Comprehensive Validation Study of Quality-of-Life Questionnaire Using Objective Clinical Measures: Breast Cancer Treatment Outcome Scale (BCTOS), Brazilian Portuguese Version

Introduction

When evaluating a quality-of-life questionnaire (QLQ), many validation studies do not correlate quality-of-life scores with objective measurements of complications associated with treatment.

Validation of the Functional Assessment of Cancer Therapy with Cervical Cancer Subscale (FACT-CX) for Quality of Life in Thai Patients Prior to Chemoradiotherapy

Objective: Cervical cancer is the second most common cancer in Thailand. For cervical cancer, there is no cancer specific quality of life questionnaire. This study aims to develop and validate Thai FACT-CX. Methods: The cross-sectional study included all women aged ≥18 years with stage IB2-IIIB who planned to undergo chemoradiotherapy. Those who did not understand Thai language, had other cancers (except for skin cancer), were diagnosed with impaired cognition and/or overt psychosis, and major depression were excluded. The FACT-CX comprises 42 items with 5 domains and a score range of 0-168. The WHOQOL-BREF comprises 26 items with 4 domains and a score range of 26-130. The participants were interviewed about demographic and clinical data. Both questionnaires were self-completed.  Factor analysis was used to compare our data with the previous structure. The reliability used Cronbach’s alpha. Spearman’s correlation determined relationship between the domains of the modified FACT-CX and WHOQOL-BREF. Both questionnaires were compared with socioeconomic and clinical variables using the Ranksum test and Kruskal-Wallis test. P-value > 0.05 considered significant. Results: The 245 participants included. Expletory factor analysis revealed an accumulative variance of 0.42 with 4 factors. The internal consistency was 0.84, 0.81, 0.78, 0.77 and 0.90 for perception of self, suffering symptoms, family support, life resilience and total questions. There was correlation between the domains of the modified FACT-CX and WHOQOL-BREF.  Both the modified FACT-CX and WHOQOL-BREF could identify differences between the groups of patients. Conclusion: Finally, the Thai modified FACT-CX was found to be reliable and valid for measuring quality of life among untreated cervical cancer patients.     

Transcultural adaptation and validation of a French version of the Prosthetic Limb Users Survey of Mobility 12-item Short-Form (PLUS-M/FC-12) in active amputees

BackgroundThe PLUS-M 12-item Short-Form is a self-questionnaire that assesses the perceived capacity of lower limb amputees (LLAs) to perform a number of daily-life activities. Its psychometric properties are excellent (intraclass correlation coefficient [ICC] > 0.9, fast administration and scoring, normative data available), and it can be used in clinical practice or for research purposes.ObjectiveWe aimed to develop a French version of this questionnaire and to assess its psychometric properties.MethodsWe followed international recommendations for translation and cross-cultural validation of questionnaires. In total, 52 LLAs (age 53 ± 16, 40 males, 28/12/12 transtibial/Gritti-Stokes/transfemoral, 20/28/4 ischemic/traumatic/other) participated. Criterion and construct validities were assessed with the Pearson correlation coefficient (PCC) between the PLUS-M 12-item Short-Form and other constructs (Prosthetic-Profile-of-the-Amputee-Locomotor Capabilities Index, Activities-specific Balance Confidence scale, 2-min walking test and Timed Up and Go test), internal consistency with the Cronbach α and reliability with the ICC in 46 individuals who completed the questionnaire twice in a 7-day interval.ResultsThe mean (SD) PLUS-M 12-item Short-Form T-score was 56.1 (7.8; range 40.3 to 71.4). Construct and criterion validity, internal consistency and reliability ranged from low to excellent (r = 0.43 to 0.84, P < 10⁻² to 0.002; Cronbach α = 0.90, ICC = 0.89 [0.81–0.94]). We found no floor or ceiling effect.ConclusionsThe French version of the PLUS-M 12-item Short-Form has good to excellent psychometric properties, comparable to those of the original version. Its use could definitely be proposed for both clinical and research purposes, once its validation is completed by assessing other psychometric qualities, especially sensitivity to change.     

Adaptation of the Youth Connectedness to Provider scale to assess the relationship between health professionals and adolescent and young adult patients

ObjectiveThe aim was to adapt an instrument that evaluates the relationship between young individuals and health professionals to the Brazilian population, which will be called the Escala de Avaliação de Vínculo entre Jovens e Profissionais de Saúde (Youth Connectedness to Provider scale).MethodThe questionnaire known as the Youth Connectedness to Provider scale consists of seven Likert-like questions. The translation, back-translation, evaluation by ten specialists, and pre-test with 43 adolescents and young adults aged between 10 and 24 years were performed to assess the clarity and reliability of meanings. The content validity index was calculated for each question. Subsequently, the clinical validation was performed with 83 patients aged 10–24 years old and Cronbach's alpha coefficient was calculated.ResultsA content validity index >0.8 (considered satisfactory) was obtained for all items analyzed by experts and adolescents. At the clinical validation, it showed a high internal consistency (Cronbach’s alpha = 0.76). The questions showed a good correlation, except for the question about judgment (Spearman’s rho = 0.03–0.19).ConclusionsThe scale adaptation showed an adequate agreement rate at the translation evaluation and a good reliability index in the questions. This instrument provides information on strengths and topics that require more attention from professionals to improve the relationship with their patients; it can be a valuable parameter in assessing the medical consultation quality.     

Disqualification of Neoadjuvant Rectal Score Based on Data of 6596 Patients From the Netherlands Cancer Registry

BackgroundThe neoadjuvant rectal score (NAR) was developed as a surrogate endpoint for overall survival in patients with rectal cancer after neoadjuvant treatment. We aimed to validate the NAR score in patients from the Netherlands Cancer Registry database.Patients and MethodsWe studied patients with rectal cancer treated with long-course neoadjuvant therapy followed by surgery in the Netherlands between 2007 and 2014. The probability of concordance with overall survival and the goodness of fit of several models were evaluated using Harrell's concordance index (c index) and the Akaike information criterion (AIC), which is used to compare the quality of statistical models.ResultsThe NAR score resulted in a c index of 0.665. We found that single pathologic parameters (pT or pN) have similar concordance as the NAR formula (c index of 0.663 and 0.655, respectively). A combination of pT and pN resulted in better concordance with the true endpoint, overall survival (c index 0.684), and a simple Cox regression model with the 3 parameters included in the NAR formula (cT, pT, and pN) improved the concordance even more (c index 0.689). When the AIC index was compared for all models, the NAR score model showed the worst fit to the true endpoint.ConclusionWe found no additional value for using the NAR formula as a surrogate endpoint for overall survival in rectal cancer patients treated with neoadjuvant therapy.