Days alive and out of hospital a validated patient-centred outcome to be used for patients undergoing transoral robotic surgery: protocol and perspectives

Abstract

Background

Days Alive and Out of Hospital (DAOH) has been validated as a suitable clinical trial outcome. It can be used as a proxy for surgical quality and reflects both procedure specific morbidity and mortality.

Aims/objectives

We propose DAOH as a supplement to established patient-related and objective outcomes, since it adds information on health care burden. Two upcoming studies incorporating DAOH are planned and will report DAOH for patients undergoing transoral robotic surgery.

Methods

Firstly, a multicentre national prospective cohort study investigating DAOH with a 1-year follow-up after TORS is planned. Secondly a retrospective study of DAOH with a 1-year follow-up period will be performed using our institute’s, the largest TORS center in Scandinavia, transoral robotic surgery (TORS) database. The database consists of more than 250 patients with more than 300 procedures performed between 2013 and 2018.

Conclusion and significance

The planned studies of DAOH may, when applied to TORS, contribute to a better interpretation of post-treatment morbidity and provide a basis for further interventional studies to enhance recovery, perioperative optimization, and serve as a comparison tool between treatment modalities.

Chinese abstract

背景：存活并出院的天数（DAOH）已被确认为合适的临床试验结果。它可以用作手术质量的指标, 并反映特定手术的发病率和死亡率。

目的：我们建议DAOH可作为已建立的与患者相关的结果及客观结果的补充, 因为它可以增添有关医疗负担的信息。已计划了两项即将进行的与DAOH相关的研究, 并为经口机器人手术的患者报告DAOH。

方法：首先, 已计划一项多中心国家前瞻性队列研究对DAOH进行调查, 并在TORS之后进行1年的随访。其次, 将进行一项1年随访的DAOH回顾性研究, 该研究使用我们研究所（斯堪的那维亚最大的TORS中心）的经口机器人手术（TORS）数据库。该数据库由250多名患者组成, 他们在2013年至2018年之间接受了300多次手术。

结论和意义：所计划的DAOH研究, 当应用于TORS时, 可能会有助于更好地解释治疗后的发病率, 为进一步的介入治疗打下基础以提高恢复能力和围手术期优化, 并作为治疗死亡率之间的一种比较工具。

Keywords:

• Perioperative medicine
• morbidity
• surgery
• cancer
• postoperative outcomes
• complications

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work is supported by the Candys Foundation under Grant 2019-304 and the Capital Region of Denmark under Grant A6682.