Abstract
Objectives
Infection following orthopaedic surgery is a feared complication and an indicator of the quality of the hospital. Surgical antibiotic prophylaxis (SAP) guidelines are not always properly followed. Our aim was to describe and evaluate the impact of a multidisciplinary intervention on antibiotic prophylaxis adherence to hospital guidelines and 30-day postoperative outcomes.
Methods
The study was carried out from January to May 2016 and consisted of creating a multidisciplinary team, updating institutional guidelines and embedding the recommendations in the computerised physician order entry system which is linked to dose and renal function alerts, educational activities and pharmaceutical bedside care of patients in the orthopaedic department. A prospective pre–post study was carried out in accordance with the Declaration of Helsinki. The following information was recorded: patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30 days after discharge. Statistical analyses were performed using SPSS 18.0.
Results
Eighty three orthopaedic patients of mean±SD age 68.2±17.0 years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included. Cefazolin was the recommended and most commonly administered antibiotic agent. In the intervention group, an improvement in global adherence to guidelines was achieved (76.7% vs 89.9%; p=0.039): antibiotic duration (75.0% vs 97.7%), correct dosage post-surgery (55.0% vs 76.7%), timing of administration (57.5% vs 72.1%), antibiotic pre-surgery prescription (92.5% vs 97.7%). Three surgical site infections were detected in the pre-intervention group and none in the intervention group (p>0.05). Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038).
Conclusions
SAP is used in daily practice in most orthopaedic patients. The implementation of a multidisciplinary programme based on health technology improved the adherence to guidelines and appeared to reduce the readmission rate.
Keywords: antibiotic prophylaxis, orthopaedics, guideline adherence, clinical outcomes, health information technologies, surgical site infection
Introduction
Post-surgical infection is one of the most dreaded complications of orthopaedic procedures. It is associated with prolonged hospitalisation and increased morbidity and mortality.1 Approximately 1–5% of patients undergoing orthopaedic operations such as total hip replacement or total knee replacement develop a superficial or deep infection.2–4 Therefore, prevention of surgical site infections (SSIs) is considered a patient safety measure and a quality standard in most quality improvement initiatives. In Spain the readmission rate due to SSIs is included in the list of health quality indicators that are published every year by regional health authorities.5
The role of antibiotic prophylaxis in total joint replacement surgery is well established in the literature.6 A meta-analysis reported that the administration of prophylactic antibiotics reduced the relative risk of wound infection by 81%.7 Moreover, optimisation of this antimicrobial prophylaxis has proved to be one of the most important interventions in preventing SSIs.8 9 Numerous guidelines on surgical antimicrobial prophylaxis (SAP) have been published, but they differ in drug selection, dosing, timing and indication for postoperative antibiotics.4 Consequently, each hospital creates its protocols based on the recommendations and its particular aetiology.10 Various studies have been conducted in different countries describing the poor adherence to SAP guidelines in clinical practice.11 Results from the National Surgical Infection Prevention Project in the USA involving patients with hip fractures showed that only 55.7% of patients received an effective first dose of SAP.12 A recent chart review from the UK found that 76% of patients with hip fractures received antibiotics outside the prescribed dosing interval.4 These results show that adherence to SAP remains suboptimal in clinical practice, which leaves much room for improvement in this area. In this context, some studies have reported that Clinical Decision Support (CDS) systems can supply real-time information that can help to improve antibiotic use, reducing variability in prescriptions and medication errors.13
We describe the design, implementation and assessment of a programme based on a multidisciplinary approach and health information technologies to increase SAP adherence in clinical practice. The objectives of this study were (1) to describe the protocol and the prescription and administration of SAP among patients undergoing orthopaedic surgery and (2) to assess the impact of the programme on improving compliance with guidelines and 30-day postoperative outcomes.
Methods
Setting
A tertiary teaching hospital performing 3700 orthopaedic surgeries per year.
Study design and population
A quasi-experimental pre–post prospective study was designed. All adult patients undergoing planned spinal, total knee, total hip or hip fracture surgery between January and May 2016 were included and divided into two groups:
Pre-intervention group: patients who underwent surgery before the programme was implemented (inclusion period March 2016 and 30 days follow-up).
Post-intervention group: patients who underwent orthopaedic surgery after the programme implementation and diffusion (inclusion period May 2016 and 30 days follow-up).
Patients who were prescribed antibiotics for the treatment of a suspected or proven infection before surgery were excluded.
The primary endpoint was a quality improvement approach: SAP adherence to hospital protocol.
Ethical aspects
The study was carried out in accordance with the World Medical Association Declaration of Helsinki and was approved by the Institutional Review Board and by the hospital’s ethics committee.
Programme: bundle of interventions
A multidisciplinary team called GAIO (Grupo de Apoyo a la Infección Osteoarticular) including surgeons, infectious diseases specialists, preventive medicine specialists and pharmacists was reactivated (January 2016).
Updating the hospital protocol: a SAP protocol was prepared in 2012 based on the clinical practice guidelines available at the time and then updated in 2016 according to recent publications.2–4 12 14 15 The major changes approved by the GAIO group were the use of vancomycin for some patients, reduction of antibiotic duration to 24 hours and description of necessary dose adjustments according to renal function and weight. This protocol provided several practical recommendations for the management of SAP in our clinical setting which are shown in table 1. It was printed in pocket size and distributed to all the personnel involved (February 2016).
Analysis of adherence to these new protocol recommendations in the pre-intervention: March 2016.
- Study intervention:
- Embedding the protocol into the computerised physician order entry system (CPOE) linked to renal function and dose alerts. The CPOE allowed surgeons to choose between cefazolin and vancomycin, then the medication dosages and administration time schedule were automatically prescribed. Therefore, when a patient was admitted to the hospital for orthopaedic surgery, the physician uploaded the SAP protocol into the electronic prescription. This electronic prescription, specifically medication dosages, was automatically checked with the patient laboratory data and an alert was automatically generated if a change must be made. This made the recommendations available to the prescriber at the time of antibiotic prescribing and to the nurses at the time of administration (April 2016).
- Offering educational sessions with the aim of promoting evidence-based SAP practice and increasing awareness. A total of 30 pharmacy-led training sessions were carried out including sessions to orthopaedic surgeons, nurses and residents (April 2016).
- Four pharmacy-led training sessions on CPOE use, alerts and electronic SAP protocol availability were also carried out (April 2016).
Pharmaceutical patient care bed monitoring (May 2016): a part-time pharmacist was assigned to patient care monitoring in the ward after surgery.
Analysis of adherence to protocol recommendations in the post-intervention group: May 2016. In addition, a pharmacist was assigned to patient care monitoring in the ward after surgery.
Table 1.
Surgical antibiotic institutional prophylaxis protocol for orthopaedic surgery
| Protocol features | Recommendation |
| Antibiotic prescription choice | Cefazolin is the drug of choice due to its broad coverage of microorganisms and its relatively low cost. Vancomycin should be prescribed as an alternative in patients with β-lactam allergy and added to cefazolin in patients with prior isolates of methicillin-resistant strains of S aureus (MRSA). |
| Pre-surgical administration: dose and timing | A single dose of 2 g cefazolin should be administered in the operating room 15–60 min before surgical incision (alternatively or additionally, 1 g vancomycin should be administered 60 min before incision, starting the administration 120 min before incision in the orthopaedic ward) |
| Intraoperative redosing | If surgery exceeded 4 hours or blood loss >1 L, a new cefazolin dose should be administered |
| Antibiotic duration | Postoperative antibiotic administration should not exceed 24 hours following surgery (a total of three doses of cefazolin every 8 hours and two doses of vancomycin every 12 hours) |
| Postoperative dosage adequate for patient weight and renal function | Doses should be adjusted to renal function (if the glomerular filtration rate is <50 mL/min) and patient body weight (cefazolin 1 g if <70 kg and 2 g if >70 kg, vancomycin 1 g if <95 kg and 1.5 g if >95 kg, respectively) |
Assessment
The following information was recorded: demographic (age, gender and body weight) and clinical data before and after surgery (haemoglobin, lymphocytes and glomerular filtration rate), type of procedure and its duration (time at beginning and end of surgery), SAP, development of fever (>37.5°C) during post-surgical hospitalisation, incidence of suspected or confirmed SSI and length of hospital stay. Patients were followed up for 30 days after discharge and visits to the emergency department or readmissions in that period were also recorded.
The information was collected without the involvement of the surgeons who prescribed or administered the SAP to avoid study bias. The information on SAP adherence was collected by trained pharmacy students and the pharmacist assigned to the orthopaedic ward. They used medical records to collect the antibiotic prescription and administration, the dose, time of antibiotic administration and redosing in the operating room. Administration of antibiotics in the ward and the duration and dosage after surgery was collected at the bedside.
Patients with missing data were considered as non-compliant with the protocol. Antibiotic appropriateness was evaluated according to global adherence to the protocol in all items (antibiotic selection, timing, intraoperative redosing, dosage and duration).
Categorical data were reported as counts and percentages while continuous data were reported as medians with IQR. Adherence to the guidelines and clinical outcomes in the pre- and post-intervention groups were compared using χ2 and Fisher’s exact tests. A significance criterion of p<0.05 was used as the threshold for significance. Statistical analyses were performed using SPSS 18.0.
Results
Forty patients met the inclusion criteria and were included in the study in the pre-intervention group and 43 in the post-intervention group. The characteristics of the patients are shown in table 2. Almost half of the patients were male (44.6%) with a median age of 73.9 years and a median weight of 72.0 kg. The most common procedure was knee surgery (41%), followed by hip surgery. No statistically significant differences were found between the characteristics of the two groups.
Table 2.
Demographic and baseline characteristics of patients in the pre- and post-intervention groups
| Characteristics | Pre-intervention group (n=40) | Post-intervention* group (n=43) | Total (n=83) |
| Gender, n (%) | |||
| Male | 17 (42.5%) | 20 (46.5%) | 37 (44.6%) |
| Age (years) | 72.8 (63.2, 81.3) | 73.0 (54.7, 78.1) | 73.9 (58.7, 81.8) |
| Weight (kg) | 71.0 (55.2, 78.2) | 75.1 (68.0, 85.2) | 72.0 (60.4, 83.7) |
| Allergy, n (%) | |||
| Beta-lactam antibiotics | 1 (2.5%) | 3 (6.9%) | 4 (4.8%) |
| Lymphocyte count (x106/L) | |||
| Pre† | 1.2 (0.8, 1.8) | 1.9 (1.2, 2.3) | 1.45 (1.0, 2.3) |
| Post | 1 (0.8, 1.3) | 1.1 (0.9, 1.4) | 1.1 (0.8, 1.3) |
| Neutrophil count (x109/L) | |||
| Pre | 5.3 (3.6, 6.4) | 4.2 (3.3, 6.2) | 4.7 (3.4, 6.3) |
| Post | 6.6 (4.2, 8.4) | 6.7 (5.3, 8.6) | 6.6 (5.2, 8.6) |
| Patients with renal impairment n (%) | |||
| Mild (<50 mg/mL) |
5 (12.5%) | 4 (9.3%) | 9 (10.8%) |
| Moderate (<30 mg/mL) |
2 (5.0%) | 2 (4.6%) | 4 (4,8%) |
| Haemoglobin level (g/dL) | |||
| Pre | 12.1 (10.7, 14.3) | 13.4 (12.4, 14.8) | 13.1 (11.3, 14.5) |
| Post | 10.7 (9.6, 12.1) | 11.5 (10.2, 12.2) | 11.2 (9.8, 12.1) |
| Orthopaedic procedure, n (%) | |||
| Total knee replacement | 15 (37.5%) | 19 (44.2%) | 34 (41.0%) |
| Total hip replacement | 15 (37.5%) | 11 (25.6%) | 26 (31.3%) |
| Lower limb | 8 (20.0%) | 7 (16.3%) | 15 (18.1) |
| Spinal | 2 (5.0%) | 6 (13.9%) | 8 (9.6%) |
All values are expressed as median (IQR) unless stated otherwise.
*p>0.05; non-significant differences between groups in all variables collected.
†Pre, before surgery; post, after surgery.
Impact of the programme on SAP adherence
In the intervention group a statistically significant improvement in total adherence to the SAP protocol was achieved (p=0.039) with 5% improvement in antibiotic selection and administration, 15% in correct timing of presurgical administration, 10% in redosing during surgery, 23% in appropriate antibiotic duration and 22% in appropriate dosage after surgery. SAP adherence to the protocol is shown in table 3.
Table 3.
Surgical antibiotic prophylaxis (SAP) adherence before and after programme implementation
| Feature | Pre-intervention group (n=40) | Post-intervention group (n=43) | Total (n=83) |
| Antibiotic prescription choice | 37 (92.5%) | 42 (97.7%) | 79 (95.2%) |
| Antibiotic administration | 37 (92.5%) | 42 (97.7%) | 79 (95.2%) |
| Presurgical antibiotic dose | 37 (92.5%) | 42 (97.7%) | 79 (95.2%) |
| Presurgical time of administration | 23 (57.5%) | 31 (72.1%) | 54 (68.4%) |
| Intraoperative redosing | 35 (87.5%) | 42 (97.7%) | 77 (92.8%) |
| Duration | 30 (75.0%) | 42 (97.7%) | 72 (86.5%) |
| Postoperative dosage | 22 (55.0%) | 33 (76.7%) | 55 (66.3%) |
All data are expressed as n (%).
Preoperative antibiotic selection, prescription and administration
All physicians used the electronic protocol embedded in the CPOE in the intervention group. Administration of the antibiotic at the time of surgery was recorded in 79 patients (95.2%): 37/40 (92.5%) and 42/43 (97.7%) patients in the pre-intervention and intervention groups, respectively.
Cefazolin was the most commonly prescribed antibiotic agent, administered in 89.2% of patients (36 in the pre-intervention group and 38 in the intervention group). Vancomycin was prescribed as a single regimen in one patient in the pre-intervention group and in four patients in the intervention group reporting an allergy to beta-lactam antibiotics or with prior isolates of MRSA. Consequently, the recommended antibiotic agent was chosen in accordance with the current protocol and guidelines (37/40 in the pre-intervention group and 42/43 in the intervention group).
Timing of preoperative antibiotic dose administration and intraoperative redosing
It is important to note that the recommended preoperative dosage (cefazolin 2 g and vancomycin 1 g) was administered in all patients who received antibiotics prior to surgery (n=79; 95.2%).
In the pre-intervention group 57.5% of patients received the preoperative dose at the recommended time compared with 72.1% in the intervention group (non-significant; p>0.05). Preoperative dose timing of SAP could not be determined in three patients in the pre-intervention group and five in the intervention group. The end of vancomycin administration was at least 30 min before the surgery in all patients (n=5). The time of administration of cefazolin before surgery is shown in figure 1. The average time of antibiotic administration before surgery was 28 min (range 9–39 min) in the pre-intervention group and 29 min (range 11–40 min) in the intervention group.
Figure 1.
Timing of cefazolin administration before surgery.
All operations were performed in less than 4 hours, so redosing during surgery was not necessary in any case according to the protocol. However, two patients in the pre-intervention group were redosed in the operating room, which was deemed as inappropriate.
Postoperative antibiotic duration and dosage
Postoperative antibiotic was prescribed and correctly chosen in 34 patients in the pre-intervention group and in 42 in the intervention group. The duration of antibiotic treatment exceeded the recommended 24 hours in four patients in the pre-intervention group, so 30 patients (75.0%) in the pre-intervention group were prescribed antibiotic agents for an adequate length of time compared with 42 patients in the intervention group (97.7%) (non-significant; p>0.05).
Almost half of the patients required a dose adjustment after surgery, 35.4% due to their body weight and 6.3% due to their glomerular filtration rate. The number of patients who received appropriate postoperative doses was 22 (55.0%) in the pre-intervention group compared with 33 (76.7%) in the intervention group (non-significant; p>0.05).
Patient clinical outcomes
During hospitalisation, 15 (37.5%) patients developed fever in the pre-intervention group compared with 12 (27.9%) in the intervention group (non-significant; p>0.05). The median duration of fever was 1 (range 0–1) versus 2 (range 1–3.5) days. The median hospital stay was reduced from 8 days to 7 days. Readmission at 30 days post-discharge was reduced from eight patients (20.0%) in the pre-intervention group to two patients (4.6%) in the intervention group (p=0.038). Five of those readmissions were related to a possible infection: three patients in the pre-intervention group and two in the intervention group (non-significant; p>0.05). The SSI was confirmed in two patients in the pre-intervention group: one was treated with antibiotics and the other one with surgery.
Discussion
There is robust evidence to support the use of SAP in orthopaedic surgery in order to reduce SSIs. Prevention and control of SSIs has recently become a healthcare quality indicator and, consequently, SAP administration should be measured and improved if necessary.4 5 Studies on SAP have identified antibiotic choice, timing, intraoperative redosing and duration as the key points to ensure SSI prevention.16 17 We found that the use of SAP in our setting was extended and that adherence to guidelines was high in the pre-intervention and intervention groups, and comparable to data in the literature.18
Bratzler and Hickson Surgical Infection Prevention Guidelines advise that antimicrobial doses should be based on the patient’s body weight and renal function12 19 In our study, 55.0% of patients received a dose which was appropriately adjusted to these variables in the pre-intervention group compared with 76.7% in the intervention group. This is a poorer result than those obtained in the literature,20 which shows that there is room for improvement in this area. Future measures will include implementing a CDS system that cross-matches body weight and renal function in real time with the prescribed antibiotic dose to trigger an alert if an inadequacy is detected. These tools have proved to be effective in reducing medication errors.21
The duration of postoperative antibiotic administration was highly appropriate with no unnecessary extra doses administered after implementation of the programme: a 24-hour regimen of intravenous SAP giving three doses after surgery was used in the majority of cases and only four patients, all in the pre-intervention group, exceeded the recommended 24 hours. Some evidence supports the trend towards shorter duration of antibiotic administration after surgery. In a systematic review of SAP for proximal femoral and other closed long bone fractures, a single dose was found to significantly reduce the risk of deep SSIs.22 Current evidence from meta-analyses, including a Cochrane review, has not shown a difference between single-dose preoperative SAP and multiple-dose prophylaxis.22 However, the authors could not definitively recommend a prophylactic regimen owing to wide confidence intervals around the pooled risk ratio. The use of a single dose has increased in our clinical practice. This may demonstrate a changing trend towards the use of single-dose prophylaxis that could be implemented in the future.
The timing of SAP remains controversial.21 Administration more than 60 min before surgery is associated with a higher risk of SSI because of the short half-life of most commonly used antibiotics. A study reported that, in a population of 32 459 patients, those who had received prophylaxis after incision were at a higher risk for SSI; hence, the authors suggested that intervention programmes should focus on timely antibiotic administration.23 In our study, more than 40% of our patients in the pre-intervention group and more than 25% in the intervention group received the preoperative dose at an inappropriate time before surgery. This result is similar to that of Beer et al 16 and contrasts with those found in other studies, which reported appropriate timing in 80% of procedures.11 It needs to be pointed out that documentation regarding the timing was missing for some of our patients, which was considered as inappropriate, so wrong timing could have been overestimated. Implementation of the programme seems to improve the timing of administration, decreasing the number of patients receiving prophylaxis less than 15 min before surgery and no patient received cefazolin more than 60 min before surgery in the intervention group. In future, the planned implementation of an electronic medication administration record to be used at the moment of drug administration in the operating room could further improve these results and decrease the number of missing data.
SAP guidelines have been available in our institution for 3 years, a checklist that includes confirmation of antibiotic administration before surgery has been long implemented and several actions promoting SAP were carried out in 2012. These facts could explain the high rates of preoperative prophylaxis administration in both groups, which was higher than in other studies: 92.5% in the pre-intervention group and 97.7% in the post-intervention group. Since cefazolin 2 g was used in most of our study population, SAP prescription can be considered fairly uniform in our clinical practice and in accordance with the recommendations of the American Society of Health System Pharmacists.2 Similarly, two studies from Canada and Australia found that almost all patients received an appropriate preoperative antibiotic dose for closed fractures24 and for prosthetic knee and hip joint replacements,25 respectively.
No previous study has described the impact on the quality of SAP of a bundle of interventions: a multidisciplinary team with expertise in infections, updating institutional guidelines, embedding the recommendations in the CPOE system also linked to dose and renal function alerts, educational activities and pharmaceutical monitoring. In a study conducted by Willemsen et al a standardised protocol for perioperative SAP was associated with improvement in antibiotic dosing and timing.26 Education strategies have also been shown to be a key aspect for protocol implementation in clinical practice.27 Moreover, it has been reported that the greatest impact is achieved when guidelines become available through computer-based reminders integrated into the clinician’s workflow, as implemented in our study.13 In a study by Yang et al the number of patients with appropriate duration of SAP improved from 11% with paper guidelines to 70% after the implementation of a CPOE.21 In our study, although the correct use of SAP was already high in the pre-intervention group, adherence to the protocol increased by 13% after implementation. Moreover, clinical outcomes also improved slightly, decreasing the length of hospital stay by 1 day and the readmission rate during the 30 days after discharge by 15%. We plan to incorporate a CDS system that will incorporate real-time recommendations, taking into account patient weight and renal function and an electronic administration medical record in the operating room. In addition, we will soon instigate a clinical pharmacist to be present in the operating room. As part of a multidisciplinary team, their feedback will help to enhance the appropriateness of drug prescribing.28
The limitations of this study include the relatively small sample size in both the pre- and post-intervention groups and the fact that it was performed at a single institution. Nevertheless, the results are consistent with previous reports from other hospitals. Another limitation is that patients were followed up for only 1 month after surgery, focusing only on superficial infections. There was no statistical difference in the readmission rate due to a possible infection. In our institution there were 1.3% of orthopaedic infections in knee operations in 2015, so we would need more than 3000 patients per group in order to demonstrate a reduction in the rate of infection from 2% to 1%. In this context our data are of interest, demonstrating an improvement in SAP adherence to the hospital protocol and contributing to the understanding of antibiotic prophylaxis prior to surgery. We believe our results may promote the extension of this easily implementable bundle of interventions to other tertiary institutions. We also suggest new measures based on health information technology that may allow continued improvement in clinical practice.
Conclusion
SAP was found to be commonly used in our institution with a high compliance with established guidelines. The implementation of a bundle of interventions based on a multidisciplinary approach, education and health technologies improved the quality and safety of patient care. The bundled metrics, improved programme design and implementation techniques are low cost and easily implementable in other teaching tertiary institutions and offer a pragmatic method of achieving healthcare excellence.
What this paper adds.
What is already known on this subject
1–5% of orthopaedic operations such as total hip replacement and total knee replacement develop a superficial or deep infection.
Antibiotic prophylaxis plays an important role in reducing the rate of surgical infections. However, there is no consensus on how to optimise drug selection, dosing, timing and the need for postoperative redosing.
What this study adds
We describe a comprehensive easy-to-implement surgical antibiotic prophylaxis protocol which achieved a high rate of adherence and improved the 30-day readmission rate in our institution.
We suggest an easy way in which available health information technologies can help to decrease the risk of surgical site infections.
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests: None declared.
Patient consent: Not required.
Provenance and peer review: Not commissioned; externally peer reviewed.
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