Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and ...non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (≥18 years) population with chronic (≥12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (
n
= 37), back school (
n
= 5), TENS (
n
= 6), low level laser therapy (
n
= 3), behavioural treatment (
n
= 21), patient education (
n
= 1), traction (
n
= 1), and multidisciplinary treatment (
n
= 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP.
What you need to know: The recommendations apply to patients under 60 years old with patent foramen ovale (PFO) who have had a cryptogenic ischaemic stroke, when extensive workup for other ...aetiologies of stroke is negative; For patients who are open to all options, we make a weak recommendation for PFO closure plus antiplatelet therapy rather than anticoagulant therapy; For patients in whom anticoagulation is contraindicated or declined, we make a strong recommendation for PFO closure plus antiplatelet therapy versus antiplatelet therapy alone; For patients in whom closure is contraindicated or declined, we make a weak recommendation for anticoagulant therapy rather than antiplatelet therapy; Further research may alter the recommendations that involve anticoagulant therapy. Options for the secondary prevention of stroke in patients younger than 60 years who have had a cryptogenic ischaemic stroke thought to be secondary to patent foramen ovale (PFO) include PFO closure (with antiplatelet therapy), antiplatelet therapy alone, or anticoagulants. International guidance and practice differ on which option is preferable. The BMJ Rapid Recommendations panel used a linked systematic review1 triggered by three large randomised trials published in September 2017 that suggested PFO closure might reduce the risk of ischaemic stroke more than alternatives.234 The panel felt that the studies, when considered in the context of the full body of evidence, might change current clinical practice.5 The linked systematic review finds that PFO closure prevents recurrent stroke relative to antiplatelet therapy, but possibly not relative to anticoagulants, and is associated with procedural complications and persistent atrial fibrillation.1 The review also presents evidence regarding the role of anticoagulants or antiplatelet therapy when PFO closure is not acceptable or is contraindicated.
Does low intensity pulsed ultrasound (LIPUS) accelerate recovery in adults and children who have experienced bone fractures or osteotomy (cutting of a bone)? An expert panel rapidly produced these ...recommendations based on a linked systematic review triggered by a large multicentre randomised trial in adults with tibial fracture.
Shoulder pain is common in primary care, and has an unfavourable outcome in many patients. Information on the costs associated with health care use and loss of productivity in patients with shoulder ...pain is very scarce. The objective of this study was to determine shoulder pain related costs during the 6 months after first consultation in general practice
A prospective cohort study consisting of 587 patients with a new episode of shoulder pain was conducted with a follow-up period of 6 months. Data on costs were collected by means of a cost diary during 6 months.
84% of the patients completed all cost diaries. The mean consumption of direct health care and non-health related care was low. During 6 months after first consultation for shoulder pain, the mean total costs a patient generated were 689 euro. Almost 50% of this total concerned indirect costs, caused by sick leave from paid work. A small proportion (12%) of the population generated 74% of the total costs.
The total costs in the 6 months after first consultation for shoulder pain in primary care, mostly generated by a small part of the population, are not alarmingly high.
It remains uncertain which diet is best for people with type 2 diabetes (T2D).
We compared the effects of dietary carbohydrate restriction with fat restriction on markers of metabolic syndrome and ...quality of life in people with T2D.
This systematic review of randomized controlled trials (RCTs) and controlled clinical trials (CCTs) compares the effects of a low-carbohydrate ≤40% of energy (%) diet with those of a low-fat (≤30%) diet over a period of ≥4 wk in patients with T2D. Two investigators independently selected studies, extracted data, and assessed risk of bias. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach was used to assess the certainty of evidence. Pooled mean differences (MDs) and 95% CIs were calculated with the use of a random-effects model.
Thirty-three RCTs and 3 CCTs (n = 2161) were included. Glycated hemoglobin declined more in people who consumed low-carbohydrate food than in those who consumed low-fat food in the short term (MD: –1.38%; 95% CI: –2.64%, –0.11%; very-low-certainty evidence). At 1 y, the MD was reduced to –0.36% (95% CI: –0.58%, –0.14%; low-certainty evidence); at 2 y, the difference had disappeared. There is low to high (majority moderate) certainty for small improvements of unclear clinical importance in plasma glucose, triglycerides, and HDL concentrations favoring low-carbohydrate food at half of the prespecified time points. There was little to no difference in LDL concentration or any of the secondary outcomes (body weight, waist circumference, blood pressure, quality of life) in response to either of the diets (very-low- to high-certainty evidence).
Currently available data provide low- to moderate-certainty evidence that dietary carbohydrate restriction to a maximum of 40% yields slightly better metabolic control of uncertain clinical importance than reduction in fat to a maximum of 30% in people with T2D. This systematic review is registered at http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017052467 as CRD42017052467.
Our objective is to develop a step-by-step approach for our institutes to evaluate the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews ...and meta-analyses for guidelines.
Methodologists from guideline organizations in the Netherlands discussed the influence of the funding body in clinical trials researching interventions. Results were discussed in our organizations and presented at the Dutch GRADE Network.
Two step-by-step approaches were developed to guide methodologists from our institutes in assessing the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews and meta-analyses for guidelines. For risk of bias, the involvement of the funding body in the study is checked as well as the direction of the effect. For publication bias, the exploration by the authors is evaluated, and any difference between industry-funded and non-funded studies in effect is checked. Guiding questions were proposed.
The step-by-step approaches make the evaluation of the influence of the funding body more objective and transparent in our institutes. The developed approaches will also be brought forward to the Grading of Recommendations Assessment, Development and Evaluation working group.
Clear communication of systematic review findings will help readers and decision makers. We built on previous work to develop an approach that improves the clarity of statements to convey findings ...and that draws on Grading of Recommendations Assessment, Development and Evaluation (GRADE).
We conducted workshops including 80 attendants and a survey of 110 producers and users of systematic reviews. We calculated acceptability of statements and revised the wording of those that were unacceptable to ≥40% of participants.
Most participants agreed statements should be based on size of effect and certainty of evidence. Statements for low, moderate and high certainty evidence were acceptable to >60%. Key guidance, for example, includes statements for high, moderate and low certainty for a large effect on intervention x as: x results in a large reduction…; x likely results in a large reduction…; x may result in a large reduction…, respectively.
Producers and users of systematic reviews found statements to communicate findings combining size and certainty of an effect acceptable. This article provides GRADE guidance and a wording template to formulate statements in systematic reviews and other decision tools.
The objective of this study was to provide guidance on the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to determine certainty in estimates of ...association between prognostic factors and future outcomes.
We developed our guidance through an iterative process that involved review of published systematic reviews and meta-analyses of prognostic factors, consultation with members, feedback, presentation, and discussion at the GRADE Working Group meetings.
For questions of prognosis, a body of observational evidence (potentially including patients enrolled in randomized controlled trials) begins as high certainty in the evidence. The five domains of GRADE for rating down certainty in the evidence, that is, risk of bias, imprecision, inconsistency, indirectness, and publication bias, as well as the domains for rating up, also apply to estimates of associations between prognostic factors and outcomes. One should determine if their ratings do not consider (noncontextualized) or consider (contextualized) the clinical context as this will may result in variable judgments on certainty of the evidence.
The same principles GRADE proposed for bodies of evidence addressing treatment and overall prognosis work well in assessing individual prognostic factors, both in noncontextualized and contextualized settings.
Shoulder pain is common in primary care, and has an unfavourable outcome in many patients. Information about predictors of shoulder pain related sick leave in workers is scarce and inconsistent. The ...objective was to develop a clinical prediction rule for calculating the risk of shoulder pain related sick leave for individual workers, during the 6 months following first consultation in general practice.
A prospective cohort study with 6 months follow-up was conducted among 350 workers with a new episode of shoulder pain. Potential predictors included the results of a physical examination, sociodemographic variables, disease characteristics (duration of symptoms, sick leave in the 2 months prior to consultation, pain intensity, disability, comorbidity), physical activity, physical work load, psychological factors, and the psychosocial work environment. The main outcome measure was sick leave during 6 months following first consultation in general practice.
Response rate to the follow-up questionnaire at 6 months was 85%. During the 6 months after first consultation 30% (89/298) of the workers reported sick leave. 16% (47) reported 10 days sick leave or more. Sick leave during this period was predicted in a multivariable model by a longer duration of sick leave prior to consultation, more shoulder pain, a perceived cause of strain or overuse during regular activities, and co-existing psychological complaints. The discriminative ability of the prediction model was satisfactory with an area under the curve of 0.70 (95% CI 0.64-0.76).
Although 30% of all workers with shoulder pain reported sick leave during follow-up, the duration of sick leave was limited to a few days in most workers. We developed a prediction rule and a score chart that can be used by general practitioners and occupational health care providers to calculate the absolute risk of sick leave in individual workers with shoulder pain, which may help to identify workers who need additional attention. The performance and applicability of our model needs to be tested in other working populations with shoulder pain to enable valid and reliable use of the score chart in everyday practice.
In prognostic studies model instability and missing data can be troubling factors. Proposed methods for handling these situations are bootstrapping (B) and Multiple imputation (MI). The authors ...examined the influence of these methods on model composition.
Models were constructed using a cohort of 587 patients consulting between January 2001 and January 2003 with a shoulder problem in general practice in the Netherlands (the Dutch Shoulder Study). Outcome measures were persistent shoulder disability and persistent shoulder pain. Potential predictors included socio-demographic variables, characteristics of the pain problem, physical activity and psychosocial factors. Model composition and performance (calibration and discrimination) were assessed for models using a complete case analysis, MI, bootstrapping or both MI and bootstrapping.
Results showed that model composition varied between models as a result of how missing data was handled and that bootstrapping provided additional information on the stability of the selected prognostic model.
In prognostic modeling missing data needs to be handled by MI and bootstrap model selection is advised in order to provide information on model stability.
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