Rob A. de Bie

The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus.

Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of randomized clinical trials (RCTs). The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently, we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, an analysis, and a feedback report. The feedback report included staff team decisions made on the basis of the analysis and their justification. A total of 33 international experts agreed to participate, of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to 9 items in three Delphi rounds. The final criteria list (the Delphi list) was satisfactory to all participants. It is a starting point on the way to a minimum reference standard for RCTs on many different research topics. This list is not intended to replace, but rather to be used alongside, existing criteria lists.

Injection Therapy for Subacute and Chronic Low Back Pain : An Updated Cochrane Review

Study Design. A systematic review of randomized controlled trials (RCTs). Objective. To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain. Summary of Background Data. The effectiveness of injection therapy for low back pain is still debatable. Heterogeneity of target tissue, pharmacological agent, and dosage, generally found in RCTs, point to the need for clinically valid comparisons in a literature synthesis. Methods. We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases up to March 2007 for relevant trials reported in English, French, German, Dutch, and Nordic languages. We also screened references from trials identified. RCTs on the effects of injection therapy involving epidural, facet, or local sites for subacute or chronic low back pain were included. Studies that compared the effects of intradiscal injections, prolotherapy, or ozone therapy with other treatments were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. Results. Eighteen trials (1179 participants) were included in this review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender-and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics, and a variety of other drugs. The methodologic quality of the trials was limited with 10 of 18 trials rated as having a high methodologic quality. Statistical pooling was not possible because of clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. Conclusion. There is insufficient evidence to support the use of injection therapy in subacute and chronic lowback pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.

Etiology and prognosis of pregnancy-related pelvic girdle pain; design of a longitudinal study

BackgroundAbsence of knowledge of pregnancy-related pelvic girdle pain (PPGP) has prompted the start of a large cohort study in the Netherlands. The objective of this study was to investigate the prevalence and incidence of PPGP, to identify risk factors involved in the onset and to determine the prognosis of pregnancy-related pelvic girdle pain.Methods/design7,526 pregnant women of the southeast of the Netherlands participated in a prospective cohort study. During a 2-year period, they were recruited by midwives and gynecologists at 14 weeks of pregnancy. Participants completed a questionnaire at baseline, at 30 weeks of pregnancy, at 2 weeks after delivery, at 6 months after delivery and at 1 year after delivery. The study uses extensive questionnaires with questions ranging from physical complaints, limitations in activities, restriction in participation, work situation, demographics, lifestyle, pregnancy-related factors and psychosocial factors.DiscussionThis large-scale prospective cohort study will provide reliable insights in incidence, prevalence and factors related to etiology and prognosis of pregnancy-related pelvic girdle pain.

The art of quality assessment of RCTs included in systematic reviews

The best evidence on the efficacy of medical interventions is provided by high-quality trials summarized in high-quality systematic reviews or meta-analyses. The methodological quality of studies included in a systematic review can have a substantial impact on the estimates of the treatment effect and therefore on the conclusions of such a review. But what is the empirical evidence to support quality assessment of randomized clinical trials (RCTs)? We elaborate on questions such as: what is the concept of quality of individual studies (RCTs), can quality be measured validly and reliably? Plans for future research on this issue are proposed.

ICF Core Sets for low back pain

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for low back pain. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS The preliminary studies identified a set of 503 ICF categories at the second, third and fourth ICF levels with 211 categories on body functions, 47 on body structures, 190 on activities and participation and 55 on environmental factors. Eighteen experts from 15 different countries attended the consensus conference on low back pain. Altogether 78 second-level categories were included in the Comprehensive ICF Core Set with 19 categories from the component body functions, 5 from body structures, 29 from activities and participation and 25 from environmental factors. The Brief ICF Core Set included a total of 35 second-level categories with 10 on body functions, 3 on body structures, 12 on activities and participation and 10 on environmental factors. CONCLUSION A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for low back pain. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Pain-related fear and daily functioning in patients with osteoarthritis.

&NA; There is growing evidence supporting the relationship between pain‐related fear and functional disability in chronic musculoskeletal pain conditions. In osteoarthritis (OA) patients the role of pain‐related fear and avoidance has received little research attention so far. The present study investigates the degree to which pain‐related fear, measured with the Tampa Scale for Kinesiophobia (TSK), influences daily functioning in OA patients. The purpose of the present paper was twofold: (1) to investigate the factor structure of the TSK in a sample of OA patients by means of confirmatory factor analysis; and (2) to investigate the role of pain‐related fear in OA compared to other factors, such as radiological findings and level of pain intensity. The results show that TSK consists of two factors, called ‘activity avoidance’ and ‘somatic focus’, which is in line with other studies in low back pain and fibromyalgia. Furthermore, pain‐related fear occurred to a considerable extent in this sample of osteoarthritis patients and was negatively associated with daily functioning. Level of pain and level of pain‐related fear were significantly associated with functional limitations. Radiological findings were not significant predictors and when compared to pain‐related fear they were not significant. These findings underscore the importance of pain‐related fear in daily functioning of OA patients. Therefore, treatment strategies aiming at reduction of pain‐related fear in OA patients need to be developed and investigated.

Effectiveness of exercise therapy and manual mobilisation in acute ankle sprain and functional instability: A systematic review

This study critically reviews the effectiveness of exercise therapy and manual mobilisation in acute ankle sprains and functional instability by conducting a systematic review of randomised controlled trials. Trials were searched electronically and manually from 1966 to March 2005. Randomised controlled trials that evaluated exercise therapy or manual mobilisation of the ankle joint with at least one clinically relevant outcome measure were included. Internal validity of the studies was independently assessed by two reviewers. When applicable, relative risk (RR) or standardised mean differences (SMD) were calculated for individual and pooled data. In total 17 studies were included. In thirteen studies the intervention included exercise therapy and in four studies the effects of manual mobilisation of the ankle joint was evaluated. Average internal validity score of the studies was 3.1 (range 1 to 7) on a 10-point scale. Exercise therapy was effective in reducing the risk of recurrent sprains after acute ankle sprain: RR 0.37 (95% CI 0.18 to 0.74), and with functional instability: RR 0.38 (95% CI 0.23 to 0.62). No effects of exercise therapy were found on postural sway in patients with functional instability: SMD: 0.38 (95% CI -0.15 to 0.91). Four studies demonstrated an initial positive effect of different modes of manual mobilisation on dorsiflexion range of motion. It is likely that exercise therapy, including the use of a wobble board, is effective in the prevention of recurrent ankle sprains. Manual mobilisation has an (initial) effect on dorsiflexion range of motion, but the clinical relevance of these findings for physiotherapy practice may be limited.

Strength training alone, exercise therapy alone, and exercise therapy with passive manual mobilisation each reduce pain and disability in people with knee osteoarthritis: a systematic review

QUESTION What are the effects of strength training alone, exercise therapy alone, and exercise with additional passive manual mobilisation on pain and function in people with knee osteoarthritis compared to control? What are the effects of these interventions relative to each other? DESIGN A meta-analysis of randomised controlled trials. PARTICIPANTS Adults with osteoarthritis of the knee. INTERVENTION TYPES: Strength training alone, exercise therapy alone (combination of strength training with active range of motion exercises and aerobic activity), or exercise with additional passive manual mobilisation, versus any non-exercise control. Comparisons between the three interventions were also sought. OUTCOME MEASURES The primary outcome measures were pain and physical function. RESULTS 12 trials compared one of the interventions against control. The effect size on pain was 0.38 (95% CI 0.23 to 0.54) for strength training, 0.34 (95% CI 0.19 to 0.49) for exercise, and 0.69 (95% CI 0.42 to 0.96) for exercise plus manual mobilisation. Each intervention also improved physical function significantly. No randomised comparisons of the three interventions were identified. However, meta-regression indicated that exercise plus manual mobilisations improved pain significantly more than exercise alone (p = 0.03). The remaining comparisons between the three interventions for pain and physical function were not significant. CONCLUSION Exercise therapy plus manual mobilisation showed a moderate effect size on pain compared to the small effect sizes for strength training or exercise therapy alone. To achieve better pain relief in patients with knee osteoarthritis physiotherapists or manual therapists might consider adding manual mobilisation to optimise supervised active exercise programs.

Systematic reviews on the basis of methodological criteria

Summary This paper describes a method of systematic reviewing. This method puts much emphasis on the methodological quality of the randomised clinical trials involved. Various items concerning the internal validity, precision and relevance of the studies are scored in such a way that next to the methodological quality the amount of uncertainty about it also becomes visible. These quality assessments are not only useful for systematic reviews, but also have an educational function for researchers with respect to the design and publication of a clinical trial.

Segmental stabilizing exercises and low back pain. What is the evidence? A systematic review of randomized controlled trials

Study design: A systematic review of randomized controlled trials. Objectives: To evaluate the effectiveness of segmental stabilizing exercises for acute, subacute and chronic low back pain with regard to pain, recurrence of pain, disability and return to work. Methods: MEDLINE, EMBASE, CINAHL, Cochrane Controlled Trials Register, PEDro and article reference lists were searched from 1988 onward. Randomized controlled trials with segmental stabilizing exercises for adult low back pain patients were included. Four comparisons were foreseen: (1) effectiveness of segmental stabilizing exercises versus treatment by general practitioner (GP); (2) effectiveness of segmental stabilizing exercises versus other physiotherapy treatment; (3) effectiveness of segmental stabilizing exercises combined with other physiotherapy treatment versus treatment by GP and (4) effectiveness of segmental stabilizing exercises combined with other physiotherapy treatment versus other physiotherapy treatment. Results: Seven trials were included. For acute low back pain, segmental stabilizing exercises are equally effective in reducing short-term disability and pain and more effective in reducing long-term recurrence of low back pain than treatment by GP. For chronic low back pain, segmental stabilizing exercises are, in the short and long term, more effective than GP treatment and may be as effective as other physiotherapy treatments in reducing disability and pain. There is limited evidence that segmental stabilizing exercises additional to other physiotherapy treatment are equally effective for pain and more effective concerning disability than other physiotherapy treatments alone. There is no evidence concerning subacute low back pain. Conclusion: For low back pain, segmental stabilizing exercises are more effective than treatment by GP but they are not more effective than other physiotherapy interventions.