Importance Of Health-related Quality Of Life Research Articles

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.

Factors important for health-related quality of life in men and women: The population based SCAPIS study.

Health-related quality of life (HRQoL) is essential for human wellbeing, influenced by a complex interplay of factors, and is reported lower in women than men. We aimed to evaluate which factors were the most important for HRQoL in a middle-aged general population. This was a cross-sectional, multi-centre study of 29,212 men (48%) and women (52%) aged 50-64 in the general population in Sweden. Physical and mental HRQoL (0-100) was assessed using the Short Form 12 questionnaire, and association was evaluated for 356 variables including demographics, lifestyle, symptoms, physiological measurements, and health conditions. Using machine learning, each variable´s importance for HRQoL was measured by an importance score, comparable to effect size, and summarised in 54 factors, in men and women separately. Men and women had similar mean and standard deviation (SD) scores for physical HRQoL (53.4 [SD 8.1] vs 51.4 [9.7]) and mental HRQoL (37.1 [5.0] vs 37.3 [5.4]). The most important factors for physical HRQoL were (importance score) physical activity (40), employment (36), pain (33), sleep (33), and sense of control (26). The most important factors for mental HRQoL were sense of control (18), physical activity (12), depression (12), pain (6), and employment (5). The factors important for HRQoL identified by this study are likely to be amenable to interventions, and our findings can support prioritising interventions. The identified factors need to be a target even before middle-age to lay the foundation for long and happy lives.

Association Between Exercise Self-Efficacy and Health-Related Quality of Life Among Dialysis Patients: A Cross-Sectional Study.

BackgroundExercise self-efficacy is a vital determinant of an individual’s active participation in regular exercise, and exercise is a critical component of improving health-related quality of life (HRQOL) in dialysis patients. This study aimed to describe the relationship between exercise self-efficacy and HRQOL in dialysis patients.Materials and MethodsA cross-sectional study was conducted in Shanghai, China. Structured questionnaires distributed to the patients collected socio-demographic and disease-related information. Physical activity was assessed by a self-administered questionnaire, and the exercise self-efficacy scale (ESES) was used to measure exercise self-efficacy. HRQOL was evaluated by the kidney disease quality of life instrument-short form version 1.3 (KDQOL-SF™ v1.3). Data were analyzed using a univariate generalized linear model, Spearman correlation, and hierarchical multiple regression.ResultsA positive association was observed between exercise self-efficacy and HRQOL (r = 0.310, p < 0.001). Physical activity as a predictor variable explained 9.8% of the variance in overall HRQOL (p < 0.001). Exercise self-efficacy explained an additional 7.1% of the HRQOL variance. In total, 24.6% of the variation in the HRQOL was explained by the socio-demographic variables, disease-related factors, physical activity, and exercise self-efficacy.ConclusionOverall, only 16.9% of the change in HRQOL was explained by physical activity and exercise self-efficacy. Future research is still needed to further explore the factors influencing the HRQOL in dialysis patients. However, this finding suggests the need to consider the importance of HRQOL and physical activity as well as exercise self-efficacy when developing intervention programs.

Health-related quality of life after esophagectomy in patients with esophageal cancer.

Esophageal cancer is one of the malignant tumors with the poorest prognosis. Esophagectomy, which is the mainstay of curative-intent treatments, imposes excessive surgical stress on the patients, and postoperative morbidity and mortality rates after esophagectomy remain high. On the other hand, the number of survivors after esophagectomy for esophageal cancer is increasing due to recent improvements in surgical techniques and multidisciplinary treatments for this cancer. However, esophagectomy still has a great influence on the fundamental aspect of patients' lives, that is, the health-related quality of life (HR-QOL), including their physical, emotional, and social functions in the short- and long-term postoperatively. HR-QOL is a multifactorial concept used to assess the symptoms and functional changes caused by the disease itself and treatments from the patients' perspectives. Therefore, assessing the HR-QOL of patients with esophageal cancer after esophagectomy is becoming increasingly important. However, the status of HR-QOL changes after esophagectomy has not been satisfactorily evaluated, and there is no worldwide consensus as to how the postoperative HR-QOL can be improved. This review aimed to raise awareness of healthcare providers, such as surgeons and nurses, on the importance of HR-QOL in patients with esophageal cancer after curative-intent esophagectomy by providing multifaceted information concerning the short- and long-term HR-QOLs, including the status of changes and the determinants of HR-QOL after esophagectomy, and furthermore, essential points for improvement of HR-QOL after esophagectomy.

Emerging trends and utilization of patient-reported outcomes (PROs) in clinical trials of chimeric antigen receptor (CAR) T-cell therapies.

e19142 Background: Patient-reported outcomes (PROs) are an important tool to assess the impact of new therapies on health-related quality of life (HRQoL). This study aimed to describe if and what PRO instruments are currently being utilized in CAR-T cell therapy studies in solid and hematological malignancies while assessing the patterns of inclusion and trends of HRQoL data reporting. Methods: We used Citeline to search for clinical trials between Jan 2008 - Jan 2020, excluding planned or terminated studies, non-oncology, non-treatment, and duplicates. Reviewers extracted various parameters for included trials, then cross-matched data with EU Clinical Trials Register, Clinical trials.gov, trial protocols (when available), and Google. The reporting of PRO data was then assessed for those Closed/Completed trials that included a PRO via PubMed/MEDLINE, Sponsor, and Google. Results: A sample of 664 CAR-T trials was identified. PROs were included in only 6.17% (41/664) studies. Of the 41 trials that included a PRO, 63.41% (26/41) utilized more than one PRO, with the generic EORTC QLQ-C30 and the EQ-5D being used predominately. Median HRQoL follow-up was 5-years on most trials. No studies used PROs as primary endpoints. The majority of PROs were observed to be utilized in early phase trials (phase I, 12; Phase I/II, 17). PROs were first incorporated in CAR-T trials beginning in 2014, and the utilization rate has increased steadily, except for 2019. PROs were included in 3 first line trials, 22 second line, 5 third line, and 11 fourth line or greater. PRO utilization between solid tumor trials and hematologic malignancies was comparable (6.04% [9/149], and 6.26% [32/511]). Of the completed/closed trials, 28.57% (3/14) published PRO data and met at least eight of the CONSORT-PRO quality indicators. Conclusions: The utilization of PROs in CAR-T trials (6.17%) is under the industry average of 27%, despite the growing importance of HRQoL and its impact on value-based care. The findings from this review reflect the overall increased attention to CAR-T as a new therapeutic entity and the continued deficiency of including and reporting of PROs in trial designs.

Health-related quality of life in children and adolescents with celiac disease: patient-driven data from focus group interviews

Celiac disease (CD) is a chronic inflammatory disease requiring constant management with a gluten-free diet (GFD). Little is known about how CD impacts on health-related quality of life (HRQOL) in children and adolescents, and how they feel about and cope with CD and GFD. This qualitative study explores the impact of CD and GFD on HRQOL in everyday living of children and adolescents. In focus group interviews, we investigated HRQOL in children and adolescents with CD in order to identify patient concerns in living with CD and on a GFD. Seven focus groups were formed with 23 children/adolescents and 3 parents. Interviews were transcribed verbatim. Grounded theory approach was applied to analyse the interviews. CD had varying impact on the children and adolescents HRQOL. Two major categories emerged with importance for HRQOL in children and adolescents with CD, having CD (constructed from the six subcategories: symptoms, the diagnosis-process, self-perception, awareness of CD, social and emotional impact of CD, and thoughts about the future) and coping with CD (constructed from the two subcategories: coping with food and coping with social situations). The complexity of coping with CD in social situations that involve food is presented in a flowchart. Children and adolescents showed large diversity in how much impact CD has on their HRQOL. Different ways of coping with CD and GFD were identified. Findings will be used to generate a patient-driven disease-specific questionnaire to measure HRQOL in children and adolescents with CD.

Importance of health-related quality of life for persons with aphasia, their significant others, and SLPs: Who do we ask?

Background: Outcomes that support improved health-related quality of life (HRQL) are increasingly identified as desirable products to aphasia intervention. Although domain importance has been examined for survivors of stroke, little research evidence exists indicating what particular HRQL domains are or are not important to persons with aphasia (PwA). Aims: The study aimed to determine if persons with mild, moderate, and severe aphasia, their respective speech-language pathologists (SLPs) and respective significant others (SOs) attribute similar importance rankings to different domains and overall HRQL. Method & Procedures: This study was a prospective, observational, non-randomised group design. The Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39; Hilari, Byng, Lamping, & Smith, 2003a) and the Quality of Communication Life scale (Paul et al., 2004) were administered to 24 PwA, their treating SLPs (n = 7), and SOs (n = 24). Importance ratings on a 5-point Likert scale were obtained for each scale item. Severity of aphasia was determined by expressive ability resulting in by chance assignment of eight participants per severity group. Outcomes & Results: The SAQOL-39 physical domain was the only HRQL domain to be statistically significant with a significant group main effect, F(2, 21) = 4.057, p < .05. The SLP and SO significantly correlated with each other for importance of HRQL, but not with the PwA who had no significant correlations with the importance ratings made by the SO or the SLP on the SAQOL-39 and QCL. A total of 43% of variance in the overall importance ratings by PwA was accounted for by age, R2 = .434, F(1, 22) = 16.89, p < .01. Conclusions: Seeking importance ratings of HRQL domains from persons with mild, moderate, and severe aphasia may result in development of treatment goals more relevant to the PwA. Assessment of multiple HRQL domains is necessary to understanding priorities PwA place on rehabilitation outcomes across the continuum of care. Consideration for severity assignments beyond impairment-based assessments is discussed.

Distress and quality of life characteristics associated with seeking surgical treatment for stress urinary incontinence.

BackgroundCurrent research focuses on three variables in evaluating the impact of stress urinary incontinence (SUI) on daily living: severity of incontinence, distress or bother resulting from incontinence, and effect on health related quality of life (HRQoL). Understanding the impact of these variables is important as they are the driving force behind women seeking surgical treatment. Given the importance of HRQoL in determining need for treatment, as well as evaluating treatment success, this review provides an assessment of the degree to which HRQoL is impaired in women seeking surgical treatment.MethodsPubMed searches for the terms "quality of life and distress and urinary incontinence" and "quality of life and bother and urinary incontinence" were performed with limits of English, human and female subjects through May 2008. All studies using validated instruments were included. No time limit was placed on the search.ResultsOf 178 articles retrieved, 21 met the inclusion criteria, and 17 reported methods of scoring. The studies used the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). Wide ranges of mean and individual levels of severity of symptoms, UDI and IIQ scores were seen among women seeking surgical treatment. Fourteen studies reported baseline and post-surgical treatment distress and QoL data. Statistically significant improvements between baseline and post-surgical UDI and IIQ scores were reported in 12 studies. Reported cure rates ranged from 46% to 97%. Satisfaction with the procedure was reported in 4 studies and ranged from 84% to 91%. A minority of studies reported the relationship between reduction in symptoms and change in HRQoL.ConclusionHRQoL is the main reason women seek surgical treatment for incontinence and surgical treatment leads to a significant improvement in mean HRQoL scores. Assessment of HRQoL has proved less useful in identifying why individual women seek treatment for incontinence. Preliminary work has begun to characterize the interaction between severity of symptoms, distress or bother resulting from these urinary symptoms, impact on HRQoL, and treatment seeking behavior, but further research is needed. Greater standardization in the reporting of results of distress or bother and HRQoL would allow for comparison across studies.

A national survey of health-related quality of life questionnaires in head and neck oncology.

To identify the health-related quality of life (HRQOL) questionnaires employed by the physicians and surgeons who manage patients with head and neck cancer. Also, to gain an impression of the perceived difficulties and advantages of their use. A national survey was performed of active UK consultant clinicians on the mailing list of the British Association of Head and Neck Oncologists. Of 267 questionnaires, there were 191 replies (71.5%) from clinical oncologists (40), ENT surgeons (53), general surgeon (1), oral and maxillofacial surgeons (59), and plastic surgeons (38). Fifty-five consultants (29%) used HRQOL questionnaires and the most popular questionnaire was the University of Washington Head and Neck Cancer (65%). Questionnaires were most likely to be used both before and after treatment (67%) and administered in clinic by either nursing staff or consultants. The main reasons for not using HRQOL questionnaires included lack of resources and proven value. Despite the vast amount of literature on the importance of HRQOL in head and neck cancer, this survey shows that there is still a substantial amount of work required before HRQOL measurement becomes an established part of routine practice.

Health-related quality of life in patients attending a gastroenterology outpatient clinic: Functional disorders versus organic diseases

Background & Aims: Several gastrointestinal (GI) disorders have major effects on health-related quality of life (HRQOL), but there are few direct comparisons between functional GI disorders and organic GI diseases. This study aimed to compare HRQOL between these 2 groups and to assess factors of importance for HRQOL. Methods: Three hundred ninety-nine consecutive patients attending a GI outpatient clinic completed HRQOL instruments (Short Form 36 [SF-36] and Psychological General Well-Being index [PGWB]) and the Gastrointestinal Symptom Rating Scale (GSRS). For the analyses we divided the patients into 2 diagnostic groups: functional GI disorders (n 112) and organic GI diseases (n 287). Results: Compared with norm values on SF-36 and PGWB, both patient groups exhibited profound reductions in HRQOL. After correcting for age, gender, and disease duration, patients with a functional GI disorder had significantly lower scores than patients with an organic GI disease on 6 of 8 SF-36 domains and 5 of 6 PGWB domains. Vitality and anxiety on PGWB, abdominal pain and diarrhea on GSRS, age, and gender independently contributed to the physical component score of SF-36 (adjusted R 2 32%). Patients with a functional GI disorder had more severe reflux, abdominal pain, constipation, and indigestion, but the severity of diarrhea did not differ between the groups. HRQOL was reduced with increasing severity of GI symptoms. Conclusion: GI disorders have profound effects on HRQOL, and the impact is greater in patients with functional GI disorders as compared with organic GI diseases. The reduction in HRQOL is associated with the severity of both psychological and GI symptoms.

Health-related quality-of-life assessments in patients with advanced cancer of the prostate.

Health-related quality of life (HR-QOL) research, in general, is developing. It is becoming increasingly recognised as being important and knowledge on how to assess HR-QOL is spreading. Modern HR-QOL research should assess prevalence and severity of symptoms or functions, as well as the bother that symptoms or changes in functions inflict and whether this bother affects the overall well-being of the patient. In the prostate cancer field, HR-QOL assessments have evolved rapidly during the last decade. The importance of HR-QOL and associated research in prostate cancer is being more and more appreciated. Most published studies concern patients with early prostate cancer; studies in patients with late advanced stages are less frequent. In early stages, patients often have no or few symptoms from the disease. HR-QOL aspects for these patients are thus often associated with anxiety and treatment adverse effects such as changes in sexual, urinary and bowel functions. Changes in these functions also often affect HR-QOL in patients with more advanced local stages of prostate cancer or metastatic disease. Moreover, HR-QOL in these patients is also affected by endocrine treatment aiming to castrate the patient. Monotherapy with antiandrogens as endocrine treatment may be the treatment alternative that affects HR-QOL the least. This alternative may, however, not be as effective as castration. In the palliative phase, patients with prostate cancer have problems common to patients dying of other cancers. HR-QOL research should be encouraged and the knowledge on how HR-QOL can be assessed needs to be disseminated. HR-QOL assessments should be as natural in outcomes research as survival assessments. The technology of assessing HR-QOL needs to be further investigated and improved particularly with respect to the understanding of differences in performance between instruments using summary scores and item-specific assessments. Also, we need an increased understanding of the mechanisms behind patients' trade-offs and of how information should be communicated to patients in order to give the best possibilities for making informed treatment decisions.

Optimizing hospital-based home care for dying cancer patients: a population-based study.

Health-related quality of life (HRQL) is difficult to define and measure. It is a generic term that includes concepts such as physical health, life satisfaction, psychological well-being and self-integrity. Realizing and appreciating the importance of HRQL is crucial for physicians if they are to be in a position to offer appropriate suggestions in assisting patients and their families in the decision-making process regarding cancer treatment and terminal care. In order to determine whether Greek physicians take into consideration HRQL when assessing different therapeutic options, we conducted a postal survey. A total of 1500 Greek physicians (internists, oncologists and anaesthesiologists) were asked to complete a questionnaire. We received replies from 1280 (85%). In summary, we found that Greek physicians: (1) have already started taking HRQL into consideration when reviewing their therapeutic options; (2) increasingly include HRQL in research studies as an outcome measure; (3) do not yet have thoroughly sufficient training in the holistic care of cancer patients and their families; (4) mostly do not have the opportunity to work in interdisciplinary therapeutic teams where they can exchange ideas and consider different aspects of alternative therapeutic methods. It is concluded that HRQL has already been introduced as an important determinant of therapeutic choices in cancer care in Greece. However, efforts need to be made to allow HRQL to enjoy its appropriate place in cancer care.