Effectiveness of different exercises and stretching physiotherapy on pain and movement in Patellofemoral Pain Syndrome: A critical appraisal

This blog is a critical appraisal of the following randomized controlled trial: Effectiveness of different exercises and stretching physiotherapy on pain and movement in patellofemoral pain syndrome: a randomized controlled trial.

Background

Patellofemoral pain syndrome (PFPS) is patella pain accompanied with high load activity in knee flexion or extension, therefore it is predominately seen in sports medicine clinics (Petersen et al., 2013). PFPS is prevalent mainly in young females. Evidence supports non-surgical treatment and focusing on physical functional issues. Literature has supported and has evidence that taping, exercise programs, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and possibly foot orthosis or patella braces are all valid interventions, but these are all short-term solutions.

What was the Study?

This study’s researchers enrolled 74 patients that met the following criteria; A pain history of more than 6 months with no previous history of Apophysitis or osteoarthritis; and they had to have positive results in the Patellofemoral Grinding test and Patellofemoral compression test.

The purpose of this study was to compare the efficacy of proprioceptive neuromuscular facilitation (PNF) combined with exercise, stretching intervention, and educational intervention at improving function and pain in PFPS patients. The participants were sorted into three groups: a control group, classic stretching group, and a PNF stretching group. The stretching intervention consisted of following a soft tissue protocol from a study published by Syme et al involving active exercises and stretching exercise for hip and knee muscles (including quadriceps, hamstrings, iliotibial band, gastrocnemius, soleus, and anterior hip structures). The active exercises within the study focused on quadriceps strengthening, but did not specify which exercises were included. The PNF stretching group followed the PNF stretching protocol which is applied to the quadriceps and hamstrings – the study included a detailed plan that was quite specific. The aerobic exercise portion was only 45 minutes conducted by a personal trainer, however there were no specific exercises stated. A control group received health education around PFPS and were advised not to follow any interventions until after the trial.

Randomisation was completed by a random number generator in blocks of eight with no stratification. The person in charge of randomisation was different to the blinded assessor in charge of eligibility. The outcome measures were Anterior knee pain scale, Visual Analog Scale (VAS) for pain, Patellofemoral compression test, Patellofemoral grinding test, Quadriceps angle, Thigh perimeter, and Knee range of motion. Baseline measures were taken and then a 4-month follow up measurement was taken from all participants.

What were the results?

The p-value was ≤ 0.001 in the intervention groups, which is smaller than the alpha value from the study that was set at 0.05, observing that the outcome measures showed an increase in pain relief and function after the two interventions. The control group was shown to have a p-value of 0.621. This shows there is a significant difference in the results from pre-to-post intervention.

To apply the therapy interventions the confidence interval (CI) needs to be considered, in this case they used a 95% CI. This is valid because it says that 95% of the time this study is done it will replicate these results.

What were the strengths and weaknesses of the study?

To evaluate a study in more depth a guideline must be used, in this critical appraisal the Centre for Evidence-based medicine (CEBM) RCT tool was followed. The study detailed all features of the PICO question – Population, Interventions, Control, and Outcome measure, some in more detail than others.

The population section had a few aspects that could be a deficiency in the study. The sample size was small (74 participants) for the prominence of this condition. This may have been avoidable if there was recruitment following the same eligibility criteria from more than one physiotherapy clinic. The groups had an equal spread of participant characteristics apart from the male to female ratio. This condition occurs mainly in young females yet there were predominately more males in all three groups.

During follow-up treatment, it is stated that 2 participants were ‘lost’, however there is no intention-to-treat analysis for missing data.

This study had a randomised allocation through a number generator and the assessor involved in eligibility was not involved in randomisation which was carried out off site. The assessor may have been blinded to the specific treatment of the participants, but the physiotherapist cannot be blinded in a clinical intervention as they must oversee the treatment. Also, the participants were not blinded for ethical reasons. Lack of bias creates a clinically accurate study.

Conclusion

The findings of the study discussed using Proprioceptive neuromuscular facilitation techniques and aerobic exercise which showed a decrease in pain and an increase in function in this intervention group vs the stretching group. There needs to be a larger scale study with more participants, particularly more female participants due to the prevalence in this group. Also, the two intervention groups were quite close so a further follow up would have helped determine more information about the different treatments specificity.

References

CEBM. (2017). Critical Appraisal tools – CEBM. [online] Available at: http://www.cebm.net/blog/2014/06/10/critical-appraisal/ [Accessed 12 Dec. 2017].

Petersen, W., Ellermann, A., Gosele-Koppenburg, A., Best, R., Rembitzki, I., Bruggemann, G. and Liebau, C. (2014). Patellofemoral Pain Syndrome. Knee Surgery, Sports Traumatology, Arthroscopy, 22(10), pp. 2264-2274.

Revelles Moyano, F., Valenza, M., Martin Martin, L., Castellote Caballero, Y., Gonzalez-Jimenez, E. and Valenza Demet, G. (2012). Effectiveness of different exercises and stretching physiotherapy on pain and movement in patellofemoral pain syndrome: a randomized controlled trial. 27(5):409-417.

Syme G, Rowe P, Martin D and Daly G. (2009) Disability in patients with chronic patellofemoral pain syndrome: a ran­domised controlled trial of VMO selective training versus general quadriceps strengthening.Man Ther, 14(3): 252–263.

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Responsiveness of Myofascial Trigger Points to Single and Multiple Trigger Point Release Massages: A critical appraisal

This blog is a critical appraisal of the following randomized controlled trial: Responsiveness of Myofascial Trigger Points to Single and Multiple Trigger Point Release Massages

Background

During a recent Musculoskeletal (MSK) placement, I encountered the use of trigger point therapy for treatment of a skeletal muscle disorder characterised by regional muscular pain (myofascial pain syndrome [MPS]).

Myofascial trigger points (MTrPs) are nodules in a tight band of skeletal muscle which have an exaggerated response to moderate stimuli. These MTrPs are present in patients with MPS. In tension-type headache (TTH), a type of MPS, MTrPs in the cervical muscles have been identified as potential treatment sites for pain reduction (Fernández-de-las-Peñas et al., 2011). However, placebo-controlled studies on the effect of multiple sessions of massage on MTrPs are currently lacking.

Study Methods

The aim of this study was to assess changes in MTrP pressure-pain threshold (PPT) after single and multiple massage interventions at two muscles in patients with TTH. A total of 69 subjects were screened against eligibility criteria, with 7 subjects excluded; therefore, 62 subjects were randomised. The study subjects were assigned to treatment using block randomisation and the study statistician was blinded to group allocation.

The intervention was twice-weekly massage for 6 weeks, which was compared to sham ultrasound for 6 weeks or wait-list control. In each subject, MTrPs were identified by massage therapists using published criteria and the PPT of the bilateral upper trapezius and suboccipital muscles was assessed before and after the first and last intervention sessions or at a time-matched period for the wait-list control group. The primary outcome measure was algometric assessment of PPT at a MTrP.

Study Results

This study showed that single and multiple massage applications increased PPT at MTrPs when compared to placebo or wait-list control interventions in subjects with TTH. Additional gain in PPT was observed even after multiple massage treatments, suggesting that the number and length of massage treatments needs to be optimised.

Critical Appraisal of Study

The strengths and weaknesses of the study design and the value of the evidence were assessed using the Critical Appraisal Skills Programme (CASP) randomised controlled trial tool as a basis to guide the appraisal. The study population, intervention and control groups, study endpoints, and assessments used were clearly outlined. In addition, the study protocol was registered with ClinicalTrials.gov which shows that the researchers were transparent in their methods and used a standardized protocol.

In order to reduce selection bias between the treatment groups, block randomisation was used. This also ensured that equal numbers of patients were assigned to each treatment group, which is particularly important when the sample size is small (Efird, 2011). Another commonly used method to reduce bias is the concealment of treatment group allocation through blinding (Karanicolas, et al., 2010). In this study, patients and therapists were not blinded to treatment group due to the nature of the interventions. However, the patients and the nurses performing the placebo control ultrasound were blinded to the sham nature of the technique. Also, the statisticians who analysed the outcome data were blinded to treatment group assignment. Thus, although this was not a fully blinded study, measures were taken to minimise bias during data analysis.

The main limitation of this study is that the sample size was very small. Although there was a statistically significant increase (p<0.05) in PPT in the massage intervention group, it cannot be concluded with any certainty that the same results would be obtained in a larger population. A small local sample of the TTH population is not necessarily truly representative of the wider global population of patients with this condition.

The primary endpoint of change in PPT was measured using an algometer, which is a validated technique (Kinser, et al., 2009), particularly when study staff are trained in its use as they were in this study. However, pain is always very subjective and so difficult to accurately measure. The researchers tried to control for changes in pain sensitivity over time by also measuring PPT on the tibia of each patient, and demonstrated no significant change. While change in PPT is a relevant and valid endpoint, a more pertinent question may have been whether massage therapy actually improved TTH symptoms, which was not addressed in this study. Perhaps this could have been included as a secondary endpoint.

Conclusions

This well-designed study clearly achieved its objective by showing a statistically significant effect of massage therapy on PPT of MTrPs. However, the evidence is not currently robust enough to lead to changes in clinical practice. Further studies are needed to test this technique on larger populations so that a systematic review of the overall evidence can be performed.

References

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When a Personal Loan Can Save You Money

More financial advisers are advising clients to consider personal loans to save on everything from debt consolidation to starting their own business.

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A critical appraisal of spinal mobilization vs conventional physiotherapy in the management of chronic low back pain due to spinal disc degeneration: a randomized controlled trial

This blog is a critical appraisal of the following randomized controlled trial: Spinal mobilization vs conventional physiotherapy in the management of chronic low back pain due to spinal disk degeneration

Background

Chronic Lower Back Pain (LBP) is a common problem affecting approximately 60-80% of the world’s population during their lifetime. In the UK, it is the most common cause of disability and number of days off work in young adults (Duthey, 2013).

At present, there is no definitive cure for chronic LBP due to insufficient evidence supporting any particular treatment modality (Krekoukias et al., 2016). As a result, a patient-centric approach aiming to enhance patient’s functionality and reduce pain has been the mainstay of treatment for chronic LBP.

The prognosis for chronic LBP, post-treatment, varies between patients and is scored based on disability scores. Those reporting lower disability and pain scores had better recovery rates than their counterparts (Costa et al., 2009).

What was the study?

The research article that will be discussed sought to determine the efficacy of spinal mobilisation on health outcomes in chronic LBP sufferers with disc degeneration.

75 subjects living with chronic LBP for longer than three months were recruited to this study. All of them met the inclusion criteria. They were randomly allocated to the Conventional Physiotherapy (CP) group, Spinal Mobilisation (SM) group and Sham Treatment (ST) group respectively. All received treatment from the same physiotherapist who was also in charge of data collection, thus blinding of the researcher was not carried out.

The Numerical Pain Rating Scale (NPRS) was adopted as the primary outcome measure while secondary outcome measures were the self-reported Greek version of the Oswestry and Roland-Morris questionnaire.

Altogether, there were five sessions of treatment lasting five weeks and outcome measures at final treatment were compared against the baseline. To explore the longer-term effects from the three groups, a 6-month follow-up after the final treatment was also included. There was no loss to follow-up observed during the trial and follow-up assessment, thus intention-to-treat analysis was not necessary.

In the CP group a series of static hamstring stretches, Swedish massage and Transcutaneous Electrical Nerve Stimulation (TENS) were applied at the lumbar region lasting a total of 40 minutes. No further treatment (i.e. a home exercise programme) was given. In the SM group, 10 minutes of passive physiological accessory movement and passive physiological intervertebral movement was delivered at the vertebral level that showed signs of disc degeneration. Finally in the ST group, a placebo skin-touch procedure on the lumbar region, with treatment duration similar to the SM group was given.

Findings

The study demonstrated a significant improvement in all clinical parameters post-treatment in the SM group and a positive correlation between the degree of disc degeneration and effects of SM on secondary outcomes. Further illustrated was the 6 month follow-up, where patients in the SM group showed the least need for further physiotherapy treatment versus the CP and ST groups.

In comparison to the ST group, the CP group had relatively higher clinical significance, with p<0.05 on the NPRS and Roland Morris questionnaires.

Strengths and Weaknesses

Results from this study will be appraised using the CASP RCT tool for its validity and usefulness relative to future clinical practice.

The study attempted to reduce noise in the data by randomly allocating participants through a computerised software to prevent selection bias. In order to reduce the possibility of generating an extreme clinical significance due to no-treatment, the control group received placebo treatment. This meant that all participants expected an outcome from the treatments hence any confounding variance observed between the intervention and placebo group is a result of real clinical benefit (Hrobjartsson et al., 2011).

However, internal validity was compromised as the researcher took on a dual role as the lead physiotherapist. This could introduce bias in generating and interpreting results to fit the researcher’s pre-conceived assumptions. Corroborating this, a systematic review also showed substantial observer bias and more positive results in interventions derived from randomised-controlled trials with non-blinded assessors as opposed to blinded assessors (Hrobjartsson et al., 2012).

 

Although the population specified addressed the research question, there was no basis for which the multiple-armed RCT was adopted and it was not clear whether the CP group was a control or intervention group. Moreover, having multiple comparators against the treatment of interest (i.e. SM group) did not allow for in-depth focus into the research question and increases the probability of a type 1 error occurring (Wason et al., 2014).

In order to determine the reliability of the intervention, a 95% Confidence Interval (CI) was used. This is where a range of values is calculated to see whether the estimate of the population mean difference pre and post-treatment sits within the sample mean difference. With the baseline characteristics of the three groups being relatively similar during pre-treatment, and the CI values of the three outcome measures statistically different in the SM group (NPRS: 4.11,5.37) than the CP (NPRS: 0.69,1.38) and ST group (NPRS: −0.05, 0.53), we can assume that SM as an intervention is an independent variable that affects LBP outcomes.

Conclusion

The study shows clinically significant improvement in chronic LBP on patients that received spinal mobilisation. However it is noteworthy that the study presents several weaknesses, especially that of observer bias which serves to skew existing data. Further research with blinding of the researcher, reducing the number of control group and possibly increasing the sample size should be done, to ensure validity of the original study.

References

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How to Manage Your Financial Priorities – When Your Friends Have Other Plans

Managing your financial priorities is a personal decision, and we all spend money differently.

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My Cochrane Elective Experience

The Cochrane UK Student Elective is a bi-annual opportunity for students to learn and participate in the activities of Cochrane through the Cochrane UK office, based in Oxford. To find out more just go to the Cochrane UK website, where the next Elective dates will be published. If selected, you will be able to work in Oxford for 4 weeks, be introduced to the organisation and given the opportunity to participate in projects and initiatives. Overall it is a second to none way in which valuable experience can be gained in a short period of time.

Having come across the opportunity myself I applied thinking I would probably not be successful as I assumed it would be for young students. My own academic experience was limited and at that time only one published paper to my name entitled – Do creative arts therapies reduce substance misuse? A systematic review and the full paper is available online at https://www.sciencedirect.com/science/article/pii/S0197455617300424.

The Elective interview process was interesting and seemed to be really encouraging. I was delighted to be offered a place. Not knowing what to expect I was pleasantly surprised when I turned up on the first day. A small office in Oxford with around 7 permanent staff and a further 7 or so coming and going, it was friendly and welcoming.

We were given a timetable with meetings scheduled over the four-week period. In the first week we were asked to write down our personal objectives that we wanted to achieve over the Elective period. During the first few days we met many of the staff and their roles were sometimes outlined clearly, where others were more nebulous. It was hard to get an exact picture of the Cochrane organisation and how Cochrane UK fitted into the whole. As time went on I was able to understand more and more and by the last week it was much cleare

Cochrane is a worldwide organisation and disparate in its format, with funding coming from all directions. Pinning down the details is somewhat difficult as there does not seem to be a standard pattern structure. I also know now that Cochrane, being a dynamic organisation, is constantly changing, for example through the newly introduced Networks, which you can read more about here.

One of the highlights of the experience, if not the most prominent, was being invited to attend the review author training level 3 and 4. This two-day course was particularly interesting, learning about the advanced analysis within the REVMAN system, which is used to produce Cochrane Systematic Reviews. More information on Cochrane training can be found at https://training.cochrane.org.

Another highlight was briefly meeting Sir Iain Chalmers who started the Cochrane organisation  some 25 years ago in 1993. Now, he’s still based just down the corridor from the Cochrane UK office.

During the Elective time we were introduced to new skills and were able to contribute to Cochrane Crowd, update Wikipedia, Cochrane UK social media accounts, and also blog for Students 4 Best Evidence (S4BE).

Most of time was taken up by an Elective project which, although optional, gave us a challenge that we as a team wanted to achieve. It meant that we focussed more on this project than the other opportunities although I tried to find a balance and managed to achieve all four of my original objectives with the project only being one of them.

The data extraction for the project occupied three out of our four weeks and as a result, it was an impossible challenge to complete this project during our time at Cochrane UK. I was one of a team of four and we all pulled together to get the data. Unfortunately, the project wasn’t able to be completed by the time we left but we do want to finalise it. Hopefully this will happen in due course.

Each week the Cochrane UK team, together with several Cochrane Fellows, meet to discuss recently published or about to be published reviews. We were invited to attend part of the meeting during which the collective would decide whether to disseminate the results and in which format.  The primary reason for the Cochrane UK office is its focus on distributing evidence. This is undertaken in a number of different ways through social networks, blogs and the media. It was a privilege to be part of this meeting each week and seeking to understand what the decision making process was for each published review. It seemed to be determined by the review results and how interesting this might be to the different audiences Cochrane UK was targeting.

During the last week I was able to visit Oxford a couple of times and consolidate my knowledge gained. I was also able to become a reader at the Bodleian Library, one of the worlds’ largest collections. At the weekend I joined a walking tour with https://www.wanderoxford.co.uk which is free but be prepared to offer a tip to your guide at the end of the tour. There are plenty of different companies offering such tours and generally they start at either 11am or 1pm from Broad Street in the centre of Oxford. There is also an open topped bus tour for around £15 and you can get off and on as many times as you like during the day.

Finding somewhere to stay in Oxford is a challenge with hotel prices being very high compared with other locations in the UK. I was able to find very nice accommodation through Airbnb.co.uk which was reasonably priced between £20 and £30 per night for a room. Of course if you have friends to stay within Oxford that is perfect and some did. Others used a family stay service which included breakfast and an evening meal. There is university accommodation that is sometimes accessible but this depends on when the Elective is scheduled, during our stay only a few days were available and only in the first week.

I’m glad I participated in this experience. It has added to my research knowledge on how evidence based medicine is collated and distributed. Cochrane takes an independent view and is officially an advocate of medical evidence which, through its reviews, is informing health related professionals of its findings. The task of integrating this evidence into practice remains an ongoing obstacle which they are addressing with vigour.

I would encourage all students to consider this one-month experience as a valuable contribution to their overall learning. If you can afford to spend one month in Oxford, then do! Ensure you make some time to enjoy this beautiful city whilst you are there.

 

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Halloween on a Budget: Last Minute Tips

We have five options for you to scare up decorations and costumes on a budget.

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The EU Trials Tracker: a new tool to help fight publication bias

Publication bias is a topic that has already been covered on Students 4 Best Evidence in a great article here.

The concept is very simple: if all the evidence is not available to search, we cannot make evidence-based decisions regarding patient care. It is well established that trials reporting positive results are more likely to be published than studies that find no relationship.

When unpublished trials are not included in systematic reviews and meta-analysis, results may suggest a positive overall effect of an intervention when in reality there is none. Non-reporting of trials undermines our quest for evidence-based practice and has real life consequences.

Publication bias in real life

Trials of the antidepressant Reboxetine, a drug which was regulated for use due to promising trial results, epitomise these real-life implications. A systematic review in 2010 cast doubt on these promising trial results. Investigators (1) scoured through as much unpublished literature as they could get their hands on in order to produce the most comprehensive review possible. The results were worrying. Of all the studies comparing Reboxetine to either placebo or selective serotonin reuptake inhibitors (SSRIs), 74% of all the study participants in the meta-analysis were from unpublished studies. When all the available data was collated, the evidence showed Reboxetine to be no more effective than placebo, inferior to SSRIs and possibly more harmful. Patients on Reboxetine may not have been receiving the best care possible, because of the non-reporting of trials.

The conclusion: when all the data is available, our view of a drug can drastically change.  

In an ideal world where science rules supreme, results from all studies should be published.

EU Trials Tracker

By law, since December 2016, all clinical trials on the European Union Clinical Trials Register (EUCTR) must report the results of their study directly to the EUCTR within one year of completion. This, in theory, should be quick and easy – direct reporting means no delay in peer and editorial review and should ensure full and complete results are produced. Sounds simple. So what’s the problem?

Here’s where the EU Trials Tracker comes in.

In September 2018, the Evidence-Based Medicine (EBM) DataLab at Oxford, headed by doctor and prominent science writer Ben Goldacre, published a paper in the BMJ: “Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource”(2). They demonstrated that there is significant under reporting of trials on the EUCTR. Despite the requirement being enshrined by law, only 49% of Europe’s clinical trials reported results within the year as they are required to.

Alongside this, the EBM DataLab team have released an online audit and feedback resource at EU.trialstracker.net. It keeps track of studies that are yet to report results and who the organisation or sponsor of that study is.

 

The goal, through auditing, is that universities and pharmaceutical companies can view their own performance, compare it to the gold standard, look at areas in which they can improve and ultimately bring about meaningful change.

And if you excuse the informality – it’s a really cool website. Easy to use, well designed and effective, I implore anyone reading this to go on and explore. You can log on, type in your institutions name, see if they are publishing trial results and whether they have any results outstanding. You can even go as far as viewing the individual trials who have not reported their results.

The EBM DataLab have created various innovative, live tools which also include the FDAAA Trials Tracker, Trials Tracker and COMPare – take a look! Here is a useful S4BE blog written by 2 students (at the time) who were part of the COMPare project.

A word from the creator

I recently got in contact with Ben Goldacre and asked him what he would say to any students who are coming across Trials Tracker for the first time, and why it is such a useful tool…

Trial reporting is a huge problem and has been ongoing for a very long time. We spent a lot of time thinking about the best way to address it with the low resources available to us. We can’t change the law; and we know that compliance with laws is, in any case, poor. We can’t impose fines on those who breach the reporting rules. We decided that public accountability was the most effective route available to us. This is often crudely characterised as “naming and shaming” but I think it’s much more positive than that. It shows those universities and companies with poor trial-reporting performance that it is possible to report all trials. Poor performers can now identify those universities and companies who are doing well, and learn from them. Furthermore, we give data on each individual overdue trial, which is a vitally important service, because trial sponsors can use our data to find the individual overdue trials that they need to get reported. We know that universities are already using our data to get trials reported, because they are contacting us, and thanking us for the service!

The FDAAA Trials Tracker received this feedback from two major US institutions, highlighting the real-world impact that these tools are having.

Take Action

Please go and check out your institutions and universities on the website. Compare against your friends and colleagues – bragging rights are up for grabs! For more information I also recommend reading the original paper for a more in-depth analysis of the results.

Non-reporting of trials is and will continue to be a problem in modern medicine, but modern initiatives such as Trials Tracker may be part of the solution.

References

1. Eyding D, Lelgemann M, Grouven U, Harter M, Kromp M, Kaiser T et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341(oct12 1):c4737-c4737.

2. Goldacre B, DeVito N, Heneghan C, Irving F, Bacon S, Fleminger J et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ. 2018;362:k3218.

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Fixed vs. Variable Interest Rates: Which is Right For You?

Here’s what you need to know about each option before taking out a loan.

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Why School Graduation and Retention Rates Are Important to Consider

Two figures that are gaining more interest in the last few years are graduation and retention rates. But what is so important about these? 

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Lingo You Should Know Before Signing a Loan

Check out Earnest's list of important vocab terms you might see when signing a loan.

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How to Avoid Student Loan Default

If you find yourself in loan delinquency or default, there are options to get your loans back under your control.

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Psychological Therapies in Humanitarian Crises

Introduction

A systematic review published in the Cochrane Database of Systematic Reviews 2018 aimed to show how effective psychological therapies are in low- and middle-income countries affected by humanitarian crises (1). Why is this important for medical students to be aware of? In our future clinical work we will be seeing patients from different backgrounds and cultures so having more of an understanding of how people affected by humanitarian crises can be helped will be extremely valuable. In the shorter term, many of us undertake medical electives in countries that have been affected by these crises so it is helpful to know what options are available for those affected.

What is a Humanitarian Crisis?

A humanitarian crisis is defined as “an event…that represents a critical threat to the health, safety, security or wellbeing of a community” (2) that can lead to rapid psychological and social changes affecting individuals and families (3). It is a significant problem because, in the last decade, the number of people who have been affected by a humanitarian crisis has nearly doubled (4). Despite the psychological needs of the people affected, there is still a shortage of mental health workers in lower and middle income countries. Even in Liberia and Sierra Leone, two large countries affected by the Ebola outbreak, there is only one trained psychiatrist currently working (4). This is why it is important that we talk about how psychological therapies can help those affected by crises.

A humanitarian crisis is defined as an event that represents a critical threat to the health, safety, security or wellbeing of a community.

Cultural Background

Humanitarian crises are often destructive to the normal support systems people have in place. Therefore, while it is acknowledged that social and psychological issues affect most people, it is necessary to understand that everyone’s experience will be unique and different groups will have different resources to help them cope with the crisis (5). People’s reactions may differ for several reasons including their culture, development of their country and severity of the crisis (3). Due to this, international organisations and charities have started focusing on understanding the context of humanitarian crises when developing programmes to help. This allows us to respect the communities’ wishes which is an essential part of managing their mental health (3).

Mental Health Conditions

People affected by humanitarian crises have been shown to have an increased risk of mental health conditions including post-traumatic stress disorder (PTSD), major depressive and anxiety disorders and other psychological conditions (1). People are at risk because in these contexts they have a reduced ability to focus on their daily needs and to engage with and reconstruct their local community (3).

The impact may depend on the type of humanitarian crisis that has occurred. Populations may be able to find more motivation to rebuild their community after a natural disaster because this can be seen as an impersonal crisis. However, a conflict which may cause more suspicion towards others around them may reduce motivation (3). There are different ways that psychological problems can be expressed after crises including insomnia and anxiety in adults, and bedwetting or lack of enjoyment in play in children (3).

The World Health Organisation (WHO) found that 35-50% of those affected by a crisis had light to moderate distress which was managed through psychological interventions. They also found 3-4% had a major psychiatric disorder and needed further treatment (6). As well as this, children are particularly susceptible to psychological distress because they may be separated from their parents, or parents lose their ability to provide for them. They are also at an increased risk of exploitation and abuse (3).

For these reasons, it is so important that we learn how to manage people’s mental health after a humanitarian crisis. It is important to note, however, that this distress is not always a mental illness and it is often a normal response to their situation. Varying responses are often due to the community’s culture, their previous situation and their resources (3).

The World Health Organisation (WHO) found that 35-50% of those affected by a crisis had light to moderate distress which was managed through psychological interventions.

Treatment

In a crisis, there are often interventions in place to meet people’s basic needs, contributing to their safety and therefore their psychological wellbeing (3). However, a holistic approach is necessary to protect people’s mental health in emergency situations. It is particularly important that we think about the human aspect when dealing with the consequences of a crisis and not just treat them as ‘refugees’ (3). Any help we give should aim to strengthen communities rather than replace the coping mechanisms of their culture (3) due to the fact people have different resources and methods to cope.

The systematic review by Purgato et al 2018, compared psychological therapies to control conditions. Control conditions included being on the waiting list for treatment, no treatment and treatment as usual, and people were randomly allocated to either group (1). The review looked at sub-Saharan Africa, the Middle East and North Africa and Asia, and crises studied included armed conflicts and natural hazards. It is useful that more than one type of crisis was included due to the different impact they may have. Different therapies studied included cognitive-behavioural therapy (CBT), eye movement desensitisation and reprocessing (EMDR), interpersonal therapy (IPT), trauma/general supportive counselling and thought field therapy (TFT). Two common features between the therapies were psychoeducation and learning coping skills.

For adults, this review found low-quality evidence for a substantial reduction of PTSD and depressive symptoms at endpoint, as well as a moderate reduction of anxiety symptoms at endpoint. On the other hand this review found very low-quality evidence for lower PTSD symptoms at endpoint in children and adolescents. Disappointingly, there was no data found on depression and anxiety in children although as highlighted earlier, they are a vulnerable group of people in conflicts.

Future

What has this systematic review taught us? There is a huge need for more evidence on psychological therapies in humanitarian crises, especially for children and adolescents who are some of the most vulnerable people in these situations. So far we know that we can achieve large benefits in the short term for adults so now we also need to follow up these people for a longer period of time to ensure that we are still managing to help. While developing therapies it is essential that we keep them appropriate to the local culture, and we can only do this by working with communities to ensure their needs are met.

References

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Debt Snowball vs. Debt Avalanche: How to Pay Off Your Student Loans and Other Debts

Which method will motivate you to stick to a debt repayment plan?

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GRADE and quality of evidence

Our every visit to the doctor is built upon evidence

Let’s imagine that you visit a doctor due to chronic sleep problems (chronic insomnia). In this case, the doctor is a sleep specialist and follows the latest research, basing his conclusions on a comparative effectiveness review of treatments for insomnia. The review shows that there are two effective treatments: Cognitive behavioural therapy for insomnia (CBT-I) (moderate evidence) and various sleeping pills (low evidence).

Comparative effectiveness reviews and systematic reviews (in future sentences, both are referred to just as systematic reviews) are widely held as the gold standard of evidence in many sciences. In traditional reviews, authors typically collect together the studies they already know or can easily identify. This often leads to overemphasising studies that are in line with his/her own hypothesis. With systematic reviews, authors first specify a research question and then they have to search, identify, take into account and potentially statistically sum up all studies according to a carefully pre-planned strategy.

It is often illustrated that in systematic reviews, individual studies are the “participants” of the meta-analysis. Often, and in the case of this blog, systematic reviews are used to determine how effective on average the intervention is (e.g. how many minutes the sleep time of insomniacs is increased on average).

What is GRADE?

The most prominent framework for evaluating the effectiveness of systematic reviews is GRADE (Grading quality of evidence and strength of recommendations). GRADE is used to rate the certainty of evidence for a treatment efficacy from high to very low. The GRADE system takes in two types of studies: randomized controlled trials (RCTs) and observational studies (also including non-randomized trials). In RCTs, one group of participants is randomized to a treatment and another group to placebo or an alternative condition. In observational studies, participants that took part in the treatment are simply compared to placebo, no treatment, or an alternative condition without randomization. Observational studies can be conducted as trials where participants are recruited via email or other means but are not randomized, or they can be conducted using data that is collected during routine work in hospitals or other medical centres. Studies without a control group can also be counted as observational studies, although they are less often used in systematic reviews that use GRADE assessment.

Observational studies suffer from a problem of confounding. If sleeping pills, on average, worked better compared to placebo pills, it can always be possible that it only worked because the comparison group were younger and the drug only works for young people, or because the treatment group had a placebo effect. Although there are many statistical methods to control for confounding, no method can fully account for unknown confounding factors – that may be the real reason for the difference between treatment and control group.  Randomized studies are considered the gold standard as successful randomization takes out both known and unknown confounding factors. Interestingly, in economics, there exists methods that use natural random effects to control for confounding.

The GRADE criteria

In the GRADE system, the evidence is therefore initially set to either high (if included studies are randomized studies) or low (if they are observational studies).  There are then 5 criteria that can be used to downgrade one, two, or in the case of indirectness, sometimes three steps. These are:

1. Risk of bias in individual studies – e.g. methodological issues in included studies such as inadequate blinding (participants knew they were in control/treatment group)
2. Inconsistency of results between studies
3. Indirectness of evidence – e.g. participants were children although the systematic review was about adults
4. Imprecision – results were not statistically significant, or the effect was clinically important once the studies were meta-analysed
5. Publication bias – result was biased due to a file-drawering effect, as studies not showing a statistically significant effect are less likely to be published.

Additionally, observational studies starting at low can be upgraded based on 3 criteria: large effect, dose-response effect and “Effect of all plausible confounding factors would be to reduce the effect (where an effect is observed) or suggest a spurious effect (when no effect is observed)”. An example of the ‘dose-response effect’ refers to a finding that a larger dose of medicine leads to better treatment outcomes. The last criteria is complex but refers to situations where there is a bias (e.g. all doctors are told about a potential side effect) among clinicians to overdiagnose certain side effects but nevertheless no increased number of side effects is found in the studies.

If you were to look at a systematic review for chronic insomnia with a GRADING of moderate for sleep quality outcome for CBT-I, we would find out that there are many gold standard studies, randomized controlled trials conducted, that have compared CBT-I against control (placebo) condition. Therefore, a GRADING of moderate for sleeping pills would be achieved because the evidence was downgraded from high to moderate using one of the following 5 criteria for downgrading evidence: Risk of bias (in individual studies), Inconsistency, Imprecision, Indirectness or Publication bias.

On the other hand, when it comes to sleeping pills it might be possible in a hypothetical scenario (even though in this case that is not true) that instead of the gold standard RCT we would only have observational studies with no individual randomization. Therefore, the evidence would have started for sleeping pills from low, and as none of the 3 criteria for upgrading the evidence for observational studies were fulfilled (large effect, dose-response effect, or plausible confounding/bias would have led to over/underestimation of the effect) the evidence would stay low.

Summary of GRADE for systematic reviews

The table below from the GRADE handbook provides a very useful summary of the 5 downgrading and 3 upgrading criteria:

Schünemann, H., Brozek, J., & Oxman, A. (2013). GRADE handbook for grading quality of evidence and strength of recommendations. Updated October.

This blog aims to clarify the structure of GRADE the most advanced evidence hierarchy (or evidence base hierarchy) in evidence-based medicine (Blunt, 2015).

During the last 15 years, the outlined GRADE system has become a widely used global standard. It is used by guideline makers, such as the World Health Organization. As Blunt points out, the term global standard may be slightly overconfident, as many guideline makers who have started to use GRADE still use other systems at the same time. However, it is the single most prominent system available and is constantly developing and providing a platform for co-operation for different guideline makers (Centers for Disease Control and Prevention (CDC), 2011).

For example, in recent years, GRADE has become a mandatory element for newly published systematic reviews conducted by Cochrane, widely held as the most prominent evidence-based medicine organization. You can read more about Cochrane’s Strategy 2020 here.

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Useful resources:

www.gradeworkinggroup.org: For visual clarification, the GRADE website provides videos and articles to get started.

Understanding GRADE: an introduction. Goldet, G & Howick J (2013)

A visual explanation of GRADE from the gdt GRADE pro website

References

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How a Personal Loan Gave This Woman a Fresh Start After Her Divorce

After an expensive home sale and divorce, Marquit turned to a personal loan to help finance her move.

The post How a Personal Loan Gave This Woman a Fresh Start After Her Divorce appeared first on Earnest Blog | Money Advice for Young Professionals.

A beginner’s guide to confounding

Confounding means the distortion of the association between the independent and dependent variables because a third variable is independently associated with both.

A causal relationship between two variables is often described as the way in which the independent variable affects the dependent variable. The independent variable can take different values independently, and the dependent variable varies according to the value of the independent variable.

So, let’s say you want to find out how alcohol consumption affects mortality…

You decide to compare the mortality rates between two groups – one consisting of heavy users of alcohol, one consisting of teetotallers. In this case alcohol consumption would be your independent variable and mortality would be your dependent variable.

If you find that people who consume more alcohol are more likely to die, it might seem intuitive to conclude that alcohol use increases the risk of death. In reality, however, the situation might be more complex. It is possible that alcohol use is not the only mortality-affecting factor that differs between the two groups.

People who consume less alcohol might be more likely to eat a healthier diet or less likely to smoke, for example. Eating a healthy diet or smoking might in turn affect mortality. These other influencing factors are called confounding variables. If you ignore them and assume that any differences in mortality must be caused by a difference in alcohol consumption, you could end up with results that don’t reflect reality all that well. You might find associations where in reality there are none, or fail to find associations where they do in fact exist.

How to minimise the effects of confounding during study design

If you are investigating the effects of an intervention, you can randomly assign people to an intervention and control group. The aim of randomization is to evenly distribute the known and the unknown confounders between the two groups. The groups might still differ in potential confounders by chance but randomization minimises these differences.

In other types of studies you can address confounding through restriction or matching. Restriction means only studying people who are similar in terms of a confounding variable – for example, if you think age is a confounding variable you might only choose to study people older than 65. (This would obviously limit the applicability of your results to other groups). Matching means pairing people in the two groups based on potential confounders.

How to minimise the effects of confounding during statistical analysis

After completing the study you can minimise the effects of confounding using statistical methods.

If there is only a small number of potential confounders you can use stratification. In stratification you produce smaller groups in which the confounding variables don’t vary and then examine the relationship between the independent and dependent variable in each group. In the example we used before, for example, you might want to divide the sample into groups of smokers and non-smokers and examine the relationship between alcohol use and mortality within each.

If there is a larger number of potential confounders you can use multivariate analysis, for example logistic or linear regression.

Conclusions

The association between two variables might be modified by a third variable, and this can lead to distorted results. Even after taking this into account in study design and data analysis your data could still be distorted by confounding – there might e.g. be other confounding factors you don’t know of – but the first steps in reducing its effects are being aware of its potential to distort your results and planning accordingly.

Sources:

Pourhoseingholi, M. A., Baghestani, A. R., & Vahedi, M. (2012). How to control confounding effects by statistical analysis. Gastroenterology and Hepatology From Bed to Bench, 5(2), 79–83.

Catalogue of bias collaboration, Aronson JK, Bankhead C, Nunan D. Confounding. In Catalogue Of Biases. 2018. https://catalogofbias.org/biases/confounding/

http://www.ucl.ac.uk/ich/short-courses-events/about-stats-courses/stats-rm/chapter_1_content/Confounding_Factors

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Can a Robo-Advisor Help You Save for Retirement?

It may seem like a challenge to prioritize retirement savings when you’re paying off debt, but robo-advisors make it easier to get started.

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