Interdisciplinaire revalidatie versus multidisciplinaire revalidatie
Uitgangsvraag
Uitgangsvraag Comparison 1
What is the effectiveness of interdisciplinary rehabilitation compared to multidisciplinary rehabilitation in 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 interdisciplinary rehabilitation on HRQoL when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Mangels (2009), Monticone (2013); Den Hollander (2016, 2018) |
Disability
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation on disability when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Linden (2014); Mangels (2009); Monticone (2013); Smeets (2006, 2008, 2009); Lera (2009); Brendbekken (2016, 2017); Nicholas (2013, 2017); Den Hollander (2016, 2018) |
Self-efficacy
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation on self-efficacy when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Mangels (2009); Thieme (2003); Nicholas (2013, 2017) |
Pain
|
Low |
Interdisciplinary rehabilitation may reduce pain post-treatment and a year after treatment when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Linden (2014); Monticone (2013); Smeets (2006, 2008, 2009); Thieme (2003); Nicholas (2013, 2017); Den Hollander (2016, 2018) |
Anxiety
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation on anxiety when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Brendbekken (2016, 2017); |
Depression
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation on depression when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Mangels (2009); Smeets (2006, 2008, 2009); Brendbekken (2016, 2017); Nicholas (2013, 2017); |
Cost-effectiveness
|
Low |
Interdisciplinary rehabilitation in the form of active physical treatment combined with cognitive behaviour therapy may not reduce the costs of treatment from a societal perspective and may result in little to no difference in disability and QALYs one year after treatment as compared to a program with exercise only in adults with musculoskeletal chronic pain.
Interdisciplinary rehabilitation in the form of cognitive behavior therapy may reduce the costs of treatment from a societal perspective and may result in little to no difference in disability and QALYs one year after treatment as compared to a program with exercise only in adults with musculoskeletal chronic pain.
Sources: Smeets (2009); |
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation (exposure in vivo) on cost-effectiveness when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Den Hollander (2018); |
Work participation
|
Very low |
The evidence is very uncertain about the effect of interdisciplinary rehabilitation on work participation when compared with multidisciplinary rehabilitation in adults with musculoskeletal chronic pain.
Sources: Kool (2007); Brendbekken (2016, 2017); |
Samenvatting literatuur
Comparison 1. Interdisciplinary rehabilitation compared to multidisciplinary care
Linden (2014) performed a randomized controlled trial in Germany, including 103 patients with chronic back pain. Patients were randomly allocated to a multimodal inpatient orthopedic rehabilitation programme and six sessions of cognitive behaviour group therapy for back pain (intervention group: n=53, mean age 50.4±6.9, 32% men) or general orthopaedic inpatient treatment alone (n=50, mean age 49.7±7.1, 32% men). Measurements were performed three times a day for pain, and before and after treatment (not further specified) for disability and mental health. Outcome measures included disability (Pain Disability Index (PDI), ranging from 0-‘no disability’ to 10-‘total disability’) on 7 items, for a total score of 0-70, pain (VAS; 0-10).
Mangels (2009) performed a randomized controlled trial in Germany, including 363 patients with chronic back pain. Patients were randomly allocated to three treatment arms: behavioural-medical rehabilitation with subsequent booster sessions (BMR+B) (intervention group with boosters: n=119 patients, mean age 48.3±15.8, 24.4% men), behavioural-medical rehabilitation alone (BMR) (n= 113, mean age 49.5±9.0, 21.2% men), and traditional orthopaedic rehabilitation (n= 131 patients, mean age 48.7±14.7, 21.4% men). Measurements were performed at admission, discharge, and 12 months follow-up. Outcome measures included health status and health-related quality of life (SF12, yielding scores with a mean of 50±10), pain disability (Pain Disability Index (PDI), ranging from 0-‘no disability’ to 10-‘total disability’) on 7 items, for a total score of 0-70, self-efficacy (Pain Self-efficacy Questionnaire (PSEQ), ranging from 0-‘not at all confident’ to 6-‘completely confident’ on 10 items, for a total score of 0-60), and depression (Beck Depression Inventory (BDI), ranging from 0 to 63).
Kool (2007) conducted a randomized controlled trial in Switzerland, in which 174 patients with non-acute nonspecific low back pain participated. Eighty-seven patients were randomized to function-centered treatment (FCT, mean age 41.6 ± 8.4, 79% men) and 87 patients were randomized to pain-centered treatment (PCT, mean age 42.5±8.4, 78% men). Patients with two or more positive predictive tests for non-return to work were excluded. The multidisciplinary team providing FCT consisted of five healthcare professionals: a rheumatologist, a physical and occupational therapist trained in ergonomics, a sports therapist, a social worker, and a nurse. This treatment was based on work hardening and functional restoration programs. The duration of treatment was three weeks and 4 hours a day. The main goal was to increase work-related capacity while emphasizing improving self-efficacy. The team providing PCT consisted of three healthcare professionals: a rheumatologist, a physiotherapist, and a nurse. The duration of treatment was three weeks and 2.5 hours a day. The primary goal was pain reduction and the secondary goal was to decrease disability and improve return to work. In both groups, a rheumatologist prescribed medications such as analgesics and nonsteroidal anti-inflammatory drugs.
Outcome measures included number of calendar work days in the follow-up year (assessed by sending questionnaires to the employer) and return to work.
Monticone (2013) performed a randomized superiority-controlled study in which 90 patients with chronic low back pain participated. Patients were randomly assigned to a multidisciplinary program consisting of cognitive-behavior therapy (CBT) and exercise training (n=45, mean age 48.96± 7.97, 40% men) or exercise training alone (n=45, mean age 49.71± 7.01, 44% men). CBT was conducted under the supervision of a clinical psychologist, patients followed weekly CBT sessions (60min), 1x/week for 5 weeks CBT then monthly for 1y. The patients in the control group underwent a multimodal motor program consisting of active and passive mobilizations of the spine, and exercises aimed at stretching and strengthening muscles, and improving postural control. Measurements were assessed at 5 weeks, 12 months, and 24 months after the intervention. Outcome measures included disability (Roland-Morris Disability Questionnaire Scale, ranging from 0-no disability to 24-maximum disability), pain intensity (Neuropathic Pain Scale), HRQOL (SF-36).
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. The comparisons between CBT and APT and between CT and APT are relevant for Comparison 1 (interdisciplinary vs. multidisciplinary care). The comparison between CBT and CT is relevant for Comparison 3 (interdisciplinary care versus other form of interdisciplinary care). 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.
Lera (2009) included 83 patients (mean age 51.1±8.7, no men were included) with fibromyalgia a randomized controlled trial. Both the intervention program (n=43) and the control program (n=40) lasted four months. The multidisciplinary intervention program (MT) consisted of 14 group sessions (1h/wk) for four months, in which 4 sessions were dedicated to physical education by slides and videos (led by rheumatologist and rehabilitation practitioner), and 10 sessions devoted to exercise, reducing fatigue and stiffness (led by physiotherapist). Additionally, the intervention group, participated in the Cognitive Behavior Therapy program. This group-based program consisted of 15 90-minutes sessions, was led by a clinical psychologist, and focused on education on pain processing, training to reduce physiological and mental stress, techniques to improve quality of sleep, promotion of activities to increase mental health, self-esteem, and achievement of objectives, planning and ordering of activities and goals, detection and modification of negative cognitions related with pain, training in coping skills and social assertiveness, and psychosocial support. The control group only received the MT program. Outcome measure is disability as measured with the FIQ total score.
Thieme (2003) performed a randomly controlled trial including 61 women with fibromyalgia. Patients were randomized into an experimental group (n=40; mean age 46.61±8.67) or control group (n=21; mean age 48.51±7.51). Both arms were inpatient programs and started with a four-hours education module delivered by a rheumatologist. The experimental program took place in small (five to seven) groups, daily, over five weeks with a total of 75 hours. The program consisted of education, time contingent intake and reduction of medication, increase body activity, reduction of interference of pain in the family, at work, leisure time and social activities, reduction of pain behaviors in dealing with medical system, training in assertive pain incompatible behavior, role play, and homework. The program was supervised by a psychologist, rheumatologist, physical therapist, and nursing personnel. The control group received a standard medical treatment with physical therapy in open groups in daily sessions over five weeks with a total of 75 hours. Patient received seven types of mainly passive physical therapy exercises (muscle relaxation with thermotherapy, mud bath, concentrated relaxation, light movement therapy in warm water. In addition, patients received antidepressants. Outcome measures were pain intensity and self-efficacy measured with the MPI scales.
Brendbekken (2016, 2017) conducted a randomized controlled trial and included 284 patients with musculoskeletal pain (mean age 41.3; 46% men) into a multidisciplinary intervention or brief intervention (BI). The multidisciplinary intervention program (n=141) was based on the Interdisciplinary Structured Interview with a Visual Educational Tool (ISIVET). After an interview and physical examination the ISIVET-method was used to personalize the rehabilitation plan for every patient and focussed on ‘working conditions’ and ‘quality of life’. Actions in the rehabilitation plan were typically related to the handling of pain and fear avoidance, to lifestyle, particularly physical activity, and to family or work matters. The multidisciplinary intervention program was delivered by a social worker, a physician and a physiotherapist. The control group received a brief intervention (BI) and compromised of two sessions and included consultations with a physician and physiotherapist. The BI program is based on the ‘non-injury model’, emphasizing the lack of any objective signs of injury, and the non-directive communication, included medical examination and explanation/education on musculoskeletal pain, and was supervised by a physician and physiotherapist. The essential feature of this intervention is to give the patient time to express problems, worries and thoughts. Outcome measures were ability (physical function based on the Norwegian Function Assessment Scale; Norfunk), pain (Numeric Rating Scale; NRS), anxiety (Hospital Anxiety and Depression Scale; HADS, and Hopkins Symptom Checklist-25; HSCL-25), depression (HADS and HSCL-25) and return to work at 12 and 24 months.
Nicholas (2013; 2017) conducted a randomized controlled trial including in patients 65 years and older with chronic noncancer pain. The study did not report for which pain indications the patients were included in the study. Patients were randomized into 1) waiting list 2) pain self-management group and 3) exercise-attention control (the latter two are relevant for the current clinical question). The intervention of the pain self-management group (n=49, mean age 74.59 ±5.98, 35% men) was based on the cognitive behavioural pain management skills.
Each participant was given a copy of the self-management text Manage Your Pain and encouraged to read it and to regard it as the manual for the treatment. The psychologist and the physiotherapist were present throughout and actively promoted integration of both aspects (the activities/exercises and the psychological skills), such as using helpful self-talk while performing exercises. The participants in this group were encouraged to perform the exercises and skills during the treatment sessions, as well as at home between sessions. Patients randomized into the exercise attention control (n=53, mean age 72.40 ± 5.5, 30% men) attended on the same time basis (i.e., same number and length of sessions) as the
pain self-management group, and both the clinical psychologist and physiotherapist
were present throughout each session. The exercise component of the sessions was the same as for the PSM group, with practice in each session. However, no encouragement was given for home practice and no home exercise charts were provided. The treatment manual used in the PSM condition was not provided for this group and instead of instruction in
pain self-management strategies, this group was offered open discussions about their pain and its impact on their lives. Outcome measures included pain intensity (NRS), disability (Roland & Morris Disability Questionnaire-Modified), depression (DASS), self-efficacy (PSEQ) measured at one, six and twelve months follow-up.
In a randomized controlled trial from the Netherlands, patients with complex regional pain syndrome type I (CRPS-I) were randomized to exposure in vivo (n=23, mean age 45.83±11.26, 22% men) with pain-contingent treatment as usual (n=23, mean age 43.87 ±11.37, 17% men) (Den Hollander, 2016, 2018). Participants were enrolled by a physiatrist, who examined patients and decided whether to include patients, and provided supervision to the professionals who delivered the intervention. The exposure in vivo treatment specifically aims at improving functional ability through the reduction of the perceived harmfulness of activities and was given in a 17-week schedule by a psychologist and physical or occupational therapist with experience in exposure in vivo. Treatment as usual was a standardized physical therapy treatment aimed at increasing control over pain and optimize coping with CRPS-I and was given in a 17-week schedule by a physical therapist with specific training for the current protocol. Outcome measures included HRQoL (SF-36 Mental Component Score; Physical Component Score) and Neuropathic Pain Scale. Disability was measured by Radboud Skills Questionnaire (RASQ) for upper limb disability and Walking Ability Questionnaire (WAQ) for lower limb disability.
Outcome measures for the cost-effectiveness analysis were HRQoL (SF-36 Physical Component Score) and quality-adjusted life years (QALYs) (SF-36, QALYs were calculated by multiplying the utility based on SF-36 scores with the amount of time a patient spent in this particular health status), assessed at 6 months. A societal viewpoint was used for the cost-effectiveness analysis. Cost measures included intervention costs (calculated based on the 17 hours of treatment each patient received according to the protocol), other healthcare costs, patient and family costs, and productivity losses (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 cost-effective using different cost-effectiveness thresholds.
Table 1.1 Additional study and baseline characteristics and outcomes of included studies (interdisciplinary rehabilitation vs multidisciplinary care)
|
Study |
Study population |
Intervention and Control |
Outcomes |
Remarks |
|
Linden (2014) |
103 German patients with chronic back pain
Inclusion criteria: - back pain for at least six months - referred for inpatient treatment by health or pension insurance because their ability to work is endangered
Exclusion criteria: - at present applying for early retirement
No baseline differences
|
Control group (n=50): All patients were treated as inpatients for 21 days undergoing a general orthopedic inpatient treatment, i.e., they were regularly seen by physicians, got medication as needed and participated on a daily basis in sport therapy and physiotherapy, balneotherapy, massages, or electrotherapy. They also got occupational therapy to support their reintegration in work. There were also general patient education sessions with information on how to understand and cope with the illness. In order to control for unspecific therapeutic attention, they got additional occupational therapy sessions where they played games and were motivated to engage in positive leisure activities.
Intervention group (n=53): In addition to the general orthopedic inpatient treatment, patients got three cognitive behaviour group therapy sessions per week, each 90 minutes. The therapist was a physician with training in CBT. The “cognitive behaviour group therapy for back pain” (CBT-BP) was designed in reference to the GRIP [24,25] and the pain and illness management program from with additional cognitive behavior therapy interventions which aims at stress reduction and problem solving, self monitoring, pain management, change in dysfunctional cognitions, reduction of avoidance behavior, and wellbeing therapy. |
Measurements: VAS-pain three times a day every day of the 21-day program, BDI and SCL were completed before and after treatment (not further specified)
Disability due to pain (PDI; 0-70) Pre: I: 21.43±10.5 / C: 21.80±13.7 Post: I: 19.94±12.1 / C: 21.14±14.8 Interaction: p=0.549
Pain (VAS; 0-10; average across all ratings per patient) Pre: I: 6.04±1.3 / C: 5.86±1.8 Post: I: 3.06±1.6 / C: 4.10±2.2 Interaction: p=0.002
|
Table 2 shows the results in both the intervention and control group. For the intervention group, mean (sd) values are shown. In the column for the control group, instead of ‘mean (sd)’, ‘MW’ is shown. Is this an error or do the numbers reported present something other than mean (sd)?
This paper does not include a paragraph describing the statistical analysis |
|
Mangels (2009) |
363 German patients with chronic low back pain
Inclusion criteria: - musculoskeletal disease (ICD-10 M00- 99) - ability to understand German
Exclusion criteria: - surgeries during the previous 3 months - an intended length of treatment shorter than 3 weeks (eg, owing to hospital or individual reasons) - an unexpectedly short admission process hindering the randomization process
No baseline differences
|
Control group (n=131): The ‘traditional’ orthopedic rehabilitation program included orthopedic care as usual as it is mostly offered in routine healthcare settings. Patients received medical care (including analgetic medication if necessary), physiotherapy, back school, and occupational therapy. The treatment took place in individual sessions or open groups. Further therapeutic elements were massages, electrotherapy, hydrotherapy, thermotherapy, and nutritional and social advice. The participation at a progressive muscle relaxation group was optional. The intended length of this treatment program was 3 weeks.
Intervention group (n=113) In addition to traditional orthopedic rehabilitation, a group for psychologic pain management (according to cognitive behavioural principles) was introduced, which consisted of 9 group sessions of 90 minutes and was conducted by a trained behavioural psychotherapist. Furthermore, patients participated in a progressive muscle relaxation training program and had the opportunity to engage in weekly individual sessions with the psychotherapist. The intended length of treatment was 4 weeks. In contrast to the traditional orthopaedic treatment, the behavioural-medical treatment was less individualized. For the most part, therapies (physiotherapeutic and psychologic) were arranged in groups with a group size from 10 to 12 patients.
Intervention with booster sessions (n=119): After completing the behavioral-medical rehabilitation treatment described above, patients additionally participated in 7 booster sessions, which were conducted by telephone within 12 months after discharge by 2 trained clinical psychologists. The interval between 2 sessions varied from 4 weeks in the beginning to 3 months at the end. Each session lasted 20 minutes on average.
|
Measurements: discharge, at 1-year follow-up
Physical health status (SF12; mean scores 50±10) Pre: I+B: 33.5±9.1 / I: 33.6±7.4 / C: 33.9±8.7 Post: I+B: 38.9±9.4 / I: 39.3±9.9 / 38.6±8.6 12mo: I+B: 38.4±10.4 / I: 38.4±9.7 / C: 38.4±10.1 F value (interaction group*time): 0.24 (p>0.05)
Mental health status (SF12; mean scores 50±10) Pre: I+B: 43.9±12.1 / I: 44.0±11.1 / C: 44.5±11.5 Post: I+B: 48.9±12.1 / I: 50.8±10.5 / C: 50.9±10.5 12mo: I+B: 45.6±11.7 / I: 46.0±11.2 / C: 45.0±11.7 F value (interaction group*time): 0.95 (p>0.05)
Disability due to pain (PDI; 0-70) Pre: I+B: 26.9±13.9 / I: 26.1±11.8 / C: 24.8±12.1 Post: I+B: 21.7±13.3 / I: 20.3±13.9 / C: 21.0±13.1 12mo: I+B: 22.6±16.0 / I: 22.0±14.0 / C: 20.6±13.5 F value (interaction group*time): 1.20 (p>0.05)
Self-efficacy (PSEQ; 0-60) Pre: I+B: 41.3±11.8 / I: 42.1±10.6 / C: 41.2±10.3 Post: I+B: 45.1±10.8 / I: 46.0±10.1 / C: 44.6±9.7 12mo: I+B: 44.3±12.3 / I: 43.2±12.0 / C: 43.2±10.6 F value (interaction group*time): 1.05 (p>0.05)
Depression (BDI; 0-63) Pre: I+B: 11.4±9.8 / I: 11.1±8.2 / C: 10.1±8.1 Post: I+B: 7.2±7.8 / I: 6.7±6.0 / C: 7.8±7.8 12mo: I+B: 10.7±8.8 / I: 10.4±7.8 / C: 11.4±8.2 F value (interaction group*time): 2.57 (p<0.05) F value (TOR vs BMR pre-post): 8.03 (p<0.05) F value (TOR vs BMR pre-follow-up): 3.88 (p>0.05) F value (TOR vs BMR+B pre-post): 7.54 (p<0.05) F value (TOR vs BMR+B pre-follow-up): 3.37 (p>0.05)
|
This study was also included for the comparison between different types of interdisciplinary rehabilitation (BMR+B vs BMR).
The main analysis of overall treatment outcome was performed using 3 (treatment) x 3 (time points) ANOVAs. Group differences were analyzed using post hoc 2 (treatment) x 2 (time points) ANOVAs. |
|
Kool (2007) |
174 Swiss patients with chronic low back pain - between 20 and 55 years of age - primary diagnosis of nonacute (duration, ≥6wks) nonspecific low back pain - at least 6 weeks of sick leave in the previous 6 months
Exclusion criteria: - patients with two or more positive predictive tests for non-return to work were excluded.
|
Intervention (n=87): Function-centered treatment (FCT), the multidisciplinary team consisted of a rheumatologist, a physical and occupational therapist trained in ergonomics, a sports therapist, a social worker, and a nurse. FCT was based on work hardening and functional restoration programs for 4 hours a day. Primary goal: increase work-related capacity while emphasizing improving self-efficacy. The rheumatologist informed patients about the benign character of nonspecific LBP. Treatment was based on the patient’s job demands; revealed in a work-related assessment; and consisted of work simulation, strength, and endurance. Patients were encouraged to continue their activities even if their pain increased.
Control (n=87): Patient centered-treatment, the PCT team consisted of a rheumatologist, a physiotherapist, and a nurse. Primary goal: pain reduction, secondary goal was to decrease disability and improve return to work. The duration of treatment was 3 weeks and 2.5 hours a day. Physical therapy used individually selected mobilization, stretching, strength training, and a 4-hour mini back school with education and exercise. Low-intensity movement therapy in the pool as well as progressive muscle relaxation using systematic contraction and relaxation of specific muscle groups further enhanced relaxation. Passive pain-modulating treatments such as hot packs, electrotherapy, or massage were used daily. In contrast to the FCT group, patients in the PCT group were told to stop activities when pain increased. |
Work days and return to work (1-year follow-up period)
(59.8%) than in the PCT group (41.4%). |
|
|
Monticone (2013) |
90 Italian patients with chronic low back pain (CLBP)
Inclusion criteria: - Diagnosis of nonspecific CLBP (a documented history of pain lasting for >3mo), - Good understanding of Italian, - Aged >18 years.
Exclusion criteria: - Cognitive impairment, - All causes of specific CLBP (previous spinal surgery, deformity, infection, fracture or malignancy, and systemic or neuromuscular diseases), - Patients receiving compensation for work-related disabilities, - Patients who previously participated in a cognitive-behavioural intervention. |
Intervention (n=45): Program consisting of cognitive-behaviour therapy (CBT) and exercise training. 2 physiatrists, a psychologist, and 4 physiotherapists were involved.
Control (n=45): Exercise training alone.
CBT: under the supervision of a clinical psychologist, patients followed weekly CBT sessions (60min), 1x/week for 5 weeks CBT then monthly for 1y.
Exercise training: under supervision of a physiatrist and 2 physiotherapists. Patients followed 60min sessions, 2x/week for 1y. |
HRQOL (SF-36) There was a significant effect in all SF-36 domains in favour of the intervention group, with exception of domain “Physical Role”. Differences are also clinically relevant.
Disability (RMDQ Roland-Morris Disability Questionnaire, range: 0-24) 5wk: I: 5.04±2.04 / C: 11.04±2.27 12mo: I: 1.31±1.59 / C: 11.00±2.00 24mo: I: 1.40±1.19 /C: 11.07±2.22 Time*group: p<0.001.
Pain (NRS) Base: I: 7.02± 1.07 / C: 7.02± 1.30 12mo: I: 1.38±1.07 / C: 5.33±1.22 24mo: I: 1.47±1.10 / C: 6.24±0.85 Time*group: p<0.001.
|
- No LTFU in both groups in 2 years. - Limited generalizability: the intervention cannot be delivered in every setting, a hospital specialized in chronic pain management is required, patients who received financial compensation were excluded. - Questions can be raised concerning differences in contact time between the treatment groups due to the psychological intervention. |
|
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 CBT (n=61): A combination of the APT and CBT 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]) APT vs CT, difference Base: APT: 14.15 ± 3.70 / CT 13.51 ± 3.92 Post: -0.05 (-1.71 to 1.62) 12 mo: 1.16 (-0.52 to 2.84)
APT vs CBT, difference Base: APT: 14.15 ± 3.70 / CBT 13.74 ± 3.65 Post: -0.62 12 mo: -0.46
Pain (100-mm VAS)
Post: -0.18 (-9.34 to 8.99) 12 mo: 8.04 (-1.23 to 17.31)
Base: APT: 51.23 ± 26.55 / CBT: 48.84 ± 23.51
APT vs CBT, difference Post: -5.53 12 mo: -0.84
Depression (Beck Depression Inventory[0 to 63])
APT vs CT, difference Post: 2.17 (0.18–4.17) 12 mo: 1.05 (-0.97 to 3.07)
Base: APT: 10.38 ± 7.62/ CBT: 10.45 ± 7.06
APT vs CBT, difference Post: 0.55 12 mo: 1.15
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]) Baseline APT: 39.3 (6.3) / CBT 39.4 (6.7) / CT 39.6 (6.9)
Mean (SD) improvement from baseline until 12 months APT: 3.21 (4.77) / CT 1.98 (4.55)
CT vs APT, difference (95% CI) 12 months: -1.23 (-3.01 to 0.55)
APT: 3.21 (4) / CBT 3.25 (4.29)
CBT vs APT, difference (95% CI) 12 months: 0.04
Health-related quality of life (EuroQol 5-D QALY) mean (SD) improvement from baseline until 12 months APT: 0.693 (0.228) / CT: 0.679 (0.191)
CT vs APT, difference (95% CI) 12 months: -0.014 (0.094 to 0.066)
APT: 0.693 (0.228) / CBT: 0.723 (0.197)
APT vs CBT, difference (95% CI) 12 months: 0.03
Total costs (in €) 10 weeks of treatment and 52 weeks of follow-up mean (SD) APT: €20,015 (SD 19,675) CBT: €14,794 (SD 17,209) CT: €19,559 (SD 14,708)
CT vs APT, difference (95% CI) -407 (-6987 to 5900)
CBT vs APT, difference (95% CI) -5221 (-5826 to -4616)
CEA (outcome measure RDQ) CT vs APT: to gain one extra point of reduction of RDQ, it costs €371 by offering APT instead of CT 44% probability inferiority of CT 4% probability superiority of CT
CUA (outcome measure QALY) CT vs APT: to gain one extra QALY, it costs €35,060 by offering APT instead of CT 37% probability inferiority of CT 31% 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 CBT and APT approach each other. The cost-effectiveness acceptability curve for QALY showed that CBT is most likely to be cost-effective.
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|
|
Lera (2009) |
83 patients with fibromyalgia, in Spain
Inclusion criteria: -diagnosis of fibromyalgia -being female -not involved in litigation with government regarding disability pensions
Exclusion criteria: -being male -severe depression -psychosis -delusional disorder |
Intervention (n=43): The intervention group received a multidisciplinary program (MT), in combination with Cognitive behavior therapy (CBT). This four-months MT-program consisted of 14 group session (1h/wk) for four months, in which 4 sessions were dedicated to physical education by slides and videos (led by rheumatologist and rehabilitation practitioner), and 10 sessions devoted to exercise, reducing fatigue and stiffness (led by physiotherapist)
Additionally, the intervention group, participated in the CBT-program. This group-based program consisted of 15 90-minutes sessions, was led by a clinical psychologist, and included: -education on pain processing -training to reduce physiological and mental stress -techniques to improve quality of sleep -promotion of activities to increase mental health, self-esteem, and achievement of objectives -planning and ordering of activities and goals -detection and modification of negative cognitions related with pain -training in coping skills and social assertiveness -Psychosocial support
Control (n=40): The control group received the MT-program without CBT. |
FIQ total score Base: I: 59.2 (9.6) / C: 58.4 (10.4) 4mo: I: 53.2 (13.4) / C: 57.2 (11.3) Time*group: p-value=0.99
Loss to follow-up: posttreatment I: 18.6% / C: 22.5%
|
76% of the sample also suffered from fatigue (besides pain)
Only women included in the sample
Not all outcome measures were assessed at the 6mo follow-up. Such as the SCL-90-R
High loss to posttreatment follow-up of I: 18.6% / C: 22.5%. loss to follow-up at 6mo: I: 30.2% / C: 35%
Subscores for anxiety and depression as part of the SF-36 and FIQ were not reported |
|
Thieme (2003)
|
61 female patients with fibromyalgia syndrome (FMS), in Germany
Inclusion criteria: -diagnosed with FMS
Exclusion criteria: -Inflammatory cause of the pain -neurologic complications -duration pain < 4mo -pregnancy -other severe disease, e.g. tumor, liver, renal disease -major psychiatric disorders -problems with German language
|
Intervention (n=40): The (inpatient) intervention program (OTG) took place in small (5-7) groups. Daily sessions over 5 weeks with a total of 71 hours.
The program started with a 4-hours education module delivered by a rheumatologist. The program further comprised: -time contingent intake and reduction of medication -increase body activity -reduction of interference of pain in the family, work, leisure time and social activities -reduction of pain behaviors in dealing with medical system -training in assertive pain incompatible behavior -role play -homework Under supervision of psychologist, rheumatologist, physical therapist, nursing personnel
Control (n=21) The (inpatient) control group received a standard medical treatment with physical therapy (PTG) (open groups). Daily sessions over 5 weeks with a total of 71 hours.
The program started with a 4-hours education module delivered by a rheumatologist. Patient received 7 types of mainly passive physical therapy exercises (muscle relaxation with thermotherapy, mud bath, concentrated relaxation, light movement therapy in warm water -use of antidepressants |
Multidimensional Pain Inventory: Self efficacy Base I: 3.05 (1.53) / C: 2.66 (1.46) Post I: 3.67 (0.73) / C: 1.76 (1.14) 6mo I: 3.75 (1.27) / C: 1.90 (1.09) 15mo I: 4.07 (0.92) / C: 1.41 (0.93) t0-post, t-6mo, t0-15mo: alle ES >0.7
Multidimensional Pain Inventory: Pain intensity Base I: 4.43 (0.98) / C: 4.34 (1.11) Post I: 3.82 (0.96) / C: 5.47 (1.06) 6mo I: 3.66 (1.22) / C: 4.85 (0.86) 15mo I: 3.18 (1.27) / C: 5.28 (0.83)
Loss to follow-up: Posttreatment I: 3% / C: 0%.
|
All participants were women
The two treatments were not provided at the same time Both arms were inpatient programs which seems to be the exception in most countries à generalizability? |
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Brendbekken (2016, 2017) |
284 patients with musculoskeletal pain, in Norway
Inclusion criteria: -Age 20 – 60 yo -at least 50% employed
Exclusion criteria: -pregnancy -current cancer -osteoporosis -recent physical trauma/injury -serious mental illness -rheumatic inflammatory diseases -not capable of understanding and speaking Norwegian -involved in an on-going health insurance claim |
Intervention (n=141): The MI-program was based on the Interdisciplinary Structured Interview with a Visual Educational Tool (ISIVET). After an interview and physical examination the ISIVET-method was used to personalize the rehabilitation plan for every patient and focussed on ‘working conditions’ and ‘quality of life’. This program was delivered by a social worker, a physician and a physiotherapist.
Control (n=143): The control group received a Brief Intervention (BI) and compromised two sessions and included consultations with a physician and physiotherapist. The BI program is based on the ‘non-injury model’, emphasizing the lack of any objective signs of injury, and the non-directive communication, included medical examination and explanation/education on musculoskeletal pain, and was supervised by a physician and physiotherapist. |
Ability (physical function with Norwegian Function Assessment Scale; Norfunk [0-3]) Base: I: 1.44 (0.28) / C: 1.44 (0.30) 12mo I: 1.32 (0.34) / C: 1.30 (0.29)
Pain Numeric Rating Scale (NRS) “Both groups had reduction in their average pain levels during the follow-up, but there were no significant differences between the groups at 3 or 12 months on pain by activity or back pain (results not shown).”
Anxiety (Hospital Anxiety and Depression Scale; HADS [0-21]) 3mo I: 4.82 (3.34) / C: 5.74 (4.12) 12mo I: 4.53 (4.25) / C: 4.78 (4.08) Time*group: p-value= 0.02
Depression (Hospital Anxiety and Depression Scale; HADS [0-21]) Base: I: 4.58 (3.42) / C: 4.50 (3.55) 3mo I: 3.83 (3.35) / C: 4.86 (4.11) 12mo I: 3.71 (3.85) / C: 3.99 (3.65)
Loss to follow-up was 3mo I: 20.6% / C: 33.6. 12mo I: 39.7% / C: 39.2%.
Fully return to work 12 months: I 44.7% ; C 44.8% 24 months: 42.6%; C 36.6%
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Nicholas (2013, 2017) |
102 patients with chronic pain
Inclusion criteria: range short-term memory functioning)
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Intervention (n=49) behavioural pain management skills. Each participant was given a copy of the self-management text Manage Your Pain and encouraged to read it and to regard it as the manual for the treatment. The psychologist and the physiotherapist were present throughout and actively promoted integration of both aspects (the activities/exercises and the psychological skills), such as using helpful self-talk while performing exercises. All participants were encouraged to perform the exercises and skills during the treatment sessions, as well as at home between sessions. Specific skills taught included: setting specific, functional (and realistic) goals that were meaningful to the participant, activity pacing, etc. The exercises taught included stretching, aerobic, and strengthening. Functional tasks included repetitions of step-ups and walking. The appropriate use of medication for pain was discussed in one session, but medication reduction was not a goal.
Control (n=53) same time basis (i.e., same number and length of sessions) as the PSM group, and both the clinical psychologist and physiotherapist were present throughout each session. The exercise component of the sessions was the same as for the PSM group, with practice in each session. However, no encouragement was given for home practice and no home exercise charts were provided. If participants chose to practice their exercises at home, that was left up to them, but it was not reinforced with praise or other forms of attention by the treatment team. The treatment manual used in the PSM condition was not provided for this group and instead of instruction in pain self-management strategies, this group was offered open discussions about their pain and its impact on their lives. These discussions were led by the clinical psychologist and were intended to provide a form of control for the attention provided by the clinical psychologist in the PSM condition. The clinical psychologist offered participants the opportunity to discuss their experiences of living with chronic pain, but was reflective rather than directive in approach. |
Disability (RMDQ) 1mo: I 9.86 (4.93); C 12.21 (4.93) 12mo: I 10.84 (5.90); C 12.18 (5.59) ES: 0.37 (-0.04 to 0.77) Proportion of >3points change from base-12mo: Not statistically significant
Self-efficacy (PSEQ) ES: -0.06 (-0.46 to 0.35)
Pain intensity (NRS)
Depression (DASS) 1mo: I 9.86 (4.93); C 12.21 (4.93);
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Den Hollander (2016, 2018) |
46 patients with Complex regional pain syndrome type I, based on Association for the Study of Pain Orlando criteria. Except for 5 patient (I:3, I:2) the participants also met the more stringent Budapest criteria.
Inclusion criteria: -Adult CRPS-I (physiatrist confirmed based on Orlando criteria) patients reporting substantial pain-related disability despite former treatment were included.
Exclusion criteria: -insufficient comprehension of Dutch language were excluded. |
Intervention group (n=23): Included cognitive–behavioral analysis of complaints (pain and its consequences), identifying movements/activities that are threatening using PHODA, education, : exposure with behavioral experiments; systematic and repeated exposure to feared movements, activities and/or sensations. Catastrophic interpretations regarding these stimuli are challenged and corrected, to lower the threat value of these stimuli.
Control group (n=23): Treatment as usual. Analysis of pain and complaints, establish the current level of control over pain (low-moderate-high) and explanation of treatment rationale. Depending on the level of control over pain: -Connective tissue massage -Transcutaneous electric nerve stimulation -Exercises aiming at pain reduction (stimulation of kinetic receptors type I and II) -Improving skills by practicing compensatory strategies -Training skills and instructions about body position |
Pretreatment to posttreatment Reported results are group differences
SF-36-Physical Component Scale (100-0) Pre-post: -25.93 (235.91 to 215.92) p-value<0.001*
SF-36-Mental Component Scale (100-0)
Radboud Skills Questionnaire (SD) [scores 0-5] -indicating upper limb disability Walking Ability Questionnaire (0-10) – indicating lower limb disability Pre-post: 3.06 (20.02 to 6.13) not significant after multiple testing correction
Neuropathic Pain Scale (0-10)_
For the cost-effectiveness analysis, data from 38 patients was included (I n=19, C n=19) Outcomes were HRQoL (SF-36) (for the CEA) and quality-adjusted life years (for the CUA)
SF-36 Physical Component Scale (100-0) 6 months: I: 66.93 (23.36) / C: 45.91 (22.68) Mean difference: 21.02 (5.08 to 36.17) P=0.008
QALY 6 months: I: 0.62 (0.07) / 0.55 (0.10) Mean difference: 0.07 (0.02 to 0.13) p=0.011
Total costs (in €) treatment and 6 months of follow-up mean (SD) I: €3178.09 (758.69) C: € 4220.89 (635.05)
CEA (outcome measure SF-36) EXP resulted in a larger health benefit than PPT and although treatment costs for EXP were higher than for PPT the total societal costs six months after treatment clearly favored EXP. 94.5% probability of EXP being superior to PPT (more effective at lower costs) To gain 1 additional unit on the SF-36 PCS, it does not matter if the highest (€80,000) or lowest (€16,000) threshold value is chosen: EXP is more cost-effective than PPT.
CUA (outcome measure QALY) EXP resulted in a greater health benefit than PPT. 95.1% probability of EXP being superior to PPT (more effective at lower costs) The probability of the intervention being cost-effective ranges between 95 percent and 98 percent, depending on the threshold value of €16,000 and €80,000, respectively.
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Table 1.2: Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)
Research question: What is the effectiveness of interdisciplinary rehabilitation compared to multidisciplinary rehabilitation in adult patients with musculoskeletal chronic pain?
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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 |
|
Linden (2014) |
No information;
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No information;
|
Definitely no;
Reason: After randomization 3 patients withdrew their consent because they were disappointed that they were not allocated to the special treatment. Limitations of the study are that such psychotherapy studies can not be done blinded, inspite of the control group. Patients of the intervention group know what therapists expect from them and this could also show up in the ratings. |
Probably yes;
Reason: One patient had for other reasons to end the inpatient stay early, so that he only participated in two sessions. He was counted as drop out. In Table 2 data are reported for all 103 patients. |
Probably yes;
Reason: all outcomes described in the Methods section are reported, no trial registration or study protocol available. |
Table 2 shows the results in both the intervention and control group. For the intervention group, mean (sd) values are shown. In the column for the control group, instead of ‘mean (sd)’, ‘MW’ is shown. Is this an error or do the numbers reported present something other than mean (sd)?
This paper does not include a paragraph describing the statistical analysis
|
HIGH (pain, disability, mental health) |
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Mangels (2009) |
Probably no;
Reason: Randomization was carried out by an administration secretary of the rehabilitation hospital who received random numbers from the study center. No further details about how these random numbers were generated and groups were unequal sizes (I: 113 / I+B: 119/ C:131) |
Definitely yes;
Reason: Randomization was carried out by an administration secretary of the rehabilitation hospital who received random numbers from the study center, and who was not involved in further treatment decisions. Therefore, treatment was allocated in a blind way. A list of a random sequence was prepared at the beginning of the study specifying the sequence of the 3 treatment conditions; subsequent patients fulfilling the inclusion criteria were allocated to the condition indicated on the list. |
Definitely no;
Reason: patients were not blinded and statistical analyses were not performed blind to treatment condition |
Probably yes;
Reason: drop out was low and comparable between the groups (6 or 7%) |
Probably yes;
Reason: all outcomes described in the Methods section are reported, no trial registration or study protocol available. |
Probably no;
Reason: For the behavioral-medical condition with subsequent booster sessions, 8 patients refused to participate in this aftercare treatment program before commencement; they were, however, willing to participate at follow-up assessment. Reasons for refusal were having no time or no need for further support. Six patients dropped out after the first or second session owing to the same reasons as described above.
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Some concerns
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Kool (2007) |
No information; |
No information; |
Probably no;
Reason: Patients and health care providers not blinded. Patients could not be blinded to treatment, but they received no detailed information about the difference between the 2 treatments. Outcome assessors were blinded.
|
Probably yes;
Reason: 82/87 (94%) patients included in analysis for FCT, 84/87 (97%) patients included in analysis for PCT |
Probably yes;
Reason: all outcomes described in the Methods section are reported, no trial registration or study protocol available. |
Probably yes; |
Some concerns |
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Monticone (2013) |
Definitely yes;
A list previously generated by a biostatistician (SAS PROC PLAN) |
No information; |
Probably yes;
Reasons: To limit any expectation bias, the patients were blinded to the hypothesis of the study by telling them that the trial was intended to compare 2 common approaches to CLBP rehabilitation, the efficacy of which had not yet been established. The Principal Investigator obtaining and assessing the outcome data, and the biostatisticians making the analyses, were all blinded to the treatments. For obvious reasons, the physiatrists, psychologist, and physiotherapists could not be blinded.
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Definitely yes;
Reasons: no loss to follow up |
Probably yes;
Reason: all outcomes described in the Methods section are reported, no trial registration or study protocol available. |
Probably yes; |
LOW |
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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.
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LOW (disability, pain, depression) |
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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) |
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Lera (2009) |
Definitely yes;
Reason: randomization was done by flip of a coin |
No information; |
Probably yes;
Reason: All efforts were made to maintain participants as blind as possible to the contents of the other treatment.
(some) outcomes were assessed by blinded assessor.
No information regarding blinding of evaluators |
Probably no;
Reason: Loss to posttreatment follow-up was considerable I: 18.6% / C: 22.5%. Unclear ITT results. |
Probably no;
Reason: only two domains of the SF-36 were reported, despite description in the method section. |
Probably no;
Reason: limited analyses at 6mo. Age and one of the two domains of SF-36 different at baseline |
Some concerns |
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Thieme (2003)
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No information;
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No information;
|
Probably no;
Reason: no information on blinding of patients/evaluators/therapists |
Definitely yes;
Reason: very low dropout rate |
Definitely yes;
Reason: All relevant outcomes were reported |
Probably yes;
Reason: the two treatments were not provided simultaneously (but corrected for) |
Some concerns
Note: OTG and PTG teams were composed of different personnel to prevent experimenter bias |
|
Brendbekken (2016, 2017) |
Definitely yes;
Reason: randomization done according to a computer-generated randomization list set-up by a statistician |
Definitely yes;
Reason: randomization was concealed. A research assistant, not involved in the treatment, informed the research institute about which treatment the patient should receive. |
Definitely no;
Reason: there was no blinding to treatment of therapists or participants |
Definitely no;
Reason: high loss to follow-up. Also dropout imbalance during intervention period and follow-up measurement.
on baseline, non-responders scored significantly lower on depression (HSCL) than responders.
|
Probably no;
Reason: pain was not fully reported at follow-up |
Probably yes;
Reason: The BI group had fewer and more experienced therapists compared to the MI group |
HIGH
depression (HSCL): Non-responders scored significantly lower on depression (HSCL) than responders.
pain: outcome measure ‘pain’ was not fully reported at follow-up |
|
Nicholas (2013, 2017) |
No information |
Probably yes; |
Probably no;
Outcome assessor was blinded. Treatment team not blinded. Patients not described. |
Probably no;
25% dropout at 12mo. Noncompleters scored higher on pain, depression, and catastrophising measures at the start of the study compared to those who completed the study |
Probably yes; |
Probably no; |
Some concerns |
|
Den Hollander (2016, 2018) |
Definitely yes;
Reason: A computerized “adaptive biased urn randomization” was used to generate a randomization schedule,with parallel assignment in a 1:1 ratio, prestratifying by gender, affected extremity (upper, lower, both upper and lower), and pain-related fear level (PHODA score #58 and .58), resulting in 8 strata
|
Probably yes;
A predetermined and computer-generated randomization schedule, only accessible by one researcher, was used to allocate participants to EXP or PPT. Participants were informed about the allocated treatment during the first treatment session.
|
Probably no;
Reasons: The content of allocated treatment was revealed in the first treatment session, the content of the other treatment remained unaddressed. Research assistants were not informed about treatment assignment. Their coordinating role in receiving data (audiotapes, planning of measurements) made it practically impossible to keep them fully blinded. Because all questionnaires were completed electronically using the online platform EMIUM25 in the patients’ home setting, this could not have affected outcomes. |
Probably yes;
Reasons: Eight participants (3 EXP, 5 TAU) did not complete treatment protocol; they were requested to complete further measurements, but only 3 (all TAU) continued testing, resulting in 38 postmeasurements (19 EXP, 19 TAU). At 6-month follow-up, 35 participants (18 EXP, 17 TAU) completed the measurements.
|
Definitely yes;
Reason: all outcomes described in the Methods section are reported |
6 TAU participants crossed over to EXP because they were dissatisfied with treatment results and requested further rehabilitation treatment during the consultation with their physiatrist |
Some concerns |
|
Probably no;
For the cost-effectiveness analysis: 19/23 patients (83%) from each group analysed |
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 potential issues with randomisation and allocation); heterogeneity (-1; inconsistency between studies); and number of included patients (-1; imprecision).
Disability
The level of evidence regarding the outcome measure disability was downgraded by three levels because of study limitations (-1; risk of bias because of potential issues with randomisation and allocation, lack of blinding, loss to follow-up); heterogeneity (-1; inconsistency between studies); and number of included patients (-1; 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 potential issues with randomisation and allocation, lack of blinding, loss to follow-up); heterogeneity (-1; inconsistency between studies); and number of included patients (-1; imprecision).
Pain
The level of evidence regarding the outcome measure pain was downgraded by two levels because of study limitations (-1; risk of bias because of potential issues with randomisation and allocation, lack of blinding, loss to follow-up); and number of included patients (-1; imprecision).
Anxiety
The level of evidence regarding the outcome measure anxiety 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).
Depression
The level of evidence regarding the outcome measure depression was downgraded by three levels because of study limitations (-1; risk of bias because of potential issues with randomisation and allocation, lack of blinding, (selective) loss to follow-up); and number of included patients (-1; imprecision).
Cost-effectiveness
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).
Work participation
The level of evidence regarding the outcome measure work participation was downgraded by three levels because of study limitations (-1; risk of bias because of potential issues with randomisation and allocation, lack of blinding, loss to follow-up); heterogeneity (-1; inconsistency between studies); and number of included patients (-1; imprecision).
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
- Brendbekken R, Eriksen HR, Grasdal A, Harris A, Hagen EM, Tangen T. Return to Work in Patients with Chronic Musculoskeletal Pain: Multidisciplinary Intervention Versus Brief Intervention: A Randomized Clinical Trial. J Occup Rehabil. 2017 Mar;27(1):82-91. doi: 10.1007/s10926-016-9634-5. PMID: 26910406; PMCID: PMC5306180.
- Brendbekken R, Harris A, Ursin H, Eriksen HR, Tangen T. Multidisciplinary Intervention in Patients with Musculoskeletal Pain: a Randomized Clinical Trial. Int J Behav Med. 2016 Feb;23(1):1-11. doi: 10.1007/s12529-015-9486-y. PMID: 25920707; PMCID: PMC4747998.
- den Hollander M, Goossens M, de Jong J, Ruijgrok J, Oosterhof J, Onghena P, Smeets R, Vlaeyen JWS. Expose or protect? A randomized controlled trial of exposure in vivo vs pain-contingent treatment as usual in patients with complex regional pain syndrome type 1. Pain. 2016 Oct;157(10):2318-2329. doi: 10.1097/j.pain.0000000000000651. PMID: 27429174.
- den Hollander M, Heijnders N, de Jong JR, Vlaeyen JWS, Smeets RJEM, Goossens MEJB. EXPOSURE IN VIVO VERSUS PAIN-CONTINGENT PHYSICAL THERAPY IN COMPLEX REGIONAL PAIN SYNDROME TYPE I: A COST-EFFECTIVENESS ANALYSIS. Int J Technol Assess Health Care. 2018 Jan;34(4):400-409. doi: 10.1017/S0266462318000429. Epub 2018 Jul 26. PMID: 30047357.
- Kool J, Bachmann S, Oesch P, Knuesel O, Ambergen T, de Bie R, van den Brandt P. Function-centered rehabilitation increases work days in patients with nonacute nonspecific low back pain: 1-year results from a randomized controlled trial. Arch Phys Med Rehabil. 2007 Sep;88(9):1089-94. doi: 10.1016/j.apmr.2007.05.022. PMID: 17826451.
- Lera S, Gelman SM, López MJ, Abenoza M, Zorrilla JG, Castro-Fornieles J, Salamero M. Multidisciplinary treatment of fibromyalgia: does cognitive behavior therapy increase the response to treatment? J Psychosom Res. 2009 Nov;67(5):433-41. doi: 10.1016/j.jpsychores.2009.01.012. Epub 2009 Mar 6. PMID: 19837206.
- Linden M, Scherbe S, Cicholas B. Randomized controlled trial on the effectiveness of cognitive behavior group therapy in chronic back pain patients. J Back Musculoskelet Rehabil. 2014;27(4):563-8. doi: 10.3233/BMR-140518. PMID: 25096315.
- Mangels M, Schwarz S, Worringen U, Holme M, Rief W. Evaluation of a behavioral-medical inpatient rehabilitation treatment including booster sessions: a randomized controlled study. Clin J Pain. 2009 Jun;25(5):356-64. doi: 10.1097/AJP.0b013e3181925791. PMID: 19454868.
- Monticone M, Ferrante S, Rocca B, Baiardi P, Dal Farra F, Foti C. Effect of a long-lasting multidisciplinary program on disability and fear-avoidance behaviors in patients with chronic low back pain: results of a randomized controlled trial. Clin J Pain. 2013 Nov;29(11):929-38. doi: 10.1097/AJP.0b013e31827fef7e. Erratum in: Clin J Pain. 2021 Mar 1;37(3):249. PMID: 23328343.
- Morley S, Williams A, Eccleston C. Examining the evidence about psychological treatments for chronic pain: time for a paradigm shift? Pain. 2013 Oct;154(10):1929-1931. doi: 10.1016/j.pain.2013.05.049. Epub 2013 Jun 3. PMID: 23742793.
- Nicholas MK, Asghari A, Blyth FM, Wood BM, Murray R, McCabe R, Brnabic A, Beeston L, Corbett M, Sherrington C, Overton S. Self-management intervention for chronic pain in older adults: a randomised controlled trial. Pain. 2013 Jun;154(6):824-35. doi: 10.1016/j.pain.2013.02.009. Epub 2013 Feb 26. PMID: 23522927.
- Nicholas MK, Asghari A, Blyth FM, Wood BM, Murray R, McCabe R, Brnabic A, Beeston L, Corbett M, Sherrington C, Overton S. Long-term outcomes from training in self-management of chronic pain in an elderly population: a randomized controlled trial. Pain. 2017 Jan;158(1):86-95. doi: 10.1097/j.pain.0000000000000729. PMID: 27682207.
- 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.
- Thieme K, Gromnica-Ihle E, Flor H. Operant behavioral treatment of fibromyalgia: a controlled study. Arthritis Rheum. 2003 Jun 15;49(3):314-20. doi: 10.1002/art.11124. PMID: 12794785.
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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