THE CLINICAL GOVERNANCE OF CONSENT ANDREW TOY Prim Dent J. 2015;4(1):26-29
Introduction Quality management of consent within our practice comes with a unique set of challenges. In simple terms, a patient can provide valid consent to a procedure if they have enough knowledge about it and the alternative options; enough time to consider them and, crucially, enough understanding to make a reasonable decision.1 How do we measure the quality of consent? We don’t have defined, physical parameters such as the time, temperature and pressure of an autoclave during instrument decontamination. High quality consent is patient-specific – each set of clinical, medical and social circumstances being unique to them. The type of consent also depends on the procedure, with more risky treatments needing a different approach to the simple and straightforward. The patient can also withdraw consent at any time, too, so it is a complex and indefinite area of practice. That does not mean we can’t apply our clinical governance principles to consent, though. This article assumes that we need to be most concerned about those procedures that carry the greatest risk. This means complex, expensive and/or time-consuming treatments such as surgical, complex restorative and cosmetic treatments.
Structure, process and outcome One way of looking at these issues surrounding consent is to apply the structure, process and outcome framework.2 Briefly, your practice’s ‘consent structure’ could be regarded as the resources available; such as your website, any documentation or leaflets, audio-visual aids, a treatment coordinator or consultation area. The ‘consent process’ would be the way those resources are
TA B L E 1
EVIDENCE OF CONSENT Structure (The resources available to support high quality consent)
Process (How the resources are applied)
Possible evidence • Comprehensive information available online/offline in a form that patients can understand. • Comprehensive examination procedure in place (including assessment of dental, medical and social needs). • Written treatment plan templates that can be customised to the specific patient and include details such as the nature of the procedure and its material risks, alternatives available, the cost and time involved. • Treatment procedures provide an opportunity for the patient to withdraw consent. • Team members trained to understand and deliver consent. • A suitable environment (such as a consultation room). •
•
•
AUTHOR
Andrew Toy BDS, MFGDP(UK), MMedSci (Clinical Education) General dental practitioner, and chief executive officer of The Dental Business Academy
26
used to assist the patient in making their decision. The ‘consent outcome’ is obviously what happens as a result of the process – the consent obtained would be either ‘valid’ or ‘invalid’. The inference is that the quality of the outcome is influenced by the quality of the structure and process – which is probably true as long as one understands that it is unlikely to be a direct, linear relationship. We are talking about human understanding, after all.
Outcome • (The difference made by the application of the structure and the resources)
Records to show the practice follows its comprehensive examination procedure and effectively assesses the patient’s dental, medical and social needs. Records to show the patient is provided with information in verbal/written/visual form to enable them to gain knowledge about the procedure (and alternatives) in a way they can understand – including material risks (such as provision of leaflets, treatment coordinator consultations, written treatment plans). Records to show the patient is given sufficient time to make a decision about the treatment. Evidence of understanding is difficult to record: • Written agreement to treatment, signed and dated? • Patient provides the correct answers on a pre-treatment questionnaire about their treatment? • High scores in a post-treatment consent survey?
P R I M A R Y D E N TA L J O U R N A L
Table 2: An example of a patient questionnaire following treatment
Describing consent with this framework enables you to begin to control the quality of consent in your practice. By defining the standard you would wish to attain for structure and process, you can then gather evidence of your own resources and performance and compare it with the standard. Table 1 shows some examples of evidence for consent in practice. Structure and process are relatively easy to audit. There should be lots of written evidence in the records, copies of information leaflets available and clinical procedures can be observed. But how does one measure the outcome in consent? How can one be sure the patient has sufficient understanding about the procedure they are agreeing to? In research on the consent process for implant treatment, Toy, Rosenbaum,
Shah and Dennick (see pages 19-25) met this challenge with the development of a comprehensive questionnaire for patients. They asked 19 questions about the procedure (including risks, costs, timescales, etc.) before embarking on treatment. Asking patients to complete such a questionnaire will help practitioners to gauge their patients’ level of understanding. Such a step would also demonstrate a practice’s efforts to measure understanding! However, while 19 detailed questions may be justified before embarking on risky and complex treatments, it seems a little excessive for many dental procedures. Surely the best way to find out if the outcome of the practice’s consent
VOL. 4 NO. 1 FEBRUARY 2015
27
THE CLINICAL GOVERNANCE OF CONSENT
Patient Consent Audit Tool Practice name:
R Results esults and a analysis nalysis D Data: ata: scores (ie, (ie, scores scores o ‘1’) iin n tthe he ‘‘Actual Actual % ox b elo w IInsert nsert tthe he ttotal otal p percentage ercentage o off positive positive scores off ‘1’) %’’ b box below a nd compare compare w with ith yyour our ttarget. arget. and
Date:
Aim To monitor and improve the level of satisfaction with our service in respect of:
R Re Result s u lt
E Ex Expected p e c te d
Target T rget % Ac Ta A Actual tu a l %
Ta Target rg et %
100
1. The treatment outcome 2. The quality of the consent process Standard
90
En E Enough ough IInfo In fo T Ta Target rg e t % 100
A Ac Actual tu a l %
Ea E Easy sy d e rs U Un Unders T Ta Target rget % Ac Actual tu a l % 100
En Enough ough ttime ime Ta T Target rg e t %
A Ac Actual tu a l %
100
Comments (No Note N te kkey ey ccomments o m m e n ts h here) e re ) ! Comments
We believe it is very important to achieve a very high standard of patient satisfaction with our treatment and the consent process. Perfect results for every patient every time are not realistic, however.
!
Target
!
Question 1 End result 2 Treatment as expected 3 Enough information 4 Easy to understand 5 Enough time
Target 100% ‘Good’ or ‘Very Good’ 90% ‘Yes exactly’ or ‘Yes mostly’ 100% ‘Yes’ responses 100% ‘Yes’ responses 100% ‘Yes’ responses
!
! !
Action Plan Plan Action
Method
Ch Change ange req required equired
1. Decide which type(s) of treatment you wish to survey. High risk treatments such as surgical or cosmetic procedures are the most important. 2. Decide how many patients to survey or for what period. 3. Give each patient who has finished treatment a post-treatment patient consent questionnaire to be completed before they leave the practice. 4. Enter the results on the Consent Audit Data Capture Form, including any comments. Insert a ‘1’ in the corresponding box related to the patient’s rating if it is ‘Very Good’ or ‘Good’, ‘Yes exactly’ or ‘Yes mostly’ or ‘Yes’. If the patient has not rated it highly, insert a ‘0’. 5. Make sure you follow-up any poor scores to find out why the patient was dissatisfied. Enter the reasons in the ‘Comments’ section. 6. When you have recorded the results of at least 10 patients, add up the scores in the columns and calculate the percentage of positive scores (to calculate the percentage, divide the total number of ‘1’ scores by the total number of patients and multiply by 100). 7. Insert the % scores in the appropriate box in the Results & Analysis table below. 8. Make any notes that will help to interpret the data or improve your service. 9. Use any testimonials for your practice marketing. 10. Discuss the results with your team and create an action plan. 11. Set a re-audit date and new target. 12. And so on!. Copyright © Invisinet Ltd 04/12/2014
Page 1 of 2
!
SMART SM MART s steps teps required r e q u ir e d
Resources e q u ir e d Resources rrequired (people/time/money/space/ (people/time/money/space/ materials) equipment/ma equipment/materials)
By w ho who (Name) (Name)
By w when hen (Date) (D ate)
audit date: date: Re-a Re Re-audit !!!!!!!!!!!!!!.. Pra ctice m anager Signed: Signed: !!!!!!!!!!!!!!.. Practice manager
Date: !!!!!. !!!!!. Date:
Copyright Copyright © In Invisinet visinet L Ltd td 04/12/2014 04/12/2014
Pa Page ge 2 of 2
!
Table 3: Post-treatment patient consent audit tool
procedure was successful is to ask the patient after the treatment has been delivered. In essence, you need to know if the treatment produced the result you agreed with the patient, and if the treatment progressed as they expected. For more extensive treatments, it’s possible to sit down with the patient to review the results and process of a comprehensive treatment plan. This step provides an opportunity to reflect on where the patient started and what you have achieved together. It’s a great way to mark the end of what has hopefully been a fulfilling, professional relationship for both parties and helps to raise the value of the treatment in the patient’s mind. It’s a great time to ask for referrals, too! Most dental treatments do not warrant
28
Ac Actual tu a l %
such an in-depth review, so the use of a questionnaire delivered directly after the last appointment in the treatment plan should suffice. The use of questionnaires is fraught with statistical challenges and the quality of the evidence obtained will be limited. However, with those limitations in mind, there is still some value in asking the patient’s opinion – especially if they are able to provide anonymous feedback and do not fear any reprisals if they give a poor review.
Questionnaire design So how many questions would you ask, and what areas would you cover to provide evidence of the quality of your consent process? Too many questions could easily lead to a rushed response, so approximately four to six questions would probably be enough to elicit a considered set of answers.
P R I M A R Y D E N TA L J O U R N A L
Table 4: Post-treatment patient consent audit data capture form
!"#$%#&'()*+&',-&-'!-.&)/%'0"/1 ()*+&'2%/+"* ,%#&+$&'5,
> ? @ A B C D E F >G >> >? >@ >A >B >C >D >E >F ?G 6"&-
Introduction Quality management of consent within our practice comes with a unique set of challenges. In simple terms, a patient can provide valid consent to a procedure if they have enough knowledge about it and the alternative options; enough time to consider them and, crucially, enough understanding to make a reasonable decision.1 How do we measure the quality of consent? We don’t have defined, physical parameters such as the time, temperature and pressure of an autoclave during instrument decontamination. High quality consent is patient-specific – each set of clinical, medical and social circumstances being unique to them. The type of consent also depends on the procedure, with more risky treatments needing a different approach to the simple and straightforward. The patient can also withdraw consent at any time, too, so it is a complex and indefinite area of practice. That does not mean we can’t apply our clinical governance principles to consent, though. This article assumes that we need to be most concerned about those procedures that carry the greatest risk. This means complex, expensive and/or time-consuming treatments such as surgical, complex restorative and cosmetic treatments.
Structure, process and outcome One way of looking at these issues surrounding consent is to apply the structure, process and outcome framework.2 Briefly, your practice’s ‘consent structure’ could be regarded as the resources available; such as your website, any documentation or leaflets, audio-visual aids, a treatment coordinator or consultation area. The ‘consent process’ would be the way those resources are
TA B L E 1
EVIDENCE OF CONSENT Structure (The resources available to support high quality consent)
Process (How the resources are applied)
Possible evidence • Comprehensive information available online/offline in a form that patients can understand. • Comprehensive examination procedure in place (including assessment of dental, medical and social needs). • Written treatment plan templates that can be customised to the specific patient and include details such as the nature of the procedure and its material risks, alternatives available, the cost and time involved. • Treatment procedures provide an opportunity for the patient to withdraw consent. • Team members trained to understand and deliver consent. • A suitable environment (such as a consultation room). •
•
•
AUTHOR
Andrew Toy BDS, MFGDP(UK), MMedSci (Clinical Education) General dental practitioner, and chief executive officer of The Dental Business Academy
26
used to assist the patient in making their decision. The ‘consent outcome’ is obviously what happens as a result of the process – the consent obtained would be either ‘valid’ or ‘invalid’. The inference is that the quality of the outcome is influenced by the quality of the structure and process – which is probably true as long as one understands that it is unlikely to be a direct, linear relationship. We are talking about human understanding, after all.
Outcome • (The difference made by the application of the structure and the resources)
Records to show the practice follows its comprehensive examination procedure and effectively assesses the patient’s dental, medical and social needs. Records to show the patient is provided with information in verbal/written/visual form to enable them to gain knowledge about the procedure (and alternatives) in a way they can understand – including material risks (such as provision of leaflets, treatment coordinator consultations, written treatment plans). Records to show the patient is given sufficient time to make a decision about the treatment. Evidence of understanding is difficult to record: • Written agreement to treatment, signed and dated? • Patient provides the correct answers on a pre-treatment questionnaire about their treatment? • High scores in a post-treatment consent survey?
P R I M A R Y D E N TA L J O U R N A L
Table 2: An example of a patient questionnaire following treatment
Describing consent with this framework enables you to begin to control the quality of consent in your practice. By defining the standard you would wish to attain for structure and process, you can then gather evidence of your own resources and performance and compare it with the standard. Table 1 shows some examples of evidence for consent in practice. Structure and process are relatively easy to audit. There should be lots of written evidence in the records, copies of information leaflets available and clinical procedures can be observed. But how does one measure the outcome in consent? How can one be sure the patient has sufficient understanding about the procedure they are agreeing to? In research on the consent process for implant treatment, Toy, Rosenbaum,
Shah and Dennick (see pages 19-25) met this challenge with the development of a comprehensive questionnaire for patients. They asked 19 questions about the procedure (including risks, costs, timescales, etc.) before embarking on treatment. Asking patients to complete such a questionnaire will help practitioners to gauge their patients’ level of understanding. Such a step would also demonstrate a practice’s efforts to measure understanding! However, while 19 detailed questions may be justified before embarking on risky and complex treatments, it seems a little excessive for many dental procedures. Surely the best way to find out if the outcome of the practice’s consent
VOL. 4 NO. 1 FEBRUARY 2015
27
THE CLINICAL GOVERNANCE OF CONSENT
Patient Consent Audit Tool Practice name:
R Results esults and a analysis nalysis D Data: ata: scores (ie, (ie, scores scores o ‘1’) iin n tthe he ‘‘Actual Actual % ox b elo w IInsert nsert tthe he ttotal otal p percentage ercentage o off positive positive scores off ‘1’) %’’ b box below a nd compare compare w with ith yyour our ttarget. arget. and
Date:
Aim To monitor and improve the level of satisfaction with our service in respect of:
R Re Result s u lt
E Ex Expected p e c te d
Target T rget % Ac Ta A Actual tu a l %
Ta Target rg et %
100
1. The treatment outcome 2. The quality of the consent process Standard
90
En E Enough ough IInfo In fo T Ta Target rg e t % 100
A Ac Actual tu a l %
Ea E Easy sy d e rs U Un Unders T Ta Target rget % Ac Actual tu a l % 100
En Enough ough ttime ime Ta T Target rg e t %
A Ac Actual tu a l %
100
Comments (No Note N te kkey ey ccomments o m m e n ts h here) e re ) ! Comments
We believe it is very important to achieve a very high standard of patient satisfaction with our treatment and the consent process. Perfect results for every patient every time are not realistic, however.
!
Target
!
Question 1 End result 2 Treatment as expected 3 Enough information 4 Easy to understand 5 Enough time
Target 100% ‘Good’ or ‘Very Good’ 90% ‘Yes exactly’ or ‘Yes mostly’ 100% ‘Yes’ responses 100% ‘Yes’ responses 100% ‘Yes’ responses
!
! !
Action Plan Plan Action
Method
Ch Change ange req required equired
1. Decide which type(s) of treatment you wish to survey. High risk treatments such as surgical or cosmetic procedures are the most important. 2. Decide how many patients to survey or for what period. 3. Give each patient who has finished treatment a post-treatment patient consent questionnaire to be completed before they leave the practice. 4. Enter the results on the Consent Audit Data Capture Form, including any comments. Insert a ‘1’ in the corresponding box related to the patient’s rating if it is ‘Very Good’ or ‘Good’, ‘Yes exactly’ or ‘Yes mostly’ or ‘Yes’. If the patient has not rated it highly, insert a ‘0’. 5. Make sure you follow-up any poor scores to find out why the patient was dissatisfied. Enter the reasons in the ‘Comments’ section. 6. When you have recorded the results of at least 10 patients, add up the scores in the columns and calculate the percentage of positive scores (to calculate the percentage, divide the total number of ‘1’ scores by the total number of patients and multiply by 100). 7. Insert the % scores in the appropriate box in the Results & Analysis table below. 8. Make any notes that will help to interpret the data or improve your service. 9. Use any testimonials for your practice marketing. 10. Discuss the results with your team and create an action plan. 11. Set a re-audit date and new target. 12. And so on!. Copyright © Invisinet Ltd 04/12/2014
Page 1 of 2
!
SMART SM MART s steps teps required r e q u ir e d
Resources e q u ir e d Resources rrequired (people/time/money/space/ (people/time/money/space/ materials) equipment/ma equipment/materials)
By w ho who (Name) (Name)
By w when hen (Date) (D ate)
audit date: date: Re-a Re Re-audit !!!!!!!!!!!!!!.. Pra ctice m anager Signed: Signed: !!!!!!!!!!!!!!.. Practice manager
Date: !!!!!. !!!!!. Date:
Copyright Copyright © In Invisinet visinet L Ltd td 04/12/2014 04/12/2014
Pa Page ge 2 of 2
!
Table 3: Post-treatment patient consent audit tool
procedure was successful is to ask the patient after the treatment has been delivered. In essence, you need to know if the treatment produced the result you agreed with the patient, and if the treatment progressed as they expected. For more extensive treatments, it’s possible to sit down with the patient to review the results and process of a comprehensive treatment plan. This step provides an opportunity to reflect on where the patient started and what you have achieved together. It’s a great way to mark the end of what has hopefully been a fulfilling, professional relationship for both parties and helps to raise the value of the treatment in the patient’s mind. It’s a great time to ask for referrals, too! Most dental treatments do not warrant
28
Ac Actual tu a l %
such an in-depth review, so the use of a questionnaire delivered directly after the last appointment in the treatment plan should suffice. The use of questionnaires is fraught with statistical challenges and the quality of the evidence obtained will be limited. However, with those limitations in mind, there is still some value in asking the patient’s opinion – especially if they are able to provide anonymous feedback and do not fear any reprisals if they give a poor review.
Questionnaire design So how many questions would you ask, and what areas would you cover to provide evidence of the quality of your consent process? Too many questions could easily lead to a rushed response, so approximately four to six questions would probably be enough to elicit a considered set of answers.
P R I M A R Y D E N TA L J O U R N A L
Table 4: Post-treatment patient consent audit data capture form
!"#$%#&'()*+&',-&-'!-.&)/%'0"/1 ()*+&'2%/+"* ,%#&+$&'5,
> ? @ A B C D E F >G >> >? >@ >A >B >C >D >E >F ?G 6"&-
