Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol.

INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated. METHODS AND ANALYSIS: Data will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30. ETHICS AND DISSEMINATION: All patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID 'blue book' which will be made available online on the EORTC Quality of Life Group website as a free guideline document

Fundamental movement skills and accelerometer-measured physical activity levels during early childhood: a systematic review

Early childhood is a key period for children to begin developing and practicing fundamental movement skills (FMS), while aiming to perform sufficient physical activity (PA). This study reviews the current evidence for the levels of achievement in FMS and PA measured using accelerometers among 4–5-year-old children and examines differences by gender. This review was conducted using the PRISMA framework. Keyword searches were conducted in Pubmed, Medline, Google Scholar and SPORTDiscus. Inclusion criteria included age: 4–5 years old; FMS measurement: Test of Gross Motor Development 2 and 3; PA measurement: objective methods; balance measurement: static single limb; study design: cross-sectional observational/descriptive, randomised control trials, intervention studies; language: English. Twenty-eight articles from twenty-one countries met the inclusion criteria and were split into either FMS and PA articles (n = 10) or balance articles (n = 18). Three articles showed children achieving 60 min of moderate to vigorous PA per day, two articles demonstrated significant differences between girls’ and boys’ performance of locomotor skills and five reported locomotor skills to be more proficient than object control skills at this age for both genders. Balance was measured in time (n = 12), points score (n = 3) or biomechanical variables (n = 3), displaying heterogeneity of not only measurement but also outcomes within these data, with static single limb balance held between 6.67 to 87.6 s within the articles. Four articles reported girls to have better balance than boys. There is little conclusive evidence of the current levels for FMS, PA and balance achievement in young children 4–5 years of age. The academic literature consistently reports low levels of FMS competence and mixed evidence for PA levels. Inconsistencies lie in balance measurement methodology, with broad-ranging outcomes of both low and high achievement at 4–5 years old. Further research is required to focus on increasing practice opportunities for children to improve their FMS, increase PA levels and establish sufficient balance ability. Consistent and comparable outcomes during early childhood through more homogenous methodologies are warranted.N/

Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients

Background: We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients. Materials and methods: World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. Results: Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14. Conclusion: These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trial

The Added Value of Analyzing Pooled Health-Related Quality of Life Data: A Review of the EORTC PROBE Initiative

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers. METHODS: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided. RESULTS: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient- and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P < .001), vomiting (P = .01), nausea (P < .001), and constipation (P = .01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed. CONCLUSIONS: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses