Abraham Ned S, Hewett Peter, Young Jane M, Solomon Michael J
The Faculty of Medicine, Coffs Harbour Health Campus, The University of New South Wales, Coffs Harbour, New South Wales, Australia.
ANZ J Surg. 2006 Sep;76(9):825-9. doi: 10.1111/j.1445-2197.2006.03878.x.
There is currently a need to assess the reasons for non-entry of eligible patients into surgical randomized controlled trials to determine measures to improve the low recruitment rates in such trials.
Reasons for non-entry of all eligible patients not recruited into the Australasian Laparoscopic Colon Cancer Study were prospectively recorded using a survey completed by the participating surgeons for a period of 6 months.
In the 6-month period of the study, 51 (45%) out of 113 eligible patients examined by the 18 actively participating surgeons were recruited into the trial. Eighty-nine reasons were recorded for the non-entry of the 62 eligible patients. The most commonly recorded reason was preference for one form of surgery (42%) or the surgeon (31%) by the patient (45 patients (73%) in total). This was followed by lack of time (10 patients (16%)), hospital accreditation (7 patients (11%)) or staffing/equipment (6 patients (10%)). Concern about the doctor-patient relationship or causing the patient anxiety was recorded for three (5%) and two (3%) patients, respectively. Recruitment was positively associated with the availability of a data manager (chi2 = 19.91; P < 0.001, odds ratio (95% confidence interval) = 9.50 (3.53-25.53)) and negatively associated with an increased caseload (more than five eligible patients seen by the surgeon in the study period) (continuity adjusted chi2 = 16.052; P < 0.001, odds ratio (95% confidence interval) = 0.11(0.04-0.30)).
Having a preference for one form of surgery by the patient or the surgeon was the most common reason for non-entry of eligible patients in the Australasian Laparoscopic Colon Cancer Study. Concern about the doctor-patient relationship played a minimal role in determining the outcome of recruitment. Patient and surgeon preferences, caseload and the distribution of supportive staff such as data managers according to patient population density should be considered in the planning of future trials.
目前需要评估符合条件的患者未纳入手术随机对照试验的原因，以确定提高此类试验低招募率的措施。
使用参与研究的外科医生填写的一份为期6个月的调查问卷，前瞻性记录所有未被纳入澳大利亚腹腔镜结肠癌研究的符合条件患者未被纳入的原因。
在研究的6个月期间，18名积极参与的外科医生检查的113名符合条件的患者中有51名（45%）被纳入试验。记录了62名符合条件患者未被纳入的89个原因。最常记录的原因是患者（总共45名患者（73%））偏爱某种手术方式（42%）或外科医生（31%）。其次是时间不足（10名患者（16%））、医院认证（7名患者（11%））或人员配备/设备（6名患者（10%））。分别有3名（5%）和2名（3%）患者表示担心医患关系或给患者造成焦虑。招募与数据管理员的可用性呈正相关（χ2 = 19.91；P < 0.001，优势比（95%置信区间） = 9.50（3.53 - 25.53）），与病例量增加呈负相关（研究期间外科医生看过的符合条件患者超过5名）（连续性校正χ2 = 16.052；P < 0.001，优势比（95%置信区间） = 0.11（0.04 - 0.30））。
患者或外科医生偏爱某种手术方式是澳大利亚腹腔镜结肠癌研究中符合条件的患者未被纳入的最常见原因。担心医患关系在决定招募结果中起的作用最小。在未来试验的规划中，应考虑患者和外科医生的偏好、病例量以及根据患者人群密度分配数据管理员等支持人员。
