Authors advocate for low-evidence treatment guidelines
When it comes to managing persistent post-concussion symptoms (PPS), weak evidence may be preferable to no evidence. recommendation of good clinical practice from the data.
Most people with concussion or mild head injury (MCI) recover quickly, but a significant minority of patients suffer from PPS, a condition made up of a combination of physical, cognitive and emotional symptoms. or behavioral, which last for months or even years.
“There is uncertainty regarding the effectiveness of non-pharmacological interventions commonly applied to treat PPS, and to our knowledge there is a dearth of dedicated meta-analyzes on this topic”, Hana MalÃ¡ Rytter, PhD, of the Danish Concussion Center at Copenhagen, and colleagues explained in JAMA network open. âIn addition, although systematic approaches are generally applied, the Grades of Recommendation, Assessment, Development and Assessment (GRADE) approach has only been used sporadically.
Rytter and his colleagues set out to systematically assess and summarize the evidence for outcomes related to seven non-pharmacologic PPCS treatments for adults (routinely offered information and advice, graduated physical exercise, vestibular rehabilitation, manual spinal therapy, oculomotor vision treatment, psychological treatment and interdisciplinary coordinated rehabilitation) in order to provide recommendations for use in clinical practice.
Their analysis, which looked at 19 randomized clinical trials (RCTs) with 2,007 participants, found that the evidence for the seven interventions ranged from no evidence meeting the inclusion criteria to very low and low levels of evidence.
“Based on very low to low certainty of evidence, the guideline panel provided weak recommendations for early information and advice, graduated physical exercise, vestibular rehabilitation for persistent vestibular dysfunction, manual treatment neck and back, psychological treatment, and interdisciplinary coordinated rehabilitation treatment, “they wrote.” A consensus recommendation has been provided for the treatment of oculomotor vision to treat persistent visual symptoms. ”
Based on these findings, the guidelines panel concluded that there is “an urgent need for more methodologically robust research evaluating the outcomes of non-pharmacologic treatments for persistent symptoms after concussion or TCM”.
That being said, Rytter and colleagues also argued that low-quality evidence is still sufficient to offer treatment recommendations for patients and clinicians.
âExpert groups have used the lack of evidence of the pros or cons of a particular intervention as an argument for not making a recommendation,â they said. âHowever, such positions have been frustrated by healthcare professionals who turn to expert groups for advice. Fortunately, the GRADE approach adapts to these circumstances because it provides interpretations for patients, clinicians and policy makers. When faced with non-existent or weak evidence, it is important for patients to know that their particular preference among different treatments should guide the choice of intervention; clinicians need to recognize that different interventions may be appropriate for different patients and help each patient reach a management decision consistent with their values. Policy makers should involve relevant professional groups and stakeholders when determining care pathways. It is important to note that expert groups should not refrain from making recommendations because patients and individual clinicians will make different choices when faced with a weak recommendation. In fact, that is to be expected. Therefore, the GRADE working group encourages panels to make recommendations wherever possible, whether or not they are based on solid evidence.
For their review and meta-analysis, Rytter and colleagues searched Embase, MEDLINE, PsycINFO, CINAHL, PEDro, OTseeker, and Cochrane Reviews for RCTs evaluating one of the seven non-pharmacological PPCS treatments from the first possible year of publication through ‘as of March 3, 2020. To be included, studies had to be intervention studies with a control group and focus specifically on PPS.
The primary outcome for most interventions was âthe collective burden of post-concussion symptoms supplemented by another primary outcome closely reflecting the objective of the respective interventions (p. Treatment),â the review authors wrote. . Secondary outcomes varied between interventions and included pain, physical functioning, emotional symptoms, behavioral response, quality of life, negative effect on prognosis, and return to daily activities.
The certainty of the evidence for all outcome measures was determined based on grade level, resulting in four possible ratings: high, moderate, low, and very low. A strong or weak recommendation for or against an intervention was made based on a combined assessment of the strength of the available evidence, assumed patient preferences, and the weighting of pros and cons. In the absence of available evidence, the panel could make a recommendation of good clinical practice, a recommendation based on professional consensus among working group members that is weaker than any evidence-based recommendation.
Their final analysis consisted of 19 RCTs with 2,007 participants (1,064 women [53.0%]; 943 male [47.0%]) for six of the seven MYP interventions. Evidence and recommendations for each intervention were assigned as follows:
- Systematically offered information and advice: very low certainty evidence; weak recommendation in favor.
- Graduated physical exercise: very low-certainty evidence; weak recommendation in favor.
- Vestibular rehabilitation: very low-certainty evidence; weak recommendation in favor.
- Manual spinal therapy: very low-certainty evidence; weak recommendation in favor.
- Treatment of oculomotor vision: no relevant evidence identified; statement of good clinical practice.
- Psychological treatment: low-certainty evidence; weak recommendation in favor.
- Interdisciplinary coordinated rehabilitation treatment: low-certainty evidence; weak recommendation in favor.
“Since concussion or mTBI may be associated with persistent symptoms and disability, there has been a shift from passive expectation of symptom remission to recommendation of active management when symptoms persist, âthe panelists noted. “Thus, our recommendations align with the Practice Summary Guidelines of the US Congress of Rehabilitative Medicine Mild TBI Working Group”; the American Physical Therapy Association (APTA) guidelines for the assessment and treatment of physiotherapy after concussion or mild TBI; the third edition of the Ontario Neurotrauma Foundation (ONF) guidelines for concussions or mild TBI and persistent symptoms; and the latest update on the consensus statement released by the Concussion in Sports Group (CISG). However, compared to our guideline, these guidelines have different scopes and include pediatric and adolescent populations. Additionally, although these guidelines apply a systematic approach to guideline generation, they do not apply the GRADE approach.
âIn the end, Rytter and his colleagues did a service in the field by again emphasizing the paucity of studies and the need for much more and better evidence to guide the treatment of PPS,â Keith Owen Yeates, PhD, of the University of Calgary in Alberta. , Canada, and colleagues wrote in an editorial accompanying the journal.
Yeates and colleagues noted that the guidelines panel âis to be commendedâ for constructing their analysis; however, they also pointed out “several apparent omissions or simplifications” in the final product. For example, the comparator treatment in some studies is not clear and the usual treatment is not always clarified; the review omitted cognitive rehabilitation from its assessment of non-pharmacological treatments, as well as the timing, duration or intensity of included interventions; and in some cases, the components of treatment “have been described as occurring in isolation when given in combination (eg, manual therapy)”.
Despite these limitations, Yeates and colleagues concluded that the lack of data on non-pharmacological treatments for PPS may justify a shift in reliance on RCTs to develop treatment guidelines.
âWe may need to reconsider the accepted wisdom regarding the hierarchy of evidence and reduce our reliance on traditional randomized clinical trials as the standard for informing treatment efficacy,â they wrote. âThe adoption of alternative designs, including observational comparative efficacy studies, pragmatic and adaptive trials, personalized N-of-1 trials, and meta-analyzes of individual participant data, will likely be necessary if we are to do moving the field forward with the eagerness that our patients and the public deserve.
Based on a systematic review and meta-analysis of non-pharmacological treatments for persistent post-concussion symptoms (PPS), a panel of experts gave weak recommendations for early information and advice, the graduated physical exercise, vestibular rehabilitation, manual treatment of the neck and back. , interdisciplinary coordinated psychological and rehabilitation treatment, and a recommendation of good clinical practice for the treatment of oculomotor vision, to treat adults with PPS.
The expert group concluded that there is an urgent need for methodologically more robust research evaluating the outcomes of non-pharmacologic treatments for persistent symptoms after concussion or mild head injury, but expert groups should be prepared to make weak recommendations for use in clinical practice.
John McKenna, Associate Editor, BreakingMED â¢
Rytter said he received grants from the Danish Ministry of Health where his employer received financial compensation while conducting the study. Other co-authors reported relevant relationships with the Danish Ministry of Health and Danish Health Authority as well as with the Danish Concussion Center, Copenhagen, Denmark.
Yeates reported relevant relationships with the Canadian Institutes of Health Research and the Brain Canada Foundation, Guilford Press and Cambridge University Press, and the American Psychological Association outside of the submitted work. Co-author Schneider reported relevant relationships with Spring Into Action Physical Therapy Ltd outside of the submitted work. Co-author Silverberg said he received grants from the Canadian Institutes of Health Research, the Michael Smith Foundation for Health Research, and personal expenses from the National Hockey League and WorkSafeBC outside of the submitted work.
Cat ID: 130
Topic ID: 82 130 730 130 474 138 192 925