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Consent in Elective Hip Arthroplasty: What Has Changed Over the Last 15 Years?

It is regular practice that patients undergoing orthopaedic procedures, particularly those related to arthroplasty are given both verbal and written information prior to their surgery. This is regarded as good practice, and studies have shown that patients recall more information when given written details than just verbal responses. (1) Patient information is now available from numerous sources both in printed literature and also on the Internet. However, there is little evidence that providing written literature prior to surgery improves longterm outcomes. (2)

Both legally and ethically it is a vital part of any surgical intervention that the patient understands both the benefits of the proposed procedure as well as the possible complications and is made aware of alternative therapies that may be available.

Consent is an essential document of evidence of the consent process signifying that an informed decision has been taken by the patient regarding their proposed treatment and should usually take the form of a two-way discussion between the patient and the operating surgeon. Recent published work, however, suggests that this may not always be the case, particularly among medical staff. There is much published work on the legal aspects and consequences of poorly taken or documented consent. (3-9)

Booklets and videos, or even meetings between the patient and other patients who have already undergone the procedure, can augment consent. (10) As physicians, our primary interest in the consent process should be to ensure that our patients have as full an understanding of the proposed procedure as possible.

At our unit, all patients undergoing primary total hip replacements are provided with written and DVD information regarding their surgery. The information presented in a written booklet or video format provides patients with information regarding all aspects of their surgery, including preoperative information and what to expect prior to surgery through to postoperative advice and rehabilitation, and can be referred to on repeated occasions. The written booklets and DVDs containing information for patients on total hip arthroplasty are believed to be both comprehensive and thorough. They contribute to the education provided, including material regarding the consent process and the risks of surgery and also issues surrounding prevention of venous thromboembolism.

In 2000, a study was carried out at our institution in order to assess patients' understanding and recollection of information provided verbally at the time of consent. It revealed marked deficiencies in patients' comprehension as to what they had signed and why. As a direct result of this, patient information booklets were developed and introduced at our hospital. A re-audit in 2002 still revealed marked deficiencies.

The aim of this study was to complete the audit loop again by assessing the patient understanding of the consent process in elective orthopaedic surgery following the introduction of DVDs, web links, and meetings with health care professionals and patients (joint school). We then compared this data to the initial study with the same questionnaire to see if all the technological advances have improved patient understanding over the past 15 years.

Method

All patients undergoing arthroplasty surgery are routinely reviewed at a pre-assessment clinic 2 weeks prior to admission. The surgery, risks, and potential complications are discussed in detail with each patient at this clinic. An information booklet and DVD is given to each patient at this stage with an explanation of its contents. Consent is taken by either the specialist registrar or by the consultant.

Over three separate 4-week period from the year 2000 to 2015, 150 patients (50 patients in each cycle of the study) undergoing primary total hip arthroplasty were counselled about the audit and prospectively enrolled. All these patients were asked to complete a questionnaire relating to the consent process. This occurred during their in-patient stay. The audit loop was completed twice, once following the introduction of information booklets (2002) and with the introduction of DVDs, joint school, and web links (2015).

The exact same questionnaire has been used for the past 15 years (Table 1).

The patient information booklet and DVD consist of four parts; hip replacement surgery, how to prepare for your hip replacement, your hospital stay, and your rehabilitation. They were developed between the nursing, medical, physiotherapy, and occupational therapy departments. Plain language was used throughout with diagrams illustrating the text. Patients were encouraged to read the book and watch the DVD. At preoperative assessment each section was explained to the patient.

Joint school is a 60 minute interactive presentation about what is expected during the operation, hospital stay, and rehabilitation. It is an informal environment where patients are given the opportunity to ask questions and alleviate any pre-existing anxieties. This session is led by nurses, physiotherapists, and ex-patients.

Data analysis was performed using an SPSS package.

Results

One hundred fifty patients were involved in this study (Table 2). The mean score out of 25 during each audit cycle is shown in Figure 1. The number of patients aware that infection is a recognized risk factor is shown in Figure 2. The number of patients aware that dislocation is a recognized risk factor is shown in Figure 3. The number of patients aware that death is a recognized risk factor is shown in Figure 4. The number of patients aware that venous thromboembolism is a recognized risk factor is shown in Figure 5.

From the initial study in year 2000, some of the striking results were that 30% did not know the name of the consultant in charge of their care, 3% did not know what operation they were about to undertake, 60% were aware of dislocation and leg length discrepancy in THR, 45% were aware that neurovascular damage was a possible complication, 48% were aware that there was a risk of DVT, and 56% were aware that death was a possible complication.

The only question that showed a statistically significant improvement when the 2000 and the 2002 studies were compared was that there was an increase in the number of people who knew their named consultant in charge of their care (70% to 90%).

There were no questions that showed statistically significant improvement when the 2002 and the 2015 studies were compared.

Discussion

Obtaining true informed consent for surgery is dependent upon the patient having sufficient understanding of the procedure and the potential benefits and risks so that they can make a balanced decision as to whether to proceed. This process is fraught with difficulty as attempting to explain complex procedures to patients in the short time available in clinic can lead to both the patient and the surgeon being dissatisfied. (4-8,10-13) The provision of a booklet, explaining in layman's terms the procedure, likely outcome, rehabilitation, and any potential complications that can occur, would appear to be a practical solution to this problem.

Patients' expectations are rising and demand for more information is increasing. An information booklet and DVD's would seem to satisfy both these "demands." So if expectations and demand for information are increasing and the information booklets and DVDs would appear to satisfy the demands for more information, then why do they appear not to work? Firstly, patients may not read the information booklets. Kearns and coworkers stated that 28% of their patients given information booklets found them upsetting. (14) If this were the case in our cohort, then this would mean that patients are less likely to refer to the booklets.

Secondly, information booklets act as a ready reference source for patients that, if read, one would expect to help with retention of information via reinforcement. However, Turner and Williams have shown that patient's recall of information following consent is helped little by information booklets. (15,16)

Thirdly, the information booklets and DVDs may have been too difficult to understand although every effort was made to explain information in basic and layman's terms so that it could be easily understood by a wide range of people with varying levels of understanding. In addition to this, every patient is given the opportunity to attend "joint school" where prospective hip arthroplasty patients can informally discuss any aspects of the experience with health care professionals and previous patients.

The final point is that the initial consent process may have led to a poor patient understanding of the procedure. Although the booklet is in no way a substitute for an adequate consultation, one would, however, expect that it should supplement an indisposed understanding of the verbal explanation given, thereby hopefully improving the comprehension of information.

In the original audit in 2000, the patients were asked whether they felt that a booklet or DVD would assist with their understanding of their surgery. Thirty-four of the 50 patients (68%) felt that a booklet would assist with their understanding of their surgery. However, by completing the audit loop, we have found that the use of booklets has improved patient understanding of the procedures they have undergone in very few areas, and there has actually been deterioration in others. In the majority of areas, the level of understanding remains similar to the 2000 cohort. With regard to information recall, the information booklet may just provide proof for the surgeon that information has been provided to the patient.

Despite the apparent lack of improvement in patient understanding, the patients felt that the booklets and DVDs were useful in that they provided an easily accessible aide-memoire when carrying out their postoperative rehabilitation. In this respect, the patient information booklet is an important adjunct to the patients' experience of surgery but does little to improve patient understanding of the consent process.

Conclusion

There have been several technological advances over the past 15 years in an attempt to improve patients' understanding and comprehension of the consent process in total hip replacement surgery. Vast amounts of time and expenditure have been used in order to improve patient satisfaction and minimise medicolegal insult for the surgical team. This study has shown that despite these efforts, there has been very little improvement in patients understanding. However, patients remain satisfied with this extra information. The remaining underlying question is whether patients actually want to know all the potential complications that can occur.

Disclosure Statement

None of the authors have a financial or proprietary interest in the subject matter or materials discussed, including, but not limited to, employment, consultancies, stock ownership, honoraria, and paid expert testimony.

References

(1.) Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Ann R Coll Surg Engl. 2002 Nov;84(6):404-8.

(2.) Daltroy LH, Morlino CI, Eaton MH. Preoperative education for total hip and knee replacement patients. Arthritis Care Res. 1998 Dec;11(6):469-78.

(3.) Dyer C. Consultant suspended for not getting consent for cardiac procedure. BMJ. 1998;316:955.

(4.) Gild WM. Informed consent: A review. Anaesth Analg. 1989 May;68(5):649-53.

(5.) Katz J. Reflections on informed consent: 40 years after its birth. J Am College Surg. 1998 Apr;186(4):466-74.

(6.) Wientraub MI. Documentation and informed consent. Neurol Clin. 1999 May;17(2):371-81.

(7.) Molnar J. Consent in the 90's. Med Law. 1997;16(3):567-79.

(8.) Faunce TA. Medical disclosure and consent forms: Proposal for an international standard. Med Law. 1997;16(3):581-91.

(9.) Vansweevelt T. Informed consent and extended operations. Med Law. 1998;17:125-30.

(10.) Alderson P, Goodey C. Theories in health care and research: theories of consent. BMJ. 1998 Nov 7;317(7168):1313-5.

(11.) Harris KA. The informed needs of patients with cancer and their families. Cancer Pract. 1998 Jan-Feb;6(1):39-46.

(12.) Stanley BM, Walters DJ, Maddern GJ. Informed consent: How much information is enough? Aust N Z J Surg. 1998 Nov;68(11):788-91.

(13.) Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90.

(14.) Kerans S, Kingston R, Froman S, Murray P. How informed is consent? Use of an information booklet in patients undergoing total hip replacement. Ir Med J. 2001 Jun;94(6)171-2.

(15.) Turner P, Williams C. Informed consent: patients listen and read, but what information do they retain? N Z Med J. 2002 Oct 25;115(1164):U218.

(16.) Graham N, Leese N, Jones SR. Informed consent in elective orthopaedic surgery: is the message getting through? NHSLA Review. 2001;21.

Rohit Singh, M.B.C.H.B., B.Med.Sci, M.R.C.S., P.G.C., M.Sc., George Evans, Amit Patel, M.B.C.H.B., F.R.C.S.(Orth.), and Richard Spencer Jones, M.B.C.H.B., F.R.C.S.(Orth.)

Rohit Singh, M.B.C.H.B., B.Med.Sci, M.R.C.S., P.G.C., M.Sc., George Evans, Amit Patel, M.B.C.H.B., F.R.C.S.(Orth.), and Richard Spencer Jones, M.B.C.H.B., F.R.C.S.(Orth.), SPR Trauma and Orthopaedics, Robert Jones Agnes Hunt Orthopaedic Hospital, Oswetsry, United Kingdom.

Correspondence: Rohit Singh, M.B.C.H.B., B.Med.Sci, M.R.C.S., P.G.C., M.Sc., SPR Trauma and Orthopaedics, Robert Jones Agnes Hunt Orthopaedic Hospital, Oswetsry SY10 7AG, United Kingdom; rohitamolsingh@hotmail.com.

Caption: Figure 1 Mean score out of 25 over past 15 years.

Caption: Figure 2 Number of patients aware that infection is risk factor with total hip replacements.

Caption: Figure 3 Number of patients aware that dislocation is risk factor with total hip replacements.

Caption: Figure 4 Number of patients aware that death is risk factor with total hip replacements.

Caption: Figure 5 Number of patients aware that venous thromboembolism is a risk factor with total hip replacements.
Table 1 Questionnaire

 1.  What is the name of the consultant in charge of your care during
     this admission?
 2.  What operation are you currently an in-patient for?
 3.  Have you signed a consent form for your operation?
 4.  Who explained the operation and asked you to sign the consent form?
 5.  Did you understand what you were told about the operation?
 6.  Have you been given an opportunity to ask questions about your
     operation?
 7.  Are there complications or side effects possible from your
     operation?
 8.  How many years do you expect your new joint to last?
 9.  What are the chances of your operation being a complete success
     without any complications?
10.  What are the chances of your joint becoming infected?
11.  If your new joint becomes infected, will further surgery be needed?
12.  If you are having a hip replacement, have you been warned of the
     risk of dislocation?
13.  Are you aware that your legs may not be exactly the same length
     after the operation even though you probably won't notice it?
14.  What are the chances of you getting a blood clot (DVT) in your legs
     as a result of the surgery you are going to have?
15.  Do you know what a pulmonary embolus is?
16.  If you answered "no" or "don't know" to the last question, have you
     heard of blood clots in the lungs?
17.  Are you at risk of blood clots in the lungs from your operation?
18.  Is there any chance of you dying as a result of your operation?
19.  Have you heard of anyone dying as a result of the operation that
     you are about to have?
20.  What is the main aim of your operation?
21.  Is there a risk of amputation associated with your operation?
22.  How long will you be in hospital?
23.  Are there any blood vessels or nerves that can be damaged by your
     operation?
24.  Would a booklet be helpful in explaining the pros and cons of your
     operation?
25.  Would a video of other patients who have had your operation be
     helpful in explaining your operation?

Table 2 Table Showing Number of Patients in Each Audit Cycle Over Past
15 Years

Year  Number of patients

2000  50
2002  50
2015  50
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Article Details
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Author:Singh, Rohit; Evans, George; Patel, Amit; Jones, Richard Spencer
Publication:Bulletin of the NYU Hospital for Joint Diseases
Article Type:Report
Geographic Code:1USA
Date:Oct 1, 2017
Words:2645
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