scholarly journals Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients

2020 ◽  
Vol 7 (6) ◽  
pp. 668-675 ◽  
Author(s):  
Marijke B Coomans ◽  
Martin J B Taphoorn ◽  
Neil K Aaronson ◽  
Brigitta G Baumert ◽  
Martin van den Bent ◽  
...  

Abstract Background Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions. Methods HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items. Results Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item “hair loss” showed a significant and clinically relevant change (ie, ≥10 points) over time, whereas change scores on the other scales/items were statistically significant only (all P < .001; range in change score, 0.1-6.2). Although a large proportion of patients had stable HRQoL over time (range, 27%-84%) on the patient level per scale/item, many patients deteriorated (range, 6%-43%) or improved (range, 8%-32%) on a specific scale/item. At the individual patient level, the majority of patients (86%) showed both deterioration and improvement, whereas only 1% remained stable on all scales. Conclusions Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi197-vi198 ◽  
Author(s):  
Marijke Coomans ◽  
Martin Taphoorn ◽  
Neil Aaronson ◽  
Brigitta Baumert ◽  
Martin van den Bent ◽  
...  

Abstract BACKGROUND: Health-related quality of life (HRQoL) is an important outcome in glioma research, reflecting the impact of disease and treatment on a patient’s functioning and wellbeing. Data on changes in HRQoL scores provide important information for clinical decision-making, but different analytical methods may lead to different interpretations of the impact of treatment on HRQoL. This study aimed to study whether different methods to evaluate change in HRQoL result in different interpretations. Methods: HRQoL and sociodemographical/clinical data from 15 randomized clinical trials were combined. Change in HRQoL scores was analyzed: (1)at the group level, comparing mean changes in scale/item scores between treatment arms over time, (2)at the patient level per scale/item by calculating the percentage of patients that deteriorated, improved or remained stable on a scale/item per scale/item, and (3)at the individual patient level combining all scales/items. Results: Data were available for 3727 patients. At the group scale/item level (method 1), only the item ‘hair loss’ showed a significant and clinically relevant change (i.e. ≥10 points) over time, whereas change scores on the other scales/items showed a statistically significant change only (all p< .001, range in change score:0.1–6.2). Analyses on the patient level per scale (method 2) indicated that, while a large proportion of patients had stable HRQoL over time (range:27–84%), many patients deteriorated (range:6–43%) or improved (range:8–32%) on a specific scale/item. At the individual patient level (method 3), the majority of patients (86%) showed both deterioration and improvement, while only 1% of the patients remained stable on all scales. Conclusion: Different analytical methods of changes in HRQoL result in distinct interpretations of treatment effects, all of which may be relevant for clinical decision-making. Additional information about the joint impact of treatment on all outcomes may help patients and physicians to make the best treatment decision.


2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii14-iii14
Author(s):  
M Coomans ◽  
M J B Taphoorn ◽  
N Aaronson ◽  
B G Baumert ◽  
M van den Bent ◽  
...  

Abstract BACKGROUND Health-related quality of life (HRQoL) is often used as an outcome in glioma research, reflecting the impact of disease and treatment on a patient’s functioning and wellbeing. Data on changes in HRQoL scores may provide important information for clinical decision-making, but different analytical methods may lead to different interpretations of the impact of treatment on HRQoL. This study aimed to examine three different methods to evaluate change in HRQoL, and to study whether these methods result in different interpretations. MATERIAL AND METHODS HRQoL and sociodemographical/clinical data from 15 randomized clinical trials were combined. Change in HRQoL scores was analyzed in three ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms over time, (2) at the patient level per scale/item by calculating the percentage of patients that deteriorated, improved or remained stable on a scale/item per scale/item, and (3) at the individual patient level combining all scales/items. RESULTS Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level (method 1), only the item ‘hair loss’ showed a significant and clinically relevant change (i.e. ≥10 points) over time, whereas change scores on the other scales/items showed a statistically significant change only (all p<.001, range in change score: 0.1–6.2). Analyses on the patient level per scale (method 2) indicated that, while a large proportion of patients had stable HRQoL over time (range 27–84%), many patients deteriorated (range: 6–43%) or improved (range: 8–32%) on a specific scale/item. At the individual patient level (method 3), the majority of patients (86%) showed both deterioration and improvement, while only 1% of the patients remained stable on all scales. Clustering on clinical characteristics (WHO performance status, sex, tumor type, type of resection, newly diagnosed versus recurrent tumor and age) did not identify subgroups of patients with a specific pattern of change in their HRQoL score. CONCLUSION Different analytical methods of changes in HRQoL result in distinct interpretations of treatment effects, all of which may be relevant for clinical decision-making. Additional information about the joint impact of treatment on all outcomes, showing that most patients experience both deterioration and improvement, may help patients and physicians to make the best treatment decision.


Author(s):  
Eline Verhaak ◽  
Wietske C. M. Schimmel ◽  
Karin Gehring ◽  
Wilco H. M. Emons ◽  
Patrick E. J. Hanssens ◽  
...  

Abstract Purpose Increasingly more patients with multiple (> 4) brain metastases (BM) are being treated with stereotactic radiosurgery (SRS). Preserving patients’ health-related quality of life (HRQoL) is an important treatment goal. The aim of this study was to assess (individual) changes in HRQoL in patients with 1–10 BM over time. Methods A total of 92 patients were assessed before (n = 92) and at 3 (n = 66), 6 (n = 53), and 9 (n = 41) months after Gamma Knife radiosurgery (GKRS), using the Functional Assessment of Cancer Therapy-Brain (FACT-Br). The course of HRQoL was analyzed using linear mixed models. Clinical minimally important differences were used to evaluate individual changes. Results At group level, patients’ physical well-being worsened, whereas emotional well-being improved over 9 months. Scores on other HRQoL subscales did not change significantly. Number (1–3 versus 4–10) and volume (small, medium, and large) of BM did not influence HRQoL over time, except for the subscale additional concerns; medium intracranial tumor volume was associated with less additional concerns. On the individual level as well, physical well-being declined while emotional well-being improved in most patients over 9 months after GKRS. At patient level, however, most patients had both declines as well as improvements in the different HRQoL aspects. Conclusion Our results indicate that even in patients with up to 10 BM, both at group and individual subscale level, aspects of HRQoL remained stable over nine months after GKRS, except for an improvement in emotional well-being and a decline in physical well-being. Nevertheless, HRQoL scores varied considerably at the individual patient level. Trail registration number ClinicalTrials.gov Identifier: NCT02953756, November 3, 2016.


2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii132-ii132
Author(s):  
Marthe Peeters ◽  
Hanneke Zwinkels ◽  
Johan Koekkoek ◽  
Maaike Vos ◽  
Linda Dirven ◽  
...  

Abstract BACKGROUND The aim of this study was to explore the impact of the timing of health-related quality of life (HRQoL) measurements in clinical care on obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression. METHODS Patients completed the EORTC Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) at two time points. All patients completed the first measurement on the day of the MRI-scan (t=0), but the second measurement (t= 1) depended on randomization; group 1 (n= 49) completed the questionnaires before and group 2 (n= 51) after the consultation with the physician. RESULTS Median HRQoL scale/item scores on t0/t1 and change scores were comparable between the two groups. Between 8-58% of patients changed to a clinically relevant extent (i.e. ≥ 10 points) on the evaluated HRQoL scales/items in about one week time, in both directions, with only 3% of patients remaining stable in all scales. The mean number of the 26 evaluated HRQoL scales/items that changed to a clinically relevant extent per patient was 7 (SD= 4). Patients with stable role functioning had a lower HADS anxiety change score. However, this association was no longer significant in the multivariable regression when corrected for confounding factors. The HADS depression score was not associated with a change in HRQoL. DISCUSSION Measuring HRQoL before or after the consultation did not impact HRQoL scores on group level. However, the large majority of patients reported a clinically relevant difference in at least one HRQoL scale/item between the two time points, which was in general not influenced by feelings of anxiety or depression. Nevertheless, these findings highlight the importance of a standardized timing (e.g. at the day of the scan, consultation or first day of treatment) of patient-reported outcome assessments in clinical trials.


2000 ◽  
Vol 4 (1) ◽  
pp. 45-50 ◽  
Author(s):  
Patricia Price ◽  
Keith Harding

Background: The concept of health-related quality of life (HRQoL) has been the focus of much debate in recent years. However, within diabetes the focus has centred on the behavioural adaptation to a chronic disease state. The impact of foot complications is witnessed regularly in the clinical setting; amputation in this group is usually preceded by ulceration and a worsening cycle of foot problems. Objective: This review sets out to investigate the literature on foot complications in those with diabetes, to assess the cost to the individual in terms of impact on everyday living. Conclusion: The literature on the specific impact of foot complications is limited, but indicates a situation in which those with diabetic foot ulceration may have an even poorer HRQoL than those who have experienced an amputation related to diabetes. In order to assess the full impact of new treatments or therapeutic interventions, it is vital that further research is conducted in this area.


Author(s):  
Taneeya Joshi ◽  
Alexander Rahman ◽  
Sabine Rienhoff ◽  
Jan Rienhoff ◽  
Tanja Stamm ◽  
...  

Abstract Objectives The aim of this study was to compare oral health–related quality of life (OHRQoL) in children with and without molar incisor hypomineralization (MIH) and to assess the impact of severity of MIH on OHRQoL in children between 8–10 years using the German version of the Child Perceptions Questionnaire (CPQ-G8-10). Materials and methods Children aged 8–10 years were recruited at a pediatric dental clinic in Hannover, Germany. Half of them were affected by MIH. Participants were evaluated for presence and severity of MIH (MIH-TNI), plaque and dental caries status. Children were asked to answer the CPQ-G8-10. Statistical analysis was performed using GraphPad Prism-software version 8. Results One hundred eighty-eight children (mean age 8.80 [± 0.84]; 43.10% female) were included in the study with 94 children having MIH. CPQ-G8-10 mean scores in MIH-affected children were significantly higher than in children showing no MIH (13.87 [± 8.91] vs. 4.20 [± 3.74]; p < 0.0001) showing that MIH has negative impact OHRQoL. Similar trends were seen in all four subdomains. Regarding severity, CPQ-G8-10 mean scores increased from mild to severe forms of MIH. Conclusion Children affected by MIH show an impaired OHRQoL compared to children without MIH; with increasing severity, OHRQoL gets more impaired. Clinical relevance To understand the patient’s perception and the individual oral health needs will help to prioritize MIH and recognize its impact.


2004 ◽  
Vol 171 (4S) ◽  
pp. 42-42 ◽  
Author(s):  
Kevin P. Weinfurt ◽  
Liana D. Castel ◽  
Yun Li ◽  
Fred Saad ◽  
Justin W. Timbie ◽  
...  

Author(s):  
Phillippa Carnemolla ◽  
Catherine Bridge

The multi-dimensional relationship between housing and population health is now well recognised internationally, across both developing and developed nations. This paper examines a dimension within the housing and health relationship – accessibility – that to date has been considered difficult to measure. This paper reports on the mixed method results of larger mixed-method, exploratory study designed to measure the impact of home modifications on Health-Related Quality of Life, supported by qualitative data of recipients’ experiences of home modifications. Data was gathered from 157 Australian HACC clients, who had received home modifications. Measurements were taken for both before and after home modifications and reveal that home modifications were associated with an average 40% increase in Health-Related Quality of Life levels. The qualitative results revealed that participants positively associated home modifications across six effect themes: increased safety and confidence, improved mobility at home, increased independence, supported care-giving role, increased social participation, and ability to return home from hospital. This exploratory research gives an insight into the potential for accessible architecture to impact improvements in community health and wellbeing.


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