Abstract
Objective
To undertake an in-depth analysis of all complaints over a 12-month period in an orthopaedic department in the NHS.
Setting
Department of Orthopaedics in a UK NHS Trust.
Methods
Sixteen complaints files and associated patient case-notes were retrospectively reviewed by an independent consultant orthopaedic surgeon and members of the research team.
Results
There were some common themes in the adverse events reported. For example, failure to obtain adequately informed consent and lack of information given to patients were the most common adverse events that were identified by the review process. There were 36 adverse events/complications in the sample, 30 were adverse events and six were complications. Half of the complaints reviewed (18/36) related directly to adverse events. The majority of the adverse events that were identified by this study and review of complaints (27/36) were covered by the adverse event list and should have triggered an incident report.
Conclusion
Adverse events are not being acknowledged and there is a need for more openness with patients. As such, a larger study is needed to explore the extent of these issues.
Background
Studies investigating adverse event rates in hospitals 1–5 have highlighted the significance of medical error and its potential to increase clinical claims and complaints. In addition, it is known that malpractice litigation is costly, for instance it is estimated that medical error costs the US government in the range of $29 billion annually and that there are up to 98,000 preventable deaths a year as a result of medical error. 4 Complaints are also significant; it is estimated nearly 39,000 written complaints are received yearly about aspects of primary care. 6 In 2006–2007, approximately 91,000 hospital complaints were received. 7
Complaints can have a huge impact on those involved and have been known to increase stress and reduce job satisfaction among those who have complaints made against them. 8 However, data from claims and complaints has the potential to provide valuable information on adverse events and the potential for prevention. 9 Complaints and claims can occur for a variety of reasons, perhaps the most common being communication failure or lack of informed consent. 10–12 Claims and complaints are not always associated with an adverse event 1,11 and an increased severity of the injury does not appear to increase the likelihood of a complaint. 11
Although there have been a number of studies investigating the relationship between claims and adverse events, there is very little information on why patients complain and if complaints are associated with an adverse outcome. 13 The specialty of orthopaedics has a malpractice claim rate of 8%, which is higher than other surgical specialties and it is ranked 5th in the total number of reported claims. 10 In spite of this it is difficult to obtain data on claims and complaints in orthopaedics. 10 In view of the lack of research investigating the relationship between complaints and adverse events and the obvious importance of orthopaedics as a specialty with a high number of claims, this pilot study focused on an in-depth analysis of complaints in an orthopaedic department in the NHS. The main aim of this study was to undertake an in-depth review of all complaints over a 12-month period in one orthopaedic department in the NHS.
Methods
A retrospective review of clinical records and complaints files was conducted in the department of orthopaedics at one hospital. Three hospitals were approached, but two declined to take part mainly because of fears of re-opening closed complaints. All clinical complaints relating to the remaining orthopaedic department over a 12-month period were identified (n = 20). Consent was sought from the patients or legal guardian (in the case of those under 18 years old or those who were deceased) in order to review their complaint file and associated clinical records. Each of the complainants' files and clinical records were then anonymized. Following this process, 16 sets of files, associated patient case-notes and X-rays (where available) were reviewed by an independent consultant orthopaedic surgeon. An adaptation of the University College London Tool record review tool was used as a guide. 14 Each case was subsequently discussed in depth by the research team, consisting of a professor of law, a consultant in public health and a researcher in patient safety.
Adverse event list
The purpose of the review was to:
Summarize the nature of the complaint as presented by the complainant in written or verbal form (the latter being noted by hospital complaints staff); To identify the presence of documentary evidence in the case-notes of adverse events
a
/complications;
b
To generate an opinion as to whether the adverse event/complication related to the complaint; To assess whether or not the adverse event/complication was acknowledged to the patient and mentioned in the complaint letter; Whether the adverse event(s)/complication(s) would have been picked up by an adverse event list (Figure 1) being used as a trigger list in the department at the time;
15,16
Form an opinion on whether the adverse event was negligent
c
and how this was done.
The results of the case-note review process are presented below.
Results
A total of 20 complaints were identified for the 12-month period, 17 of which gave written consent. However, only 14 sets of case-notes could be retrieved for review, the other three were unavailable because they were lost in medical record files.
Four of the cases were male complainants and 10 were female complainants. The age range was 16–78 years (Table 1).
Age (years) and gender of complainants
Summary of the complaint
Table 2 (available online at
Complaint case where lack of information was identified as the major reason for the complaint
A 40-year-old woman, referred with a history of numbness in the right hand that was waking her, suspected carpal tunnel syndrome. She was sent for EMG studies which proved to be normal, the results of which appeared to disappoint her. On examination she was found to have severe tenderness over the common extensors of the right forearm and a diagnosis of tennis elbow was made. She was given an injection of Kenalog (a steroid used for joint pain, swelling, etc.) and local anaesthetic with instant relief to be reviewed four weeks later. Following the injection she went to her car, her arm had turned blue, was numb and she could not move her fingers. Her husband rang the clinic and was told it was the side-effects from the local anaesthetic and it would wear off in about four hours. She then made a verbal complaint that she was not informed that she could not drive for 24 hours. As such the main adverse event and reason for the complaint in this case appears to be lack of sufficient information about the injection and its consequences.
Occurrence of an adverse event(s)/complication(s)
There were 36 adverse events/complications in the sample, 30 were adverse events and six were complications.
Did the complaint relate to an adverse event(s)/complication(s)?
Half of the complaints reviewed (18/36) related directly to adverse events that were identified by the review process (Table 2).
Boxes 2 and 3 summarize two cases where the complaint related to an adverse event (Box 2) and where the complaint was not related to an adverse event (Box 3).
Complaint case where the complaint related to an adverse event
A 16-year-old boy attended A&E with pain in the left lower limb. He had stepped off a bus and experienced a sharp pain in the thigh. He had previously fallen one week earlier and hit his left thigh on a stone. He had complained of pain ever since. There was obvious deformity. On examination there was no bony tenderness and the left thigh was neither tender nor swollen. Distal pulses were documented as present. Capillary refill was ticked meaning OK. Sensation was intact. A diagnosis of a soft tissue injury to the left thigh was made, advice was given for rest, immobilization, analgesia, ice and massage, and the patient was allowed home. The patient returned to A&E the following day with left hip pain, partial weightbearing, painful on movement, and a clicking feeling in hip on walking. A diagnosis of SUFE (slipped upper femoral epiphysis) to the left leg was made and the patient was referred to the Orthopaedic Unit and admitted that day. At some later stage he was readmitted to have the screw removed. Removal failed because the threads in the screw had slipped and the screw would not undo and it was therefore left in situ.
A complaint was then made because the patient had been sent home from A&E and had to be admitted the following day and then told to have an operation. This complaint directly relates to the adverse event identified in this case, the failure of the SHO in the A&E Department to pick up a SUFE at initial A&E attendance.
Complaint case where the complaint did not relate to an adverse event
A 48-year-old woman attended A&E having fallen down the stairs two days previously suffering injuries to her left buttock, left hip and her left ring finger. She sustained a fracture subluxation of the PIP joint of the left ring finger.
She underwent a special type of external fixation known as an S-Quattro. Nine days later, one of the pins of the fixation procedure had come out, it was re-applied under LA ring block. X-ray showed a satisfactory reduction and position had been achieved. She then made a complaint about the attitude of the consultant and the fact that she believed the consultant caused her undue pain. There were two adverse events identified from this case:
One of the pins coming out early; The development of degenerative changes in the PIP joint of her left ring finger could be viewed as an adverse event, it was inevitable in this case and was recognized by the clinical team. Treatment with a joint replacement was offered to the patient but declined.
However these adverse events did not directly relate to her complaint.
The adverse event list (Figure 1) 15,16 being used in the department at the time had the major aim of alerting healthcare professionals as to what constituted an adverse event and consequently what they should report through the incident reporting process. It appears that on the whole the adverse events/complications identified in the 16 complaints cases should have been identified and reported by the adverse event list (Figure 1). It was however not possible to connect the adverse events identified within the complaints with the incident reporting system being used at the time.
Would the adverse event(s)/complication(s) have been identified by the adverse event list?
The majority of the adverse events that were identified by this study and review of complaints (27/36) were covered by the adverse event list and should have triggered an incident report (Table 2).
Discussion
In spite of previous research suggesting that complaints are not often related to adverse events, 11 the results of this study suggest that the cases that generate a complaint, particularly in orthopaedics, may have underlying adverse events and/or complications. It may be that complaints that relate to a specific adverse event cannot be as easily avoided. For instance, complaints that occur when there is no apparent adverse event, often tend to be a result of poor communication or lack of informed consent. If communication systems were to improve, the majority of complaints where no adverse event occurred may well be prevented. It would also be interesting to explore if patients recognize adverse events and whether they may play an important part in the identification and investigation of adverse events. Moreover, with an increased emphasis on being open 17 to patients about the occurrence of adverse events, it would also be interesting to explore what impact this may have on the complaints systems. It could potentially reduce the number of complaints if patients are kept informed and are a central part of the investigation process. This study suggests that there may be weaknesses in the incident reporting system being used at the time, as it failed to link the adverse events identified within the complaints with the incident reporting system itself.
Another interesting finding from this study relates to the response letters following complaints. The reviewer felt that the majority of complaints were dealt with sufficiently and appropriately. However there were three cases when the reviewer felt there was an inadequate response by the hospital. In such a small sample it is not possible to suggest that this may reflect the pattern on a larger scale, however the fact that some complaints were not dealt with adequately is a potential cause of further complaints in the future and needs to be explored.
Limitations
This study included a limited number of case-notes and in one specialty which may not be representative. A larger more comprehensive study involving more sites and specialties would be required to ensure extrapolation would be possible. However, the results do follow some of the patterns found in other studies, for example the fact that lack of information appears to be the most common reason for complaints, 1,2,14 an issue that may merit further investigation.
Conclusion
This study has taken an in-depth analysis of claims/complaints in an orthopaedic department. It suggests that adverse events are not being acknowledged and that there is a need for more openness with patients. As such, a larger study is needed to explore the extent of these issues.
Footnotes
a
‘Any event or circumstance arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage’ 18
b
Complications often occur as part of surgical procedures, but a complication is something that is usually an expected part of a specific procedure, rather than unexpected in the case of adverse events. However, these two definitions are not mutually exclusive, i.e. half of most adverse events are not preventable and so are considered to be complications 1,2,14
c
Negligence is the omission to do something which a reasonable person, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do or doing something which a prudent and reasonable person would not do (Powers and Harris)