Niet-medicamenteuze behandeling handartrose
Uitgangsvraag
Wat is de plaatsbepaling van niet-medicamenteuze interventies bij handartrose?
De uitgangsvraag omvat de volgende deelvragen:
- Wat is de effectiviteit van oefentherapie bij handartrose?
- Wat is de effectiviteit van ergonomische maatregelen bij handartrose?
- Wat is de effectiviteit van spalken bij handartrose?
- Wat is de effectiviteit van hulpmiddelen bij handartrose?
- Wat is de effectiviteit van combinatie programma’s en zelfmanagement bij handartrose?
- Wat is de effectiviteit van warmte therapie bij handartrose?
Aanbeveling
Draag zorg dat alle patiënten met handartrose voorlichting en instructie in ergonomische principes, handoefeningen, energieverdeling en het gebruik van hulpmiddelen krijgen.
Overweeg voor alle patiënten oefentherapie om functie en spierkracht te verbeteren, en pijn te verminderen
Overweeg een orthese (voor tenminste 3 maanden) voor symptoomvermindering bij patiënten met handartrose.
Overweeg een verwijzing naar een handtherapeut (een ergo- of fysiotherapeut met deze specialisatie) voor specifieke advisering over hulpmiddelen, het aanmeten van orthoses en/of specifieke oefentherapie.
Overwegingen
Voorlichting over handartrose en de mogelijkheden om met klachten om te gaan is een essentieel element in de behandeling van handartrose. Deze voorlichting bevat bij voorkeur de volgende elementen: de beschikbaarheid van hulpmiddelen, en instructie in handoefeningen, ergonomische principes en energieverdeling. De verouderde term “gewrichtsbescherming” dient bij voorkeur niet gebruikt te worden, omdat deze term impliceert dat men de gewrichten moet beschermen en beter niet kan gebruiken. Er is voldoende bewijskracht voor het bevorderen van zelfmanagement door middel van instructie in ergonomische principes (Dziedzic et al., 2015), het gebruik van hulpmiddelen (Hill et al., 2010; Kjeken et al., 2011) en het doen van handoefeningen (zie de volgende paragraaf). Er zijn echter geen aanwijzingen dat intensieve programma’s of combinatie-programma’s die deze zorg omvatten, effectiever of kosteneffectiever zijn dan eenvoudigere strategieën (Oppong et al., 2015).
Naar de mening van de werkgroep kunnen veel mensen met handartrose, na voorlichting en instructie hierin, omgaan met hun klachten in het dagelijks leven. Om deze reden is de EULAR aanbeveling ten aanzien van voorlichting en instructie uitgebreid met instructie over handoefeningen. Voorbeelden van hulpmiddelen en handoefeningen zijn door de EULAR verwerkt in verschillende voorlichtingsfilmpjes (te gebruiken door zorgverleners en patiënten) en te vinden op https://www.youtube.com/watch?v=MKqbN_pnz8c&ab_channel=EULAR.
Voorlichting over ergonomische principes, handoefeningen, hulpmiddelen en energieverdeling kan verzorgd worden door een reumaverpleegkundige, fysio- of ergotherapeut en/of verwerkt worden in schriftelijk materiaal. Verwijzing naar een handtherapeut (een ergo- of fysiotherapeut met deze specialisatie) kan overwogen worden voor specifieke advisering over hulpmiddelen, het aanmeten van orthoses en/of specifieke oefentherapie. Ook als de patiënt problemen ondervindt om de aangeboden (schriftelijke) voorlichting, ergonomische principes en energieverdeling toe te passen in zijn eigen dagelijkse activiteiten of als de reumaverpleegkundige, algemeen fysio- of ergotherapeut aanvullende expertise bij betreffende patiënt wenselijk acht.
De EULAR aanbeveling van 2018 over oefentherapie is gebaseerd op meerdere onderzoeken (n = 7) waarvan de resultaten zijn samengevat in een Cochrane-review (Østeras et al., 2017). Er werd aangetoond dat handoefeningen kleine gunstige effecten hebben op pijn en functie, gewrichtsstijfheid en grijpkracht, met weinig en niet-ernstige bijwerkingen. De onderzochte interventies waren echter heterogeen, variërend van oefeningen thuis na één instructiesessie tot meerdere begeleide sessies per week gedurende meerdere weken, en ook de frequentie van de training, het aantal herhalingen per oefening en het soort oefeningen (bijv. stretching) waren variabel. In de huidige update zijn er twee studies toegevoegd aan de literatuursamenvatting (Kang et al., 2019; Wouters et al., 2019). Ondanks dat deze studies gedegen opgezette en uitgevoerde studies zijn was het niet mogelijk deze mee te nemen in de gepoolde data (de studie van Wouters et al. 2019 is een cohort studie en de studie van Kang et al. 2019 leidt tot een te grote heterogeniteit in de gepoolde data). Beide studies ondersteunen echter wel de gunstige effecten van oefentherapie op pijn en functie bij mensen met handartrose.
Oefeningen moeten gericht zijn op het verbeteren van de mobiliteit van de gewrichten, de spierkracht en de stabiliteit van de duimbasis. Trainingsprotocollen gericht op het eerste carpometacarpale (CMC-1) gewricht verschillen van die voor interfalangeale gewrichten.
De onderzoeken die reeds door de EULAR zijn opgenomen bewijzen de gunstige effecten van een duimbasisorthese, vooral op pijn en in mindere mate op het functioneren, maar niet op de grijpkracht bij langdurig gebruik (minimaal 3 maanden). Recent zijn de resultaten van een RCT gepubliceerd (Adams et al., 2021) die een vervolg was op de pilot-RCT (Adams et al. 2014) die meegenomen is in de EULAR-update. In deze studie werden de effecten van een zelfmanagement programma vergeleken met de toevoeging van een duimbasisorthese of een sham-orthese. Pijn en functioneren verbeterden van baseline naar 8 en 12 weken follow-up voor alle groepen. Er werden echter geen klinische of statistische significante verschillen tussen de groepen gevonden. Deze resultaten veranderen de aanbeveling ten aanzien van korte termijn gebruik van ortheses dus niet. Langdurig gebruik wordt dus geadviseerd.
Op basis van de literatuur kan er geen eenduidig advies worden gegeven voor het type orthese (kort of lang, op maat gemaakt of geprefabriceerd, neopreen, thermoplast of ander materiaal) of het gebruik ervan (tijdens rust of tijdens activiteiten). Door de heterogeniteit van geïncludeerde studies kon er geen voordeel van het ene type orthese ten opzichte van het andere worden vastgesteld. De studies die een langdurig gunstig effect van orthesegebruik aantoonden, onderzochten een op maat gemaakte thermoplastische lange orthese om te dragen tijdens activiteiten van het dagelijks leven (Gomes Carreira et al., 2010), en een op maat gemaakte neopreen lange orthese om 's nachts te dragen (Rannou et al., 2009). Eén studie onderzocht het gebruik van een lange en een korte duimbasisorthese, maar vond geen verschillen in pijn en functioneren (Cantero-Téllez et al., 2018). De werkgroep adviseert het dragen van een orthese overdag te beperken tot de uitvoering van handactiviteiten om verlies van spierkracht en beweeglijkheid te voorkomen.
Het is belangrijk om aandacht te besteden aan het voorschrijven van een goed passende orthese, bij voorkeur op maat gemaakt door een gespecialiseerde zorgverlener (ergotherapeut, handtherapeut, orthopedisch instrumentmaker). Het is aannemelijk dat dit de therapietrouw van patiënten verbetert en het gebruik op de lange termijn vergroot.
De meeste studies werden uitgevoerd bij patiënten met artrose van de duimbasis. Eén niet-gerandomiseerde studie onderzocht het nachtelijk gebruik van ortheses van pijnlijke distale interfalangeale (IP) gewrichten en vond niet een duidelijk positief effect op pijn tussen de groepen (Watt et al., 2014). In de huidige update van de literatuur werd 1 trial gevonden die wel een effect vond op pijn en functioneren van een ’s nachts gedragen orthese van de proximale en distale IP gewrichten gedurende een jaar (Silva et al., 2020).
Ten aanzien van de topicale toepassing van warmte sluit de werkgroep zich aan bij de overweging van EULAR; topicale toepassing van warmte wordt gezien als een zelfmanagementstrategie die patiënten thuis kunnen toepassen, waarvoor zwak en tegenstrijdig bewijs is voor een mogelijk gunstig effect (Dilek et al., 2013; Favaro, 1994; Stange-Rezende et al., 2006). Het is daarom niet als aparte aanbeveling opgenomen. Koude kompressen, in het geval van een ontsteking tijdens een artrose opvlamming, kunnen ook symptomatische verlichting geven. Er zijn echter geen studies in handartrose uitgevoerd, maar enkel één onderzoek bij knieartrose, waarin warme en koude toepassing met de gebruikelijke zorg werd vergeleken. In deze studie werden geen verschillen gevonden tussen de groepen (Aciksoz et al., 2017).
Onderbouwing
Achtergrond
Niet-medicamenteuze interventies vormen een belangrijk onderdeel van de behandeling voor mensen met handartrose. Naast educatie kunnen oefentherapie, het toepassen van ergonomische principes (in het verleden aangeduid als “gewrichtsbeschermende maatregelen”), en advisering over spalken en hulpmiddelen de klachten verminderen en patiënten leren omgaan met de aandoening in het dagelijks leven. De laatste decennia is er veel onderzoek gedaan naar niet-medicamenteuze interventies bij handartrose. In de huidige module wordt de beschikbare evidentie voor niet-medicamenteuze interventies bij handartrose beschreven.
Conclusies
Exercise
Pain
|
Low GRADE |
Exercise may slightly reduce pain when compared with no exercise in patients with hand osteoarthritis.
Sources: (Østeras et al., 2017) |
Function
|
Low GRADE |
Exercise may slightly improve function when compared with no exercise in patients with hand osteoarthritis.
Sources: (Østeras et al., 2017) |
Samenvatting literatuur
In this module, we first provide a summary of literature addressing non-pharmacological treatment in patients with hand OA as presented in the systematic review that informed the European League Against Rheumatism (EULAR) guideline for management of hand osteoarthritis (OA) (Kroon et al., 2018). Judgements about the risk of bias in this module are adopted from the systematic review (Kroon et al., 2018) and studies that were added in the update were judged following the same procedure (i.e., Cochrane tool (Higgins et al., 2011)). Except for exercise therapy, which the EULAR adopted from a Cochrane Review, no GRADE levels or conclusions were included in de EULAR recommendations. Therefore, no GRADE conclusions are formulated in this module.
Results
First, we describe the results of the EULAR review. Then we will describe any new studies or longer follow-up results we found in our current update.
1. Exercise
EULAR
In summary, exercise leads to beneficial effects on hand pain, function, joint stiffness and grip strength, although effect sizes are small. Few (non-severe) AEs were reported, showing a signal for increased number of AEs in participants undergoing exercise therapy, in particular increased joint inflammation and hand pain (RR 4.6 (95% CI 0.5 to 39.3)) (Østeras et al., 2017).
Update
Kang et al. (2019) compared an 8-week finger exercise program combined with paraffin bath therapy to paraffin bath therapy alone (Kang et al., 2019). A significant difference was found in favour of the exercise program group in the post-intervention values for hand grip strength (p=0.015) and AUSCAN index subscale scores (pain, p < 0.001; physical function, p = 0.020). A cohort study reported a large decrease in pain at rest and pain during physical load (0-100) after combining exercises with thermoplastic, custom made orthotics, compared to orthotics use alone in patients with CMC-I OA (MD 11.1 (95%CI 1.9 to 20.3) and MD 22.7 (95%CI 13.6 to 31.0) respectively) (Wouters et al., 2019).
Level of evidence of the literature
The level of evidence regarding the outcome measure pain was downgraded by 2 levels because of study limitations (risk of bias) and number of included patients (imprecision).
The level of evidence regarding the outcome measure function was downgraded by 2 levels because of study limitations (risk of bias) and number of included patients (imprecision).
No level of evidence was reported for the outcome measures OARSI-OMERACT responder criteria and grip strength. Therefore, no GRADE conclusions are formulated on these outcomes.
2. Joint protection
EULAR
Joint protection led to a higher proportion of participants being classified as a responder to treatment according to OARSI-OMERACT criteria after 6 months, although mean AUSCAN pain and function subscales did not differ between groups (Dziedzic et al., 2015).
Update
No studies on joint protection were identified in the literature update.
3. Splints
EULAR
On the short term (< 3 months), thumb base splinting did not lead to pain relief or functional improvement (Adams & Hislop, 2014; Arazpour et al., 2017; Gomes Carreira et al., 2010; Hermann et al., 2014; Rannou et al., 2009), though studies assessing long-term use showed that this was associated with more pain relief and improved function (Gomes Carreira et al., 2010; Rannou et al., 2009). Studies assessed many different types of splints (eg, short or long, custom-made or prefabricated, neoprene or thermoplast or other material) and instructions for use (eg, during activities of daily living, at night, constantly). Only short versus long thumb base splints (ie, including only CMC joint vs both CMC and MCP joint) could formally be compared and were not associated with different clinical outcomes (Becker et al., 2013; Cantero-Tellez et al., 2018; Wajon & Ada, 2005). For other splint types or instructions, no consistent benefit of one over another could be identified in RCTs/CCTs or crossover studies (Bani et al., 2013; Sillem et al., 2011; Vegt et al., 2017; Weiss et al., 2000, 2004). A single study assessed night-time DIP splinting specifically, but did not show improvements in pain, function or pinch strength after 3 months (Watt et al., 2014).
Update
One trial (high RoB) evaluated short term thumb base splinting (Can & Tezel, 2020). Small changes in pain, function, grip strength and pinch strength were reported, compared to no changes in the control group. Long-term use resulted in improvement in pain and hand function in one RCT (Silva et al., 2020). No differences in pain and function were found in a comparison of long and short thumb base splints (Cantero-Téllez et al., 2018)
4. Assistive devices
EULAR
Use of assistive devices led to small improvements in function, as measured with the patient-specific Canadian Occupational Performance Measure (COPM) and the AUSCAN function subscale, but not in pain (Kjeken et al., 2011).
Update
One RCT (high RoB) comparing the use of assistive devices in daily living with a guideline leaflet with information on joint protection and disease features was included in the literature analysis (Amaral et al., 2018). Small improvements in function (as measured with the COPM and Assessment and Quantification of Chronic Rheumatoid Affections (SACRAH)) and pain (VAS) were found in the intervention group. A significant difference in COPM (performance and satisfaction scale) was found between groups at 30 days follow-up.
5. Combination programmes
EULAR
Several studies assessed different combination programmes of multiple non-pharmacological interventions (Boustedt et al., 2009; Dziedzic et al., 2015; Perez-Marmol et al., 2017; Stamm et al., 2002; Stukstette et al., 2013; Stukstette, 2014; Villafane et al., 2013; Wajon & Ada, 2005). Three trials compared a programme including education, joint protection and hand exercises to education alone, and although no formal meta-analysis was performed, no between-group differences in pain, function or grip strength could be confirmed (Dziedzic et al., 2015; Stamm et al., 2002; Stukstette et al., 2013). The other studies of combination programme were more heterogeneous, especially in the type of intervention studied. Some reported positive effects of the combination versus non-combination interventions, especially on subjective measures like pain (Boustedt et al., 2009; Villafane et al., 2013), and not on more objective measures like hand strength (Perez-Marmol et al., 2017; Villafane et al., 2013), though others reported no between-group differences (Stukstette, 2014; Wajon & Ada, 2005).
Update
Two trials evaluating combination programmes (education, joint protection including splints and exercise) compared to usual care + massage ball and information respectively reported improvements in grip strength (Stoffer-Marx et al., 2018; Tveter et al., 2020).
6. Thermal modalities
EULAR
Application of heat was assessed in three heterogeneous trials, both in design and type of intervention (high RoB). Two studies reported improvements in, for example, pain and grip strength in the intervention group compared with control (Dilek et al., 2013; Favaro L, 1994), and one cross-over trial reported no between-group differences (Stange-Rezende et al., 2006).
Update
Two trials (high RoB) reported improvements in pain, function, grip and pinch strength compared to control after peloid therapy (Kasapoğlu Aksoy & Altan, 2018; Kasapoglu Aksoy et al., 2017).
Level of evidence of the literature
As evidence was adapted from the review of Kroon et al. (2018) (Kroon et al., 2018), and level of evidence was not evaluated using the GRADE method, no GRADE conclusions regarding joint protection, splints, assistive devices and combination programmes were formulated.
Zoeken en selecteren
To answer the clinical questions, the 2018 update of the European Alliance of Associations for Rheumatology (EULAR) guideline for management of hand osteoarthritis (OA) (Kloppenburg et al., 2019) was updated on the interventions: exercise, joint protection, splinting, assistive devices, combination programs and thermal modalities. In this module, we refer to a systematic review that informed the EULAR recommendations for the management of hand OA (Kroon et al., 2018).
Relevant outcome measures
Efficacy outcomes were considered as proposed by the OMERACT core set for domains in clinical trials for hand OA (Kloppenburg et al., 2015). Main efficacy outcomes were pain (preferably measured on visual analogue scale (VAS), numerical rating scale (NRS), or a validated questionnaire, e.g., Australian/Canadian Hand Osteoarthritis Index (AUSCAN) or Michigan Hand Outcomes Questionnaire (MHQ)), hand function (using a validated questionnaire, e.g., Functional Index for Hand OsteoArthritis (FIHOA), AUSCAN or MHQ) and hand strength (grip or pinch strength). Additional efficacy outcomes that were considered included patient global assessment (VAS or NRS), health-related quality of life (Short-Form 36, EuroQoL), structural damage, hand mobility (e.g., Hand Mobility in Scleroderma test, modified Kapandji index, fingertip-to-palm-distance) and the number of participants fulfilling the OMERACT-OARSI responder criteria (Pham et al., 2004). The primary safety outcome was the number of withdrawals due to adverse events (AEs). In addition, serious AEs and AEs categorized by bodily system (e.g., gastrointestinal, cardiovascular) were assessed in the included efficacy studies. Studies that did not assess any efficacy or safety outcomes were excluded.
Search and select (methods)
A systematic search was conducted in PubMed/MEDLINE, Embase and the Cochrane CENTRAL databases up to February 27th 2021. The detailed search strategy is depicted under the tab Methods.
Studies were selected based on the following selection criteria:
- Participants: adults diagnosed with hand OA (other diagnoses were only eligible for inclusion if the results were presented separately for participants with hand OA)
- Intervention: exercise, joint protection, splinting, assistive devices, combination or multimodal program, or thermal modalities
- Comparators: placebo, care-as-usual, any other non-pharmacological, pharmacological or surgical intervention, or the same intervention in a different dose, duration, or delivery mode.
- Outcomes: Pain, hand function, hand strength, patient global assessment, health-related quality of life, structural damage, hand mobility, number of participants fulfilling the OMERACT-OARSI responder criteria, and safety outcomes
- Study design: Cochrane systematic reviews, RCT, CCT, observational (to assess safety, but only if a comparator group was available and the number of participants per group was at least 50).
A total of 442 records were identified in the updated search. Forty-five studies were initially selected based on title and abstract screening. After reading the full text, 35 studies were excluded (see the table with reasons for exclusion under the tab Methods), and 10 studies were included in the literature analysis.
Results
A total of 10 studies addressing non-pharmacological interventions were included in the analysis of the literature in addition to the 31 studies included in the EULAR recommendations. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables. Safety outcomes of studies included in the EULAR recommendations are presented in the online supplement of the informing systematic review (Kroon et al., 2018).
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- Marotta, N., Demeco, A., Marinaro, C., Moggio, L., Pino, I., Barletta, M., . . . Ammendolia, A. (2021). Comparative Effectiveness of Orthoses for Thumb Osteoarthritis: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil, 102(3), 502-509. doi:10.1016/j.apmr.2020.06.012
- Meireles, S. M., Jones, A., & Natour, J. (2019). Orthosis for rhizarthrosis: A systematic review and meta-analysis. Semin Arthritis Rheum, 48(5), 778-790. doi:10.1016/j.semarthrit.2018.07.013
- Nafai, S., Stevens-Nafai, E., Salman, H. The Effectiveness of Hand Exercise and Thermal Modalities Agents in Managing Osteoarthritis and Rheumatoid Arthritis in Hands: Randomized Controlled Study. Am J Occup Ther July 2017, Vol. 71(4_Supplement_1), 7111520286p1. doi: https://doi.org/10.5014/ajot.2017.71S1-PO4025
- Orlova, E. (2020) Efficiency of complex rehabilitation program in patients with osteoarthritis. Ann Rheum Dis, 79: suppl 1. Doi: 10.1136/annrheumdis-2020-eular.6381
- Osteras, N., Kjeken, I., Smedslund, G., Moe, R. H., Slatkowsky-Christensen, B., Uhlig, T., & Hagen, K. B. (2017). Exercise for Hand Osteoarthritis: A Cochrane Systematic Review. J Rheumatol, 44(12), 1850-1858. doi:10.3899/jrheum.170424
- Perez-Marmol, J. M., Garcia-Rios, M. C., Ortega-Valdivieso, M. A., Cano-Deltell, E. E., Peralta-Ramirez, M. I., Ickmans, K., & Aguilar-Ferrandiz, M. E. (2017). Effectiveness of a fine motor skills rehabilitation program on upper limb disability, manual dexterity, pinch strength, range of fingers motion, performance in activities of daily living, functional independency, and general self-efficacy in hand osteoarthritis: A randomized clinical trial. J Hand Ther, 30(3), 262-273. doi:10.1016/j.jht.2016.12.001
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- Robbins, S.R., Duong, V., Deveza, L., Fu, K., Oo, W., Riordan, E.A., . . . Hunter, D.J. (2019) Effect of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis (COMBO): a randomised controlled trial. Osteoarthritis & Cartilage, 27: suppl 1 s32-s33. Doi: 10.1016/j.joca.2019.02.048
- Rocchi, L., Merolli, A., Giordani, L., Albensi, C., & Foti, C. (2017). Trapeziometacarpal joint osteoarthritis: a prospective trial on two widespread conservative therapies. Muscles Ligaments Tendons J, 7(4), 603-610. doi:10.11138/mltj/2017.7.4.603
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- Silva, F.C., Adolph, S., Silva, R.D., & Natour, J. (2017). THU0728-HPR Comparison of the effectiveness of functional and night splint for rhizarthrosis: one-year follow-up of a controlled, randomized, blinded clinical trial. Annals of the Rheumatic Diseases, 76, 1478 - 1479.
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Evidence tabellen
Research question: What is the effectiveness of exercise in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SLR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
A: Østeras, 2017
Study design: A: SLR (6 RCT, 1 CO)
Setting and Country: NR in SLR
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 534
Mean age (SD), yrs [intervention/control] A: 60-81
Sex, % female [intervention/control] A: median 90
OA location, definition A: Hand (6) or CMC (1), ACR or clinical diagnosis |
A: Hand exercise, 6-12 months |
A: no exercise (N=6); different CMC exercise programme (N=1), 6-12 months
|
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Pooled effect
Outcome measure: Pain A: Effect estimates (95% CI): SMD −0.27 (−0.47 to −0.07)*
Outcome measure: Function A: Effect estimates (95% CI): SMD −0.28 (−0.58 to 0.02)*
Outcome measure: OARSI_OMERACT criteria A: Effect estimates (95% CI): RR 2.8 (1.4 to 5.6)*
Outcome measure: Grip strength A: Effect estimates (95% CI): SMD 0.34 (−0.01 to 0.69)*
|
|
Update |
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|
Kang 2019 |
Study design: RCT
Setting and country: male career workers recruited from an automobile assembly line, South Korea
Source of funding and conflicts of interest: NR; none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 15/14
Mean age (SD), yrs [intervention/control] 46.7 (4.6) / 47.9 (4.0)
Sex, % female [intervention/control] 0 / 0
OA location, definition Hand, ACR |
Hand exercise 30 min/day, 5 times a week, 8 weeks. + Paraffin bath 30 min/day, 5 times a week, 8 weeks
|
Paraffin bath 30 min/day, 5 times a week, 8 weeks
|
End point of follow-up: 8 weeks
Loss-to-follow-up [intervention/control]: 0/0
Incomplete outcome data: NR |
Outcome measure: Pain (AUSCAN) Mean within group difference (SD): 21.6 (8.3) vs. 7.9 (5.5), p=0.00
Outcome measure Grip strength Mean within group difference (SD): 3.5 (2.0) vs. 0.6 (0.6), p=0.00
Outcome measure: Function (AUSCAN) Mean within group difference (SD): 13.9 (4.5) vs. 10.3 (14.4), p=0.37
|
|
Wouters, 2019 |
Study design: Cohort study
Setting and Country: 13 outpatient clinics for hand therapy and surgery, The Netherlands
Source of funding and conflicts of interest: Handtherapie Nederland, Xpert Clinic, Erasmus MC Rotterdam, and Geert Geertsen Foundation; none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 42 / 42
Mean age (SD), yrs [intervention/control] 60.8 (9.1) / 58.9(7.6)
Sex, % female [intervention/control] 73.8 / 76.2
OA location, definition CMC-1, Rx E-L |
Splint (custom-made, thermoplast, CMC/MCP) 3 months (use full time first 6 wks, usage reduced wk 6-3mo
|
Splint (custom-made, thermoplast, CMC/MCP) 3 months (use full time first 6 wks, usage reduced wk 6-3mo) + exercise program (3 months)
|
End point of follow-up: 3 months
Loss-to-follow-up [intervention/control]: NA
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain (VAS) at rest Mean between group difference (95% CI): 11.1 (1.9 to 20.3)*
Outcome measure: Pain (VAS) during physical load Mean between group difference (95% CI): 22.7 (13.6 to 31.0)*
Outcome measure: Function (MHQ) Mean between group difference (p-value): 4.4 (0.071)*
|
Values are mean (SD) or median (min–max).
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; AUSCAN, Australian/Canadian Hand Osteoarthritis Index; CMC, first carpometacarpal joint; CO, cross-over trial; MHQ, Michigan Hand Outcomes Questionnaire; N, number; NR, not reported; OA, osteoarthritis; RCT, randomised controlled trial; SLR, systematic literature review; SMD, standardized mean difference.
Research question: What is the effectiveness of joint protection in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SLR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
A: Dziedzic, 2015
Study design: A: RCT
Setting and Country: NR in SLE
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 62/65/65/65
Mean age (SD), yrs [intervention/control] A: 65.5(8.6) / 64.5(9.0) / 66.0(9.3) / 67.2(9.5)
Sex, % female [intervention/control] A: 69/63/71/62
OA location, definition A: ACR
|
A: Group-based joint protection programme (including splints) (JP+, HEx–), 4 sessions in 4 weeks
|
A1: Group-based exercise programme (HEx+, JP–), 4 sessions in 4 weeks A2: Group-based combination programme: education, joint protection (including splints), exercise (JP+, HEx+), 4 sessions in 4 weeks A3: Education alone (JP–, HEx–), 4 weeks
|
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Outcome measure: Pain A: Effect estimates (95% CI): MD −0.79 (−1.7 to 0.12) on AUSCAN pain scale (range 0–20)*
Outcome measure: Function A: Effect estimates (95% CI): MD −0.6 (−1.9 to 1.1) on AUSCAN function scale (range 0–36)*
Outcome measure: OARSI_OMERACT criteria A: Effect estimates (95% CI): OR 2.1 (1.1 to 4.0)*
Outcome measure: Grip strength A: Effect estimates (95% CI): MD −0.47 (−1.9 to 0.94) kg†
|
Values are mean (SD) or median (min–max).
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; AUSCAN, Australian/Canadian Hand Osteoarthritis Index; HEx, home exercise; JP, joint protection; MD, mean difference; N, number; NR, not reported; OA, osteoarthritis; OR, odds ratio; RCT, randomised controlled trial; Systematic literature review.
Research question: What is the effectiveness of splints in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
A: Adams, 2014 B: Arazpour, 2016 C: Bani, 2013 D: Becker, 2013 E: Cantero-Tellez, 2016 F: Gomes-Carreira, 2010 G: Hermann, 2013 H: Rannou, 2009 I: Sillem, 2011 J: Wajon, 2005 K: Watt, 2014 L: Weiss, 2000 M: Weiss, 2014 N: van der Vegt, 2017
Study design: A: RCT (A) B: RCT C: CO (WA+) D: RCT E: CCT F: RCT G: RCT H: RCT I: CO (WA-) J: RCT K: CCT L: CO (WA-) M: CO (WA-) N: CO (WA+)
Setting and Country: NR in SLE
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 9/9/9 B: 16/9 C: 24/11 D: 58/61 E: 44/40 F: 20/20 G: 30/29 H: 57/55 I: 56 J: 19/21 K: 26/26 L: 26 M: 25 N: 63
Mean age (SD), yrs [intervention/control] A: 61.2 (9.4) B: 50.2 (5.7) / 52.3 (6.4) C: 53.4 / 54.9 / 58.6 D: 62.8 (7.7)/ 63.3 (8.5) E: 59.7 (9.6) / 60.5 (9.8) F: 62.8 (8.5) / 65.1 (10.1) G: 70.7 (7.3) / 70.2 (6.2) H: 63.0 (7.9) / 63.5 (7.6) I: 64.1 (8.6) J: 59.7 (9.0) / 61.2 (12.5) K: 63 (51–78) L: 57 (36–88) M: NR N: 60.1 (8.2)
Sex, % female [intervention/control] A: 78 B: 87/88 C: 67/75/73 D: 80/75 E: 93/90 F: 100/90 G: 97/100 H: 93/85 I: 91 J: 74/81 K: 88 L: 81 M: 84 N: 70
OA location, definition A: CMC, NR B: CMC, clinical diagnosis and E-L stage I–II C: CMC, clinical diagnosis and E-L stage I-II D: CMC, clinical diagnosis E: CMC, clinical and Rx diagnosis F: CMC, clinical diagnosis and E-L stage II–III G: CMC, ACR, thumb pain H: CMC, clinical and Rx diagnosis I: CMC, clinical diagnosis J: CMC, clinical diagnosis and E-L stage I–III K: DIP, ACR, Rx damage DIP L: CMC, clinical and Rx diagnosis M: CMC, clinical diagnosis and E-L stage I–II N: CMC, clinical and Rx diagnosis
|
A: Splint+occupational therapy, 4 weeks (NR) B: Splint (custom-made, thermoplast, CMC), 4 weeks (use during ADLs, not at night) C: Splint (custom-made, thermoplast), 4 weeks (use during ADLs, not at night) D: Splint (custom-made, thermoplast, CMC/MCP), 8–10 weeks (use as needed during ADLs and at night) E: Splint (custom-made, thermoplast, CMC/MCP), 12 weeks (use during ADLs (3–4 hours/day) and at night) F: Splint (custom-made, CMC/MCP), 12 weeks (NR) G: Splint+hand exercises (prefabricated, fabrifoam, CMC/MCP), 8 weeks (use as needed) H: Splint (custom-made, neoprene, CMC/MCP), 1 year (use at night) I: Splint (custom-made, neoprene, CMC/MCP), 4 weeks (use when symptomatic, during heavy tasks and at night if preferred) J: Splint (custom-made, thermoplast, CMC) +abduction exercise regimen, 2 weeks splint only, 4 weeks splint +exercise (use full-time) K: Splint (custom-made, thermoplast, DIP), 12 weeks (use at night) L: Splint (custom-made, thermoplast, CMC), 1 week (use when symptomatic) M: Splint (custom-made, thermoplast, CMC), 1 week (use when symptomatic) N: Splint (custom-made, thermoplast, CMC/MCP), 2 weeks (NR)
|
A1: Placebo splint+occupational therapy, 4 weeks (NR) A2: Occupational therapy only, 4 weeks (NR) B: No intervention C1: Splint (prefabricated, neoprene, CMC/MCP), 4 weeks (use during ADLs, not at night) C2: No intervention, 4 weeks D: Splint (prefabricated, neoprene, CMC), 8–10 weeks (use as needed during ADLs and at night) E: Splint (custom-made, thermoplast, CMC), 12 weeks (use during ADLs (3–4 hours/ day) and at night) F: No intervention, 12 weeks (NR) G: Hand exercises, 8 weeks (use as needed) H: Usual care I: Splint (prefabricated, neoprene, IP to wrist), 4 weeks (use when symptomatic, during heavy tasks and at night if preferred) J: Splint (custom-made, thermoplast, CMC/MCP) + pinch exercise regimen, 2 weeks splint only, 4 weeks splint + exercise (use full-time) K: No intervention L: Splint (custom-made, thermoplast, CMC to wrist), 1 week (use when symptomatic) M: Splint (prefabricated, neoprene, CMC/MCP), 1 week (use when symptomatic) N: Splint (prefabricated, semirigid, CMC), 2 weeks (NR)
|
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Primary outcome measures A: AUSCAN pain B: NR C: NR D: DASH E: NR F: VAS pain G: NRS pain H: VAS pain I: AUSCAN pain J: NR K: NRS pain L: NR M: NR N: VAS pain
Thumb splints vs usual care or no intervention Outcome measure: Pain Effect estimates (95% CI): B F G H: MD −2.9 (−12.2 to 6.5) on 100 mm VAS* F H: MD −17.4 (−25.6 to −9.2) on 100 mm VAS*
Outcome measure: Function Effect estimates (95% CI): B H: SMD 0.24 (−0.11 to 0.60)† H: MD −6.3 (−10.9 to −1.7) on Cochin hand function scale (range 0–90)*
Outcome measure: Grip strength Effect estimates (95% CI): F: MD 0.8 (−3.1 to 4.7) kg*
Long thumb splint (MCP+CMC joint) vs Short thumb splint (only CMC joint) Outcome measure: Pain Effect estimates (95% CI): D E J: MD −0.85 (−5.1 to 3.4) on 100 mm VAS*
Outcome measure: Function Effect estimates (95% CI): D E: MD 1.7 (−0.94 to 4.3)†
DIP splint vs no intervention Outcome measure: Pain Effect estimates (95% CI): M: Median difference 0.5 (range −7 to 3.5, p=0.53) on 10 cm VAS*
Outcome measure: Function M: No between-group difference |
|
Update |
||||||
|
Can, 2020 |
Study design: RCT
Setting and country: Outpatient hand clinic, Turkey
Source of funding and conflicts of interest: NR, NR |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 40 / 40
Mean age (SD), yrs [intervention/control] 56.1 (7.5) / 56.6 (9.2)
Sex, % female [intervention/control] 91.7 / 89.3
OA location, definition Thumb CMC; clinical diagnosis and Rx |
Splint (prefabricated, neoprene, CMC/MCP), 6 weeks (use full-time) + information
|
Information
|
End point of follow-up: 6 weeks
Loss-to-follow-up [intervention/control]: 5/12
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain (AUSCAN) Pre-post mean difference (SD): NR p<0.001
Outcome measure: Function (AUSCAN) Pre-post mean difference (SD): NR p<0.001
Outcome measure: Function (Q-DASH) Pre-post mean difference (SD): NR p<0.001
Outcome measure: Grip strength Pre-post mean difference (SD): NR p<0.001
Outcome measure: Pinch strength Pre-post mean difference (SD): NR p=0.001
|
|
Cantero-Téllez, 2018 |
Study design: RCT
Setting and country: Tecan Hand Center clinic, Spain
Source of funding and conflicts of interest: None, none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 33 /33
Mean age (SD), yrs [intervention/control] 63.7 (10.3) / 63.8 (8.9)
Sex, % female [intervention/control] 81.8 / 84.8
OA location, definition Thumb CMC; Rx E-L |
Splint (custom-made, thermoplast, CMC/MCP), 1 week (use at night + 3-4 hours during ADL)
|
Splint (custom-made, thermoplast, CMC), 1 week (use at night + 3-4 hours during ADL)
|
End point of follow-up: 1 week
Loss-to-follow-up [intervention/control]: NR
Incomplete outcome data [intervention/control]: 5 |
Outcome measure: Pain (VAS) Effect estimates (95% CI): MD 0.7 (-3.9 to 5.1)*
Outcome measure: Function (QuickDASH) Effect estimates (95% CI): MD 0.4 (-3.4 to 2.7) †
|
|
Silva, 2020 |
Study design: RCT
Setting and country: Outpatient clinic Universidade Federal de Sao Paulo, Brazil
Source of funding and conflicts of interest: Sao Paulo Research Foundation, NR |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 26 / 26
Mean age (SD), yrs [intervention/control] 64.1 (8.4) / 63.5 (7.8) Sex, % female [intervention/control]
OA location, definition DIP/PIP, ACR |
Splint (custom-made gutter, thermoplast, DIP and PIP), 6 months (use at night) + educational program 3 x 40-min sessions |
Educational program 3 x 40-min sessions |
End point of follow-up: 180 days
Loss-to-follow-up [intervention/control]: 1/0
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain at rest (NRS) Effect estimates (95% CI): Cohen’s d -1.06 (-1.62 to -0.46)*
Outcome measure: Pain during activity (NRS) Effect estimates (95% CI): Cohen’s d -0.81 (-1.36 to -0.23)*
Outcome measure: Pain (AUSCAN) Effect estimates (95% CI): Cohen’s d -0.49 (-1.03 to 0.07)*
Outcome measure: Function (AUSCAN) Effect estimates (95% CI): Cohen’s d 0.33 (-0.22 to 0.87)*
|
Values are mean (SD) or median (min–max). (A) indicates conference abstract.
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; ADLs, activities of daily living; AUSCAN, Australian/Canadian Hand Osteoarthritis Index; BDI, Beck Depression Inventory; CCT, controlled clinical trial; CMC, first carpometacarpal joint; CO, cross-over trial; DASH, Disabilities of the Arm, Shoulder and Hand; DIP, distal interphalangeal joint; E-L, Eaton-Litter; kgf, kilogram-force; MCP, metacarpal phalangeal joint; MD, mean difference; MPUT, Moberg Pick Up Test; N, number; NR, not reported; NRS, numerical rating scale; OA, osteoarthritis; PIP, proximal interphalangeal joint; SMD, standardized mean difference; RCT, randomised controlled trial; Rx, radiography; SLR, systematic literature review; STAI, State Trait Anxiety Inventory; VAS, visual analogue scale; WA, wash-out period.
Research question: What is the effectiveness of assistive devices in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SLR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
A: Kjeken, 2011
Study design: A: RCT
Setting and Country: NR in SLE
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 35/35
Mean age (SD), yrs [intervention/control] A: 61.1 (6.0) / 59.9 (7.5)
Sex, % female [intervention/control] A: 97/97
OA location, definition A: ACR |
A: Provision of assistive devices+information, 12 weeks (NR) |
A: Information alone |
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Outcome measures A: COPM
Outcome measure: Pain A: Effect estimates (95% CI): MD 0.4 (−9.8 to 10.6) on 100 mm VAS†
Outcome measure: Function A: Effect estimates (95% CI): MD −0.3 (−0.6 to 0.01) on AUSCAN function scale (range 1–5)*
|
|
Update |
|
|
|
|
|
|
|
Amaral, 2018 |
Study design: RCT
Setting and country: Rheumatology Outpatient Clinic, Clinics Hospital of Pernambuco, Brazil.
Source of funding and conflicts of interest: All study costs were paid by the main researcher, none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 19/20
Mean age (SD), yrs [intervention/control] 59.0 (9.0) / 60.2 (6.2)
Sex, % female [intervention/control] 100 / 100
OA location, definition Hand, ACR |
Provision of assistive devices+information 4 sessions, 4 weeks. 2 phone calls to reinforce
|
Guideline leaflet
|
End point of follow-up: 30 days and 90 days
Loss-to-follow-up [intervention/control]: 2/0
Incomplete outcome data [intervention/control]: NR |
Outcome measure: occupational performance (COPM performance) Post intervention between group difference: p = 0.001 (30 days); p = 0.059 (60 days)
Outcome measure: Pain at rest (VAS) No significant between group difference
Outcome measure: Function (SACRAH) No significant between group difference
|
Values are mean (SD) or median (min–max).
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; COPM, Canadian Occupational Performance Measure; MD, mean difference; N, number; NR, not reported; OA, osteoarthritis; RCT, randomised controlled trial; SLR, systematic literature review; VAS, visual analogue scale.
Research question: What is the effectiveness of combination programmes in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SLR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
A: Boustedt, 2009 B: Dziedzic, 2015 C: Perez-Marmol, 2017 D: Stamm, 2002 E: Stukstette, 2013 F: Stukstette, 2014 G: Villafane, 2013 H: Wajon, 2005
Study design: RCT, CCT A: RCT B: Factorial RCT C: RCT D: CCT E: RCT F: RCT (A) G: RCT H: RCT
Setting and Country: NR in SLE
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 22/20 B: 62/65/65/65 C: 25/23 D: 20/20 E: 76/75 F: 147 G: 30/30 H: 19/21
Mean age (SD), yrs [intervention/control] A: 61 (40–76)/ 61 (50–76) B: 65.5 (8.6)/ 64.5 (9.0)/ 66.0 (9.3)/ 67.2 (9.5) C: 82.8 (8.3)/ 79.2 (10) D: 60.5 (8.3)/ 60.4 (6.4) E: 60 (7)/ 58 (9) F: 59 (8) G: 82 (2)/ 83 (1) H: 59.7 (9.0)/ 61.2 (12.5)
Sex, % female [intervention/control] A: 100 B: 69/63/71/62 C: 84/74 D: 85/90 E: 82/84 F: 84 G: 90/80 H: 74/81
OA location, definition A: CMC, clinical and Rx diagnosis B: ACR C: Clinical diagnosis D: ACR E: ACR F: ACR G: CMC, clinical diagnosis and Rx damage H: CMC, clinical diagnosis and E-L stage I–III
|
A: Group-based combination programme: education, joint protection, exercise, splints, 10 sessions in 5 weeks B: Group-based joint protection programme (including splints) (JP+, HEx–), 4 sessions in 4 weeks C: Fine motor skills occupational therapy, 24 sessions in 8 weeks D: Individual combination programme: education, joint protection, exercise, Single session, 3 months E: Group-based combination programme: education, joint protection (including splints), exercise, 4 sessions in 12 weeks F: Group-based booster session after combination Programme, Single session, 1 year G: Individual combination programme: manual therapy, Exercise, 12 sessions in 4 weeks H: Splint (custom-made, thermoplast, CMC)+abduction exercise regimen, 2 weeks splint only, 4 weeks splint+excercise; use full-time
|
A: Group-based joint protection programme B1: Group-based exercise programme (HEx+, JP–), 4 sessions in 4 weeks B2: Group-based combination programme: education, joint protection (including splints), exercise (JP+, HEx+), 4 sessions in 4 weeks B3: Education alone (JP–, HEx–), 4 weeks C: Conventional occupational therapy D: Education alone, 3 months E: Education alone, 12 weeks F: No booster session after combination programme, 1 year G: Sham intervention (non-therapeutic ultrasound of the thumb region), 12 sessions in 4 weeks H: Splint (custom-made, thermoplast, CMC/ MCP)+pinch exercise regimen, 2 weeks splint only, 4 weeks splint+excercise; use full-time |
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Outcome measures A: NR B: OARSI-OMERACT responder C: DASH D: Grip strength E: AUSCAN function, OARSI-OMERACT responder F: AUSCAN function, OARSI-OMERACT responder G: VAS pain H: NR
Outcome measure: Pain E: Effect estimates (95% CI): MD 0.40 (−0.50 to 1.3) on AUSCAN pain scale (range 0–20)†
Outcome measure: Function E: Effect estimates (95% CI): MD 0.49 (−1.0 to 2.0) on AUSCAN function scale (range 0–36)*
Outcome measure: OARSI_OMERACT criteria E: Effect estimates (95% CI): OR 0.82 (0.42 to 1.6)†
Outcome measure: Grip strength D E: Effect estimates (95% CI): SMD −0.21 (−0.49 to 0.08)† |
|
Update |
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|
Stoffer-Marx, 2018 |
Study design: RCT
Setting and Country: Rheumatology outpatient clinic of the Medical University of Vienna, Austria
Source of funding and conflicts of interest: EU Commission Ergotherapie Austria & Physio Austria, Austrian Science fund and österreichische Gesellschaft für Rheumatologie & Rehabilitation. |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 74 / 77
Mean age (SD), yrs [intervention/control] 60.1 (10.9) / 59.1 (10.4)
Sex, % female [intervention/control] 79.7 / 88.3
OA location, definition Hand, ACR
|
Individual combination programme: education, joint protection (including splints and assistive devices), exercise. 1 session + 1 follow-up consultation after 1 month, 2 months
|
Usual care + massage ball
|
End point of follow-up: 2 months
Loss-to-follow-up [intervention/control]: 15 / 8
Incomplete outcome data [intervention/control]:
|
Outcome measure: Pain (11-point likert scale) mean difference (SD) -1.35 (2.38) vs. –0.88 (2.12), p = 0.339*
Outcome measure: Function (AUSCAN total score) mean difference (SD) -1.55 (4.95) vs. -0.63 (4.12), p = 0.316*
Outcome measure (Grip strength) Effect estimates (95%CI): OR 2.572 (1.233 to 5.365)*
|
|
Tveter, 2020 |
Study design: RCT
Setting and Country: 3 hospitals, Norway
Source of funding and conflicts of interest: The Interregional research fund (HELSEFORSK); none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 90 / 90
Mean age (SD), yrs [intervention/control] 62.8 (7.5) / 63.0 (7.6)
Sex, % female [intervention/control] 81/ 79
OA location, definition CMC, NR
|
Individual self-management combination programme: education, joint protection (including splints and assistive devices), exercise. 1 session, 3 months
|
Written and oral information
|
End point of follow-up: 3-4 months
Loss-to-follow-up [intervention/control]: 4 / 6
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain at rest (NRS) Effect estimates (95% CI): MD -1.4 (-0.7 to -2.0)*
Outcome measure: Function (QuickDASH) Effect estimates (95% CI): MD -8.1 (-4.6 to -11.5)*
Outcome measure: Grip strength Effect estimates (95% CI): MD 23.4 (7.5 to 39.3)*
Outcome measure: Pinch strength Effect estimates (95% CI): MD 3.1 (-0.2 to 6.4)*
|
Values are mean (SD) or median (min–max). (A) indicates conference abstract.
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; AUSCAN, Australian/Canadian Hand Osteoarthritis Index; CCT, controlled clinical trial; CMC, first carpometacarpal joint; CO, cross-over trial; DASH, Disabilities of the Arm, Shoulder and Hand; E-L, Eaton-Litter; HEx, hand exercise; MCP, metacarpophalangeal; JP, joint protection; JT, Jebsen-Taylor Hand Function; MD, mean difference; N, number; NR, not reported; NRS, numerical rating scale; OA, osteoarthritis; OR, odds ratio; RCT, randomised controlled trial; Rx, radiography; SLR, systematic literature review; VAS, visual analogue scale.
Research question: What is the effectiveness of thermal modalities in patients with hand osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C)
|
Follow-up |
Outcome measures and effect size |
|
Kroon, 2018
individual study characteristics deduced from Kroon, 2018
|
SLR and meta-analysis of RCTs
Literature search up to the 6th of June 2017
B: Favaro, 1994 C: Strange, 2006
Study design: A: RCT B: CCT C: CO (WA+)
Setting and Country: NR in SLE
Source of funding and conflicts of interest: NR; none |
N [intervention/control] A: 29 / 27 B: 39 / 9 C: 45 / 45
Mean age (SD), yrs [intervention/control] A: NR B: NR C: NR
Sex, % female [intervention/control] A: NR B: NR C: NR
OA location, definition A: Hand, ACR criteria B: erosive Hand, clinical and Rx C: Hand, ACR criteria
|
A: Paraffin bath 50°C, 5 times/wk, 3wk B: Infrared radiation lamp, 10 times 20 min C: Hands on tiled stove, 3 times 3h/wk (Duration: 3 weeks - 2wk WO - 3 weeks)
|
A: No intervention, 3wk B: Sham lamp, 10 times 20 min C: Usual care
|
End-point of follow-up: NR in the SLR
For how many participants were no complete outcome data available? (intervention/control) NR in the SLR
|
Outcome measures A: Pain (VAS, AUSCAN, tender joint count); function (AUSCAN, Dreiser functional index); grip and pinch strength; range of motion (finger-palm-distance) B: Pain; grip strength; joint swelling; morning stiffness C: Pain (VAS, AUSCAN); function (AUSCAN, VAS); grip strength; functional performance (Moberg Pick Up Test); quality of life (SF-36).
|
|
Update |
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|
Kasapoglu Aksoy 2017 |
Study design: RCT
Setting and country: Department of Physical Medicine and Rehabilitation, Bursa University of Health Sciences Hospital, Turkey
Source of funding and conflicts of interest: NR; none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 33/30
Mean age (SD), yrs [intervention/control] 58.17 (9.26) / 60.6 (8.52)
Sex, % female [intervention/control] 96.7 / 88
OA location, definition Hand, KL |
Peloid therapy, 5 30min-sessions a week, 2 weeks + home exercise program
|
Home exercise program
|
End point of follow-up: 6 weeks after baseline
Loss-to-follow-up [intervention/control]: 3/5
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain (VAS) Median difference (min-max) -3.1 (-8.00 to 1.00) vs. -0.32 (-3 to 3), p < 0.001*
Outcome measure: Function (AUSCAN) Median difference (min-max) -4 (-8 to 0) vs. -0.00 (-5 to 2), p < 0.001*
Outcome measure: Grip strength Median difference (min-max) 1.30 (-4 to 10.6) vs. -1.17 (-1 to 1), p = 0.017*
Outcome measure: Pinch strength Median difference (min-max) 0.63 (-1 to 3) vs. 0.08 (-1 to 1), p = 0.042*
|
|
Kasapoglu Aksoy 2018 |
Study design: RCT
Setting and country: Department of Physical Medicine and Rehabilitation, Bursa University of Health Sciences Hospital, Turkey
Source of funding and conflicts of interest: None; none |
Inclusion criteria:
Exclusion criteria:
N [intervention/control] 31/30
Mean age (SD), yrs [intervention/control] 57.2 (10.6) / 61.3 (8.4)
Sex, % female [intervention/control] 90.3 / 89.3
OA location, definition Hand, ACR |
Peloid therapy, 5 30min-sessions a week, 2 weeks + home exercise program
|
Home exercise program
|
End point of follow-up: 6 weeks after baseline
Loss-to-follow-up [intervention/control]: 0/2
Incomplete outcome data [intervention/control]: NR |
Outcome measure: Pain (VAS) Median difference (min-max) -3.00 (-9 to 1) vs. -0.60 (-4 to 3), p < 0.001*
Outcome measure: Function (AUSCAN total score) Median difference (min-max) -4 (-6 to 0) vs. -1 (-5 to 2), p < 0.001*
Outcome measure: Grip strength Median difference (min-max) 1.96 (-1.1 to 9.6) vs. 0.45 (-4 to 3.6), p =0.026*
Outcome measure: pinch strength Median difference (min-max) 1.09 (-2 to 5.00) vs. 0.21 (-1 to 2), p =0.012*
|
Values are mean (SD) or median (min–max
*In favour of the intervention group. †In favour of the control group.
ACR, American College of Rheumatology; AUSCAN, Australian/Canadian Hand Osteoarthritis Index; CO, cross-over trial, KL, Kellgren-Lawrence; N, number; NR, not reported; NRS, numerical rating scale; OA, osteoarthritis; RCT, randomised controlled trial; Rx, radiographic; SLR, systematic literature review; VAS, Visual Analogue Scale; WA, wash-out.
Risk of bias table for intervention studies (randomized controlled trials)
|
Study |
Random sequence generation |
Allocation concealment |
Blinding of participants and personnel |
Blinding of outcome assessment |
Incomplete outcome data |
Selective reporting |
Other bias |
Overall |
Comments |
|
Exercise |
|||||||||
|
Kang 2019 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded |
|
Joint protection |
|||||||||
|
Dziedzic 2015 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded. |
|
Splints |
|||||||||
|
Adams 2014 |
U |
U |
H |
U |
U |
U |
U |
U |
Conference abstract containing little information to assess risk of bias; participants and personnel likely not blinded; baseline imbalance between groups. |
|
Arazpour 2016 |
L |
U |
H |
U |
L |
L |
L |
H |
Allocation concealment unclear; blinding of outcome assessor not described; participants and personnel not blinded and no control/sham intervention provided. |
|
Bani 2013 |
L |
L |
H |
H |
L |
L |
L |
H |
Cross-over study; participants, personnel and outcome assessor not blinded. |
|
Becker 2013 |
L |
U |
H |
H |
H |
L |
H |
H |
Allocation concealment unclear; participants, personnel and outcome assessor not blinded; high dropout rate in both treatment arms; variable length of follow-up; many cointerventions allowed, including other splints. |
|
Cantero-Tellez 2018 |
H |
H |
H |
L |
L |
L |
U |
H |
Patients allocated to treatment arm using an Excel database in order of arrival (not random, allocation not concealed); participants and personnel not blinded; baseline imbalance in pain and disability scores. |
|
Gomes-Carreira 2010 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded. |
|
Hermann 2013 |
L |
L |
H |
L |
L |
U |
L |
H |
Participants and personnel not blinded. |
|
Rannou 2009 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded. |
|
Sillem 2011 |
L |
L |
H |
H |
L |
L |
L |
H |
Cross-over study; participants, personnel and outcome assessor not blinded. |
|
Wajon 2005 |
U |
U |
H |
L |
H |
L |
H |
H |
Method of randomisation not described; participants and personnel not blinded; more dropouts in control group (5/21 vs 1/19) who were younger with less severe disease and shorter disease duration; low compliance to splints at end of study. |
|
Watt 2014 |
H |
H |
H |
U |
L |
L |
L |
H |
Study not randomised; participants and personnel not blinded; blinding of outcome assessor unclear. |
|
Weiss 2000 |
U |
U |
H |
U |
L |
L |
H |
H |
Cross-over study; method of randomisation and blinding of outcome assessor not described; participants and personnel not blinded; 8/26 participants had concomitant hand problems besides CMC OA; carryover effect not assessed and no wash-out period included. |
|
Weiss 2004 |
U |
U |
H |
U |
U |
L |
U |
H |
Cross-over study; method of randomisation, blinding of outcome assessor, and loss-to-follow-up not described; participants and personnel not blinded; carryover effect not assessed and no wash-out period included. |
|
Van der Vegt 2017 |
U |
L |
H |
H |
L |
L |
L |
H |
Cross-over study; method of randomisation not described; participants, personnel and outcome assessor not blinded. |
|
Can, 2020 |
L |
U |
H |
U |
H |
L |
L |
H |
Allocation concealment not described, blinding of participants and personnel not described, blinding of outcome assessor not described, high drop out in both treatment arms. |
|
Cantero-Téllez, 2018a |
U |
H |
H |
U |
H |
H |
L |
H |
Allocation concealment not described, blinding of participants and personnel not described, blinding of outcome assessor not described, participants excluded for not following protocol or missing follow-up. |
|
Silva, 2020 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants not blinded |
|
Assistive devices |
|||||||||
|
Kjeken 2011 |
L |
L |
H |
L |
U |
L |
H |
H |
Participants and personnel not blinded; some patients excluded from analysis due to surgery during the trial (3/35 vs 1/35); contamination (some participants in the control group reported use of assistive devices). |
|
Amaral 2018 |
L |
U |
H |
L |
L |
L |
L |
H |
Allocation concealment unclear, principal researcher and participants not blinded |
|
Combination programme |
|||||||||
|
Bousteds 2009 |
H |
H |
H |
H |
U |
L |
L |
H |
Treatment allocation according to order of admission; participants, personnel and outcome assessor not blinded; only per-protocol analysis reported. |
|
Dziedzic 2015 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded. |
|
Perez-Marmol 2017 |
L |
U |
U |
U |
L |
L |
L |
U |
Allocation concealment and blinding of outcome assessor not described; participants and personnel not blinded, but intensity and type of intervention in both arms similar, reducing risk of bias. |
|
Stamm 2002 |
U |
U |
H |
L |
U |
U |
L |
H |
Method of randomisation and loss-to-follow-up not described; participants and personnel not blinded; some outcomes only reported to be “not statistically significant” without providing effect estimates. |
|
Stukstette 2013 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded. |
|
Stukstette 2014 |
U |
U |
H |
U |
U |
U |
L |
U |
Conference abstract containing little information to assess risk of bias; participants and personnel not blinded. |
|
Villafane 2013 |
L |
U |
H |
L |
L |
L |
L |
H |
Allocation concealment not described; participants and personnel not blinded (control/sham intervention was provided). |
|
Wajon 2005 |
U |
U |
H |
L |
H |
L |
H |
H |
Method of randomisation not described; participants and personnel not blinded; more dropouts in control group (5/21 vs 1/19) who were younger with less severe disease and shorter disease duration; low compliance to splints at end of study. |
|
Stoffer-Marx, 2018 |
L |
L |
H |
L |
H |
L |
L |
H |
Participants and personnel not blinded, high drop-out rate in both treatment arms. |
|
Tveter, 2020 |
L |
L |
H |
H |
L |
L |
L |
H |
Participants and personnel not blinded, although statistician is blinded the outcome assessors are not. |
|
Thermal modalities |
|||||||||
|
Dilek, 2013 |
L |
L |
H |
L |
L |
L |
L |
H |
Participants and personnel not blinded and no control/sham intervention provided. |
|
Favaro, 1994 |
H |
H |
L |
U |
U |
U |
L |
H |
No random assignment of treatment; blinding of outcome assessor not described; no information on loss-to-follow-up; unclear why some continuous data was categorized. |
|
Strange, 2006 |
U |
U |
H |
L |
L |
L |
U |
H |
Cross-over study; randomisation procedure not described; participants and personnel not blinded; assessment of possible carry-over effects not described. |
|
Aksoy Kasapoğlu, 2017 |
L |
U |
H |
L |
H |
L |
L |
H |
Allocation concealment not described, participants not blinded, high drop-out in both treatment arms |
|
Aksoy Kasapoğlu, 2018 |
L |
U |
H |
U |
L |
L |
L |
H |
Allocation concealment not described, participants not blinded, blinding outcome assessment not described |
The risk of bias (RoB) was assessed with regard to random sequence generation, allocation concealment, blinding (participants, care provider, outcome assessor), incomplete outcome data, selective outcome reporting and other sources of bias according to the ‘Cochrane tool’ (Higgins et al., 2011). Each item was judged as low, high or unclear RoB (lack of information or uncertainty over potential bias). An ‘overall assessment’ for each study was based on the judgements for each RoB item. Selection bias (sequence generation, allocation concealment) and blinding were considered ‘key domains’, that is, the most important domains in a study’s RoB.
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) |
|
Wouters, 2019 |
unlikely |
unlikely |
unclear |
unlikely |
- 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.
- 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.
- Failure to adequately measure all known prognostic factors and/or failure to adequately adjust for these factors in multivariate statistical analysis.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 30-11-2022
Laatst geautoriseerd : 30-11-2022
Geplande herbeoordeling :
Algemene gegevens
De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door de Nederlandse Vereniging voor Reumatologie en werd gefinancierd uit de Kwaliteitsgelden Medisch Specialisten (SKMS).
De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2020 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met handartrose.
De werkgroepleden zijn door hun beroepsvereniging gemandateerd voor deelname. De werkgroep is verantwoordelijk voor de integrale tekst van deze richtlijn.
Werkgroep
- Dr. W.Y. (Wing-Yee) Kwok, reumatoloog, Rijnstate, NVR (voorzitter)
- A. (Anda) Alkadrie, patiëntvertegenwoordiger, P-AL
- Dr. J. (Jessica) Bijsterbosch, reumatoloog, Amphia Ziekenhuis, NVR
- Dr. C.H.M. (Els) van den Ende, senior onderzoeker, Sint Maartenskliniek, KNGF
- Prof. dr. G. (Margreet) Kloppenburg, reumatoloog, LUMC, NVR
- Dr. F. P. B. (Féline) Kroon, reumatoloog in opleiding, Zuyderland, NVR
- D. (Diana) Lewinski, patiëntvertegenwoordiger, RZN
- Dr. E. A. M. (Elien) Mahler, reumatoloog en epidemioloog, Sint Maartenskliniek, NVR
- Prof. dr. M.J.P.F. (Marco) Ritt, plastisch chirurg, Amsterdam UMC, locatie AMC, NVPC
- Dr. N. (Naghmeh) Riyazi, reumatoloog, internist, Haga Ziekenhuis, NVR
- V. (Vanja) Rutten, ergotherapeut, handtherapeut, Samen praktijk voor ergotherapie, EN
- K. (Kim) van Slingerland, MSc, verpleegkundig specialist, ErasmusMC, V&VN
- Dr. A.J.H. (Anne) Vochteloo, orthopedisch chirurg, OCON Orthopedische kliniek Hengelo, NOV
- Dr. R.M. (Robbert) Wouters, assistant professor/universitair docent, handtherapeut/fysiotherapeut (CHT-NL), ErasmusMC, KNGF
Met ondersteuning van
- Dr. A.A.O.M. (Aniek) Claassen, senior beleidsmedewerker, NVR
- Dr. M. (Myrthe) van Vilsteren, senior beleidsmedewerker, NVR
Met dank aan
- I. (Ingeborg) van Dusseldorp, literatuurspecialist
- Dr. E. (Ekaterina) van Dorp, adviseur, Kennisinstituut van Medisch Specialisten
Belangenverklaringen
De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.
Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.
|
Werkgroeplid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Wing-Yee Kwok |
Reumatoloog, Rijnstate Arnhem |
Lid ICT Klankbordgroep Rijnstate ziekenhuis, onbetaald / Lid ICT expertgroep Medisch specialisten Rijnstate ziekenhuis, onbetaald |
Geen |
Geen actie |
|
Margreet Kloppenburg |
Reumatoloog/hoogleraar Leids Universitair Medisch Centrum (LUMC) |
Bestuurslid van de Nederlandse Vereniging voor Reumatologie (NVR). Financiele vergoeding voor LUMC. / Bestuurslid Osteoarthritis Research Society International (OARSI), onbetaald. |
|
1-3. Geen actie 4.exclusie participatie als trekker opstellen aanbeveling voor een bepaald onderwerp (werkgroeplid mag bespreken en stemmen voor aanbeveling, maar niet trekker zijn)
|
|
Elien Mahler |
Reumatoloog-epidemioloog Sint Maartenskliniek Nijmegen |
Geen |
Geen
|
Geen actie |
|
Nagmeh Riyazi |
Reumatoloog, internist, Hagaziekenhuis |
Geen |
Geen |
Geen actie |
|
Jessica Bijsterbosch |
Reumatoloog, Amphia Ziekenhuis |
Geen |
Geen |
Geen actie |
|
Féline Kroon |
AIOS reumatologie (momenteel vooropleiding interne geneeskunde) in Zuyderland medisch centrum (0,8fte) |
Onderzoeker, afdeling reumatologie, Leids Medisch Centrum (onbetaald) |
Betrokken bij de opzet, uitvoering en analyse van de HOPE studie |
exclusie participatie als trekker opstellen aanbeveling voor een bepaald onderwerp (werkgroeplid mag bespreken en stemmen voor aanbeveling, maar niet trekker zijn)
|
|
Marco Ritt |
staflid afd. Plastische, Reconstructieve en Handchirurgie Amsterdam UMC, hoogleraar Plastische Chirurgie, i.h.b. de Handchirurgie, locatie AMC 0,6 fte. Tevens 0,2 fte werkzaam in The Hand Clinic als hand- en polschirurg. |
Ik verricht expertises, betaald |
Geen |
Geen actie |
|
Anne Vochteloo |
Orthopedisch (hand) chirurg, OCON Orthopedische Kliniek Hengelo |
Onbetaald: secretaris bestuur Nederlandse Vereniging voor Handchirurgie / penningmeester werkgroep Hand Pols NOV |
Geen |
Geen actie |
|
Robbert Wouters |
Postdoctoraal onderzoeker ErasmusMC Rotterdam (afdeling Plastische chirurgie & revalidatiegeneeskunde, handchirurgie en -revalidatie) / Research Fellow ICHOM, standard set adult Hand & Wrist conditions / Handfysiotherapeut CHT-NL |
Onbetaald: bestuurslid Nederlandse vereniging voor Handtherapie, eindredacteur Nederlands Tijdschrift voor Handtherapie |
Betrokken bij meerdere onderzoeken omtrent de (kosten-)effectiviteit van oefentherapie in aanvulling op spalktherapie bij patiënten met duimbasisatrose (bijv. THETA study) |
exclusie participatie als trekker opstellen aanbeveling voor een bepaald onderwerp (werkgroeplid mag bespreken en stemmen voor aanbeveling, maar niet trekker zijn)
|
|
Els van den Ende |
Senioronderzoeker Sint Maartenskliniek, afdeling Research (1,0fte) |
Lid bestuur NHPR (onbetaald) / Redactielid Nederlands Tijdschrift voor Reumatologie (onbetaald) / Convenor Online Course dor Health Professionals (onbetaald) |
Geen |
Geen actie |
|
Vanja Rutten |
Ergotherapeut, handtherapeut en mede eigenaar van Samen, praktijk voor ergotherapie. / Ergotherapeut afdeling reumatologie ambulate zorg Leids Medisch Centrum (stopt per 15 maart 2020). / Onderzoeks assisstent bij het Radboud Universitair Medisch Centrum (onderzoek: Life Balance) |
Geen |
Geen |
Geen actie |
|
Kim van Slingerland |
Verpleegkundig specialist, Erasmus MC |
Bestuurslid V&VN reumatologie, lid werkgroep derskundigheidsbevordering V&VN reumatologie |
Geen |
Geen actie |
|
Diana Lewinski |
Patiëntvertegenwoordiger |
Patiëntpartner en bestuurslid bij Nationale Vereniging ReumaZorg Nederland (onbetaald) |
Geen |
Geen actie |
|
Anda Alkadrie |
Patiëntvertegenwoordiger |
bestuurslid Poly-Artrose Lotgenoten (P-AL) |
Geen |
Geen actie |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door afgevaardigden van twee patiëntenverenigingen in de werkgroep. De conceptrichtlijn is tevens voor commentaar voorgelegd aan de patiëntenverenigingen Nationale Vereniging ReumaZorg Nederland en Poly-Artrose Lotgenoten Vereniging en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Werkwijze
AGREE
Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010). Bij deze richtlijn is er sprake van een versnelde adaptatie van een internationale richtlijn naar de Nederlandse praktijk. Daarvoor zijn de stappen gevolgd conform het advies “Adapteren van internationale richtlijnen naar de Nederlandse praktijk” (RK-17.07.07, bijlage bij adviesrapport ‘Adapteren van internationale richtlijnen naar de Nederlandse praktijk. Opgesteld door de adviescommissie richtlijnen, en vastgesteld op 27 juni 2017).
Knelpuntenanalyse en uitgangsvragen
In het kader van een versnelde adaptatie is een knelpuntenanalyse niet uitgevoerd.
De werkgroep beoordeelde de uitgangsvragen en aanbeveling(en) uit de internationale richtlijnmodule (European Alliance of Associations for Rheumatology (EULAR), 2018) op noodzaak tot update.
Uitkomstmaten
Relevante uitkomstmaten werden overgenomen zoals geformuleerd in de internationale richtlijn.
Methode literatuursamenvatting
Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur en de beoordeling van de risk-of-bias van de individuele studies is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. Deze beschrijving en beoordeling zijn overgenomen van de internationale richtlijn, en waar nodig aangevuld met nieuwe studies die geselecteerd zijn bij het updaten van desbetreffende richtlijnmodules. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.
Beoordelen van de kracht van het wetenschappelijke bewijs
Indien aanwezig in de internationale richtlijn werd de kracht van bewijs overgenomen. De kracht van het wetenschappelijke bewijs voor nieuwe modules werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).
GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).
|
Definitie |
|
|
Hoog |
|
|
Redelijk |
|
|
Laag |
|
|
Zeer laag |
|
Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).
Overwegingen (van bewijs naar aanbeveling)
Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk. Zo worden aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie meegewogen. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinie. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE-methodiek.
Formuleren van aanbevelingen
De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. Gezien de huidige richtlijn een adaptatie is van een internationale richtlijn, zijn de aanbevelingen uit deze internationale richtlijn als uitgangspunt genomen. De werkgroep heeft op basis van overwegingen specifiek voor de Nederlandse praktijk en eventueel aanvullende literatuur, de aanbevelingen aangepast.
In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel voor enkele voorbeelden). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.
|
Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers |
||
|
|
Sterke aanbeveling |
Zwakke (conditionele) aanbeveling |
|
Voor patiënten |
De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet. |
Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. |
|
Voor behandelaars |
De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen. |
Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren. |
|
Voor beleidsmakers |
De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid. |
Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. |
Organisatie van zorg
Meer algemene, overkoepelende, of bijkomende aspecten van de organisatie van zorg die opgenomen zijn in de internationale richtlijn worden behandeld in de module Organisatie van zorg.
Commentaar- en autorisatiefase
De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.
Zoekverantwoording
Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.