新工具使临床试验中的患者更容易报告副作用

总结

癌症专家越来越认识到测量患者'的重要性；临床试验期间的生活质量，调查人员正在寻找新的方法来评估他们的经验科学的副作用。MSK等研究人员已经开发出一种新的问卷，准确地测量这些症状，增加患者将他们的医疗保健团队报告的可能性。

集锦 以往的研究发现，在临床试验中的副作用被低估。 一个新的问卷部分由研究人员要求患者对MSK的副作用问题的直接。 这些问题包括疼痛、疲劳、恶心和皮肤问题。 患者在与他们的医生和护士见面之前填写调查表。

临床试验的主要作用是测量新的癌症疗法是否会缩小或控制肿瘤。但越来越多的癌症专家承认患者'的重要性；生活质量，调查人员正在寻找方法来更科学地评价治疗的副作用。

&ldquo；在过去的十年中，我们已经越来越认识到，我们作为临床医生在发现一些症状的患者，&rdquo；解释了伊森豹驰，医疗肿瘤学家和健康结果的研究。&ldquo；在临床试验中，这可能意味着对患者副作用的负担被低估。因此，当我们去评估一个新的治疗的风险和益处，我们往往低估了风险。”；

以前的研究已经表明，副作用少报发生的各种原因。患者可能会集中在竞争的问题，如测试结果，在与他们的医疗团队的任命，并可能也不愿意分享他们的症状。医生也可能不完全记录病人告诉他们什么。

有些癌症患者可能会不愿意与他们的医疗团队讨论他们的副作用。

现在一组由美国国家癌症研究所（NCI）和由Memorial Sloan-Kettering癌症中心的研究人员和其他一些已经开发了一个用于测量患者是有效的系统；在临床试验经验。该集团最近发布的工具'的分析；在杂志的效果JAMA肿瘤学。

验证新系统

The questionnaire — called the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events, or PRO-CTCAE — asks patients 124 questions about 78 potential side effects, such as pain, fatigue, nausea, and skin problems。 In the study, about 1,000 patients filled out the questionnaire once a week while they were in active treatment。

“The largest stakeholder in clinical research is the patient,” says Thomas Atkinson, head of the Behavioral Research Methods Core Facility at MSK and one of the study’s authors。 “When we developed the questionnaire we worked with patients to determine which side effects they were able to measure and to develop simple, patient-friendly language that would allow us to capture these symptoms。”

The largest stakeholder in clinical research is the patient。 Thomas Atkinson outcomes researcher

The patients filled out the questionnaire before each of their appointments, including when they were seen for follow-up care。 The researchers compared those results against already established ways to measure symptoms, including reports from clinicians, data on the characteristics of the patients’ tumors and treatments, and prescription information。

Statistical analysis comparing the information found that the PRO-CTCAE was accurate when compared with standard measurement tools。 Researchers believe the tool also will greatly increase the likelihood that side effects will be conveyed to clinicians。

“A study that assesses this many symptoms is really unprecedented,” says Dr。 Basch, an outcomes researcher at MSK who is also affiliated with the Lineberger Cancer Center at the University of North Carolina and is the study’s senior author。 “The fact that we were able to validate 124 items is a methodological breakthrough in many ways。”

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测量病人的经验

“Patients who take part in clinical trials are active partners in the work and are very enthusiastic about participating in different aspects of research,” Dr。 Basch adds。 “The majority of patients who participated in this study and regularly filled out the questionnaire said that they found it valuable and that it helped them to have better discussions with their doctors and nurses。”

Patients who take part in clinical trials are [our] active partners。 伊森豹驰 肿瘤和预后研究

Both researchers explain that once the new tool is adopted by the NCI, they expect it will be integrated into the clinical trials that the institute funds。

“This tool will impact clinical decision-making and may potentially influence which drugs are approved,” Dr。 Atkinson says。 “There may be situations where patients are expected to tolerate a treatment, yet they consistently report side effects that are severe enough to stop the treatment。 On the flip side, there may be a drug that clinicians expect will be too toxic for patients to continue, and yet the patients report few or no side effects。”

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