Medical Affairs Support, Jenapharm GmbH und Co KG 07743, Jena, Germany.
BMC Womens Health. 2012 Aug 20;12:24. doi: 10.1186/1472-6874-12-24.
Abnormal uterine bleeding is often investigated in clinical studies and critical to identify during gynecological consultation. The current standard for quantification of menstrual blood loss is the alkaline-hematin-method. However, this method is expensive and inconvenient for patients. Bleeding diaries, although widely used, provide only qualitative information on menstrual blood loss. Other methods have been developed, but still do not provide reliable quantitative data.
We estimated blood loss volume using data from two clinical studies in women suffering abnormal menstrual bleeding. These estimations were derived from mixed linear models based on diary data, hematological parameters and age. To validate the models, we applied our results to data from a third study with a similar patient population.
The resulting best fitting model uses diary entries on bleeding intensity at a particular day, information on occurrence and frequency of single bleeding intensities in defined time windows, hemoglobin and ferritin values and age of the patient all as predictors of menstrual blood loss volume. Sensitivity and specificity for the diagnosis of excessive bleeding were 87% and 70%, respectively. Our model-based estimates reflect the subjective assessment by physicians and patients in the same way as the measured values do.When applying the model to an independent study, we found a correlation of 0.73 between estimated and measured values for the blood loss in a single day. Further models with reduced number of parameters (simplified for easier practical use) still showed correlation values between 0.69 and 0.73.
We present a method for estimating menstrual blood loss volume in women suffering from prolonged or excessive menstrual bleeding. Our statistical model includes entries from bleeding diaries, laboratory parameters and age and produces results which correlate well with data derived by the alkaline-hematin-method. Therefore, this model may be used to estimate menstrual blood loss volume in both routine gynecological counseling and clinical studies.
异常子宫出血在临床研究中经常被调查，对于妇科咨询中识别这种情况至关重要。目前，月经出血量的定量标准是碱性血红素法。然而，这种方法既昂贵又不方便患者使用。虽然出血日记被广泛使用，但只能提供月经出血量的定性信息。其他方法已经被开发出来，但仍然无法提供可靠的定量数据。
我们使用患有异常月经出血的女性的两项临床研究的数据来估计出血量。这些估计值是基于日记数据、血液学参数和年龄的混合线性模型得出的。为了验证模型，我们将结果应用于具有相似患者群体的第三项研究的数据中。
产生的最佳拟合模型使用特定日子的出血强度日记条目、特定时间窗口内单一出血强度发生和频率的信息、血红蛋白和铁蛋白值以及患者年龄作为月经出血量的预测因子。对于诊断过度出血的敏感性和特异性分别为 87%和 70%。我们的基于模型的估计与医生和患者的主观评估一样，反映了测量值。当将模型应用于独立研究时，我们发现一天内出血量的估计值与测量值之间存在 0.73 的相关性。具有较少参数的进一步模型（简化为更易于实际使用）仍然显示出 0.69 到 0.73 之间的相关值。
我们提出了一种用于估计患有长期或过度月经出血的女性月经出血量的方法。我们的统计模型包括出血日记、实验室参数和年龄的条目，并产生与碱性血红素法得出的数据高度相关的结果。因此，该模型可用于常规妇科咨询和临床研究中估计月经出血量。
