Impaired Health-related Quality Research Articles

Incidence, disease burden and clinical presentation of patients newly diagnosed with inflammatory bowel disease in a population-based inception cohort.

Emerging data indicate a stabilizing incidence of inflammatory bowel diseases (IBD), including ulcerative colitis (UC), Crohn's disease (CD), and IBD unclassified (IBDU) in Western countries. We aimed to investigate the incidence of IBD, its initial clinical presentation, and patient-reported burden. Copenhagen IBD Inception Cohort is a prospective, population-based cohort of patients with newly diagnosed IBD according to the ECCO guidelines in the period between May 2021 and May 2023, within a catchment area covering 20% of the Danish population. Based on 554 patients (UC: 308, CD: 201, and IBDU: 18), the incidence rates per 100,000 person-years were: IBD: 23.4 (95% confidence interval, 21.5-25.4), UC: 14.0 (12.6-15.6), CD: 8.6 (7.4-9.8), and IBDU: 0.8 (0.5-1.3). The median diagnostic delay was significantly shorter for UC (2.5 months (interquartile range [IQR] 1-6)) than for CD (5 months (IQR 1.5-11), p<0.01). Moderate-to-severe disability was reported by 34% of CD patients and 22% of UC patients (p=0.01), severe fatigue by 30% and 26% (p=0.43), and severely impaired health-related quality of life (HRQoL) by 43% and 30% of patients, respectively (p=0.01). Hospitalization rates (UC: 20%, CD: 34%, p<0.01), and need for immunomodulators, biologics, or surgery within three months of diagnosis, were high in both UC (3%, 7%, and 37%, respectively) and CD (31%, 18%, and 10%, respectively). We found a high incidence of IBD in Copenhagen with a substantial disease burden characterized by early and high requirement for advanced therapies and high rates of fatigue, disability and impaired HRQoL at diagnosis.

Incremental hemodialysis transition in veterans and nonveterans with kidney failure.

Initiation of hemodialysis treatment with a thrice-weekly prescription is currently the standard of care irrespective of patients' residual kidney function (RKF), comorbidities, and preferences. Each year ∼12 000 Veterans with advanced kidney disease progress to end-stage kidney disease (ESKD) requiring dialysis and comprise greater than 10% of the US incident ESKD population. Dialysis is costly and is associated with impaired health-related quality of life (HRQOL) and high mortality risk, especially in the first year of treatment. Evidence suggests an incremental dialysis transition using twice-weekly hemodialysis provides various benefits, including more dialysis-free time, longer RKF preservation, less vascular access damage, and lower patient burden. Pragmatic studies are needed to inform the efficacy and safety of incremental hemodialysis as a personalized dialysis regimen, and could inform its consideration as a conservation strategy during times of supply shortages. Broadly implementing twice-weekly hemodialysis could also potentially allow more Veterans to receive care within VA-based dialysis units. The VA IncHVets Trial is a pragmatic, multicenter, randomized controlled trial comparing the efficacy and safety of twice-weekly incremental vs. thrice-weekly hemodialysis among Veterans transitioning to ESKD. Further research is needed to determine whether incremental hemodialysis is well tolerated, effective, and facilitates a more favorable transition to dialysis.

Impaired Oral Health-Related Quality of Life in Individuals with Chronic Obstructive Pulmonary Disease: A Systematic Review

Impaired Oral Health-Related Quality of Life in Individuals with Chronic Obstructive Pulmonary Disease: A Systematic Review

Effectiveness of a psychoeducational intervention on myositis patients’ quality of life and well-being: a randomized controlled trial

BackgroundMyositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.MethodsAll myositis patients in a health district were contacted. Thirty-four eligible patients were randomly assigned to the experimental (n = 17) or control (n = 17) group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life was conducted only in experimental patients. Several reliable tools to measure quality of life and well-being were administered twice, before and after the intervention, to both groups.ResultsIn the experimental group, post-test scores were higher than pre-test in quality of life, well-being, and self-efficacy to manage the disease. Improvements were more evident in the experimental group than controls in 70% of the variables studied. Specifically, sedentariness decreased and satisfaction with social relationships increased in the post-test evaluation to a greater degree in the experimental group than in controls.ConclusionsThis randomized controlled trial on a representative sample of myositis patients in an extensive population provides evidence indicating the effectiveness of a psychoeducational intervention for improving HRQoL, well-being, and self-efficacy to manage the disease.Trial registration: NCT06300983.

Primary headache in SLE –systematic review and meta-analysis

ObjectivesTo systematically review and synthesize literature on: 1) the overall prevalence of primary headaches and specifically migraines, in patients with lupus since previous systematic review published in 2004; 2) the risk factors associated with primary headaches in patients with lupus; 3) the association of primary headaches with structural brain changes; and 4) “lupus headaches”. MethodsThis review used (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) PRISMA guidelines and literature searches in four databases: Ovid-based Medline, Embase, PsycINFO, and Cochrane Database of Systematic Reviews from inception until 4/2022. Papers on primary headaches in patients with lupus were identified. Included studies were critically appraised and analyzed. Since a systematic review on this topic was published in 2004, only papers published in 2004 and later were included in this review. Statistical and publication bias was assessed using funnel plots. ResultsA total of 5096 references were identified, 189 were selected for detailed review and 11 papers were included in the final analysis. 1) The pooled prevalence of primary headaches in lupus was 26.8 % (95 %CI 25.1–28.6). The prevalence of primary headaches was similar between patients with lupus and healthy controls, odds ratio (OR) 2.14, 95 %CI 0.97–4.76, p value=0.06, however publication bias was significant according to the Egger test. Lupus patients seem to have a higher prevalence of primary headaches compared to patients with rheumatoid arthritis (RA) and primary Sjogren's syndrome (pSS), OR 2.5, 95 % CI 1.56–4, p < 0.0001. Regarding the prevalence of migraines specifically, no difference was found between patients with lupus compared to healthy controls and patients with RA or pSS. 2) Primary headaches seem to be associated with depression and impaired health related quality of life rather than lupus activity or damage. There is insufficient data to conclude whether specific lupus treatments affected primary headaches in lupus, however, one study did suggest hydroxychloroquine reduced the frequency of primary headaches. Raynaud phenomenon was associated with migraines. 3) One study which examined MRI scans of patients with lupus compared to healthy controls did suggest that larger gray matter volumes reduced the odds for headaches in general (OR 0.98, p = 0.048) and for migraines in particular (OR 0.95, p = 0.004), and larger white matter volumes increased the odds for migraine (OR 1.04, p = 0.007). However, these findings might reflect disease activity or damage, therefore further studies are required to clarify this issue. 4) The only study which specifically addressed the prevalence of “lupus headaches” is Hanly's study from 2013 of the SLICC cohort. In this large cohort, only 1.5 % of patients had "lupus headaches", as defined by SLE Disease Activity Index-2000 (SLEDAI-2 K). Therefore “Lupus headache” is a rare entity in SLE and should be suspected after excluding other possible explanations for headaches, especially when there is no known prior history of primary headaches. ConclusionsPatients with lupus seem to have a similar prevalence of primary headaches, and specifically migraines, compared to healthy controls. These primary headaches are associated with depression and Raynaud phenomenon and not with disease activity nor damage. Scarce data is published regarding structural changes associated with primary headaches. Currently is seems “lupus headaches” are a distinct rare manifestation of lupus and more data are needed.

Development of a systematic referral model to primary care health interventions for patients with atrial fibrillation. a delphi study

Abstract Background The European Society of Cardiology (ESC) guidelines for the management of atrial fibrillation (AF) recommend integrated care in AF, combining medical treatment with lifestyle modifications and psychosocial management in a multi-disciplinary set-up. Research show that patients with AF can benefit from lifestyle interventions and psychosocial management, like patient education. According to World Health Organization recommendations, these health interventions are moving from hospitals to primary healthcare settings. Therefore, patients with AF should be systematically referred to these interventions. Yet, an evidence-based referral model that can support this transition is lacking. Purpose The purpose is to develop a systematic referral model for primary care health interventions for patients with AF. Methods We used the Delphi-technique with three rounds of questionnaires (figure 1). International and national clinical experts in AF across disciplines and health sectors were invited to participate. In the first round, the expert panel evaluated items that could be part of a referral model on relevance, improvability and self-reporting. In the second round, the expert panel evaluated each item as either an inclusion or exclusion criteria, important knowledge to have, or not relevant. In the third round, the expert panel evaluated the items according to data source and outcome status. A final model was drawn based on items reaching consensus. The study was reported according to the guidance on conducting and reporting Delphi studies (CREDES). Results In total, 69 of 139 invited experts accepted to participate (50%). These were mostly academics or clinicians (90%), stemming from primary sector (16%), secondary sector (35%) and research (32%). Most were medical doctors (36%) and nurses (35%). However physiotherapist, psychologists, dieticians, and other disciplines along with six patients with AF were also represented. The expert panel (60% females) had a mean age of 50 years, and 65% were from Denmark. For the final referral model (figure 2), AF symptom burden and impaired health-related quality of life, anxiety and poor medicine compliance combined with a risk factor profile were the main inclusion criteria. Furthermore, it was important to know about the patients’ mental well-being, self-management abilities and comorbidities. Conclusion Consensus was reached for a generic referral model, which can be further adjusted in the appropriate clinical context. The model includes inclusion criteria which closely correlate with guidelines for AF management focusing on reducing the patients’ symptom and risk factor burden. The referral model is expected to increase the number of patients with AF referred to primary care health interventions, which could lead to better quality of life, fewer hospital admissions and lowered health care costs in AF.

Depression, Anxiety, and Pain Predict Quality of Life in Patients with Differentiated Thyroid Cancer Postradiotherapy Ablation in Taiwan: A 48-Week Follow-Up Study.

Despite the generally good prognosis of differentiated thyroid cancer (DTC), impairments in health-related quality of life (HRQoL) remain a major concern in these patients. This study examined the patterns and predictors of change in mental and physical HRQoL in DTC survivors following radiotherapy ablation. Two hundred patients with DTC who received radiotherapy ablation in southern Taiwan between 2015 and 2018 were interviewed using the Taiwan version of the 36-item Short-form Health Survey (SF-36), the Taiwanese Depression Questionnaire (TDQ), and the Hamilton Rating Scale for Anxiety (HAM-A) at baseline and after 24 and 48 weeks of treatment. The demographic characteristics, thyroid-related factors, recombinant human thyroid-stimulating hormone (rhTSH), and serum calcium level were also collected. Improvements in both mental and physical HRQoL were noted over the first 24 weeks following radiotherapy ablation. Between 24 and 48 weeks, mental HRQoL was increasing, whereas physical HRQoL decreased. Higher levels of anxiety and pain predicted both poor physical and mental HRQoL. Further, higher levels of depression predicted poor mental HRQoL. Additionally, factors such as low income, rhTSH use, elevated TSH levels, low free T4, and higher physical HRQoL were associated with poorer mental HRQoL during the follow-up period. The early detection and intervention of depression, anxiety, and pain should be the objective for programs aiming to improve HRQoL.

Psychological morbidity and quality of life of patients with pulmonary tuberculosis.

Tuberculosis (TB) is associated with psychological distress, poor coping, deterioration in health-related quality of life (HRQL), and stigma. However, these issues have never received sufficient attention as a part of routine care. The healthcare workers and physicians of primary contact are not sensitized to use discrete screening questionnaires to identify and address these issues. A longitudinal study was hence conducted in the Department of Pulmonary Medicine in collaboration with the Department of Psychiatry. 75 microbiologically confirmed 'new' pulmonary TB patients were enrolled. Socio-demographic and clinical details were noted. The patients were then evaluated for psychological distress using the General Health Questionnaire-12-Hindi version (GHQ-12) and Patient Distress Thermometer (PDT); coping strategies using the Coping Strategy Check List-Hindi Version (CSCL); HRQL using the World Health Organization Quality of Life-Brief-Hindi version (WHOQOL-Bref), and stigma using the Explanatory Model Interview Catalogue-affected persons Stigma Scale (EMIC-SS), at the start of treatment. Those having a GHQ-12 score ≥3 were labeled as 'screen positive' for psychological distress and referred to a consultant psychiatrist for detailed psychological assessment. Treatment was given by the psychiatrist if diagnosed with a psychiatric illness. All those without the diagnosis of a psychiatric illness were counseled by a pulmonologist. All patients were called for a follow-up visit and repeat assessments on the 15th day at the end of the intensive phase, using the same instruments employed at baseline. The patients already on treatment by the psychiatrist were again evaluated for their psychiatric illness. 32 (42.7%) patients had psychological distress (GHQ-12≥3) at baseline. 20 of them (26.7%) were diagnosed with a psychiatric illness. However, only 2 (2.7%) patients had psychological distress and psychiatric illness at follow-up (p<0.001). Mean scores of GHQ-12, PDT, CSCL, WHOQOL-Bref-26, and EMIC-SS at baseline were 3.000±1.9590, 2.333±1.2980, 3.480±2.2017, 311.63±30.201 and 5.267±1.8478, respectively. All the scores improved significantly at follow-up (p<0.001). The scores of the various instruments used in the study significantly correlated with each other. Comprehensive screening for psychological distress and assessment of HRQL should be part of routine TB care. The healthcare workers under the program should be sensitized to use the various screening tools on a day-to-day basis to identify patients who require expert psychiatrist care. The majority of the patients with distress, but without a psychiatric illness, can be handled well with dedicated counseling sessions by the healthcare workers themselves. The ancillary staff should be encouraged and trained to meet the demands in resource-constrained settings. A multidisciplinary approach, with close integration of TB programs with mental health services, is urgently required to eliminate TB.

Prevalence and Association of Pruritus and Its Current Treatment During the First Year of Dialysis: A DOMESTICO Study.

Pruritus is common in dialysis patients and associated with impaired health-related quality of life (HRQoL) and sleep disturbances. Its pathophysiology remains unclear resulting in limited treatment options and lack of treatment guidelines. The exact trajectory of pruritus after dialysis initiation nor the state of current medical treatment has been studied. Incident dialysis patients (n=1438), included in the Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO), were studied. Outcome parameters were prevalence of pruritus, severity of pruritus and the use of antipruritic medication, repeatedly measured during the first year of dialysis. Associations between treatment, pruritus and quality of life were longitudinally studied using linear mixed models. The prevalence of pruritus ranged from 50.5% to 56.6% during the first year of dialysis. Throughout the year approximately 35% experienced persistent pruritus and 40% fluctuating pruritus. During follow-up 21.5% to 26.5% received medical treatment for pruritus. Emollients were associated with more severe pruritus (adjusted β = 0.31, 95% CI 0.15; 0.48), the remaining treatments did not show any association. Pruritus was significantly associated with lower physical and mental HRQoL (adjusted β = -2.04, 95% CI -2.78; -1.30 and β = -1.73, 95% CI -2.51; -0.94, respectively), irrespective of treatment. During the first year of dialysis, pruritus is highly prevalent, predominantly fluctuating, and associated with impaired HRQoL. The minority of patients received medical treatment; in our study current treatment was not associated with an improvement of pruritus. These results highlight the need for more awareness among clinicians and for the development of effective treatment options.

A Scoping Review of Patient Health-Related Quality of Life Following Surgery or Molecular Testing for Individuals with Indeterminate Thyroid Nodules.

Molecular testing can reduce the need for diagnostic thyroidectomy in cytologically indeterminate thyroid nodules. However, the health-related quality of life in patients managed with molecular testing is not well studied. The objective of this scoping review was to identify and analyze the health-related quality of life outcomes in patients with indeterminate thyroid nodules who are expected to undergo or have undergone surgery or molecular testing. A comprehensive search was conducted on PubMed, Scopus, PsychINFO, and Embase to identify relevant studies. The search terms included "thyroid neoplasms" or "thyroid nodule" and "molecular testing" or "surgery" and "quality of life". The included articles were analyzed for their main study objective, study design, participant characteristics, and main results. Eight studies were included in this scoping review. Four evaluated the quality-adjusted life years for patients with indeterminate thyroid nodules. Three of these studies found that molecular testing slightly improved quality-adjusted life years compared to surgery, while one study found no difference. Two studies assessed surgical health-related quality of life outcomes and reported that patients with indeterminate thyroid nodules who were expected to undergo surgery favored surgical procedures, while those who underwent surgery experienced impaired health-related quality of life. Two studies evaluated molecular testing in patients with indeterminate thyroid nodules and found that the final molecular test result significantly impacted health-related quality of life outcomes. Patients with suspicious/positive molecular test results had worse symptoms of goiter, anxiety, and depression, while those with benign results had preserved health-related quality of life scores. Patients with benign results from molecular testing experience better health-related quality of life within the first year compared to those with benign surgical outcomes. This scoping review highlights the importance of considering health-related quality of life outcomes in the management of patients with indeterminate thyroid nodules. Benign molecular testing results yield better quality of life than benign surgical outcomes within the first year, suggesting molecular testing as a preferable option. Further research comparing the impact of surgery and molecular testing on health-related quality of life is needed to improve shared decision-making and patient outcomes.

Bleeding and quality of life in people with Glanzmann thrombasthenia—insights from the Glanzmann’s 360 study

BackgroundGlanzmann thrombasthenia (GT) is a rare platelet function disorder that results in severe bleeding. We assessed clinical symptoms and psychological parameters to identify the unmet needs associated with GT. ObjectivesGlanzmann’s 360 is a mixed-methods study designed to give a contemporary snapshot of the impact of living with GT. MethodsThe study comprised a self-completion online survey complemented by interviews conducted with affected individuals and carers recruited via social media and hemophilia treatment centers. ResultsThe survey was completed by 88 people with GT and 29 carers of children/young people with GT aged <16 years. The population ranged in age from <2 years to >70 years; 56% were female. Although 47% had been diagnosed with GT under the age of 2 years, 12% were diagnosed after 20 years of age. For 82%, a bleeding phenotype was apparent by the age of 5 years. Most respondents (88%) had experienced at least one bleed in the past week. Bleeding disproportionally affected women. Bleeds resulted in frequent hospital contact and considerable psychological distress: 26% of the population had scores suggestive of low self-esteem, while 30% met criteria suggestive of symptomatic depression. Exploratory analyses suggest that bleed experiences are associated with impaired health-related quality of life. ConclusionThe Glanzmann’s 360 study reveals the significant physical, psychosocial, and quality-of-life impairments that are likely to be linked to the frequent bleeds experienced by those with GT. Clinicians treating people with GT should promote access to multidisciplinary comprehensive care, including psychosocial support.

Efficacy of a cognitive-behavioral digital therapeutic on psychosocial outcomes in rheumatoid arthritis: randomized controlled trial

Cognitive behavioral therapy improves psychosocial outcomes in rheumatoid arthritis (RA), but access is limited. We conducted a randomized controlled trial to evaluate the efficacy of a cognitive-behavioral digital therapeutic, reclarit, on psychosocial outcomes in adult RA patients with impaired health-related quality of life. Participants were randomized to reclarit plus treatment as usual (TAU) or TAU plus educational and informational material (active control). The primary outcome was SF-36 mental (MCS) and physical (PCS) component summary scores at 3 months, with additional assessments at 6 months. reclarit significantly improved SF-36 MCS scores compared to control (mean difference 3.3 [95% CI 0.7, 5.9]; p = 0.014), with high user satisfaction and sustained improvements at 6 months. Depression, anxiety, fatigue, and social/work functioning also improved significantly, while SF-36 PCS, pain, and disability scores did not differ. In conclusion, reclarit offers immediate, effective, evidence-based and personalized psychological support for RA patients.

454. QUALITY OF LIFE AFTER ESOPHAGECTOMY WITH INTRATHORACIC VS CERVICAL ANASTOMOSIS: A NATIONWIDE COHORT STUDY

Abstract Background Transthoracic esophagectomy with either intrathoracic or cervical anastomosis is considered standard of care in patients with mid to distal esophageal or gastroesophageal junction (GEJ) cancer. Patients after esophagectomy will experience a deterioration in health-related quality of life (HR-QoL) after esophageal cancer surgery. Whilst some reports describe long-lasting deterioration, other reports show recovery of HR-QoL comparable with the general population after 2 years. The aim of this study was to investigate the difference in HR-QoL in patients after a transthoracic esophagectomy with either intrathoracic- or cervical anastomosis in a nationwide database. Methods A nationwide cohort study was performed combining data from two registries: Netherlands Cancer Registry (NCR) and Prospective Observational Cohort Study of Esophageal-Gastric Cancer Patients (POCOP). All patients after esophagectomy for mid/distal esophageal or GEJ cancer between 2015 and 2022 were included. HR-QoL was measured at baseline, 3, 6, 9, 12, 18, and 24 months postoperatively using EORTC QLQ-C30 and OG-25 questionnaires. Linear mixed models were used to assess the mean score difference between patients with intrathoracic and cervical anastomosis. A difference of 10 points or more was considered clinically relevant. Adjustments were made for potential confounders (age, gender, ASA classification). Results Of the 4269 registered patients in the NCR, in 1274 patients at least one questionnaire was available. Of these patients 346 underwent an esophagectomy with cervical - and 928 with intrathoracic anastomosis. Patients after esophagectomy with cervical anastomosis reported statistically significant more problems in the following categories: dysphagia, couching, trouble eating with others and swallowing saliva during the first 3 months, choked when swallowing and trouble talking during the first 12 months postoperatively. In all other categories no significant difference was found. Only trouble talking at the 3-month time point was considered as a clinically relevant difference. Conclusion Although the intrathoracic anastomosis is associated with significantly better HR-QoL in several categories, only trouble talking at 3 months postoperatively was considered clinically relevant. Overall HR-QoL was comparable for esophageal cancer patients after an esophagectomy with either a cervical or intrathoracic anastomosis.

Chair-based yoga programme for older adults with multimorbidity: RCT with embedded economic and process evaluations.

Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga's Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI -0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Longer-term cost-effectiveness modelling and identifying subgroups of people who are most likely to benefit from this type of intervention. This trial is registered as ISRCTN13567538. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information.

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.

Comment on: Impaired health-related quality of life in idiopathic inflammatory myopathies: a cross-sectional analysis from the COVAD-2 e-survey: Reply.

Comment on: Impaired health-related quality of life in idiopathic inflammatory myopathies: a cross-sectional analysis from the COVAD-2 e-survey: Reply.

Comment on: Impaired health-related quality of life in idiopathic inflammatory myopathies: a cross-sectional analysis from the COVAD-2 e-survey.

Comment on: Impaired health-related quality of life in idiopathic inflammatory myopathies: a cross-sectional analysis from the COVAD-2 e-survey.

Interstitial Lung Disease Patients' Global Impressions of Symptoms, Severity Ratings, and Meaningfulness of Changes Over Time.

In interstitial lung disease (ILD), symptoms drive impairments in health-related quality of life (HRQL). Patient-reported outcome measures (PROs) can assess whether interventions change symptom severity. The meaningfulness of change in a PRO's score is estimated by anchoring it to a related variable for which meaningful change has been previously established. Patient global impressions of severity (PGIS) are single item PROs that may make trustworthy anchors, but for ILD, the meaningfulness of change in PGIS items for shortness of breath, cough, and fatigue/low energy are unknown. To improve understanding of how patients with ILD rate and categorize symptoms; how differing levels of symptom severity affect lived experiences; and how patients derive and apply meaningfulness to change in symptoms. We used one-on-one interviews and an electronic survey to collect data from patients with various forms of ILD. Interviews were conducted to provide richness and context to survey responses. We conducted certain analyses with respondents stratified by oxygen use. Interviewees (N=18) confirmed shortness of breath (SOB), cough and fatigue/low energy are the most bothersome symptoms of ILD. Among 298 survey respondents, on a PGIS for SOB with a 0 to 4 numeric rating scale, on average, those who used O2 had more severe SOB than non-users, and most respondents considered a 2-point change meaningful for worsening (45.5%) or improvement (47.2%). On a PGIS with a 5-option ordinal response scale, for SOB, most considered a 1-category change meaningful for worsening (49.8%) and a 2-category change meaningful for improvement (42.3); for cough frequency, most respondents considered a 1-category change on the 5-option ordinal response scale meaningful for worsening (48.2%) or improvement (45.0%). Survey responses for how SOB is now compared to 3 months ago (patient global impressions of change or PGIC) were biased toward the present state. PGIS's can be used as anchors for meaningful change analyses of PRO's that assess SOB or cough in patients with ILD. PGIC's demonstrate present state bias and should not be used. Patients' descriptions paint a vivid picture of lived experience with varying levels of symptom severity and can help contextualize change scores.

Menopause in adult women with human papillomavirus: health-related quality of life and determinants.

Human papillomavirus (HPV) infection and menopause entail a considerable impairment in health-related quality of life (HRQoL). The objective of the present study was to analyze the impact of the menopause status on HRQoL in women with HPV infection. A cross-sectional, nationwide, multicenter sample of women with HPV infection was conducted throughout clinics of gynecology representative of the Spanish population with regard to age, geographic density, and autonomous regions. Demographic and clinical characteristics and the specific HPV-QoL questionnaire score with its domains were compared according to reproductive status: premenopausal and peri-/postmenopausal. Correlation with other validated patient-reported outcomes measurements was also tested, including General Health Questionnaire-12 (GHQ-12), Female Sexual Function Index (FSFI), and Hospital Anxiety and Depression Scale (HADS). A sample of 1,016 noninstitutionalized women, aged 18-80 y, was recorded, 191 (18.8%) peri-/postmenopausal and 825 (81.2%) premenopausal. Total HPV-QoL scoring was significantly lower in peri-/postmenopausal (38.8, 95% CI [35.2-42.4]) compared to premenopausal (46.4, 95% CI [45.0-47.8]) women, and also in every domain of the scale (P < 0.05), except in social well-being and health domains, with a small effect size of 0.39. In women with sexual dysfunction according to FSFI, adjusted total scoring and domains sexuality, general well-being, and psychological well-being scored significantly higher in premenopause women (P < 0.01), although the magnitude of differences were of small to moderate size. HRQoL was impaired during menopause in women with HPV infection according to HPV-QoL questionnaire. The sexuality domain was the most differentiating dimension between these populations.

Health-related quality of life is an independent predictor of mortality and hospitalisations in transthyretin amyloid cardiomyopathy: a prospective cohort study

PurposeTransthyretin amyloid cardiomyopathy (ATTR-CM) is associated with severely impaired health-related quality of life (HRQL). HRQL is an independent predictor of outcome in heart failure (HF), but data on patients with ATTR-CM is scarce. This study therefore aims to evaluate the association of HRQL with outcome in ATTR-CM.MethodsPatients from our prospective ATTR-CM registry were assessed using the Kansas City cardiomyopathy questionnaire (KCCQ), the Minnesota living with HF questionnaire (MLHFQ), and the EuroQol five dimensions questionnaire (EQ-5D). Cox regression analysis was utilised to assess the impact of HRQL on all-cause mortality.Results167 patients [80 years; interquartile range (IQR): 76–84; 80.8% male] were followed for a median of 27.6 (IQR: 9.7–41.8) months. The primary endpoint of all-cause mortality was met by 43 (25.7%) patients after a median period of 16.2 (IQR: 9.1–28.1) months. In a univariate Cox regression for mortality, a 10-point change in the KCCQ implied a hazard ratio (HR) of 0.815 [95%-confidence interval (CI): 0.725–0.916; p = 0.001], in the EQ-5D VAS of 0.764 (95%-CI: 0.656–0.889; p < 0.001), and 1.163 (95%-CI: 1.114–1.433; p < 0.001) in the MLHFQ. After adjustment for established biomarkers of HF, all-cause mortality was predicted independently by the EQ-5D VAS (HR: 0.8; 95%-CI: 0.649–0.986; p = 0.037; per 10 points) and the MLHFQ (HR: 1.228; 95%-CI: 1.035–1.458; p = 0.019; per 10 points).ConclusionHRQL is a predictor of outcome in ATTR-CM. The EQ-5D VAS and the MLHFQ predict survival independent of biomarkers of HF.