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Abstract
Ojectives Low energy hip fractures are one of the greatest causes of morbidity and mortality in orthopaedics. This study aims to evaluate written consent forms with respect to basic standards as set out in the Good Practice in Consent Initiative. In particular the stated risks and benefits of each procedure were assessed.
Methods 100 consecutive consent forms were reviewed prospectively. The stated procedure, side and complications were recorded. Appropriate signature and legibility was assessed. 13 consultant orthopaedic surgeons were surveyed to identify what risks and benefits they thought should be stated.
Results Of 100 consent forms, 31 were for patients who are unable to consent. All 100 consent forms were correctly filled in with patient details and signed. 98% were legible. All stated the side of the operation. The number of complications listed per form ranged from 4 to 11. Infection, bleeding and thromboembolic complications were stated in the majority of consent forms. In total, 30 different complications were recorded; some were only stated once.
Discussion and Conclusions This work suggests consent forms are completed well with respect to patient identifiers, legibility and procedure. The variability of complications stated is vast. We suggest standard pre-printed consent forms containing risks and benefits should be used as this may improve standards of informed consent. This has also been recently supported by the British Orthopaedic Association.
- Consent forms
- hip fracture
- complications
- surgery
- quality
- orthopaedics
- informed consent
- aged
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Introduction
Low energy hip fractures are one of the greatest causes of morbidity and mortality in orthopaedic surgery. The predicted increased incidence of fragility fractures due to increasing life expectancy will create a large workload for orthopaedic trauma services.1
Written consent for hip fracture surgery is often taken by the most junior member of the surgical team. Recent guidance suggests the person obtaining consent should have been specifically trained to do so or be capable of performing the procedure.2 Inadequate consent can contribute to wrong site and wrong procedure surgery. It can contribute to patient dissatisfaction if perioperative complications occur. Information recorded is scrutinised if litigation occurs. Litigation is costly for the NHS.3 Written consent is common practice and formally documents information provided to the patient. Consent need only be verbal from a legal perspective.
Pre-printed consent forms for common procedures in orthopaedic surgery have recently been supported by the British Orthopaedic Association.4 Use of pre-printed consent forms has not been widely incorporated into standard practice. Informed consent involves giving the patient the information necessary to make an informed decision and this will depend on the patient's level of understanding. Informed consent helps alleviate dissatisfaction with perioperative complications.
This study evaluates written consent forms to assess if basic standards are achieved. Subjective information including risks and benefits explained will be evaluated. A copy of the consent form should be given to the patient in accordance with Department of Health guidelines in the Good Practice in Consent Initiative2 and this is also evaluated.
Patients and methods
One hundred consent forms were prospectively reviewed over a 3 month period from October to December 2007. All acute hip fracture admissions were included in the study. There were 29 males and 71 females with an age range from 63–98 years. Thirteen different consultant orthopaedic surgeons at the Derbyshire Royal Infirmary were responsible for the patients' care. The consent forms were reviewed and correlated with the operative note. Presence of patient demographic details was recorded. Clear indication of the side of surgery was assessed. Complications were recorded. Appropriate signatures and legibility (subjective assessment by LR) was assessed. Whether or not a copy of the form was given to the patient was also recorded. Consent forms for patients who are unable to consent (ie, Consent form 2) do not have a section for complications to be listed and therefore could not be used for part of the study. The 13 consultant orthopaedic surgeons within the unit were surveyed to identify what risks and benefits they felt should be included. Results were analysed using descriptive statistics.
Results
Of 100 consent forms 69 were for patients able to provide consent and could therefore be assessed for benefits and complications stated; 31 of the consent forms were consultant consent forms for patients without capacity.
Of the 100 operations there were 46 dynamic hip screws; 42 hemiarthroplasties of which 11 were uncemented; seven internal fixation with cannulated screws; four cephalomedullary devices, and one total hip replacement.
All 100 consent forms were correctly filled in with the patients' details (table 1) and appropriately signed. Two patients who were not able to give consent had only one doctor's signature. Of the consent forms, 98% were judged to be legible. All consent forms correctly stated on which side the operation was to be performed. On one consent form this was abbreviated to ‘®’ for right. Of 69 cases, where patients were able to provide consent in only eight cases was it documented that a copy of the consent form was given to the patient. Two forms failed to identify the hip joint as the site of hemiarthroplasty. Dynamic hip screws was inappropriately abbreviated on four forms. Some forms used alternative terminology for example internal fixation instead of dynamic hip screws.
Percentage of forms with appropriate documentation
The number of complications listed per consent form ranged from four to 11. Infection, bleeding and thrombo-embolic complications were stated in the majority of consent forms (98.5%, 82.6% and 95.6% respectively). A total of 30 different complications were stated (table 2) and some of these for example ‘pressure sore’, ‘medical complications’ and ‘loss of limb’ were only stated once.
Complications stated on consent form 1 for all procedures
From the consultant survey—infection, bleeding, thromboembolism, neurovascular complications and death were the most frequent general complications considered essential to be stated as risks. There were 27 different complications stated by the consultants, 13 of which were only stated once, for example, urinary retention. A further 18 complications were identified relevant to certain procedures, for example, dislocation for hemiarthroplasty.
A total of six benefits (table 3) were identified and pain relief allowing mobilisation was felt essential by all 13 consultant orthopaedic surgeons.
Benefits of surgery as stated by consultants
Discussion
The implication of sustaining a hip fracture is serious. Mortality can be as high as 9% in the first 30 days.5 A reduction in walking status can also be expected and independent living may be compromised.6 Informed consent is essential to formally document the information given to the patient.
This study has suggested consent forms are completed well with respect to patient identifiers, legibility, accuracy of procedure and in general appropriately signed. The variability of complications is vast in terms of those stated and those desired among a small sample of consultants. Complications that arguably are of little relevance were mentioned, for example, tendon damage and scar. Terminology of little precision and value was used, for example, damage to adjacent structures, failure of procedure. The latter presumably implied, and should therefore have stated, need for further surgery. Guidance suggests complications that are serious and frequent should be stated and a number in this audit are therefore not appropriate. Consent should be at a level comprehensible to the patient and thus leg length discrepancy may be appropriate for the alert, independent ambulator but not for the mildly confused non ambulator.
Pre-printed consent forms, available online7 and endorsed by the British Orthopaedic Association, are available for use. Included in the copy of the consent form retained by the patient could be a concise, informative and basic summary of the condition and associated rehabilitation that would benefit patients. Use of these consent forms would help standardise the consent process and enhance communication with patients. However, widespread use of these pre-printed forms may only happen if it is endorsed by the Department of Health. Pre-printed forms are already widely used in Austaralia and can for example be accessed online at the Queensland government website.8 In addition to pre-printed consent forms, an alternative may be to have a stamp in the department which can provide standardised instructions on complications without changing the format for the hospitals current forms.
Conclusion
We suggest that standard pre-printed consent forms containing risks and benefits felt essential following combined discussion among consultants in their particular unit may improve the standard of informed consent in hip fracture surgery. For this purpose online resources may be helpful.
Footnotes
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
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