Uitgangsvraag

Wat is het optimale interval van routinematige follow-up na een totale arthroplastiek en welke rol speelt beeldvorming hierbij?

Aanbeveling

Routinematige follow-up van patiënten moet in ieder geval plaatsvinden zes tot twaalf weken, een jaar, en na tenminste vijf jaar na een totale heupvervanging, of eerder als de operateur daar aanleiding toe ziet.

 

Op basis van de recente literatuur is het niet mogelijk om een optimale frequentie van follow-up aan te geven na het vijfde jaar.

 

Röntgenonderzoek dient onderdeel te zijn van routinematige follow-up.

Inleiding

After a successful total hip arthroplasty (THA), the question is whether routine clinical and radiological examinations are indicated. At the moment routine clinical and radiological examinations are advised six to twelve weeks, one year and five years after THA.

Conclusies

Very low

GRADE

There seems to be no benefit of routine follow-up in asymptomatic patients within 5 years after total hip arthroplasty.

 

Sources (Christensen, 2013; King, 2004; Röder, 2003)

Samenvatting literatuur

Description of studies and results

One new study was included Christensen, (2013). Also, two studies are described that were also included in the 2010 guideline (King, 2004 and Röder, 2003).

 

Christensen (2013) used a retrospective chart review of 249 patients after uncomplicated cementless primary THA, to study consequences of radiographic follow-up after three months and after twelve months. The radiographic examination had direct consequences in five cases (1.2%) out of 417 outpatient visits. However, in only two cases did the radiographs result in consequences other than increased follow-up Christensen, (2013).

 

Röder (2003) analysed the follow-up of 18,486 patients with a THA between 1967 and 2001 (18,486 THAs). Sensitivity, specificity, negative and positive predictive values with respect to acetabular and femoral loosening were evaluated for ten clinical variables: five different locations of pain (hip, buttock, groin, thigh, knee), four elements of pain on testing (over trochanter, on axial compression, internal rotation and external rotation) and range of flexion. Sensitivities were all low (between 0.0 and 0.6), specificity values were all between 0.89 and 1.0. Positive predictive values increased from 0.00 to 0.66 in the ten years after surgery, negative predictive values decreased from 1.00 to 0.86. The authors concluded that routine follow-up of asymptomatic patients with THA was not necessary during the first five or six years Röder, (2003).

 

King (2004) found no difference in clinical outcome between 30 patients who had not shown up for follow-up between 6 months and 5 years following surgery, compared to 131 patients that had routine postoperative controls.

 

Grading of evidence

The quality of evidence started as low as only observational studies were included and was downgraded one level to very low because studies with other time frames were used (indirectness).

Zoeken en selecteren

To answer the question a systematic literature analysis was performed for the following research question: What are the (un)favourable effects of routine follow-up in patients that underwent a total hip arthroplasty?

 

P: patients that underwent a total hip arthroplasty;

I: follow-up

C: -

O: -

 

The working group did not define outcomes a priori, but used definitions as provided in the studies.

 

Search and select (Method)

A literature search was performed with relevant search terms on 18 May 2017 in the database (Medline (via OVID). The search strategy is provided in the tab “Methods”. The literature search resulted in 197 hits. Studies were selected using the following selection criteria: effects of follow-up in patients who underwent a total hip arthroplasty. Studies comparing two different types of follow-up were not selected (for example web-based compared to in-person). Based on title and abstract eight studies were pre-selected. After obtaining full text, one new studies was included in literature analysis. Two studies of the 2010 guideline fulfilled the PICO and were also included in the literature summary. No studies were found evaluating the kind of radiographic imaging necessary for routine follow-up after a THA.

 

The most important study characteristics are described in evidence tables.

Referenties

  1. Christensen M, Folkmar K. No clinical value of post-operative routine X-ray following uncomplicated cementless primary total hip arthroplasty. Dan Med J. 2013;60(4):A4613. PubMed PMID: 23651720.2e.
  2. Kingsbury SR, Dube B, Thomas CM, et al. Is a questionnaire and radiograph-based follow-up model for patients with primary hip and knee arthroplasty a viable alternative to traditional regular outpatient follow-up clinic? Bone Joint J. 2016;98-B(2):201-8. doi: 10.1302/0301-620X.98B2.36424. PubMed PMID: 26850425.3e.
  3. King PJ, Malin, AS, Scott, RD, et al. The fate of patients not returning for follow-up five years after total knee arthroplasty. J Bone Joint Surg Am. 2004;86-A- 897.
  4. Lovelock TM, Broughton NS. Follow-up after arthroplasty of the hip and knee; are we over-servicing or under-caring? Bone Joint J. 2018;100-B:6-10.
  5. Röder C, Eggli S, Aebi M, et al. (2003). The validity of clinical examination in the diagnosis of loosening of components in total hip arthroplasty. J Bone Joint Surg Br. 2003;85:37-44.
  6. Sandgren B, Crafoord J, Olivecrona H, et al. Risk factors for periacetabular osteolysis and wear in asymptomatic patients with uncemented total hip arthroplasties. ScientificWorldJournal. 2014;2014:905818. doi: 10.1155/2014/905818. Epub 2014 Nov 16.

Evidence tabellen

Research question: What are the (un)favourable effects of routine follow-up in patients that underwent a total hip arthroplasty?

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Christensen, 2013

Type of study: retrospective chart review

 

Setting: hospital

 

Country: Denmark

 

Source of funding: unknown

Inclusion criteria: patients undergoing cementless primary THA from August to November 2009 at Hørsholm Hospital, Orthopaedic Hip Clinic

 

Exclusion criteria: major per- or post-operative complications such as fracture, deep infection, or dislocation and cases requiring bone transplantation were excluded. Patients having complaints that led to early referral and additional outpatient follow-up outside of the planned three- and 12-month follow-up visits were also excluded.

 

N total at baseline:

N=249

 

Important prognostic factors2:

Age ± SD: 68 (26 to 93)

 

Sex:

36 % M

 

Main indication was osteoarthritis (OA) (n = 215; 91%). Other indications were dysplasia (n = 10; 4%), sequelae from fracture (n = 6; 2.5%), rheumatoid arthritis (n = 4; 1.7%) and caput necrosis (n = 1; 0.4%).

Describe intervention (treatment/procedure/test):

 

Radiographic follow-up

 

 

Describe control (treatment/procedure/test):

 

-

Length of follow-up:

3 and 12 months

 

Loss-to-follow-up:

A total of 11 patients were excluded before the three month follow-up visit; seven patients had fractures, four of which occurred during surgery. The remaining four patients had major post-operative complications requiring revision; two had loosening of the cup and two had deep infection.

 

One patient had fallen between the two outpatient visits and had suffered a trochanteric fracture and was thus excluded at the 12-month follow-up.

 

 

 

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

 

Among 417 outpatient visits, the radiographic examination had direct consequence in five cases (1.2%;95% confidence interval (CI): 0.4 to 2.8%); however, in only two cases (0.48%; 95% CI: 0.06 to 1.72) did the radiographs result in consequences other than increased follow-up.

 

Röder (2003)

Type of study:

Analysis of follow-up data

 

Setting:

Data were derived from the database of the Maurice E. Müller Institute for Evaluative Research in Orthopaedic Surgery. Data were collectd between 1967 and 2002 from 41 hospitals.

 

Country:

Several European countries

 

Source of funding:

No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

Inclusion criteria:

- osteoarthritis as the main diagnosis, primary THA, age over 20 years at THA, and the availability of serial documented follow-up examinations for at least ten years after operation with a complete set of preoperative, immediately postoperatieve and follow-up radiographs.

 

Exclusion criteria:

-

 

N total at baseline: the database search identified 15743 patiens

 

Important prognostic factors2:

Age ± SD:

The median age at surgery was 67.4 years with a 75% percentile of 73.8 years and a 25% percentile of 60.1 years.

 

Sex:

50,4% male

49,6% female

Describe intervention (treatment/procedure/test):

Total hip arthroplasty

 

 

Describe control (treatment/procedure/test):

-

 

Length of follow-up:

Patients with a follow-up of at least 20 years were selected.

Loss-to-follow-up:

-

 

 

 

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

 

Sensitivity and specificity:
Sensitivities ranged between

0.00 and 0.49 for uncemented and between 0.00 and 0.6 for

cemented cups. Figure 2 and Tables V and VI give the mean

values. A slight time-dependent increase in sensitivity was

seen during the first decade after operation. The specificity

of all indices was constantly between 0.89 and 1.00, regardless

of the mode of fixation of the cup. Figure 3 gives the

mean values. Time trends of specificity were slightly negative

and, unlike sensitivity, the specificities of the various

clinical indices appeared to be homogenous.

For the stems, sensitivities ranged between 0.0 and 0.57

for cemented and between 0.0 and 0.46 for uncemented

components. The sensitivities of most variables showed

more constant time trends compared with those of the cups.

Figure 2 and Tables VII and VIII give the mean values. Most

values in the uncemented group had a higher variability over

time within the mentioned range. The specificity of all

indices was constantly between 0.9 and 1.0 for both types of

fixation. Time trends of specificity were also slightly negative

and homogenous, compared with the sensitivities.

Figure 3 gives the mean values. The variability of values

with time was again higher in the uncemented group.

 

Predictive values
With regard to loosening of the cup some

types of pain were rarely diagnosed and therefore predictive

values could not be calculated in all cases. PPVs increased

during the first decade after operation from 0.00 to 0.66.

The time-dependent variation was similar for both cemented

and uncemented cups (Fig 4, Tables V and VI). NPVs

decreased over time from 1.00 to 0.86. This decrease was

relatively constant for uncemented cups whereas for

cemented cups a relatively sharp decrease in NPV was

observed at six years after operation (Fig. 5, Tables V and

VI).

The calculated NPVs for loosening of the stem from one

to ten years were constantly above 0.87 regardless of the

year of follow-up and type of fixation of the stem. For both

methods of fixation, the NPV at four years after operation

was higher than at eight years (Fig. 5, Tables VI and VIII). PPVs varied considerably, especially in the uncemented

group, and were rarely higher than 0.5 with a slight constant

upward trend with time (Fig. 4, Tables VI and VIII).

 

King (2004)

Type of study:

Retrospective review of records

 

Setting:

Hospital based

 

Country:

Boston, Massachusetts, United States

 

Source of funding:

The authors did not receive grants or outside funding in support of their

research or preparation of this manuscript. One or more of the authors

received payments or other benefits or a commitment or agreement to

provide such benefits from a commercial entity (DePuy, a Johnson and

Johnson Company). No commercial entity paid or directed, or agreed to

pay or direct, any benefits to any research fund, foundation, educational

institution, or other charitable or nonprofit organization with which the

authors are affiliated or associated.

Inclusion criteria:

Retrospectively reviewed the records of 161 patients with a total of 200 consecutive toal knee replacements perfomed between April 1996 and July 1997 by the same surgeon with the same prosthesis (PFC Sigma; DePuy, Warsaw, Indiana).

 

All of the operations were performed at one of two hospitals,

and all follow-up examinations were conducted at the same

office. For the purposes of this study, we defined patients as

not having returned for follow-up if they had had no contact

of any type with their surgeon beyond six months after the

date of the surgery.

Exclusion criteria: -

 

N total at baseline: 161 patients

 

Important prognostic factors2:

Age ± SD:

Control: mean age at time of surgery was 71.3 years (range 44 to 83)
Intervention: mean age at the time of surgery was 68.1 years (range 40 to 84)

 

Sex:

Control: nine (30%) of the patients were male

Intervention: 54 (30%) were male

 

Weight:

Control: mean weight at time of surgery was 82.0 kg (range 52 to 11)

Intervention: mean weight 79.0 kg (range 30 to 130)

 

No significant differences in baseline sex, diagnosis, deformity (varus or valgus), or weight.

 

The patients who had not attended

follow-up appointments tended to be older at the time

of the surgery than those who had attended follow-up appointments and more of them had died

 

Describe intervention (treatment/procedure/test):


Returned for follow-up after total knee arthroplasty

Patients who had been returning for follow-up appointments

were evaluated in the same fashion. If the patient had

already returned for a follow-up appointment at a minimum

of five years, the Knee Society pain and function scores were

determined from the chart. If the patient had been keeping

follow-up appointments but had not yet returned for the fiveyear

evaluation, he or she was contacted by one of the authors, who administered the pain and function components

of the Knee Society Clinical Rating System in a telephone

interview. The scores were compared with the preoperative

values recorded in the chart. All patients who had not yet returned

for a clinical evaluation at a minimum of five years

were asked to return for clinical and radiograph examination. When a patient had been keeping the prescribed follow-up appointments but had not yet returned for the five-year followup evaluation and could not be contacted with use of the last known contact information in the chart, an attempt was made

to locate that patient with use of the standardized Internet search algorithm employed for the patients who had not returned

for follow-up.



 

 

Describe control (treatment/procedure/test):


Not returned for follow-up

after total knee arthroplasty

Patients who had not returned for follow-up were evaluated by one of the authors (A.S.M.), who had not been involved in their care. The evaluation was carried out by means of a telephone interview, during which the patients were asked

about the status of the knee prosthesis, the reason that they did not return for follow-up, and whether a different surgeon had been evaluating or treating the knee. A patient who gave more than one reason for not adhering to the recommended follow-up regimen was asked to identify which reason he or she considered to be primary. Scores for the pain and function

components of the Knee Society Clinical Rating System were

determined on the basis of this telephone interview and were

compared with the preoperative values recorded in the patient’s chart. Patients were educated about the importance of the recommended follow-up regimen. All patients were asked to schedule an appointment for complete physical examination

and radiographs.

Length of follow-up:

The minimum duration of follow-up was five years (mean, 64.0 months; range, sixty to secenty-three months).

Loss-to-follow-up:

Control group: seven patients (8 knees) had died of unrelated causes.

Intervention group: ten patients (11 knees) had died of unrelated causes

 

 

 

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

 

None of the patients who had not returned for follow-up

had required additional surgery on the knee; six patients who

had returned for a follow-up evaluation at a minimum of five

years had required additional surgery on the knee. This difference

was not significant. The reasons for additional surgery included

late infection (two patients), arthroscopic manipulation

(two), synovectomy with exchange of the polyethylene liner because

of recurrent varus deformity (one), and excision of a lateral

joint line cyst (one).

 

Both the patients who had returned

for follow-up and those who had not had a significant

improvement in the postoperative scores for the pain and

function components of the Knee Society Clinical Rating System

compared with the preoperative values (p <0.0001).

There was no significant difference in the pain and function

scores at a minimum of five years between the patients who

had and those who had not attended follow-up appointments.

 

Two patients who had not returned for follow-up appointments and four who had returned reported that they were dissatisfied with the knee replacement (p = 0.25). Of the two dissatisfied patients who had not returned for follow-up appointments, one had bilateral osteoarthritis of the knee and complained of a limb-length discrepancy following correction of a large varus deformity in one of the knees. The other patient complained of residual stiffness one month after the surgery and did not return for follow-up again.

An attempt was made to locate patients who had not returned

for follow-up at a minimum of five years by using their

last known contact information or the last known information

on their next of kin. When a patient could not be located with

use of this information, a series of searches of free, readily available

Internet databases was carried out with use of the patient’s

most recent demographic information as a starting point (see article).

 

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 (observational: non-randomized clinical trials, cohort and case-control studies)

Research question:

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)

Christensen (2013)

Unlikely (all THA patients Aug-Nov 2009)

Likely (follow-up too short)

Unclear

Unclear

Röder (2003)

Not applicable

Unclear

Unlikely

Likely (only age and gender)

King (2004)

Unclear (It is written in the study that total knee replacements performed between 1996 and July 1997 by the same surgeon with the same prosthesis were selected. However, it is not stated if a preselection is made of all the knee replacements performed by the surgeon)

Unclear (it is unclear if the reasons for (not) returning to the follow-up appointments differ between the two groups)

Likely (outcome assessors were not blinded)

Likely (no multivariate statisitical analysis done)

  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. 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

Monitoring of patients shortly (6 to 12 weeks) after the operation concentrates on healing of the wound and on recovery of function. Broadly speaking, this stage is complete one year after surgery, including the fixation of an uncemented prosthesis. After the first year, routine follow-up is aimed at detection of complications such as polyethylene wear or osteolysis and at deterioration of function.

 

Lovelock and Broughton (2018) (expert opinion) discussed the need for routine follow-up after arthroplasty of the hip and knee. They stated that the early failure of the THA (within five years) is decreased because of the diminishing incidence of dislocation due to the increased use of the 32 mm head size and the use of components rated as Orthopaedic Data Evaluation Panel (ODEP) 10A. Nevertheless, they recommend to offer routine follow-up depending on age of the patient and type of prosthesis Broughton, (2018).

 

Polythylene particles could lead to osteolysis and subsequent loosening. When detecting this loosening on X-rays, an operative intervention should be advised. Loosening of components usually leads to complaints, although a few patients remain asymptomatic. Sandgren (2014) studied a cohort of 206 asymptomatic patients with several uncemented cup prostheses with a median follow-up of 10 years after surgery (range 7 to 14 years). They analysed peri-acetabular osteolysis using CT examinations. They found that 57 patients (27.7%) had peri-acetabular osteolysis of more than 10 mm. Wear was associated with osteolysis. Sandgren (2014) advised follow-up on a regular basis with CT scan. However, mostly these adverse reactions do not occur within the first 5 to 10 years after surgery. Therefore, it is questionable whether routine follow-up of many patients for a long time, with high radiation levels of the CT scan, to detect only a few patients with asymptomatic osteolysis or loosening is justified.

 

However, absence of any routine follow-up might lead to undetected silent osteolysis or loss of function, which may increase risk of falling with possibly devastating consequences.

 

If routine follow-up is considered, the following aspects might play a role in determining the optimal frequency:

  • Risk of complications: risk is low in the first 5-10 years after surgery.
  • Age of the patient at surgery: with a 10-year survival of 95% for a prosthesis, it is not necessary to routinely follow-up patients aged 70 years or older. These patients should be advised to return when they have complaints.
  • Type of prosthesis.
  • Not all patients will spontaneously contact their doctor. They should be reminded. By being followed up every 1, 2, or 3 years, patients get used to regular follow-up at a later stage, especially younger patients.
  • Quality control: it is important for an orthopaedic surgeon to know the results of his/her own work. This is only possible by regular clinical and radiological monitoring of his or her own patients.

 

The working group recommends performing routine follow-up on patients six to twelve weeks, one year and at least five years after THA. Asymptomatic patients do not need routine follow-up within the first five years after surgery. Radiographic imaging should at least be done during routine follow-up. If wear is detected on X-ray during follow-up, a CT-scan may be considered.

Autorisatiedatum en geldigheid

Laatst beoordeeld : 12-02-2019

Laatst geautoriseerd : 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

Routine follow-up

NOV

2018

2023

Every five 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

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