Uitgangsvraag

Welke benadering geniet de voorkeur bij totale heupprothese: anterieur, posterieur of lateraal?

Aanbeveling

Zowel de posterieure, als de laterale en anterieure benadering kunnen gebruikt worden bij het plaatsen van een totale heupprothese.

Inleiding

Traditionally total hip arthroplasties (THAs) are placed through the posterior, anterolateral (anterior) or the straight lateral approach. In the past decade the anterior approach has gained in popularity. In this chapter, the three most commonly used approaches in The Netherlands - the posterior, anterior and straight lateral approach - are compared in terms of complications, need for revision and functional recovery.

Conclusies

Lateral versus posterior approach

Complications (such as need for revision and dislocation)

Very low

GRADE

It is unclear whether a lateral or posterior approach results in a higher risk of dislocation.

 

Sources (Berstock, 2015; Amlie, 2014, Mjaaland, 2017)

 

Functional recovery

HOOS-scores

Very low

GRADE

Functional outcome (as measured with HOOS) seems to be better for posterior than for lateral approach.

 

Sources Amlie, (2014)

 

VAS pain

Very low

GRADE

The lateral approach seems to result in more pain (as measured with the VAS-scale) than the posterior approach.

 

Sources Amlie, (2014)

 

VAS satisfaction

Very low

GRADE

The lateral approach seems to result in less satisfaction (as measured with the VAS-scale) than the posterior approach.

 

Sources Amlie, (2014)

 

Anterior versus posterior

Complications (such as need for revision and dislocation)

Very low

GRADE

There seem to be more postoperative dislocations in patients operated using the posterior than the anterior approach.

 

Sources (Higgins, 2015; Mjaaland, 2017; Maratt, 2016)

 

Functional outcome

Very low

GRADE

There seems to be no difference in functional recovery measured by unlimited walking and Harris Hip Score between the anterior and posterior approach.

 

Sources (Higgins, 2015; Christensen, 2015)

 

Length of hospital stay

Very low

GRADE

Length of hospital stay seems to be shorter for anterior approach than for posterior approach

 

Sources (Higgins, 2015; Christensen, 2015; Maratt, 2016)

 

Anterior versus lateral

Complications (such as need for revision and dislocation)

Very low

GRADE

There seems to be no difference in risk of revision due to dislocation between a lateral approach and an anterior approach.

 

Sources (Amlie, 2014; Mjaaland, 2017)

 

Functional recovery

Very low

GRADE

Functional recovery showed inconsistent results comparing the lateral approach and the anterior approach.

 

Sources (Amlie, 2014; De Anta Diaz, 2015)

Samenvatting literatuur

Lateral versus posterior approach

Description of studies

Three studies were included: one meta-analysis including three RCTs and three prospective cohort studies Berstock, (2015), and two cohort studies (Amlie, 2014; Mjaaland, 2017).

 

Berstock (2015) included three RCTs and three prospective cohort studies (517 patients) in a systematic review and meta-analysis that compared the posterior and lateral surgical approach. Primary outcome was dislocation; functional recovery was also reported by using functional assessment scores Berstock, (2015).

 

In a cohort study Amlie, (2014) 1,273 patients filled out PROMs questionnaires one to three years after THA surgery. These patients were identified through the Norwegian Arthroplasty Register. Patients reported complications (such as dislocation) and patient-reported outcome measures (PROMs) including the Hip disability Osteoarthritis Outcome Score (HOOS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), health-related quality of life (EQ-5D-3L) and visual analogue scales (VAS) addressing pain and satisfaction Amlie, (2014).

 

Mjaaland (2017) is a cohort study from the Norwegian arthroplasty register with 21,690 THAs. MIS anterior, MIS anterolateral, posterior and direct lateral approach were compared. Outcomes reported were implant survival, and revision for any cause and specifically for infection, dislocation, femoral fracture, aseptic loosening and other causes Mjaaland,(2017).

 

Results

Complications (such as need for revision and dislocation)

The meta-analysis Berstock, (2015) showed that there was no difference in dislocation (odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.09 to 1.48, p-value (p)=0.16) between the posterior approach and the lateral approach.

 

In the cohort study by Amlie (2014), the patient self-reported dislocation rate was 3.7% for the lateral approach and 2.4% for posterolateral approach, which was not statistically significant.

 

Mjaaland (2017) reported a relative risk (RR) of revision due to dislocation using the posterior approach of 2.1 (95% CI = 1.5 to 3.1, p <0.001) compared to the direct lateral approach.

 

Functional recovery

Berstock (2015) did not report individual study results and there were not enough data to enable a meta-analysis for functional outcomes.

 

In the cohort study Amlie, (2014) patients filled out PROMs questionnaires one to three years after surgery. Lateral approach had worse HOOS scores for pain (adjusted mean difference = -3.6, CI = -6.3 to -0.9), other symptoms (adjusted mean difference = -3.2 , CI =-6.1 to -0.4), activities of daily living (ADL) (adjusted mean difference = -4.0, CI = -6.8 to -1.3), sport/recreation (adjusted mean difference = -4.6, CI = -8.6 to -0.6) and quality of life (adjusted mean difference = -3.7, CI =-7.2 to -0.3). The lateral approach was associated with statistically significantly worse outcomes than the posterolateral approach on the VAS-scales for both patient satisfaction (adjusted mean difference = -4.8, CI-8.4 to -1.2) and pain in the operated hip (adjusted mean difference = -4.8, CI = -7.8 to -1.7) Amlie, (2014).

 

Grading of evidence

Complications (such as need for revision and dislocation)

Results of the different studies were inconsistent and mainly based on cohort studies, therefore the level of evidence was graded as very low.

 

Functional outcome

This was assessed in a cohort study and downgraded to very low for risk of bias.

 

Anterior versus posterior

Description of studies

A systematic review of 17 comparative studies Higgins, (2015) was selected, together with one RCT Christensen, (2015) and one retrospective study Maratt, (2016). Moreover, a study of Mjaaland (2017) was selected.

 

Higgins (2015) included 17 studies that compared the anterior with the posterior approach (two RCTs, five prospective comparative studies and ten retrospective comparative studies). Reported outcomes were dislocation rate and validated patient-reported outcome measures (pain, functioning); secondary outcomes were intra-operative, post-operative and radiographic comparisons. Follow-up ranged from direct postoperative to two years Higgins, (2015).

 

Christensen (2015) conducted a RCT in 51 patients that compared functional recovery during the early postoperative period (6 weeks) after direct anterior and posterior approaches. Outcomes measured were length of hospital stay, pain score and functional recovery Christensen, (2015).

 

Maratt (2016) retrospectively compared the direct anterior approach for a THA with a posterior approach. In total 2147 patients who underwent the direct anterior approach were propensity score matched with 2147 patients who underwent a posterior approach. Outcomes measured were dislocation rate and complications such as fractures and hematomas within 90 days Maratt, (2016).

 

Mjaaland (2017) is a cohort study from the Norwegian arthroplasty register with 21,690 THAs. MIS anterior, MIS anterolateral, posterior and direct lateral approach were compared. Outcomes reported were implant survival, revisions for any cause and specifically for infection, dislocation, femoral fracture, aseptic loosening and other causes Mjaaland, (2017).

 

Results

Complications (such as need for revision and dislocation)

Higgins (2015) estimated the Peto odds ratio and showed a pooled (fixed) effect of 0.29 (95% CI = 0.09-0.95, p-value (p) = 0.04) favouring the anterior approach. In this analysis 728 patients (two dislocations) who underwent an anterior approach were compared with 745 patients (nine dislocations) who were operated using the posterior approach Higgins, (2015).

 

Maratt (2016) showed no difference in dislocation rate, which was 0.84% for the anterior approach versus 0.79% for the posterior approach (P=0.88) Maratt, (2016).

 

Mjaaland (2017) does not report a direct comparison between anterior versus posterior approach but reports relative risks of minimally invasive surgery (MIS) anterior/anterolateral and posterior approach compared to direct lateral. The relative risk of revision due to dislocation (154 patients) using the posterior approach was 2.1 (95% CI = 1.5 to 3.1, p<0.001) compared to the direct lateral approach. The relatieve risk for the MIS anterior and MIS anterolateral approaches compared with the direct lateral approach was 0.71 (95% CI = 0.40 to 1.3, p = 0.25) Mjaaland, (2017).

 

Functional recovery

 One RCT included in the systematics review of Higgins (2015) reported patient-reported pain (visual analogue scale (VAS)) and function (Harris Hip Score (HHS) and Hip disability and Osteoarthritis Outcome Score (HOOS)). Early functional results favoured the anterior approach, there was no difference on the longer term. There was no difference in pain between the two approaches. The other prospective and retrospective studies in Higgins’ review showed little or no difference in functional outcome Higgins, (2015).

 

A randomized controlled trial of Christensen (2015) reported greater pain relief after surgery was in the anterior group (P=0.04), none of the other functional measures differed between the two groups. There were no differences in Harris Hip Scores after six weeks Christensen, (2015).

 

Length of stay (LOS)

The study of Higgins (2015) reporter shorter length of hospital stay in the anterior group compared to the posterior approach (mean difference = -0.53, 95%CI = -1.01 to -0.04).

 

The RCT of Christensen (2015) showed that length of hospital stay was significantly shorter for the anterior approach than the posterior approach (1.4 versus 2.0 days, p=0.01).

 

A retrospective study of Maratt (2016) did not find a difference in length of hospital stay between the anterior and the posterior approach (2.37 versus 2.54 days, P=0.28).

 

Grading of evidence

Complications (such as need for revision and dislocation)

Evidence of the systematic review was graded as very low due to high risk of bias and because of heterogeneity.

 

Functional outcome

This was estimated based on one RCT and two cohort studies with a high risk of bias and a retrospective analysis and graded as very low, because of hetereogeneity.

 

Length of stay

Evidence of the systematic review was graded as low due to high risk of bias, for the outcome length of hospital stay it was graded as very low because of high heterogeneity.

 

Description of studies

Three studies compared the anterior with lateral approach (Amlie, 2014; De Anta Diaz, 2015, Mjaaland, 2017).

 

In a cohort study Amlie, (2014) 1273 patients filled out Patient Reported Outcome Measures (PROMs) questionnaires one to three years after THA surgery. These patients were identified through the Norwegian Arthroplasty Register. Patients reported complications such as dislocation, and pPROMs including the Hip disability Osteoarthritis Outcome Score (HOOS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), health-related quality of life (EQ-5D-3L), and visual analog scales (VAS) addressing pain and satisfaction Amlie, (2014).

 

De Anta Diaz (2015) was a RCT study of 49 patients who received a direct anterior THA and 50 patients who received a lateral approachTHA. Outcomes reported were muscle damage and functional recovery De Anta Diaz, (2015).

 

Mjaaland (2017) is a cohort study from a registry with 21,690 THAs. MIS anterior, MIS anterolateral, posterior and direct lateral approach were compared. Outcomes reported were implant survival, revisions for any cause and femoral fractures Mjaaland, (2017).

 

Results

Complications (such as need for revision and dislocation)

Self-reported dislocation was 3.7% for lateral approach and 3.1% for anterior approach; this difference was not statistically significant Amlie, (2014). Mjaaland (2017) found no difference in dislocation. The RR of revision due to dislocation using the anterior/anterolateral approach compared to the direct lateral approach was 0.71 (95% CI = 0.40 to 1.30, p=0.25) Amlie, (2014).

 

Functional recovery

The cohort study Amlie, (2014) had the following results. Lateral approach scored worse on HOOS scores for pain (adjusted mean difference = -3.6, CI =-6.1 to -1.1), other symptoms (adjusted mean difference = -3.8, CI = -6.5 to -1.1), ADL (adjusted mean difference = -4.8, CI = -7.3 to -2.2), sport/recreation (adjusted mean difference = -4.8, CI =-8.6 to -1.0) and quality of life (adjusted mean difference = -5.0, CI =-8.3 to -1.8). The lateral approach was associated with statistically significantly worse outcomes than the anterior approach on the VAS for both patient satisfaction (adjusted mean difference = -3.8, CI = -7.2 to -0.4) and pain in the operated hip (adjusted mean difference = -3.9, CI = -6.9 to -1.1) Amlie, (2014).

 

One RCT compared the anterior with the lateral approach. It showed no difference in Harris Hip Scores (96.2 versus 94.5) De Anta Diaz, (2015).

 

Grading of evidence

Complications (such as need for revision and dislocation)

Evidence was graded as very low as there were two cohort studies used here that had heterogeneous results.

 

Functional recovery

The level of evidence started as low (observational study) and was downgraded to very low because of risk of bias.

Zoeken en selecteren

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

 

PICO 1: What are the effects of a posterior approach, compared to a lateral approach, for total hip prosthesis in adult patients?

P: adult patients with total hip prosthesis;

I: posterior approach;

C: lateral approach;

O: complications (such as need for revision and dislocation) and functional recovery.

 

PICO 2: What are the effects of an anterior approach, compared to a posterior or lateral approach, for total hip prosthesis in adult patients?

P: adult patients with total hip prosthesis;

I: anterior approach;

C: posterior or lateral approach;

O: complications (such as need for revision and dislocation) and functional recovery.

 

Relevant outcome measures

The working group decided that complications such as dislocation and need for revision were critical outcome measures for decision-making and postoperative functional recovery was important for decision-making.

 

Search and select (Method)

A literature search was performed with relevant search terms on 23 january 2017 in the databases Medline (OVID) and Embase. The search strategy is provided in the tab ”Methods”. The literature search resulted in 632 hits. Studies were selected using the following selection criteria: using an anterior, posterior or lateral approach for total hip arthroplasty (THA), describing at least one of the selected outcome measures and including at least 50 patients. Based on title and abstract 33 studies were preselected. After obtaining full text, 25 studies were excluded (see exclusion table) and eight studies were included in the literature analysis.

 

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

Referenties

  1. Amlie E, Havelin LI, Furnes O, et al. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty. A cross-sectional questionnaire study of 1,476 patients 1 to 3 years after surgery. Acta Orthop. 2014;85(5):463-9. PubMed PMID: 24954494.
  2. Berstock JR, Blom AW, Beswick AD. A systematic review and meta-analysis of complications following the posterior and lateral surgical approaches to total hip arthroplasty. Ann R Coll Surg Engl. 2015;97(1):11-6. PubMed PMID: 25519259.
  3. Christensen CP, Jacobs CA. Comparison of Patient Function during the First Six Weeks after Direct Anterior or Posterior Total Hip Arthroplasty (THA): A Randomized Study. J Arthroplasty. 2015;30(9 Suppl):94-7.
  4. De Anta Diaz B, Serralta-Gomis J, Lizaur-Utrilla A, et al. No differences between direct anterior and lateral approach for primary total hip arthroplasty related to muscle damage or functional outcome. International Orthopaedics. 2016;40:2025-2030.
  5. Higgins BT, Barlow DR, Heagerty NE, et al. Anterior versus posterior approach for total hip arthroplasty, a systematic review and meta-analysis. J Arthroplasty. 2015;30(3):419-34. PubMed PMID: 25453632.
  6. Maratt JD, Gagnier JJ, Butler PD, et al. No Difference in Dislocation Seen in Anterior versus Posterior Approach Total Hip Arthroplasty. J Arthroplasty. 2016;31(9 Suppl):127-30. PubMed PMID: 27067754.
  7. Mjaaland KE, Svenningsen S, Fenstad AM, et al. Implant Survival After Minimally Invasive Anterior or Anterolateral Versus Conventional Posterior or Direct Lateral Approach: An Analysis of 21,860 Total Hip Arthroplasties from the Norwegian Arthroplasty Register (2008 to 2013). J Bone Joint Surg Am. 2017;99(10):840-847.

Evidence tabellen

Research question: Which chirurgical approach is preferred?

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Berstock, 2015

 

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of 3 RCTs and 3 non-randomised prospective cohort studies

 

Literature search up to January 2014

 

A: Weale, 1996

B: Baker, 1989

C: Downing,

 2001

D: Witzleb, 2009

E: Teratani, 2010

F: Ji, 2012

 

 

Setting and Country: see review

 

Source of funding:

NHS Trust Springboard Fund

 

Inclusion criteria SR: adult participants (>19 years old) undergoing primary THA, largely for the treatment of osteoarthritis, who were either operated on via the direct lateral or the posterior approach

 

Exclusion criteria SR: minimally invasive surgery, the anterolateral (Watson-Jones) approach or an approach utilising a trochanteric osteotomy, surgical approach in the setting of hip fracture, infection, revision surgery or resurfacing arthroplasty, retrospective studies and cohorts

 

6 studies included

 

 

Important patient characteristics at baseline: not reported in the review

 

Groups comparable at baseline? Not reported

Posterior approach

 

 

Lateral approach: direct lateral approach was defined as an approach requiring a release of approximately one-third of the gluteus medius from the trochanter but not the use of an osteotomy.

 

End-point of follow-up:

Unclear

 

 

For how many participants were no complete outcome data available?

Evaluated in quality assessment, in one of five studies not OK

 

Dislocation:

I: 2 (1%)

C: 6 (3%)

OR: 0.37, 95% CI: 0.09 to 1.48, p=0.16

 

Heterotopic ossification:

I: 4

C: 9

Peto OR: 0.41, 95% CI: 0.13 to 1.31, p=0.13

 

Stem malposition

Two studies observed fewer stem malpositions with the posterior approach (Peto OR: 0.24, 95% CI: 0.08 to 0.78, p=0.02).

 

Functional assessment scores: not enough studies

 

 

Higgins, 2015

 

(individual study characteristics deduced from (1st author,

year of publication

))

 

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of 17 comparative studies

 

Literature search up to February 2014

 

For details of these studies see publication

 

Country: USA

 

Source of funding:

No external funds were received

 

Inclusion criteria SR: patients underwent primary THA, one group received anterior THA and the other posterior THA, at least one quantifiable pre-specified outcome was reported

 

Exclusion criteria SR: -

 

17 studies included

 

 

Important patient characteristics at baseline:

 

N, mean age

N: see review,

Age: Not reported in review

 

Sex:

Not reported

 

Groups comparable at baseline?

Not reported

Describe intervention: single incision anterior THA

 

 

Describe control:

Single incision posterior THA

 

 

End-point of follow-up:

unclear

 

 

For how many participants were no complete outcome data available?

(intervention/control)

unclear

 

 

Rapportage op basis van prioritering uitkomstmaten

 

blood loss, intraoperative fractures, length of hospital stay, postoperative dislocation

 

Estimated blood loss

Effect measure: mean difference (95% CI):

Ant: N=378

Post: N=381

Pooled effect (random effects model):

76.02 (95% CI -38.12 to 190.16) favoring posterior

Heterogeneity (I2): 91%

 

Intraoperative fractures

Effect measure: Peto odds ratio (95% CI):

Ant: N=9/675

Post: N=8/686

Pooled effect (random effects model):

1.14 (95% CI 0.44 to 2.96) favoring none

Heterogeneity (I2): 0%

 

Length of hospital stay

Effect measure: Mean difference (95% CI):

Ant: N=369

Post: N=375

Pooled effect (random effects model):

-0.53 (95% CI -1.01 to 0.04) favoring anterior

Heterogeneity (I2): 84%

 

 

 

Postoperative dislocation

Effect measure: Peto odds ratio (95% CI):

Ant: N=2/728

Post: N=9/745

Pooled effect (fixed effects model):

0.29 (95% CI 0.09 to 0.95) favoring anterior

Heterogeneity (I2): 0%

 

Facultative:

 

Brief description of author’s conclusion

 

Personal remarks on study quality, conclusions, and other issues (potentially) relevant to the research question

 

Level of evidence: GRADE (per comparison and outcome measure) including reasons for down/upgrading

 

Sensitivity analyses (excluding small studies; excluding studies with short follow-up; excluding low quality studies; relevant subgroup-analyses); mention only analyses which are of potential importance to the research question

 

Heterogeneity: clinical and statistical heterogeneity; explained versus unexplained (subgroupanalysis)

 

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

Berstock et al., 2015

Yes

Yes

Yes

Unclear

Unclear

Yes

Unclear

Yes

Yes

Higgins, 2015

Yes

Yes

Yes

Yes

Unclear

Yes

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 than 10 included studies.
  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.

 

Evidence-table for intervention studies

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Amlie, 2014

Type of study: cohort from a registry

 

Setting: hospital

 

Country: Norway

 

Source of funding: unknown

Inclusion criteria:

Patients registered in the NAR (population-based clinical database for arthroplasty operations) as having undergone THA for primary osteoarthritis between Jan 2008 and Jan 2010, femoral head size 28-32mm, 50-80y

 

Exclusion criteria: registered before 2011 with bilateral THA or trochanteric osteotomy

 

N total at baseline:

A: 421

L: 431

P: 421

 

Important prognostic factors2:

age ± SD:

A: 67 ± 7.1

L: 66 ± 7.3

P: 66 ± 7.1

 

Sex:

A: 31 % M

L: 36 % M

P: 36 % M

 

Groups comparable at baseline? In P group the average femoral head diameter was greater than in the other groups

 

Anterior approach (A)

 

Posterolateral approach (P)

 

Lateral Approach (L)

 

Length of follow-up: 24-33 months (1 to 3 years)

 

Response rate to follow-up questionnaire 86%

 

Incomplete outcome data:

170 patients did not answer after a reminder and 25 did not want to or were unable to participate, 6 patients were not reached and 2 had died

 

Of those who underwent THA with a lateral approach, the non-responders were generally older (mean 69 years, SD 7.1) than the study

participants (mean 66 years, SD 7.3; p = 0.001).

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

HOOS (adjusted mean difference):

L vs A:

Pain: -3.6 (-6.1 to 1.1)

Other symptoms: -3.8 (-6.5 to 1.1)

ADL: -4.8 (-7.3 to 2.2)

Sport/recreation: -4.8 (-8.6 to -1.0)

Quality of life: -5.0 (-8.3 to 1.8)

 

L vs P:

Pain: -3.6 (-6.3 to 0.9)

Other symptoms: -3.2 (-6.1 to -0.4)

ADL: -4.0 (-6.8 to-1.3)

Sport/recreation: -4.6 (-8.6 to -0.6)

Quality of life: -3.7 (-7.2 to -0.3)

 

VAS Absence of Pain Score:

L: 84

A: 89

P: 90

L vs A (adjusted mean difference): -3.9 (-6.9; -1.1)

L vs P (adjusted mean difference): -4.8 (-7.8; -1.7)

 

Dislocation

L: 16 (3.7%)

A: 13 (3.1)

P: 10 (2.4%)

Average femoral head diameter was greater in

patients who underwent THA with the posterolateral approach than in those who underwent THA with anterior and lateral approaches. In posterolateral patients, the proportion of those with 32-mm head size increased from 45% to 72% during the study period. The groups also differed regarding follow-up time, with the anterior approach having a shorter mean followup time than the other 2 approaches.

Christensen, 2015

Type of study: RCT

 

Setting: hospital

 

Country: USA

 

Source of funding: unknown

Inclusion criteria:

 

Exclusion criteria: <18 or >85 y, diagnosed with inflammatory or rheumatoid arthritis, BMI >40, or previously undergone ipsilateral hip surgery including arthroscopy, if patients had characteristics that led the surgeon to believe that the patient would clearly benefit from one particular technique over the other

 

N total at baseline:

Intervention: 28

Control: 23

 

Important prognostic factors2:

For example

age ± SD:

I: 64.3 ± 9.1

C: 65.2 ± 9.1

 

Sex:

I: 52% M, C: 48% M

Describe intervention (treatment/procedure/test):

 

 

Direct anterior (A)

N=28

 

Describe control (treatment/procedure/test):

 

 

Posterior (P)

N=23

Length of follow-up: 6 weeks

 

 

Loss-to-follow-up:

Intervention: 3 patients did not receive allocated intervention because of medical reasons

 

Control: 1 patient chose not to participate in the study prior to having surgery.

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Length of hospital stay:

A: 1.4 ± 0.6 days

P: 2.0 ± 1.1 days

 

Unlimited walking:

A: 4 (14%)

P: 5 (22%)

 

Pain (increase in score)

A: 27.8 ± 16.6

P: 20.7 (+/- 14.8)

 

Harris hip score

A: 42:

P: 32

 

Follow-up is only 6 weeks!

De Anta Diaz, 2015

Type of study: RCT

 

Setting: hospital

 

Country: Spain

 

Source of funding: unknown

Inclusion criteria: >=55 y, diagnosis of primary osteoarthritis, asymptomatic opposite hip

 

Exclusion criteria: prior hip surgery, arthroplasty to treat a fracture, inflammatory arthroplasties, autoimmune disease, immunosuppressive treatment, cancer

 

N total at baseline:

Intervention: 49

Control: 50

 

Important prognostic factors2:

I: 63.5 ± 12.5

C: 64.8 ± 10.1

 

Sex:

I: 53 % M

C: 52 % M

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

Direct anterior approach (A)

 

 

Describe control (treatment/procedure/test):

 

Lateral approach (L)

Length of follow-up:

12 months

 

Loss-to-follow-up:

Intervention: 2

Intraoperative wound infection

 

Control: 1 intra-operative trochanteric fracture

 

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Harris Hip Score:

A: 96.2

L: 94.5

 

Maratt, 2016

Type of study: retrospective analysis in a registry

 

Setting: hospital

 

Country: USA

 

Source of funding: Blue cross blue shield and the Blue Care Network as part of the BCBSM Value Partnership Program

Inclusion criteria: included in MARCQI registry, undergoing unilateral primary THA utilizing a DAA or PA between Feb 2012 and Sept 2014,

 

Exclusion criteria: cases were matched based on propensity scores, they were excluded if there was no match in 9 cases

 

N total at baseline:

Intervention: 2147

Control: 2147

 

Important prognostic factors2:

I: 64.8

 

Sex:

47% M

 

Groups comparable at baseline?

Describe intervention (treatment/procedure/test):

 

Direct Anterior Approach (A)

 

 

Describe control (treatment/procedure/test):

 

Posterior approach (P)

Length of follow-up: unclear

 

 

Loss-to-follow-up: unclear

 

Incomplete outcome data: unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Dislocation rate:

A: N=18 (0.84%)

P: N=17 (0.79%)

No significant difference

 

Blood transfusion

A: 173 (8.06%)

P: 208 (9.69%)

 

Fracture postoperative

A: 31 (1.44%)

P: 24 (1.12%)

 

Fracture intraoperative

A: 21 (0.98%)

P: 26 (1.21%)

 

Hematoma

A: 43 (2.0%)

P: 27 (1.26%)

Retrospective, patients not randomly assigned to treatment

Mjaaland, 2017

Type of study: cohort study from a registry

 

 

Setting: hospital

 

Country: Norway

 

Source of funding: No financial support or grant was received for the study.

Inclusion criteria:

primary THAs done with an uncemented stem performed between 2008 and 2013,

 

Exclusion criteria: -

 

N total at baseline:

MIS anterior: 2017

MIS anterolateral: 2087

Conventional posterior:5961

Conventional direct lateral: 11795

 

Important prognostic factors2:

Age:

MIS anterior: 67 ± 11

MIS anterolateral: 67 ± 11

Conventional posterior: 65 ± 12

Conventional direct lateral: 64 ± 12

 

Sex:

MIS anterior: 33.5 %M

MIS anterolateral: 36.5 %M

Conventional posterior:35.3 %M

Conventional direct lateral:38.7 %M

 

Groups comparable at baseline? Differences in age distribution, head size, ,type of articulation, use of cemented cups and primary diagnosis

Describe intervention (treatment/procedure/test):

 

 

MIS anterior

 

MIS anterolateral

 

 

Describe control (treatment/procedure/test):

 

 

Conventional posterior

 

Conventional direct lateral

Length of follow-up:

Five years

 

Loss-to-follow-up:

unknown

 

Incomplete outcome data:

unknown

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Implant survival

MIS anterior: 96.8 (96.0 to 97.6)

MIS anterolateral: 96.5 (95.5 to 97.5)

Posterior 96.4 (95.8 to 97.0)

Direct lateral 96.0 (95.6 to 96.4)

 

Revision (any cause):

Direct lateral: comparison

MIS anterior: 0.90 (0.68 to 1.2)

MIS anterolateral 0.95 (0.71 to 1.3)

Posterior 0.90 (0.75 to 1.1)

 

Dislocation

Direct lateral: comparison: 0.71 (95% CI = 0.40 to 1.3, p = 0.25)

MIS anterior/ anterolateral:

Posterior: 2.1, 95% CI = 1.5 to 3.1, p <0.001)

 

Revision due to fracture

Direct lateral:

MIS anterior/anterolateral: 0.85 (0.40 to 1.8)

Posterior:0.87 (0.43 to 1.7)

 

Notes:

  1. Prognostic balance between treatment groups is usually guaranteed in randomized studies, but non-randomized (observational) studies require matching of patients between treatment groups (case-control studies) or multivariate adjustment for prognostic factors (confounders) (cohort studies); the evidence table should contain sufficient details on these procedures.
  2. Provide data per treatment group on the most important prognostic factors ((potential) confounders).
  3. For case-control studies, provide sufficient detail on the procedure used to match cases and controls.
  4. For cohort studies, provide sufficient detail on the (multivariate) analyses used to adjust for (potential) confounders.

 

Risk of bias table for intervention studies (randomized controlled trials)

Study reference

 

 

 

(first author, publication year)

Describe method of randomisation1

Bias due to inadequate concealment of allocation?2

 

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?3

 

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?4

 

 

 

(unlikely/likely/unclear)

Bias due to loss to follow-up?5

 

 

 

 

 

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?6

 

 

 

(unlikely/likely/unclear)

Christensen, 2015

No details provided

Likely

Likely

Likely

unclear

unlikely

unlikely

unlikely

De Anta Diaz, 2015

No details provided

Likely

Likely

Likely

unclear

unlikely

unlikely

unlikely

  1. Randomisation: generation of allocation sequences have to be unpredictable, for example computer generated random-numbers or drawing lots or envelopes. Examples of inadequate procedures are generation of allocation sequences by alternation, according to case record number, date of birth or date of admission.
  2. Allocation concealment: refers to the protection (blinding) of the randomisation process. Concealment of allocation sequences is adequate if patients and enrolling investigators cannot foresee assignment, for example central randomisation (performed at a site remote from trial location) or sequentially numbered, sealed, opaque envelopes. Inadequate procedures are all procedures based on inadequate randomisation procedures or open allocation schedules.
  3. Blinding: neither the patient nor the care provider (attending physician) knows which patient is getting the special treatment. Blinding is sometimes impossible, for example when comparing surgical with non-surgical treatments. The outcome assessor records the study results. Blinding of those assessing outcomes prevents that the knowledge of patient assignement influences the proces of outcome assessment (detection or information bias). If a study has hard (objective) outcome measures, like death, blinding of outcome assessment is not necessary. If a study has “soft” (subjective) outcome measures, like the assessment of an X-ray, blinding of outcome assessment is necessary.
  4. Results of all predefined outcome measures should be reported; if the protocol is available, then outcomes in the protocol and published report can be compared; if not, then outcomes listed in the methods section of an article can be compared with those whose results are reported.
  5. If the percentage of patients lost to follow-up is large, or differs between treatment groups, or the reasons for loss to follow-up differ between treatment groups, bias is likely. If the number of patients lost to follow-up, or the reasons why, are not reported, the risk of bias is unclear.
  6. Participants included in the analysis are exactly those who were randomized into the trial. If the numbers randomized into each intervention group are not clearly reported, the risk of bias is unclear; an ITT analysis implies that (a) participants are kept in the intervention groups to which they were randomized, regardless of the intervention they actually received, (b) outcome data are measured on all participants, and (c) all randomized participants are included in the analysis.

 

Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)

Study reference

 

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?1

 

 

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2

 

 

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?4

 

 

(unlikely/likely/unclear)

Amlie, 2014

unlikely

Likely

unlikely

unlikely

Lin, 2016

unclear

Likely

unlikely

unlikely

Maratt, 2016

unlikely

Unlikely

unlikely

unlikely

Mjaaland, 2017

unlikely

Unlikely

unlikely

unlikely

  1. Failure to develop and apply appropriate eligibility criteria: a) case-control study: under- or over-matching in case-control studies; b) cohort study: selection of exposed and unexposed from different populations.
  2. 2 Bias is likely if: the percentage of patients lost to follow-up is large; or differs between treatment groups; or the reasons for loss to follow-up differ between treatment groups; or length of follow-up differs between treatment groups or is too short. The risk of bias is unclear if: the number of patients lost to follow-up; or the reasons why, are not reported.
  3. Flawed measurement, or differences in measurement of outcome in treatment and control group; bias may also result from a lack of blinding of those assessing outcomes (detection or information bias). If a study has hard (objective) outcome measures, like death, blinding of outcome assessment is not necessary. If a study has “soft” (subjective) outcome measures, like the assessment of an X-ray, blinding of outcome assessment is necessary.
  4. Failure to adequately measure all known prognostic factors and/or failure to adequately adjust for these factors in multivariate statistical analysis.

Overwegingen

The differences between the three most frequently used hip approaches in The Netherlands are small in current literature. Each of the approaches has their own set of complications and benefits. Learning curves exist for all approaches and therefore proper surgical training is warranted. Surgeons are recommended to choose the approach together with the patient.

 

If surgeons choose the posterior approach, they should reconstruct the posterior capsule and the external rotators. This has been shown to decrease the risk of dislocation.

Autorisatiedatum en geldigheid

Laatst beoordeeld : 12-02-2019

Laatst geautoriseerd : 12-02-2019

In theory, assessment will take place after five years to determine whether this module is still up-to-date. Are there reasons to suspect a need for earlier revision? For example, large studies that still need to be published?

 

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

Surgical approach

NOV

2018

2023

5 years

NOV

-

Initiatief en autorisatie

Initiatief : Nederlandse Orthopaedische Vereniging

Geautoriseerd door:
  • Koninklijk Nederlands Genootschap voor Fysiotherapie
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging voor Klinische Geriatrie
  • Nederlandse Vereniging voor Medische microbiologie

Algemene gegevens

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

Doel en doelgroep

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.

Samenstelling werkgroep

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

Belangenverklaringen

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

 

Inbreng patiëntenperspectief

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.

Methode ontwikkeling

Evidence based

Implementatie

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.

Werkwijze

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.

Zoekverantwoording

Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.