Question

What is the policy regarding systemic antibiotics for the prevention of postoperative wound infection?

Recommendation

Administer a systemic antibiotic prophylaxis to all patients undergoing total hip arthroplasty, preferably cefazolin (kefzol) 2 grams i.v., 15 to 60 minutes before incision.

 

If BMI is >40 kg/m2 and/or if bodyweight is >130 kilograms, use cefazolin (kefzol) 3 grams i.v., 15 to 60 minutes before incision.

 

Give an additional dose (cefazolin 1 gram i.v.) if the operation lasts more than 4 hours or in case of blood loss >1500 milliliters.

 

In case 24 hours antibiotic prophylaxis is preferred, administer with cefazolin 1 gram after 8 hours and after 16 hours postoperatively (NB maximum dose 6 grams /24 hours).

 

Antibiotic prophylaxis should not be given for more than 24 hours.

 

Be aware of impaired renal function: if clearance 10 to 34, give cefazolin 500 milligrams 12 hours postoperatively; if clearance <10 no postoperative dose).

 

In case of cefalosporin allergy: clindamycin 600 milligrams (>180 kilograms: 900 milligrams), 15 to 60 minutes before incision. Give an additional dose (clindamycin 600 mg i.v.) if the operation lasts more than 6 hours or in case of blood loss >1500 milliliters.

 

In case 24 hours antibiotic prophylaxis is preferred: treat with 600 milligrams 8 and 16 hours postoperatively (clindamycin dose irrespective of renal function).

 

An alternative for clindamycin is vancomycin 1 gram i.v. (>100 kilograms: 10 milligrams/kilogram), start 60 to 120 minutes before incision. Give an additional dose (vancomycin 1 gram i.v.) if the operation lasts more than 8 hours or in case of blood loss >1500 milliliters. In case 24 hours antibiotic prophylaxis is preferred: repeat 1 gram i.v. after 12 hours*** (if clearance <50: no second dose).

 

***(assuming a daily dose of 2000 milligrams)

Introduction

The percentage of deep surgical wound infection after total hip arthroplasty (THA) in the Netherlands in the period 2012 to 2016 was 1.2% (1,162/100,254) (RIVM, 2017). Although THA is regarded as “clean surgery”, due to the severe consequences of these infections administration of systemic antibiotic prophylaxis is indicated. The antibiotic used for prophylaxis should be effective against the main bacterial causes and optimising the timing and dosage are essential to achieve the optimal concentration during the procedure, to prevent infection of the prosthesis.

Conclusions

Low

GRADE

Systemic antibiotics, compared to placebo, seem to decrease the risk of infection after total hip arthroplasty.

 

Sources (AlBuhairan, 2008; Voigt, 2015)

Literature summary

Description of studies

Two studies were included in this literature summary (see the evidence table) (Voigt, 2015; AlBuhairan, 2008). One study on pre-operative systemic antibiotics and antiseptics included a meta-analysis of three RCTs on pre-operative systemic antibiotics (N=1176) compared to placebo (N=1172) for hip replacement. Main outcome reported was infection at six months Voigt, (2015).

 

Another study, also included in the previous guideline, included seven RCTs (3065 patients) AlBuhairan, (2008).

 

Results

Infection risk

The study of Voigt (2015) showed that systemic antibiotics, compared to a placebo decreased the risk of infection after total hip prosthesis at six months (RR 0.23; 95%CI 0.12 to 0.43).

 

In the study of AlBuhairan (2018), the administration of antibiotics reduced the relative risk (RR) of wound infection by 81% (RR 0.19; 95% CI 0.12 to 0.31; chi-squared test, p<0.00001). Because such events are rare, this translates to an absolute risk reduction of 8%, meaning that one wound infection would be prevented for every 13 people treated compared with no administration of antibiotics (risk difference -0.08; 95% CI -0.03 to -0.12) AlBuhairan, (2008).

 

Grading of evidence

Infection risk

The evidence was graded as low, because there was not enough information provided in the RCTs to evaluate their quality regarding randomisation procedure and allocation concealment, and outcome assessors were not blinded to group assessment (risk of bias). Moreover, the study reported also broad confidence intervals (imprecision).

Search and select

To answer the question a systematic literature analysis was performed for the following research question:

 

What are the favourable and unfavourable effects of systemic antibiotics, compared to no antibiotics, in patients selected for total hip arthroplasty?

P: patients selected for total hip arthroplasty;

I: systemic antibiotic;

C: no antibiotics;

O: surgical site infection;

 

Relevant outcome measures

The working group decided that surgical site infections were critical outcome measure for decision making.

 

The working group defined any decrease of deep infections as clinically relevant.

 

Search and select (Method)

A literature search was performed with relevant search terms on november 23 2016 in the databases Medline (via OVID) and Embase (via Embase.com). The search strategy is provided in the tab ”Methods”. The literature search resulted in 209 hits. Studies were selected using the following selection criteria: original article, systematic review or meta-analysis; relevant to the question. Based on title and abstract 14 studies were preselected. After obtaining full text, thirteen studies were excluded (see exclusion table) and one study was included in literature analysis. Another study, included in the previous guideline, also fulfilled the PICO and was added to the literature summary.

 

The most important study characteristics are described in evidence tables. The assessment of risk of bias is provided in risk of bias tables.

References

  1. AlBuhairan B, Hind D, Hutchinson A. Antibiotic prophylaxis for wound infections in total joint arthroplasty: a systematic review. J Bone Joint Surg Br. 2008;90(7):915-9. PMID:18591602.
  2. Engesaeter LB, Lie SA, Espehaug B, et al. Antibiotic prophylaxis in total hip arthroplasty: effects of antibiotic prophylaxis systemically and in bone cement on the revision rate of 22,170 primary hip replacements followed 0-14 years in the Norwegian Arthroplasty Register. Acta Orthop Scand. 2003;74(6):644-51.
  3. van Kasteren ME, Manniën J, Ott A, Kullberg BJ, de Boer AS, Gyssens IC. Antibiotic prophylaxis and the risk of surgical site infections following total hip arthroplasty: timely administration is the most important factor. Clin Infect Dis. 2007; 44(7):921-7.
  4. PREZIES. Referentiecijfers 2012 tot 2016: Postoperatieve Wondinfecties PREZIES – versie: september 2017, Rijksinstituut voor Volksgezondheid en Milieu, RIVM.
  5. SWAB-Richtlijn: peri-operatieve profylaxe. 2017. https://www.swab.nl/swab/cms3.nsf/uploads/4D94EDC20735770BC12582BB002BDDCE/$FILE/SWAB%20richtlijn%20perioperatieve%20profylaxe%20algemeen%20juni%202018%20def%20%2B%20specifieke%20adviezen.pdf
  6. Voigt J, Mosier M, Darouiche R. Systematic review and meta-analysis of randomized controlled trials of antibiotics and antiseptics for preventing infection in people receiving primary total hip and knee prostheses. Antimicrob Agents Chemother. 2015;59(11):6696-707. PMID: 26259793.

Evidence tables

Evidence-table for systematic review of RCTs

Research question: Wat is het beleid met betrekking tot systemische antibiotica ter preventie van postoperatieve wondinfectie?

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control ©

 

Follow-up

Outcome measures and effect size

Comments

Voigt et al., 2015

SR and meta-analysis of 10 RCTs for preoperative systemic antibiotics in hip and knee: 4 RCTs studied preoperative systemic antibiotics compared to placebo

 

Literature search up to April 2015

 

A: Ericson, 1973, Sweden

B: Gunst, 1984, France

C: Hill, 1981, France

D; Schulitz, 1980

 

Inclusion criteria: RCTs that investigated the effect of perioperative antibiotic prophylaxis, with or without antiseptics, on outcomes related to surgical site infections (SSIs) during primary THA (a first-time replacement of the femoral head of the femoral bone and the acetabulum (socket) of the pelvic bone)

 

Exclusion criteria: -

Describe intervention:

 

Postoperative antibiotic prophylaxis with no restrictions applied to agent, dose or duration

 

A: cloxacillin (a type of penicillin) 1 g IM 1 h prior to operation and thereafter 3 times at 6 h intervals followed by oral administration of 2 x 0.5 g cloxacillin tablets every 6 h until day 14 plus 2 x 0.5 g probenecid tablets (which make antibiotics more effective by preventing body from passing them in urine) orally twice a day for 14 days (n = 60)

B: IV cefamandole 1,5 g before incision followed by 1,5 g every h up to 24 h

C: cefazolin at induction of anesthesia, and every 6 h post-surgery for 5 days

D: 600 mg lincomycin (for participants allergic to penicillin or where bacteria have developed resistance to penicillin) IV 1 h and 6 h post-surgery and 2 further 600 mg lincomycin IV injections on 2nd day post-surgery. From day 3 to day 10, 1 g lincomycin given 3 times daily

Describe control:

 

Placebo or no treatment

 

A: placebo administered in the same manner along with probenecid (n = 58)

B: no antibiotic

C: placebo given at induction of anaesthesia and every 6 h post-surgery for 5 days

D: no antibiotic therapy was administered at any time

 

End-point of follow-up:

 

A: 1 to 2,5 years and up to 5 to 6,5 years

B: 6 days, 3 months and 1 year

C: 2 years and 3-5 years in publication Doyton 1987

D: 2 years

 

 

For how many participants were no complete outcome data available?

A: 59 participants were eliminated/excluded from the trial 31 (19 from cloxacilin; 12 from placebo) because of side effects)

B: all participants in report after one year

C: study conducted at 10 sites, but 1 did not send follow-up forms and was excluded from the analysis. Consequently the data for evaluation came from 9 study sites. It was not clear how many participants were excluded as a result of this

D 65/259 participants were excluded due to: 18 deaths; 12 from Group 2 who received antibiotics post-surgery; 16 received another antibiotic during the 2 year follow-up; 7 because additional surgery was required for reasons other than infection; and 10 had a bilateral implant within <6 months of the first surgery. In total, 40 were excluded from Group 2 and 25 from Group 1

Outcome measure-1 Surgical site infection at 6 months (A, B and C):

 

I: 11/1176

C: 50/1172

Pooled effect (random effects model) RR 0.23 (0.12 to 0.43)

I2=0%

 

Outcome measure-1 Surgical site infection at 2,5 years (A and D)

 

I: 3/165

C: 20/147

Pooled effect (random effects model) RR 0.15 (0.05 to 0.47)

I2=26%

 

Outcome measure-1 Surgical site infection at >5 years (A and C)

 

I: 12/1130

C: 63/1125

Pooled effect (random effects model) RR 0.19 (0.10-0.35)

I2=0%

Risk of bias tables showed that much information needed for quality evaluation was not reported

 

 

Study A conducted from November 1970-may 1972

Albuhairan, 2008

SR and meta-analysis of 7 RCTs

 

Literature search up to July 2007

 

A: Heydemann et al., 1986; United States

B: Kanellakopoulou

et al., 2009, Greece

C: Ritter et al., 1989

D: Wymenga et al., 1991

 

 

Setting and Country: USA

 

Source of funding:

 

Inclusion criteria: 1) types of participant, patients undergoing a primary or revision THR or TKR, irrespective of the type of prosthesis; 2) types of antibiotic administered at any time pre-operatively, irrespective of dose and route of administration and including β-lactams, glycopeptides, aminoglycosides and any others; 3) outcome, wound infection being defined as visible purulent exudate at the surgical site (deep or superficial) reported at the maximum follow-up time; and 4) types of study (randomised controlled trial (RCT)

 

Exclusion criteria:

wound infection was not an outcome or if they only compared different doses of the same drug

Describe intervention:

 

Postoperative antibiotic prophylaxis with no restrictions applied to agent, dose or duration

 

Describe control:

 

Placebo or no treatment

Follow-up ranged from ten days to ten years

In a pooled analysis of seven studies32–34,36,38,41,43 (n = 3065) the administration of antibiotics reduced the relative risk (RR) of wound infection by 81% (RR 0.19; 95% CI 0.12 to 0.31; chi-squared test, p <0.00001). There was no statistical heterogeneity (I2 = 0%).

Because such events are rare, this translates to an absolute risk reduction of 8%, meaning that one wound infection would be prevented for every 13 people treated compared with no administration of antibiotics (risk difference −0.08; 95% CI −0.03 to −0.12).

 

Methodological quality was variable

 

Table of quality assessment for systematic reviews of RCTs and observational studies

Based on AMSTAR checklist (Shea, 2007; BMC Methodol 7: 10; doi:10.1186/1471-2288-7-10) and PRISMA checklist (Moher, 2009; PLoS Med 6: e1000097; doi:10.1371/journal.pmed1000097)

Study

 

 

 

 

 

First author, year

Appropriate and clearly focused question?1

 

 

 

Yes/no/unclear

Comprehensive and systematic literature search?2

 

 

 

Yes/no/unclear

Description of included and excluded studies?3

 

 

 

Yes/no/unclear

Description of relevant characteristics of included studies?4

 

 

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?5

 

 

 

 

Yes/no/unclear/notapplicable

Assessment of scientific quality of included studies?6

 

 

 

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?7

 

Yes/no/unclear

Potential risk of publication bias taken into account?8

 

 

 

Yes/no/unclear

Potential conflicts of interest reported?9

 

 

 

Yes/no/unclear

Voigt, 2015

yes

yes

Yes

yes

unclear

Yes

yes

yes

yes

ALbuhairan, 2008

Yes, though joints are hip and knee

yes

Yes

no

unclear

No, only description: quality variable

unclear

no

no

 

  1. Research question (PICO) and inclusion criteria should be appropriate and predefined.
  2. Search period and strategy should be described; at least Medline searched; for pharmacological questions at least Medline + EMBASE searched.
  3. Potentially relevant studies that are excluded at final selection (after reading the full text) should be referenced with reasons.
  4. Characteristics of individual studies relevant to research question (PICO), including potential confounders, should be reported.
  5. Results should be adequately controlled for potential confounders by multivariate analysis (not applicable for RCTs).
  6. Quality of individual studies should be assessed using a quality scoring tool or checklist (Jadad score, Newcastle-Ottawa scale, risk of bias table et cetera).
  7. Clinical and statistical heterogeneity should be assessed; clinical: enough similarities in patient characteristics, intervention and definition of outcome measure to allow pooling? For pooled data: assessment of statistical heterogeneity using appropriate statistical tests (for example Chi-square, I2)?
  8. An assessment of publication bias should include a combination of graphical aids (for example funnel plot, other available tests) and/or statistical tests (for example Egger regression test, Hedges-Olken). Note: If no test values or funnel plot included, score “no”. Score “yes” if mentions that publication bias could not be assessed because there were fewer
  9. Sources of support (including commercial co-authorship) should be reported in both the systematic review and the included studies. Note: To get a “yes,” source of funding or support must be indicated for the systematic review AND for each of the included studies.

Considerations

Given the enormous consequences of prosthetic joint infections, a low threshold for antibiotic prophylaxis is required. The antibiotic prophylaxis should cover the main causes of infections after total hip arthroplasty.

 

Stichting Werkgroep Antibiotica Beleid (SWAB) is a Dutch organisation involved in optimising the use of antibiotics, amongst others by developing guidelines. The guideline “peri-operatieve profylaxe”, is a generally accepted guideline, on which recommendations regarding choice, dosage and duration in this guideline are based.

 

According to the SWAB guideline, cefazolin 2 grams i.v., is administered in a single dose 30 to 60 minutes before incision. A study by Van Kasteren et al. (2007) showed less SSI if antibiotic prophylaxis was given 1 to 30 and 30 to 60 minutes before incision. This finding was the reason that in the Netherlands the policy to administer antibiotics 15 to 60 minutes before operation has generally been implemented as part of a nationwide hospital safety management program; the performance of each hospital on this subject is annually checked by the Health and Youth Care Inspectorate.

 

Use 3 grams if BMI is over 40 and/or if bodyweight is over 130 kilograms.

 

Since it is standing practice (90% of hospitals) to provide antibiotic prophylaxis for 24 hours in orthopaedic implant surgery this single dose is generally followed by additional doses of 1 gram 8 and 16 hours after the preoperative dose. Limited evidence exists regarding a difference in outcome between a single dose and 24 hours in favour of the latter. Administration for longer than 24 hours has no additive value Engesaeter, (2003).

 

In case the patient has a history of a rash in response to a penicillin (amoxicillin et cetera), the chance of an adverse reaction to a cephalosporin is very small and cefazolin can be given Engesaeter, (2003).

 

In case the patient has a history of an IgE-mediated reaction (or a direct reaction) to a penicillin - like pruritus, urticaria, angioedema, laryngeal edema - cephalosporins are contra-indicated and alternatives are: clindamycin 600 miligrams (>180 kilograms: 900 miligrams), 15 to 60 minutes before incision, or vancomycin 1 gram i.v. (>100 kilograms: 10 miligrams/kilograms), start infusion 60 to 120 minutes before incision. In case of known MRSA carriership vancomycin is advised Engesaeter, (2003).

Authorization date and validity

Last review : 12-02-2019

Last authorization : 12-02-2019

Module

Party in control

Year of authorization

Next assessment of actuality

Frequency of assessment actuality

Which party/parties monitors actuality

Important factors that might lead to change in recommendations

Systemic antibiotic prophylaxis

NOV en NVMM

2018

2023

Eens in de vijf jaar

NOV en NVMM

?

Initiative and authorization

Initiative : Nederlandse Orthopaedische Vereniging

Authorized by:
  • Koninklijk Nederlands Genootschap voor Fysiotherapie
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging voor Klinische Geriatrie
  • Nederlandse Vereniging voor Medische microbiologie

General details

The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).

Scope and target group

Aim of the guideline

The main purpose of the guideline is to provide the best possible care to patients with osteoarthritis of the hip, by informing optimal treatment decisions and reducing unwarranted variation in the delivery of care and long-term failure of the implants.

 

Envisaged users of the guideline

This guideline was developed for all Dutch healthcare providers of patients with osteoarthritis of the hip.

Members of the guideline panel

This guideline was developed and sponsored by the Netherlands Orthopaedic Association (NOV), using government funding from the Quality Funding for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten in the Netherlands, SKMS). Patient participation was cofinanced by the Quality Funding Patient Consumers (Stichting Kwaliteitsgelden Patiënten Consumenten, SKPC) within the program ‘Quality, insight and efficiency in medical specialist care’ (Kwaliteit, Inzicht en Doelmatigheid in de medisch specialistische Zorg, KIDZ). The early preparative phase started in October 2016. The guideline was officially authorised by the Netherlands Orthopaedic Association on February 12, 2019. Decisions were made by consensus. At the start of guideline development, all working group members completed conflict of interest forms.

 

Members of the guideline development working group

  • Dr. B.A. Swierstra, orthopaedic surgeon, Sint Maartenskliniek, Nijmegen, NOV, Chair
  • Dr. R.H.M. ten Broeke, orthopaedic surgeon, Maastricht University Medical Centre, NOV
  • Drs. P.D. Croughs, medical microbiologist, Erasmus University Medical Center, NVMM
  • Dr. R.A. Faaij, geriatrician, Diakonessen Hospital, Utrecht, NVKG
  • Dr. P.C. Jutte, orthopaedic surgeon, University Medical Center Groningen, NOV
  • D.E. Lopuhaä, policy worker patient advocacy, Dutch Arthritis Society
  • Dr. W.F.H. Peter, physiotherapist, Leiden University Medical Center, KNGF
  • Dr. B.W. Schreurs, orthopaedic surgeon, Radboud University Medical Centre, Nijmegen, NOV
  • Dr. S.B.W. Vehmeijer, orthopaedic surgeon, Reinier de Graaf Hospital, Delft, NOV
  • Dr. A.M.J.S. Vervest, orthopaedic surgeon, Tergooi Hospital, Hilversum, NOV
  • J. Vooijs†, patient with osteoarthritis, National Association ReumaZorg Nederland
  • Drs. G. Willemsen-de Mey, chairperson, National Association ReumaZorg Nederland

 

Readers:

  • S. Nijssen, medical microbiologist, VieCuri Medical Center, Venlo, NVMM
  • R.J. Rentenaar, medical microbiologist, University Medical Center, Utrecht, NVMM
  • Dr. A.T. Bernards, medical microbiologist, Leiden University Medical Center, NVMM

 

With the help of:

  • Dr. M.A. Pols, senior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • Dr. M.L. Molag, advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • A.L.J. Kortlever- van der Spek, junior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • M.E. Wessels MSc, clinical librarian, Knowledge Institute of the Dutch Association of Medical Specialists

Declaration of interest

At the start of the project, the members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These declarations of interest can be requested from the secretariat of the Knowledge Institute of the Dutch Association of Medical Specialists. See below for an overview.

 

Werkgroeplid

Mogelijke conflicterende belangen met betrekking tot deelname werkgroep

Toelichting

Dr. B.W. Schreurs

Presentaties voor Stryker over de Exeter totale heupprothese (educational fee naar afdeling)

Doet reviews voor DEKRA KEMA (betaald)

Voorzitter European Hip Society (onbetaald)

Voorzitter wetenschappelijke adviesraad LROI (onbetaald)

Voorzitter adviesraad botbank Sanquin (onbetaald)

Lid Commissie Orthopedisch Implantaten Classificatie NOV (onbetaald)

 

Dr. P.C. Jutte

Hoofdonderzoeker LEAK-studie (ZonMW)

Voorzitter werkgroep weke delen en bottumoren

Lid werkgroep orthopedische infecties NOV

Lid werkgroep bottumoren NOV

Lid commissie beentumoren Nederland

Lid onderwijscommissie NOV

Lid medische adviesraad patientvereniging Sarcoma NL

 

D.E. Lopuhaä

Geen belangen

 

Dr. R.H.M. ten Broeke

Voorzitter werkgroep "Heup" (Dutch Hip Society) NOV sinds 2015 (onbetaald)

Daarvoor gedurende 3 jaar reeds bestuurslid van deze werkgroep (onbetaald)

Klinisch onderzoek gefinancierd door firma Stryker (RSA en PET-CT-onderzoek bij vergelijking van 2 ongecementeerde cupdesigns) (onbetaald)

 

Dr. W.F.H. Peter

Geen belangen

 

Dr. P.D. Croughs

Geen belangen

 

Dr. S.B.W. Vehmeijer

Directeur Orthoparc (onbetaald)

Bestuurslid Dutch Hip Society (onbetaald)

National Representative European Hip Society (onbetaald)

Consulent Zimmer Biomet (betaald)

 

Dr. B.A. Swierstra

Voorzitter Stichting OrthoResearch (onbetaald)

Advisory Board Arthroplasty Watch (onbetaald)

Lid Wetenschappelijke Advies Raad Landelijke Registratie Orthopaedische Implantaten (onbetaald)

Board of Directors International Society of Orthopaedic Centers (onbetaald)

Coeditor Acta Orthopaedica (onkostenvergoeding)

 

Dr. R.A. Faaij

Geen belangen

 

Dr. A.M.J.S. Vervest

Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald)

Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald)

 

J. Vooijs

Geen belangen

 

Drs. G. Willemsen – de Mey

Geen belangen

 

Meelezers

Drs. S. Nijssen

ISO 15189 auditor, betaald door RvA

 

Dr. R.J. Rentenaar

Commissie bacteriologie Stichting Kwaliteitsbewaking Medische Laboratoria (SKML) (tegen onkostenvergoeding).

Verschillende producenten stellen soms kleine hoeveelheden van producten ter beschikking kosteloos of tegen gereduceerd tarief t.b.v. verificatie doeleinden

 

Dr. A.T. Bernards

Geen belangen

 

Patient involvement

Attention was paid to the patients’ perspective by participation in the working group of the Dutch Arthritis Society and National Association ReumaZorg Nederland. In addition, the Patients Federation Netherlands assessed the draft guideline during the consultation phase and made suggestions for improvement of the guideline.

Method of development

Evidence based

Implementation

Recommendation

Time needed for implementation:
<1 year,

1 to 3 years or

>3 years

Expected effects on costs

Conditions for implementation

Possible barriers to implementation1

Actions for implementation2

Reponsibility for these actions3

Other remarks

All

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

Methods and proces

The guideline was developed in agreement with the criteria set by the advisory committee on guideline development of the Dutch Association of Medical Specialists (Medisch Specialistische Richtlijnen 2.0; OMS 2011), which are based on the AGREE II instrument (Brouwers (2010); www.agreetrust.org). The guideline was developed using an evidence-based approach endorsing GRADE methodology, and meeting all criteria of AGREE-II. Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a systematic approach for synthesising evidence and grading of recommendations offering transparency at each stage of the guideline development (Guyatt, 2011; Schünemann, 2013).

 

The guideline development process involves a number of phases: a preparatory phase, development phase, commentary phase, and authorisation phase. After authorisation, the guideline has to be disseminated and implemented and its uptake and use have to be evaluated. Finally, the guideline has to be kept up-to-date. Each phase involves a number of practical steps Schünemann, (2014).

 

As a first step in the early preparatory phase, a broad forum discussion was held and all relevant stakeholders were consulted to define and prioritise the key issues the recommendations should address. Subsequently, the methodologist together with the chairman of the working group created a draft list of key issues, which was extensively discussed in the working group.

 

Despite aiming for an update of the guideline from 2010, due to financial constraints not all clinical questions from the former edition could be updated, so it was decided to perform a so-called modular update. Selecting modules with a higher priority for update formed part of this discussion and selection process. This resulted in the following approach.

 

Modules that were updated:

  • Indications for primary total hip arthroplasty.
  • Type of bearing (part of the module surgical techniques).
  • Diameter of the head (part of the module surgical techniques).
  • Surgical approach (part of the module surgical techniques).
  • Systemic antibiotics (part of the module perioperative care in primary total hip arthroplasty).
  • Antibiotic-impregnated bone cement (part of the module perioperative care in primary total hip arthroplasty).
  • Preoperative decolonisation (part of the module perioperative care in primary total hip arthroplasty).
  • Routine follow-up (part of the module postoperative care).

 

Modules considered still valid:

  • cemented versus uncemented hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).

 

Modules removed from the guideline:

  • Resurfacing hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
  • Minimally invasive surgery (part of the module surgical techniques in primary total hip arthroplasty).
  • Guidelines for MRSA carriers (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were replaced by a reference to related guidelines:

  • Hematogenous infection (part of the module postoperative care).
  • Prevention of thrombo-embolic complications (part of the module perioperative care in primary total hip arthroplasty).
  • Physcial therapy (part of the module perioperative care in primary total hip arthroplasty).

 

Modules not updated because guidelines are expected soon:

  • Anaesthesiological technique (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were added:

  • Patient Reported Outcome Measures.
  • Place and organisation of fasttrack.
  • Organization of care for frail elderly.

 

The selected (high priority) issues were translated into carefully formulated clinical questions, defining patient/problem, intervention, and prioritising the outcomes relevant for decision-making.

 

The literature was systematically searched using the databases MEDLINE (Ovid), Embase and the Cochrane Database of Systematic Reviews. Selection of the relevant literature was based on predefined inclusion and exclusion criteria and was carried out by a member of the working group in collaboration with the methodologist. For each of the clinical questions, the evidence was summarised by the guideline methodologist using the GRADE approach: a systematic review was performed for each of the relevant outcomes and the quality of evidence was assessed in one of four grades (high, moderate, low, very low) by analysing limitations in study design or execution (risk of bias), inconsistency of results, indirectness of evidence, imprecision, and publication bias. The evidence synthesis was complemented by a working group member considering any additional arguments relevant to the clinical question. Evidence synthesis, complementary arguments, and draft recommendations were extensively discussed in the working group and final recommendations were formulated. Final recommendations are based on the balance of desirable and undesirable outcomes, the quality of the body of evidence across all relevant outcomes, values and preferences, and (if relevant) resource use. The strength of a recommendation reflects the extent to which the guideline panel was confident that desirable effects of the intervention outweigh undesirable effects, or vice versa, across the range of patients for whom the recommendation is intended. The strength of a recommendation is determined by weighting all relevant arguments together, the weight of the body of evidence from the systematic literature analysis, as well as the weight of all complementary arguments. Guideline panels must use judgment in integrating these factors to make a strong or weak recommendation. Thus, a low quality of the body of evidence from the systematic literature analysis does not exclude a strong recommendation, and weak recommendations may follow from high quality evidence Schünemann, (2013).

 

After reaching consensus in the working group, the draft guideline was subjected to peer review by all relevant stakeholders. Amendments were made and agreed upon by the working group, and the final text was presented to the Netherlands Orthopaedic Association (NOV), the Royal Dutch Society for Physical Therapy (KNGF), the Dutch Society of Medical Microbiology (NVMM) and the Dutch Geriatrics Society (NVKG) for formal authorisation and to the National Association ReumaZorg Nederland and the Dutch Arthritis Society for approval. The final guideline was approved by the National Association ReumaZorg Nederland and the Dutch Arthritis Society, and was officially authorised by the Netherlands Orthopaedic Association, the Royal Dutch Society for Physical Therapy, the Dutch Society of Medical Microbiology and the Dutch Geriatrics Society. The guideline was published and is freely accessible in the Dutch guideline database (Richtlijnendatabase, www.richtlijnendatabase.nl). The Dutch guideline database has a modular structure, with each clinical question as a separate entry, thus allowing for modular updates.

 

References

Brouwers M, Kho ME, Browman GP, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec;182:E839-842; doi: 10.1503/cmaj.090449.

Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology. 2011;64 383–394. (doi:10.1016/j.jclinepi.2010. 04.026).

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from www.guidelinedevelopment.org/ handbook.

Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42. doi: 10.1503/cmaj.131237. Epub 2013 Dec 16. PubMed PMID: 24344144.

OMS, Orde van Medisch Specialisten. Eindrapport Medisch Specialistische Richtlijnen 2.0. Available from: https://www.demedischspecialist.nl/onderwerp/raad-kwaliteit. 2011.

Search strategy

Searches are available upon request. Please contact the Richtlijnendatabase.