The Quality Assurance programme of the Radiotherapy Group of the European Organization for Research and Treatment of Cancer (EORTC): a critical appraisal of 20 years of continuous efforts

In 1982, the European Organization for Research and Treatment of Cancer (EORTC) Radiotherapy Group established the Quality Assurance (QA) programme. During the past 20 years, QA procedures have become a major part of the activities of the group. The methodology and steps of the QA programme over the past 20 years are briefly described. Problems and conclusions arising from the results of the long-lasting QA programme in the EORTC radiotherapy group are discussed and emphasised. The EORTC radiotherapy group continues to lead QA in the European radiotherapy community. Future challenges and perspectives are proposed.     

Quality assurance in medical oncology within the EORTC. European Organisation for Research and Treatment of Cancer

Quality assurance (QA) lately arrived in the medical arena in comparison to other fields. EORTC focused initially its attention on the aspects related to clinical trial data handling. In the late 1980s, the EORTC appointed a Quality Control Committee (QCC) with the remit to expand the QA activities to the main disciplines involved in cancer treatment. From 1990 to 1996, two projects supported by the European Commission enabled the QCC to address, amongst others, specific questions related to medical oncology. Both projects focused on the practices of chemotherapy delivery and the quality of data reporting. Following these projects, the QCC developed standard guidelines to advise on chemotherapy delivery and also a systemic chemotherapy checklist to enable an easy collection of essential data onto the patient's files. More recently, the EORTC QA Committee proposed a minimal set of quality control procedures to be implemented by all EORTC groups.     

Quality assurance for prospective EORTC radiation oncology trials: The challenges of advanced technology in a multicenter international setting

The European Organization for the Research and Treatment of Cancer (EORTC) is a pan-European structure charged with improving cancer treatment through the testing of new therapeutic strategies in phases I-III clinical studies. Properly conducted trials in radiation oncology are required to demonstrate superiority of a new treatment over the current standard. The Radiation Oncology Group (ROG) has initiated a complex quality assurance (QA) program to ensure safe and effective treatment delivery. Most modern trials are multicenter and multidisciplinary, further increasing the importance of early, strict and consistent QA in radiotherapy (RT). QART measures confirm whether a site possesses minimum staff and equipment for participation. Dummy runs, reviews of patient treatment plans and complex dosimetry checks verify the ability of an institution to comply with the protocol. Data required for evaluation are increasingly exchanged digitally, allowing detailed plan reconstruction, evaluation of target volume delineation and recalculation of dose-volume parameters for comparison against predefined standards. The five tiers of QA implemented in EORTC trials are reviewed, along with past, current and future QART initiatives. As substantial human and financial resources are increasingly invested in QART, the importance of cost-benefit analysis of QA and its impact on clinical outcome cannot be overstated.     

Multidisciplinary quality assurance and control in oncological trials: Perspectives from European Organisation for Research and Treatment of Cancer (EORTC)

Quality assurance (QA) programmes are one of the mainstays of clinical research and constitute the pillars on which European Organisation for Research Treatment of Cancer (EORTC) delivers multidisciplinary therapeutic progress. Changing practice treatments require solid evidence-based data, which can only be achieved if integral QA is part of the infrastructure sustaining research projects. Cancer treatment is a multimodality approach, which is often applied either in sequence and/or in combination. Each modality plays a key role in cancer control. The modalities by which QA is applied varies substantially within and across the disciplines. In addition, translational and diagnostic disciplines take an increasing role in the era of precision medicine. Building on the structuring effect of clinical research with fully integrated multidisciplinary QA programmes associated with the solutions addressing the chain of custody for biological material and data integrity as well as compliance ensure at the same time validity of clinical research output but also have a training effect on health care providers, who are more likely to apply such principles as routine. The principles of QA are therefore critical to be embedded in multidisciplinary infrastructure to guarantee therapeutic progress. These principles also provide the basis for the functioning of multidisciplinary tumour board. However, technical, operational and economic challenges which go with the implementation of such programmes require optimal know-how and the coordination of the multiple expertise and such efforts are best achieved through centralised infrastructure.     

Do results of the EORTC dummy run predict quality of radiotherapy delivered within multicentre clinical trials?

ObjectiveThe European Organisation for the Research and Treatment of Cancer (EORTC) Radiation Oncology Group (ROG) has performed radiotherapy quality assurance (QA) in clinical trials, including dummy runs (DR) and individual case reviews (ICR), since 1991. We investigated the influence of DR results on subsequent QA and patient outcomes.MethodsEORTC ROG studies were reviewed for DR inclusion, QA and mature clinical outcomes. A DR was classified as a failure if corrections necessitated re-submission. ICR were graded as acceptable, minor or major deviation overall. Fisher’s exact test characterised potential correlations and the Mantel–Haenszel statistic quantified pooled odds ratios (OR).ResultsDR and ICR data were available from 12 and 3 protocols, respectively. The proportion of institutions successful at first DR attempt varied per trial from 5.6% to 68.8%. Participants were 3.2 times more likely to pass at first attempt after previous DR participation (p = 0.0002). Pooled OR for an acceptable ICR was 1.69 (p = 0.06) for institutions successful at DR first attempt. The effect of DR participation was not significantly correlated with patient outcome in the trial available for analysis.ConclusionsImplementing QA measures in ROG clinical trials should ensure optimal radiotherapy delivery. Centres which previously participated in a DR were significantly more likely to be successful at subsequent QA procedures.     

Quality of life measurement in oncology—a matter of the assessment instrument?

Two widely used quality of life questionnaires European Organization for Research and Treatment of Cancer Core (EORTC QLQ-C30), Functional Assessment of Cancer Therapy—General (FACT-G) were examined for their comparability using four different groups of cancer patients. During a follow-up investigation, 418 cancer patients (Hodgkin's disease, breast cancer, bone marrow transplantation (BMT), chronic lymphatic leukaemia (CLL) completed both the EORTC QLC-C30 and the FACT-G during the same session. For an illustration of the differences between the two Quality of Life (QoL) instruments, pairs of diagnostic groups were formed and their QoL scores using the EORTC QLQ-C30 and FACT-G compared. The corresponding subscales of the EORTC-QLC-C30 and the FACT-G show only low to moderate intercorrelations across all four groups of cancer patients studied. In particular, a comparison of pairs, namely Hodgkin's disease versus breast cancer patients and BMT versus CLL patients, highlights substantial differences in the corresponding subscales of the EORTC QLQ-C30 and the FACT-G. The results of the QoL investigations should not be interpreted independently of the instrument used and an interpretation of results must be based on the contents of items of the respective questionnaires.     

Development of clinical trial protocols involving advanced radiation therapy techniques: the European Organisation for Research and Treatment of Cancer Radiation Oncology Group approach

The European Organisation for Research and Treatment of Cancer (EORTC) Master Protocol for phase III radiation therapy (RT) studies was published in 1995 to define in a consistent sequence the parameters which must be addressed when designing a phase III trial 'from the rationale to the references'. This was originally implemented to assist study investigators and writing committees, and to increase homogeneity within Radiation Oncology Group (ROG) study protocols. However, RT planning, delivery, treatment verification and quality assurance (QA) have evolved significantly over the last 15 years and clinical trial protocols must reflect these developments. The goal of this update is to describe the incorporation of these developments into the EORTC-ROG protocol template. Implementation of QA procedures for advanced RT trials is also briefly described as these essential elements must also be clearly articulated. This guide may assist both investigators participating in current ROG trials and others involved in writing an advanced RT trial protocol.     

食管癌术后康复期患者营养状况及生命质量的纵向研究

目的 了解食管癌术后康复期患者营养状况及生命质量的变化趋势及相关关系。方法 以四川省肿瘤专科医院行食管癌手术治疗的75例患者为研究对象,在患者术后1个月、3个月和6个月时运用患者主观整体营养评估量表进行营养评估,采用肿瘤生命质量测评量表和食管癌患者补充量表进行生命质量评定。结果 食管癌患者术后随时间的延长营养不良发生率由73.4%下降至33.5%。生活质量各维度评分在各评估时间点差异均有统计学意义（P<0.05）,功能领域和症状领域在术后1个月与术后3个月、术后6个月比较有统计学意义（P<0.05）,术后3个月与术后6个月比较差异无统计学意义（P>0.05）。患者营养状态与躯体、角色、情绪及社会功能呈负相关（P<0.05）,与吞咽困难、进食、反流、梗阻、食欲减退、咳嗽症状呈正相关（P<0.05）。结论 食管癌术后1个月患者营养状况及生命质量较差,随时间推移逐渐好转。医护人员应根据患者在不同时间点营养状况及生命质量的变化特点,制定规范化和个体化的延续护理方案,以促进患者术后康复、提高生命质量。     

Cervical cancer screening in Europe: Quality assurance and organisation of programmes

BackgroundCervical screening programmes have reduced cervical cancer incidence and mortality but the level of success is highly variable between countries. Organisation of programmes is essential for equity and cost-effectiveness. However, there are differences in effectiveness, also among organised programmes. In order to identify the key organisational components that determine effectiveness, we performed a Europe-wide survey on the current status of organisation and organised quality assurance (QA) measures in cervical cancer prevention programmes, as well as organisation-associated costs.MethodsA comprehensive questionnaire was developed through systematic review of literature and existing guidelines. The survey was sent to programme organisers, Ministries of Health and experts in 34 European Union (EU) and European Free Trade Agreement (EFTA) countries. Detailed aspects of programme organisation, quality assurance, monitoring, evaluation and corresponding line-item costs were recorded. Documentation of programme guidelines, protocols and publications was requested.ResultsTwenty-nine of 34 countries responded. The results showed that organised efforts for QA, monitoring and evaluation were carried out to a differing extent and were not standardised, making it difficult to compare the cost-effectiveness of organisation and QA strategies. Most countries found it hard to estimate the costs associated with launching and operating the organised programme.ConclusionsTo our knowledge, this is the first questionnaire to request detailed information on the actual organisation and QA of programmes. The results of this survey can be used as a basis for further development of standardised guidelines on organisation and QA of cervical cancer screening programmes in Europe.     

Health related quality of life outcomes in cancer clinical trials

Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.     

Quality assurance in EORTC clinical trials. European Organisation for Research and Treatment of Cancer

Quality assurance (QA) has become a major factor over recent years in the management and analysis of clinical trials. The EORTC recognised very early the importance of QA in clinical data handling and started in 1992 with the development of the first SOP in the format of a 'Procedures manual' which, from the beginning, had incorporated the EU GCP guidelines. In 1995, a Quality Assurance Unit (QAU) was created to coordinate the various QA activities and to guarantee that all clinical trials do comply at all levels with a minimum of QA requirements. The QAU coordinates internal and external audits and is a mandatory partner in the audits performed by national/international authorities and pharmaceutical industries. This process has been prolonged at the Data Center with the development of a full set of standard operating procedures (SOPs), the implementation of training programmes for each category of staff and an ongoing interval monitoring process.     

EORTC QLQ-INFO26: a questionnaire to assess information given to cancer patients a preliminary analysis in eight countries

Information disclosure is a key factor in the support for cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed a questionnaire to evaluate the level of information received by cancer patients at different stages of their disease and treatment: the EORTC QLQ-INFO26. It can be used in clinical practice and research, including clinical trials. The questionnaire was developed following EORTC Quality of Life Group guidelines. The paper presents the data on 133 patients from eight countries. The resulting EORTC QLQ-INFO26 questionnaire includes four sub-scales on information regarding their cancer, medical tests, treatment and other services and several single items.     

Trial design on prophylaxis and treatment of brain metastases: Lessons learned from the EORTC Brain Metastases Strategic Meeting 2012

Brain metastases (BM) occur in a significant proportion of cancer patients and are associated with considerable morbidity and poor prognosis. The trial design in BM patients is particularly challenging, as many disease and patient variables, statistical issues, and the selection of appropriate end-points have to be taken into account. During a meeting organised on behalf of the European Organisation for Research and Treatment of Cancer (EORTC), methodological aspects of trial design in BM were discussed. This paper summarises the issues and potential trial strategies discussed during this meeting and may provide some guidance for the design of trials in BM patients.     

Validation of the Chinese version of EORTC QLQ‐BN20 for patients with brain cancer

This is a single centre study in mainland China aiming to evaluate the reliability, validity and responsiveness of the Chinese version of EORTC QLQ‐BN20, designed by The European Organization for Research and Treatment of Cancer Quality of Life Group to evaluate the life quality of patients with brain tumour, cancer or metastases. One hundred and eighty‐eight patients with primary or secondary brain cancer from Hunan Provincial Tumor Hospital during September 2013 to June 2014 completed the Chinese EORTC QLQ‐C30/BN20 questionnaires developed by translation, back translation and cultural adaptation. Results were statistically analysed using SPSS17.0. The internal consistency (Cronbach's α coefficient) was between .753 and .869, the correlation coefficients among items and its own dimension were bigger than .4, and all items had a better correlation with its own dimension. The Spearman was used to analyse the correlation of each dimension between EORTC QLQ‐BN20 and EORTC QLQ‐C30, and the result showed that individual dimensions were moderately correlated, other dimensions were weakly correlated. In conclusion, the Chinese version of EORTC QLQ BN20 questionnaire had great relevance, reliability, convergent validity and discriminant validity. It provides a valuable tool for the assessment of health‐related quality of life in clinical studies of Chinese patients with primary or secondary brain cancer.     

The challenges and achievements involved in implementing Quality of Life research in cancer clinical trials

Over the last decade, Quality of Life (QOL) research has become an important aspect of cancer clinical trials. A dramatically increasing number of published studies, both randomised and non-randomised, report QOL outcomes. There is increasing evidence that QOL results impact on both future research and treatment decisions for clinicians. The rising number of studies with QOL components is mirrored within the European Organization for Research and Treatment of Cancer (EORTC), one of the largest cancer clinical trial organisations in Europe. Clinical trial groups have frequently reported on the difficulties and challenges of implementing QOL research. In the following paper, we therefore examine past experience in EORTC QOL studies, with a focus on the challenges presented and the improved approaches that are being implemented to obtain more meaningful outcomes.     

The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24

BACKGROUND: The authors report on the development and validation of a cervical cancer module for the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life (QoL) questionnaire (QLQ), which was designed to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. METHODS: The cervical cancer module (EORTC QLQ-CX24) was developed in a multicultural, multidisciplinary setting to supplement the EORTC QLQ-C30 core questionnaire. The QLQ-C30 and the cervical cancer module were administered to 346 patients with cervical cancer who underwent radical hysterectomy and received radiotherapy and chemotherapy. Psychometric analyses were performed by using data from 2 independent samples. RESULTS: The QLQ-CX24 consists of 3 multiitem scales and 5 single-item scales. Multitrait scaling analyses revealed high internal consistencies for the subscales with Cronbach alpha coefficients ranging from .72 to .87 (Symptom Experience, .72; Body Image, .86; Sexual/Vaginal Functioning, .87). Convergent and discriminant validity were fulfilled with scaling errors below 3%. The QLQ-CX24 was capable of discriminating between clinical subgroups. All items exhibited good compliance with <3% missing values. Most patients completed the EORTC QLQ-C30 and the QLQ-CX24 in <15 minutes (86%), and many did not require any assistance to complete the questionnaires (65%). CONCLUSIONS: The current psychometric analyses supported the content and construct validity and the reliability of the EORTC QLQ-CX24 module. This newly developed module is a useful instrument for assessing the QoL of patients who are treated for cervical cancer both in clinical trials and in clinical practice.     

Effects of a 4-Week Multimodal Rehabilitation Program on Quality of Life,Cardiopulmonary Function,and Fatigue in Breast Cancer Patients

Purpose

This study examines the effects of a rehabilitation program on quality of life (QoL), cardiopulmonary function, and fatigue in breast cancer patients. The program included aerobic exercises as well as stretching and strengthening exercises.

Methods

Breast cancer patients (n=62) who had completed chemotherapy were randomly assigned to an early exercise group (EEG; n=32) or a delayed exercise group (DEG; n=30). The EEG underwent 4 weeks of a multimodal rehabilitation program for 80 min/day, 5 times/wk for 4 weeks. The DEG completed the same program during the next 4 weeks. The European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23), predicted maximal volume of oxygen consumption (VO₂max), and fatigue severity scale (FSS) were used for assessment at baseline, and at 2, 4, 6, and 8 weeks.

Results

After 8 weeks, statistically significant differences were apparent in global health, physical, role, and emotional functions, and cancer-related symptoms such as fatigue and pain, nausea, and dyspnea on the EORTC QLQ-C30; cancer-related symptoms involving the arm and breast on the EORTC QLQ-BR23; the predicted VO₂max; muscular strength; and FSS (p<0.050), according to time, between the two groups.

Conclusion

The results of our study suggest that a supervised multimodal rehabilitation program may improve the physical symptoms, QoL, and fatigue in patients with breast cancer.     

Reliability and Validity of the EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale) among Thai Women with Breast Cancer Undergoing Taxane-Based Chemotherapy

Objective: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) is the common method for determining taxane-induced peripheral neuropathy (TIPN) symptoms. However, there have been no studies on the psychometric properties of the Thai Version of EORTC QLQ-CIPN20. The aim of this study was to evaluate the test–retest reliability, concurrent validity, and contrasting group validity of the Thai Version of EORTC QLQ-CIPN20 among women with breast cancer who received taxane-based chemotherapy. Methods: Twenty-eight breast cancer patients and 28 healthy controls participated in the study. Internal consistency, test–retest reliability, and inter-rater reliability were assessed using Cronbach α and the intraclass correlation coefficient (ICC). Concurrent validity was assessed via the Spearman correlation coefficient of the total scale of the EORTC QLQ-CIPN20 and the Total Neuropathy Score clinical version (TNSc), and contrasting group validity was assessed via the Mann-Whitney U test. Results: The internal consistency, test–retest reliability, and inter-rater reliability of the Thai Version of EORTC QLQ-CIPN20 was high to excellent (Cronbach α = 0.89, ICC = 0.84–0.95 and 0.78–0.94, respectively). However, the concurrent validity between the Thai Version of EORTC QLQ-CIPN20 and TNSc was not considered statistically significant. Contrasting group validity demonstrated statistically significant differences between breast cancer patients and healthy controls. Conclusions: The results support that the Thai Version of EORTC QLQ-CIPN20 is reliable and valid in measuring TIPN symptoms in Thai women with breast cancer. The findings suggest that the Thai Version of EORTC QLQ-CIPN20 may be used to distinguish TIPN symptoms between healthy controls and women with breast cancer undergoing taxane-based chemotherapy.     

Understanding the reliability and validity of the EORTC QLQ-C30 in Turkish cancer patients

Quality of life (QOL) has become an important area to address. The most commonly used QOL tool in oncology is the European Organization for Research and Treatment of Cancer QOL measure (EORTC QLQ-C30). The aim of this study is to examine the reliability and validity of this widely used questionnaire in Turkish language. A total of 114 cancer patients were recruited in this study. The internal consistency of the subscales, concurrent validity between EORTC QLQ-C30 version 3.0 and Short Form-36 (SF-36), the correlations between the subscales of EORTC QLQ-C30 and Hospital Anxiety and Depression scale-Anxiety (HADS-A), and Hospital Anxiety and Depression scale-Depression (HADS-D) were also evaluated. Cronbach's alpha-coefficient for multi-item scales ranged from 0.56 to 0.85, with emotional functioning having the highest Cronbach's alpha-coefficient. General health/QOL subscale was correlated significantly with all other subscales. Modest correlations were found between relevant subscales of SF-36 and EORTC QLQ-C30 scales indicating good convergent validity. Although score of emotional functioning subscale was significantly correlated with HADS-A, no correlation was found with HADS-D. The correlations between general health/QOL and HADS-A and HADS-D were significant though Pearson's coefficients were below 0.4. The EORTC QLQ-C30 version 3.0 is a reliable and valid instrument and suitable for measuring the QOL in cancer patients in Turkey.     

Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29.The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire.Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health.The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.