Clinical evaluation: how does it influence medical practice?

This paper reviews reports of the effects of clinical evaluations on physician awareness and behavior. Among the reviewed papers, there are 28 studies of the effect of specific randomized clinical trials (RCTs) on 19 different medical practices. After analyzing these 28 papers, there remain two (7%) where the RCT has clear implications for practice, where the pattern of practice reported quantitatively over time conforms fully to the RCT findings, where the RCT preceded the change in the pattern of practice, and where findings from the RCT differ from the results of other forms of evaluation. The majority of the reviewed papers do not support an inference that RCTs have a strong, direct influence in changing established clinical practices. Clinical evaluation is one among many factors bearing on changes in medical practices. Improving the care of patients requires both improved methods of evaluation and more effective translation of the results of evaluation into practice. Evaluations are likely to exert a greater impact on medical practices if they are buttressed by attention to other controllable factors, like channels of communication and environmental constraints and incentives, that affect the adoption and abandonment of medical practices.     

Ethical Conduct of Research in the Clinical Environment

Clinical research has a long history of questionable ethical practice. Abuse of subjects and neglectful research practices have harmed individuals, groups, and the reputation of the scientific community. Policies, codes, and guidelines have been implemented and enforced as a result. To ensure ethical research practice, clinical trials and studies need to be assessed at various stages to ensure ethical design, just recruitment practices, voluntary informed consent, safe and ethical conduct, and appropriate dissemination of results. This paper identifies and explains ethical principles that apply to research. The purpose and focus of the four fundamental policy documents that inform current research practice are outlined. Ethical challenges that a researcher may face are also discussed. The requirements related to the humane use of animals for research purposes will be considered. Lastly, controversies and challenges with exporting research to developing countries will be briefly discussed.     

Telling the truth to patients with cancer: what is the truth?

Attitudes and practices of truth-telling to people with cancer have shifted substantially in the past few years. However, cultural and individual differences persist, and some difficulties common to all medical specialties are magnified in oncology. In this Personal View, I review and analyse data for attitudes and practices of truth-telling worldwide. I also assess ethical justifications, with special reference to interpersonal aspects of patients' autonomy and the dynamic nature of truth in the clinical context. Examples are provided to show how this ethical perspective can help oncologists to frame the discourse on truth-telling and to find solutions to the dilemmas of whether, when, and how to tell the truth to their patients in clinical practice. Finally, I identify future targets for research.     

Practice guidelines in western countries

The concept of clinical practice guidelines was established in the 1960's to reduce medical costs that had been increasing dramatically in the US. To reduce medical expenses without lowering the quality of medical care, thorough control of medical practices was undertaken by rationalization of these practices. Guidelines were started initially for social and economical reasons, but were eventually accepted widely by society for several reasons. First, the concept of patients' autonomy was widely accepted after 1970, which supported full disclosure of information to patients. Second, there was too much information, necessitating ranking by scientific certainty. Third, the risk of litigation for doctors in the USA increased dramatically during these years. Whether a medical practice follows the guidelines or not has become one of the most important issues in medical lawsuits. Fourth, there is a constant demand for the effective use of social resources. Methods for developing clinical practice guidelines are already established in many societies. The first step is an intensive review of relevant articles to generate evidence-based recommendations (EBR). Then, to formulate practice guidelines, these EBR are ratified and modified by clinicians to whom they apply. They are then reviewed by independent experts. After final adjustment of the EBR or guidelines for administrative reasons, they are adopted with a future expiry date. Practice guidelines are not actually adopted in European countries. However, the concept of guidelines is well appreciated and medical practice is based on scientific evidence. In socialistic European countries like Sweden, Denmark or the Netherlands, there is huge pressure to control limited social resources, leading to aggressive efforts to reduce unexplained and inappropriate variations in medical practice.     

Centralised treatment of soft tissue sarcomas in adults

The clinical research developed in specialised centres and oncologic cooperative groups has permitted various scientific societies to collect recommendations used in the treatment of soft tissue sarcomas (STS) and incorporate them into clinical practice guidelines (CPG). Some studies have been conducted in diverse healthcare ambits to assess the influence of CPG. This revision of the medical literature analyses the impact that healthcare management -centralised or otherwise- and clinical practice in conformity with CPG have on the clinical outcome variables of STS. Eight CPG have been identified, as well as 12 conformity studies or audits. These conformity studies and audits demonstrate that the grade of adaptation of medical interventions with CPG, medical healthcare in reference centres and procedures of referrals to these centres, as well as the process of organising healthcare teams into Sarcoma Committees, have a significant influence on clinical outcome. We can conclude that excellent healthcare of STS implies the adaptation of healthcare practice to CPG, the existence of Reference Centres guided by Sarcoma Committees, and the observance of strict referral procedures within the Healthcare Area.     

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.     

Supportive care treatment guidelines: value, limitations, and opportunities

Evidence-based guidelines in clinical oncology practice are now prominent, with emphasis on clinical, health outcome and economic perspectives. Given the complexity of cancer management, a multidisciplinary approach is essential. Evidence-based guidelines to address supportive cancer care have merged expert opinion, systematic evaluation of clinical and research data, and meta-analyses of clinical trials. Production of supportive care guidelines by the interdisciplinary team is dependent on sufficient high-quality research studies. Once published, it is essential they be customized at institutional and national levels. Implementation in clinical practice is perhaps the greatest challenge. Optimal management occurs through integration of country-specific issues, including care access, healthcare resources, information technology, and national coordination of healthcare practices. The purpose of this article is to: (1) provide an overview of interdisciplinary cancer management using evidence-based guidelines; (2) delineate the theory and practice of guideline dissemination, utilization and outcome assessment; and (3) recommend future research strategies to maximize guidelines use in clinical practice.     

Peutz-Jeghers syndrome: a patient’s view

Life with Peutz-Jeghers syndrome (PJS) is complex and demanding, affecting not only the patients, but also their family members, loved ones, and clinicians. In general, clinicians and researchers have defined the syndrome. Now, in addition, people with PJS and their caregivers use the Internet for medical research and to find others with whom to share information and support. An online support group for people interested in PJS has been an important resource since 2000. This article is meant to complement the medical literature and clinician practice by sharing knowledge gained from this group and through the author’s personal experience as a PJS patient. Clinicians and researchers may benefit from a better-rounded view of the syndrome, a long list of questions and issues, and tips for future research and clinical practice. This is offered with the intent to ease suffering and improve future patient care.     

Myth busting: does real-world experience lead to better drug choices?

In the era of evidence-based medicine, clinical guidelines, andpersonalized medicine, one would think that convincing clinical trial data would influence clinical practice if disseminated in an appropriate manner. However, it has been estimated that only 50% of current medical practice is evidence-based, clearly demonstrating a compelling need to collect and analyze additional data to better inform practice. Current data are usually gathered from a variety of sources, including clinical trials, observational studies, and meta-analyses. Yet according to Jeff Forringer, CEO of IntrinsiQ, data from oncology practices provide real-world outcomes that give better insight into the efficacy of cancer therapeutics.     

免疫治疗的真实世界研究现状

真实世界研究（real-world study,RWS）应用广泛,类型多样,可以充分反映临床实际景象。随着人工智能等数据分析手段的发展,利用多样的现实世界数据,可以得出更多强有力的真实世界证据（real-world evidence,RWE）。近年来,中国大力支持RWS发展,国内外相关利好政策频频出台。免疫治疗不良反应小、作用持久,是继化疗、靶向治疗之外的又一项高效治疗手段,在肿瘤患者中得到广泛应用,在真实世界中积累了大量使用经验。通过RWS可以更加全面地认识免疫治疗临床应用情况,评价药物真实疗效和安全性,锁定受益人群,促进开展精准治疗,探寻更优实践方式。本文对RWS中免疫治疗的进展进行系统性介绍。      

碰撞瘤研究的相关进展及历史回顾

碰撞瘤属于临床罕见病,是指两种独立起源的原发性肿瘤相互碰撞或相互浸润,几乎可以发生在身体的任何部位。关于碰撞瘤的个案报道相对不多,国内尚无相关综述总结。笔者在pubmed、万方、中国知网等数据库阅读近5年相关国内外病例的报道,对碰撞瘤的好发部位、常见病理类型、发病机制等展开综述,旨在帮助我们更好的了解和认识碰撞瘤。     

Surviving the perfect storm: an RVU-based model to evaluate the continuing impact of MMA on the practice of oncology

The Resource-Based Relative Value Scale (RBRVS) system instituted by Centers for Medicare and Medicaid Services has lead to the implementation of a new financial analysis paradigm based on relative value units (RVUs). RVU-based financial tools have great potential to allow in-depth analysis of all components of the cancer care delivery system. Because all medical oncology practices must become conversant in RVU terminology and methodology, RVU-based financial tools will allow standardization and benchmarking for intra- and interpractice comparisons. Understanding this approach is essential for sound business management. The emotional and financial pressures facing the medical oncologist in private practice are enormous, with no real relief in sight. The complexity of managing the business of private practice oncology rivals that of managing the complexity of cancer care. With anticipated reductions in total net revenue per clinical treatment protocol per course of care, funds available for providers and their practices will be severely reduced. Only those practices with superlative RVU-based cost and revenue accounting systems will be able to prospectively and efficiently manage their businesses. Clearly, management of the Oncology Practice Econometric Model (OPEM) expense RVU or similar RVU-based data will be required for survival. The purpose of this article is to explore an RVU-based model to analyze the professional, infusion, and therapeutic components of contemporary cancer care.     

Economic impact of harmonizing medical practices: compliance with clinical practice guidelines in the follow-up of breast cancer in a French Comprehensive Cancer Center.

PURPOSE: The introduction of clinical practice guidelines (CPGs) and the increasing desire to harmonize clinical practices draw attention to the economic impact of these trends. In 1994, CPGs were introduced in a French Comprehensive Cancer Center (Centre Régional Léon Bérard, Lyon). We evaluated the application of these CPGs in addition to the consequences of harmonizing clinical practices with respect to the distribution of resources by specifically analyzing the posttherapeutic follow-up of patients with localized breast cancer. METHODS: A before-and-after analysis of the records of patients who received posttherapeutic follow-up for localized breast cancer as of either 1993 or 1995 was performed. Two hundred records were chosen at random, 100 from 1993 and 100 from 1995. Follow-up was continued for as long as possible and CPG compliance was studied for each year of the follow-up periods. RESULTS: Follow-up that was not CPG-compliant required a significantly greater amount of resources. This difference was due to neither consultations nor mammographies, but was due to other examinations that were systematically performed without any warning signs to justify them. Depending on the follow-up year, noncompliant follow-up cost the Social Security from 2.2 to 3.6 times more than compliant follow-up. A noticeable change in medical practices was observed after the introduction of CPGs in 1994. This was confirmed by a sharp decrease in mean Social Security expenditure per patient of more than one third between 1993 and 1995, regardless of the follow-up year considered. CONCLUSION: In the follow-up of patients with localized breast cancer, a large decrease in costs has been observed along with the evolution of medical practices toward CPG compliance. This finding is probably generalizable to other settings, but there is nothing that proves that it is applicable to other treatment strategies.     

Zur Finanzierungsfrage der Versorgungsforschung

For some time now the general conditions of medical care have forced the pace in the discussion on health services research in medical health care. Particularly with regard to medical progress and the financing of the social health care system, clinical studies on effectiveness are no longer effectual. It is more necessary to give answers on questions of additional benefits and effects in the medical health care practice. Therefore health services research must be established as effective, efficient and unbureaucratic. The following article discusses the basic principles and future opinions of financing in health services research.     

Methodological challenges in supportive and palliative care cancer research

As a growing medical field, palliative and supportive care should incorporate evidence-based medical practice. The gold standard research method continues to be the randomized clinical trial. This has been pursued with regard to cancer trials focused on cure. It has specific operational and methodological challenges in advanced disease. There are numerous reasons why effective research in palliative and supportive care is difficult. A consensus on the best research strategies and design is lacking. We will discuss the principles of palliative and supportive care research, examine the inherent challenges particularly in randomized controlled trials, and offer some suggestions to overcome them.     

How to use clinical vignettes in hematology—A pilot survey in the context of chronic lymphocytic leukemia

RationaleCase vignettes have been validated as an efficient tool for assessing the quality of clinical practices, and have been used in a variety of medical settings. However, their use in the field of hematology has not been tested.ObjectivesWe undertook a study to pre-test seven case vignettes, and thereby to assess practice patterns and, when possible, guideline adherence in the treatment of chronic lymphocytic leukemia (CLL) by French hematologists.FindingsOf the 64 hematologists who agreed to participate, 26 (41%) completed the vignettes. We found significant differences in the physicians’ patterns of ordering further investigations among young and old patients in the same clinical context. This is not consistent with published guidelines. Moreover, the most striking differences concerned the physicians’ interpretations of prognostic factors and the use of radiological testing before treatment. Modalities of treatment were variable across clinical situations, especially with regard to second-line treatments. Clinicians understood the vignettes well, except for those that dealt with stem cell transplantation.ConclusionsThis pilot study showed the feasibility of the use of case vignettes to assess the quality of clinical practice in CLL. The initial results identified deviations from the published guidelines. A large-scale European survey will commence in a few months.     

Démarche palliative et prise de décision éthique

The practice of hematology-oncology has become more diverse, complex and democratic to the extent that it is now inconceivable that physicians make decisions in isolation. The long-established practices of multidisciplinary committees have accustomed oncologists to making deci-sions collectively, but medical justifications are still confined to medical and technical logic. Research in clinical ethics carried out in North America has greatly improved the quality of the discussion about difficult cases by welcoming disciplines so far unknown to the medical world, such as theology, law, philosophy and the humanities. But this approach (which few consider specific) does not appear to suit European culture. Finally, assuming the heritage of the pioneers of palliative care in oncology, and with a goal of promoting the participation of a properly trained and supported medical teams open to cross-disciplinary assistance, the palliative approach is the best avenue to take to ensure the conditions needed to make ethical decisions concerning people with cancer.     

Use of radiomics in the radiation oncology setting: Where do we stand and what do we need?

Radiomics is a field that has been growing rapidly for the past ten years in medical imaging and more particularly in oncology where the primary objective is to contribute to personalised and predictive medicine. This short review aimed at providing some insights regarding the potential value of radiomics for cancer patients treated with radiotherapy. Radiomics may contribute to each stage of the patients’ management: diagnosis, planning, treatment monitoring and post-treatment follow-up (toxicity and response). However, its applicability in clinical routine is currently hindered by several factors, including lack of automation, standardisation and harmonisation. A major effort must be carried out to automate the workflow, standardise radiomics good practices and carry out large-scale studies before any transfer to daily clinical practice.     

Growth factor usage patterns and outcomes in the community setting: collection through a practice-based computerized clinical information system.

PURPOSE: Although use of colony-stimulating factor (CSF) is widespread and guidelines for use have been disseminated, actual practice patterns of medical oncologists are unknown. The purpose of this study was to collect these data using an office-based computerized clinical information system. PATIENTS AND METHODS: Data were collected on patients at 10 community-based oncology practices. Information regarding CSF use was captured at the time of prescribing through a computerized clinical support tool and stored in a data warehouse, and an analysis was carried out retrospectively. RESULTS: A total of 6,813 cancer regimens administered to 5,034 patients were evaluated for growth factor use. Overall, CSFs were used in 14% of regimens, with breast, lymphoma, lung, and ovarian being the most common cancers for which CSFs were used. In 49.4% of regimens, CSF was initiated during cycle 1, with an average duration of 1 week, and was used in two or three cycles per regimen. Afebrile neutropenia is rarely followed by CSF initiation. Granulocyte colony-stimulating factor (G-CSF) is associated with fewer dose adjustments, delays, and hospitalizations when compared with granulocyte-macrophage colony stimulating factor (GM-CSF). There is wide variation among oncologists in CSF use, and several substantial differences were noted between the prescribing behavior of American Society of Clinical Oncology (ASCO) survey-reported oncologists and actual clinical practice, as captured by the computerized clinical information system. CONCLUSION: Computerized clinical information systems can collect detailed information regarding practice patterns of medical oncologists. ASCO physician practice survey data do not accurately reflect actual practice patterns and must be interpreted with caution. Substantial deviations from ASCO growth factor guidelines remain, and oncologists' use of CSFs demonstrates wide variation. There may be important clinical differences between G-CSF and GM-CSF, but definitive phase III trials are needed for confirmation.