Launched a multicenter prospective collaborative study with four hospitals in Japan, centered on Tokyo Bay Urayasu Ichikawa Medical Center~ Prospective validation of clinical diagnosis and prediction rules using NEXT Stage ER~

TXP Medical Co. Ltd. (headquarter: Bunkyo-ku Tokyo, President: Tomohiro Sonoo, hereinafter "TXP Medical") announces that it has initiated a prospective multicenter study led by Tokyo Bay Urayasu Ichikawa Medical Center (Principal Investigator: Tak Funakoshi, Director, Department of Emergency Intensive Care) to validate clinical prediction rules using the NEXT Stage ER.

【Background】
In clinical practice in the emergency department, the clinical prediction rule (clinical prediction rule) is used to make diagnoses and predictions based on medical history, symptoms, and findings. However, many of the clinical prediction rules were developed overseas, and it is not clear whether the performance of these rules is guaranteed in Japanese emergency departments. Therefore, the purpose of this study is not only to validate these clinical prediction rules in the Japanese emergency department, but also to develop new clinical prediction rules based on the data obtained.

【Initiatives at this time】
We will conduct a prospective validation of clinical prediction rules for minor head and neck trauma in the emergency departments of four hospitals in Japan where our NEXT Stage ER is installed.

< Hospitals participating in this initiative >

• Tokyo Bay Urayasu Ichikawa Medical Center

• Kyoto Prefectural University of Medicine Hospital

• Saiseikai Utsunomiya Hospital

• Hitachi General Hospital

【The Role of TXP Medical】
In conventional electronic medical record systems, medical records are kept in the SOAP field during routine medical care, and all research data collection must be performed manually.

However, the NEXT Stage ER provided by TXP Medical can improve the efficiency of data collection in prospective studies, greatly reducing the burden on the field, and enabling the acquisition of high-quality data, as described below.

1. Next Stage Display an information checklist on the ER to facilitate input. (Centralization of EDC for prospective studies and the media used to describe them during routine medical care)

2. Enables one-click extraction of data entered for clinical information and research purposes.

3. Case reminder function, including automatic screening and alerts for relevant chief complaints and diagnoses.

The NEXT Stage ER also facilitates research by automatically structuring the fluctuations in the notation of chief complaints and disease names, and the validity of this structuring has been reported by the journal Acute Medicine & Surgery（PMID: 32884825）.

【Taku Funakoshi Chief, Department of Emergency and Intensive Care Medicine, Tokyo Bay Urayasu Ichikawa Medical Center】
Minor head and neck trauma in adults is a very common symptom, accounting for about 7% of the chief complaints in emergency department visits (1), although intracranial hemorrhage and cervical spine fractures have been reported in 5%-15% of cases(2,3).

CT imaging is recommended to detect these diseases, but there are no validated guidelines in Japan for determining which patients should be imaged.

On the other hand, the Japanese emergency medical care system does not always have skilled emergency physicians, and even non-specialists are required to judge whether CT imaging is indicated in the field. Despite the fact that it is often difficult for non-specialists to accurately determine indications, no high-quality clinical prediction rules have been developed for minor head and neck trauma in Japan, and many of the clinical prediction rules developed overseas have not been validated.

It is important to consider clinical prediction rules developed overseas in Japan. This is because 1) bleeding and coagulation reactions at the time of trauma differ by race, and 2) Japan has good access to medical facilities and CTs, so results verified overseas cannot be used as is. Therefore, it is unclear whether these existing rules can be generalized in Japan, and verification and application of these rules are necessary to avoid excessive imaging examinations in terms of radiation exposure and medical costs. In addition, existing clinical prediction rules have the following problems: 1) CT imaging is recommended for all patients over 65 or 70 years of age, and 2) patients taking oral antithrombotic drugs are excluded.

The verification of existing rules and the development of new rules will enable physicians, regardless of their expertise, to provide medical care based on highly reliable decision-making criteria for an aging society, thereby minimizing radiation exposure and medical costs while ensuring patient safety.

(Principal investigator: Taku Funakoshi, Member of a research project : Tadahiro Goto)

Reference document
1. Middleton K, Hing E. National Hospital Ambulatory Medical Care Survey: 2003 outpatient department summary. Adv Data. 2005(366):1-36.
2. Stiell IG, Clement CM, McKnight RD, Brison R, Schull MJ, Rowe BH, et al. The Canadian C-spine rule versus the NEXUS low-risk criteria in patients with trauma. N Engl J Med. 2003;349(26):2510-8.
3. Stiell IG, Clement CM, Rowe BH, Schull MJ, Brison R, Cass D, et al. Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury. Jama. 2005;294(12):1511-8.