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Completed

NCT Number: NCT05760859

Quality of Medical History Taking and Diagnostic Accuracy

This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy

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Key information

Conditions

Diagnostic Error Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

About this study

Diagnostic errors are a relevant health-care problem. As medical history taking is usually the first step in a patient's assessment its quality is most likely a first and important barrier against diagnostic errors. There are, however, only limited data on the association of the quality of medical history taking and diagnostic accuracy.This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy. 198 medical students (135 females) were given the task to assess a patient presenting with simulated acute pulmonary embolism. Participants were randomized to six versions of the scenario differing only in the initial cues, i.e. in the reply of the patient to the initial question about the reason for his visit. In three of six versions, initial cues were restricted to thoracic symptoms (chest pain, dyspnoea, or combination of both). In the remaining three versions, initial cues consisted of thoracic and extra-thoracic (leg pain, immobilization) symptoms. The primary outcome was diagnostic accuracy. The mannequin was equipped with a speaker in its head that broadcasts the voice of a remote operator (experienced physician) allowing verbal interaction of the participants with the "patient". The "patient" did not speak unless asked and responded to all participants' questions during history taking according to a pre-defined checklist.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4th year medical students participating in voluntary simulator-based workshops

Exclusion criteria

  • decline to give written informed consent

Treatment and study plan

Initial cue

Other

Symptom volunteered by the "patient"

Primary outcomes

  1. Stating the correct diagnosis

    Time frame: 5 minutes

    At the end of the study time (5 minutes), a study physician enters the simulator room and asks the participate on his/her presumptive diagnosis. Simualtions are video-taped and the analysis of the outcome is performed by trained observers by video analysis. "Stating the correct diagnosis" is a binary outcome, rated either as "yes" (correct presumptive diagnosis of pulmonary embolism is stated) or "no" (correct presumptive diagnosis of pulmonary embolism is NOT stated).

Secondary outcomes

  1. Depth of history taking

    Time frame: 5 minutes

    Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. Questions were categorized in six pre-defined categories (chest pain, dyspnoea,associated symptoms, risk factors for pulmonary embolism,cardiovascular risk factors, personal history). Depth of information gathering is assessed for each category separately and is defined as the total number of questions asked in any given category.

  2. Breadth of history taking

    Time frame: 5 minutes

    Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. The three problem areas chest pain, dyspnea, and leg pain or leg swelling were defined à priori as relevant. Breadth of information gathering is defined as number of relevant problem areas identified (possible range from 0 to 3).

  3. Systematics of history taking

    Time frame: 5 minutes

    Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. Questions were categorized in six pre-defined categories (chest pain, dyspnoea,associated symptoms, risk factors for pulmonary embolism,cardiovascular risk factors, personal history). All questions will be rated as either "systematic question" or "non-systematic question". A systematic questions is defined as question, that is either immediately preceded or immediately followed by a question of the same category. "Systematic questions" will be expressed as percentage of all questions asked during history taking (possible range 0% to 100%)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Effects of Initial Cues and the Quality of Medical History Taking on Diagnostic Accuracy

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2023
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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