile similar to that of other published studies. We demonstrated that EQ-5D-5L increased by 0.203 pre- to post-initiation, and was 0.030 and 0.057 higher than those receiving HU and those who had previously received HU, respectively, in the voxelotor-treated group. These are in line with the ranges of minimally important differences (0.030-0.098) reported for the EQ-5D-5L in other chronic diseases. As such and despite the limitations of small sample size and variability in pre- to post-initiation changes, a statistically significant improvement in HRQoL was observed after initiating voxelotor, as well as in comparison to HU treatment pathways. Similarly, pre- and post-initiation wearables data demonstrated early positive trends in voxelotor's impacts on sleep and activity using an FDA-cleared device, highlighting a need for further research into these metrics and the impact of SCD-modifying treatment.

Near-Optimal Recovery Within 3 Months: Investigating Health-Related Quality of Life and Functional Outcomes After Single-Stage Bilateral Hip Replacement for Osteoarthritis.

Single-stage bilateral hip replacement (SSBHR) is a safe and successful orthopaedic intervention for patients suffering from bilateral osteoarthritis of the hip. Data on short- and mid-term recovery outcome studies are, unfortunately, scarce. The purpose of this study was to investigate the change in the functional measures and quality of life after SSBHR and to determine the patient's willingness to undergo the same procedure again. Data were prospectively collected and analyzed from patients with bilateral symptomatic hip osteoarthritis who underwent SSBHR from January 2019 until December 2020. Patients were excluded only if they failed to sign an informed consent or were unable to fill out questionnaires due to language or cognitive problems. Preoperatively and 3 and 12 months after surgery, health-related quality of life (HRQOL) and physical functioning were measured. Twelve months after surgery, patient satisfaction (willingness to undergo the same procedure again) was obtained. Complications, blood loss, and length of stay (LOS) were abstracted from the clinical notes and the electronic patient files. Patients improved significantly on all domains of HRQOL (16.0%-59.7%) and physical functioning (14.7%-15.8%) 3 months after surgery in comparison with preoperatively. No improvement was reported on HRQOL and physical functioning, except the Timed Up and Go score (14.1%), at 12 months after surgery in comparison with 3 months. No major or minor complications were found, and LOS was 2.9 days on average. One year after the surgery, all patients expressed satisfaction as suggested by their willingness to undergo the same surgical procedure again. Our study demonstrates that SSBHR offers a rapid recovery time and significant improvements in both functional status and HRQOL within 3 months after surgery. These findings can inform healthcare professionals and patients, suggesting that SSBHR is a viable treatment option for patients with bilateral hip osteoarthritis. Further research, including multicenter randomized controlled trials, is recommended to compare the recovery outcomes of SSBHR with two-stage bilateral hip replacement and confirm our findings.

Health-Related Quality of Life effects of rectus repair during body contouring surgery in post-bariatric patients: A prospective study.

Massive weight loss after bariatric surgery often leads to psychological and physical dissatisfaction, resulting in an increased demand for body contouring surgery (BCS). As a result of these surgeries, Health-Related Quality of Life (HRQL) is improved. However, little is known about the impact of rectus plication during BCS on HRQL. This multicenter prospective cohort study included post-bariatric primary BCS patients with a minimum follow-up period of 12 months between January 2016 and December 2019. Patients were divided into two groups based on plication status. Using the BODY-Q, a patient-reported outcome measure, HRQL was measured preoperatively and at least 12 months postoperatively. Six HRQL domains were investigated: Body image, physical function, psychological function, sexual function, social function, and physical symptoms. A total of 305 patients were included in this study: 201 of these patients (66%) did not undergo plication, while 104 patients (34%) did. HRQL improved significantly 12 months after BCS in all measured domains, regardless of plication status. Delta scores were significantly higher in the plication group in all HRQL domains. After adjusting for baseline score and other significant variables through multivariate linear regression, three scales remained significant: Body image (P = 0.001), psychological function (P = 0.035), and sexual function (P = 0.035). Three out of six domains showed significant improvement in HRQL after BCS with rectus plication, predominantly body image. Preoperative counseling and surgical planning could benefit from this information. The long-term effects of rectus plication on HRQL should be explored in future research.

A Real-World Prospective Cohort Study of Patients With Newly Diagnosed Crohn's Disease Treated by a Multidisciplinary Team: 1-Year Outcomes.

Real-world data on outcomes of patients with newly diagnosed Crohn's disease (ndCD) is limited. We aimed to assess the achievement of corticosteroid-free clinical remission (CS-free CR) and other therapeutic targets 1 year after diagnosis in a cohort of patients with ndCD treated by a multidisciplinary team (MDT). A prospective observational cohort study was conducted on consecutive treatment-naïve adults with ndCD. Patients received management at the treating physician's discretion, along with a tailored nutritional plan provided by an inflammatory bowel disease (IBD)-oriented dietitian. Patients were guided and educated by an IBD nurse, with flexible communication access to the IBD team. Therapeutic targets were assessed at 1 year. Multivariable logistic regression was used to evaluate predictors of CS-free CR. Seventy-six patients (50% female) with a median age of 27 (22-39) years were eligible. Over 75% of patients were assessed by IBD-oriented dietitians and the IBD nurse. Within a median of 4.3 (2.5-6.7) months from diagnosis 60.5% initiated biologics (96% anti- tumor necrosis factor). Dietary intervention was applied to 77.6% of the cohort, either monotherapy (33.9%) or add-on (66.1%). At 1 year, 64.5% of patients achieved sustained CS-free CR, 56.6% biochemical remission, 55.8% endoscopic response, 44.2% endoscopic remission, 30.8% deep remission, and in 39.5% there was an improvement in health-related quality of life (HRQoL). Predictors for CS-free CR were uncomplicated phenotype (B1/P0), lower body mass index, and lower patient-reported outcome 2 scores at diagnosis. In a real-world setting at a tertiary medical center, a cohort of ndCD patients treated by an MDT resulted in favorable 1-year outcomes. Over 60% achieved CS-free CR, along with significant improvements in biomarkers and HRQoL.

Effects of Comprehensive Geriatric Assessment (CGA) Guided Care vs. Usual Care on Overall Survival (OS) and Health-Related Quality of Life (HRQL) for Older Adults with Cancer: A Systematic Review of Randomized Trials (RCTs)

There is evidence from RCTs demonstrating that our current models of CGA guided care can reduce treatment related toxicity effectively. However, it is unclear if CGA guided care can improve OS and HRQL. We aimed to determine the effect of CGA guided care compared with usual care on OS and HRQL. We searched MEDLINE, EMBASE, CENTRAL and CINAHL from date of inception to October 2022 for RCTs comparing CGA guided care with usual care for patients with cancer who were 60 years old and greater on OS and HRQL. We assessed the risk of bias using Cochrane ROB 2 tool. We performed the meta-analysis using random-effects models. The I2 statistic was adopted to assess heterogeneity between studies. We adopted the Synthesis without meta-analysis approach for data not amenable for meta-analysis. The certainty of evidence was rated using the GRADE approach. This study is registered with Cochrane Database of Systematic Reviews. We found 15 eligible RCTs including 3507 participants. There are variations in types of CGA used with 4 trials using CGA to recommend oncology treatment regimen and 10 trials making no recommendation on oncology treatment. The implementation of CGA recommendations were carried out by a geriatrician in 14 trials, but by the primary oncologist in 1 trial. Six, five and four RCTs were judged to have low, unclear and high risk of bias respectively. Eleven and six RCTs reported OS and HRQL outcomes respectively. There was no significant difference between CGA guided and usual care for OS (Hazard Ratio 1.02, 95% CI (0.90 to 1.15), I2 = 0%; moderate certainty). There was significant variation in the measurement of HRQL in terms of instruments, summary measures and time points. EORTC QLQ C30 and ELD 14 were used in 3 RCTs. The effects of CGA guided care on HRQL were inconsistent. Two trials using FACT-G or Elderly Functional Index (ELFI) reported significant improvement in HRQL at 3 and 6 months post randomization. Meta-analysis of the mean difference in the change of the EORTC QLQ C30 and E14 HRQL scores relative to baseline at 6 months post randomization demonstrated no significant difference between CGA guided and usual care for HRQL across various domains (moderate certainty evidence). The current models of CGA guided care did not improve OS and had variable effects on HRQL when compared to usual care in older patients with cancer. The inconsistent effects of CGA guided care on HRQL suggest that CGA guided care may have more significant effects on the social and functional outcomes domains, aspects of HRQL that is predominantly measured in FACT-G and ELFI score respectively. There is also heterogeneity in how CGAs are performed and implemented. Future research should focus on developing new models of CGA guided care to improve OS and HRQL.

Improved Quality of Life in Metastatic Castration-Resistant Prostate Cancer Patients Receiving Consecutive Cycles of 177Lu-PSMA I&T.

The aim of this retrospective analysis was to evaluate health-related quality of life (HRQoL) for patients with metastatic castration-resistant prostate cancer (mCRPC) receiving consecutive cycles of 177Lu-prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) using the reliable and validated European Organisation for Research and Treatment of Cancer core quality-of-life (QoL) questionnaire. In addition, differences in HRQoL between patients with early discontinuation of treatment because of disease progression and patients who were defined as eligible for treatment continuation were analyzed. Methods: In total, 60 mCRPC patients were included in this analysis. The European Organisation for Research and Treatment of Cancer core QoL questionnaire was completed at baseline, before each treatment cycle up to the sixth treatment cycle, and at the time of PSMA-ligand PET/CT scans after the second and fourth treatment cycles. QoL assessment included global health status, functional scales, and symptom burden during treatment. Results: Global health was significantly improved at the second and fourth cycles of 177Lu-PSMA RLT (P = 0.014 and P = 0.039, respectively). In line with this, role and emotional functioning showed significant improvements at the second and fourth treatment cycles (role functioning, P = 0.045 and P = 0.048, respectively, and emotional functioning, P = 0.035 and P = 0.007, respectively). In addition, compared with baseline, fatigue and pain were significantly alleviated at the second and fourth treatment cycles (pain, P = 0.035 and P = 0.034, respectively, and fatigue, P = 0.042 and P = 0.041, respectively). Other aspects of HRQoL, even if not significantly improved, remained stable over time, except for deterioration of fatigue at the study's end (P = 0.014) and reduction of dyspnea at the second treatment cycle (P = 0.012). Patients with early discontinuation of treatment showed a concordant decline in HRQoL. Conclusion: mCRPC patients showed significant improvement in HRQoL in the course of treatment with 177Lu-PSMA RLT. Furthermore, patients with early discontinuation of treatment showed an analogous decline in HRQoL.