D'Amico Gennaro, Malizia Giuseppe, D'Amico Mario
Gastroenterology Unit, V Cervello Hospital, Ospedale V. Cervello, Via Trabucco 180, Palermo, Italy.
Radiology Section, DIBIMED. University of Palermo, Via del Vespro 129, 90127, Palermo, Italy.
Intern Emerg Med. 2016 Mar;11(2):251-60. doi: 10.1007/s11739-016-1404-z. Epub 2016 Feb 24.
The interest in prognosis research has been steadily growing during the past few decades because of its impact on clinical decision making. However, since the methodology of prognosis research is still incompletely defined, the quality of published prognosis studies is largely unsatisfactory. Seven major domain for risk of bias in prognosis research have been identified, including study participation, attrition, selection of candidate predictors, outcome definition, confounding factors, analysis, and interpretation of results. The methodology for performing prognostic studies is currently aimed at avoiding such potential biases. Amongst methodologic requirements in prognosis research, the following should be considered most relevant: beforehand publication of the study protocol including the full statistical plan; inclusion of patients at a similar point along the course of the disease; rationale and biological plausibility of candidate predictors; complete information; control of overfitting and underfitting; adequate data handling and analysis; publication of the original data. Validation and analysis of the impact that prediction models have on patient management, are key steps for translation of prognosis research into clinical practice. Finally, transparent reporting of prognostic studies is essential for assessing reliability, applicability and generalizability of study results, and recommendations are now available for this aim.
在过去几十年中，由于预后研究对临床决策的影响，人们对其的兴趣一直在稳步增长。然而，由于预后研究的方法仍未完全确定，已发表的预后研究质量在很大程度上不能令人满意。已确定了预后研究中偏倚风险的七个主要领域，包括研究参与、失访、候选预测因素的选择、结局定义、混杂因素、分析以及结果的解释。目前进行预后研究的方法旨在避免此类潜在偏倚。在预后研究的方法学要求中，以下几点应被视为最相关的：事先发表包括完整统计计划的研究方案；纳入疾病进程中处于相似阶段的患者；候选预测因素的合理性和生物学似然性；完整信息；控制过度拟合和欠拟合；充分的数据处理和分析；原始数据的发表。预测模型对患者管理影响的验证和分析，是将预后研究转化为临床实践的关键步骤。最后，预后研究的透明报告对于评估研究结果的可靠性、适用性和可推广性至关重要，目前已有针对此目的的建议。
