Comparison of Instruments for Measuring Health-Related Quality of Life and Their Applicability to Ehealth Applications

Health-related Quality of Life (HRQoL) assessment has proven as a good means for assessing treatment options or impact of applications supporting the patient in adherence, monitoring and better understanding of health issues. While most of the HRQoL instruments were designed several years ago, their capability to assess the impact of ehealth application is in question. The objective of this paper is to assess HRQoL instruments including a focus on the ehealth domain. Methods: Generic and specific instruments are selected based on their widespread use. Published criteria for assessing HRQoL instruments are used for a baseline, which are amended by criteria covering both the ehealth domain and the conditions of use of instruments and structured in groups. Results: Seven instruments have been selected and assessed using the established criteria. The instruments scored differently regarding the ehealth domain, however overall rather low. Applying weighting per group allows highlighting specific aspects. Based on the assessment, further research should consider the development of a ehealth domain module as part of the specific instruments.

Impact of recurrence on health-related quality of life in patients at high risk of recurrence after radical surgery for muscle-invasive urothelial carcinoma (MIUC): Results from the phase 3 CheckMate 274 trial.

4540 Background: Patients (pts) undergoing radical surgery for MIUC face a high risk of disease recurrence. Recurrence is associated with worse survival, but its effect on health-related quality of life (HRQoL) is unclear. This post hoc analysis assessed the impact of recurrence on HRQoL using data from the phase 3 CheckMate 274 trial. Methods: Pts who had undergone radical surgery for high-risk MIUC (≤ 120 days previously) were randomized 1:1 to nivolumab 240 mg Q2W or placebo for ≤ 1 year. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L every 4–6 weeks during treatment; 35 and 115 days after the last dose; and every 3 months after that until the end of the study (EQ-5D-3L only). The analysis included pts with a valid HRQoL assessment at baseline and at ≥1 post-baseline visits. Confirmed deterioration in HRQoL was defined as worsening exceeding an a priori points threshold (± 10 for the EORTC QLQ-C30 domains, –7 for the EQ-5D visual analogue scale [VAS]) at ≥ 2 consecutive visits. Recurrence was classified as local only or distant (with or without local recurrence). The effect of recurrence on HRQoL deterioration was assessed by Cox proportional hazards regression with recurrence as a time-dependent covariate. The models controlled for treatment arm and baseline HRQoL score, and were stratified by PD-L1 expression, pathologic nodal status, and use of neoadjuvant cisplatin-based chemotherapy. Results: The analysis included 645 pts for EORTC QLQ-C30, of whom 71 (11%) had local recurrence only and 136 (21%) had distant recurrence during the HRQoL assessment period; and 648 pts for EQ-5D-3L. with recurrence had a significantly higher risk of confirmed deterioration in all HRQoL domains than those without recurrence (see table). However, hazard ratios were consistently greater for distant recurrence than for local recurrence across all HRQoL domains. For local recurrence only, a higher risk of confirmed deterioration in HRQoL compared to no recurrence was observed only for global health status/QoL. Conclusions: Recurrence, particularly distant recurrence, had a significant, negative impact on HRQoL. This suggests that treatment delaying recurrence after radical surgery for high-risk MIUC may prevent or delay HRQoL deterioration in these pts. Clinical trial information: NCT02632409. [Table: see text]

Unravelling the heterogeneity of soft tissue and bone sarcoma patients’ health-related quality of life: a systematic literature review with focus on tumour location

Patients with sarcoma experience many physical and psychological symptoms, adversely affecting their health-related quality of life (HRQoL). HRQoL assessment is challenging due to the diversity of the disease. This review aims to unravel the heterogeneity of HRQoL of patients with sarcoma with regard to tumour location and to summarise the used measures in research. English-language literature from four databases published between January 2000 and April 2019 was reviewed. Studies that described adult sarcoma HRQoL outcomes were included and classified according to primary sarcoma location. Eighty-seven articles met the inclusion criteria covering sarcoma of the extremities (n=35), pelvis and axial skeleton (n=9), pelvis and extremities (n=5), head and neck (n=4), retroperitoneum (n=2) and multiple sarcoma locations (n=33), respectively. Urogenital and thoracic sarcoma were lacking. Fifty-four different questionnaires were used, most often cancer-generic or generic HRQoL questionnaires. Patients with sarcoma reported lower HRQoL than the general population. Distinctive patterns of HRQoL outcomes according to tumour location regarding symptoms, physical functioning, disability and psychosocial well-being were identified. In metastatic sarcoma, mostly constitutional symptoms were present. To comprehensively assess HRQoL, a sarcoma-specific measurement strategy should be developed and used covering the heterogeneity of sarcoma including location-specific issues to improve personalised HRQoL assessment in future research and clinical practice.

Language barriers in HRQOL assessment: development of a picture-based questionnaire (PictoQOL)

Background Translations and adaptations of standardized HRQOL questionnaires (e.g., SF-8) are available for many large population groups. For smaller groups, like certain migrant communities, whose language use can differ from the respective population in their countries of origin, often no adequate adaptations are available. Nonverbal, picture-based questionnaires could address these challenges. The present study provides insights into the development of such a measure (PictoQOL) for HRQOL assessment. Methods We used a qualitative design. We conducted 6 focus group discussions with a total of 18 adults from different cultural backgrounds to identify suitable visual cues based on the the dimensions of the SF-8 and WHOQOL-BREF and to create drafts of visual representations for different items. Subsequently, we developed a draft of the questionnaire and further revised it according to findings from 45 cognitive interviews, based on a think aloud and verbal probing approach. Results Preferred visual representations and understanding of pictorial elements differed between participants from different cultural backgrounds. Simpler concepts were considered easier to understand than compounded concepts. Preferences in element style and composition were similar between the groups. In addition, using a recurring character was considered helpful for identification. Conclusions In the development of the PictoQOL, decisions concerning style and composition of pictorial elements were culture-independent. In contrast, preferences of visual representations of abstract concepts were strongly dependent on cultural aspects, confirming the need of a participatory approach to develop the measure. The PictoQOL is likely to be comprehensible cross-culturally without further need of adaptation. Key messages To ensure cross-cultural comprehensibility development of a picture-based questionnaire, a participatory approach to development is necessary. The PictoQOL is suitable to measure health-related quality of life in understudied, culturally diverse populations.

Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial

Background: Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.Methods: In this study, we will include 342 women with non-metastatic hormone receptor positive BC with an indication for treatment with ET. Patients will be randomized 1:1 by minimization and stratified by: age, stage, type of ET prescribed and presence of comorbidities or not, in 2 arms. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist on 3 workshops related to understanding the prescription, nutrition and fatigue. A reminder letter will also be send to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12-month. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care, and clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed. Discussion: This study will allow clinicians to identify and better understand the areas in which patients on ET have difficulties, and thus assist clinicians with patient management. Systematic evaluation of HRQoL could also provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients treated with ET.Trial Registration: ClinicalTrials.gov NCT04176809. Registered 25 November 2019, https://clinicaltrials.gov/ct2/show/NCT04176809.

Health-related quality-of-life results from JCOG0912: A phase III noninferiority trial comparing open and laparoscopy-assisted distal gastrectomy for stage I gastric cancer.

293 Background: Laparoscopy-assisted distal gastrectomy (LADG) was non-inferior to open (ODG) in patients with stage I gastric cancer in randomized phase 3 non-inferiority trial (JCOG0912). Here, we present the results of health-related quality of life (HRQoL) which was a secondary endpoint in JCOG0912. Methods: Among 33 institutions participated in JCOG0912, 4 major cancer centers were selected for HRQOL assessment. HRQoL was assessed using EORTC QLQ-C30 and the EORTC-STO22 before (baseline) and at 1, 3, 12, and 36 months after surgery. The primary HRQOL scale was QLQ-C30 global health status. We defined clinically meaningful decrease of HRQoL as decrease in 10 points or more from the baseline. Missing data were regarded as decrease. Assuming that expected %decrease of global health status at 3 months was 61% in ODG and 45% in LADG with 80% power and two-sided alpha of 0.05, sample size for HRQOL assessment was calculated to be 304. When this hypothesis at 3 months was confirmed, statistical comparison was tested in turn at 12 and 36 months. Results: Among 921 enrolled patients in JCOG0912 from Mar 2010 to Nov 2013, 592 were enrolled from the 4 centers in this HRQoL study. The %decrease of global health status at 3 months was different between ODG and LADG (37.2% (109/293) in ODG vs 29.2% (86/295) in LADG, odds ratio [OR] 0.65 (95% CI: 0.45-0.93, p = 0.020)), but was not different in 1 month (56.0% (164/293) vs 55.3% (163/295), OR 0.92 (0.61-1.32)), 12 months (26.3% (77/293) vs 27.8% (82/295) (OR 1.07 (0.73-1.56))and 36 months (31.4% (91/293)vs 30.8% (91/295) (odds ratio, 0.96 (0.67-1.37))). Among the other subscales, LADG had significantly better symptom scores for pain at 1 and 3 months, constipation at 3 and 12 months, and eating restrictions at 3 months. Conclusions: Decrease of HRQoL was less frequently observed in LADG than ODG especially in the early phase after surgery. Considering non-inferiority and better HRQoL of LADG, LADG is strongly recommended for stage I gastric cancer. However, we have to be careful to expand the indication of LADG for advanced gastric cancer until a solid evidence is obtained. Clinical trial information: UMIN000003319.

Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer

Background: Despite its proven effectiveness in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC. Methods: In this study, we will include 342 women with non-metastatic hormone receptor positive BC with an indication for treatment with ET. Patients will be randomized 1:1 by minimization and stratified by: age, stage, type of ET prescribed and presence of comorbidities or not, in 2 arms. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist on 3 workshops related to understanding the prescription, nutrition and fatigue. A reminder letter will also be send to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12-month. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care, and clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed. Discussion: This study will allow clinicians to identify and better understand the areas in which patients on ET have difficulties, and thus assist clinicians with patient management. Systematic evaluation of HRQoL could also provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients treated with ET. Trial Registration: ClinicalTrials.gov NCT04176809. Registered 25 November 2019, https://clinicaltrials.gov/ct2/show/NCT04176809.

Assessing the Quality of Life of Filipino Cancer Patients: A Survey of Filipino Oncologists

Introduction Recent trials of new drugs have placed much emphasis on survival. However, several guidelines have emphasized the need for assessing health-related quality of life (HRQoL) as part of the holistic approach in the management of cancer patients. There are currently no national governing guidelines and no existing data on the status of HRQoL assessments by Filipino oncologists, thus this study. Study Design This was a cross-sectional study that utilized a validated questionnaire. Descriptive and multivariate analyses were used to analyze the data. Results A total of 312 oncologists participated in this study. Majority were medical oncologists (41%), followed by radiation oncologists (25%), hematologists (14%), gynecologic oncologists (12%), and surgical oncologists (8%). About 96% reported that HRQoL assessment was important for clinical work; however, 58% perceived HRQoL to be a vague term and 55% felt they were insufficiently trained to assess HRQoL. About 89% reported that they will be more confident if local HRQoL assessment guidelines will be present, and 93% agreed to the use of a unified HRQoL assessment tool for Filipino cancer patients. About 85% thought that the optimal number of questions for a HRQoL assessment tool should be between 5 and 15 questions. The significant predictors of HRQoL assessment among oncologists were field of oncology and years in practice/training (p < 0.05). Conclusion Filipino oncologists perceived HRQoL patient assessments to be important in clinical practice. However, majority did not know which tool to use and did not feel sufficiently trained to assess HRQoL. The creation of a practice guideline that would facilitate the use of a unified HRQoL assessment tool for Filipino cancer patients is highly recommended.