OJAI, California (EGMN) – In a prospective study of 778 patients undergoing surgery for non–small cell lung cancer, investigators found no significant relationships between any of 53 health care benchmarks and mortality.
The investigators did, however, find an association between 10 critical benchmarks and morbidity, said Dr. Robert J. Cerfolio at the annual meeting of the Western Thoracic Surgical Association.
“It appears that the quality of the patient is a better predictor of outcomes than ... the quality of the health care provider,” said Dr. Cerfolio of the University of Alabama at Birmingham. Dr. Cerfolio conducted the study along with Dr. Ayesha S. Bryant, also from the university.
In performing the study, the investigators first developed a list of 53 facets of optimal patient care that might be expected to affect outcomes in patients undergoing surgery for non–small cell lung cancer (NSCLC).
They identified 14 preoperative benchmarks, 8 day-of-surgery benchmarks, 18 intraoperative benchmarks, and 13 postoperative benchmarks. Within those, they designated 10 “critical” benchmarks – those that appeared necessary for a good outcome.
Among the critical benchmarks were enrolling the patient in a cardiopulmonary rehab program at home prior to surgery, performing the lobectomy in less than 100 minutes, losing less than 125 mL of blood during the operation, and discharge by postoperative day 4.
The 778 patients ranged in age from 19 to 86 years and received their operations between 2007 and 2009. Physicians performed a lobectomy or bi-lobectomy on 64% of the patients, sublobar resection on 34%, and pneumonectomy on 2%. Among the patients, 15% had diabetes mellitus, 21% had coronary artery disease, and 35% had a smoking history of at least 20 pack-years.
The health care team met 99.8% of the day-of-surgery benchmarks, 96.8% of the intraoperative benchmarks, 94% of the postoperative benchmarks, and 90.5% of the preoperative benchmarks. Of the critical benchmarks, 89% of the patients received all 10 and 98% got 9 of the 10. But only 60% of the patients received all 53 of the benchmarks, a result that Dr. Cerfolio described as disappointing and embarrassing.
About 2% of the patients died, 9.25% experienced major morbidity, and the overall morbidity rate was 27%.
In a univariate analysis the investigators identified six patient characteristics associated with mortality, including an age above 67 years, the type of resection, and forced expiratory volume in one second (FEV1) greater than 78%. But in a multivariate analysis that controlled for numerous potential confounders, only two factors remain statistically significant: Whether the patient was a smoker and whether he or she had coronary artery disease.
The researchers identified 11 different factors with a univariate relationship to major morbidity, but the only ones that were statistically significant in the multivariate analysis were age, smoking status, coronary artery disease, and whether the healthcare team delivered all 10 critical benchmarks.
Similarly, 11 factors had a significant univariate relationship with overall mortality, but only four of them remained statistically significant in the multivariate analysis. They were: age greater than 67, smoking status, type of pulmonary resection, and meeting all 10 critical benchmarks.
Dr. Cerfolio noted some limitations of this study. For one thing, the investigators developed the 53 benchmarks subjectively, and some of the benchmarks were nothing more than surrogates for good outcomes, such as “avoid ICU admission,” or “go home by postoperative day 4.” In addition, the study was relatively small, and it was conducted at a single institution.
Dr. Cerfolio said that he undertook the study in part to evaluate whether “pay-for-performance” seemed to be appropriate in treating patients requiring surgery for NSCLC. “In this very small study the concept of pay for performance is unsupported,” he concluded.
Dr. Cerfolio serves as a consultant for Deknatel, Closure Medical Corp., and Neomend Inc., and as a speaker for E Plus Healthcare LLC¸ Medela, Ethicon, Covidien, OSI Systems Inc., Precision Medical Inc., and DaVinci Medical Group.
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加利福尼亚州奥哈伊(EGMN)——在一项纳入778例因非小细胞肺癌而接受手术治疗患者的前瞻性研究中，研究者发现，患者的死亡率与53项医疗保健基准指标中的任意一项均无显著关联。
Robert J. Cerfolio博士在美国西部胸外科协会年会上发言说，然而，这些研究者们确实发现患者患病率和10项关键基准指标之间存在关联。
阿拉巴马大学伯明翰分校的Cerfolio博士说：“在预测患者的临床转归方面，患者自身的特征似乎是比……医务人员素质更好的指标”。Cerfolio博士与来自同所大学的Ayesha S. Bryant博士一起开展了该研究。
在该研究的实施过程中，研究者首先列出了一份清单，其中包括对患者进行最优护理的53个方面，据研究者预计，这些指标有可能影响因非小细胞肺癌(NSCLC) 而接受手术治疗患者的临床转归。
他们确认了14项术前基准指标，8项手术当日的基准指标，18项术中基准指标和13项术后基准指标。在这些基准指标的基础上，研究者最终选定了10项“关键的”基准指标——即为了保证患者良好临床转归所必需的那些基准指标。
在确定这些关键基准指标的同时，研究者正从某个心肺康复项目中招募患者，其纳入标准是：手术前未入院治疗，肺叶切除术耗时<100 min，术中失血<125 ml，且在术后第4天便被允许出院。
该项目的778例患者年龄介于19~86岁之间，且均在2007~2009年间接受了手术。医生对其中64%的患者进行了单侧肺叶切除术或双侧肺叶切除术，对其中34%的患者进行了肺段切除术，还对其中2%的患者进行了全肺切除术。在这些患者中，15%患有糖尿病，21%患有冠状动脉疾病，还有35%的患者存在至少20包·年的吸烟史。
该医疗团队达到了99.8%的手术当日基准指标、96.8%的术中基准指标、94%的术后基准指标和90.5%的术前基准指标。有89%的患者达到了全部10项关键基准指标，98%的患者达到了9/10项关键基准指标。但是仅有60%的患者达到了全部53项基准指标，Cerfolio博士在描述该结果时称其令人失望且尴尬。
有大约2%的患者死亡，有9.25%的患者出现了重大疾病，患者的总体发病率为27%。
研究者通过单因素分析确定了6项与死亡率相关的患者特征，其中包括年龄>67岁，所接受切除术的类型和第1秒用力呼气容积(FEV1)>78%。但是在研究者对众多潜在混淆因素进行校正后的多因素分析中，仅有2种因素仍然具有统计学显著性：即患者是否为吸烟者和他(或她)是否存在冠状动脉疾病。
通过单因素分析研究者确认了11种与重大疾病发病存在关系的不同因素，但经多因素分析后，其中仍具有统计学显著性的因素仅剩下年龄、吸烟状况、冠状动脉疾病和医疗团队是否实现了全部10项关键基准指标。
类似的，研究者通过单因素分析发现，有11项因素与患者总体死亡率存在显著关系，但经多因素分析后其中仅有4项还具统计学显著性。这些因素是年龄>67岁、吸烟状况、肺切除术的类型和达成全部10项基准指标。
Cerfolio博士指出该研究存在某些局限性。首先，研究者依据自身的主观判断制定了这53项基准指标，其中某些基准指标只不过是良好临床转归的替代指标罢了，譬如“避免入住重症监护病房(ICU)”或“术后4天返家”。此外，该研究的规模相对较小，且其试验地点局限于单个医疗机构。
Cerfolio博士说他开展此项研究的部分目的在于评估在对那些需要接受手术的NSCLC患者进行治疗时“按绩效付酬”是否恰当。他总结说：“这项规模极小研究的结果不支持按绩效付酬这一观念”。
Cerfolio博士在Deknatel、Closure Medical公司和Neomend公司担任顾问一职，他同时还担任E Plus医疗保健有限责任公司、美德乐公司、爱惜康公司、Covidien公司、OSI Systems公司、Precision Medical公司和DaVinci医疗集团的演讲者。
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