Verschillende vormen van Interdisciplinaire revalidatie
Uitgangsvraag
Uitgangsvraag Comparison 3.
Which type of interdisciplinary rehabilitation is most effective for (various subgroups of) adult patients with musculoskeletal chronic pain?
Aanbeveling
Zie module Interdisciplinaire revalidatie
Overwegingen
Zie module Interdisciplinaire revalidatie
Onderbouwing
Conclusies
HRQoL
|
Very low |
The evidence is very uncertain about the effect of exposure in vivo on HRQoL when compared with graded activity in adults with musculoskeletal chronic pain.
Sources: Goossens (2015); |
Disability
|
Low |
CBT may reduce disability at 12 months (but not post-treatment or at 6 months) when compared with combined treatment (active physical training plus CBT) in adults with musculoskeletal chronic pain.
Sources: Smeets (2006, 2008, 2009); |
|
Very low |
The evidence is very uncertain about the effect of exposure in vivo on disability when compared with graded activity in adults with musculoskeletal chronic pain.
Sources: Leeuw (2008); Goossens (2015); |
Self-efficacy
|
Very low |
The evidence is very uncertain about the effect of a pain management program with graded exposure in vivo on self-efficacy when compared with a pain management program in adults with musculoskeletal chronic pain.
Sources: Bliokas (2007); |
Pain
|
Low |
CBT may reduce pain post-treatment, at 6 months and at 12 months when compared with combined treatment (active physical training plus CBT) in adults with musculoskeletal chronic pain.
Sources: Smeets (2006, 2008, 2009); |
|
Very low |
The evidence is very uncertain about the effect of exposure in vivo on pain when compared with graded activity in adults with musculoskeletal chronic pain
Sources: Leeuw (2008); |
|
Very low |
The evidence is very uncertain about the effect of a pain management program with graded exposure in vivo on pain when compared with a pain management program in adults with musculoskeletal chronic pain.
Sources: Bliokas (2007); |
Anxiety
|
No |
The evidence is very uncertain about the effect of a pain management program with graded exposure in vivo on anxiety when compared with a pain management program in adults with musculoskeletal chronic pain.
Sources: Bliokas (2007); |
Depression
|
Low |
CBT may reduce depression post-treatment (but not at 6 or 12 months) when compared with combined treatment (active physical training plus CBT) in adults with musculoskeletal chronic pain.
Sources: Smeets (2006, 2008, 2009); |
|
Very low |
The evidence is very uncertain about the effect of a pain management program with graded exposure in vivo on depression when compared with a pain management program in adults with musculoskeletal chronic pain.
Sources: Bliokas (2007); |
Cost-effectiveness
|
Very low |
The evidence is very uncertain about the effect of CBT on cost-effectiveness when compared with active physical treatment combined with CBT in adults with musculoskeletal chronic pain.
Sources: Smeets (2006, 2008, 2009); |
|
Very low |
The evidence is very uncertain about the effect of exposure in vivo on cost-effectiveness when compared with graded activity in adults with musculoskeletal chronic pain
Sources: Goossens (2015); |
Work participation
|
No |
- Sources: |
Samenvatting literatuur
Comparison 3. Interdisciplinary rehabilitation compared to other forms of interdisciplinary rehabilitation
Smeets (2006, 2008, 2009) conducted a randomized controlled trial with four arms, including 223 patients with chronic low back pain. Patients were randomly allocated to either: 1) the Active Physical Treatment (APT, n= 53; mean age 42.68±9.06; 58% men); 2) Cognitive-Behavioral Treatment and problem solving (CBT, n=58; mean age 42.52±9.67; 41% men); 3) Combined Treatment (CT) (n=61; mean age 40.67±10.14; 62% men); or 4) waiting List (WL) (n=51; mean age 40.55±11.17; 51% men). The current analysis does not include waiting list, as this was not part of our pre-defined PICOs. CBT and CT both meet the criteria for interdisciplinary rehabilitation. All programs lasted ten weeks and were supervised by a physiatrist who saw each patient at least three times during treatment. APT consisted of aerobic training and strengthening exercises, guided by two physiotherapists. (3x p/wk for 1:45h). CBT consisted of operant behavioral graded activity training, and problem-solving training, was guided by a physiotherapist or occupational therapist and a clinical psychologist or social worker with a frequency of three times per week, for 1:45h. The CT was a combination of the APT and CBT program, with the same frequency and duration including 19 sessions with a total of 11h. Outcome measures were disability (Roland Disability Questionnaire), pain (pain rating index) and depression (Beck Depression Inventory), and assessed posttreatment at 10 weeks and 12 months. Outcome measures for the cost-effectiveness analysis were disability (Roland Disability Questionnaire) and quality-adjusted life years (QALYs) (EuroQol-5D, QALYs were calculated by multiplying the utility based on EuroQol scores with the amount of time a patient spent in this particular health status), assessed at 12 months. A societal viewpoint was used for the cost-effectiveness analysis. Cost measures included intervention costs (calculated by collecting checklists completed by the health professionals involved), other direct healthcare costs (not related to the allocated treatment), direct non-healthcare and indirect costs due to absenteeism from paid work (calculated using patient completed cost diaries). The uncertainty in the costs was analysed using bootstrapping. Cost-effectiveness acceptability curves were constructed to show the probability that an intervention was most cost-effective using different cost-effectiveness thresholds.
Leeuw (2008) performed a randomized controlled trial of exposure in vivo treatment (EXP) versus graded activity (GA). A total of 85 Dutch patients with chronic low back pain were randomly allocated to EXP (intervention group: 42 patients, 47.6% male, mean age 46.45±9.33) or GA (control group: 43 patients, 55.8% male, mean age 44.21±9.54). Measurements were performed twice before treatment, post-treatment, and after six months. Outcome measures included functional disability (Quebec Back Pain Disability Scale, ranging from 0-‘no trouble’ to 100-‘unable to’), main complaints (Patient Specific Complaints, ranging from 0-‘no problem at all’ to 100-‘impossible’), and pain intensity (McGill Pain Questionnaire Visual Analogue Scales, 0-‘no pain at all’ to 100-‘unbearable pain’).
Goossens (2015) performed a long-term cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) as viewed from a societal perspective. Patients from the Leeuw (2008) study were included in the economic analysis if cost diary information was available for at least three months after treatment. Sixty-two patients were included, 31 patients in the EXP group (intervention: 50% male, mean age 47.13±9.58) and 31 patients in the GA group (control: 50% male, mean age 45.45±8.42). Measurements were performed before, during, and after treatment, and at 6 and 12 months after treatment. Outcomes were self-reported disability (Quebec Back Pain Disability Scale, ranging from 0-‘no trouble’ to 100-‘unable to’) (for the CEA) and quality-adjusted life years (QALYs) (SF-36, utilities estimated based on the HRQoL scores, multiplied by the time in that particular health state) (for the CUA). Cost measures included intervention costs (calculated on the basis of health professionals’ salaries and patients’ travel expenses), other health care costs, patient and family costs, and productivity losses (calculated using patient completed cost diaries). The uncertainty in the costs and effects was represented in a scatter plot of simulated incremental cost and effect pairs. Cost-effectiveness acceptability curves were constructed to show the uncertainty concerning the cost-effectiveness of EXP compared to GA by looking at a range of ceiling ratio values (ranging from €16,000 per QALY in case of the lowest disease burden to €80,000 per QALY in diseases with the highest burden).
Bliokas (2007) performed a randomized controlled trial in Australia, comparing the effectiveness of adding graded exposure (GE-PMG program, n=58, mean age 45.5 ± 10.8, 41% men) in vivo into a multidisciplinary chronic pain management group (PMG program, n=44, mean age 46.3 ± 9.8, 43%) in patient with chronic pain. The majority of participants (n = 81; 56.6%) presented with low back pain, although the participants were a mixed-pain cohort with 15 (10.5%) classified as having extremity pain, 8 (5.6%) fibromyalgia, 6 (4.2%) neck pain, and 33 (23.2%) other or mixed pain. Both PMG and GE-PMG programs included a graded activity component, which was a 1-hour exercise session included on each day of attendance. This consisted of a walking and stretching program, supervised by a physiotherapist, which had received prior approval from each patient’s doctor. Both groups also received psycho-education, information on healthy eating, relationship issues, depression, and additional practice in communication skills. Participants in the GE-PMG group were taught the rationale for graded to feared and avoided activities during their initial goal setting session, as per Vlaeyen et al. Outcome measures included self-efficacy, pain intensity, anxiety and depression measured after an eight-week period.
Table 3.1 Additional study and baseline characteristics and outcomes of included studies – interdisciplinary rehabilitation compared to other forms of interdisciplinary rehabilitation
|
Study population |
Intervention and Control |
Outcomes |
Remarks |
|
|
Smeets (2006, 2008, 2009)
|
223 patients with chronic low back pain in the Netherlands
Inclusion criteria: - patients, age 18-65 yo -non-specific low back pain >3mo -functional limitation due to CLBP -ability to walk uninterrupted >100m
Exclusion criteria: -vertebral fracture -spinal inflammatory disease -spinal infections or malignancy -current nerve root pathology, spondylolysis or spondylolisthesis -lumbar spondylodesis -medical co-morbidity making intensive exercising impossible -ongoing diagnostic procedures or treatment for CLBP at time of referral -clear treatment preference -not proficient in Dutch -pregnancy -substance abuse that could interfere with rehabilitation treatment |
Each of the 3 treatment programs lasted 10 weeks.
Combined Treatment (CT) of APT and PST (n=61): A combination of the APT and APT program, with the same frequency and duration. 19 sessions with a total of 11h.
Cognitive-Behavioral Treatment (CBT, n=58): Consisted of operant behavioral graded activity training, and problem-solving training (PST). This program was guided by a physiotherapist or occupational therapist and a clinical psychologist or social worker. Introductory group meetings, followed by individual sessions. Treatments for 3x-1x p/wk with a total of 11.5h.
Active Physical Treatment (APT, n=53): Consisted of aerobic training and strengthening exercises, guided by two physiotherapists. (3x p/wk for 1:45h)
|
Disability ( Roland Disability Questionnaire[0-24]) CBT vs CT, difference Base: CBT 13.74 ± 3.65 / CT: 13.51 ± 3.92 Post: 0.58 (-1.08 to 2.24) 12 mo: 1.62 (-0.06 to 3.31)
Pain (100-mm VAS) Post: 5.35 (-3.37 to 14.42) 12 mo: 8.88 (-0.36 to 18.13)
Depression (Beck Depression Inventory[0 to 63]) Post: 1.62 (-0.36 to 3.61) 12 mo: -0.09 (-2.11 to 1.93)
For the cost-effectiveness analysis, data from 160 patients was included (APT n=52, CBT n=52, CT n=56)
Outcomes were self-reported disability (for the CEA) and quality-adjusted life years (for the CUA)
Disability (Roland Disability Questionnaire[0-24]) mean (SD) improvement from baseline until 12 months 12 months: -1.27 (-2.96 to 0.42)
Health-related quality of life (EuroQol 5-D QALY) mean (SD) improvement from baseline until 12 months CBT: 0.723 (0.197) / CT: 0.679 (0.191) 12 months: -0.045 (-0.119 to 0.029)
Total costs (in €) 10 weeks of treatment and 52 weeks of follow-up mean (SD) CBT: €14,794 (17,209) CT: €19,559 (14,708)
CBT vs CT, difference (95% CI) 4787 (-984 to 10,540)
CEA (outcome measure RDQ) CT vs CBT: one can save €3759 by offering CBT instead of CT 89% probability inferiority of CT 1% probability superiority of CT
CUA (outcome measure QALY) CT vs CBT: one can save €108,857 by offering CBT instead of CT 83% probability inferiority of CT 1% probability superiority of CT
Cost-effectiveness acceptability curve for RDQ showed that CT is never cost-effective. The higher the willingness to pay, the more the curves of GAP and APT approach each other. The cost-effectiveness acceptability curve for QALY showed that CBT is most likely to be cost-effective.
|
|
|
Leeuw (2008) and Goossens (2015) |
85 Dutch patients with chronic low back pain (CLBP) (62 were included in the economic analysis)
Inclusion criteria: - back pain for at least 3 months that was not caused by serious spinal injury - age between 18 and 65 years - presence of a sufficient level of disability (Roland Disability Questionnaire (RDQ) > 3) - presence of at least moderate fear of movement/(re)injury (Tampa Scale for Kinesiophobia > 33).
Exclusion criteria: - illiteracy, pregnancy - substance abuse interfering with treatment - involvement in any litigation concerning the patients ability to work or disability income - specific medical disorders or cardiovascular diseases preventing participation in physical exercise - serious psychopathology (SCL-90> 241, BDI ‘negative self view’ subscale > 14) |
Both groups (n=85/62): Treatments carried out by a mini-team consisting of a psychologist, and a physiotherapist or occupational therapist, who were supervised by a rehabilitation physician. Both treatments started with a psychological intake and included an educational session by the rehabilitation physician and the therapist mini-team. Treatment sessions were provided twice a week in 1-h sessions, with a decreasing frequency during the final weeks of treatment.
Intervention (n=42/31): Exposure in vivo Approximately 16 treatment sessions. Treatment started with personal graded hierarchy of fear-eliciting activities. Treatment sessions included gradual but systematic exposure to personally tailored and fear-provoking activities and behavioural experiments to test the validity about beliefs about the harmful consequences of activities.
Control (n=43/31): Graded activity Approximately 26 treatment sessions. Treatment goals were identified in terms of patients’ most important specific functional activities confined by their pain problem. The tolerance level of these activities was determined and activities were then performed at 70-80% of the baseline activity level, and then gradually increased towards the preset treatment goals. Two additional sessions with a psychologist to help spouses with positively reinforcing activity levels. |
Measurements: pre-treatment 1 and 2, post-treatment, 6mo, 12mo
Leeuw (n=85):
Functional disability (QBPDS; 0-100) Pre : I: 53.61±11.63 / C: 51.88±13.54 Post: I: 35.90±20.45 / C: 41.69±22.58 6mo: I: 39.00 ± 20.93/ C: 41.94±19.29 MD at post-treatment and 6mo: -5.89 (95%CI -12.68 to 0.90)
Main complaints (PSC; 0-100) Pre: I: 68.82 ± 14.94/ C: 73.36 ± 14.69 Post: I: 40.24 ± 29.42 / C: 45.98 ± 27.49 6mo: I: 38.52 ± 26.71 / C: 44.06 ± 28.48 MD at post-treatment and 6mo: -10.03 (95%CI -21.27 to 1.21)
Pain intensity (MPQ VAS; 0-100) Pre: I: 52.54 ± 12.77/ C: 54.66 ± 11.88 Post: I: 43.72 ± 21.24 / C: 44.07 ± 22.86 6mo: I: 41.15 ± 22.26/ C: 40.45 ± 22.25 MD at post-treatment and 6mo: -0.56 (95%CI -9.24 to 8.11)
For the economic analysis from a societal perspective (n=62): Outcomes were self-reported disability (for the CEA) and quality-adjusted life years (for the CUA)
Health-related quality of life (SF-36, QALY) 15mo: I: 0.83±0.13 / C: 0.82±0.12 MD at 15mo: 0.01 (95%CI -0.6 to 0.07)
Functional disability (QBPDS; 0-100) Pre: I: 55.02±11.41 / C: 53.53±12.79 15mo: I: 38.19±20.84 / C: 40.42±22.34 MD at 15 mo: −2.23 (95%CI -13.20 to 8.75)
Total costs (in €) Pre: I: 1,204.73±282.12 / C: 1,529.32±371.80 15 mo: I: 10,843.50±1747.89 / C: 13,477.71±2450.28 MD at 15moa: −2,643 (95%CI -8,535 to 3,058)
CEA EXP versus GA The CEA showed that EXP resulted in a mean improvement of 2.2 points on the QBPDS at a mean saving of €2,634 compared to GA. - dominance: 56% - inferiority: 8% - cheaper but less effective: 26% - more expensive but more effective: 10% Using a ceiling of €16,000 per QALY as the maximum amount of money that society is prepared to pay for an improvement in disability, the probability of EXP treatment being cost-effective is 67%.
CUA EXP versus GA The CUA showed that EXP resulted in 0.01 additional QALYs at a mean saving of €2,634 compared to GA. - dominance: 49% - inferiority: 10% Using a ceiling of €16,000 per QALY as the maximum amount of money that society is prepared to pay for an improvement in HRQoL, the probability of EXP treatment being cost-effective is 81%. When the maximum ceiling ratio of €80,000 is used, the probability diminishes slightly, to 76%.
|
The mean of both pre-treatment measurements was calculated for each measure and patient, and used in subsequent analyses, since none of the variables showed a significant change between the two pre-treatment assessments.
Unequal baseline scores in depressive symptoms (BDI; 0-63) were found (EXP: mean 12.75±7.46, GA: mean 9.50±7.30; p =0.03)
Treatment was prematurely terminated either by the patient or the therapist in 12 patients (29%) of the EXP condition, and in 14 patients (33%) of the GA condition for various reasons (1 patient experienced adverse effects related to GA). Protocol deviations in 8 patients (fewer sessions because treatment was successful (4 EXP, 1 GA), personal circumstances (1 EXP, 2 GA)).
No indication was found that EXP is superior to GA in the subgroup of highly fearful patients, thus both treatments appear of equal value irrespective of the patient’s level of fear. EXP may not be suitable in the absolute absence of fear of movement/(re)injury.
Out of the 85 patients included in the Leeuw (2008) study, 62 patients completed enough diary entries during the months of treatment and follow-up to be included in the economic analysis. |
|
Bliokas (2007) |
143 Australian patients with chronic pain
Inclusion criteria: - referred to the pain management group program of a pain management service
Exclusion criteria: - aged above 70 years - primary presenting pain problem was arthritis - presented with a primary drug and/or alcohol problem - severe psychiatric condition - inability to read and speak English - unwillingness or inability to attend a PMG program - deemed unsuitable for a group program in other ways, such as exhibiting poorly controlled anger, having immediately imminent court proceedings, or planned significant medical interventions. |
Intervention (n=58/35): Graded Exposure in Vivo Pain Management Group (GE-PMG)
8-week period on an outpatient basis. total of 66.5 contact hours with the treatment team
Participants were taught the rationale for GEXP to feared and avoided activities during their initial goal setting session, as per Vlaeyen et al. Consultation with psychologist to list ‘avoided activities’ and then a program was designed which included a range of activities with this action.
Control (n=44/34) Pain Management Group (PMG)
8-week period on an outpatient basis. total of 66.5 contact hours with the treatment team.
Two sessions of goal setting, third session to monitor participants’ goals. Four further sessions provided PMG group participants with information on healthy eating, relationship issues, depression, and additional practice in communication skills.
Both groups
Both PMG and GE-PMG programs included a graded activity component, which was a 1-hour exercise session included on each day of attendance. This consisted of a walking and stretching program, supervised by a physiotherapist, which had received prior approval from each patient’s doctor. Daily 45-minute relaxation training session (content of those sessions differed between the groups). Both groups also received psycho-education, information on healthy eating, relationship issues, depression, and additional practice in communication skills. Both treatment programs also included tasks that participants were expected to complete at home between treatment sessions.
|
Pain Self-efficacy Questionnaire (PSEQ) (0-60), mean (SD) Pre: I: 24.2 (11.2) / C: 28.1 (12.5) Post: I: 9.71 (11.34) / C: 9.32 (14.10) p=0.279
Pain intensity (VAS) (0-10), mean (SD) Pre: I: 6.1 (1.8) / C: 6.2 (1.9) Change scores: Post: I: -0.34 (2.03) / C: -0.87 (1.74) p=0.093
Anxiety subscale, Depression Anxiety and Stress Scales (DASS) (0-42), mean (SD) Pre: I: 15.1 (9.6) / C: 12.3 (10.7) Change scores: Post: I: -4.19 (9.19) / C: -2.00 (7.02) p=0.565
Depression subscale, Depression Anxiety and Stress Scales (DASS) (0-42), mean (SD) Pre: I: 19.2 (11.7) / C: 18.5 (12.3) Change scores: Post: I: -6.29 (10.94) / C: -7.24 (8.89) p=0.814
|
The majority of participants (n=81; 56.6%) presented with low back pain, although the participants were a mixed-pain cohort with 15 (10.5%) classified as having extremity pain, 8 (5.6%) fibromyalgia, 6 (4.2%) neck pain, and 33 (23.2%) other or mixed pain. |
Table 3.2 Risk-of-bias table for intervention studies (randomized controlled trials)
Research question: -Which type of interdisciplinary rehabilitation is most effective for (various subgroups of) adult patients with musculoskeletal chronic pain with musculoskeletal chronic pain?
|
Study reference
(first author, publication year) |
Was the allocation sequence adequately generated? a
Definitely yes Probably yes Probably no Definitely no |
Was the allocation adequately concealed?b
Definitely yes Probably yes Probably no Definitely no |
Blinding: Was knowledge of the allocated interventions adequately prevented?c
Were patients blinded?
Were healthcare providers blinded?
Were data collectors blinded?
Were outcome assessors blinded?
Were data analysts blinded?
Definitely yes Probably yes Probably no Definitely no |
Was loss to follow-up (missing outcome data) infrequent?d
Definitely yes Probably yes Probably no Definitely no |
Are reports of the study free of selective outcome reporting?e
Definitely yes Probably yes Probably no Definitely no |
Was the study apparently free of other problems that could put it at a risk of bias?f
Definitely yes Probably yes Probably no Definitely no |
Overall risk of bias If applicable/necessary, per outcome measureg
LOW Some concerns HIGH
|
|
Smeets (2006; 2008; 2009) |
Definitely yes;
Reason: randomized using permuted blocks, done by independent statistician |
Definitely yes;
Reason: Concealment of randomization was successfully achieved since no one of the referring physicians was aware of the type of treatment the referred patient would be randomized to. |
Probably yes;
Reason: research assistants stayed blind during study. Assessments were supervised and carried out by blinded research assistants. Therapists and patients were not blinded. To control for expectation bias, patients were told that the study was being performed to compare three currently used treatments for CLBP. |
Definitely yes;
Reason: low dropout rate for outcomes disability, pain and depression
|
Definitely yes;
Reason: All relevant outcomes were reported |
Probably yes;
Reason: ITT-protocol, but patient compliance not very high.
|
LOW (disability, pain, depression) |
|
Probably no;
Relatively high dropout rate due to missing cost diary data: APT: 8% / CBT: 33% / CT: 26%
Missing data imputed. |
Some concerns (cost-effectiveness analysis) |
||||||
|
Leeuw, 2008 and Goossens, 2015 |
Definitely yes;
Reason: Patients were randomized following a predetermined and computer-generated randomization schedule, prestratified by therapist team, and degree of pain catastrophizing and disability.
|
Definitely yes;
Reason: Within each stratum, a randomized block design with a block size of 2 was used to ensure that important patient characteristics were equally distributed across conditions, and that each therapist team would approximately treat an equal number of patients in each treatment condition. Because of the complexity of the randomization schedule, forthcoming assignments could never be predicted. |
Probably no;
Reason: The treatment names were not revealed (they were called ‘BackActive-E’ and ‘BackActive-G’), to ensure the study be single-blinded.
The teams always performed both EXP and GA, and were therefore not blinded to the contents of the treatments being compared.
The 2 research assistants collecting the data were not blinded to treatment allocation, but all questionnaires were administered electronically through a computer program.
The data analysts were blinded during all the data analyses. Blinding (patient allocation) was broken afterwards.
|
Probably no;
Reason:
Leeuw Post-treatment: 2.4% (EXP) and 16.3% (GA) loss to follow-up (1/42 and 7/43)
Follow up 1: 9.5% (EXP) and 18.6% (GA) loss to follow-up (4/42 and 8/43)
Goossens 31/42 (73.8%) (EXP) and 31/43 (72.1%) (GA) completed enough diary entries to be included in the economic analysis. So 26.2% and 27.9% loss to follow-up.
Intention-to-treat analyses were employed, including all patients that were originally enrolled in the study, irrespective of their completing therapy or assessments
|
Probably no;
Reason: disability was included in the trial registration, pain is not mentioned
|
Probably no;
Reason:
Unequal baseline scores in depressive symptoms
Treatment was prematurely terminated either by the patient or the therapist in 12 patients (29%) of the EXP condition, and in 14 patients (33%) of the GA condition for various reasons (1 patient experienced adverse effects related to GA).
|
HIGH |
|
Bliokas (2007) |
Definitely yes;
Reason:
A central randomization process was used to allocate participants to 3 experimental conditions and WL control. A random generation of the numbers 1 to 3 was produced at the commencement of the study, with each number corresponding to the 3 experimental conditions. |
No information; |
Probably no;
Reason: Only described that patients were blinded |
Probably no;
Reason: 10/44 patients (23%) in the PMG group were lost to follow-up, and 23/58 patients (40%) in the GE-PMG group were lost to follow-up |
Probably yes;
Reason: All relevant outcomes were reported |
Definitely no;
No intention to treat analysis |
High |
Level of evidence of the literature
All evidence was derived from randomized controlled trials, therefore, the level of evidence for all outcomes started at ‘high quality’.
HRQoL
The level of evidence regarding the outcome measure HRQoL was downgraded by three levels because of study limitations (-1; risk of bias because of lack of blinding and loss to follow-up); and low number of included patients in a single RCT (-2; imprecision).
Disability
Smeets (active physical training plus CBT versus CBT only)
The level of evidence regarding the outcome measure disability was downgraded by two levels because of the low number of included patients in a single RCT (-2; imprecision).
Leeuw/Goossens (exposure in vivo versus graded activity):
The level of evidence regarding the outcome measure disability was downgraded by three levels because of study limitations (-1; risk of bias because of lack of blinding, loss to follow-up); and low number of included patients in a single RCT (-2; imprecision).
Self-efficacy
The level of evidence regarding the outcome measure self-efficacy was downgraded by three levels because of study limitations (-1; risk of bias because of lack of blinding and loss to follow-up), and low number of included patients in a single RCT (-2; imprecision).
Pain
Smeets (active physical training plus CBT versus CBT only)
The level of evidence regarding the outcome measure pain was downgraded by two levels because of the low number of included patients in a single RCT (-2; imprecision).
Leeuw/Goossens (exposure in vivo versus graded activity):
The level of evidence regarding the outcome measure pain was downgraded by three levels because of study limitations (-1; risk of bias because of lack of blinding and loss to follow-up); and the low number of included patients in a single RCT (-2; imprecision).
Bliokas (Graded Exposure in Vivo Pain Management Group (GE-PMG) vs Pain Management Group (PMG):
The level of evidence regarding the outcome measure pain was downgraded by four levels because of study limitations (-2; risk of bias because of incomplete reporting, lack of blinding and loss to follow-up); and the low number of included patients in a single RCT (-2; imprecision).
Anxiety
No studies reported on anxiety.
Depression
Smeets (active physical training plus CBT versus CBT only)
The level of evidence regarding the outcome measure depression was downgraded by two levels because of the low number of included patients in a single trial (-2; imprecision).
Bliokas (Graded Exposure in Vivo Pain Management Group (GE-PMG) vs Pain Management Group (PMG):
The level of evidence regarding the outcome measure depression was downgraded by four levels because of study limitations (-2; risk of bias because of incomplete reporting, lack of blinding and loss to follow-up); and the low number of included patients in a single RCT (-2; imprecision).
Cost-effectiveness
Smeets (active physical training plus CBT versus CBT only)
The level of evidence regarding the outcome measure cost-effectiveness was downgraded by three levels because of study limitations (-1; risk of bias because of loss to follow-up); and low number of included patients in a single RCT (-2; imprecision).
Goossens
The level of evidence regarding the outcome measure pain was downgraded by three levels because of study limitations (-1; risk of bias because of lack of blinding and loss to follow-up); and the low number of included patients in a single RCT (-2; imprecision).
Work participation
No studies reported on work participation.
Zoeken en selecteren
Definition interdisciplinary rehabilitation
The working group defined interdisciplinary rehabilitation according to the definition by Gatchel, 2014, i.e.:
(a) a common philosophy treatment in line with the biopsychosocial model of pain;
(b) a treatment component where patients actively participated by means of tasks, training and/or exercise;
(c) at least three different healthcare professionals from various disciplines that provided the interdisciplinary treatment;
(d) a single facility where each patient received treatment. This last criterion excluded care-network settings, but not multicenter trials.
Relevant outcome measures
The guideline development group considered health-related quality of life (HRQOL), (dis)ability and self-efficacy as a critical outcome measure for decision making; and pain, anxiety, depression, cost-effectiveness and work participation as an important outcome measure for decision making.
The outcome measure work participation was defined as sick leave/days, return to work and percentage employed. Return to work and employment was defined as actual return to work, not the ability to work. A priori, the working group did not define the outcome measures listed above but used the definitions of the selected studies. The outcomes had to be measured with a validated questionnaire or scale with sufficient clinimetric properties, specifically responsiveness.
Clinically relevant differences
The working group defined the following clinically relevant differences:
- HRQOL, pain, disability, self-efficacy, depression, anxiety: ≥10% difference. This difference is based on baseline scores, e.g. ≥0.6 points difference between groups posttreatment, when mean baseline score is 6.0.
- Work participation: percentage employed: ≥10%
- Return to work: ≥ 2 weeks earlier/later
- Sick leave/days: ≥ 2 weeks more/less in one year
- Cost effectiveness: threshold €16,000 / €80,000 per QALY in the Netherlands
Search and select (Methods)
One literature search was performed for all abovementioned questions. The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until November 3rd, 2020. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 2.723 hits. Studies were selected based on the following criteria: systematic review or randomized controlled trial; study design according to one or more of the four relevant PICOs; interdisciplinary rehabilitation according to Gatchel, 2014. In case of mixed cohorts, at least 75% of the patients had to experience musculoskeletal chronic pain.
238 studies were initially selected based on title and abstract screening. After reading the full text, 201 publications were excluded (see the table with reasons for exclusion under the tab Methods), and 37 publications were included (Becker, 2000; Bendix, 2000; Bliokas, 2007; Brendbekken, 2016; Brendbekken, 2017; Castel, 2013; van Eijk-Hustings, 2013; Goossens, 2015; den Hollander, 2016; den Hollander, 2018; Jousset, 2004; Kääpä, 2006; Kool, 2007; Leeuw, 2008; Lera, 2009; Linden, 2014; Mangels, 2009; Martín, 2012; Martín, 2014; Martín, 2014; Monticone, 2013; Nicholas, 2013; Nicholas, 2017; Reneman, 2020; Roche, 2007; Roche-Leboucher, 2011; Ronzi, 2017; Schmidt, 2021; Skouen, 2006; Smeets, 2006; Smeets, 2008; Smeets, 2009; Tavafian, 2011; Tavafian, 2014; Tavafian, 2017; Thieme, 2003; Turner-Stokes, 2003).
The guideline working group was aware of three additional relevant publications that were also included (Castel, 2013; Kool, 2007; Smeets, 2009), for a total of 38 publications.
Referenties
- Bliokas VV, Cartmill TK, Nagy BJ. Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups? Clin J Pain. 2007 May;23(4):361-74. doi: 10.1097/AJP.0b013e31803685dc. PMID: 17449998.
- Goossens ME, de Kinderen RJ, Leeuw M, de Jong JR, Ruijgrok J, Evers SM, Vlaeyen JW. Is exposure in vivo cost-effective for chronic low back pain? A trial-based economic evaluation. BMC Health Serv Res. 2015 Dec 14;15:549. doi: 10.1186/s12913-015-1212-6. PMID: 26651828; PMCID: PMC4677446.
- Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Köke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1. PMID: 18242858.
- Smeets RJ, Severens JL, Beelen S, Vlaeyen JW, Knottnerus JA. More is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain. Eur J Pain. 2009 Jan;13(1):71-81. doi: 10.1016/j.ejpain.2008.02.008. Epub 2008 Apr 22. PMID: 18434221.
- Smeets RJ, Vlaeyen JW, Hidding A, Kester AD, van der Heijden GJ, van Geel AC, Knottnerus JA. Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229]. BMC Musculoskelet Disord. 2006 Jan 20;7:5. doi: 10.1186/1471-2474-7-5. PMID: 16426449; PMCID: PMC1382224.
- Smeets RJEM, Vlaeyen JWS, Hidding A, Kester ADM, van der Heijden GJMG, Knottnerus AJ. Chronic low back pain: physical training, graded activity with problem solving training, or both? The one-year post-treatment results of a randomized controlled trial. Pain. 2008 Feb;134(3):263-276. doi: 10.1016/j.pain.2007.04.021. Epub 2007 May 10. PMID: 17498879.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 10-04-2024
Laatst geautoriseerd : 10-04-2024
Geplande herbeoordeling : 10-04-2028
Algemene gegevens
De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) 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 in de chronische pijnrevalidatie.
Werkgroep
- prof. Dr. R.J.E.M. Smeets, hoogleraar revalidatiegeneeskunde & revalidatiearts, Universiteit Maastricht & CIR Clinics in Revalidatie Eindhoven, Nederlandse Vereniging van Revalidatieartsen (voorzitter)
- prof. Dr. A.M.C.F. Verbunt, hoogleraar revalidatiegeneeskunde & revalidatiearts, Universiteit Maastricht & Adelante Zorggroep, Nederlandse Vereniging van Revalidatieartsen
- drs. M.B.M. van Melick, ergotherapeut, Universiteit Maastricht, Ergotherapie Nederland
- drs. C.J. van Oort, anesthesioloog, Ikazia Ziekenhuis, Nederlandse Vereniging voor Anesthesiologie
- drs. S. van der Plas, huisarts, Huisartsenpraktijk Buis en Van der Plas, Nederlands Huisartsen Genootschap
- dr. A.J.A. Köke, fysiotherapeut & bewegingswetenschapper, Universiteit Maastricht & Adelante Zorggroep, Koninklijk Nederlands Genootschap voor Fysiotherapie
- dr. R.N.J.T.L. de Nijs, reumatoloog, Elkerliek ziekenhuis, Nederlandse Vereniging voor Reumatologie
- drs. I.L. Thomassen-Hilgersom, patiëntvertegenwoordiger, Pijnpatiëntennaaréénstem
- E. de Jong, oefentherapeut, Oefentherapie & Coachpraktijk Eveline de Jong, Vereniging van Oefentherapeuten Cesar en Mensendieck
- drs. M.W. Havinga, orthopedisch chirurg, OCON Orthopedische kliniek, Nederlandse Orthopaedische Vereniging
- dr. H.R. Schiphorst Preuper, revalidatiearts, UMCG, Nederlandse Vereniging van Revalidatieartsen
- dr. C. D. Schröder, GZ-psycholoog, Healthsupport4you, Nederlands Instituut van Psychologen (sinds november 2022)
- dr. J.J.A. Samwel, klinisch psycholoog, Revalis, Nederlands Instituut van Psychologen. (tot juli 2022)
Met ondersteuning van
- dr. J. Buddeke, senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- drs. T. Lamberts, senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- dr. L. Oostendorp, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- drs. L. Niesink-Boerboom, literatuurspecialist, Kennisinstituut van de Federatie 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 |
|
Smeets |
Revalidatiearts |
Hoogleraar Revalidatiegeneeskunde, Lid examencommissie EFIC curriculum medici Ediotrial board lid European Journal of Physiotherapy and Pain Practice |
Geen |
Geen restrictie |
|
Van Melick |
Ergotherapeut |
Lid van de Landelijke werkgroep Ergotherapie en chronische pijn, |
Geen |
Geen restrictie |
|
Samwel |
Klinisch psycholoog |
Voorzitter sectie Pijnonderwijs van PA!N Lid van het Algemeen Bestuur van PA!N als gemandateerde vanuit NIP (Nederlands Instituut voor Psychologen) Afgevaardigde Revalis in Netwerk Chronische Pijn Jeroen Bosch Ziekenhuis Afgevaardigde Revalis in Netwerk Chronische Pijn Bernhoven Ziekenhuis |
Geen |
Geen restrictie |
|
Schiphorst-Preuper |
Revalidatiearts |
Revalidatiearts, Universitair docent, Lid werkgroep Pijnrevalidatie Nederland, Lid algemeen bestuur Pijn Alliantie Nederland tot 2024. Kernredactielid NTPP tot 2024. Vice voorzitter werkgroep Leidraad organisatie van zorg chronische pijn namens de VRA. Lid WPN. |
Geen |
Geen restricties |
|
Schröder |
GZ-psycholoog |
Voorzitter sectie revalidatiepsychologie NIP |
Geen |
Geen restricties |
|
Thomassen |
Voorzitter Samenwerkingsverband Pijnpatiënten naar één stem |
Voorzitter Patiëntenvereniging CRPS |
Geen |
Geen restricties |
|
Verbunt |
Revalidatiearts |
Hoogleraar revalidatie-geneeskunde. Commissie VENI ZonMW betaald, Vice voorzitter wetenschaps-commissie VRA Editioral board lid European Journal of Pain |
Project Netwerk Pijnrevalidatie Limburg, gefinancierd door zorgverzekeraars VGZ, CZ en Zilveren Kruis |
Geen restricties |
|
De Jong |
Oefentherapeut |
Bestuurslid Landelijk Netwerk Oefentherapeuten Chronische Pijn |
Geen |
Geen restricties |
|
De Nijs |
Reumatoloog |
geen |
Adviesraad AMGEN met betrekking tot osteoporose. PROFILE trial Sarilumab bij RA (gefinancierd door Sanofi Genzyme) Aandelen in Farma & medische technologie |
Restrictie: Is niet betrokken bij de besluitvorming rondom wel/niet afbouwen van pijnmedicatie voor start MSR. |
|
Havinga |
Orthopedisch chirurg |
Lid beroepsbelangen-commissie NOV |
Geen |
Geen restrictie |
|
Köke |
Senior onderzoeker Revalidatie-geneeskunde |
Afstudeerbegeleider Zuyd Hogeschool Heerlen, opleiding fysiotherapie. Coördinator Innovatie Kenniscentrum Adelante Hoensbroek |
Geen |
Geen restricties |
|
Van Oort |
Anesthesioloog Anesthesioloog-pijnspecialist (tot 2022) |
Lid Centraal Medisch Tuchtcollege; adviseur NVA; |
Geen |
Geen resricties |
|
Van der Plas |
Huisarts, praktijkhouder, kaderhuisarts bewegingsapparaat |
Instructeur Outdoor Medicine: vrijwilligersvergoeding
Medische commissie Nederlandse Klim- en bergsport Vereniging: vrijwillig en onbetaald
Nascholingen geven bij huisartsen coöperatie Medicamus: betaald
Lezingen en workshops geven over outdoor- en bergsportgeneeskunde op persoonlijke titel: vrijwillig met onkostenvergoeding |
|
Geen restricties |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door de patiëntorganisaties Pijnpatiëntennaaréénstem en de Patiëntenfederatie Nederland uit te nodigen voor de invitational conference. Het verslag hiervan [zie bijlagen] is besproken in de werkgroep. Ook heeft een afgevaardigde van de patiëntenvereniging Pijnpatiëntennaaréénstem zitting genomen in de werkgroep.
De conceptrichtlijn is tevens voor commentaar voorgelegd aan de Patiëntenfederatie Nederland en Pijnpatiëntennaaréénstem en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Wkkgz & Kwalitatieve raming van mogelijke substantiële financiële gevolgen
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijn is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling zijn richtlijnmodules op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).
Uit de kwalitatieve raming blijkt dat er waarschijnlijk geen substantiële financiële gevolgen zijn, zie onderstaande tabel.
Module |
Uitkomst raming |
Toelichting |
|
Module Effectiviteit Interdisciplinaire revalidatie |
Geen financiële gevolgen |
Uitkomst 3. Op basis van gegevens uit het DBC-informatiesysteem (DIS) wordt aangenomen dat er jaarlijks minder dan 15.000-20.000 WPN 3 en 4 patiënten zijn. Verder worden geen substantiële investeringen bij het uitvoeren van de aanbevelingen verwacht. |
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).
Knelpuntenanalyse en uitgangsvragen
Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de chronische pijnrevalidatie. Tevens zijn er knelpunten aangedragen door verschillende partijen via een schriftelijke knelpunteninventarisatie en een invitational conference. Een verslag van de invitational conference is opgenomen als bijlage.
Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.
Uitkomstmaten
Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.
Methode literatuursamenvatting
Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. Indien mogelijk werd de data uit verschillende studies gepoold in een random-effects model. Review Manager 5.4 werd gebruikt voor de statistische analyses. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht. De beoordeling van de methodologische kwaliteit van de literatuur is uitgevoerd door adviseurs van het Kennisinstituut van de Federatie Medisch Specialisten.
Beoordelen van de kracht van het wetenschappelijke bewijs
De kracht van het wetenschappelijke bewijs 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).
|
GRADE |
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).
De werkgroep voorzag reeds bij de start van het ontwikkeltraject dat de bewijskracht van de beschikbare evidence, beoordeeld middels GRADE, laag tot zeer laag zou zijn. Er zijn een aantal beperkingen inherent aan onderzoek in het domein revalidatiegeneeskunde, waaronder de onmogelijkheid om volledige blindering toe te passen en de kosten van behandeling waardoor het aantal geïncludeerde patiënten laag blijft, met onzekerheid in de grootte van het effect tot gevolg. Gezien deze beperkingen ligt het niet in de lijn der verwachting dat de bewijskracht zoals beoordeeld met GRADE in de toekomst hoger uit zal vallen.
In de module Interdisciplinaire Pijnrevalidatie heeft de werkgroep in de overwegingen een uitgebreide reflectie geschreven hieromtrent omdat zij van mening is dat er meer bewijs voorhanden is dan aan de hand van de GRADE methodiek in de literatuuranalyse is beschreven. Aanvullend bewijs verkregen via onderzoeksdesigns zoals Single Case Experimental Designs (SCED) en cohortstudies heeft een plaats gekregen in de overwegingen. De werkgroep heeft al het wetenschappelijk bewijs gewogen in de overwegingen en tot uitdrukking proberen te brengen in haar aanbevelingen.
Overwegingen (van bewijs naar aanbeveling)
Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. 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. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.
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). 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
In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen. Meer algemene, overkoepelende, of bijkomende aspecten van de organisatie van zorg 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.
Literatuur
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.
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