Discusses pitfalls associated with the shift from the old 'paternalistic' model to the current 'informative, patient-centred' model for consent.
Highlights that patients need further education to understand the legalities of the consent process; without this understanding, consent can be invalid.
Aim The purpose of the consent process is to give patients enough information to allow them to make an informed decision and preserve their autonomy. The patient's satisfaction and also their understanding of the consent process are audited only rarely and reports of such audits in dental practice are sparse. Reports from other specialties indicate that patients' understanding of the process is incomplete and often incorrect. We set about to perform such an audit to assess both our patients' satisfaction and their understanding of the consent process itself.
Design A prospective questionnaire study of adults with capacity.
Setting Primary care dental practice.
Design A two-part questionnaire was designed, based on a questionnaire used for a similar purpose in paediatric surgery; the first part assessed the patient's opinion and satisfaction with the consent obtained by their dental professional and the second part assessed their understanding of the consent process in general and the legal issues around it.
Results Part 1 – satisfaction with the consent process. Patients reported high level of satisfaction with the consent process at the practice (near 100% in major factors analysed). Part 2 – Understanding of the consent process. Significant misconceptions were identified: 60% thought that the form was for the protection of the dentist/hospital and 10-16% thought that by signing a consent form they relinquish their rights. A high level of patients' uncertainty (19–27%) was also evident for several of the questions.
Conclusions Although this study shows a very high level of patient satisfaction with the consent process at our dental practice, it also demonstrates very significant deficiencies in the patients' understanding of the consent process itself. This study corroborates the findings of other investigators in different medical disciplines and calls into question the adequacy of the current consent procedures as many patients are still unaware of the legal implications of consent; the majority of patients still do not recognise that the consent process should primarily be serving their interests by allowing them to express their autonomous choice pertaining to their treatment. Education will help reduce this discrepancy and promote a change from the past 'paternalistic' to the current 'informative, patient-centred' model of care.
Introduction – purpose
The healthcare professional–patient relationship has evolved and changed significantly. Originally a paternalistic relationship, with the dentist/doctor directing and almost dictating treatment, it has evolved through deliberative, interpretive and informative models,1 resulting in more of a relationship between the parties thus helping patients take informed decisions about their treatment;1,2,3,4 a recent supreme court ruling unquestionably moves the legal framework of 'consent' away from the old paternalistic model and firmly establishes the current patient-centred informed consent model.5 The purpose of the consent process is to give patients enough information to allow them to make an informed decision and preserve their autonomy. Patient consent should be obtained before every medical/dental procedure. Indeed, professional regulatory bodies and other professional organisations issue regularly updated detailed guidance on the process.6 The mainstay of informed consent is a continuing process whereby the patient is given enough information to allow them to take a decision voluntarily and without coercion. They need to be given explanations (in appropriate language and terminology) to allow them to understand the nature of their condition, the nature of the proposed treatment and other alternatives, their benefits and the risks, and also the consequences if no action is taken. It must also be ensured that the patient has the capacity to consent. In the current context, the patient needs to know whether they are treated under the NHS or privately, they need to have a statement of the costs involved and, where treatment will be on-going, a clear treatment plan.
The patient's satisfaction and also their understanding of the consent process are audited only rarely and reports of such audits in dental practice are sparse.4,7,8 Reports from other specialties (obstetrics and gynaecology9 and paediatric surgery10) also indicate that patients'/guardians' understanding of the process is incomplete and often incorrect. We set about to perform such an audit at Smile Dental Care to assess both our patients' satisfaction and their own understanding of the consent process itself.
The study took place in a primary care dental practice.
The audit was carried out via prospective questionnaire study with a sample of 52 adult patients with capacity (similar number included in another published study in a UK Dental Hospital setting8). A two-part questionnaire was designed for this audit (see Appendix 1) based on a validated questionnaire used for a similar purpose in paediatric surgery.10 The first part of our questionnaire detailed the patient's opinion and satisfaction with the consent obtained by their dental professional. The second part assessed the patient's own understanding of the consent process in general and the legal issues around it. Patients presenting at the practice during a 2-week period were included in the study.
The questionnaires of all 52 patients attending the dentist during the study period were valid and are included in the analysis. Forty patients (75.5%) identified themselves on the form and 37 stated the name of their dentist (70%). Forty-four patients (83%) reported that they gave verbal consent.
Part 1: Satisfaction with the consent process
Patients reported high level of satisfaction at the practice: satisfaction with the consent process and seniority of the dentist were both 100% (Table 1). Furthermore, they reported that even when they were having no procedure performed (for example, a check-up examination) explanation was still given; 55% felt that a leaflet (standard leaflets provided by the British Dental Association) would not be necessary to complement the explanations offered (Table 1). The breakdown of the procedures performed appears in Table 2.
Part 2: Understanding of the consent process
Ninety-six percent of patients believed that the consent form gave permission to the dentist to perform the procedure and 84% felt that it confirmed that enough information was given to help the patient decide for themselves. Sixty percent thought that the form was for the protection of the dentist/hospital. Ten percent felt that they could not ask any further questions and 16% that they would not be able to claim compensation for mishaps after the form was signed. A high level of patient uncertainty was evident for several of the questions (19–27% replied: 'not known' – Table 3).
Discussion – summary
Although this study shows a very high level of patient satisfaction with the consent process at our dental practice (overall satisfaction with the consent process and seniority of the dentist were both 100%), it also demonstrates very significant deficiencies in the patients' understanding of the consent process itself.
Our study only included adult patients with capacity. Special considerations apply for children and individuals with incapacity. The legal issues in these cases are complex and expert advice is usually necessary;2,11 these are not within the scope of this study and would warrant further specific research.
Whichever of the models of patient–dentist/doctor relationships is correct,1 the consent process is designed to preserve patient autonomy and, correctly applied, it not only safeguards patients' interests but also helps reduce uncertainty, disputes and litigation. The recent determination by the Supreme Court5 not only firmly established the 'patient-centred–informed consent' model as the mainstay of the consent process, it also has several other far reaching implications and important repercussions for health-related litigation. The Supreme Court has determined that the duty to advise a patient about risks is to be based on what the 'reasonable patient' would expect to be told and this would be determined by the Court and not by experts in the field. Although this determination pertained to a claim for medical negligence, it would apply to dental practice as well. In practical terms, healthcare professionals need to ensure that their patients are fully informed about risks and alternatives in relation to proposed treatment, and that discussions and agreements are fully documented in the health records. Therefore, it would no longer be the medical/dental profession alone that would determine what a patient should be told for the purposes of a litigation claim.
Two studies assessing patient perception of the dental consent process in a university setting7,8 demonstrated shortfalls in the understanding of the consent process in addition to complaints ranging from uncertainty to deceit.8 Interestingly, and perhaps counterintuitively, the level of uncertainty was proportional to the education level of the patients:7 the most highly educated individuals being more critical and inquisitive probably identified more areas of uncertainty in the consent process. Another study presented the difficulties with research in consent for simple dental implants in primary care.4 The authors of that study highlighted the difficulties in engaging other practitioners in questionnaire studies and reported that their questionnaire was not intended for statistical analysis.4 Previous studies in other specialties have shown that many patients are unaware that the consent process safeguards their interests and had the misconception that it is designed to protect the hospitals, clinics and practitioners.9,10 One study in obstetrics and gynaecology has shown that patients had limited understanding of the legal standing of written consent: 46% believed the primary function of consent forms was to protect hospitals and 68% thought consent forms allowed doctors to assume control; only 41% of patients believed consent forms made their wishes known.9 Similar results were reported in a paediatric surgical setting: 51% of the patients thought consent was to protect the hospitals and 23% believed that by signing the form they relinquished their right to claim compensation if complications arose.10 Such findings are also reflected in our study in primary dental care: 60% of dental patients thought the consent process was to protect the hospital/practice and 10–16% thought they were relinquishing their right to claim compensation. In addition, 44% erroneously thought signing a consent form was a legal necessity. To our knowledge this is the first study systematically auditing both satisfaction and understanding of the consent process in primary dental care.
In conclusion, this study corroborates the findings of other investigators in different medical disciplines and dental settings and calls into question the adequacy of the current consent procedures as many patients are still unaware of the legal implications of consent. Indeed, the majority of patients still do not recognise that the consent process should primarily be serving their own interests by allowing them to express their autonomous choice pertaining to their treatment.
Education will help reduce this discrepancy and promote a change from the past 'paternalistic' to the current 'informative, patient-centred' model of care.
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Hajivassiliou, E., Hajivassiliou, C. Informed consent in primary dental care: patients' understanding and satisfaction with the consent process. Br Dent J 219, 221–224 (2015). https://doi.org/10.1038/sj.bdj.2015.687