The “Universal Protocol” (UP) was launched as a regulatory compliance standard by the Joint Commission on 1st July 1 2004, with the primary intent of reducing the occurrence of wrong-site and wrong-patient surgery. As we’re heading into the tenth year of the UP implementation in the United States, it is time for critical assessment of the protocol’s impact on patient safety related to the incidence of preventable never-events. This article opens the debate on the potential shortcomings and pitfalls of the UP, and provides recommendations on how to circumvent specific inherent vulnerabilities of this widely established patient safety protocol.
Patient-centred medicine is an approach to medical care that emphasises the patient experience. Treatment outcome measures reflect this experience, and outcomes are measured by obtaining patient feedback. Central to this type of care is the patient-physician relationship. Communication, physician empathy, and shared decision making are key components of this relationship. Patient-centred care is correlated with better patient outcomes across medical specialties and higher patient perceived quality of care. Payors are now using patient-centred quality measures in their physician reimbursement schedules.
We determined the frequency, rate and extent
of development of scoliosis (coronal plane deformity) in wheelchair-dependent
patients with Duchenne muscular dystrophy (DMD) who were not receiving
steroid treatment. We also assessed kyphosis and lordosis (sagittal
plane deformity). The extent of scoliosis was assessed on sitting anteroposterior
(AP) spinal radiographs in 88 consecutive non-ambulatory patients
with DMD. Radiographs were studied from the time the patients became
wheelchair-dependent until the time of spinal fusion, or the latest assessment
if surgery was not undertaken. Progression was estimated using a
longitudinal mixed-model regression analysis to handle repeated
measurements. Scoliosis ≥ 10° occurred in 85 of 88 patients (97%), ≥ 20° in
78 of 88 (89%) and ≥ 30° in 66 of 88 patients (75%). The fitted
longitudinal model revealed that time in a wheelchair was a highly
significant predictor of the magnitude of the curve, independent
of the age of the patient (p <
0.001). Scoliosis developed in
virtually all DMD patients not receiving steroids once they became
wheelchair-dependent, and the degree of deformity deteriorated over
time. In general, scoliosis increased at a constant rate, beginning
at the time of wheelchair-dependency (p <
0.001). In some there
was no scoliosis for as long as three years after dependency, but
scoliosis then developed and increased at a constant rate. Some
patients showed a rapid increase in the rate of progression of the
curve after a few years – the clinical phenomenon of a rapidly collapsing
curve over a few months. A sagittal plane kyphotic deformity was seen in 37 of 60 patients
(62%) with appropriate radiographs, with 23 (38%) showing lumbar
lordosis (16 (27%) abnormal and seven (11%) normal). This study provides a baseline to assess the effects of steroids
and other forms of treatment on the natural history of scoliosis
in patients with DMD, and an approach to assessing spinal deformity
in the coronal and sagittal planes in wheelchair-dependent patients
with other neuromuscular disorders. Cite this article:
Despite the increasing prevalence of sleep apnoea,
little information is available regarding its impact on the peri-operative
outcome of patients undergoing posterior lumbar fusion. Using a
national database, patients who underwent lumbar fusion between
2006 and 2010 were identified, sub-grouped by diagnosis of sleep
apnoea and compared. The impact of sleep apnoea on various outcome
measures was assessed by regression analysis. The records of 84
655 patients undergoing posterior lumbar fusion were identified
and 7.28% (n = 6163) also had a diagnostic code for sleep apnoea.
Compared with patients without sleep apnoea, these patients were
older, more frequently female, had a higher comorbidity burden and
higher rates of peri-operative complications, post-operative mechanical
ventilation, blood product transfusion and intensive care. Patients
with sleep apnoea also had longer and more costly periods of hospitalisation. In the regression analysis, sleep apnoea emerged as an independent
risk factor for the development of peri-operative complications
(odds ratio (OR) 1.50, confidence interval (CI) 1.38;1.62), blood
product transfusions (OR 1.12, CI 1.03;1.23), mechanical ventilation
(OR 6.97, CI 5.90;8.23), critical care services (OR 1.86, CI 1.71;2.03), prolonged
hospitalisation and increased cost (OR 1.28, CI 1.19;1.37; OR 1.10,
CI 1.03;1.18). Patients with sleep apnoea who undergo posterior lumbar fusion
pose significant challenges to clinicians. Cite this article:
There have been a few reports of patients with
a combination of lumbar and thoracic spinal stenosis. We describe six
patients who suffered unexpected acute neurological deterioration
at a mean of 7.8 days (6 to 10) after lumbar decompressive surgery.
Five had progressive weakness and one had recurrent pain in the
lower limbs. There was incomplete recovery following subsequent
thoracic decompressive surgery. The neurological presentation can be confusing. Patients with
compressive myelopathy due to lower thoracic lesions, especially
epiconus lesions (T10 to T12/L1 disc level), present with similar
symptoms to those with lumbar radiculopathy or cauda equina lesions.
Despite the rarity of this condition we advise that patients who
undergo lumbar decompressive surgery for stenosis should have sagittal
whole spine MRI studies pre-operatively to exclude proximal neurological
compression. Cite this article:
The October 2013 Research Roundup360 looks at: Orthopaedics: a dangerous profession?; Freezing and biomarkers for bone turnover; Herniation or degeneration first?; MARS MRI and metallosis; Programmed cell death in partial thickness cuff tears; Lead glasses for trauma surgery?; Smoking inhibits bone healing; Optimising polyethylene microstructure.
We investigated the pre-operative and one-year post-operative health-related quality of life (HRQoL) outcome by using a Euroqol (EQ-5D) questionnaire in 230 patients who underwent surgery for lumbar spinal stenosis. Data were obtained from the National Swedish Registry for operations on the lumbar spine between 2001 and 2002. We analysed the pre- and postoperative quality of life data, age, gender, smoking habits, pain and walking ability. The relative differences were compared to a Swedish EQ-5D population survey. The mean age of the patients was 66 years, and there were 123 females (53%). Before the operation 62 (27%) of the patients could walk more than 500 m. One year after the operation 150 (65%) were able to walk 500 m or more. The mean EQ-5D score improved from 0.36 to 0.64, and the HRQoL improved in 184 (80%) of the patients. However, they did not reach the level reported by a matched population sample (mean difference 0.18). Women had lower pre- and post-operative EQ-5D scores than men. Severe low back pain was a predictor for a poor outcome.
This study assessed the effect of concomitant
back pain on the Oxford knee score (OKS), Short-Form (SF)-12 and patient
satisfaction after total knee replacement (TKR). It involved a prospectively
compiled database of demographics and outcome scores for 2392 patients
undergoing primary TKR, of whom 829 patients (35%) reported back
pain. Compared with those patients without back pain, those with
back pain were more likely to be female (odds ratio (OR) 1.5 (95%
confidence interval (CI) 1.3 to 1.8)), have a greater level of comorbidity,
a worse pre-operative OKS (2.3 points (95% CI 1.7 to 3.0)) and worse
SF-12 physical (2.0 points (95% CI 1.4 to 2.6)) and mental (3.3
points (95% CI 2.3 to 4.3)) components. One year post-operatively, those with back pain had significantly
worse outcome scores than those without with a mean difference in
the OKS of 5 points (95% CI 3.8 to 5.4), in the SF-12 physical component
of 6 points (95% CI 5.4 to 7.1) and in the mental component of
4 points (95% CI 3.1 to 4.9). Patients with back pain were less
likely to be satisfied (OR 0.62, 95% CI 0.5 to 0.78). After adjusting for confounding variables, concomitant back pain
was an independent predictor of a worse post-operative OKS, and
of dissatisfaction. Clinicians should be aware that patients suffering
concomitant back pain pre-operatively are at an increased risk of
being dissatisfied post-operatively. Cite this article:
We studied 70 consecutive patients with adolescent idiopathic scoliosis who underwent corrective surgery. They were divided into two groups. In the study group of 38 patients one or more modern blood-conservation measures was used peri-operatively. The 32 patients in the control group did not have these measures. Both groups were similar in regard to age, body-weight, the number of levels fused and the type of surgery. Only two patients in the study group were transfused with homologous blood and these transfusions were ‘off-protocol’. Wastage of autologous pre-donated units was minimal (6 of 83 units). By contrast, all patients in the control group were transfused with homologous blood. In the study group there was a significant decrease (p = 0.005) in the estimated blood loss when all the blood-conservation methods were used. The use of blood-conservation measures, the lowering of the haemoglobin trigger for transfusion and the education of the entire team involved in the care of the patient can prevent the need for homologous blood transfusion in patients undergoing surgery for adolescent idiopathic scoliosis.
We investigated the spinopelvic morphology and
global sagittal balance of patients with a degenerative retrolisthesis
or anterolisthesis. A total of 269 consecutive patients with a degenerative
spondylolisthesis were included in this study. There were 95 men
and 174 women with a mean age of 64.3 years ( A backward slip was found in the upper lumbar levels (mostly
L2 or L3) with an almost equal gender distribution in both the R
and R+A groups. The pelvic incidence and sacral slope of the R group
were significantly lower than those of the A (both p <
0.001)
and R+A groups (both p <
0.001). The lumbar lordosis of the R+A
group was significantly greater than that of the R (p = 0.025) and
A groups (p = 0.014). The C7 plumb line of the R group was located
more posteriorly than that of the A group (p = 0.023), but was no
different from than that of the R+A group (p = 0.422). The location
of C7 plumb line did not differ between the three groups (p = 0.068).
The spinosacral angle of the R group was significantly smaller than
that of the A group (p <
0.001) and R+A group (p <
0.001). Our findings imply that there are two types of degenerative retrolisthesis:
one occurs primarily as a result of degeneration in patients with
low pelvic incidence, and the other occurs secondarily as a compensatory
mechanism in patients with an anterolisthesis and high pelvic incidence. Cite this article:
We hypothesised that the use of computer navigation-assisted
surgery for pelvic and sacral tumours would reduce the risk of an
intralesional margin. We reviewed 31 patients (18 men and 13 women)
with a mean age of 52.9 years (13.5 to 77.2) in whom computer navigation-assisted
surgery had been carried out for a bone tumour of the pelvis or
sacrum. There were 23 primary malignant bone tumours, four metastatic
tumours and four locally advanced primary tumours of the rectum.
The registration error when using computer navigation was <
1 mm
in each case. There were no complications related to the navigation,
which allowed the preservation of sacral nerve roots (n = 13), resection
of otherwise inoperable disease (n = 4) and the avoidance of hindquarter
amputation (n = 3). The intralesional resection rate for primary
tumours of the pelvis and sacrum was 8.7% (n = 2): clear bone resection
margins were achieved in all cases. At a mean follow-up of 13.1
months (3 to 34) three patients (13%) had developed a local recurrence.
The mean time alive from diagnosis was 16.8 months (4 to 48). Computer navigation-assisted surgery is safe and has reduced
our intralesional resection rate for primary tumours of the pelvis
and sacrum. We recommend this technique as being worthy of further
consideration for this group of patients. Cite this article:
We investigated the capacity of patient warming
devices to disrupt the ultra-clean airflow system. We compared the effects
of two patient warming technologies, forced-air and conductive fabric,
on operating theatre ventilation during simulated hip replacement
and lumbar spinal procedures using a mannequin as a patient. Infection
data were reviewed to determine whether joint infection rates were
associated with the type of patient warming device that was used. Neutral-buoyancy detergent bubbles were released adjacent to
the mannequin’s head and at floor level to assess the movement of
non-sterile air into the clean airflow over the surgical site. During
simulated hip replacement, bubble counts over the surgical site
were greater for forced-air than for conductive fabric warming when
the anaesthesia/surgery drape was laid down (p = 0.010) and at half-height
(p <
0.001). For lumbar surgery, forced-air warming generated
convection currents that mobilised floor air into the surgical site
area. Conductive fabric warming had no such effect. A significant increase in deep joint infection, as demonstrated
by an elevated infection odds ratio (3.8, p = 0.024), was identified
during a period when forced-air warming was used compared to a period
when conductive fabric warming was used. Air-free warming is, therefore,
recommended over forced-air warming for orthopaedic procedures.
This study evaluates the long-term survival of
spinal implants after surgical site infection (SSI) and the risk
factors associated with treatment failure. A Kaplan-Meier survival analysis was carried out on 43 patients
who had undergone a posterior spinal fusion with instrumentation
between January 2006 and December 2008, and who consecutively developed
an acute deep surgical site infection. All were appropriately treated
by surgical debridement with a tailored antibiotic program based
on culture results for a minimum of eight weeks. A ‘terminal event’ or failure of treatment was defined as implant
removal or death related to the SSI. The mean follow-up was 26 months
(1.03 to 50.9). A total of ten patients (23.3%) had a terminal event.
The rate of survival after the first debridement was 90.7% (95%
confidence interval (CI) 82.95 to 98.24) at six months, 85.4% (95%
CI 74.64 to 96.18) at one year, and 73.2% (95% CI 58.70 to 87.78)
at two, three and four years. Four of nine patients required re-instrumentation
after implant removal, and two of the four had a recurrent infection
at the surgical site. There was one recurrence after implant removal
without re-instrumentation. Multivariate analysis revealed a significant risk of treatment
failure in patients who developed sepsis (hazard ratio (HR) 12.5
(95% confidence interval (CI) 2.6 to 59.9); p <
0.001) or who
had >
three fused segments (HR 4.5 (95% CI 1.25 to 24.05); p = 0.03).
Implant survival is seriously compromised even after properly treated
surgical site infection, but progressively decreases over the first
24 months. Cite this article:
The April 2013 Shoulder &
Elbow Roundup360 looks at: biceps, pressure and instability; chronic acromio-clavicular joint instability; depression and shoulder pain; shoulder replacement and transfusion; cuff integrity and function; iatropathic plexus injury; the accuracy of acromio-clavicular joint injection; and tennis as a risk factor for tennis elbow.
The purpose of this study was to investigate
the clinical predictors of surgical outcome in patients with cervical spondylotic
myelopathy (CSM). We reviewed a consecutive series of 248 patients
(71 women and 177 men) with CSM who had undergone surgery at our
institution between January 2000 and October 2010. Their mean age
was 59.0 years (16 to 86). Medical records, office notes, and operative
reports were reviewed for data collection. Special attention was
focused on pre-operative duration and severity as well as post-operative
persistence of myelopathic symptoms. Disease severity was graded
according to the Nurick classification. Our multivariate logistic regression model indicated that Nurick
grade 2 CSM patients have the highest chance of complete symptom
resolution (p <
0.001) and improvement to normal gait (p = 0.004)
following surgery. Patients who did not improve after surgery had
longer duration of myelopathic symptoms than those who did improve
post-operatively (17.85 months (1 to 101) vs 11.21 months (1 to
69); p = 0.002). More advanced Nurick grades were not associated
with a longer duration of symptoms (p = 0.906). Our data suggest that patients with Nurick grade 2 CSM are most
likely to improve from surgery. The duration of myelopathic symptoms
does not have an association with disease severity but is an independent
prognostic indicator of surgical outcome. Cite this article:
The June 2014 Spine Roundup360 looks at: spinal pedicle screws in paediatric patients; improving diagnosis in lumbar spine stenosis; back pain all in the head?; brace three patients, save one scoliosis operation; pedicle screws more often misplaced than one would think; and incidental dural tears usually no problem
We compared a group of 46 somatised patients with a control group of 41 non-somatised patients who had undergone elective surgery to the lumbar spine in an attempt to identify pre-operative factors which could predict the outcome. In a prospective single-centre study, the Distress and Risk Assessment method consisting of a modified somatic perception questionnaire and modified Zung depression index was used pre-operatively to identify somatised patients. The type and number of consultations were correlated with functional indicators of outcome, such as the Oswestry disability index and a visual analogue score for pain in the leg after follow-up for six and 12 months. Similar improvements in the Oswestry disability index were found in the somatised and non-somatised groups. Somatised patients who had a good outcome on the Oswestry disability index had an increased number of orthopaedic consultations (50 of 83 patients (60%) vs 29 of 73 patients (39.7%); p = 0.16) and waited less time for their surgery (5.5 months) (