Additionally, at 12 months the intervention group were more likely to report reduced pain, fear, less depression, and better general health. Patients given the stratified care intervention were also significantly more likely to be satisfied with their treatment compared with current best care at 4 months, and took fewer days off work because of back pain over the 12 month study period. The stratified management intervention also resulted in a greater health benefit that was achieved at a lower average health-care cost.
Anne: Why do you think the study is important? Jonathan: The STarT Back trial was the first study to test a stratified care approach for the management of back pain in primary care, and published in The Lancet, has been ground breaking in providing a simple and practical model for improving the effectiveness and costs of care compared to conventional pathways. Stratified care also enables clinicians to deliver more tailored services for patients with back pain and has challenged the existing one-size-fits-all and stepped care models suggested in current guidelines.
Anne: What lead you to do the study? Although trials have reported the benefits of a wide range of treatments such as exercise, manual therapies and cognitive behavioural approaches compared with standard care, a lack of evidence about which patients are likely to benefit from which interventions has reduced the efficiency of primary care management.
The findings of this study represent an important advance in primary care management of back pain, and have important implications for commissioners and providers of services for back pain.
Anne: What studies are you conducting now? The Keele team are currently undertaking research using a large clinical trial to test if a stratified care approach can be extended using a combination of prognosis and clinical signs for patients with sciatica presenting to primary care, including identifying which patients may need a fast-track pathway to receive a surgical opinion. A separate programme of research is also testing a new stratified care approach for patients with the 5 most common musculoskeletal conditions presenting to primary care including back, neck, shoulder, knee, and multi-site pain.
Watch a video summarising the Machado trial:. Watch a video summarising the Schweickert trial:. Anne: Could you explain what you did in the study Amy: We divided patients who had recently been placed on a ventilator into two groups.
One group underwent physical and occupational therapy when we would have typically seen them at that time, when the breathing tube was removed or a more permanent breathing tube was placed. The other group received physical and occupational therapy as early as possible after they had been placed on the ventilator.
Patients in both groups received optimal nutrition, blood glucose control and a protocol that is used to reduce the usage of sedative medications. Both groups received physical and occupational therapy which included activities such as sitting in the chair, walking and participating in their own bathing and dressing. The difference between groups is that one group underwent physical and occupational therapy much earlier and while still requiring a ventilator and a breathing tube.
At the time of the study, completing various out of bed activities such as standing, walking, and self-care tasks with patients on a ventilator with a breathing tube was not a common intervention. Amy: Physical and occupational therapy were initiated much sooner in the early group; an average of 1.
More patients were able to return immediately home after hospitalization as opposed to going to an alternate rehabilitation facility. Anne: Why do you think your study is important? Amy: There are many known long-lasting strength and cognition complications for patients who are in bed for days, weeks and even just hours. The study demonstrated that it is safe and possible to engage patients who need to be on a ventilator and while they are quite ill in aggressive physical and occupational therapy including out-of-bed activity very early in their hospital stay and that the patients who did so showed superior outcomes related to activities that are important to having a positive quality of life.
This study helped change the way we manage patients with critical illness and this intervention is becoming the standard of care both in the United States and internationally. Amy: Historically, patients with respiratory failure who were placed a ventilator were given medications to keep the patient calm, sedated, and immobile.
We knew from earlier studies that when the sedative medications were not used, or used less, patients remained comfortable and were able to get off the ventilator sooner. However, often times these patients were still having chronic weakness and cognitive deficits which impair their day to day tasks.
Our study built on this concept. We considered the possibility that, if the patients are safe and comfortable when awake on the ventilator and had improved outcomes, they might do even better if they did not remain confined to the bed but, instead, were engaged in activity to stimulate both the body and mind.
Amy: Our study followed the patients until they left the hospital. But, it did not tell us what happened in the long run. We are replicating the original study but following the patients after they leave the hospital to see if the improvements we had noted in the first study hold up over time.
Anne: Amy, thank you for making such a valuable contribution to physiotherapy. Watch a video summarising the Hancock trial:. Watch a video summarising the Bisset trial:. Erik: In the FOPANU Study it was demonstrated that the exercise program had important positive effects on, for example, gait, lower-limb strength, balance, and dependency in activities of daily living when compared to a control activity program. In addition, the exercise program used in the trial the High-Intensity Functional Exercise Program, the HIFE Program was shown to be as applicable for people with dementia as for people without.
Erik: The FOPANU Study was the first trial evaluating a high-intensity functional exercise program in older people with severe cognitive and physically impairment including those with dementia. Among the participants, all living in residential care facilities; mean age was 85 years, half had a dementia diagnosis and two thirds were not able to rise up from a chair independently.
Rehabilitation for older people with impairments is an important and expanding working field in clinical practice and research for physiotherapists, especially considering that the world population is aging rapidly. Today around 35 million people have dementia and this number is estimated to double by and more than triple by According to the World Health Organisation WHO , dementia is defined as the leading course of disability and dependency among older people and should be considered as a public health priority.
We wanted to develop an exercise program that could easily be implemented due to well-described exercises, standardized instructions, and portable exercise equipment. We knew from the literature that high intensity and functional exercises were important for the exercise effect and wanted to evaluate if it was feasible and effective also for older people with severe cognitive and physically impairments.
Hopefully, the first results from this study will be published in the beginning of next year. Anne: Erik, thank you for making such a valuable contribution to physiotherapy. Watch a video summarising the Olsen trial:. Anne: Explain what you did in the study Odd-Egil: In the study we investigated the effect of a structured warm-up program designed to reduce the incidence of knee and ankle injuries in young people participating in sports.
We followed team handball clubs and registered all injuries during one 8-month season. At the start of the league season, the clubs in the intervention group received a program of warm-up exercises to prevent injuries, while the clubs in control group where doing their training as usual. Odd-Egil: The main finding was that a structured warm-up program with exercises to improve awareness and knee and ankle control during landing and pivoting movements reduces injuries to the lower limb in youth team handball.
Preventive training should therefore be routine and a natural part of youth sports training programs. Also, programs focusing on technique and balance training should be implemented in players as young as years. It seems reasonable to assume that the prevention program used in the study also could be modified to be used in other similar sports, and that question should lead to future research.
The risk of serious knee injuries, such as injuries to the anterior cruciate ligament, is high among adolescents playing pivoting sports such as football, basketball, or team handball. Previously studies showing that it may be possible to reduce the incidence of knee and ankle injuries among young people have been small and mainly non-randomised, with significant methodological limitations.
Therefore, we initiated the randomised controlled trial with high enough sample size to investigate the effect of a prevention program. Odd-Egil: One of the coauthors of the paper, Associate Professor Grethe Myklebust, has followed the anterior cruciate ligament injury incidence in female handball for 15 years, and received important lessons learned from the Norwegian anterior cruciate ligament prevention study.
Get Set provides injury prevention exercises, which were created for the occasion of the Youth Olympic Games. That is, while individuals may be assigned to treatment or control, these assignments are rarely required or controlled. In this case, the control group no longer serves as a true counterfactual. Non-compliance, then, can threaten the integrity of randomization if individuals are able to self-select into groups.
While non-compliance can never totally be eliminated, it can be minimized. One method is to choose a unit of randomization large enough such that the two groups are unlikely to mix. Note, however, when control group individuals take up the program, and treatment individuals do not, this resembles the encouragement design.
This can be especially concerning, because it essentially un-randomizes your sample, as people are self-selecting out of one group or the other. It is important to note that, while the rates of attrition may look the same, differential attrition may still be occurring if the reasons people are leaving the treatment or control groups is related to the treatment. In the microfinance example, differential attrition could occur if some households in treatment neighborhoods obtain loans, grow their businesses, and become wealthy enough to leave the neighborhood — out of our sample.
It is therefore very important to follow up with households, especially in the case of differential attrition. Non-differential attrition occurs when attrition from the treatment or control groups occurs for reasons unrelated to the treatment: people may move away, die, or otherwise drop out of our sample, and it has nothing to do with whether they are in treatment or control.
In this case, we would only worry if non-differential attrition erodes our sample size such that issues of statistical significance or power crop up. In theory, if randomization has been successfully implemented, an endline survey is sufficient in determining an internally valid impact estimate.
However, baseline surveys, beyond providing empirical assurance that randomization has generated balanced treatment and control groups, provide an additional benefit in the form of increased power. In general, more frequent data collection such as a baseline, midline, and endline can give us the same power for a smaller sample size. Also, baseline results allow us to measure heterogeneous effects i. For example it allows us to measure the test-score impact of an education innovation on the subgroup of children who scored poorly on the exam at baseline.
Without the baseline, we would not be able to identify which children these were. If we want to detect the difference between two variations of a program, then we will need more power — and, consequently, a larger sample size. If we simply want to compare having a program to not having a program, then less power and thus a smaller sample size, relatively is sufficient. Duflo, E. Using randomization in development economics research: A toolkit.
Handbook of development economics, 4, This course explores impact evaluation, focusing on when and how to use randomized impact evaluations.
Are RCTs a new approach in evaluation? What should you do if randomization does not produce equivalent groups? I'm planning to implement an RCT evaluation to evaluate the impact of stunting prevention within children aged groups between 6 and 23 months.
This RCT will be held in a health centre in charge of nutrition recovery and treatment. All children will receive the treatment and I'm planning to create 3 groups of children: group 1: Children with high risk to fall down into stunting category or who are suffering of stunting; group 2: Children who are low risk to fall down into stunting category, I call them children at risk to fall in stunting; group 3: Children who are well being, taking treatment just to prevent stunting.
The goal of this evaluation is to measure impact of prevention treatment of stunting. Do you have documentation that you can share with me to prepare a terms of reference and protocole of this evaluation? Thanks for getting in touch. Login Login and comment as BetterEvaluation member or simply fill out the fields below. Simple one treatment, one control In a microfinance study by the Abdul Latif Jameel Poverty Action Lab J-PAL , a large Indian microfinance institution, Spandana, identified low-income neighborhoods in Hyderabad, India, which were potential locations to open a branch office.
Rotation A remedial tutoring program in India used rotation design. Encouragement In many situations, it is politically, ethically or administratively untenable to deny services to a control group. A special thanks to this page's contributors. Angela Ambroz. Marc Shotland. Hira Siddiqui. Patricia Rogers. Share RSS Print version. Related Content Blog entry. Week Rumination 3: Fools' gold: the widely touted methodological "gold standard" is neither golden nor a standard.
Blog entry. Emma Smith 12th October Hi Stephen, Thanks for getting in touch. Best wishes, Emma. A confounder can be defined as any factor that is related not only to the intervention e. McNamee R. Confounding and confounders. Occup Environ Med. One good example is age: in a study on the relationship between smoking exposure and lung cancer outcome , age could be implicated as a factor that would increase the incidence of the outcome.
Thus, if one of the groups smokers or non-smokers has an older population, the increase in lung cancer could be influenced by age as a confounder , and not by the exposure studied. However, advanced statistical tools may enable good and reliable control over many confounders.
Some tools like propensity scores and sensitivity analysis, when correctly performed, could drastically reduce the bias caused by the lack of randomization. Invited commentary: propensity scores. Am J Epidemiol. Some authors have studied the results from RCTs, compared with similar observational studies.
Concato et al. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. In other words, if the observational study has good methodological quality, the results are quite similar. Many investigators have pointed out that the main strength of observational studies is their greater proximity to "real life situations", since RCTs have stricter inclusion criteria and rigid protocols that may not reflect clinical practice.
By definition, observational studies have greater heterogeneity of medical interventions and patient populations that are closer to clinical practice. Other advantages of observational studies are that they are usually cheaper than RCTs and can be used to investigate rare outcomes and to detect unusual side effects, and that some designs are easily and quickly performed. Observational studies also are important for creating new hypotheses, proving the external validity of RCTs already performed, establishing the sample size for an RCT and evaluating which patient subsets really benefit from each alternative intervention of effective alternative therapies.
In this way, it can be said that observational studies can be complementary to RCTs. Although the evidence level of observational studies appears to be lower than that of RCTs, it is clear that this kind of investigation is crucial for elucidating many scientific questions. Not only authors but also editors around the world are giving more attention to these studies. The take-home message is that the study question and the quality of the methodology applied to answer it are much more important than the study design.
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