Health-related Quality Of Life Outcomes Research Articles

A systematic review of the prevalence of chronic postsurgical pain in children.

Two prior reviews highlight the scarcity and conflicting nature of available data on chronic postsurgical pain in children, reporting a wide prevalence range of 3.2% to 64% (at ≥3 months). This updated systematic review aimed to consolidate information on the prevalence of pediatric chronic postsurgical pain. A thorough literature search of full English-text publications from April 2014 to August 2021 was conducted using Ovid MEDLINE, PubMed, and Cochrane Database of Systematic Reviews, with search terms: postoperative pain, child, preschool, pediatrics, adolescent, chronic pain. Seventeen relevant studies were identified. Most assessed chronicity once greater than 3 months duration postoperatively (82%), were predominantly prospective (71%) and conducted in inpatient settings (88%). The surgeries examined included orthopedic (scoliosis and limb), urological, laparotomy, inguinal, and cardiothoracic procedures, involving numbers ranging from 36 to 750, totaling 3137 participants/2792 completers. The studies had wide variations in median age at surgery (6 days to 16 years), the percentage of female participants (unspecified or 12.5% to 90%), and follow-up duration (2.5 months to 9 years). Various pain, functional, psychosocial, and health-related quality of life outcomes were documented. Chronic postsurgical pain prevalence varied widely from 2% to 100%. Despite increased data, challenges persist due to heterogeneity in definitions, patient demographics, mixed versus single surgical populations, diverse perioperative analgesic interventions, follow-up durations and reported outcomes. Interpretation is further complicated by limited information on impact, long-term analgesia and healthcare utilization, and relatively small sample sizes, hindering the assessment of reported associations. In some cases, preoperative pain and deformity may not have been addressed by surgery and persisting pain postoperatively may then be inappropriately termed chronic postsurgical pain. Larger-scale, procedure-specific data to better assess current prevalence, impact, and whether modifiable factors link to negative long-term outcomes, would be more useful and allow targeted perioperative interventions for at-risk pediatric surgical patients.

How much does dysphagia cost? Understanding the additional costs of dysphagia for New Zealand in patients hospitalised with stroke.

Dysphagia (i.e., disordered swallowing) is a consequence of stroke. Existing literature on the marginal cost of dysphagia after stroke is limited and ignores long-term impacts. Our aim was to determine the marginal 12-month cost attributable to dysphagia, including health-related quality of life (HRQoL) impacts, among patients hospitalised with stroke in New Zealand. Secondary analysis of observational data from the REGIONS Care study, a national study from New Zealand of consecutively hospitalised patients with acute stroke between 1st May 2018 and 30th October 2018 including an outcome survey at 12 months among those who provided consent. Patients were identified as dysphagic if they received a swallow screen in hospital resulting in a Speech Language Therapist review. Patients that required a nasogastric feeding tube in hospital were classified as 'severe'. Optimal linear propensity score matching was utilised to provide a group for patients to compare with stroke and dysphagia. All costs were converted to 2021NZ$. Overall, of the 2,379 patients in the REGIONS cohort (51% male, median age:78), 40% (944/2,379) were dysphagic (52% male, median age: 78), and 5% (111/2,379) were classified as severely dysphagic. Within 12-months of hospital discharge, dysphagia reduced HRQoL overall by 0.06 index points (95%CI, 0.028 to 0.100), and severe dysphagia by 0.12 index points (95%CI, 0.03 to 0.20). The estimated marginal 12-month cost attributable to stroke-related dysphagia was $24,200 on average per patient. This estimate includes the additional hospitalisation costs ($16,100), community rehabilitation services ($570), hospital-level aged residential care ($4,030) and reduced HRQoL ($3,470) over a 12-month period post-hospital discharge. The overall total marginal cost for those with severe dysphagia was $34,000 per patient. We report cost estimates to 12 months from a national perspective on the additional costs and HRQoL outcomes of dysphagia for people hospitalised with stroke in New Zealand. Findings provide a novel contribution internationally since few prior studies have extended beyond the acute hospital phase of care. By quantifying the economic burden, we provide information to decision makers to improve dysphagia management strategies and ultimately enhance the overall HRQoL for people with stroke and dysphagia.

Supplementation with selenium and coenzyme Q10 in an elderly Swedish population low in selenium — positive effects on thyroid hormones, cardiovascular mortality, and quality of life

BackgroundSelenium-dependent deiodinases play a central role in thyroid hormone regulation and metabolism. In many European countries, insufficient selenium intake may consequently lead to adverse effects on thyroid function. In this randomised placebo-controlled double-blind study, we examined the effect of supplementation with selenium and coenzyme Q10 on thyroid hormonal status, cardiovascular (CV) mortality and health-related quality of life (Hr-QoL).MethodsFree T3, free T4, reverse T3, and TSH were determined in 414 individuals at baseline, and the effect of selenium yeast (200 µg/day) and coenzyme Q10 (200 mg/day) supplementation on hormone concentrations, CV mortality and Hr-QoL was evaluated after 48 months using Short Form 36 (SF-36). Pre-intervention plasma selenium was low, mean 67 µg/L, corresponding to an estimated intake of 35 µg/day. Changes in concentrations of thyroid hormones following the intervention were assessed using T-tests, repeated measures of variance, and ANCOVA analyses.ResultsIn the total population, the group with the lowest selenium concentration at baseline presented with significantly higher levels of TSH and lower levels of fT3 as compared to subjects with the highest selenium concentration. Supplementation with selenium and coenzyme Q10 for 4 years significantly increased fT3 and rT3, decreased fT4, and diminished the increase in TSH levels compared with placebo treatment (p = 0.03, all). In the placebo group, TSH and fT4 values above the median were associated with an increase in 10-year CV mortality, as compared with the mortality rate among those with TSH and fT4 below the median (p < 0.04, both), with no difference in mortality rate according to TSH and fT4 levels in the active intervention group. Similarly, TSH > median and fT3 < median were associated with a decline in mental Hr-QoL measures vs. TSH < and fT3 > median in the placebo group during 4 years of follow-up, but this was wiped out in the active group.ConclusionsSupplementation with selenium and coenzyme Q10 had a beneficial effect on thyroid hormones with respect to CV mortality and Hr-QoL outcomes. The initial deficient selenium status was associated with an impaired thyroid function and the changes in thyroid hormone levels can be explained by increased activity of deiodinases. We conclude that a substantial part of the elderly study population might suffer from suboptimal thyroidal function with adverse clinical implications due to selenium deficiency.Trial registrationThis study was registered at ClinicalTrials.gov and has the identifier NCT01443780. Since it was not mandatory to register at the time the study began, the study has been registered retrospectively.

CAHQL: A patient reported outcome instrument to assess health-related quality of life in congenital adrenal hyperplasia.

Measuring health-related quality of life (HRQoL) is a crucial aspect of evaluating health care outcomes. Patients with congenital adrenal hyperplasia (CAH) often self-report deficiencies in HRQoL. The aim of our study was to develop a disease-specific patient reported outcome (PRO) instrument to evaluate the HRQoL of patients >16 years old with classic congenital adrenal hyperplasia (CAH). Following the FDA guidelines for developing PRO instruments, we developed a conceptual framework for the instrument. A preliminary instrument was created after interviewing a representative sample of 12 patients with CAH between 16 to 68 years old and 3 parents, and obtaining expert feedback from 4 endocrinologists. The instrument was edited after cognitive interviews with 6 patients. Internal consistency of the instrument was evaluated using Cronbach's alpha. Validity was assessed by comparing the scores of our instrument with scores from widely used validated instruments for HRQoL and PRO not specific to CAH. Sixty-nine patients 16 to 75 years old participated in validating our preliminary instrument. The final questionnaire consists of 44 questions within 7 domains: General Health, Adrenal Insufficiency, Glucocorticoid Excess, Physical Functioning, Mental Health and Cognition, Social Functioning, and Sexual Functioning, with acceptable internal consistency (Chronbach's alpha≥0.6) and validity (r = -0.350 to 0.866). CAHQL is the first validated PRO instrument to capture disease specific HRQoL outcomes in CAH. In addition to its anticipated use in the clinical setting, the instrument could be used to assess the efficacy of novel treatments in development.

Feasibility and Acceptability of a Meditation Mobile App Intervention for Adolescent and Young Adult Survivors of Childhood Cancer

Background: Adolescent and young adult (AYA) survivors of childhood cancer are increasingly recognized as a vulnerable group with unique emotional, social, and practical needs due to the intersection of cancer survivorship and normal developmental processes. Mindfulness meditation has shown early efficacy in improving psychological distress among cancer patients. However, the overall scientific study of app-based mindfulness-based interventions is still in its early stages. The goal of this study was to evaluate the feasibility and acceptability of a commercially available mindfulness mobile app intervention “Ten Percent Happier” among AYA survivors of childhood cancer. Methods: We conducted a single-arm pilot intervention with 25 AYA survivors of childhood cancer ages 18–29 years. Results: A total of 108 potentially eligible individuals were initially identified for screening. Of the 45 individuals reached (contact rate = 41.67%), 20 declined to participate; 25 were enrolled in the study and completed the baseline survey (enrollment rate = 55.56%). Twenty-one participants completed the study (retention rate = 84%). Changes in several outcomes were promising, with medium to large effect sizes: Mindfulness (d = 0.74), Negative Emotion (d = 0.48), Perceived Stress (d = 0.52), and Mental Health (d = 0.45). Furthermore, results suggested that participants with consistent app usage showed greater improvement in reported outcomes than those who stopped their usage (e.g., Mindfulness: d = 0.74, Perceived Stress: d = 0.83, Mental Health: d = 0.51; Meaning and Purpose: d = 0.84; and Sleep Disturbance: d = 0.81). Qualitative feedback indicated high satisfaction, but participants suggested adding group or individual peer support to improve their experience with the app. Conclusions: AYA survivors can be difficult to reach, but a mindfulness app was feasible and acceptable to this group. In particular, the robust retention rate and high satisfaction ratings indicate that the meditation mobile app was well received. Preliminary results suggest positive changes in health-related quality of life outcomes, warranting a larger efficacy trial.

EFFECTS OF A PRESCRIBED, SUPERVISED EXERCISE PROGRAMME ON HEALTH-RELATED QUALITY OF LIFE IN ONCOLOGY PATIENTS: A RETROSPECTIVE OBSERVATIONAL COHORT STUDY

INTRODUCTION &amp; AIMS Individuals diagnosed with cancer experience significant physical and psychosocial consequences from oncological treatment. Based on current research, exercise therapy may be a valuable non-pharmacological approach to improve health-related quality of life (HRQoL). However, the effectiveness of individually tailored exercise programs to improve quality of life in real-world settings is understudied. The current study aims to analyse preliminary clinical data regarding the impact of tailored exercise supervised within an Australian private day hospital (LIFT) on HRQoL in individuals diagnosed with cancer. METHODS A retrospective longitudinal cohort study was conducted on adults diagnosed with cancer who attended the LIFT clinical service for at least 12 months between 2020 and 2023. QoL and symptoms were assessed using the Functional Assessment of Cancer Treatment – General Questionnaire (FACT-G). Data collected included diagnosis (type and stage), medical treatment, session frequency, and demographic data. RESULTS Overall, 40 patients (age=67.0±16.8 years) met the inclusion criteria. A within-group analysis demonstrated significant findings in the subscales of emotional wellbeing (p = 0.008) and functional wellbeing (p = 0.003), and significance was also found in the total FACT-G score (p = 0.0019). Interestingly, while not statistically significant, a clinically significant difference in HRQoL was found between individuals completing ≤1 or ≥ 2 supervised exercise sessions per week at LIFT cancer care centre, favouring those completing ≥ 2 sessions. CONCLUSION Preliminary analysis indicated that a “real-world” individualised supervised moderate-vigorous exercise within a day hospital has the potential to significantly improve HRQoL outcomes in individuals diagnosed with cancer.

Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan.

Ultrasound-guided percutaneous cryoablation (PCA) for early-stage breast cancer (ESBC) can be performed under local anesthesia in an outpatient clinic. This study continues a pilot stage to examine local control, safety, patient quality of life (QoL), satisfaction and cosmetic outcomes of cryoablation for ESBC. PCA was performed under local anesthesia for patients with primary ESBC, followed by radiation and endocrine therapies. Oncologic outcomes were examined by imaging (mammography, ultrasound, MRI) at baseline and 1, 6, 12, 24, 36, and 60 months post-cryoablation. EQ-VAS, EQ-5D-5L, subjective satisfaction and Moiré topography were used to measure health-related QoL outcomes. Eighteen patients, mean aged 59.0 ± 9.0 years, mean tumor size 9.8 ± 2.3mm, ER + , PR + (17/18), HER2-, Ki67 < 20% (15/18), underwent PCA and were followed for a mean of 44.3 months. No serious adverse events were reported, and no patients had local recurrence or distant metastasis in the 5-year follow-up. Cosmetic outcomes, satisfaction level, and QoL all improved post-cryoablation. Five-year average reduction rates of the cryolesion long, short, and depth diameters, on US, were 61.3%, 42.3%, and 22.8%, respectively, compared to the 86.2% volume reduction rate on MRI. The correlation coefficient between MRI and US measurement criteria was highest for the long diameter. During follow-up, calcification of the treated area was observed in 13/18 cases. Cryoablation for ESBC is an effective and safe procedure with excellent cosmetic outcomes and improved QoL. This study contributes to the growing evidence supporting cryoablation as a potential standard treatment for ESBC, given compliance to pre-defined patient selection criteria.

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.

E071 Bimekizumab demonstrates sustained improvement in quality of life up to week 52 in patients across the full spectrum of axial spondyloarthritis: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has demonstrated rapid and clinically meaningful improvements in disease activity in patients across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS]/ radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we report health-related quality of life (HRQoL) outcomes (ASQoL, SF-36 and EQ-5D-3L) from the two parallel phase 3 studies up to Week (Wk)52. Methods BE MOBILE 1 and 2 have similar study designs: 16-Wk double-blind placebo (PBO)-controlled period followed by 36-Wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1; 2:1 in BE MOBILE 2) to receive BKZ 160 mg Q4W or PBO. All patients received BKZ 160 mg Q4W from Wk16 to Wk52. We report ASQoL, SF-36 - physical component summary (PCS) and SF-36 - mental component summary (MCS) scores up to Wk52 and proportion of patients with ’no problem’ in each of the 5 EQ- 5D-3L domains (mobility, selfcare, usual activity, pain/discomfort, and anxiety/ depression). The results are presented as observed cases (OC), and missing data were imputed using multiple imputation (MI). Results 254 nr-axSpA (BKZ: 128; PBO: 126) and 332 r-axSpA(BKZ: 221; PBO: 111) patients were randomised with 86.6% and 89.8% completing to Wk52, respectively. At Wk16, BKZ treated patients reported greater improvements in ASQoL and SF-36 PCS compared to PBO (p &amp;lt; 0.001, all comparisons, using Analysis of Covariance [ANCOVA]). By Wk52, these improvements across all HRQoL outcomes were sustained in BKZ treated patients and improved in patients who switched to BKZ at Wk16. (Table). The baseline SF-36 MCS levels indicated that on average patients had normal scores which remained unchanged throughout the study. The proportion of patients reporting ‘no problem’ across all five EQ-5D-3L domains improved over time up to Wk52. In patients with ASQoL ≥4 at baseline, &amp;gt;60% of patients had ≥4-point improvement in ASQoL at Wk52. Conclusion Across the axSpA disease spectrum, treatment with BKZ compared with PBO at Wk16 significantly improved quality of life outcomes measured by EQ-5D-3L, ASQoL and SF-36 PCS scores which were sustained to Wk52. Disclosure N.D. McKay: Consultancies; NDM has received consultancy fees from Gilead and UCB Pharma. Other; NDM has received a registration fees for attendance at a conference from Abbvie, Novartis and UCB Pharma, NDM has received a fee for lecturing from Gilead, NDM has taken part in education meetings, programmes and examinations for a wide range of pharmaceutical companies. A. Bennett: Honoraria; AB received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB received research grants from Pfizer. Other; AB received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Lilly. N. Goodson: Honoraria; NG has received honoraria from UCB Pharma and Novartis. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma. K. Gaffney: Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received honoraria/ consultation fees from Novartis, AbbVie, UCB Pharma, Lilly and Pfizer, KG has received speaker’s bureau from Novartis, UCB Pharma, AbbVie and Lilly; meeting expenses from AbbVie, Lilly, Roche, Novartis, Pfizer and UCB Pharma.

Bariatric surgeons' views on pre-operative factors associated with improved health-related quality of life following surgery.

Bariatric surgery is an effective treatment for severe obesity, affording significant improvements in weight loss and health-related quality of life. However, bariatric surgeons' views on whether certain pre-operative factors predict improvements in post-operative health-related quality of life, and if so, which ones, are largely unknown. This cross-sectional survey study examined the views of 58 bariatric surgeons from Australia and New Zealand. A total of 18 factors were selected for exploration based on their mention in the literature. Participants rated the extent to which they thought these pre-operative factors would improve post-operative health-related quality of life. Responses showed that bariatric surgeons held diverse perspectives and revealed a lack of consensus regarding "predictive" factors. Generally, respondents agreed that better than average health literacy, higher socioeconomic status, good physical and psychological health, and positive social support were predictors of improved health-related quality of life following surgery. However, poor eating behaviours, smoking, and the use of alcohol or other substances were deemed negative predictors. Interestingly, aside from higher socioeconomic status, good psychological health, and positive social support, none of the aforementioned views aligned with existing literature. This study offers an initial insight into bariatric surgeons' views on the influence of different pre-operative factors on post-operative health-related quality of life. The array of views identified suggests that there may be an opportunity for medical education, but the findings warrant caution due to the sample size. Replication with a larger survey may be useful, especially as predicted health-related quality of life outcomes could guide decisions regarding surgical (non)progression.

Surgical Intervention is Associated with Improvement in Health-Related Quality of Life Outcomes in Patients with Symptomatic Sacral Tarlov Cysts: Results from a Prospective Longitudinal Cohort Study

The treatment of symptomatic Tarlov cysts remains a controversial topic within neurosurgery. We describe our experience with patients who underwent surgical intervention for sacral Tarlov cysts at a single institution. General and disease-specific outcome measures were used to assess health-related quality of life. Patients who underwent surgical treatment for one or more sacral Tarlov cysts between 2018 and 2021 were included. The Tarlov Cyst Quality of Life (TCQoL), a validated disease-specific measure, was the primary outcome of the study. Secondary outcomes included general outcome measures: 36-Item Short Form Survey, the Oswestry Disability Index, and Visual Analog Scale. Patients were followed at 3, 6, and 12 months postoperative. Repeated measures analyses were used to assess change from preoperative to 12 months postoperative. Data were obtained from 144 patients who underwent surgery for sacral Tarlov cysts, average age 52.3 ± 11.3 years, 90.3% female. Patients reported significant mean improvement on the TCQoL over time (preoperative 3.2±0.1; 3-months postoperative 2.1±0.1; 6-months 1.9±0.1; 12-months 1.9±0.1; P< 0.001). Patient age and duration of symptoms were not associated with outcome. 82.3% of patients reported improvement on TCQoL. There was not a significant difference in the proportion of patients reporting improvement on TCQoL by cyst size (small 90.9% vs. large 77.9%; P = 0.066). Our longitudinal series demonstrated patient-reported improvement following surgery for symptomatic sacral Tarlov cysts using a validated disease-specific health-related quality of life scale through 12 months following surgery. Patient age and preoperative duration of symptoms were not correlated with outcome.

Longitudinal course and predictors of health-related quality of life, mental health, and fatigue, in non-hospitalized individuals with or without post COVID-19 syndrome.

Long-term information on health-related quality of life (HRQOL) and mental health of non-hospitalized individuals with "post COVID-19 syndrome" (PCS) is scarce. Thus, the objectives of the present study were to compare HRQOL and mental health of individuals with and without PCS in a German sample of non-hospitalized persons after SARS-CoV-2 infection, to characterize the long-term course up to 2 years and to identify predictors for post COVID-19 impairments. Individuals with past SARS-CoV-2 infection were examined at the University Hospital of Augsburg from November 2020 to May 2021 and completed a postal questionnaire between June and November 2022. Participants who self-reported the presence of fatigue, dyspnea on exertion, memory problems or concentration problems were classified as having PCS. HRQOL was assessed using the Veterans RAND 12-Item Health Survey, mental health was measured by the Patient Health Questionnaire and the Fatigue Asessment Scale was used to assess fatigue severity. Multivariable linear regression models with inverse probability weighting were used to determine the association between PCS and health outcomes. From the 304 participants (58.2% women, median age 52 years), 210 (69.1%) were classified as having PCS in median 26 months after SARS-CoV-2 infection. Persons with PCS showed significantly more often depressive and anxiety disorders. PCS was independently and significantly associated with higher levels of depression, post-traumatic stress and fatigue, as well as poorer physical and mental HRQOL in median 9 months as well as 26 months after SARS-CoV-2 infection. A large number of acute symptoms and a prior diagnosis of depression were independently associated with poor mental health and HRQOL. While post-traumatic stress and mental HRQOL improved from 9 months to 26 months post infection onset, depressiveness, fatigue and physical HRQOL remained stable in both, persons with and without PCS. PCS in non-hospitalized persons after SARS-CoV-2 infection is often associated with long-term impairments of mental health and HRQOL outcomes.

Sinonasal inverted papilloma and predictors of health-related quality of life after endonasal endoscopic surgery: A prospective cohort study.

Existing knowledge on health-related quality of life (HRQoL) after surgical removal of sinonasal inverted papilloma (IP) is limited. Moreover, predictors for a better or worse post-operative HRQoL outcome are not known. Our aim was to assess HRQoL in all three health domains (physical, psychological, and social), track its post-operative trajectory, investigate if pre-operative observations could predict distinct post-operative HRQoL outcomes, and evaluate whether physicians' interventions could contribute to improved post-operative HRQoL. Prospective cohort study. Tertiary referral hospital. Seventy-four patients who underwent surgery for an IP were included. They were asked to fill in the Endonasal Endoscopic Sinus and Skull-Base Surgery Questionnaire (EES-Q) pre-operatively, and then 2 weeks, 3 months, and 1 year post-operatively. Linear mixed models analyses were performed to evaluate the overall post-operative HRQoL and the separate health domains, as well as the impact of specific variables (sex, age, American Society of Anaesthesiologists [ASA] classification, smoker, Krouse staging, pre-operative EES-Q score, type of surgery, and post-operative antibiotics) on HRQoL improvement. The total EES-Q score (p < .001) as well as the physical (p < .001), psychological (p = .049), and the social (p = .002) domains significantly improved post-operatively. ASA classification (p = .049), pre-operative EES-Q score (p < .001) and post-operative antibiotics (p = .036) were significant variables. Overall HRQoL, as well as each of the three health domains, improved significantly. A higher ASA score, a higher pre-operative EES-Q score, and the administration of post-operative antibiotics were significant predictors for better HRQoL recovery post-operatively. Further research is necessary to confirm these results.

Enrolment of the first paediatric cohort into the Australian lupus registry and biobank: A single-centre experience.

We aim to report on the feasibility of establishment of the first paediatric cohort as part of the longitudinal database of the Australian Lupus Registry and Biobank (ALRB) and to describe the enrolment data with a focus on clinical characteristics, serological data, treatment strategies and patient/parent-reported outcome measures. All patients under the age of 18years with a diagnosis of systemic lupus erythematosus (SLE) attending the paediatric rheumatology service of a single, tertiary hospital were identified. Patients were enrolled in the ALRB if they met ≥4/11 of the American College of Rheumatology (ACR) 1997 SLE classification criteria or the Systemic Lupus International Collaborating Clinics (SLICC) 2012 classification criteria. Enrolment data including demographics, clinical characteristics, serological profiles, disease activity and damage assessments were recorded. Peds-QL Rheumatology and General Modules were used to assess patient and parent-reported outcomes. Twenty-seven patients were eligible for inclusion, with 26 patients (96%) consenting for enrolment. Twenty-five patients (92%) consented for biobanking. Twenty patients (77%) were female. The median age at enrolment was 16years (interquartile range (IQR) 13.7, 17.4). The median disease duration from diagnosis was 3.2years (IQR 1.4, 5.3). Sixteen patients (62%) had synovitis, 16 (62%) had cutaneous involvement, 4 (15%) had serositis, 17 (65%) had haematological involvement and 7 (27%) had renal involvement at enrolment. Nineteen patients (73%) were prescribed at least two disease-modifying anti-rheumatic medications (DMARDs). Hydroxychloroquine (n = 22, 85%) and mycophenolate mofetil (n = 9, 35%) were the most commonly prescribed DMARDs. The median SLEDAI-2K score was 2 (IQR 2, 4). Six patients (23%) had active disease (SLEDAI-2K ≥6) at enrolment. Three patients (11.5%) had reported damage using the SLICC/ACR Damage Index. Twenty-three children (88%) and eighteen parents (69%) completed the Paediatric Quality of Life Inventory. Quality of life scores reported across domains of physical, emotional, social and school functioning at enrolment were comparable to previously studied paediatric cohorts with SLE and other chronic diseases. We have established our centre as the first paediatric participating site of the ALRB, providing contemporary data on the clinical characteristics, serological profile and health-related quality of life outcomes of Australian children with SLE. Paediatric involvement with this national registry will provide a unique perspective for future clinical and scientific research. Collection of Australian-specific paediatric longitudinal data will also enable a broader understanding of SLE within a multicultural Australian population.

Is smokeless tobacco use associated with lower health-related quality of life? A cross-sectional survey among women in Bangladesh.

Bangladesh has 22 million adult users of smokeless tobacco (ST). The prevalence among women is higher (24.8%). Health-related quality of life outcome (HRQoL) for ST use is little known. We investigated the association between HRQoL and daily ST use among adult women in Bangladesh. Using multi-stage design, a cross-sectional survey was conducted. Adult women (randomly selected) were surveyed from 4 purposively selected divisions (Dhaka, Chittagong, Khulna and Rangpur). Female ST users and non-users were compared using HRQoL scores. Self-perceived Visual Analogue Scale (EQ-VAS) values and HRQoL scores were modelled to examine their association with ST use. A total of 2610 women (1149 users and 1461 non-users) were surveyed. The proportion reported any type of problem in all health dimensions was significantly higher among female ST users than non-users (mobility: 43.3% vs 19.5%, self-care: 29.6% vs 11.9%, usual activities: 48.7% vs 21.8%, pain or discomfort: 69.8% vs 40.6%, and anxiety or depression: 61.3% vs 37.5%). The average HRQoL scores were 0.79 (95% CI: 0.78-0.81) and 0.90 (95% CI: 0.89-0.90) for users and non-users, respectively. Moreover, EQ-VAS average values were significantly higher for non-users [80.7 (95% CI: 79.9-81.6) vs 70.27 (95% CI: 69.2-71.2)]. Controlling the sociodemographics, ST use significantly reduced the HRQoL score by an average of 0.15 points. The EQ-VAS values on average decreased by 0.04 points for ST use. ST use is significantly associated with the HRQoL of females in Bangladesh. Considering the higher prevalence of ST, especially among women, HRQoL hazards need to be communicated for awareness building.

Association of depressive symptom severity and suicidal ideation with health-related quality of life among stroke survivors, NHANES 2005-2018

Stroke, a critical health issue in the US, not only has physical repercussions but also potentially affects the health-related quality of life (HRQoL) through neuropsychiatric outcomes like depressive symptoms and suicidal thoughts. This study utilized a nationally representative sample of 1302 US stroke survivors (age ≥ 20) from the US National Health and Nutrition Examination Survey (2005–2018) to assessed relationships between QoL via the CDC HRQOL-4 and evaluated depressive symptoms and suicidal ideation using the Patient Health Questionnaire-9 (PHQ-9). Participants (mean age: 64.4; 56.0 % female) showed that 40.7 % had at least mild depressive symptoms, and 18.8 % exhibited major depressive symptoms. Suicidal ideation was reported by 8.1 %. After sociodemographic and health condition adjustments, mild and major depressive symptoms, along with suicidal ideation, were associated with poorer general health status and more physically and mentally unhealthy days and activity limitation days. A dose-response relationship between PHQ-9 scores and HRQoL outcomes was evident (All P for trend <0.001). Stroke survivors with suicidal ideation also experienced more physically and mentally unhealthy days and activity limitation days. Depressive symptoms and suicidal ideation are associated with reduced HRQoL among US stroke survivors, underscoring the importance of thorough neuropsychiatric evaluations and interventions to bolster stroke survivors' well-being.

Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacywere evaluated in a randomized controlled trial (RCT). Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). Seventy-one patients were randomized to the IG (n=34) or the CG (n=37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

Early predictors of health-related quality of life outcomes at 12 months post-burn: ABLE study

There remains a paucity of evidence on the early predictors of long-term Health-Related Quality of Life (HRQoL) outcomes post-burn in hospitalised adults. The overall aim of this study was to identify the factors (personal, environmental, burn injury and burn treatment factors) that may predict long-term HRQoL outcomes among adult survivors of hospitalised burn injuries at 12 months post-burn. A total of 274 participants, aged 18 years or over, admitted to a single state-wide burn centre with a burn injury were recruited. Injury and burn treatment information were collected from medical records or the hospital database and surveys collected demographic and social data. HRQoL outcome data were collected at 3-, 6- and 12-months using the 12-Item Short Form Survey (SF-12 v1) and Burns Specific Health Scale-Brief (BSHS-B). Personal, environmental, burn injury and burn treatment factors were also recorded at baseline. Analyses were performed using linear and logistic regression. Among 274 participants, 71.5 % (N=196) remained enrolled in the study at 12 months post-burn. The majority of participants reported HRQoL outcomes comparable with population norms and statistically significant improvements in generic (SF-12 v1) and condition-specific (BSHS-B) outcomes over time. However, for participants with poor HRQoL outcomes at 12-months post-burn, Univariable predictors included longer hospital length of stay, unemployment at the time of injury, a diagnosed pre-injury mental health condition, inadequate pre-burn social support, intentional injury, recreational drug use pre-injury and female gender. The early multivariable predictors of insufficient HRQoL outcomes were female gender, a previously diagnosed mental health condition, unemployment, inadequate social support, intentional injury, and prolonged hospital length of stay. These results suggest potential factors that could be used to screen and burns patients for psychosocial intervention and long-term follow up.

Health-related quality of life following trauma: Prevalence of problems and factors associated with six-month outcomes in a New Zealand cohort

Injury is a leading cause of health loss in Aotearoa me Te Waipounamu (New Zealand; NZ). The NZ Trauma Registry was established in 2015 to monitor outcomes in those experiencing severe injury and to identify ways of improving the quality of care for these patients. Few NZ studies have assessed outcomes in trauma patients using patient-reported outcome measures (PROMs) despite increasing recognition that the impacts of injury are better understood through PROMs. Our aim was to estimate the prevalence of self-reported problems with health-related quality of life (HRQoL) outcomes six months post-injury, and identify factors associated with these, in a cohort of Māori (the Indigenous population of NZ) and non-Māori individuals who had experienced major trauma. HRQoL outcomes were measured according to the five dimensions of the EQ-5D-5L. This information, along with sociodemographic data, was collected via structured telephone interviews. Participants (n=870), aged 16 years or more, were recruited following admission to a trauma hospital in one of three (of NZ's four) trauma regions. Multivariable models were developed using modified Poisson Regression to identify factors associated with outcomes for both Māori and non-Māori patients. The prevalence and severity of problems across each of the five EQ-5D-5L dimensions was similar for Māori and non-Māori except for Anxiety/Depression. The prevalence and severity of problems with Anxiety/Depression was greater for Māori. Factors associated with HRQoL problems at six-months were also largely similar for each cohort. Those commonly associated with outcomes were age, hospital length of stay, adequacy of household income, and participants’ expectations regarding recovery from injury. Further research examining recovery expectations in trauma patients to determine which factors contribute to formulating recovery expectations, and the potential impact of recovery expectations on treatment and rehabilitation, would be of value. Should expectations, at least in part, influence HRQoL outcomes, then routinely collecting data on patients’ recovery expectations, adequacy of household income and potential barriers to treatment and rehabilitation, could help inform post-hospital treatment plans, and identify those who may require additional support following discharge from hospital.

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.