Wednesday, December 19, 2018

Resources for First Generation College Students

Here’s where to look if you’re the first in your family to go to college.

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Interventions for Preterm Birth: a Cochrane Review

Whats the problem?

Across the world, over 34% of infant deaths can be attributed to preterm birth (PTB) (Callaghan et al, 2006). Whilst advances in neonatal medicine are improving these mortality rates, the lost weeks of fetal development increase the risk of morbidities. These are likely to have significant, long-lasting impacts on a child, their family and the economy. An abundance of research has evaluated a variety of interventions aimed at preventing preterm birth. However, conflicting evidence makes it difficult to decipher what is actually beneficial. A recent Cochrane review has summarised some of the interventions used to reduce the risk of PTB. This will help clinicians and other stakeholders make evidence-based decisions with the aim to improve the impact of premature delivery.

What worked?

36 systematic reviews evaluated interventions for preventing premature delivery. Cervical cerclage (cervical stitch) showed clear benefit for women at high risk of PTB, but different interventions benefited those at a lower risk. These included zinc supplements and antenatal infection screening. However, midwife-led continuity care (MLCC) was the most effective intervention, reducing both PTB rates and infant mortality.

Image result for premature baby

The findings provide promising results regarding the effectiveness of some interventions. However, many of these targeted specific populations of women. Consequently, the effects may be not be the same for the general population. For example, zinc tablets were beneficial for women with poor nutrition, but the effect may not be as significant for those who eat a balanced diet. 

Many interventions were found to have an unknown harm or benefit at reducing premature delivery or neonatal mortality. For low-risk women, alternative antenatal care, calcium and vitamin supplements, routine ultrasounds and thyroid screening were shown to have clear evidence of no effect of equivalence, as was the case for bedrest and preventative prescriptions of antibiotics for high-risk mothers.

How good was the evidence?

There was a lack of high-quality evidence for effectiveness of interventions in women with multiple pregnancies. 40% of twins are born prematurely, so the need to find effective treatments to reduce the risk in these women is of high priority (Goldenberg et al, 2008).

Medley et al (2018) did not evaluate some of the most commonly used interventions in preventing PTB (e.g cervical length screening and progesterone supplementation). This was due to lack of current evidence. However, Medley et al (2018) point out that there are ongoing reviews evaluating the effectiveness of these interventions. This research could then be utilised when deciding on the most appropriate intervention for an expectant mother.

What does this change?

Midwife-led continuity care was the most effective intervention for reducing the risk of PTB and perinatal mortality. This promotes the use of one midwife throughout a woman’s pregnancy, childbirth and post-natal period (Sandall et al, 2016). The reasons for why the MLCC is effective is likely to be complex, but its benefits in reducing fetal mortality and PTB, as well as other adverse maternal outcomes, are notable. Research needs to be conducted to assess MLCC’s benefits for women at high-risk of PTB, as they are likely to be in need of a more complex care plan.

Image result for midwife

Many interventions given as a cautionary measure to women at low risk of premature delivery were not effective at reducing the risk of preterm birth. With limited resources available for the NHS, initial screening would provide valuable stratification of those of high risk. These women could then go on to receive the more resource-intense interventions with the aim of reducing their risk of PTB.

This summary presented clear evidence regarding the ineffectiveness of a variety of interventions. It could be argued that the administration of these interventions should be cautioned against.

What can we conclude?

In conclusion, Medley et al (2018) summarise the latest evidence regarding the effectiveness of a variety of preterm birth interventions. Midwife-led Continuity Care was the most effective at reducing the risk of premature birth and perinatal mortality. Whilst this may be resource intensive, the beneficial long-term effects on not only PTB and infant mortality but to overall infant and parental health may help to reduce costs in the future.

An important priority for research is updating systematic reviews on interventions not covered in this overview. This would provide a more comprehensive evaluation of the possible interventions, allowing stakeholders to make informed decisions when implementing the research into policy and practice.

Finally, this study signals the importance of individual differences in expectant mothers. Therefore, it is important to gain an insight into the woman and her history before deciding on the most suitable plans for her pregnancy.

It should also be noted that not every woman is in need of an intervention to prevent preterm birth. With incidence of preterm birth estimated at only 10%, screening may be a useful way to decipher where the high-risk cases are to aid prioritisation of resources.

References

Callaghan, William M., et al. “The contribution of preterm birth to infant mortality rates in the United States.” Pediatrics 118.4 (2006): 1566-1573.

Medley  N, Vogel  JP, Care  A, Alfirevic  Z. Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews. Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD012505. DOI: 10.1002/14651858.CD012505.pub2

Goldenberg, R.L., Culhane, J.F., Iams, J.D. and Romero, R., 2008. Epidemiology and causes of preterm birth. The lancet371(9606), pp.75-84.

Sandall, J., Soltani, H., Gates, S., Shennan, A. and Devane, D., 2016. Midwife‐led continuity models versus other models of care for childbearing womenCochrane database of systematic reviews, (4).

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Tuesday, December 18, 2018

Psychological e-health interventions for children and adolescents

In this blog, Sophia discusses a recent Cochrane review which asked the question: Are psychological e-health interventions for children and adolescents with long-term physical conditions effective for reducing depression and anxiety? 

Background

The prevalence of long-term physical conditions in childhood is increasing, with conditions lasting longer than 3 months that are judged to impair functioning, affecting 10 -12% of children globally (van der Lee et al., 2007; Eiser, 1997). These conditions include things such as asthma, diabetes, epilepsy, Crohns disease, chronic kidney disease, neurological conditions, and cancers (Burkart, 2002). Children and adolescents with long-term physical conditions are at greater risk of psychological problems (Pao & Bosk, 2011) and currently the access to first line treatment, psychological therapy, for these psychological problems is limited (Bennett et al., 2015).

E-health presents a possible solution to address the need for psychological interventions for children and adolescents with long-term physical conditions. E-health is conceptualized as the provision of health care using digital technology; it is interactive and patient-tailored (McLean et al., 2010). The increasing popularity of digital technology has led to the design and release of app-based interventions and the following review by Thabrew, Stasiak, Hetrick, Wong, Huss, & Merry (2018) synthesizes the available evidence for e-health interventions for anxiety and depression in children and adolescents with long-term physical conditions.

The Thabrew et al., (2018) review assessed the effectiveness of e-health interventions in comparison with waiting list controls, attention and psychological placebos, or non-psychological interventions for treating anxiety and depression in children and adolescents with long-term physical conditions.

The review in more detail

Five trials of three interventions were identified; Breathe Easier Online, Web-MAP, and multimodal cognitive behavioural therapy (CBT). Across the five included studies there were 463 participants with an age range of 10 to 18 years. Conditions included chronic headache (migraine, tension headache and others), chronic pain conditions (musculoskeletal, abdominal and others) and respiratory illnesses (asthmas, cystic fibrosis and others) with symptoms of anxiety or depression.

The authors concluded the quality of evidence was low across trials for primary and secondary outcomes due to the introduction of bias. The nature of the interventions means that blinding of participants and research staff was not possible or it was unclear, and only one trial had published a protocol for the trial. All three interventions tested in the five included trials were conducted by developers of those interventions, and sample sizes were small. The high risk of bias means that it could not be determined whether e-health interventions were clearly better than any comparison in reducing depression or anxiety or improving quality of life and functioning or the physical health symptoms.

There was very low quality evidence that e-health was less acceptable than comparators  in children and adolescents with long-term conditions. Most of the trials worked with adolescents so it is impossible to comment on the effectiveness of these interventions for children under the age of 10.

What were the characteristics of the participants?

There are some points to be considered regarding the sample size of this review. First, considerably less than half of the total of participants (n=463) were male: 15% (Law, 2015), 25% (Palermo, 2016a), 30% (Palermo, 2009), 45% (Trautmann, 2010), 50% (Newcombe, 2012) creating an overall gender imbalance in the sample. This may be reflective of population-level sex differences in affective disorders in adolescence, whereby rates are much higher for females (Thapar et al., 2012) but this was not commented on in the review, nor were differences between male and female participants explored in the trials.

Secondly, the majority of participants were white: 92% (Law, 2015), 100% (Newcombe, 2012), 90% (Palermo, 2009), 85% (Palermo, 2016a) and Trautmann (2010) did not specify.

Third, all the trials were conducted in high income countries: USA (Law, 2015; Palermo, 2009; Palermo 2016a), Australia (Newcombe, 2012), Germany (Trautmann, 2010)., and fourth some excluded people without access to a computer. Although e-health is championed as cost-effective and could be widely available to difficult to reach populations or those who wish to be private about their therapy, it is impossible to determine if these interventions would be effective in populations from low- and middle-income countries, and other cultures or populations.

Mobile phone

E-health is conceptualized as the provision of health care using digital technology; it is interactive and patient-tailored.

Interventions and outcome measures

Three of the five trials evaluated the same intervention: Web-MAP (Law, 2015; Palermo, 2009; Palermo, 2016a) a web-based intervention for managing chronic pain. Two other trials evaluated Breathe Easier Online (Newcombe, 2012) and an online form of multimodal CBT training for reducing headaches (Trautmann, 2010). This makes the pain management intervention more dominant in the sample. Web-MAP also included modules for the parents of the child, 8 modules for the child and 8 modules for parents, and the others did not. This is a fundamental difference in the way the intervention is delivered because involving the parent in the homework tasks may change the way the child or adolescent engages in the intervention. It might be important, therefore, to compare the effectiveness of Web-MAP to the effectiveness of Breathe Easier Online and the multimodal CBT intervention as they address different long-term conditions and are delivered in a different format?

An oversight by four of the trials which is close to my heart (and research) is measurements of quality of life. Only one trial (Trautmann, 2010) included in this review measured improvements in quality of life. Historically, the outcomes measured in trials are chosen by health professionals and methodologists rather than patients. The resulting data often only represent a snap shot in time and are not relevant to the patient. Patients are interested in long term quality of life improvement as part of effective treatment (Haywood, Wilson, Staniszewska, & Salek, 2016). This is particularly important for those living with long-term conditions when complete recovery is not a realistic part of their future.

Discrepancies between healthcare measures and patient measures in research can be resolved by involving the specific patient population concerned in the design of the trials and introducing PROM (patient reported outcome measures) of outcomes such as functional status, well-being and quality of life (Staniszewska, Haywood, Brett, & Tutton, 2012).

One final point, which is perhaps the most important, is that none of the interventions were designed to treat anxiety or depression as a primary focus, exposing a large gap in the evidence.  There is need for more evidence in this area.

A strength of this review is that it included trials with many mixed, long-term conditions with both anxiety and depression. It also included participants with comorbidities such as diabetes, asthma or another mental health condition besides anxiety and depression. This was good to see and is reflective of the real-life contexts within which these e-health interventions would be used. Long-term physical health conditions are often extremely complex, as are psychological problems, and co-morbidities are the norm rather than the exception.

In conclusion…

In the case of long-term conditions, the aim is often to improve quality of life rather than pursuing an absence of symptoms. It is therefore discouraging that the trials in this review did not collect data regarding the participants’ quality of life before and after using the interventions. Similarly, other secondary outcomes such as school attendance, and functioning, which may have been important to the patient, were either not recorded or not followed up past the end of the trial.

Due to the high risk of bias and the small sample, it is concluded by the authors that there was very low-quality evidence available and so it could not be determined whether these e-health interventions were better than comparators. I completely agree. Perhaps the inclusion of quasi-randomised and non-randomised trials in future reviews could provide a clearer view.

References

Photo within blog by Rodion Kutsaev on Unsplash

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Monday, December 17, 2018

Wednesday, December 12, 2018

Monday, December 10, 2018

How Much Does College Cost in 2019?

What goes into the price of a college degree, and how can you minimize your costs?

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Antihypertensive drugs for primary prevention – at what blood pressure do we start treatment?

The Question

Clinical guidelines generally recommend initiating antihypertensive drug therapy in most patients with systolic blood pressure (SBP) over 140 mm Hg or diastolic blood pressure (DBP) over 90 mm Hg, even if they do not have a history of cardiovascular (CV) disease, e.g., myocardial infarction, stroke, or heart failure. This is to prevent these and other complications of hypertension (primary prevention). The 2017 AHA/ACC guidelines even recommend initiation if blood pressure is over 130/80 mm Hg if their expected 10-year chance of these complications is 10%. Some guidelines, such as the 2018 Hypertension Canada guidelines, recommend the same threshold if patients have diabetes. However, a recent Therapeutics Initiative Letter concluded that “in mild hypertension (140-159/90-99) antihypertensive drugs have not been proven to reduce mortality and morbidity.” Why is there such a discrepancy?

The Evidence

Background

From a meta-analysis of observational studies published in 2002 in the Lancet, we know that increasing blood pressure is associated with CV diseases starting as low as 115/75 mm Hg. However, this by itself does not guarantee that simply lowering blood pressure with medications will reduce risk of CV disease. After all, well-done observational studies also showed that increased vitamin E intake was associated with reduced CV disease, but later randomized controlled trials (RCTs) showed that taking vitamin E supplements had no benefit.

A meta-analysis of RCTs of antihypertensive drugs was published in the Lancet in 2016 and showed similar proportional reductions in CV risk no matter the starting blood pressure, down to a starting SBP of <130 mm Hg. In other words, as long as the starting blood pressure was greater than about 120 mm Hg, lowering SBP with medications by 10 mm Hg yielded relative risk reductions of:

  • 20% for all major CV events, 95% CI: 17% to 23%
  • 17% for coronary heart disease (CHD), 95% CI: 12% to 22%
  • 27% for stroke, 95% CI: 23% to 32%
  • 28% for heart failure, 95% CI: 22% to 33%
  • 13% for all-cause death, 95% CI: 9% to 16%

For these outcomes, relative risk reductions increase with greater BP lowering, up to at least a 20 mm Hg reduction in SBP (e.g., a 20 mm Hg reduction would give about a 40% relative risk reduction in major CV events). However, this meta-analysis included trials where patients had already had a history of CV disease or were already on a blood pressure-lowering drug before the trial began (‘at baseline’). These limit the generalizability of these findings when we are wondering when to start these drugs as a form of primary prevention. Fortunately, the meta-analysis found that relative risk reduction was similar whether or not one had a history of CV disease. However, for more direct evidence, we will consider meta-analyses that have looked at this specific population more closely.

2012 Cochrane Review and 2015 BPLTTC Update

The Therapeutics Initiative based their conclusion on a 2012 Cochrane review which looked at and pooled RCTs carried out on patients with mild hypertension with no history of CV disease or renal failure. For an RCT to qualify, >80% of patients needed to fit this description, or it had to have available individual patient data. They found four such RCTs, with 8,912 participants. However, this number was still too low to be able to reliably detect any benefit from antihypertensive medications even if there was one, which lead the reviewers to state that “more RCTs needed as a significant benefit may have been missed.”

In 2015, the Blood Pressure Lowering Treatment Trialists’ Collaboration (BPLTTC) redid the exact same review, but because the BPLTTC has access to the individual patient data from more studies, they were able to add 6,361 participants to the 8,912 included in the Cochrane review. They detected statistically significant changes in some outcomes, but because 60% of the patients in the new data were already taking antihypertensive medications at baseline, its applicability is questionable. It is encouraging, though, that a subgroup analysis did not detect a difference in outcomes based on whether patients were taking antihypertensives at baseline.

Thomopoulos et al. 2014 and 2017

A similar meta-analysis published in 2014 in the Journal of Hypertension excluded trials where antihypertensive drug use at baseline was prevalent, although it did not exclude a history of CV disease. In a secondary analysis limited to trials or subgroups where the control arm had a 10-year CV death risk of 4.5% (roughly 15-20% risk of any CV event, correlating to primary prevention), they still found statistically significant reductions in risk of stroke, CHD, and all-cause death. CV death was borderline significant (RR = 0.57, 95% CI 0.32-1.02). This meta-analysis did not include the results of the HOPE-3 trial, which was published in 2016. This trial too showed that lowering SBP by a mean of 6 mm Hg yielded a reduction (RR = 0.73, 95% CI 0.56-0.94) in the composite outcome of CV death + nonfatal myocardial infarction + nonfatal stroke in the pre-specified subgroup with SBP >143.5 mm Hg (mean 154.1 mm Hg) of an entirely primary prevention population where roughly 22% of the trial participants were on an antihypertensive drug at baseline (although this percentage may have been higher with SBP >143.5 mm Hg). The rate of CV events in the placebo arm was 6.5% over 5.6 years.

A 2017 meta-analysis by the same group looked at the benefit of lowering blood pressure when starting SBP was below 140 mm Hg or starting DBP was below 90 mm Hg, again with minimal antihypertensive medications being taken at baseline. Patients could not have had recent myocardial infarction or heart failure, but a past history of CV disease was not excluded. Overall, a benefit was detected only in the composite outcome of stroke + CHD, mostly due to stroke prevention. However, no benefit was detected in the subgroup with 10-year CV death risk of 2.4%, which correlates best to a primary prevention population. The confidence intervals are relatively wide (e.g., for all-cause death: 0.93 to 1.31, for a SBP reduction of 5 mm Hg), meaning they are consistent with both the benefit seen at other baseline blood pressures as well as harm. In other words, this analysis may have been underpowered to detect an effect.

The Bottom Line

Overview meta-analyses of RCTs have shown that proportionate benefits of blood pressure reductions with drugs in outcomes such as CHD, stroke, all-cause mortality, or CV death, do not depend on baseline blood pressure, going down to <130 mm Hg. Sensitivity analyses did not show difference whether baseline blood pressure had been lowered with drugs or whether there was a history of CV disease. Combining this with the observational data that CV risk increases linearly with increasing blood pressure from 115/75 mm Hg gives us extrapolated evidence for risk reduction in all major outcomes even at low starting blood pressures.

More direct meta-analyses confirm that this is true for initial untreated blood pressure in the range 140-160/90-99 mm Hg in the outcomes of CHD, stroke, all-cause mortality, and likely also CV death, at least in patients with intermediate CV event risk (15-20% 10-year risk). When starting SBP is below 140 mm Hg, direct evidence of benefit is only available for stroke in patients with a 10-year CV death risk of >10% and a history of CV disease. In other words, direct evidence is absent for initiating antihypertensive drugs when blood pressure before any drug therapy is below 140 mm Hg in a primary prevention setting. However, clinicians may feel the extrapolated evidence is strong enough to consider it in high-risk primary prevention patients.

In deciding when to begin antihypertensive drug therapy, decision making should be aided by considering the absolute risk reductions in outcomes, an overall estimate of which can be calculated by multiplying the relative risk for major CV events found in meta-analyses (e.g., from the 2016 Lancet meta-analysis: 0.8 for a 10 mm Hg reduction in SBP) by a predicted absolute CV risk like the Framingham Risk Score, which has been validated for that region. A patient with mild hypertension could very well also have relatively low CV risk (e.g., 5% over 10 years) and may decide that a 1% absolute risk reduction over 10 years is too little for starting drugs to be worth it. It should also be noted that a 10 mm Hg reduction in SBP is harder to achieve when starting blood pressure is already relatively low, so even this risk reduction may be an overestimate unless multiple medications are used. Different patients will make different decisions.

References

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Friday, December 7, 2018

Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial: Critical appraisal

This blog is a critical appraisal of the following randomized controlled trial: Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain

Background

Non-specific low back pain (NSLBP) is described as that which has no specific known cause, with ‘chronic’ referring to persistent pain lasting a minimum of 12 weeks (Airaksinen et al. 2006). NSLBP has an extreme worldwide prevalence, and is the leading cause of missed work days worldwide (with the UK racking up 100 million per year), due to any disease/injury (WHO 2013). Although exercise therapy is the first call treatment method (as per European guidelines), there lacks a consensus on the most effective form of exercise due to the lack of evidence. However, there are numerous studies being carried out aiming towards such answers.

The study

This was a single-blinded randomised control trial (RCT) comprising of 120 participants following rigorous screening to rule out any conclusive reasoning for the pain. 12 participants dropped out for various reasons and this is well documented within a flow sheet. This left 108 participants in the study, with all undergoing a lumbar spinal examination before treatment commenced. The purpose of this study was to determine whether core strengthening exercises, as explained by Kisner, had any better outcome in the management for NSLBP, compared to routine exercise therapy. This was carried out in the form of a RCT, with routine exercise set as the control, and all patients receiving a baseline treatment of Transcutaneous electrical nerve stimulation (TENS) and ultrasound, as well as a home exercise routine.

The initial participants were randomly allocated to the control or core exercise group via computer randomisation, and blinded from their treatment method. With pain being the focus of the study, this was measured using the visual analog scale (VAS), with scores being recorded at the end of the 2nd, 4th and 6th week and compared with the baseline measurement taken before treatment commenced.

Results

The results reported from this study showed that the use of both exercise methods proved to be effective in the management of lower back pain statistically, with p = 0.01 in both groups respectively. However, there was a much greater clinical significance in pain reduction from the core stabilisation group (mean VAS reduction > 3cm (Lee et al. 2003)), proving that this was the most effective treatment approach for NSLBP.

Strengths and weaknesses of the study

In order to interpret this information more accurately, the CASP RCT tool was used as a guide to develop a systematic approach. At first glance this study presents a clearly focused issue as it covers all aspects in terms of intervention and comparators given, considered outcomes, and the population at hand.

However, researchers designed this trial following a pilot study which used a formula outlined by Sakpal in 2010. This provided a minimum requirement of subjects (100) which researchers were able to recruit, allowing them to complete the study with above minimum requirements following 12 drop outs. Although adequate numbers were used, this cohort does not provide any clinical significance as this study only includes members of the Pakistani population (within Lahore). In order for this to have any significance clinically, this would need to include a more heterogeneous population as height, body weight and structure vary considerably across various cultures.

All participants were accounted for via a flow chart, with tables displaying the groups equality in terms of height, weight, BMI and age, however, they failed to highlight the male : female ratio. It is well known that there are physical differences between males and females, with women experiencing pain much more intensely (Stanford medicine 2012), and LBP much more frequently than men (Hoy et al. 2012). By using a single outcome measure based solely on individual’s feedback on pain, this could have an indirect impact on the outcome should one group have a greater female population. And, although VAS is a well renowned and reliable assessment tool (Hawker et al. 2011), secondary outcome measures could be used to provide more clinically relevant results, as pain has a major impact on functional ability and quality of life (Dueñas et al. 2016).

In order to reduce bias and increase internal validity, patients were blinded to the treatment they received following random allocation via the use of a computer generated random numbers table. However, in this case, both groups were treated by the same therapist (most likely due to the number of researchers involved), combined with the nil blinding of the assessors/analysts means there is a much greater potential for rater bias (Karnicolas 2010).

Although all received baseline treatment, there is no follow-up or record of compliance with home programmes (which are undisclosed), which may have impacted results. With statistical significance shown across the board, the clinically significant reduction in pain within the core exercise group could simply be due to greater compliance with home programmes.

Conclusion

Results of the original study show that the use core stabilisation exercises in pain management for NSLBP is more effective than routine exercise methods. However, limitations described show there is a need for further research to include more heterogeneous population groups, an increase in blinding within the trials, and methods to ensure consistency in compliance throughout the patient groups involved in order to increase the validity and clinical impact of the research.

References

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Thursday, December 6, 2018

Effectiveness of Aquatic Exercises in Women with Rheumatoid Arthritis: A critical appraisal

This blog is a critical appraisal of the following randomized controlled trial: Effectiveness of Aquatic Exercises in Women With Rheumatoid Arthritis: A Randomized, Controlled, 16-Week Intervention-The HydRA Trial.

Background

Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation of the joints. Typical symptoms of RA are pain, swelling and stiffness in the joints, and fatigue. RA may affect adults at any age, but starts most commonly in adults aged between 40 and 50. Women are affected more than men. Treatment options usually consist of medication, therapy, and/or surgery to correct any joint problems (Arthritisresearchuk.org, 2018) (nhs.uk, 2018). Hydrotherapy is used by some as treatment for RA, and involves special exercises carried out in a warm pool. The water supports the patient’s weight, and the heat is found to relieve arthritic pain (Arthritisresearchuk.org, 2018).

What was the study?

This study aimed to compare the effectiveness of water-based and land-based exercises in women with RA, assessing the outcomes of muscle strength (MS) in flexion and extension of the knee, disease activity, functional ability and body composition. The study recruited a total of 133 women, aged between 40 and 65 years, with a diagnosis of RA, all from the Rheumatic Diseases outpatient clinic in Sao Paulo, Brazil. 33 women were excluded for various reasons, and 100 were randomly allocated by a computerized randomization table into three groups; Land-based (LB), water-based (WB) and control group (CG). The LB performed only aerobic land-based exercises, while the WB only performed aerobic exercises in water, following the same protocol three times per week. The patients in the CG were instructed not to change their routines or participate in any other physical activities during the time of intervention. 18 patients were discontinued from the study due to poor adherence, loss of follow-up and 1 death. To minimise bias the data were analysed by intention to treat.

The groups were evaluated by a blinded physiotherapist and rheumatologist three times – the first time at randomization, then after 8 weeks of intervention and lastly at the end of 16 weeks. The main outcome measures for this study were a Biodex multi-joint system 3 PRO isokinetic dynamometer for muscle strength, Disease activity score 28 erythrocyte sedimentation rate for disease activity, Health Assessment questionnaire-modified to assess function and a whole body bone densitometry using a densitometer for body composition.

What were the results?

The study found that aquatic exercise had a significant improvement on disease activity and functional activity after 8 and 16 weeks in women with RA, as well as reduced daily intake of NSAID’s, compared to land-based exercise and control group. However, there was no significant increase in flexor and extensor MS of the knee or body composition.

Strengths and weaknesses

This study was a randomized controlled trial where randomization was carried out through a randomization table generated by a computer program, which is the ideal method of randomization. This ensures there are no systematic differences between the intervention groups that may affect the outcome of the trial. All three groups were similar and comparable at baseline, with no significant differences that could affect outcome. The sample size required was calculated to 27 patients in each group, in total 81 patients. 100 patients were recruited and randomized, which means the sample size reflects the target population more accurately, increasing the internal validity of the study.

However, the researchers have chosen to only include women with RA in this trial, which does not accurately represent the entire population of people with RA, meaining the outcome of this trial may only be generalized to women with RA. For this study to be representative for the entire population of patients with RA, the study should have included an equal amount from both genders.

Furthermore, the participants are only recruited from the Rheumatic Diseases outpatient clinic at Federal University of Sao Paulo in Brazil. There is evidence suggesting that lifestyle factors may affect inflammation and RA (Arthritisresearchuk.org, 2018). Recruiting patients from one clinic only affects the internal validity of the trial, increasing the risk of bias sampling towards the social class going to that clinic, which may have a different lifestyle to patients in other clinics.

By the nature of the interventions, neither physiotherapist nor patient could be blinded, increasing the risk of bias towards the care delivered by the physiotherapist as well as the patient’s motivation and expectations influencing outcome. To reduce the risk of bias and ensuring that all the patients were treated the same, the evaluator was blinded and a defined standard procedure was made for assessment which improves this trials internal validity. The study mentions a research protocol was made, and thoroughly explains the trial, allowing the trial to be reproduced.

Conclusion

The findings in this good quality randomised control trial suggest that water-based aerobic exercise is beneficial in treating women with RA regarding disease activity and functional ability. In order to change practice, further research must be done including a wider sampling and possibly including nutritional/lifestyle factors.

References

Arthritisresearchuk.org., 2018. What causes rheumatoid arthritis? | Arthritis Research UK. [online] Available at: https://www.arthritisresearchuk.org/arthritis-information/conditions/rheumatoid-arthritis/causes.aspx [Accessed 12 Jan. 2018].

Arthritisresearchuk.org., 2018. What is hydrotherapy? | Arthritis Research UK. [online] Available at: https://www.arthritisresearchuk.org/arthritis-information/therapies/hydrotherapy/what-is-hydrotherapy.aspx [Accessed 12 Jan. 2018].

Arthritisresearchuk.org., 2018. What is rheumatoid arthritis? | Arthritis Research UK. [online] Available at: https://www.arthritisresearchuk.org/arthritis-information/conditions/rheumatoid-arthritis/what-is-rheumatoid-arthritis.aspx [Accessed 12 Jan. 2018].

nhs.uk., 2018. Rheumatoid arthritis. [online] Available at: https://www.nhs.uk/conditions/rheumatoid-arthritis/ [Accessed 11 Jan. 2018].

Siqueira, U., Orsini Valente, L., de Mello, M., Szejnfeld, V. and Pinheiro, M. 2017. Effectiveness of Aquatic Exercises in Women With Rheumatoid Arthritis. American Journal of Physical Medicine & Rehabilitation, 96(3), pp.167-175.

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Effectiveness of robotic-assisted gait training in stroke rehabilitation: A retrospective matched control study

This blog is a critical appraisal of the following randomized controlled trial: Effectiveness of robotic-assisted gait training in stroke rehabilitation: A retrospective matched control study

Background

Stroke occurs due to the disruption of oxygen transportation to the brain. An impairment associated with stroke is the loss of motor function resulting in decreased mobility. Physiotherapy intervention is required as a result and early rehabilitation is beneficial. Robotic-Assisted gait training (RAGT) is a new physiotherapy approach that incorporates repetitive task-specific practice to promote mobility and improved motor function.

What was the study?

This study aims to compare the RAGT approach compared to traditional physiotherapy intervention in promoting motor function recovery post stroke. 41 patients with subacute stroke (4-31 days post stroke) were selected in total. All patients were selected from the same ward and treatments were delivered by the same physiotherapy team 5 days per week.

14 participants received the robotic system device RAGT intervention which involved wearing a motor driven orthosis to assist in lower limb training. The patient’s whole body weight was supported over a treadmill throughout. The patients lower limbs were then guided by a speed controlled treadmill in order to induce the stance and swing phase of the gait pattern. These were selected due to the fact they had received four or more previous RAGT sessions.

The other 27 participants received traditional physiotherapy treatments for stroke rehabilitation to correspond with the Hong Kong Hospital Authority protocol. These approaches involved limb mobilisation, muscle tone normalisation, muscle strengthening, electrical muscle stimulation, transfer training, gait training and balance training.

The study used 4 functional outcome measures to assess the intervention, including the Modified Functional Ambulation Category (MFAC), Modified Rivermead Mobility Index (MRMI), Berg balance Scale (BBS) and Modified Barthel Index (MBI). Factors that were assessed included ambulation, mobility, balance and ADL’s of the participant. These measures were then used to compare the RAGT group with the control group in both pre- and post-intervention.

Results

According to the study, those in the RAGT group showed higher changes in all functional outcome measures than those in the control group. Greater improvements were identified in MFAC, MRMI, BBS and MBI scores for those receiving the RAGT intervention.

Strengths & Weaknesses of the study

To critically appraise this study, the CASP Case Control Study tool was used, with study aim and objectives, participant selection and results and outcomes all addressed during this study.

One striking weakness of this study was the small sample size. Due to the strict inclusion/exclusion criteria such as age, session participation, post stroke ability, the sample size was limited. Although the starting number of patients screened was 1,170, only 41 in total were suitable. An unequal sample size in each group was seen, as the control group consisted of a much larger sample. In order to develop a more significant data set a larger sample size would be required. The strict exclusion criteria made it difficult to maintain a larger number of participants. The time period that the study was conducted over (which was a year) was appropriate, however a larger sample size over this time could possibly have been more beneficial.

Aspects of the methods used noted that participant’s time in each session lasted 60-90 minutes, illustrating that not all participants received the same amount and it was judged on the tolerance of the patient. This means that some participants received more session time per week which could have affected the final results.

The allocation of the groups could have resulted in selection bias as the RAGT group had a specific criteria of four or more RAGT sessions. This familiarity with the treatment could ultimately lead to more favourable results. While blinding in this case could not be achieved it may lead to rater bias.

The study attempted to limit bias through a strict participation criteria, this meant that it resulted in a high drop-out level among patients. This approach strengthened the validity of the results as all participants were similar when starting the study with homogeneity being maintained in terms of age, duration of stroke and functional ability on admission. No significant differences (p<0.05 in all post recording), proving that higher gains were seen in the RAGT intervention group.

In addition, the implementers were all trained physiotherapists qualified to work both with the traditional physiotherapy group (control) as well as being certified to use the Lokomat Pro (robotic device) in the RAGT sessions.

Conclusion

The research indicates that the use of RAGT as a treatment method for stroke rehabilitation is beneficial and shows higher levels of improvement than just using traditional treatment methods. The findings need further research, and a larger sample size would also provide greater significance for future reference. Randomisation of participants may also be more beneficial as it may limit any possible selection bias.

References

• SALTER K, CAMPBELL N, RICHARDSON M, MEHTA S,JUTAI J, ZETTLER L, MOSES M, A & MAYS R. (2013). Outcome Measures in Stroke Rehabilitation. Evidence-Based Review of Stroke Rehabilitation.42-73.
• PING HO CHUNG B. (2017). Effectiveness of Robotic-Assisted Gait Training in Stroke Rehabilitation: A Retrospective Matched Control Study. Hong Kong Physiotherapy Journal. 36, 10-16.
• CRITICAL APPRAISAL SKILLS PROGRAM (CASP)- MAKING SENSE OF EVIDENCE. (2017). Case Control Checklist. Available: http://docs.wixstatic.com/ugd/dded87_63fb65dd4e0548e2bfd0a982295f839e.pdf. [Last accessed 20 Dec 2017.]
• KOPEC J & ESDAILE J. (1990). Bias in Case-Control Studies. A Review. Journal of Epidemiology and Community Health. 44(3): 179-186.

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Acapella vs. PEP mask therapy: A randomised trial in children with cystic fibrosis during respiratory exacerbation. A critical appraisal

This blog is a critical appraisal of the following randomized controlled trial: Acapella vs. PEP mask therapy: A randomised trial in children with cystic fibrosis during respiratory exacerbation

Background

Cystic fibrosis (CF) is an inherited genetic disease which is caused by a fault in the gene cystic fibrosis transmembrane conductance regulator (CFTR). When this gene becomes faulty it causes thick mucus to block the airways which makes it harder to breathe (Pelliccia 2017).

Physiotherapy for CF primarily consists of respiratory physiotherapy. Research which has previously been carried out has focused on positive expiratory pressure (PEP) therapy and postural drainage (Lannefors et al 1992, McIlwaine et al 1997 and Mortenson et al 1991).

What was the study?

The randomised trial recruited 23 participants, ranging from 7-18 years old. The trial participants were patients with CF who were admitted to hospital for a 10-day period with a respiratory exacerbation.  A power analysis was completed to determine how many participants were needed to give a statistically significant result. The eligibility criteria was set alongside an inclusion and exclusion criteria. The inclusion criteria was that the patient had to have previous experience with home PEP treatment, they could perform a lung function test reliably and were able to expectorate secretions successfully into a cup. Patients were excluded if they had a predicted FEV1 less than 30%; they required two or more physiotherapy sessions each day; they required supplementary oxygen; suffered from haemoptysis; were unable to complete standard PEP therapy; had surgery the previous month; and had a history of non-compliance with physiotherapy.

The purpose of the study was to investigate whether there were differences in lung function, exercise performance, weight of secretions and user satisfaction with the Acapella compared with PEP among children with CF admitted to hospital for ten days for intravenous antibiotics. Participants were given two treatment sessions each day. They were given the PEP mask or Acapella. Each session was standardised to ten sets of ten breaths followed by one or two huffs then a cough; this was carried out seated. The pressure of each device was also standardised to reflect normal clinical practice.

Groups were allocated by placing paper (18 PEP and 18 Acapella) into a double sealed envelope. A blinded researcher allocated groups by pulling paper from the envelope. They were not involved in the recruitment, assessment or treatment of the trial. Outcome measures used were a lung function test, 10m shuttle test, total of secretions expectorated and the chest physiotherapy patient satisfaction survey. All were measured at the beginning (baseline) and after ten days. The lung function test and 10m shuttle test were blinded.

Results

The study concluded that there was no statistically significant difference between the PEP group or Acapella group for any outcome measures.

What are the strengths and weaknesses of the study?

To critically appraise the article fully the Understanding Health Research tool was used.

The paper had many strengths throughout, one being that the research was carried out and funded by The Children’s Hospital Westmead Australia and there were no conflicts of interest. The trial was also reviewed and approved by an ethics committee. The authors provided clear research questions and aims which were all answered by the end of the paper. Both the sample size and withdrawal of one participant were explained and justified.  The paper only applied their findings to their population group. The trial was single-blinded, the allocation of groups was blinded and the lung function tests and 10m shuttle test. In the results, both the mean and standard deviation were given which implies the data was normally distributed. In regards to outcome measures, all four were clearly defined and explained. The modified 10 metre shuttle test has been found to be an appropriate outcome measure. It is both reliable, repeatable and sensitive (Bradley et al 2000). Although this relates to adults with CF it can be carried over to children as it is simple both to carry out and understand.

Although the paper was carried out to a high quality there were some weaknesses. One weakness of the trial was that it did not include a control group. By not including a control group, comparisons cannot be made to inform as to whether there were any changes in the health of participants caused fully by either the PEP or Acapella. The sample size of twenty-three children is a limitation as to the strength of this research as it is a small population. Although the trial was single-blinded it was not possible to double-blind the trial as those giving the treatment had to be aware of which intervention to give. The research found there was no clinically relevant findings to take into practice. The p values as stated in table two reiterates the fact that there is no difference between PEP and Acapella. In terms of outcome measures, the reliability of the chest physiotherapy patient satisfaction survey may be questioned as it is stated in the paper that parents were able to help participants. The researchers may have used a modified or diagram only outcome measure which the younger participants could complete independently.

Conclusion

To conclude, the study found no significant difference between PEP and Acapella in the treatment of children with CF and a respiratory exacerbation. Further research should be completed to decipher a conclusive answer with a larger sample size and control group.

References

The post Acapella vs. PEP mask therapy: A randomised trial in children with cystic fibrosis during respiratory exacerbation. A critical appraisal appeared first on Students 4 Best Evidence.

Hydrotherapy Versus Conventional Land-Based Exercise for the Management of Patients With Osteoarthritis of the Knee: A critical appraisal

This blog is a critical appraisal of the following randomized controlled trial:  Hydrotherapy versus conventional land-based exercise for the management of patients with osteoarthritis of the knee

Background

Osteoarthritis (OA) is highly prevalent and it is the leading cause of disability worldwide (Vina and Kwoh 2017). Knee OA patients are likely to have complex and multifactorial joint degeneration which negatively affects their physical and mental well-being. Despite being highly used in physiotherapy, the clinical evidence of knee OA hydrotherapy is poor. Therefore, this clinical trial evaluated the effectiveness of knee OA hydrotherapy and compared the outcomes with conventional land-based exercise users.

What was the study?

64 participants with knee OA were selected with inclusive criteria from one local hospital in Brazil. Researchers allocated all the participants to either the water-based or land-based exercise group randomly. Then, exercises such as strengthening and stretching of lower extremity muscles and gait training were instructed by 2 physiotherapists, who crossover between groups every week. The duration of the study was 18 weeks.

The primary outcome was pain which was measured by the visual analog scale (VAS). The secondary outcome consisted of Lequesne Index for knee OA, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), VAS for pain and time during the 50-foot walk test (50FWT), and the amount of non-steroidal anti-inflammatory drugs taken. All outcomes were measured by an independent investigator at baseline, 9 weeks and 18 weeks from the start of the program.

Results

The two groups had similar pain reduction and improvements in WOMAC, Lequesne index and the 50FWT throughout. The water-based group had resulted in a greater reduction of pain than the land-based group before and after the 50FWT test at the end of the study.

The weaknesses and strengths of the study

First of all, the sample size of the study was significantly small, consisting of 64 participants from the same hospital in Brazil. Highlighted by an observational study, the burden of knee OA in Latin American countries is highly related to demographic, ethical, methodological, and health care accessibility factors (Burgos-Vargas et al. 2014). These factors can lead to various results over different patient cultures. Therefore, a larger sample size should be implemented to get a more clinically significant result.

Although the two groups were similar in terms of demographic background, the male to female ratio in both groups differed significantly (water-based group: 2 male, 30 female and land-based group: 3 male, 29 female). Researchers suggested that women are more sensitive to pain than men (Stanford medicine 2012), thus increasing the risk of bias in the outcome: VAS for pain. According to a study, women have a significantly larger amount of cartilage loss and a greater OA heritability than men (Price and Herndon 2009). This may lead to a gap between genders in the development of OA. Moreover, it is suggested that there were more men with knee OA onset than women among Brazilians (Burgos-Vargas et al. 2014). Therefore, since the gender ratio in this study is significantly unequal when compared to the total knee OA population in Brazil, it may threaten the external validity of the study.

Moreover, the lack of control group is an obvious weakness of this study. Regarding the gold standard of a clinical trial, a control group is fundamental to show the effects of an intervention when comparing the intervention group and the control group (DeMets 1985). Although researchers had highly considered the previous positive evidence of conventional land-based exercises, they were still unable to rule out that improvements from both groups could be contributed by factors other than the intervention (e.g. duration of physiotherapy, degree of patients’ motivation and attention).

Regarding the strengths of the study, the participants were randomly allocated to groups by block randomisation and all results were measured by a blinded investigator to enhance internal validity. In the exercise program, modifications of land-based exercise were made to be performed in an aquatic setting. Therefore, the same types of exercises were used among participants, thus reducing the risk of bias. Although it was impossible for the instructors to be blinded, they crossed over between groups every week throughout the protocol to minimise factors which may alter the result. For example, the instructors skill level, amount of intervention time from each instructor and the degree of motivation from participants could cause bias in this study.

In fact, the participation rate from the water-based group (96%) is greater than the land-based group (81%), which implies a higher adherence to the intervention. It is known that adherence of the patient is essential to enhance functional ability, well-being and quality of life (Belza et al. 2002). Therefore, patients in the water-based group may be relatively more willing to follow the protocol, which could be a significant factor that alters the outcome. Although there were 7 drop-outs throughout the study due to various reasons, all data were analysed according to the intention-to-treat principle, which gives an unbiased estimation of the treatment effect (Sedgwick 2013). This study was superior to previous studies regarding the duration of intervention, lower mean age of participants and functional outcome measures.

Conclusion

Hydrotherapy was superior to conventional land-based exercise in terms of pain relief before and after walking. It showed that hydrotherapy is effective and should be included in the therapeutic approaches recommended for knee OA patients. Future research should investigate the improvement of strength and long-term effects of hydrotherapy.

References

The post Hydrotherapy Versus Conventional Land-Based Exercise for the Management of Patients With Osteoarthritis of the Knee: A critical appraisal appeared first on Students 4 Best Evidence.

A esperança pode levar a expectativas não realistas

Tuesday, December 4, 2018

Cochrane Crowd for students: what’s in it for you?

Cochrane Crowd’s Community Engagement and Partnerships Manager Emily Steele, and Co-Leader Anna Noel-Storr blog about the benefits for students of getting involved with Cochrane Crowd, Cochrane’s citizen science platform.

Student readers, do you realise that Cochrane’s citizen science platform Cochrane Crowd offers some wonderful and tangible benefits for students? By getting involved with Cochrane Crowd, you contribute to Cochrane’s mission of improving health evidence while at the same time adding to your student portfolio, improving your CV, earning Cochrane Crowd badges, working towards full Cochrane Membership, upskilling in health evidence and keeping abreast of the latest literature. Talk about an all-out win for everyone involved!

Take a look at this 2-minute introduction to Cochrane Crowd and then read on for five benefits of joining Cochrane Crowd as a student.

1. Earn a Certificate of Achievement for your student portfolio or CV

We know it’s important to build up your portfolio and CV, so once you’ve contributed 200 or more classifications to Cochrane Crowd you become eligible for a Certificate of Achievement. Since Cochrane is the global leader in health evidence synthesis, this is bound to impress, right!? Just email us at crowd@cochrane.org once you’ve reached 200 and let us know you’d like a certificate.

2. Become eligible for Cochrane Membership

If you’re a die-hard Cochranite, you might know it’s possible to earn Cochrane Membership. While everyone is invited to join Cochrane as a Cochrane supporter, once you’ve contributed in a substantive way you are offered membership, which allows you to vote in Cochrane elections, stand for internal governance positions – and let’s face it , would be another great addition to your student portfolio and CV.

By completing 1,000 classifications across Cochrane Crowd’s key tasks, you’ll receive an invitation to become a Cochrane Member. You can read more about the Cochrane Membership scheme here and here.

3. Build a collection of Cochrane Crowd badges

Anyone other than me enjoy prize incentives? Good. You’ll earn badges for every task within Cochrane Crowd: a green badge once you finish task training, bronze once you classify 100 studies, through to silver and finally a gold badge once you’ve completed 1,000 classifications. Exceptional members who are highly accurate will become tasks experts and receive purple badges. Full flush of purple, anyone?

4. Build expertise in health evidence

There are learning pathways built into Cochrane Crowd, so you’ll build health evidence skills within our supportive environment. Some of the opportunities we offer include the following:

  • When you first join Crowd you have access to our beginner-level tasks. As you progress, more challenging tasks become available.
  • We provide interactive training modules for each Cochrane Crowd task: you get immediate feedback as you progress through the exercises.
  • You can monitor your accuracy on each Crowd task through the History and Settings buttons, accessible on your dashboard. Celebrate your accurate classifications, and learn from your mistakes.

5. Keep up with the literature

If you’re passionate about a particular health topic, you can focus on that topic in Cochrane Crowd. For each task simply go to the History and Settings button/Settings tab, and enter the topic under Prioritise Records I Receive. Et voila! You’ll be reading up on your favourite topic while screening for Cochrane Crowd.

And, coming soon…

 As if all that wasn’t enough, two further developments in Cochrane Crowd that we hope will appeal to students are coming soon. The first is called Screen4Me. This is where Crowd contributors can get involved in helping screen search results for specific Cochrane reviews. We hope to launch Screen4Me by the end of the year! The second is a student pathway designed especially for studentsmade up of Crowd tasks in combination with more traditional learning modules, guiding students through a range of topics and activities from understanding study designs and PICO, through to critical appraisal and nitty gritty statistical issues.

So, what are you waiting for? Hop over and join Cochrane Crowd here.

Anna Noel-Storr is the Information Specialist for the Cochrane Dementia and Cognitive Improvement Group and also works on a number of projects including Cochrane Crowd.

If you love Crowd and think it would work for your course why not tell your lecturer about Cochrane Classmate? In Classmate, they’ll be able to set up Crowd challenges where you and your classmates collectively screen as much as possible in a set period of time. Believe us, it’s lots of fun!

And if you’re interested in contributing directly to Cochrane systematic reviews, you might also like to take a look at Cochrane’s TaskExchange platform: look out for the green leaf tasks specifically aimed at evidence newcomers!

Sign up to Cochrane Crowd, follow us on Twitter and contact us at crowd@cochrane.org.

Support for Project Transform was provided by Cochrane and the National Health and Medical Research Council of Australia (APP1114605). The contents of the published material are solely the responsibility of the Administering Institution, a Participating Institution or individual authors and do not reflect the views of the NHMRC.

 

The post Cochrane Crowd for students: what’s in it for you? appeared first on Students 4 Best Evidence.

Monday, December 3, 2018