Table 2 Selected studies regarding the informed consent process for trauma patients undergoing a surgical operation

Rossi et al. (2004, UK)

Evaluate the effectiveness of using a videotape to give patients information a common orthopedic procedure

Procedure:

 Ankle fracture fixation

ISS: no description

Conventional group: verbal

Videotape group: video

Timing:

 Immediately after receiving information and an average of 10 weeks later

Methods of evaluation:

 Multiple choice questionnaire

Content of evaluation:

 Procedure

 Benefits

 Risks/complications

 Alternatives

Patients who received information on a videotape demonstrated a significant increase in comprehension compared to patients who received this information verbally by 40.1% on the initial evaluation and 27.2% on the follow-up evaluation. Patients with education level less and equal to the 12th grade performed 67.8% better on initial evaluation after watching the video.

Bhangu et al. (2008, US)

Compare patient recall of the consent process and desire for information between orthopedic trauma and elective patients

Procedure:

 Femoral neck fracture fixation, other trauma operations/elective orthopedic operations

ISS: no description

Elective group: verbal and leaflet

Trauma group: Verbal

Timing:

 First post-operative day

Methods of evaluation:

 Questionnaire

Content of evaluation:

 Procedure

 Risks/complications

 Satisfaction with the consent process

Overall recall of complications was poor in trauma patients than in elective patients (22.4% vs 62.3%); trauma patients desire more information than elective patients (30% vs 12%). Repeated verbal explanation and additional information leaflets should be considered for trauma operation.

Sahin et al. (2010, Turkey)

Evaluate the effectiveness of the consent process and the retention of information in orthopedic patients undergoing trauma and elective surgery

Procedure:

 Fracture fixation/elective orthopedic operations

ISS: no description

Verbal and written information

Timing:

 Post-operative 1–3 days

Methods of evaluation:

 Interview and questionnaire

Content of evaluation:

 Procedure/operation

 Complications

Advanced age had a negative impact and level of education had a positive impact on recall of information. Trauma patients have higher rate of not recalling any potential complications, and most have not read the consent form.

Khan et al. (2012, UK)

Investigate the patient and process factors that influence consent information recall in mentally competent patients presenting with neck of femur fractures.

Procedure:

 Neck of femur fracture group: Femoral neck fracture fixation or hemiarthroplasty

 Total hip replacement group:

Total hip replacement

ISS: no description

Verbal and consent form

Timing:

 First post-operative day

Methods of evaluation:

 formalized questionnaire proforma for semi-structured interview

Content of evaluation:

 Procedure

 Risks

Trauma patients had poor recall of information provided at the time of consent. Twenty-six percent of trauma patients recalled correctly the surgery and 48% recalled the risks and benefits. Pre-printed consent form, information sheet, and visual aids may improve retention and recall.

Smith et al. (2012, UK)

Assess whether written information improves trauma patient’s recall of the risks of surgery

Procedure:

 Upper and lower limb fracture fixation

ISS: no description

Verbal group: verbal

Verbal and written group: Verbal and written

Timing:

 1–17 days (mean 3.2 days)

Methods of evaluation:

 Questionnaire

Content of evaluation:

 Risks

 Satisfaction with the consent process

Risk recall and satisfaction improved when patients receiving written and verbal information compared to verbal information alone. Overall recall of risks was poor in patients receiving oral information only than in patients receiving written and verbal information (mean questionnaire score: 41% vs 64%). Ninety percent of patients preferred to having written and verbal information.

Kim et al. (2018, Korea)

Investigate whether delivery of information through a mobile application is more effective than through only verbal means and a paper

Procedure:

 Close reduction for nasal bone fracture

ISS: no description

Experimental group: a mobile application with verbal descriptions and paper permission

Control group: verbal descriptions and paper permission

Timing:

 follow-up visit 4 weeks later

Methods of evaluation:

 Open question

Content of evaluation:

 Surgical risks

The mean number of recall surgical risks was 1.72 ± 0.52 in the experimental group and 1.49 ± 0.57 in the control group. Age, gender, and level of education had no influence on the number of recall surgical risks. A mobile application could contribute to the efficient delivery of information during the informed consent process.

Experimental

Control

19–29

11 (37.9)

10 (35.7)

30–39

7 (24.1)

8 (28.6)

40–49

6 (20.7)

8 (28.6)

50–59

4 (13.7)

2 (7.1)

> 60

1 (3.4)

0

Lin et al. (2018, Taiwan)

Investigate whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery

Procedure:

 trauma-related debridement surgery

ISS, ISS > 4, %:

 Control group: 23.6

 Intervention group: 18.6

Control group: written

Intervention group: video

Timing:

 Before and immediately after receiving information

Methods of evaluation:

 Multiple choice questionnaire

Content of evaluation:

 Procedure

 Benefits

 Risks/complications

 Alternatives

 Satisfaction with the consent process

Mean knowledge scores were higher in the intervention than in the control group (72.57 ± 16.21 (SD)) vs (61.67 ± 18.39). The intervention group had significantly greater difference in knowledges (coefficient: 7.646, 95% CI: 3.381–11.911). Age, injury severity score, and baseline knowledge score had significantly influence on the differences in knowledge scores. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients.

Control

Intrvention

< 20

2.8

12.9

20–29

31.9

35.7

30–39

23.6

12.9

40–49

16.7

17.1

50–59

18.1

14.3

60–69

2.8

4.3

> 69

4.2

2.9

Clarke et al. (2018, Ireland)

Investigate the effect of a standardized consenting process with patient take-home information sheets on patient information recall

Procedure:

 Wrist manipulation and K-wiring

ISS: no description

Written/written and take-home information sheet

Timing:

 Immediately and 1 day later

Methods of evaluation:

 Questionnaire

Content of evaluation:

 Procedure

 Anesthesia

 Risks

 Alternatives

Baseline scores were low on initial questioning. Information retention after 24-h was significantly decrease (mean, 8.94 versus 7.98), but rose when standardized forms were provided. Significant lower scores were noted among those participants without receiving written information (mean, 9.542 versus 6.449).