Esteva Magdalena, Ramos Maria, Cabeza Elena, Llobera Joan, Ruiz Amador, Pita Salvador, Segura Josep M, Cortes Jose M, Gonzalez-Lujan Luis
Primary Health Care Research Unit, Primary Health Care Mallorca District, Balearic Health Service, Reina Esclaramunda 9, Palma de Mallorca, Spain.
BMC Cancer. 2007 May 21;7:86. doi: 10.1186/1471-2407-7-86.
Colorectal cancer (CRC) is the second most frequent tumor in developed countries. Since survival from CRC depends mostly on disease stage at the time of diagnosis, individuals with symptoms or signs suspicious of CRC should be examined without delay. Many factors, however, intervene between symptom onset and diagnosis. This study was designed to: 1) Describe the diagnostic process of CRC from the onset of first symptoms to diagnosis and treatment. 2) Establish the time interval from initial symptoms to diagnosis and treatment, globally and considering patient's and doctors' delay, with the latter due to family physician and/or hospital services. 3) Identify the factors related to defined types of delay. 4) Assess the concordance between information included in primary health care and hospital clinical records regarding onset of first symptoms.
Descriptive study, coordinated, with 5 participant groups of 5 different Spanish regions (Balearic Islands, Galicia, Catalunya, Aragon and Valencia Health Districts), with a total of 8 acute public hospitals and 140 primary care centers. Incident cases of CRC during the study period, as identified from pathology services at the involved hospitals. A sample size of 896 subjects has been estimated, 150 subjects for each participant group. Information will be collected through patient interviews and primary health care and hospital clinical records. Patient variables will include sociodemographic variables, family history of cancer, symptom perception, and confidence in the family physician; tumor variables will include tumor site, histological type, grade and stage; symptom variables will include date of onset, type and number of symptoms; health system variables will include number of patient contacts with family physician, type and content of the referral, hospital services attending the patient, diagnostic modalities and results; and delay intervals, including global delays and delays attributed to the patient, family physician and hospital.
To obtain a nonrestricted sample of patients with CRC we have minimized selection risk by identifying the patients from pathology services. A greater constraint may be associated with information sources based on clinical records. Due to inherent features of coordinated studies, it is important to standardize the collection of information.
在发达国家，结直肠癌（CRC）是第二常见的肿瘤。由于CRC患者的生存率主要取决于诊断时的疾病阶段，因此出现CRC可疑症状或体征的个体应立即接受检查。然而，从症状出现到诊断之间存在许多干预因素。本研究旨在：1）描述CRC从首次症状出现到诊断及治疗的诊断过程。2）确定从初始症状到诊断及治疗的时间间隔，总体上并考虑患者延迟和医生延迟，后者包括家庭医生和/或医院服务导致的延迟。3）识别与特定类型延迟相关的因素。4）评估初级卫生保健和医院临床记录中关于首次症状出现的信息之间的一致性。
描述性研究，由西班牙5个不同地区（巴利阿里群岛、加利西亚、加泰罗尼亚、阿拉贡和瓦伦西亚卫生区）的5个参与组协调进行，共有8家急性公立医院和140个初级保健中心。通过参与医院的病理服务确定研究期间CRC的新发病例。估计样本量为896名受试者，每个参与组150名受试者。将通过患者访谈以及初级卫生保健和医院临床记录收集信息。患者变量将包括社会人口统计学变量、癌症家族史、症状感知以及对家庭医生的信任度；肿瘤变量将包括肿瘤部位、组织学类型、分级和分期；症状变量将包括发病日期、症状类型和数量；卫生系统变量将包括患者与家庭医生的接触次数、转诊类型和内容、诊治患者的医院服务、诊断方式和结果；以及延迟间隔，包括总体延迟以及归因于患者、家庭医生和医院的延迟。
为了获得CRC患者的无限制样本，我们通过从病理服务中识别患者来最小化选择风险。基于临床记录的信息来源可能存在更大的限制。由于协调研究的固有特点，标准化信息收集非常重要。
