Delivery of Brachytherapy for Cervical Cancer: Organisational and Technical Advice to Facilitate High-quality Care

AimsBrachytherapy is a standard therapy for cervical cancer; it allows for the delivery of a high dose of radiation to the tumour while sparing the surrounding healthy tissues. With this document, the Brachytherapy Cervical Cancer Expert Working Group (BCCEWG) aimed to provide advice on organisational and technical aspects of the delivery of brachytherapy services in Ontario, Canada.Materials and methodsWe sought technical documents, practice guidelines and standards through an environmental scan of internet resources, an iterative search of the literature on MEDLINE and EMBASE, and a search of reference lists of included documents.ResultsWe identified 20 guidance documents authored by 10 organisations; 11 documents were identified through the environmental scan, five through the literature search and four from reference lists. The recommendations included in this document were developed by the BCCEWG through the selection and review of the evidence and informal consensus.ConclusionsThese organisational recommendations aim to set the stage for high-quality delivery of brachytherapy for cervical cancer services in the province of Ontario, Canada. They address the characteristics of the practice setting, including facilities, equipment, delivery suite, imaging technologies, treatment planning and dosimetry; the practice team, including team members, roles, training, team caseload/volumes and qualifications; and the quality assurance domain, including documentation, audit, safety and quality control.     

Quality indicators in ovarian cancer surgery: Report from the French Society of Gynecologic Oncology (Société Française d'Oncologie Gynécologique,SFOG)

BackgroundBased on registries, the European experience has been that <50% of patients are treated according to protocols and/or benefit from the minimum required surgery for ovarian cancer. The French Cancer Plan 2009–2013 considers the definition of qualitative indicators in ovarian cancer surgery in France. This endeavour was undertaken by the French Society of Gynaecologic Oncology (SFOG) in partnership with the French National College of Obstetricians and Gynecologists and all concerned learned societies in a multidisciplinary mindset.MethodsThe quality indicators for the initial management of patients with ovarian cancer were based on the standards of practice determined from scientific evidence or expert consensus.ResultsThe indicators were divided into structural indicators, including material (equipment), human (number and qualification of staff), and organizational resources, process indicators, and outcome indicators.ConclusionsThe enforcement of a quality assurance programme in any country would undoubtedly promote improvement in the quality of care for ovarian cancer patients and would result in a dramatic positive impact on their survival. Such a policy is not only beneficial to the patient, but is also profitable for the healthcare system.     

Audit in clinical practice

Background and objectives

Audit dates back to as early as 1750 BC when king Hammurabi of Babylon instigated audit for clinicians with regard to outcome. Clinical audit is a way of fi nding out whether we are doing what we should be doing. It also verifi es whether we are applying the best practice.

Methods

An audit cycle involves setting-up of standards, measuring current practice, comparing results with standards (criteria), changing practice and re-auditing to make sure practice has improved

Results and interpretations

A ‘clinical audit’ is a quality improvement process that seeks to improve patient care and clinical outcomes through a systematic review of care against explicit criteria, and the implementation of change. Changes are implemented at an individual, team or service level and a subsequent re-audit is done to confi rm improvement in health care delivery.

Conclusion

The importance of audit in healthcare sector needs to be appreciated by the relevant authorities. The most frequently cited barrier to successful audit is the failure of organizations to provide suffi cient fund and protected time for healthcare teams.     

Quality assurance and quality control for radiotherapy/medical oncology in Europe: Guideline development and implementation

The past two decades have brought tremendous changes to the practice of radiation oncology and medical oncology. To manage all the complexities related to the new technologies and the new drugs, the radiation and medical oncologists have to enhance their clinical action and professional skill profile. To accomplish this they have to find reliable tools in the quality of their medical practice and in future research activities. Quality assurance (QA) and quality control (QC) for radiation and medical oncologists mean to clarify the different components of the clinical decision, to supervise with proper methodology the required steps needed to accomplish the agreed outcomes and to control them. Quality for radiation and medical oncology means to supervise each clinical and technical component of the whole process to guarantee that all steps together will arrive at the final and best possible outcome. Key components are guidelines, specialization and a multidisciplinary approach. The research of global quality could represent a further complexity, but it is the best tool to give a perspective and a chance to further improvements of our disciplines and to promote better outcome in all cancer patients.     

Patient Selection for Hyperthermic Intraperitoneal Chemotherapy in Patients With Colorectal Cancer: Consensus on Decision Making Among International Experts

BackgroundColorectal cancer (CRC) treatment for patients with peritoneal metastases is complex. The use of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has continued to be debated. The aim of the present study was to assess the consensus among international experts for decision-making regarding the use of CRS and HIPEC for patients with CRC.Materials and MethodsOf 15 experts invited, 12 had provided their decision algorithms for CRS and HIPEC for patients with, or at high risk of, peritoneal metastases from CRC. Using the objective consensus method, the results were transformed into decision trees to provide information on the consensus and discordance.ResultsOnly 1 scenario was found for which the consensus on performing HIPEC had reached 100%. The scenario was the treatment of young patients with complete cytoreduction and a peritoneal carcinomatosis index (PCI) of < 16 in the presence of certain risk factors. Five major decision criteria were identified: age, PCI, completeness of cytoreduction, extent of extraperitoneal metastases (EoMs), and, in the case of unverified EoMs, additional risk factors. Consensus was found regarding refraining from using HIPEC for older patients with a high PCI. The consensus further increased when addressing incomplete cytoreduction and an extensive extent of EoMs.ConclusionA definite consensus concerning the use of HIPEC was only determined for very selected scenarios. These findings can be used for general guidance; however, owing to the heterogeneity of each individual situation, the impracticality of presenting the information through decision trees, and the unclear future of the role of HIPEC in the adjuvant setting, a one-on-one transfer to daily clinical practice could not be achieved.     

Multidisciplinary decision-making in older patients with cancer,does it differ from younger patients?

BackgroundIn order to tailor treatment to the individual patient, it is important to take the patients context and preferences into account, especially for older patients. We assessed the quality of information used in the decision-making process in different oncological MDTs and compared this for older (≥70 years) and younger patients.Patients and methodsCross-sectional observations of oncological MDTs were performed, using an observation tool in a University Hospital. Primary outcome measures were quality of input of information into the discussion for older and younger patients. Secondary outcomes were the contribution of different team members, discussion time for each case and whether or not a treatment decision was formulated.ResultsFive-hundred and three cases were observed. The median patient age was 63 year, 32% were ≥70. In both age groups quality of patient-centered information (psychosocial information and patient's view) was poor. There was no difference in quality of information between older and younger patients, only for comorbidities the quality of information for older patients was better. There was no significant difference in the contributions by team members, discussion time (median 3.54 min) or number of decision reached (87.5%).ConclusionFor both age groups, we observed a lack of patient-centered information. The only difference between the age groups was for information on comorbidities. There were also no differences in contributions by different team members, case discussion time or number of decisions. Decision-making in the observed oncological MDTs was mostly based on medical technical information.     

Multidisciplinary cancer conferences: a systematic review and development of practice standards

BackgroundMultidisciplinary cancer conferences (MCCs) are a forum for health care providers to discuss diagnostic and treatment aspects of a cancer patient’s care. In Ontario, we have found that very few hospitals have developed cancer conferences or forums for the prospective discussion of patient cancer care. In this paper, we describe the process of creating a province-wide standards document for MCCs.MethodsA systematic review and environmental scan were conducted to evaluate the literature regarding the impact of MCCs on physician practice patterns and patient outcomes, using the methodology of the Practice Guidelines Development Cycle. An Expert Panel was created to develop draft MCC standards. Ontario administrators and practitioners were surveyed to elicit feedback regarding the standards document. The findings were collated, and practice standards were developed.ResultsMultidisciplinary care, predominantly in the form of multidisciplinary clinics, has been shown to improve patient outcomes. While only limited evidence suggested a benefit for MCCs, they have been documented as influential in changing patient management plans. MCCs were also found to be part of standard cancer care on an international level. Ontario practitioners surveyed generally supported MCC implementation.DiscussionWe have described the process of creating an Ontario MCC standards document, including a literature review and an examination of the attitudes of Ontario practitioners and hospital administrators regarding the development and implementation of a MCC Standards document.     

Standards, Options and Recommendations for non metastatic breast cancer patients

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French Cancer Centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for non metastatic breast cancer patients according to the definitions of the Standards, Options and Recommendations project. METHODS: Data were identified by searching Medline , web sites, and using the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 148 independent reviewers. RESULTS: This article is an update of the version published in 1996. The modified 2001 version of the standards, options and recommendations takes into account new information published. Important changes have been made in terms of clinical practice. They concern loco-regional and general therapy. Regarding loco-regional treatment, a increased dose to the tumor bed should be needs to be systematically delivered to the tumor bed for women under 50 years. The analysis of margin involvement is essential and constitutes an important factor for therapeutic decision. Regarding general therapy, hormone therapy with tamoxifen appeared, in 2001, as one of the standards in non-menopausal and oestrogen receptor-positive patients. Concerning patients with N- tumors, the standards and therapeutic options were refined with regard to the notion of metastatic relapse risk. Chemotherapy constitutes one of the standard treatments for non-menopausal women with one or more factor(s) predictive of metastatic relapse.     

Audit tool for external beam radiation therapy departments

PurposeDevelopment of a self-contained audit tool for external beam radiation therapy to assess compliance with the major recommendations from professional organizations and generally accepted standards of practice. Intensity modulated radiation therapy, stereotactic body radiation therapy, stereotactic radiosurgery, and volumetric modulated arc therapy were included in this review.Methods and MaterialsA physics quality working group developed a department vision, distinguished and summarized key references, and condensed important elements of good documentation practices. The results were then compiled in a checklist format and used to perform audits at 3 sites.ResultsThe final audit tool contains 65 items spanning a wide range of external beam radiation therapy practices. Several of the audit items address issues not commonly identified by other authoritative sources. A total of 48 process improvements were identified at the 3 sites audited.ConclusionsThe enclosed self-inspection list may be useful to a site as an annual review tool, as an aid in preparation for the American College of Radiology-American Society for Therapeutic Radiology and Oncology practice accreditation, or as a catalyst for general quality improvement. Sites can quickly identify opportunities for improvement by concentrating on high importance items and commonly identified areas of noncompliance.     

A Review of Shared Decision-Making and Patient Decision Aids in Radiation Oncology

Cancer treatment decisions are complex and may be challenging for patients, as multiple treatment options can often be reasonably considered. As a result, decisional support tools have been developed to assist patients in the decision-making process. A commonly used intervention to facilitate shared decision-making is a decision aid, which provides evidence-based outcomes information and guides patients towards choosing the treatment option that best aligns with their preferences and values. To ensure high quality, systematic frameworks and standards have been proposed for the development of an optimal aid for decision making. Studies have examined the impact of these tools on facilitating treatment decisions and improving decision-related outcomes. In radiation oncology, randomized controlled trials have demonstrated that decision aids have the potential to improve patient outcomes, including increased knowledge about treatment options and decreased decisional conflict with decision-making. This article provides an overview of the shared-decision making process and summarizes the development, validation, and implementation of decision aids as patient educational tools in radiation oncology. Finally, this article reviews the findings from decision aid studies in radiation oncology and offers various strategies to effectively implement shared decision-making into clinical practice.     

Simulation modeling of outcomes and cost effectiveness

Modeling will continue to be used to address important issues in clinical practice and health policy issues that have not been adequately studied with high-quality clinical trials. The apparent ad hoc nature of models belies the methodologic rigor that is applied to create the best models in cancer prevention and care. Models have progressed from simple decision trees to extremely complex microsimulation analyses, yet all are built using a logical process based on objective evaluation of the path between intervention and outcome. The best modelers take great care to justify both the structure and content of the model and then test their assumptions using a comprehensive process of sensitivity analysis and model validation. Like clinical trials, models sometimes produce results that are later found to be invalid as other data become available. When weighing the value of models in health care decision making, it is reasonable to consider the alternatives. In the absence of data, clinical policy decisions are often based on the recommendations of expert opinion panels or on poorly defined notions of the standard of care or medical necessity. Because such decision making rarely entails the rigorous process of data collection, synthesis, and testing that is the core of well-conducted modeling, it is usually not possible for external audiences to examine the assumptions and data that were used to derive the decisions. One of the modeler's most challenging tasks is to make the structure and content of the model transparent to the intended audience. The purpose of this article is to clarify the process of modeling, so that readers of models are more knowledgeable about their uses, strengths, and limitations.     

Choosing patient-reported outcome measures for cancer clinical research – Practical principles and an algorithm to assist non-specialist researchers

AimThe purpose of this article is to give practical advice to researchers wishing to choose measures of quality of life and other patient-reported outcomes (PROs) for cancer clinical research.MethodReaders are guided through the process of selecting a patient-reported outcome measure (PROM) by means of six principles, illustrated with examples.ResultsPROM selection should always be undertaken with consideration of specific objectives, samples, treatments and available resources. Guiding principles include: (1) always consider PROMs early in the design process within the context of other methodological decisions; (2) choose a primary PROM that is as proximal to the cancer and/or its treatment as will add to knowledge and inform practice; (3) identify candidate PROMs primarily on the grounds of scaling and content; (4) appraise the reliability, validity and ‘track records’ of candidate PROMs in studies similar to that planned; (5) look ahead to practical concerns; and (6) take a minimalist approach to ad hoc items.ConclusionThe principles and algorithms presented in this article will assist cancer clinical researchers who lack specialist expertise in patient-reported outcome measurement to make appropriate choices when selecting PROMs for their next study.     

EORTC–GCG process quality indicators for ovarian cancer surgery

IntroductionSurgery is the mainstay of staging and treatment of ovarian cancer. Optimal quality of ovarian cancer surgery implies complete staging and removal of all macroscopic tumour with minimal harm to the patient in order to ensure best patient outcome. However, variation in the quality of ovarian cancer surgery is apparent. In order to assess and improve the quality of care, quality indicators can be used.MethodsTo identify candidate quality indicators, a literature search was performed using relevant MESH terms. These were assessed for validity, feasibility and measurability.ResultsFive quality indicators for staging of presumed early-stage ovarian cancer and six for primary debulking surgery for advanced disease are proposed.ConclusionThe defined quality indicators can be used to monitor and improve the quality of surgery for ovarian cancer.     

Assessment of oral mucositis in clinical trials: impact of training on evaluators in a multi-centre trial

In the assessment of mucositis, the inter-evaluator variability needs to be minimised and would likely to be best accomplished by training. The aim of this study was to evaluate the effect of training on concordance of evaluators in scoring oral mucositis. The evaluators were informed about the pathobiology and clinical appearance of mucositis and were trained in scoring mucositis according the Oral Mucositis Assessment Scale (OMAS). The effect of the training was evaluated by a pre- and post-training test. Each test consisted of 15 slides depicting oral mucositis. The pre- and post-training scores were compared to the reference standard. During 8 months at 6 meetings, 65 evaluators were trained. The mean percentage correctly scored slides according the OMAS increased significantly between the pre- and post-training test (P<0.001). Training evaluators in scoring oral mucositis has a significant improvement on the outcome of mucositis assessment.     

Diagnostic Nodes of Patient Selection for Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Among Colorectal Cancer Patients: A Swiss National Multicenter Survey

BackgroundThe management of patients with colorectal cancer (CRC) with peritoneal metastases is challenging, and the roles of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are unclear and debated among experts.Materials and MethodsThe experts of the Swiss Peritoneal Cancer Group were contacted and agreed to participate in this analysis. Experts from 9 centers in Switzerland provided their decision algorithms for CRS/HIPEC for patients with or at high risk for peritoneal metastases from CRC. Their responses were converted into decision trees on the basis of objective consensus methodology. The decision trees were used as a basis to identify consensus and discrepancies.ResultsThe final treatment algorithms included a total of 5 decision criteria (age, Peritoneal Cancer Index [PCI], extraperitoneal metastases, Peritoneal Surface Disease Severity Score, and various risk factors [RF]) and 2 treatment options (HIPEC, yes or no). HIPEC was never recommended for patients without peritoneal metastases in the absence of RF for peritoneal metastases. For patients with a PCI ≤15 without organ metastases, all centers recommended CRS/HIPEC. There was also a consensus not to perform CRS/HIPEC in elderly patients (80 years and older), those with a PCI >20, and those with unresectable metastases. For patients with a PCI = 16 to 20, there was no consensus.ConclusionMultiple decision criteria relevant to all participating centers were identified. Because patient selection for CRS/HIPEC remains difficult, uniform criteria for the term “high risk” for peritoneal metastases and systemic metastases are helpful. Future trials and guidelines should take these criteria into account.     

Clinical relevance of molecular diagnostics in gastrointestinal (GI) cancer: European Society of Digestive Oncology (ESDO) expert discussion and recommendations from the 17th European Society for Medical Oncology (ESMO)/World Congress on Gastrointestinal Cancer,Barcelona

Background and scopeIn the epoch of precision medicine and personalised oncology, which aims to deliver the right treatment to the right patient, molecular genetic biomarkers are a topic of growing interest. The aim of this expert discussion and position paper is to review the current status of various molecular tests for gastrointestinal (GI) cancers and especially considering their significance for the clinical routine use.MethodologyOpinion leaders and experts from diverse nationalities selected on scientific merit were asked to answer to a prepared set of questions about the current status of molecular diagnostics in different GI cancers. All answers were then discussed during a plenary session and reported here in providing a well-balanced reflection of both clinical expertise and updated evidence-based medicine.ResultsPreselected molecular genetic biomarkers that are described and disputed in the current medical literature in different GI cancers were debated, and recommendations for clinical routine practice were made whenever possible. Furthermore, the preanalytical variations were commented and proposals for quality controls of biospecimens were made.ConclusionThe current article summarises the recommendations of the expert committee regarding prognostic and predictive molecular genetic biomarkers in different entities of GI cancers. The briefly and comprehensively formulated guidelines should assist clinicians in the process of decision making in daily clinical practice.     

Consensus Quality Measures and Dose Constraints for Prostate Cancer From the Veterans Affairs Radiation Oncology Quality Surveillance Program and American Society for Radiation Oncology Expert Panel

PurposeThere are no agreed upon measures to comprehensively determine the quality of radiation oncology (RO) care delivered for prostate cancer. Consequently, it is difficult to assess the implementation of scientific advances and adherence to best practices in routine clinical practice. To address this need, the US Department of Veterans Affairs (VA) National Radiation Oncology Program established the VA Radiation Oncology Quality Surveillance (VA ROQS) Program to develop clinical quality measures to assess the quality of RO care delivered to Veterans with cancer. This article reports the prostate cancer consensus measures.Methods and MaterialsThe VA ROQS Program contracted with the American Society for Radiation Oncology to commission a Blue Ribbon Panel of prostate cancer experts to develop a set of evidence-based measures and performance expectations. From February to June 2021, the panel developed quality, aspirational, and surveillance measures for (1) initial consultation and workup, (2) simulation, treatment planning, and delivery, and (3) follow-up. Dose-volume histogram (DVH) constraints to be used as quality measures for definitive and post-prostatectomy radiation therapy were selected. The panel also identified the optimal Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE V5.0), toxicity terms to assess in follow-up.ResultsEighteen prostate-specific measures were developed (13 quality, 2 aspirational, and 3 surveillance). DVH metrics tailored to conventional, moderately hypofractionated, and ultrahypofractionated regimens were identified. Decision trees to determine performance for each measure were developed. Eighteen CTCAE V5.0 terms were selected in the sexual, urinary, and gastrointestinal domains as highest priority for assessment during follow-up.ConclusionsThis set of measures and DVH constraints serves as a tool for assessing the comprehensive quality of RO care for prostate cancer. These measures will be used for ongoing quality surveillance and improvement among veterans receiving care across VA and community sites. These measures can also be applied to clinical settings outside of those serving veterans.     

Cost-Effectiveness Analysis of Stereotactic Ablative Body Radiation Therapy Compared With Surgery and Radiofrequency Ablation in Two Patient Cohorts: Metastatic Liver Cancer and Hepatocellular Carcinoma

AimsTo compare the cost-effectiveness of stereotactic ablative body radiation therapy (SABR) with radiofrequency ablation and surgery in adult patients with metastatic liver cancer and hepatocellular carcinoma (HCC).Materials and methodsTwo patient cohorts were assessed: liver oligometastases and HCC. For each patient cohort, a decision analytic model was constructed to assess the cost-effectiveness of interventions over a 5-year horizon. A Markov process was embedded in the decision model to simulate the possible prognosis of cancer. Data on transition probabilities, survival, side-effects, quality of life and costs were obtained from published sources and the SABR Commissioning through Evaluation (CtE) scheme. The primary outcome was the incremental cost-effectiveness ratio with respect to quality-adjusted life-years. The robustness of the results was examined in a sensitivity analysis. Analyses were conducted from a National Health Service and Personal Social Services perspective.ResultsIn the base case analysis, which assumed that all three interventions were associated with the same cancer progression rates and mortality rates, SABR was the most cost-effective intervention for both patient cohorts. This conclusion was sensitive to the cancer progression rate, mortality rate and cost of interventions. Assuming a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, the probability that SABR is cost-effective was 57% and 50% in liver oligometastases and HCC, respectively.ConclusionsOur results indicate a potential for SABR to be cost-effective for patients with liver oligometastases and HCC. This finding supports further investigation in clinical trials directly comparing SABR with surgery and radiofrequency ablation.     

First-line bevacizumab-containing therapy for breast cancer: results in patients aged ≥70 years treated in the ATHENA study

BackgroundThere are limited data on treatment outcomes in the growing population of elderly patients with locally recurrent/metastatic breast cancer (LR/mBC). To gain information on first-line bevacizumab combined with chemotherapy in the elderly, we analyzed data from the ATHENA trial in routine oncology practice.Patients and methodsPatients with human epidermal growth factor receptor-2-negative LR/mBC received first-line bevacizumab with standard chemotherapy until disease progression, unacceptable toxicity, or physician/patient decision. We carried out a subgroup analysis of safety and efficacy in patients aged ≥70 years. Possible correlations between tolerability and baseline comorbidities or Eastern Cooperative Oncology Group status were explored.ResultsBevacizumab was combined with single-agent paclitaxel in 46% of older patients. Only hypertension and proteinuria were more common in older than in younger patients (grade ≥3 hypertension: 6.9% versus 4.2%, respectively; grade ≥3 proteinuria: 4.0% versus 1.5%, respectively). Grade ≥3 arterial/venous thromboembolism occurred in 2.9% versus 3.3%, respectively. Further analysis revealed no relationship between baseline presence and severity of hypertension and risk of developing hypertension during bevacizumab-containing therapy. Median time to progression was 10.4 months in patients aged ≥70 years.ConclusionsThese findings suggest that bevacizumab-containing therapy is tolerable and active in patients aged ≥70 years. Hypertension was more common than in younger patients but was manageable. We find no evidence precluding the use of bevacizumab in older patients, including those with hypertension, although age may influence chemotherapy choice.