Changes In Quality Of Life Research Articles

Sex and gender differences in health-related quality of life in individuals treated with incremental and conventional hemodialysis.

Women treated with hemodialysis report lower health-related quality of life (HRQoL) compared with men. Whether this is related to sex-specific (biological) (e.g. under-dialysis due to body composition differences) or gender-specific (sociocultural) factors (e.g. greater domestic/caregiver responsibilities for women) is unknown. We examined the association between sex assigned at birth, gender score and HRQoL in individuals initiating conventional and incremental hemodialysis. In this prospective multi-center cohort study, incident adult hemodialysis patients were recruited between 1 June 2020 and 30 April 2022 in Alberta, Canada. Sex assigned at birth and gender identity were self-reported. Gender-related characteristics were assessed by self-administered questionnaire to derive a composite measure of gender. The primary outcome was change in Kidney Disease Quality of Life 36 physical (PCS) and mental (MCS) component scores after 3 months of hemodialysis. Sixty participants were enrolled (conventional hemodialysis: 14 female, 19 male; incremental hemodialysis: 12 female, 15 male). PCS improved from baseline with conventional (P=.01) but not incremental (P=.52) hemodialysis in female participants. No difference in MCS was observed by hemodialysis type in female participants. Gender score was not associated with changes in PCS in female participants, irrespective of hemodialysis type. Higher gender score was associated with increased MCS with incremental (P=.04), but not conventional (P=.14), hemodialysis (P=.03 conventional vs incremental) in female participants. No change in PCS or MCS was seen in male participants, irrespective of hemodialysis type or gender score. In this exploratory study, conventional hemodialysis was associated with improved PCS in female participants, while incremental hemodialysis was associated with improved MCS in female participants with more roles and responsibilities traditionally ascribed to women. Large prospective studies are required to further investigate these relationships.

Genetic markers of late radiation toxicity in the era of image-guided radiotherapy: lower toxicity rates reduce the predictive value of γ-H2AX foci decay ratio in patients undergoing pelvic radiotherapy

BackgroundA predictive assay for late radiation toxicity would allow more personalized treatment planning, reducing the burden of toxicity for the more sensitive minority, and improving the therapeutic index for the majority. In a previous study in prostate cancer patients, the γ-H2AX foci decay ratio (γ-FDR) was the strongest predictor of late radiation toxicity. The current study aimed to validate this finding in a more varied group of patients with pelvic cancer. Additionally, the potential correlation between the γ-FDR and patient-reported outcomes was investigated.MethodsProstate and gynecological cancer patients with ≥ 24 months of follow-up were included in the current analysis. Toxicity was evaluated by physician (CTCAE version 4) and patient (EORTC questionnaires). γ-FDRs were determined in ex vivo irradiated lymphocytes. Correlation between γ-FDR and toxicity was assessed using both linear and logistic regression analyses. The highest toxicity grade recorded during follow-up was used. The association between global quality of life and γ-FDR was tested by comparing the change in quality of life over time in patients with γ-FDR < or ≥ 3.41, a previously established threshold.ResultsEighty-eight patients were included. Physician-assessed and patient-reported cumulative grade ≥ 2 toxicity was 25% and 29%, respectively; which is much lower than in the previous cohort (i.e., 51% CTCAE grade ≥ 2). Patients with toxicity exhibited less favorable dose-volume parameters. In men, these parameters showed significant improvement compared to the previous cohort. The proportion of patients with a low γ-FDR increased with severity of toxicity, but this trend was not statistically significant. In addition, a γ-FDR < 3.41 was not correlated with the development of moderate to severe toxicity. Post-treatment decline in global quality of life was minimal, and similar for patients with γ-FDR < or ≥ 3.41.ConclusionsIn the present study, the γ-H2AX foci decay ratio could not be validated as a predictor of late radiation toxicity in patients with pelvic cancer. Improved radiotherapy techniques with smaller irradiated bladder and bowel volumes have probably resulted in less toxicities. Future studies on genetic markers of toxicity should be powered on these lower incidences. We further recommend taking persistency, next to severity, into consideration.

Laparoscopic Pylorus Preserving Gastrectomy vs Distal Gastrectomy for Early Gastric Cancer; A Multicenter Randomized Controlled Trial (KLASS-04).

To evaluate the long-term outcomes of laparoscopic pylorus preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer (EGC). PPG is considered as a function preserving surgery for EGC. However, there has been no multicenter randomized controlled trial comparing PPG with DG until now. A multicenter randomized controlled trial (KLASS-04) with 256 patients with cT1N0M0 gastric cancer located in the mid portion of the stomach was conducted. The primary endpoint was the incidence of dumping syndrome at postoperative 1 year. Secondary endpoints included survival and recurrence, gallstone formation, nutritional parameters, gastroscopic findings, and quality of life (QOL) for 3 years. In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at one year postoperatively (13.2% in LPPG vs. 15.8% in LDG, P=0.622). Gallstone formation after surgery was significantly lower in LPPG than in LDG (2.33% vs. 8.66%, P=0.026). Hemoglobin (+0.01 vs. -0.76gm/dL, P<0.001) and serum protein (-0.15 vs. -0.35gm/dL, P=0.002) were significantly preserved after LPPG. However, reflux esophagitis (17.8% vs. 6.3%, P=0.005) and grade IV delayed gastric emptying (16.3% vs. 3.9%, P=0.001) were more common in LPPG. Changes in body weight and postoperative QOL were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence of in each group, P=0.98). LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.

Prospective Assessment of Quality of Life and Patient-Reported Toxicities Over the First Year After Chimeric Antigen Receptor T-Cell Therapy

Chimeric antigen receptor (CAR) T-cell therapy has transformed survival outcomes in patients with relapsed and refractory large B-cell lymphoma (LBCL), but it is associated with a variety of side effects. This study examined changes in patient-reported quality of life (QoL) and toxicities, as well as risk factors for worse QoL and toxicities, in the first year after treatment. Patients with LBCL completed questionnaires assessing QoL and toxicity severity before infusion, and 90, 180, and 360 days after infusion. Mixed models were used to examine changes in QoL and toxicities over time, and clinical moderators of change in QoL and toxicities. Patients reported improvements in physical functioning and fatigue in the year after treatment (P values <.01), but there were no changes in pain, anxiety, or depression over time. Patients with active disease at day 90 reported more physical dysfunction at all postinfusion timepoints (Ps ≤ .01) compared to patients who responded to treatment. Similarly, patients with active disease at day 90 reported worsening depression over time, such that at day 360, depressive symptoms were worse for patients with active disease than patients without active disease (P = .02). Patients treated with 4+ lines of prior therapy reported worsening pain and anxiety over time, such that at day 360, both pain and anxiety were significantly worse for patients previously treated with 4 of more lines of therapy than patients treated with fewer lines of therapy (Ps ≤ .01). Regarding toxicities, patients reported decreasing overall toxicity burden up to day 180, with subsequent worsening at day 360 (P = .02). Most patients reported at least one or two grade 2 toxicities at each timepoint. Patients demonstrated unchanging or improved QoL after treatment with CAR T-cell therapy, but active disease and greater prior lines of therapy were associated with worse QoL outcomes over time. Toxicity severity also improved during the first 6 months post-treatment, but worsened thereafter, particularly among patients with active disease after treatment.

Changes in health-related quality of life, depression, and fear of progression during oncological inpatient rehabilitation and beyond: a longitudinal study

PurposeStudies evaluating oncological inpatient rehabilitation rarely include follow-up intervals beyond 6 months and larger proportions of patients other than those with breast cancer. Therefore, this study investigated changes in health-related quality of life (HRQoL), depression, and fear of progression of patients with breast, colorectal, or prostate cancer from the beginning to the end of oncological rehabilitation and a 9-month follow-up.MethodsThree hundred seventy-seven patients with breast, colorectal, or prostate cancer undergoing oncological inpatient rehabilitation (median age 61 years, 49% female) completed the EORTC QLQ-C30, the PHQ-9, and the FoP-Q-SF at each measurement point. Data analysis used 3 (tumor site) × 3 (time of measurement) repeated measures ANCOVAs with patient age and time since diagnosis as covariates. At each time point, we also compared our sample to the general population on the measures used.ResultsHaving controlled for the covariates, we found significant effects of tumor site, which were small except for Diarrhea. Effects of time of measurement were often significant and in part at least medium in size indicating improvement of HRQoL and depression during rehabilitation. At follow-up, some HRQoL domains and depression deteriorated. Women with breast cancer, in particular, showed a greater decrease in emotional functioning then. Compared to the general population, the sample’s HRQoL and depression were significantly worse on most occasions.ConclusionOncological inpatient rehabilitation may improve HRQoL. The subsequent and in part differential deterioration in some HRQoL domains suggests a need for further follow-up care within survivorship programs.

Metronomic chemotherapy using capecitabine and cyclophosphamide in metastatic breast cancer – efficacy, tolerability and quality of life results from the phase II METRO trial

BackgroundChemotherapy is commonly used in metastatic breast cancer (MBC) to prolong life and improve quality of life (QoL). The optimal dosing and sequencing beyond the second line of treatment are unknown and pose a risk of overtreatment. Continuous low oral doses of metronomic chemotherapy using capecitabine 500 mg three times daily and cyclophosphamide 50 mg once daily (MCT-CX) may be an effective and tolerable treatment option for patients with MBC. MethodsIn this open-label, single-arm single-centre phase II trial patients with MBC received MCT-CX until disease progression or unacceptable toxicity. The primary endpoint was the clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of complete (CR) or partial response (PR) at any time, or stable disease (SD) for ≥ 24 weeks according to radiological evaluation. Toxicity was assessed according to the Common Toxicity Criteria v 4.0. QoL was assessed with the EORTC-30 questionnaire. ResultsIn total, 40 patients were included. Most participants (72%) presented with visceral disease and received MCT-CX beyond the second line (58%). The CBR was 45% (8 PR and 10 SD ≥ 24 weeks). Toxicities were low grade with hand-foot syndrome being the most common. There was no significant change in QoL over the first 24 weeks. ConclusionMCT-CX is a plausible treatment option in far advanced breast cancer, with almost half of trial participants responding to treatment without QoL impairments.

376. COMPARISON OF POST-SURGICAL NUTRITIONAL STATUS BETWEEN IVOR-LEWIS ESOPHAGECTOMY AND PROXIMAL GASTRECTOMY

Abstract Background In our institution, the surgical approach for esophagogastric junction cancer (EG) is determined based on the tumor location and the extent of esophageal invasion, opting for either Ivor-Lewis esophagectomy (IL) or proximal gastrectomy (PG). Both procedures necessitate the mitigation of postoperative weight loss, with nutritional therapy using Elemental diet 300 kcal/day initiated postoperatively and nutritional guidance provided by dietitians before discharge, and at 1, 3, 6, and 12 pos-operative months (POM). Additionally, quality of life (QOL) assessment using the PGSAS-37 questionnaire is conducted, and feedback is provided to patients. Methods The aim of this study is to compare the weight changes up to 12 POM and the temporal changes in PGSAS-37 scores following IL and PG procedures in our institution. We analyzed 45 cases who underwent IL or PG in our institution between January 2019 and December 2022, excluding cases of early recurrence within 12 months and those without questionnaire responses. Patient demographics, postoperative complications, anastomotic strictures, duration of Elemental intake (months), percentage of body weight loss (BWL) at 1, 3, 6, and 12 POM, and PGSAS-37 scores were extracted from electronic medical records. Results There were 27 IL cases and 18 PG cases. Postoperative complications of Grade 3 or higher were observed in 3 of IL group and 1 of PG group. Anastomotic strictures were observed in 1 of IL group and 6 of PG group. Duration of Elemental intake (months) was 4.5 (0-39) in IL group and 0 (0-8) in PG group (p=0.001). Median BWL (%) at 1/3/6/12 POM was IL: 4.5/8.3/10.3/13.8 and PG: 3.8/8.5/8.7/10.6. Temporal changes in total symptom score were similar in both IL and PG groups, but esophageal reflux subscale at 12 POM was significantly better in PG group (p=0.04). Conclusion The questionnaire response rates were approximately 80% at 12 months for both groups, but below 12 months ranged from 22.2% to 50%, indicating difficulty in assessing temporal changes in QOL. At 12 months, the IL group exhibited a greater percentage of weight loss than the PG group (p=0.027), but QOL evaluations, except for reflux symptoms SS, were comparable between the two groups. Both IL and PG groups experienced rapid weight loss up to 3 POM, with continued decline up to 12 months. However, improving questionnaire response rates is deemed necessary for investigating the relationship with QOL.

Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video)

EndoZip (Nitinotes Ltd, Cesarea, Israel) is a fully automated, operator-independent robotic endoscopic suturing device developed for gastric volume reduction and treatment of obesity. We aim to assess the efficacy and safety of EndoZip to treat patients with obesity. We conducted a prospective multicenter study and recruited 45 patients with a body mass index of 30 to 40 kg/m2. Our primary outcome was to assess the percentage of total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the Influence of Weight on the Quality of Life questionnaire at 1 year. The mean ± standard deviation age was 44.2 ± 8.8 years, and the mean ± standard deviation body mass index was 34.5 ± 2.9 kg/m2. A majority (90.7%) of patients were female. The procedure was technically successful in all patients (100%). A median of 4 (range, 3-5) full-thickness sutures were placed, and the mean procedure time was 30.8 ± 15.8 minutes. At 12 months, the mean %TBWL was 13.21 (95% confidence interval, 10.11-16.31), and 76.6% of patients achieved≥5% TBWL. We observed significant reduction in waist circumference, glycated hemoglobin, and alanine aminotransferase levels at 12 months (P< .001). We found a significant improvement in quality of life at 12 months (51.28 ± 16.22 vs 35.8 ± 11.9, P< .001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day. Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and improvement in quality of life. (Clinical trial registration number: NCT04773795.).

A randomized controlled trial of a novel home-based palliative care program: A report of a trial that could not be completed.

In response to a growing need for accessible, efficient, and effective palliative care services, we designed, implemented, and evaluated a novel palliative care at home (PC@H) model for people with serious illness that is centered around a community health worker, a registered nurse, and a social worker, with an advanced practice nurse and a physician for support. Our objectives were to measure the impact of receipt of PC@H on patient symptoms, quality of life, and healthcare utilization and costs. We enrolled 136 patients with serious illness in this parallel, randomized controlled trial. Our primary outcome was change in symptom burden at 6 weeks. Secondary outcomes included change in symptom burden at 3 months, change in quality of life at 6 weeks and 3 months, estimated using a group t-test. In an exploratory aim, we examined the impact of PC@H on healthcare utilization and cost using a generalized linear model. PC@H resulted in a greater improvement in patient symptoms at 6 weeks (1.30 score improvement, n = 37) and 3 months (3.14 score improvement, n = 21) compared with controls. There were no differences in healthcare utilization and costs between the two groups. Unfortunately, due to the COVID-19 pandemic and a loss of funding, the trial was not able to be completed as originally intended. A palliative care at home model that leverages community health workers, registered nurses, and social workers as the primary deliverers of care may result in improved patient symptoms and quality of life compared with standard care. We did not demonstrate significant differences in healthcare utilization and cost associated with receipt of PC@H, likely due to inability to reach the intended sample size and insufficient statistical power, due to elements beyond the investigators' control such as the COVID-19 public health emergency and changes in grant funding.

Efficacy of a health education technology program in improving adherence to self-management behaviors and quality of life among adults with type 2 diabetes: A randomized controlled trial

AimThis study examined the efficacy of a health education technology program on self-management adherence behavior and quality of life among people with type 2 diabetes (T2D). MethodsA randomized experimental study design was employed. A total of 110 subjects was recruited. The experimental group received a novel technology education program plus routine shared care. The control group received routine shared care alone. Quality of life and adherence to self-management behavior questionnaires were used to measure outcomes. A linear mixed-effects model was used to analyze changes in quality of life after controlling for pre-test effects. The odds ratio was calculated for differences in adherence behavior between the two groups. ResultsThe between-group mean difference in quality of life scores and adherence to physical activity comparing pre-test at 3 months follow-up showed significant progress at 3 months post-test compared with the control group. However, the increase in mean quality of life scores and adherence behavior at 6 months did not demonstrate a sustained between-group difference. ConclusionThe results showed adherence to physical activity and improved quality of life in patients with T2D at 3 months post intervention. Therefore, the program can be used as an intensive model for diabetes shared care.

Comparative Efficacy and Safety of Ustekinumab and Secukinumab in the Treatment of Generalized Pustular Psoriasis: A 48-Week Retrospective Cohort Study with Genetic Background Analysis.

Recent studies have shown that novel biologics may provide significant clinical benefits for patients with generalized pustular psoriasis (GPP). Ustekinumab and secukinumab have been approved in Japan for GPP treatment in adult patients. However, the differences in efficacy and safety of these two drugs in GPP are not known. Based on the genetic background, we aimed to compare the efficacy and safety of secukinumab and ustekinumab in patients with GPP. Patients with moderate to severe GPP who were treated with ustekinumab/secukinumab at our department from July 2019 to May 2022 were included in this study and followed up for 48weeks. The difference in efficacy between ustekinumab and secukinumab was evaluated by assessing changes in body temperature, laboratory indices, recovery of skin lesions, and changes in quality of life. Additionally, we collected patients' saliva for genotyping and explored the effect of CARD14 genetic mutations on clinical efficacy. A total of 65 patients (32 adults and 33 children) with moderate to severe GPP were included in this study. 31 patients received ustekinumab therapy, and 34 patients were treated with secukinumab. Secukinumab demonstrated superiority to ustekinumab, as evidenced by a higher GPPASI 90 response at week 2. Additionally, the efficacy of ustekinumab and secukinumab was found to be independent of the presence of the CARD14 mutation. Secukinumab is superior to ustekinumab in rapidly clearing the skin and improving health-related quality of life. Moreover, the responses to ustekinumab/secukinumab in patients were not influenced by CARD14 gene mutations.

325. SURGERY FOR EPIPHRENIC ESOPHAGEAL DIVERTICULUM, SHORT AND LONG TERM RESULTS

Abstract Background and Objectives We present our experience with laparoscopic surgery for epiphrenic oesophageal diverticulum. We wanted to assess our surgical results focusing on the patients’ quality of life. Short- and long-term results of surgical therapy were analysed. Methods 14 patients were examined with a symptomatic causing epiphrenic diverticulum. Patients underwent complex gastroenterological examinations before and after surgery (swallowing x-ray, oesophagogastroscopy, oesophageal manometry/pH monitoring). Surgery: laparoscopic transhiatal epiphrenic diverticulectomy with Heller cardiomyotomy and Dor anterior partial fundoplication were performed in 9 patients; laparoscopic diverticulectomy in 2 patients, laparoscopic Heller-Dor operation without diverticulectomy was 1 case (small (&amp;lt; 3cm) diverticulum) and laparoscopic diverticulectomy + Heller myotomy + Nissen fundoplication in 2 cases. Changes in quality of life with regard to symptoms related to oesophageal function were evaluated in our long-term studies (averaging 60 months, 10–138 months) by Eckardt-Zaninotto score. Results We had no intraoperative complication except one. In one case, a staple line leak developed (1/14 (7%), which was resolved with conservative therapy. Functional check-ups confirmed adequate oesophageal function in majority of the patients. The total symptom score for the patients was 6.3 points before surgery, and it decreased to 1.6 (P .001) after surgery, an average of 74% subjective improvement. During the follow-up period, proton pump inhibitor therapy was started in 4 patients to treat gastroesophageal reflux. In 3 cases, drug therapy was successful; in one case, Nissen antireflux surgery was performed. Conclusion Laparoscopic transhiatal diverticulectomy and Heller–Dor surgery are effective interventions with low morbidity. Patient quality of life significantly improves in the long term, but gastroesophageal reflux disease may occur. Key Words Epiphrenic oesophageal diverticulum, Laparoscopic transhiatal surgery, Long-term results

1866P Metabolic and quality of life changes with the use of dexamethasone pre-paclitaxel in patients with breast cancer

1866P Metabolic and quality of life changes with the use of dexamethasone pre-paclitaxel in patients with breast cancer

Transition in Quality Of Life Among Older Patients With Bladder Cancer and Its Association With Treatment: A Clustering Approach

Purpose: To classify older patients with bladder cancer (BC) based on quality-of-life (QoL) measures and explore the clusters transitions over a 2-year period and patient characteristics, BC stages, and treatment. Patients with BC report a significant decline in functional status and QoL. The association of this transition and patient characteristics and treatment over time is not known. We aim to explore this association. Methods: Data were obtained from patients with BC in the SEER-MHOS database (1998-2021). Unsupervised cluster analysis was employed to identify homogeneous clusters of patients with similar functionality based on age, physical and mental component score, and ability to perform activities of daily living. Univariate and multivariable analyses were performed to assess the association of patient characteristics and treatment on cluster transitions over a 2-year interval. Results: The final cohort consisted of 2934 (age 65 or older) older patients with BC. We identified 3 distinct clusters: 67.9% in Cluster 1; 25.4% in Cluster 2; and 6.7% in Cluster 3. After 2 years, 11.7% patients showed improvement and 14% experienced a decline. Cancer/treatment characteristics were not associated with cluster transition. Younger age and being married were identified as factors associated with improvement. Older age, non–homeownership, and last-year fall were associated with transition to less healthy cluster. Conclusions: Over a 2-year interval after BC diagnosis, a quarter of patients will have substantial changes in QoL. No significant association was observed between cluster transition and BC characteristics. Age as well as marital, fall, and homeowner status do impact this transition.

Longitudinal health-related quality of life in people with thoracic aortic aneurysms.

Surgical intervention for thoracic aortic aneurysms is high risk. Understanding changes in health-related quality of life before and after endovascular stent grafting and open surgical repair can aid treatment decision-making. The Effective Treatments for Thoracic Aortic Aneurysms ('ETTAA') study (ISRCTN04044627) was a longitudinal, observational study. Adults with new/existing arch or descending thoracic aortic aneurysms greater than or equal to 4 cm in diameter were followed from 2014 to 2022. Five domains of health-related quality of life (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) were recorded using the EuroQoL, five dimensions, five levels ('EQ-5D-5L') questionnaire and analysed using a range of longitudinal mixed models. Of 886 thoracic aortic aneurysm participants, 824 completed at least 2 questionnaires. Patients had slightly worse health-related quality of life than age-matched norms. Without surgery, deterioration occurred over time in Mobility (0.072/year (95% c.i. 0.042 to 0.101), P < 0.001) and Self-Care (0.039/year (95% c.i. 0.018 to 0.061), P < 0.001) in both sexes and Pain/Discomfort in women (0.069/year (95% c.i. 0.020 to 0.118), P = 0.005). For 6 weeks after endovascular stent grafting, there was a significant impairment in Self-Care (0.214 (95% c.i. 0.112 to 0.316), P < 0.001) and (for women only) in Usual Activities (0.625 (95% c.i. 0.338 to 0.911), P < 0.001), which then returned to pre-endovascular stent grafting levels. Six weeks after open surgical repair, the impairment in health-related quality of life was greater (Mobility 0.492 (95% c.i. 0.314 to 0.669), Self-Care 0.474 (95% c.i. 0.364 to 0.583), Usual Activities 1.469 (95% c.i. 1.042 to 1.896), and Pain/Discomfort 0.561 (95% c.i. 0.363 to 0.760), all P < 0.001) and took longer to return to pre-open surgical repair levels, partly due to increased complications and longer hospitalization. Anxiety/Depression decreased after open surgical repair (-0.214 (95% c.i. -0.326 to -0.101), P < 0.001). Age, sex, frailty, smoking, New York Heart Association class, and chronic obstructive pulmonary disease were significantly associated with health-related quality of life. Without intervention, health-related quality of life declines as age increases. Changes in health-related quality of life should contribute to surgical treatment decision-making.

Association of baseline and changes in health-related quality of life with mortality following myocardial infarction: multicentre longitudinal linked cohort study.

Health-related quality of life (HRQoL) for patients following myocardial infarction (MI) is frequently impaired. We investigated the association of baseline and changes in HRQoL with mortality following MI. Nationwide longitudinal study of 9474 patients admitted to 77 hospitals in England as part of the Evaluation of the Methods and Management of Acute Coronary Events study. Self-reported HRQoL was collected using EuroQol EQ-5D-3L during hospitalization and at 1, 6, and 12 months following discharge. The data was analysed using flexible parametric and multilevel survival models. Of 9474 individuals with MI, 2360 (25%) were women and 2135 (22.5%) died during the 9-year follow-up period. HRQoL improved over 12 months (baseline mean, mean increase: EQ-5D 0.76, 0.003 per month; EQ-VAS 69.0, 0.5 per month). At baseline, better HRQoL was inversely associated with mortality [Hazard ratio (HR) 0.55, 95% CI 0.47-0.63], and problems with self-care (HR 1.73, 1.56-1.92), mobility (1.65, 1.50-1.81), usual activities (1.34, 1.23-1.47), and pain/discomfort (1.34, 1.22-1.46) were associated with increased mortality. Deterioration in mobility, pain/discomfort, usual activities, and self-care over 12 months were associated with increased mortality (HR 1.43, 95% CI 1.31-1.58; 1.21, 1.11-1.32; 1.20, 1.10-1.32; 1.44, 1.30-1.59, respectively). After MI, poor HRQoL at baseline, its dimensions, and deterioration over time are associated with an increased risk of mortality. Measuring HRQoL in routine clinical practice after MI could identify at-risk groups for interventions to improve prognosis.

Changes in Oral Health-related Quality of Life before and after Orthognathic Surgery and Predictors of Outcome

Aim: There is good evidence that orthognathic surgery improves quality of life (QoL), but it is uncertain whether QoL outcomes differ for patients with different dentofacial deformities. The aim of this study was to (i) assess changes in QoL before and after orthognathic surgery; (ii) compare QoL between deformity classes; and (iii) establish predictors of QoL Methods: This was a prospective, longitudinal, observations study of adult patients seeking orthognathic treatment. Patients were classified into class II or class III dentofacial deformities. The paired t-test was used to compare Orthognathic Quality of Life Questionnaire (OQLQ) scores before and after surgery, and multivariable linear regression was used to identify predictors of post-operative OQLQ score. Results: Of the 50 participants, 36 (72%) were female, and the average age was 29.9 ± 4.2 years. Overall and domain OQLQ scores were significantly lower after surgery (p &lt; 0.0001). The mean change in QoL score was significantly greater for class II patients (p = 0.003). Age and baseline OQLQ score were significantly associated with post-operative OQLQ score. Conclusions: This study confirms that orthognathic surgery has a very positive impact on QoL. The finding that age and baseline QoL predict subsequent QoL outcomes paves the way for targeted interventions in specific patients.

Evaluating changes in the well-being of older adults during the COVID-19 pandemic: a longitudinal cohort study.

The COVID-19 pandemic affected the lives of older adults. Yet, little is known about changes in well-being among older adults during the pandemic, especially when COVID-19 measures were relaxed. Therefore, we aimed to assess changes in the well-being of older adults during multiple turning points of the pandemic. This longitudinal study included data from Dutch older adults (≥65 years old) participating in the Lifelines COVID-19 cohort. Data consisted of seven questionnaires, administered every 2-4 months between May 2020 and October 2021. The outcomes were quality of life (n = 14682), physical fitness (n = 14761), and feelings of isolation (n = 14611), all graded on a scale from 0 to 10. Changes in well-being were analysed by multivariable linear mixed-effects models. The context of measures was described using the Government Stringency Index. Quality of life and feelings of isolation decreased when measures were tightened and increased when measures were relaxed. For example, when measures relaxed after the first lockdown in May 2020, quality of life increased by 0.23 [95% confidence interval (CI): 0.16-0.29] towards July 2020. Physical fitness decreased by 0.26 [95% CI: 0.15-0.37] during the study period. Differences between subsamples were not found, except for sex in feelings of isolation, which differences diminished after a period of relaxed measures. Changes in quality of life and feelings of isolation improved after periods of stringent COVID-19 measures. Physical fitness did not improve after measures were relaxed, suggesting a possible negative effect of the pandemic on the physical fitness of older adults.

SUCCEED Africa: protocol for a multi-method pilot study of a community-based intervention for people with psychosis in Sierra Leone, Nigeria, Zimbabwe and Malawi

BackgroundRecent reviews have highlighted the need for participatory research to design and evaluate inclusive, community-based interventions that address the diverse needs of people with lived experience of psychosis, within and beyond the health sector. The SUCCEED Africa consortium aims to co-produce a 6-year programme of research across four countries in West (Sierra Leone, Nigeria) and Southeast Africa (Zimbabwe and Malawi). This protocol describes the pilot study in which SUCCEED’s intervention, research tools and processes will be tested on a small scale in each country in preparation for future evaluation research.MethodsThe SUCCEED intervention comprises peer support, case management and livelihood activities for people with lived experience of psychosis. The pilot uses a before-and-after study design investigating change in subjective quality of life in adults diagnosed with a primary psychotic disorder or another mental disorder with psychotic symptoms who are offered the SUCCEED intervention over a 4-month period. Nested within this study are the following: a baseline assessment of the feasibility, acceptability and face validity of the selected measurement tool and validity of proxy versus self-completion; and a multi-method process evaluation examining key process indicators and implementation, service and client-level outcomes. Methods include the following: baseline cognitive interviews; semi-structed observation and routine monitoring and evaluation of service delivery; endline interviews and focus group discussions; and a comparison of provider competencies at endline. At each of the four pilot sites, participants will include the following: ten people with lived experience of psychosis, recruited from either health services or community settings using purposive sampling to maximise variation; up to ten adult family members (one per participant with lived experience) involved in their care; the peer support worker, community support worker and supervisor responsible for delivering the intervention; and the data collectors. Recruitment will take place in July and August 2023.DiscussionTo the best of our knowledge, this will be the first study of a community-based intervention incorporating lay-delivered case management, formal peer support and livelihoods activities for people with lived experience of psychosis in sub-Saharan Africa. Findings will be relevant not only to SUCCEED but also to others interested in promoting rights-based approaches to community mental health in low-resource settings.Trial registrationUS National Library of Medicine (ClinicalTrials.gov), Protocol reference ID 28346. Initially registered retrospectively July 20/2023: In review.

The Canadian Bronchiectasis and Nontuberculous Mycobacteria Registry: A Study Protocol

BackgroundBronchiectasis is a complex, chronic disease with geographic and ethnic diversity. While the most substantial cohort studies have been conducted in Europe and the USA, Canada also faces considerable challenges. The Comprehensive Canadian Bronchiectasis and Nontuberculous Mycobacterial Infection Registry aims to: (1) outline the clinical characteristics and natural history of bronchiectasis in Canada; (2) identify risk factors contributing to disease progression within Canadians; (3) integrate comprehensive clinical information to better understand the phenotypes of bronchiectasis; (4) support the development of large-scale, randomized controlled trials in Canada.MethodsThe Canadian Bronchiectasis and Nontuberculous Mycobacterial Infection Registry is an ongoing prospective, longitudinal, multi-center, observational cohort study. It aims to enroll at least 2000 participants to collect data such as medical history, etiological assessments, lung function tests, microbiological profiles, radiographic evaluations, comorbidities and quality of life (QoL) metrics. Participants will undergo annual follow-ups to gather longitudinal information regarding outcomes, treatments and changes in QoL. The inclusion criteria are a diagnosis of bronchiectasis by clinical history and computed tomography and/or pulmonary nontuberculous mycobacterial (NTM) infection as defined by ATS/IDSA guidelines. The study's protocol received ethical approval from the lead site, the University of Calgary, with future additional approval from local ethics committees at all participating centers.DiscussionThe outcomes of the registry will be instrumental in uncovering the clinical traits and natural history of bronchiectasis. This longitudinal study will be used for analysis to form evidence-based clinical practices and serve as a resource in Canada to inform future studies in NTM and bronchiectasis.