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PloS One 2016Low back pain (LBP) is one of the leading causes of disability worldwide and among the most common reasons for seeking primary sector care. Chiropractors, physical... (Review)
Review
BACKGROUND CONTEXT
Low back pain (LBP) is one of the leading causes of disability worldwide and among the most common reasons for seeking primary sector care. Chiropractors, physical therapists and general practitioners are among those providers that treat LBP patients, but there is only limited evidence regarding the effectiveness and economic evaluation of care offered by these provider groups.
PURPOSE
To estimate the clinical effectiveness and to systematically review the literature of full economic evaluation of chiropractic care compared to other commonly used care approaches among adult patients with non-specific LBP.
STUDY DESIGN
Systematic reviews of interventions and economic evaluations.
METHODS
A comprehensive search strategy was conducted to identify 1) pragmatic randomized controlled trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. Primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine effect estimates. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized using Slavin's qualitative best-evidence synthesis.
RESULTS
Six RCTs and three full economic evaluations were scientifically admissible. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). Overall, we found similar effects for chiropractic care and the other types of care and no reports of serious adverse events. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Given the divergent conclusions (favours chiropractic, favours medical care, equivalent options), mixed-evidence was found for economic evaluations of chiropractic care compared to medical care.
CONCLUSION
Moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.
Topics: Cost-Benefit Analysis; Humans; Low Back Pain; Manipulation, Chiropractic; Physical Therapy Modalities; Pragmatic Clinical Trials as Topic; Treatment Outcome
PubMed: 27487116
DOI: 10.1371/journal.pone.0160037 -
International Journal of Language &... Jul 2022It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved...
BACKGROUND
It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved pragmatic skills. Consequently, few studies focus on the pragmatic skills of children with DLD, and there is a distinct lack of studies examining the effectiveness of pragmatic interventions.
AIMS
To carry out a systematic review of the literature on pragmatic interventions for children with DLD.
METHODS & PROCEDURES
This systematic review was registered with PROSPERO (ID = CRD42017067239). A systematic search in seven databases yielded 1031 papers, of which 11 met our inclusion criteria. The included papers focused on interventions for children with DLD (mean = 3-18 years), enhancing oral language pragmatic skills, published between January 2006 and May 2020, and were based on a group-study design such as randomized control trial or pre-post-testing. Study participants were monolingual speakers. The quality of papers was appraised using the Cochrane Risk of bias tool for randomized controlled trials.
OUTCOMES & RESULTS
There was a high degree of variability between the included intervention studies, especially regarding intensity, intervention targets and outcomes. The evidence suggested that pragmatic intervention is feasible for all models of delivery (individual, small and large group) and that interventions for pragmatic language are mostly focused on encouragement of conversation and narrative skills observed through parent-child interaction or shared book-reading activities.
CONCLUSIONS & IMPLICATIONS
This study highlights the importance of promoting and explicitly teaching pragmatic skills to children with DLD in structured interventions. A narrative synthesis of the included studies revealed that in addition to direct intervention, indirect intervention can also contribute to improving oral pragmatic skills of children with DLD.
WHAT THIS PAPER ADDS
What is already known on the subject? An increasing number of studies have shown that difficulties in acquiring pragmatic language is not only present in children with autism. What this study adds to existing knowledge? Interventions for pragmatic language in children with DLD are mostly focused on encouragement of conversation and narrative skills, very often through parent-child interaction or shared book-reading activities. Interventions that target language pragmatic are feasible for all models of delivery (individual, small and large group). What are the potential or actual clinical implications of this work? The efficacy of the existing studies varies, and it is difficult to give recommendations regarding the intensity and duration of the specific intervention. In addition to offering pragmatic intervention directly from a specialist, pragmatic interventions can also be carried out indirectly if the intervention is under the continuous supervision of a specialist.
Topics: Communication; Humans; Language Development Disorders; Linguistics; Parent-Child Relations; Randomized Controlled Trials as Topic; Vocabulary
PubMed: 35445482
DOI: 10.1111/1460-6984.12716 -
BMJ (Clinical Research Ed.) Mar 2017Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting...
Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aimed to develop guidelines for transparent and accurate reporting of implementation studies. Informed by the findings of a systematic review and a consensus-building e-Delphi exercise, an international working group of implementation science experts discussed and agreed the StaRI Checklist comprising 27 items. It prompts researchers to describe both the implementation strategy (techniques used to promote implementation of an underused evidence-based intervention) and the effectiveness of the intervention that was being implemented. An accompanying Explanation and Elaboration document (published in , doi:10.1136/bmjopen-2016-013318) details each of the items, explains the rationale, and provides examples of good reporting practice. Adoption of StaRI will improve the reporting of implementation studies, potentially facilitating translation of research into practice and improving the health of individuals and populations.
Topics: Biomedical Research; Delphi Technique; Health Plan Implementation; Humans
PubMed: 28264797
DOI: 10.1136/bmj.i6795 -
Pain Jan 2022Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic...
Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for pragmatic randomised controlled clinical trials that assessed pain treatment in a clinical population of adults reporting pain. All screening steps and data extractions were performed twice. Data were synthesised descriptively, and correlation analyses between prespecified trial features and PRECIS-2 (PRagmatic-Explanatory Continuum Indicator Summary 2) ratings and attrition were performed. Protocol registration: PROSPERO-ID CRD42020178954. Of 57 included trials, only 21% assessed pharmacological interventions, the remainder physical, surgical, psychological, or self-management pain therapies. Three-quarters of the trials were comparative effectiveness designs, often conducted in multiple centres (median: 5; Q1/3: 1, 9.25) and with a median sample size of 234 patients at randomization (Q1/3: 135.5; 363.5). Although most trials recruited patients with chronic pain, reporting of pain duration was poor and not well described. Reporting was comprehensive for most general items, while often deficient for specific pragmatic aspects. Average ratings for pragmatism were highest for treatment adherence flexibility and clinical relevance of outcome measures. They were lowest for patient recruitment methods and extent of follow-up measurements and appointments. Current practice in pragmatic trials of pain treatments can be improved in areas such as patient recruitment and reporting of methods, analysis, and interpretation of data. These improvements will facilitate translatability to other real-world settings-the purpose of pragmatic trials.
Topics: Adult; Humans; Pain; Research Design
PubMed: 34490854
DOI: 10.1097/j.pain.0000000000002317 -
Frontiers in Neurology 2020Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such...
Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such settings are required. A systematic review of literature was conducted to identify pragmatic solutions and outcomes capable of enhancing stroke recovery and quality of life of stroke survivors for low- and middle- income countries. PubMed, HINARI, and Directory of Open Access Journals databases were searched for published Randomized Controlled Trials (RCTs) till November 2018. Only completed trials published in English with non-pharmacological interventions on adult stroke survivors were included in the review while published protocols, pilot studies and feasibility analysis of trials were excluded. Obtained data were synthesized thematically and descriptively analyzed. One thousand nine hundred and ninety six studies were identified while 347 (65.22% high quality) RCTs were found to be eligible for the review. The most commonly assessed variables (and outcome measure utility) were activities of daily living [75.79% of the studies, with Barthel Index (37.02%)], motor function [66.57%; with Fugl Meyer scale (71.88%)], and gait [31.12%; with 6 min walk test (38.67%)]. Majority of the innovatively high technology interventions such as robot therapy (95.24%), virtual reality (94.44%), transcranial direct current stimulation (78.95%), transcranial magnetic stimulation (88.0%) and functional electrical stimulation (85.00%) were conducted in high income countries. Several traditional and low-cost interventions such as constraint-induced movement therapy (CIMT), resistant and aerobic exercises (R&AE), task oriented therapy (TOT), body weight supported treadmill training (BWSTT) were reported to significantly contribute to the recovery of motor function, activity, participation, and improvement of quality of life after stroke. Several pragmatic, in terms of affordability, accessibility and utility, stroke rehabilitation solutions, and outcome measures that can be used in resource-limited settings were found to be effective in facilitating and enhancing post-stroke recovery and quality of life.
PubMed: 32695058
DOI: 10.3389/fneur.2020.00337 -
Diabetes Care Apr 2014OBJECTIVE To summarize the evidence on effectiveness of translational diabetes prevention programs, based on promoting lifestyle change to prevent type 2 diabetes in... (Meta-Analysis)
Meta-Analysis Review
Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis.
OBJECTIVE To summarize the evidence on effectiveness of translational diabetes prevention programs, based on promoting lifestyle change to prevent type 2 diabetes in real-world settings and to examine whether adherence to international guideline recommendations is associated with effectiveness. RESEARCH DESIGN AND METHODS Bibliographic databases were searched up to July 2012. Included studies had a follow-up of ≥12 months and outcomes comparing change in body composition, glycemic control, or progression to diabetes. Lifestyle interventions aimed to translate evidence from previous efficacy trials of diabetes prevention into real-world intervention programs. Data were combined using random-effects meta-analysis and meta-regression considering the relationship between intervention effectiveness and adherence to guidelines. RESULTS Twenty-five studies met the inclusion criteria. The primary meta-analysis included 22 studies (24 study groups) with outcome data for weight loss at 12 months. The pooled result of the direct pairwise meta-analysis shows that lifestyle interventions resulted in a mean weight loss of 2.12 kg (95% CI -2.61 to -1.63; I(2) = 91.4%). Adherence to guidelines was significantly associated with a greater weight loss (an increase of 0.3 kg per point increase on a 12-point guideline-adherence scale). CONCLUSIONS Evidence suggests that pragmatic diabetes prevention programs are effective. Effectiveness varies substantially between programs but can be improved by maximizing guideline adherence. However, more research is needed to establish optimal strategies for maximizing both cost-effectiveness and longer-term maintenance of weight loss and diabetes prevention effects.
Topics: Behavior Therapy; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Guideline Adherence; Health Promotion; Humans; Life Style
PubMed: 24652723
DOI: 10.2337/dc13-2195 -
PloS One 2019The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled...
INTRODUCTION
The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice.
AIM
To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.
MATERIAL AND METHODS
We conducted a systematic and critical appraisal of RCTs used to develop the 'psychological therapy and psychosocial interventions' section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study.
RESULTS
A total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores.
CONCLUSIONS
Two third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.
Topics: Government Agencies; Humans; Practice Guidelines as Topic; Pragmatic Clinical Trials as Topic; Psychiatric Rehabilitation; Psychotic Disorders; Research Design; Schizophrenia; United Kingdom
PubMed: 31550279
DOI: 10.1371/journal.pone.0222891 -
Complementary Therapies in Medicine Jun 2016The aim of the review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. (Review)
Review
OBJECTIVE
The aim of the review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders.
MATERIALS AND METHODS
An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.
RESULTS
24 studies were included (total sample=1840), addressing back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT can be considered effective on pregnancy related back pain but uncertain in all other gynaecological and obstetrical conditions. Only three studies (12.5%) mentioned adverse events after OMT.
CONCLUSIONS
Although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.
Topics: Female; Humans; Infertility, Female; Manipulation, Osteopathic; Menopause; Pelvic Pain; Pregnancy; Pregnancy Complications
PubMed: 27261985
DOI: 10.1016/j.ctim.2016.03.005 -
PloS One 2023Children with neurodevelopmental disorders such as attention-deficit hyperactivity disorder (ADHD), autism, developmental language disorder (DLD), intellectual... (Meta-Analysis)
Meta-Analysis
RATIONALE
Children with neurodevelopmental disorders such as attention-deficit hyperactivity disorder (ADHD), autism, developmental language disorder (DLD), intellectual disability (ID), and social (pragmatic) communication disorder (SPCD) experience difficulties with social functioning due to differences in their social, emotional and cognitive skills. Previous systematic reviews have focussed on specific aspects of social functioning rather than broader peer functioning and friendships.
OBJECTIVE
To systematically review and methodologically appraise the quality and effectiveness of existing intervention studies that measured friendship outcomes for children with ADHD, autism, DLD, ID, and SPCD.
METHOD
Following PRISMA guidelines, we searched five electronic databases: CINAHL, Embase, Eric, PsycINFO, and PubMed. Two independent researchers screened all abstracts and disagreements were discussed with a third researcher to reach consensus. The methodological quality of studies was assessed using the Cochrane Risk of Bias Tool for Randomised Trials.
RESULTS
Twelve studies involving 15 interventions were included. Studies included 683 children with a neurodevelopmental disorder and 190 typically-developing children and diagnosed with either autism or ADHD. Within-group meta-analysis showed that the pooled intervention effects for friendship across all interventions were small to moderate (z = 2.761, p = 0.006, g = 0.485). The pooled intervention effect between intervention and comparison groups was not significant (z = 1.206, p = 0.400, g = 0.215).
CONCLUSION
Findings provide evidence that some individual interventions are effective in improving social functioning and fostering more meaningful friendships between children with neurodevelopmental disorders and their peers. Effective interventions involved educators, targeted child characteristics known to moderate peer functioning, actively involved peers, and incorporated techniques to facilitate positive peer perceptions and strategies to support peers. Future research should evaluate the effectiveness of friendship interventions for children with DLD, ID and SPCD, more comprehensively assess peer functioning, include child self-report measures of friendship, and longitudinally evaluate downstream effects on friendship.
Topics: Child; Humans; Friends; Attention Deficit Disorder with Hyperactivity; Peer Group; Social Adjustment; Neurodevelopmental Disorders
PubMed: 38096327
DOI: 10.1371/journal.pone.0295917 -
Journal of Psychopharmacology (Oxford,... Aug 2013Selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line pharmacological treatment for depression and are the most commonly prescribed class of... (Meta-Analysis)
Meta-Analysis Review
Does adding noradrenaline reuptake inhibition to selective serotonin reuptake inhibition improve efficacy in patients with depression? A systematic review of meta-analyses and large randomised pragmatic trials.
Selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line pharmacological treatment for depression and are the most commonly prescribed class of antidepressants. However, there is substantial evidence that noradrenaline has a role in the pathogenesis and treatment of depression. This review aims to examine the evidence of including noradrenaline reuptake inhibition with serotonin reuptake inhibition with respect to increasing efficacy in the treatment of depression. Evidence from meta-analysis of randomised controlled trials (RCTs) and randomised pragmatic trials was found in support of greater efficacy of the serotonin noradrenaline reuptake inhibitors (SNRIs), venlafaxine and duloxetine, in moderate to severe depression compared to SSRIs but no evidence was found for superiority of milnacipran. There is sufficient current evidence that demonstrates an increase in efficacy, when noradrenaline reuptake is added to serotonin (5-HT) reuptake, to suggest that patients with severe depression or those who have failed to reach remission with a SSRI may benefit from treatment with a SNRI. However, as these conclusions are drawn from the evidence derived from meta-analyses and pragmatic trials, large adequately powered RCTs using optimal dosing regimens and clinically relevant outcome measures in severe depression and SSRI treatment failures are still required to confirm these findings.
Topics: Antidepressive Agents; Depressive Disorder; Humans; Norepinephrine; Randomized Controlled Trials as Topic; Serotonin; Selective Serotonin Reuptake Inhibitors
PubMed: 23832963
DOI: 10.1177/0269881113494937