Patient Reported Outcome Measures in THA
Question
What Patient Reported Outcome Measures should be used to assess the effect of total hip arthroplasty?
Recommendation
Register PROMs prior to total hip arthroplasty and during follow-up: at least at the time of indication, and at three and twelve months after the operation.
Use the EQ-5D as a general PROMs, and the NRS to evaluate pain in rest and during physical activity.
Use the HOOS-PS as a joint-specific PROM (consider adding the OHS to facilitate international comparisons).
Considerations
In general there is an increased use of both disease-specific and general PROMs. PROMs might particularly be valuable for measuring the effect of specific (surgical) interventions or for evaluation of care. In the future, PROMs may possibly be useful for determining practice variation (NOV, 2012).
The Netherlands Orthopaedic Association (NOV) aims to identify a set of PROMs that can contribute to continuous improvement of orthopaedic care, through recording of the outcomes in quality registrations like the Landelijke Registratie Orthopedische Implantaten (LROI) (NOV, 2012).
The NOV recommends to use the EuroQol 5 dimensions (EQ-5D), a standardized instrument for measuring generic health status, as a general PROM. The NOV initially advised to measure pain (in rest and during physical activity) in patients undergoing total hip arthroplasty with the Visual Analogue Scale (VAS). However, the Numeric Rating Scale (NRS) seems at least equivalent to the VAS and is more feasible in clinical practice. As a joint-specific PROM for THA patients the NOV recommends the Hip disability and Osteoarthritis Outcome Score (HOOS PS: a questionnaire to measure the symptoms and limitations with THA patients), which might be combined with the Oxford Hip Score (OHS) to assess function and pain with THA patients. Combining the HOOS PS and OHS facilitates international comparisons (NOV, 2012).
The PROMs should be administered at the time of indication, and three months and one year after the operation (NOV, 2012).
Evidence
Background
This module is based on the advisory report of the Netherlands Orthopaedic Association: Patient Reported Outcome Measures. Advies Nederlandse Orthopaedische Vereniging 2012 (https://www.orthopeden.org/downloads/31/Implementatieplan%20PROMs.pdf).
Patient Reported Outcome Measures (PROMs) are questionnaires which patients complete. PROMs are intended to quantify burden of disease and therefore may be helpful in the measurement of quality of care. PROMs have been used for a long time in scientific studies, but their use in the evaluation of regular care is relatively new. It is important to define an optimal set of PROMs that can be used in the assessment of the effect of a total hip arthroplasty (THA) from a patients’ perspective.
Literature summary
The recommendations are based on the advisory report of the Netherlands Orthopaedic Association: Patient Reported Outcome Measures. Advies Nederlandse Orthopaedische Vereniging 2012 (https://www.orthopeden.org/downloads/31/Implementatieplan%20PROMs.pdf) (NOV, 2012).
Search and select
No systematic literature search was performed.
References
- NOV (2012). Patient Reported Outcome Measures. Advies Nederlandse Orthopaedische Vereniging (NOV) (https://www.orthopeden.org/downloads/32/advies-proms-orthopedie.pdf).
Methods
Authorization date and validity
Last review : 12-02-2019
Last authorization : 12-02-2019
Planned reassessment :
General details
The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).
Scope and target group
Aim of the guideline
The main purpose of the guideline is to provide the best possible care to patients with osteoarthritis of the hip, by informing optimal treatment decisions and reducing unwarranted variation in the delivery of care and long-term failure of the implants.
Envisaged users of the guideline
This guideline was developed for all Dutch healthcare providers of patients with osteoarthritis of the hip.
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
Declaration of interest
At the start of the project, the members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These declarations of interest can be requested from the secretariat of the Knowledge Institute of the Dutch Association of Medical Specialists. See below for an overview.
Werkgroeplid |
Mogelijke conflicterende belangen met betrekking tot deelname werkgroep |
Toelichting |
Dr. B.W. Schreurs |
Presentaties voor Stryker over de Exeter totale heupprothese (educational fee naar afdeling) Doet reviews voor DEKRA KEMA (betaald) Voorzitter European Hip Society (onbetaald) Voorzitter wetenschappelijke adviesraad LROI (onbetaald) Voorzitter adviesraad botbank Sanquin (onbetaald) Lid Commissie Orthopedisch Implantaten Classificatie NOV (onbetaald) |
|
Dr. P.C. Jutte |
Hoofdonderzoeker LEAK-studie (ZonMW) Voorzitter werkgroep weke delen en bottumoren Lid werkgroep orthopedische infecties NOV Lid werkgroep bottumoren NOV Lid commissie beentumoren Nederland Lid onderwijscommissie NOV Lid medische adviesraad patientvereniging Sarcoma NL |
|
D.E. Lopuhaä |
Geen belangen |
|
Dr. R.H.M. ten Broeke |
Voorzitter werkgroep "Heup" (Dutch Hip Society) NOV sinds 2015 (onbetaald) Daarvoor gedurende 3 jaar reeds bestuurslid van deze werkgroep (onbetaald) Klinisch onderzoek gefinancierd door firma Stryker (RSA en PET-CT-onderzoek bij vergelijking van 2 ongecementeerde cupdesigns) (onbetaald) |
|
Dr. W.F.H. Peter |
Geen belangen |
|
Dr. P.D. Croughs |
Geen belangen |
|
Dr. S.B.W. Vehmeijer |
Directeur Orthoparc (onbetaald) Bestuurslid Dutch Hip Society (onbetaald) National Representative European Hip Society (onbetaald) Consulent Zimmer Biomet (betaald) |
|
Dr. B.A. Swierstra |
Voorzitter Stichting OrthoResearch (onbetaald) Advisory Board Arthroplasty Watch (onbetaald) Lid Wetenschappelijke Advies Raad Landelijke Registratie Orthopaedische Implantaten (onbetaald) Board of Directors International Society of Orthopaedic Centers (onbetaald) Coeditor Acta Orthopaedica (onkostenvergoeding) |
|
Dr. R.A. Faaij |
Geen belangen |
|
Dr. A.M.J.S. Vervest |
Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald) Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald) |
|
J. Vooijs |
Geen belangen |
|
Drs. G. Willemsen – de Mey |
Geen belangen |
|
Meelezers |
||
Drs. S. Nijssen |
ISO 15189 auditor, betaald door RvA |
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Dr. R.J. Rentenaar |
Commissie bacteriologie Stichting Kwaliteitsbewaking Medische Laboratoria (SKML) (tegen onkostenvergoeding). Verschillende producenten stellen soms kleine hoeveelheden van producten ter beschikking kosteloos of tegen gereduceerd tarief t.b.v. verificatie doeleinden |
|
Dr. A.T. Bernards |
Geen belangen |
|
Patient involvement
Attention was paid to the patients’ perspective by participation in the working group of the Dutch Arthritis Society and National Association ReumaZorg Nederland. In addition, the Patients Federation Netherlands assessed the draft guideline during the consultation phase and made suggestions for improvement of the guideline.
Method of development
Methods and proces
The guideline was developed in agreement with the criteria set by the advisory committee on guideline development of the Dutch Association of Medical Specialists (Medisch Specialistische Richtlijnen 2.0; OMS 2011), which are based on the AGREE II instrument (Brouwers (2010); www.agreetrust.org). The guideline was developed using an evidence-based approach endorsing GRADE methodology, and meeting all criteria of AGREE-II. Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a systematic approach for synthesising evidence and grading of recommendations offering transparency at each stage of the guideline development (Guyatt, 2011; Schünemann, 2013).
The guideline development process involves a number of phases: a preparatory phase, development phase, commentary phase, and authorisation phase. After authorisation, the guideline has to be disseminated and implemented and its uptake and use have to be evaluated. Finally, the guideline has to be kept up-to-date. Each phase involves a number of practical steps Schünemann, (2014).
As a first step in the early preparatory phase, a broad forum discussion was held and all relevant stakeholders were consulted to define and prioritise the key issues the recommendations should address. Subsequently, the methodologist together with the chairman of the working group created a draft list of key issues, which was extensively discussed in the working group.
Despite aiming for an update of the guideline from 2010, due to financial constraints not all clinical questions from the former edition could be updated, so it was decided to perform a so-called modular update. Selecting modules with a higher priority for update formed part of this discussion and selection process. This resulted in the following approach.
Modules that were updated:
- Indications for primary total hip arthroplasty.
- Type of bearing (part of the module surgical techniques).
- Diameter of the head (part of the module surgical techniques).
- Surgical approach (part of the module surgical techniques).
- Systemic antibiotics (part of the module perioperative care in primary total hip arthroplasty).
- Antibiotic-impregnated bone cement (part of the module perioperative care in primary total hip arthroplasty).
- Preoperative decolonisation (part of the module perioperative care in primary total hip arthroplasty).
- Routine follow-up (part of the module postoperative care).
Modules considered still valid:
- cemented versus uncemented hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
Modules removed from the guideline:
- Resurfacing hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
- Minimally invasive surgery (part of the module surgical techniques in primary total hip arthroplasty).
- Guidelines for MRSA carriers (part of the module perioperative care in primary total hip arthroplasty).
Modules that were replaced by a reference to related guidelines:
- Hematogenous infection (part of the module postoperative care).
- Prevention of thrombo-embolic complications (part of the module perioperative care in primary total hip arthroplasty).
- Physcial therapy (part of the module perioperative care in primary total hip arthroplasty).
Modules not updated because guidelines are expected soon:
- Anaesthesiological technique (part of the module perioperative care in primary total hip arthroplasty).
Modules that were added:
- Patient Reported Outcome Measures.
- Place and organisation of fasttrack.
- Organization of care for frail elderly.
The selected (high priority) issues were translated into carefully formulated clinical questions, defining patient/problem, intervention, and prioritising the outcomes relevant for decision-making.
The literature was systematically searched using the databases MEDLINE (Ovid), Embase and the Cochrane Database of Systematic Reviews. Selection of the relevant literature was based on predefined inclusion and exclusion criteria and was carried out by a member of the working group in collaboration with the methodologist. For each of the clinical questions, the evidence was summarised by the guideline methodologist using the GRADE approach: a systematic review was performed for each of the relevant outcomes and the quality of evidence was assessed in one of four grades (high, moderate, low, very low) by analysing limitations in study design or execution (risk of bias), inconsistency of results, indirectness of evidence, imprecision, and publication bias. The evidence synthesis was complemented by a working group member considering any additional arguments relevant to the clinical question. Evidence synthesis, complementary arguments, and draft recommendations were extensively discussed in the working group and final recommendations were formulated. Final recommendations are based on the balance of desirable and undesirable outcomes, the quality of the body of evidence across all relevant outcomes, values and preferences, and (if relevant) resource use. The strength of a recommendation reflects the extent to which the guideline panel was confident that desirable effects of the intervention outweigh undesirable effects, or vice versa, across the range of patients for whom the recommendation is intended. The strength of a recommendation is determined by weighting all relevant arguments together, the weight of the body of evidence from the systematic literature analysis, as well as the weight of all complementary arguments. Guideline panels must use judgment in integrating these factors to make a strong or weak recommendation. Thus, a low quality of the body of evidence from the systematic literature analysis does not exclude a strong recommendation, and weak recommendations may follow from high quality evidence Schünemann, (2013).
After reaching consensus in the working group, the draft guideline was subjected to peer review by all relevant stakeholders. Amendments were made and agreed upon by the working group, and the final text was presented to the Netherlands Orthopaedic Association (NOV), the Royal Dutch Society for Physical Therapy (KNGF), the Dutch Society of Medical Microbiology (NVMM) and the Dutch Geriatrics Society (NVKG) for formal authorisation and to the National Association ReumaZorg Nederland and the Dutch Arthritis Society for approval. The final guideline was approved by the National Association ReumaZorg Nederland and the Dutch Arthritis Society, and was officially authorised by the Netherlands Orthopaedic Association, the Royal Dutch Society for Physical Therapy, the Dutch Society of Medical Microbiology and the Dutch Geriatrics Society. The guideline was published and is freely accessible in the Dutch guideline database (Richtlijnendatabase, www.richtlijnendatabase.nl). The Dutch guideline database has a modular structure, with each clinical question as a separate entry, thus allowing for modular updates.
References
Brouwers M, Kho ME, Browman GP, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec;182:E839-842; doi: 10.1503/cmaj.090449.
Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology. 2011;64 383–394. (doi:10.1016/j.jclinepi.2010. 04.026).
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from https://www.gradepro.org/
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.