Variability and Sample Size Requirements of Quality-of-Life Measures: A Randomized Study of Three Major Questionnaires

2005 ◽  
Vol 23 (22) ◽  
pp. 4936-4944 ◽  
Author(s):  
Yin-Bun Cheung ◽  
Cynthia Goh ◽  
Julian Thumboo ◽  
Kei-Siong Khoo ◽  
Joseph Wee

PurposeTo compare the variability and sample size requirements of the global quality-of-life (QOL) scores of the following three major QOL instruments: the Functional Assessment of Cancer Therapy–General (FACT-G), Functional Living Index–Cancer (FLIC), and European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30).Patients and MethodsCancer patients were randomly assigned to answer two of the three instruments using an incomplete block design (n = 1,268). The instruments were compared in terms of coefficient of variation, effect size in detecting a difference between patients with different performance status, and correlation coefficient between scores at baseline and follow-up.ResultsThe FACT-G and FLIC had significantly smaller coefficients of variation than the EORTC QLQ-C30 (both P < .05). The FLIC also had significantly larger correlation coefficients between scores at baseline and follow-up than the EORTC QLQ-C30 (P < .05). The FACT-G and the FLIC had a larger effect size in a cross-sectional and longitudinal setting, respectively, than the EORTC QLQ-C30 in differentiating patients with different performance status (both P < .05).ConclusionIn some aspects, the FACT-G and FLIC global QOL scores had smaller variability and larger discriminative ability than the EORTC QLQ-C30. Further research using other criteria to compare the three instruments is recommended.

2019 ◽  
pp. bmjspcare-2018-001542 ◽  
Author(s):  
Eduardo Guilherme D’Alessandro ◽  
Daniela Ribeiro Nebuloni Nagy ◽  
Christina May Moran de Brito ◽  
Elisangela Pinto Marinho Almeida ◽  
Linamara Rizzo Battistella ◽  
...  

Chemotherapy-induced peripheral neuropathy (CIPN) can cause loss of independence and poor quality of life (QoL) due to severe disabilities, but in spite of its importance there is still a lack of data for the management of CIPN. Acupuncture has showed promising results and may be a cost-effective option for the treatment.ObjectivesTo evaluate the effect of acupuncture treatment on neurological symptoms of CIPN and QoL of oncological patients.MethodsWe performed a clinical, single-centre, randomised and controlled pilot study that involved 33 adult patients with cancer and CIPN randomised into two groups (control and acupuncture treated with 10 sessions, two times per week). Both groups were subjected to a complete physical examination and clinical assessment with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale V.2.0, FIM Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Scale and Visual Analogue Scale for pain before and 5 weeks after treatment.ResultsThere were no adverse events, and we found statistical differences in groups in physical (p=0.03) and function (p=0.04) domains of EORTC QLQ-C30 when comparing control and acupuncture groups. About NCI CTCAE Scale and neuropathy sensory symptoms, we found better results in acupuncture group, comparing pretreatment and post-treatment analyses (p=0.01). In control group, we have no differences after 5 weeks (p=0.11).ConclusionAlthough these results suggest an interesting effect of acupuncture on this patient population, the clinical significance has remained unclear. Given the tendency towards benefit and the lack of adverse effects, the authors recommend a follow-up acupuncture trial using higher follow-up time and better sample size.Trial registration numberNCT02309164.


2013 ◽  
Vol 31 (31) ◽  
pp. 3980-3986 ◽  
Author(s):  
Hany Soliman ◽  
Jolie Ringash ◽  
Haiyan Jiang ◽  
Kawalpreet Singh ◽  
John Kim ◽  
...  

Purpose To evaluate the feasibility and response of liver radiotherapy (RT) in improving symptoms and quality of life in patients with hepatocellular carcinoma (HCC) or liver metastases (LM). Patients and Methods Eligible patients had HCC or LM, unsuitable for or refractory to standard therapies, with an index symptom of pain, abdominal discomfort, nausea, or fatigue. The Brief Pain Inventory (BPI), Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-Hep), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) were completed by patients at baseline and each follow-up. The primary outcome was the percentage of patients with a clinically significant change at 1 month in the BPI subscale of symptom on average in the past 24 hours. Secondary outcomes were improvement in other BPI subscales and at other time points, FACT-Hep and EORTC QLQ-C30 at each follow-up, and toxicity at 1 week. Results Forty-one patients (30 men and 11 women) with HCC (n = 21) or LM (n = 20) were accrued. At 1 month, 48% had an improvement in symptom on average in the past 24 hours. Fifty-two percent of patients had improvement in symptom at its worst, 37% at its least, and 33% now. Improvements in the FACT-G and hepatobiliary subscale were seen in 23% and 29% of patients, respectively, at 1 month. There were also improvements in EORTC QLQ-C30 functional (range, 11% to 21%) and symptom (range, 11% to 50%) domains. One patient developed grade 3 nausea at 1 week. Conclusion Improvements in symptoms were observed at 1 month in a substantial proportion of patients. A phase III study of palliative liver RT is planned.


2021 ◽  
pp. 1-8
Author(s):  
Helwig Valentin Wundsam ◽  
Christiane Sophie Rösch ◽  
Patrick Kirchweger ◽  
Ines Fischer ◽  
Michael Weitzendorfer ◽  
...  

<b><i>Introduction:</i></b> Intraductal papillary mucinous neoplasms (IPMNs) represent the most common precancerous cystic lesions of the pancreas. The aim of our study was to investigate if resection for non-invasive IPMNs alters quality of life (QoL) in a long-term follow-up. <b><i>Methods:</i></b> Patients (<i>n</i> = 50) included in the analysis were diagnosed and resected from 2010 to 2016. QoL was assessed at a median of 5.5 years after resection. At that point in time, the current QoL as well as the QoL before resection was evaluated retrospectively. The standardised European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Pancreatic Cancer (EORTC QLQ – PAN26) was applied for the QoL assessment. <b><i>Results:</i></b> After a median of 66 months postoperatively, the total QoL score significantly worsened (92.13 vs. 88.04, <i>p</i> = 0.020, maximum achievable score = 100) for patients (median age at surgery 68.0 years), mostly due to digestive symptoms. During the same follow-up period, median Eastern Cooperative Oncology Group (ECOG) performance status did not worsen (<i>p</i> = 0.003). <b><i>Conclusions:</i></b> Long-term QoL statistically significantly worsened after pancreatic resection for IPMN. The extent of worsening, however, was small, and QoL still remained excellent. Therefore, resection in cases of IPMN is appropriate, if indicated carefully.


2012 ◽  
Vol 22 (6) ◽  
pp. 1096-1101 ◽  
Author(s):  
Guler Yavas ◽  
Nasuh Utku Dogan ◽  
Cagdas Yavas ◽  
Nilgun Benzer ◽  
Deniz Yuce ◽  
...  

ObjectiveOur aim was to evaluate the health-related quality of life (HRQoL) and psychological distress in patients treated with radiotherapy (RT) for gynecologic malignancy.MethodsFifty-seven women with either cervical or endometrial cancer were prospectively enrolled. We assessed HRQoL at baseline (after surgery before RT), at the end of RT, and during follow-up (every 3 months thereafter) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cervical Cancer Quality of Life Questionnaire 24 (EORTC QLQ-CX24), and Hospital Anxiety and Depression Scale.ResultsWe demonstrated changes in appetite loss (P= 0.03), nausea and vomiting (P= 0.02), and role function score (P= 0.003) domains of EORTC QLQ-C30. Only the mean body image score of EORTC QLQ-CX24 was significantly different during follow-up (P= 0.02). Type of surgery, histopathological diagnosis, and the menopausal and marital status of the patients affected baseline body image scores (P= 0.032, 0.004, and 0.019 and 0.005, respectively). Patients who underwent chemotherapy had higher baseline body image scores when compared with patients without any chemotherapy before RT (P= 0.028). All the complaints of patients except body image scores improved during the follow-up period. The baseline and follow-up anxiety and depression scores did not differ significantly.ConclusionsAlthough pelvic RT deteriorated HRQoL in gynecologic cancer, patients’ improvement in HRQoL during follow-up was observed. Patients receiving RT could be reassured about the improvement of acute adverse effects in the course of treatment.


2004 ◽  
Vol 22 (19) ◽  
pp. 3877-3885 ◽  
Author(s):  
Laurence Collette ◽  
George van Andel ◽  
Andrew Bottomley ◽  
Gosse O.N. Oosterhof ◽  
Walter Albrecht ◽  
...  

Purpose Patients with symptomatic metastatic hormone-resistant prostate cancer (HRPC) survive a median of 10 months and are often regarded as a homogeneous group. Few prognostic factors have been identified so far. We examined whether baseline health-related quality of life (HRQOL) parameters assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) were independent prognostic factors of survival and whether they bring extra precision to the predictions achievable with models based on clinical and biochemical factors only. Patients and Methods Data of 391 symptomatic (bone) metastatic HRPC patients from three randomized EORTC trials were used in multivariate Cox proportional hazards models. The significance level was set at α = .05. Results Of the 391 patients, 371 died, most of prostate cancer. Bone scan result, performance status, hemoglobin level, and insomnia and appetite loss as measured by the EORTC QLQ-C30 were independent predictors of survival. This model's area under the receiver operating curve was 0.65 compared with 0.63 without the two HRQOL factors. Conclusion Certain HRQOL sores, at baseline, seem to be predictors for duration of survival in HRPC. However, such measurements do not add to the predictive ability of models based only on clinical and biochemical factors.


2021 ◽  
Author(s):  
Linda Dirven ◽  
Jammbe Z Musoro ◽  
Corneel Coens ◽  
Jaap C Reijneveld ◽  
Martin J B Taphoorn ◽  
...  

Abstract Background Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. Methods Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (&gt;0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. Results A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and −4 to −14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and −4 to −16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). Conclusions MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.


2021 ◽  
pp. 0272989X2110035
Author(s):  
Dennis A. Revicki ◽  
Madeleine T. King ◽  
Rosalie Viney ◽  
A. Simon Pickard ◽  
Rebecca Mercieca-Bebber ◽  
...  

Background The EORTC QLU-C10D is a multiattribute utility measure derived from the cancer-specific quality-of-life questionnaire, the EORTC QLQ-C30. The QLU-C10D contains 10 dimensions (physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems). The objective of this study was to develop a United States value set for the QLU-C10D. Methods A US online panel was quota recruited to achieve a representative sample for sex, age (≥18 y), race, and ethnicity. Respondents undertook a discrete choice experiment, each completing 16 choice-pairs, randomly assigned from a total of 960 choice-pairs. Each pair included 2 QLU-C10D health states and duration. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. Results A total of 2480 panel members opted in, 2333 (94%) completed at least 1 choice-pair, and 2273 (92%) completed all choice-pairs. Within dimensions, weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Cancer-specific dimensions, such as nausea and bowel problems, were associated with moderate utility decrements, as were general issues such as problems with emotional functioning and social functioning. Sleep problems and fatigue were associated with smaller utility decrements. The value of the worst health state was 0.032, which was slightly greater than 0 (equivalent to being dead). Conclusions This study provides the US-specific value set for the QLU-C10D. These estimated health state scores, based on responses to the EORTC QLQ-C30 questionnaire, can be used to evaluate the cost-utility of oncology treatments.


2004 ◽  
Vol 2 (2) ◽  
pp. 115-124 ◽  
Author(s):  
JÖRG DIRMAIER ◽  
SILKE ZAUN ◽  
UWE KOCH ◽  
TIMO HARFST ◽  
HOLGER SCHULZ

Objective: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the “Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer” (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses.Methods: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument.Results: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either.Significance of results: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.


2013 ◽  
Author(s):  
Αθανάσιος Κυργίδης

Η σχετιζόμενη με την υγεία ποιότητα ζωής (Quality of Life - QοL) είναι μια καθοριστική παράμετρος της έρευνας έκβασης (outcome research), που σταδιακά από τη δεκαετία του '80 κέρδισε την προσοχή της ιατρικής κοινότητας. Η μελέτη της QoL έχει στόχο να αξιολογήσει την συνολική ευημερία των ασθενών και τον τρόπο που αυτή σχετίζεται με την ασθένεια και τη θεραπεία τους. Οι μορφές θεραπείας του καρκίνου κεφαλής και τραχήλου (HNC) θέτουν τους ασθενείς αντιμέτωπους με σημαντικές αλλαγές που αφορούν στην επικοινωνία, την κατάποση, την αναπνοή, και την εμφάνισή του προσώπου τους. Αυτές οι αλλαγές επιδρούν στην ποιότητα της ζωής των ασθενών σε άλλοτε άλλο βαθμό. Τα εξειδικευμένα ερωτηματολόγια για τον καρκίνο κεφαλής και τραχήλου φαίνεται ότι παρέχουν επιπρόσθετες πληροφορίες σε αυτές που παρέχονται από το γενικά ερωτηματολόγια QOL. Η παρούσα διδακτορική διατριβή επιβεβαιώνει τη διαγνωστική χρησιμότητα, την εγκυρότητα και την επαναληψιμότητα των ερωτηματολογίων της σχετιζόμενης με την υγεία ποιότητας ζωής EORTC QLQ-C30 και QLQ-HN35 που έχουν ήδη επικυρωθεί για χρήση σε Έλληνες ασθενείς με καρκίνο κεφαλής και τραχήλου, σε ασθενείς με οστεονέκρωση της γνάθου από διφωσφονικά. Η χρήση και επικύρωση ενός καθιερωμένου και μεταφρασμένου σε πολλές γλώσσες εργαλείου, επιτρέπει την ελάττωση του κόστους αφού δε χρειάζεται ανάπτυξη νέου εργαλείου σε τόσες χώρες και επιπλέον καθιστά εύκολη τη σύγκριση αποτελεσμάτων μεταξύ των διαφορετικών ερευνητικών κέντρων. Στο δεύτερο σκέλος της παρούσης διατριβής, καθορίζονται οι ελάχιστες κλινικά σημαντικές διαφορές στα ερωτηματολόγια EORTC QLQ-C30 και QLQ-HN35, σε ασθενείς με καρκίνο κεφαλής και τραχήλου. Η γνώση της ελάχιστης κλινικά σημαντικής διαφοράς επιτρέπει την αξιολόγηση της θεραπείας που λαμβάνει ένας ασθενής με άμεσο έλεγχο της ποιότητας ζωής του, αντίθετα με τις μέχρι τώρα διαθέσιμες μετρήσεις άλλων, πιο έμμεσων δεικτών υγείας. Επίσης επιτρέπει τον καθορισμό του μεγέθους αποτελέσματος (effect size) στα ερωτηματολόγια ποιότητας ζωής επιτρέποντας τον υπολογισμό του μεγέθους δείγματος που απαιτείται για τις κλινικές δοκιμές που έχουν ως έκβαση την ποιότητα ζωής. Στο τρίτο σκέλος της διατριβής αυτής, επαληθεύεται η ορθή πολιτισμική προσαρμογή των ερωτηματολογίων EORTC QLQ-C30 και QLQ-HN35 για Έλληνες ασθενείς με καρκίνο κεφαλής και τραχήλου. Η ανάγκη για χρήση από τους κλινικούς γιατρούς των ερευνητικών εργαλείων της σχετιζόμενης με την υγεία ποιότητας ζωής και τα πιθανά οφέλη στην βελτίωση της επικοινωνίας ιατρού-ασθενούς δεν θα πρέπει να οδηγεί στην άκριτη χορήγηση ερωτηματολογίων που δημιουργεί επιπρόσθετη επιβάρυνση στους ασθενείς. Η προσεκτική εισαγωγή των υπαρχόντων οργάνων καταγραφής της σχετιζόμενης με την υγεία ποιότητας ζωής στην κλινική πρακτική μπορεί να διευκολύνει ένα βαθύτερο επίπεδο επικοινωνίας μεταξύ του ασθενή και του ιατρού, ακόμη δε να βελτιώσει την αντίληψη του ασθενή για την θεραπεία του.


2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Antonio Augusto Claudio Pereira ◽  
Nayara De Paula Passarin ◽  
Jordana Henriques Coimbra ◽  
Gabriela Grasso Pacheco ◽  
Marcel Pereira Rangel

Introdução: A qualidade de vida de pacientes oncológicos tem sido objeto de estudo em muitos trabalhos brasileiros. Contudo, apesar da alta prevalência de indivíduos submetidos a radioterapia, poucos estudos com ênfase nesse grupo de pacientes foram identificados. Objetivo: Avaliar a qualidade de vida e a prevalência de sintomas depressivos em pacientes com neoplasias malignas durante o tratamento radioterápico. Método: Estudo transversal quantitativo realizado com 153 pacientes oncológicos em vigência de tratamento radioterápico em um centro especializado em oncologia e radioterapia, localizado no Noroeste do Estado do Parana. Os dados foram coletados entre marco e setembro de 2018. O European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) e o Inventario de Depressão de Beck foram utilizados para avaliar a qualidade de vida e os sintomas depressivos, respectivamente. Resultados: Os domínios “qualidade de vida”, “função cognitiva” e “função social” foram os que menos se mostraram prejudicados na amostra estudada, enquanto “insônia”, “perda de apetite” e “dificuldades financeiras” destacaram-se entre os maiores preditores de baixa qualidade de vida. Ademais, contatou-se que 22% dos indivíduos avaliados apresentaram algum grau de transtorno de humor, sendo 11% diagnosticados com depressão. Conclusão: O declínio na qualidade de vida e a prevalência de sintomas depressivos em pacientes oncológicos, mesmo os em vigência de radioterapia, enaltecem a importância de intervenções precoces que visem a restabelecer a funcionalidade e o bem-estar.


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