Table 2 Final list of outcome domains and accompanying explanatory text for Round 1 of Delphi survey
Outcome | Category | Domain name | Help text |
|---|---|---|---|
1 | Knowledge | Measured patient knowledge | Assessment of patient knowledge that they have gained through the consent process. This might involve a written or spoken survey undertaken by another researcher not involved in the consent process |
2 | Knowledge | Self-rated patient knowledge | For example, asking patients how well informed they feel as a result of this consent process? This might be rated on a scale from 10–1. Where 10 is very well informed and 1 is not informed at all |
3 | Knowledge | Clinician rated patient knowledge | Clinician (E.g. Doctor) rating of patient knowledge obtained through the consent process. This would be rated by the clinician undertaking the consent process. This might be rated on a scale from 10 – 1. Where 10 is very well informed and 1 is not informed at all |
4 | Knowledge | Patient rated clinician knowledge | Patient rating of the clinician’s (E.g. Doctor) level of knowledge during the consent process |
5 | Knowledge | Self-rated clinician knowledge | Clinician (E.g. Doctor) rating of their own knowledge and their ability to answer patient questions during the consent process |
6 | Knowledge | Patient desire for extra information after the consent discussion | Patient desire for extra information after the consent discussion. For example, searching for info on the internet or speaking with friends and family who have had a similar procedure |
7 | Knowledge | Patient rated satisfaction with the quality and amount of information disclosed during the consent process | Patient rated satisfaction with the quality and amount of information disclosed during the consent process |
8 | Decision making | Patient feeling that there was a choice in the consent process | Patient rating of whether they felt they had a choice in the consent process or were aware of alternative options. For example, the choice between surgery and no surgery or a choice between different surgical options |
9 | Decision making | Confidence in the decision made | Patient rated confidence in their decision to consent or not to consent to the procedure |
10 | Decision making | Patient rated feeling that the decision to consent or not to the procedure was their own | Patient rated feeling that the decision to consent or not to the procedure was their own |
11 | Decision making | Patient rating of the influence other people have on their decision to consent. For example, family, friends, other health care workers or other patients | Patient rating of the influence other people have on their decision to consent. For example, family, friends, other health care workers or other patients |
12 | Communication | Satisfaction with communication | Patient rating of their satisfaction with the quality of communication in the consent process. This communication may be oral, written or audio-visual |
13 | Communication | External rating of communication | This means another researcher observing the consent process and scoring the quality of communication. This could be by direct observation or by watching a video of the consent discussion |
14 | Trust | Trust in the clinician | Patient rated level of trust in the clinician guiding them through the consent process |
15 | Trust | Trust in the hospital | Patient rated trust in the hospital the patient is being treated in |
16 | Trust | Trust in medicine | Patient rated trust in the science and profession of healthcare |
17 | Process | Time | This means the total length of time that it takes to complete the informed consent process. This might be measured in terms of minutes or hours |
18 | Process | Adequacy of time for consent | Patient rated feeling that the length of time for the consent process was neither too rushed nor too long |
19 | Process | Number of consultations | Number of separate consultations undertaken as part of the consent process |
20 | Process | Time between consent process and the procedure | How long before the proposed procedure was the consent process conducted |
21 | Process | Presence of friend or relative | Was a friend, relative or other trusted person present with the patient during the consent process |
22 | Process | Was the consent process conducted in an emergency situation or in a planned (elective) setting | Was the consent process conducted in an emergency situation or in a planned (elective) setting |
23 | Process | Consent technique | How the consent process was conducted. For example, did it involve a face-to-face discussion, patient information leaflets, audio-visual aids or other techniques |
24 | Process | Patient satisfaction with consent process | Patient rated satisfaction with the consent process. This includes the situation for the consent consultation (For example, emergency vs. elective), the timing of the discussion, the number of consultations and the techniques used to undertake the consent process |
25 | Process | Clinician satisfaction with the consent process | Clinician rated satisfaction with the process used to undertake consent |
26 | Patient characteristics | Age | Patient age |
27 | Patient characteristics | Intelligence | For example, IQ or asking patients about their level of education |
28 | Patient characteristics | Previous experiences of healthcare | Prior experience of surgery and healthcare |
29 | Patient characteristics | Motivation for surgery | Patient motivation for procedure. Patient preference for a particular procedure before the consent process begins |
30 | Patient characteristics | Physical state | Assessment of a patient’s physical state which may impact on their ability to consent. For example, level of pain at the time of consent |
31 | Patient characteristics | Emotional State | Assessment of a patient’s emotional state which may impact on their ability to consent. For example, anxiety level at the time of the consent |
32 | Patient characteristics | Decision making style | Patient desire to be involved in the decision-making process. For example, happy for others to make decisions on their behalf or want to be in control of all the decisions related to their health care |
33 | Patient characteristics | Desire for information | Some patients like to have a lot of information. Other patients may not want any information related to their healthcare |
34 | Patient characteristics | Diagnosis | The medical problem that the patient is being treated for. For example, cancer or benign conditions |
35 | Patient characteristics | Risk Perception and Risk-Taking Behaviour | The level of risk the patient perceives the procedure to involve. Patient attitude to taking risks in general |
36 | Patient characteristics | Patient rating of how important they think the consent process is. For example, does the patient feel it is simply a box ticking exercise? | Patient rating of how important they think the consent process is. For example, does the patient feel it is simply a box ticking exercise? |