Specific Health-related Quality Of Life Research Articles

Health-related quality of life predicts prognosis in individuals with COPD hospitalized with community-acquired pneumonia – a prospective cohort study

Community-acquired pneumonia (CAP) in chronic obstructive pulmonary disease (COPD) often result in sudden and persistent reduction in health-related quality of life (HRQoL), which may be alleviated with palliative care. Among individuals with COPD, we aimed to investigate potential associations between HRQoL at admission with CAP and the risk of re-hospitalization and mortality and potential associations between specific HRQoL domains and CAP treatment outcomes. HRQoL was assessed at admission and the participants were grouped into tertiles based on the HRQoL utility index and specific domains. The results revealed that participants in the middle and highest tertiles of HRQoL had a lower 90-day re-hospitalization risk compared to those in the lowest tertile, whereas no differences in re-hospitalization risk were observed 30 and 180 days after discharge. Almost one in four had severe pain or discomfort at admission and the domain pain or discomfort emerged as a predictor of re-hospitalization. In addition, participants in the middle and highest tertiles had lower risk of 180-day mortality compared to those in the lowest, while no differences were observed in 30-day or 90-day mortality risk. An increased focus on in-hospital palliative care could alleviate the pain and discomfort reported by many participants with potential to reduce re-hospitalization rates.

Quality of life under treatment with the immune checkpoint inhibitors ipilimumab and nivolumab in melanoma patients. Real-world data from a prospective observational study at the Skin Cancer Center Kiel

PurposeCombined immunotherapy (ipilimumab + nivolumab) has improved survival in stage IV melanoma patients, making Health-related Quality of Life (HrQoL) crucial due to potential immune-related adverse events (irAEs). Previous studies treated HrQoL as secondary/explorative endpoint, and no specific HrQoL questionnaire for melanoma patients on immune checkpoint inhibitor (ICI) therapy exists. This study aimed to gather specific HrQoL data during combined ICI therapy, tracking changes during and after treatment, and examining associations with gender, irAEs, and treatment response.Methods35 melanoma patients (22 males, 13 females) undergoing combined ICI were surveyed using the Short-form 36 questionnaire (SF-36), the Inflammatory Bowel Disease Questionnaire – Deutsch (IBDQ-D), and the distress thermometer (DT). HrQoL was evaluated during treatment, after six months, and at the onset of autoimmune colitis.ResultsirAEs occurred in 51.4% of patients, with colitis being the most common (26.1%). 45.7% had progressive disease. SF-36 showed stable HrQoL during treatment and follow-up. Women had worse HrQoL on the physical component scale than men (p = 0.019). Patients with progression showed worse HrQoL over time in physical (p = 0.015) and mental health scales (p = 0.04). IBDQ-D showed constant HrQoL throughout treatment and follow-up. Distress on DT remained constant, with women reporting higher levels of distress.ConclusionHrQoL remained stable during and after therapy. Female gender and disease progression negatively impacted HrQoL. The development of irAEs was not associated with HrQoL, though this may not apply to severe irAEs like colitis, which were not assessed.

Health service utilization, economic burden and quality of life of patients with mucopolysaccharidosis in China

BackgroundPatients with mucopolysaccharidosis (MPS) often face delayed diagnoses, limited treatment options and high healthcare costs, that may significantly affect patients' quality of life. The objective of this study was to understand medical service utilization related to diagnosis and treatment, economic burden during diagnosis period, and health-related quality of life among MPS patients in China.MethodsA series of patients diagnosed with MPS registered in the national patient organization were recruited for a cross-sectional survey from May to July 2019. Information were collected from patients or their parents via phone interview, including demographic data, utilization of services related to diagnosis and treatment, total cost during the period of MPS diagnosis and health-related quality of life (HRQoL). HRQoL was assessed by PedsQL 4.0 Generic Core Scale (PedsQL) and 36-item short-form health survey (SF-36) depending on the age of patients with MPS and compared with the general Chinese population.ResultsA total of 180 MPS patients (50, 67, 15, 46, 1 and 1 for type I, II, III, IV, VI and VII), with a mean age of 9.54 years and 137 (76.11%) males, were included in analysis. The mean age at first visit to a medical doctor for MPS related symptoms was 3.65 ± 2.58 years old, while only 12 patients (6.67%) were diagnosed on their first visit. The mean diagnostic delay, which is defined as the time between the first visit to a medical doctor for MPS related symptoms and the final diagnosis, was 9.42 months, with no significant difference between types. The average number of misdiagnosis was 4.56. Before the confirmed diagnosis, the patients made an average of 6.31 visits and visited 4.3 hospitals. During diagnosis period, the mean of ¥81,086.72 direct medical costs accounted for 63.75% of the total cost. Only 32.78% of the patients had ever received specific treatments. The mean scores of PedsQL and SF-36 of patients were significantly lower than the Chinese norms. Household annual income per person, specific treatment use and MPS subtype were significantly associated HRQoL of patients.ConclusionThe results highlight challenges faced by MPS patients in terms of diagnosis, access to specific treatments, economic burden and low HRQoL. There is an urgent need to improve early detection and diagnosis, create fair and consistent mechanisms to increase access to specialized treatment and reduce the economic burden of MPS patients in China.

A novel multisite model to facilitate hepatitis C virus elimination in people experiencing homelessness

Background/aims: Only a handful of countries are on target to achieve hepatitis C virus (HCV) elimination by 2030. People experiencing homelessness (PEH) remain an important HCV reservoir. The END C study evaluated clinical, patient reported and health economic outcomes of a decentralised integrated model. MethodsThis prospective study assessed a decentralised regional service based at multiple homeless sites in southeast England. Novel linkage-care strategies were utilised. We assessed generic and liver specific health-related quality of life (HRQoL) (SF-12v2; EQ-5D-5L and SFLDQol) pre/post HCV treatment and cost per HCV case detected and cured. Primary outcome was intention-to-treat (ITT) sustained virological response (SVR12). ResultsWe recruited 418 individuals, mean age 44.45 ± 10.6, 78% were male, 74% being currently homeless, current injecting drug use/alcohol use being 25% and 65% respectively. Prevalence of cirrhosis (liver stiffness measurement >12kPa) was 12%. Twenty-eight percent (n=116) were HCV PCR positive, of whom n=105 received direct acting antiviral treatment. ITT SVR12 rates were 81% (95% CI 72%-88%), the only predictor of SVR12 being >80% treatment adherence (OR 20.69, 95% CI 6.227-68.772, p<0.001). HRQoL improved significantly after SVR12: SF-12v2 (General Health, Mental Health, Social Functioning, Mental Health Composite Score p<0.049); SFLDQoL (Symptoms/Effects of Liver Disease, Distress, Loneliness p<0.004) and EQ-5D-5L (Index Score, Visual Analog Scale p<0.001). Costs (British pound 2022) per HCV case detected and per case cured were £359 and £257 respectively. Reinfection rates were 6.82/100 person years. ConclusionThe END C study endorses a multisite decentralised service for PEH enabling excellent linkage to care, high SVR12 rates and significant improvements in generic and liver specific HRQoL, all being achieved at modest costs. Such services are paramount to help achieve HCV elimination. Impact and implicationsIn people experiencing homeless, we found a high prevalence of HCV, alcohol and substance misuse including overdoses and mental health issues. Despite this, an integrated and decentralised service resulted in excellent linkage to care with high SVR12 rates. Even in this complex cohort with multiple comorbidities, SVR12 was associated with significant improvements in both generic and liver specific health-related quality of life. This was all achieved at modest costs in a community setting. Such models of care are feasible, easy to replicate and essential if we are to achieve HCV elimination.

Health-related quality of life profile of newly diagnosed patients with Hodgkin and non-Hodgkin lymphomas: A real-world study including 3922 patients from the French REALYSA cohort

IntroductionConsidering the notable advances made in the treatment of lymphoma, assessment of health-related quality of life (HRQoL) of lymphoma patients has become a critical aspect to consider both in clinical research and routine practice. However, there is paucity of information about lymphoma specific HRQoL profile at diagnosis. Patients and methodsHRQoL at diagnosis was assessed for 3922 adult patients with newly diagnosed high-grade (HG) (n = 1994), low-grade (LG) (n = 1053) non-Hodgkin (NHL) and Hodgkin (HL) (n = 875) lymphomas included in REal world dAta in LYmphoma and Survival in Adults (REALYSA, NCT03869619), a prospective non-interventional multicentric cohort in France. Disease-specific HRQoL aspects were assessed with three validated EORTC questionnaires, namely, the QLQ‐NHL‐HG29, the QLQ-NHL-LG20 and the QLQ-HL27, for patients with NHL-HG, NHL-LG and HL, respectively. ResultsWe confirmed the high-level of completion of these questionnaires in REALYSA cohort, ranging from 84 % for QLQ-HG29 to 88 % for QLQ-HL27. The proportion of patients with impaired global health status was as follows: T-cell NHL, 67 %; diffuse large B-cell (DLBCL), 62 %; Burkitt, 61 %; HL, 53 %; marginal zone, 49 %; mantle cell, 48 %; follicular, 47 %. Multivariable regression analyses for DLBCL, follicular and HL showed that gender, performance status and B symptoms were independently associated with all HRQoL dimensions. However, a variable effect of age and stage were observed among these three subtypes. ConclusionsA comprehensive analysis was made describing the HRQoL profile of newly diagnosed patients with different types of lymphomas. Our data may help to enhance the interpretation of HRQoL results in future studies using the recently validated EORTC lymphoma specific questionnaires.

General and Specific Quality of Life Course of Individuals with Different Levels of Stroke Severity: A One-Year Prospective Longitudinal Study

ABSTRACT Objectives To compare the course of generic and specific health-related quality of life (HRQOL) of individuals with stroke, and its physical, mental, and social domains, at three, six, and 12 months after hospital discharge, considering the levels of stroke severity. Methods This is a longitudinal study, in stroke individuals, assessed during hospital admission by the National Institutes of Health Stroke Scale (NIHSS), and divided into mild (NIHSS ≤3) or moderate/severe (NIHSS ≥4) disease. At three, six, and 12 months after hospital discharge, the individuals were assessed for generic (Short Form Health Survey–36: total score and physical and mental domains) and specific (Stroke Specific Quality of Life Scale: total score and social domain) HRQOL. A 2 × 2 repeated measures analysis of variance (ANOVA) with post-hoc was applied. Results 146, 122, and 103 individuals were assessed at three, six and 12 months, respectively HRQOL courses showed different behaviors according to stroke severity (3.37≤F ≤ 4.62; 0.010≤p ≤ .036). Individuals with mild stroke showed significant changes in the physical domain, with a reduction between three and six months, and an increase between six and 12. Moderate/severe individuals showed a significant increase in all HRQOL variables between three and six months, and a maintenance of values for almost all variables, except for physical domain, which improved significantly between three and six months, and got significantly worse between six and 12. Conclusions HRQOL during the first year after stroke showed distinct trajectories, being stroke severity an important factor in identifying stroke subjects at risk of HRQOL decline. Clinical Implications These results demonstrate the importance of considering not only the phase of the stroke, the severity, and the general and specific HRQOL, but also the physical, social, and mainly the mental domain, which has long been neglected, when assessing this population.

Factors influencing the health-related quality of life of older men and women living with HIV in Spain

ABSTRACT The number of older people living with HIV (OPLHIV) is increasing worldwide. However, little is known about the factors that better predict their health-related quality of life (HRQoL). We administered the validated WHOQoL-HIV BREF questionnaire to 247 Spanish OPLHIV (192 men and 55 women). In addition to the six domains of the questionnaire, we constructed a seventh domain as theaverage of punctuations of all domains. Multivariable Poisson regression models with robust estimates by sex were constructed for the seven domains (14 in total). The best-subset selection method together with Mallow's Cp metric was used to select the model factors. The percentage of variability explained by Poisson models ranged from15-38% for men and 29-70% for women. The analysis showed that women were most affected by ageing (four domains), mobility impairments (five domains), and mental disorders (five domains). The factors with the greatest negative influence on men were heterosexuality (six domains), mental disorders (six domains), being single (five domains), and poverty risk (three domains). Physical activity was found to improve HRQoL in both men (six domains) and women (four domains). Future OPLHIV programmes would benefit from considering sex specific HRQoL factors. This could also improve the cost-effectiveness of interventions.

Acute clinical outcomes predict both generic and specific health-related quality of life six and 12 months after stroke: A one-year prospective study developed in a middle-income country

ObjectiveTo identify acute predictors of generic and specific health-related quality of life (HRQoL) six and 12 months after stroke in individuals from a middle-income country. Material and methodsThis was a prospective study. The dependent outcomes assessed during six and 12 months after stroke included both generic and specific HRQoL (Short Form Health Survey-36 [SF-36] and stroke-specific quality of life [SSQOL]). The predictors were age, sex, education level, length of hospital stay, current living arrangement, stroke severity, functional independence, and motor impairment. Results122 (59.9±14 years) and 103 (59.8±14.71 years) individuals were evaluated six and 12 months after stroke, respectively. Functional independence and sex were significant acute predictors of both generic and specific HRQoL. Functional independence was the strongest predictor (0.149≤R2≤0.262; 20.01≤F≤43.96, p<0.001), except for generic HRQoL at 12 months, where sex was the strongest predictor (R2=0.14; F=17.97, p<0.001). ConclusionGeneric and specific HRQoL in chronic individuals six and 12 months after stroke, from a middle-income country, can be predicted based on functional independence, the strongest predictor, assessed in the acute phase, except for generic HRQoL at 12 months. Functional independence can be modified by rehabilitation strategies and thus should be considered for HRQoL prognoses at chronic phase.

A domain specific health-related quality of life of omani patients living with chronic wounds

AimChronic wounds, defined as wounds that do not heal in a logical set of stages, impact patients’ quality of life by disrupting their self-esteem, sleep, social interaction, work capacity, and psychological well-being. Chronic wounds are a prevalent problem in Oman due to the high number of patients with diabetes, sickle cell disease, road traffic accidents, and decubitus ulcer. Therefore, it is paramount to analyse the health-related quality of life (HRQOL) of these patients with chronic wounds. Material and methodsAn observational, cross-sectional, descriptive study with a quantitative approach was conducted among 275 adult patients with chronic wounds in three tertiary hospitals of Muscat from June to December 2021 using a self-reported Cardiff life wound impact questionnaire and the Bates-Jensen wound assessment tool. Data were analysed with IBM SPSS version 23 using inferential statistics and chi-square test. ResultsWe found that the majority of participants were men (178; 64.7 %), aged between 41 and 60 years (107; 38.9 %), predominantly with diabetic wounds (80; 29.1 %). Respondents reported poor HRQOL across all domains: well-being (63.24 ± 18.092), physical (53.24 ± 18.387), and social (59.54 ± 19.025). Statistically significant poorer HRQOL was observed among the elderly above 60 years, illiterates, those with traumatic wounds, and those receiving medication and dressing as treatment. ConclusionsOur findings indicate that Omani patients with chronic wounds experience low HRQOL. It is imperative for healthcare providers to offer comprehensive care to these patients. To enhance their quality of life and alleviate suffering, evaluating both the wounds and HRQOL is essential. Such assessments will enable the optimisation of treatment and coping strategies for patients.

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.

Effectiveness of educational and psychological survivorship interventions to improve health-related quality of life outcomes for men with prostate cancer on androgen deprivation therapy: a systematic review

ObjectivesAndrogen deprivation therapy (ADT), a common treatment for prostate cancer, has debilitating impacts on physical and psychological quality of life. While some interventions focus on managing the physical side effects...

Health-related quality of life (HRQoL) in German early benefit assessment: The importance of disease-specific instruments

IntroductionHealth-Related Quality of Life (HRQoL) data is frequently requested in early benefit assessment in Germany. To test the hypothesis that the importance of HRQoL in general and the significance of disease-specific instruments in particular has increased since the introduction of AMNOG in Germany, we analysed all early benefit assessments between 2011 and 2022. MethodsAll 793 early benefit assessments completed between 01/01/2011 and 03/11/2022 were systematically analysed. The HRQoL instruments featured in the dossier submissions were extracted for all assessments and categorized into generic and specific instruments. All G-BA resolutions were likewise assessed for consideration and acceptance of generic and specific HRQoL instruments. In addition, it was examined whether there was an association between HRQoL data and the extent of additional benefit. ResultsSince 2014 HRQoL data have continuously been submitted in 70% to 80% of assessments per year with the exception of 2022 (63%). Generally, disease-specific instruments are favoured, regarding submissions by industry but especially with higher acceptance by the G-BA in the resolution. Subgroup analyses revealed oncology as a major contributor to the submission and acceptance rates of disease-specific instruments. Disease-specific instruments were submitted in 81% of all oncology assessments and accepted in 53% of assessments. Overall, assessments with accepted HRQoL data tend to reach a higher overall benefit. Procedures with accepted HRQoL were most likely to receive a considerable benefit (31%), while for procedures in which HRQoL data were not accepted, a benefit was most often (65%) not proven. DiscussionIndustry has followed the request for submission of specific HRQoL instruments early on. Higher submission rates of specific instruments over time which at the same time meet the methodological requirements indicate that industry has learned from early assessments. A potential reason for the high submission- and acceptance rates of specific HRQoL instruments in oncology might be the particularly high relevance of HRQoL in this indication. Possible effects of changes in legislature on the future development of submission and acceptance of HRQoL data need to be monitored. ConclusionIn Germany, HRQoL has gained a relevant position in early benefit assessment over time. Overall specific instruments are favoured, regarding submissions by industry but especially through consideration by the G-BA in the resolution. Furthermore, HRQoL data can be supportive for benefit assessments, in particular to show that advantages in morbidity and/or mortality are reflected in HRQoL and not at the expense of HRQoL.

Identifying subgroups of patients that may benefit from robotic arm-assisted total knee arthroplasty: Secondary analysis of data from a randomised controlled trial

BackgroundThe aims were to assess whether a specific subgroup(s) of patients had a clinically significant benefit in their knee specific outcome or health-related quality of life (HRQoL) when undergoing robotic total knee arthroplasty (rTKA) when compared to manually performed TKA (mTKA). MethodsOne hundred patients were randomised to either rTKA or mTKA, 50 to each group, of which 46 and 41 were available for functional review at 6-months, respectively. Subgroup analysis was undertaken for sex, age (<67-years versus ≥ 67-years), preoperative WOMAC score (<40 versus ≥ 40) and EQ-5D utility (<0.604 versus ≥ 0.604). ResultsMale patients undergoing rTKA had a clinically and statistically significant greater improvement in WOMAC pain (mean difference (MD) 16.3, p = 0.011) at 2-months, function (MD 12.6, p = 0.032) and total score (MD 12.7, p = 0.030), and OKS (MD 6.0, p = 0.030) at 6-months. Patients < 67-years old undergoing rTKA had a clinically and statistically significant greater improvement in WOMAC pain (MD 10.3, p = 0.039) at 2-months, and function (MD 12.9, p = 0.040) and total (MD 13.1, p = 0.038) scores at 6-months. Patients with a preoperative WOMAC total score of < 40 points undergoing rTKA had a clinically and statistically significant greater improvement in WOMAC pain (MD 14.6, p = 0.044) at 6-months. Patients with a preoperative EQ-5D utility of <0.604 undergoing rTKA had a clinically and statistically significant greater improvement in WOMAC pain (MD 15.5, p = 0.011) at 2-months. ConclusionPatients of male sex, younger age, worse preoperative knee specific function and HRQoL had a clinically significantly better early functional outcome with rTKA when compared to mTKA.

Functional outcome and analysis of factors affecting health-related quality of life of surgically managed pelvic ring fractures: a cross-sectional study.

Pelvic ring fractures, particularly those involving the posterior pelvis, pose significant challenges due to their inherent instability. The posterior pelvic ring is critical in providing structural support and stability to the pelvis. This study evaluates the functional outcomes and health-related Quality of life (HRQOL) of patients who underwent internal fixation for unstable pelvic fractures. Various factors influencing the outcomes are also investigated. A single-center cross-sectional study was conducted on patients with unstable sacral fractures treated with posterior tension band plate or sacroiliac plating with or without symphyseal plating between 2016 and 2020. Patient demographics, injury mechanisms, associated injuries, surgical details, complications, and return-to-work data were collected. HRQOL was assessed using specific pelvic fracture instruments and general HRQOL questionnaires. Logistic regression analysis was performed to identify factors associated with lower SF-12 and SF-36 scores RESULTS: The study included 54 patients, predominantly males (55.6%), aged 18-70 years, with high-energy trauma mechanisms, such as road traffic accidents and occupational injuries. The majority of patients had lateral compression pelvic fractures. Overall, the functional outcomes were favorable, with excellent or good outcomes observed in 86.1% of cases. Patients with associated injuries, such as abdominal, chest, or head injuries, were likelier to have lower SF-12 physical component scores. Sexual satisfaction scores remained stable for most patients post-surgery. This study highlights the favorable functional outcomes and HRQOL for patients undergoing fixation for unstable pelvic ring fractures. Younger, working-age males were the most commonly affected demographic. Associated injuries significantly affected physical HRQOL scores. Despite high-energy trauma, patients generally reported satisfactory sexual function post-surgery.

Health-related quality of life in patients with hematologic malignancies treated with chimeric antigen receptor T-cell therapy: review and current progress.

Chimeric antigen receptor (CAR) T-cell therapy has transformed the care of patients with relapsed/refractory B-cell-derived hematologic malignancies. To date, six CAR T-cell therapies, targeting either CD19 or B-cell maturation antigen, have received regulatory approval. Along with the promising survival benefit, CAR T-cell therapy is associated with potentially life-threatening adverse events, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. While clinical trials evaluating CAR T-cell therapy consistently report the incidence of these adverse events, most trials do not collect health-related quality of life (HRQoL) data. As such, the impact of the CAR T-cell therapy process and related adverse events on the physical and psychological well-being of patients remains uncertain. HRQoL and other patient-reported outcome (PRO) assessments in patients with relapsed or refractory hematologic malignancies are of utmost importance, as individuals may have unmet needs and a high demand for tolerable therapy if a cure is not obtained. In addition, it is important to standardize methods of data collection to better assess the impact of CAR T-cell therapy on quality of life, optimize patients' care and costs, and enable comparisons between different studies. We conducted a literature search up to June 2023 to identify the HRQoL tools used in clinical trials and in real-world studies investigating CAR T-cell therapy in patients with lymphomas or leukemias. In the present comprehensive review, we summarize the most commonly used CAR T-cell specific and non-specific HRQoL tools and discuss how the use of HRQoL and other PRO tools may be optimized.

HIV, multimorbidity, and health-related quality of life in rural KwaZulu-Natal, South Africa: A population-based study.

Health-related quality of life (HRQoL) assesses the perceived impact of health status across life domains. Although research has explored the relationship between specific conditions, including HIV, and HRQoL in low-resource settings, less attention has been paid to the association between multimorbidity and HRQoL. In a secondary analysis of cross-sectional data from the Vukuzazi ("Wake up and know ourselves" in isiZulu) study, which identified the prevalence and overlap of non-communicable and infectious diseases in the uMkhanyakunde district of KwaZulu-Natal, we (1) evaluated the impact of multimorbidity on HRQoL; (2) determined the relative associations among infectious diseases, non-communicable diseases (NCDs), and HRQoL; and (3) examined the effects of controlled versus non-controlled disease on HRQoL. HRQoL was measured using the EQ-5D-3L, which assesses overall perceived health, five specific domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and three levels of problems (no problems, some problems, and extreme problems). Six diseases and disease states were included in this analysis: HIV, diabetes, stroke, heart attack, high blood pressure, and TB. After examining the degree to which number of conditions affects HRQoL, we estimated the effect of joint associations among combinations of diseases, each HRQoL domain, and overall health. Then, in one set of ridge regression models, we assessed the relative impact of HIV, diabetes, stroke, heart attack, high blood pressure, and tuberculosis on the HRQoL domains; in a second set of models, the contribution of treatment (controlled vs. uncontrolled disease) was added. A total of 14,008 individuals were included in this analysis. Having more conditions adversely affected perceived health (r = -0.060, p<0.001, 95% CI: -0.073 to -0.046) and all HRQoL domains. Infectious conditions were related to better perceived health (r = 0.051, p<0.001, 95% CI: 0.037 to 0.064) and better HRQoL, whereas non-communicable diseases (NCDs) were associated with worse perceived health (r = -0.124, p<0.001, -95% CI: 0.137 to -0.110) and lower HRQoL. Particular combinations of NCDs were detrimental to perceived health, whereas HIV, which was characterized by access to care and suppressed viral load in the large majority of those affected, was counterintuitively associated with better perceived health. With respect to disease control, unique combinations of uncontrolled NCDs were significantly related to worse perceived health, and controlled HIV was associated with better perceived health. The presence of controlled and uncontrolled NCDs was associated with poor perceived health and worse HRQoL, whereas the presence of controlled HIV was associated with improved HRQoL. HIV disease control may be critical for HRQoL among people with HIV, and incorporating NCD prevention and attention to multimorbidity into healthcare strategies may improve HRQoL.

Multimorbidity patterns and health-related quality of life among community-dwelling older adults: evidence from a rural town in Suzhou, China.

The high prevalence of multimorbidity in aging societies has posed tremendous challenges to the healthcare system. The aim of our study was to comprehensively assess the association of multimorbidity patterns and health-related quality of life (HRQOL) among rural Chinese older adults. This was a cross-sectional study. Data from 4,579 community-dwelling older adults aged 60years and above was collected by the clinical examination and questionnaire survey. Information on 10 chronic conditions was collected and the 3-Level EQ-5D (EQ-5D-3L) was adopted to measure the HRQOL of older adults. An exploratory factor analysis was performed to determine multimorbidity patterns. Regression models were fitted to explore the associations of multimorbidity patterns with specific health dimensions and overall HRQOL. A total of 2,503 (54.7%) participants suffered from multimorbidity, and they reported lower HRQOL compared to those without multimorbidity. Three kinds of multimorbidity patterns were identified including cardiovascular-metabolic diseases, psycho-cognitive diseases and organic diseases. The associations between psycho-cognitive diseases/organic diseases and overall HRQOL assessed by EQ-5D-3L index score were found to be significant (β = -0.097, 95% CI -0.110, -0.084; β = -0.030, 95% CI -0.038, -0.021, respectively), and psycho-cognitive diseases affected more health dimensions. The impact of cardiovascular-metabolic diseases on HRQOL was largely non-significant. Multimorbidity was negatively associated with HRQOL among older adults from rural China. The presence of the psycho-cognitive diseases pattern or the organic diseases pattern contributed to worse HRQOL. The remarkable negative impact of psycho-cognitive diseases on HRQOL necessiates more attention and relevant medical assistance to older rural adults.

Diagnostic intervention improved health-related quality of life among teenagers with food allergy.

The aim was to examine if a diagnostic intervention set up to assess current food allergy to cow's milk, hen's egg, fish, or wheat among teenagers had an impact on generic and disease specific health-related quality of life (HRQL). The study compared HRQL scoring before and two years after the intervention, and in relation to age matched controls without reported food allergy. The study was performed within the Obstructive Lung Disease in Northern Sweden (OLIN) studies where a cohort study on asthma and allergic diseases among 8-year-old schoolchildren was initiated in 2006. At age 12 years, the 125/2612 (5%) children who reported allergy to cow's milk, hen's egg, fish, or wheat were invited to a diagnostic intervention including clinical examination, blood tests and evaluation by a pediatric allergist. Of 94 participants, 79 completed generic and disease specific HRQL questionnaires. Additionally, a random sample of 200 (62% of invited) children without food allergy from the OLIN cohort answered the generic HRQL questionnaire. The respondents of the HRQL questionnaires were re-examined two years later and 57 teenagers with and 154 without reported allergy participated. There were no significant differences in generic HRQL scores between teenagers with and without reported food allergy at study entry, or after the intervention. Among those with reported food allergy, we found a significant improvement in disease specific HRQL after the intervention (mean values: 3.41 vs 2.80, p<0.001). Teenagers with only food allergy had better disease specific HRQL compared to those with one, two or three concomitant allergic diseases, both before and after the intervention. Children with only food allergy significantly improved their HRQL after the intervention, 1.84 vs. 2.87 (p<0.001) but this association was not seen in children with one other allergic disorder (3.16 vs. 3.65, p = 0.121) or those with two or more allergic disorders (3.72 vs. 3.90, p = 0.148). The diagnostic intervention showed a long-term improvement of disease specific HRQL but not generic HRQL.

Measuring health-related quality of life in solid rare cancer patients: A study protocol

Rare cancer patients often face delayed diagnosis and lack of expert care which are a challenge to clinical practice. Patients diagnosed with a rare tumour report poorer psychosocial outcomes and impaired health-related quality of life (HRQoL). The impairment might be explained by the challenges patients with rare cancer face during their disease trajectory. Specific HRQoL assessment is important to understand the variances in the quality of life patients experience. This study aims to examine how HRQoL is currently assessed in clinical adult solid rare cancer research and identify specific HRQoL issues patients experience and issues faced in the healthcare system due to the disease’s rarity. Further, this study aims to test the content validity of existing HRQoL questionnaires. In this mixed-method research, two literature reviews will be conducted, and clinical data will be collected worldwide in a multicentre approach via interviews and questionnaires. Basic quantitative analysis will be used to analyse patient and HCP data. The project outcomes will result in standards of the HRQoL measurement in patients diagnosed with a solid rare cancer.

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

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