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  • 00:03

    [RESEARCH METHODS case study][Conducting a Prospective Intervention Studywith Adolescents]

  • 00:14

    MICHAEL SKOVDAL: Hi, my name is Michael Skovdal Rathleffand I'm a Professor at the Department of Health Scienceand Technology and the Center for General Practiceat Aalborg University here in Denmark.And today in this case study, I'mgoing to discuss a paper that we recentlydid, which was an Interventional Study on 151 kids suffering

  • 00:37

    MICHAEL SKOVDAL [continued]: from a specific knee pain complaint calledpatellofemoral pain.And then you might ask yourself, whyis knee pain in kids something of importance?Well from our research, we know that whenwe go out into schools, around onein every three adolescent experience knee pain.

  • 00:59

    MICHAEL SKOVDAL [continued]: For some, it's just maybe a week or two weeksafter strenuous training period, but for others, it'sactually something that bites them and persist evenfor several years.And when these kids develop knee pain,well first it might be something they justfeel they have a sore knee after their practice,

  • 01:20

    MICHAEL SKOVDAL [continued]: but when they've had it for a certain period of timeit often becomes so severe that it affects their sportsparticipation, their social interaction with friendsand they would have to seek care.They have low quality of life, and for some, it evenaffects their mental health as well,most likely because they can't suddenly

  • 01:42

    MICHAEL SKOVDAL [continued]: do the same things with their friendsas they used to be able to do due to the knee pain.And one of the most common types of knee pain in adolescentsis a specific condition called patellofemoral pain.And it's characterized by this diffuse anterior knee pain.And when you send them on or off for an MRI scan

  • 02:05

    MICHAEL SKOVDAL [continued]: you can't see anything.So it's actually quite similar to non-specific low back pain,but just in the knee.And it's actually one of the conditions that havea high rate of persistence.And all the studies we've done, wecan see that even after five years, more than 40% of thosediagnosed with patellofemoral pain,

  • 02:26

    MICHAEL SKOVDAL [continued]: continue to experience their pain which is severe enoughto affect their function in their sport participationin their quality of life.So yeah I'm trying to make the case that we needeffective treatments for them.And eight or nine years ago, I led a randomized trialwhere we wanted to study the effect of supervised exercise

  • 02:49

    MICHAEL SKOVDAL [continued]: for adolescents with patellofemoral pain.And the reason why this was a good idea,at least at that stage, was that supervised exerciseshad actually proven to be effective for adults sufferingfrom patellofemoral pain.So my ideas we have no evidence on effectiveness

  • 03:10

    MICHAEL SKOVDAL [continued]: of treatments for adolescents with patellofemoral pain.So we should just try and do whatever works with adultsand apply to adolescents.And then fast forward three years and Idon't know how many hundreds of hours of work,we had the results from our randomized trial, whichactually showed that the treatment wasn't

  • 03:30

    MICHAEL SKOVDAL [continued]: effective for adolescents with patellofemoral pain.If the effect is like this on adults, it was less than halfin the adolescents.That made us think, well, we need to go back to the drawingboard to develop effective interventions that arespecific to the adolescents.Because concurrently with this we've been exploring,

  • 03:53

    MICHAEL SKOVDAL [continued]: why is patellofemoral pain in adolescents actually differentcompared to adults?And we've found a number of different reasonsfor why typical treatment for adultsdon't work for adolescents.And it might make sense to you thinkingthat a 13-year-old is actually quite different compared

  • 04:15

    MICHAEL SKOVDAL [continued]: to a 35-year-old.Because the 13-year-old lives in a completely different lifewhere they have to actually learn to manage their pain,which is completely different comparedwhen you're teaching an adult to manage their pain.And this has led us to go through a seriesof different studies that have now culminated in the study

  • 04:38

    MICHAEL SKOVDAL [continued]: that I'm going to talk more about today,where we want to explore the effect of this novel managementstrategy that is actually specificand aim-- directed at the adolescentsand also their parents, because the parents are oftenthe adolescents' biggest supporters.And whenever we are doing interventional studies

  • 04:59

    MICHAEL SKOVDAL [continued]: for adolescents, you always have to thinkwhere are the parents in this?So in this study, we used a single cohort prospectivedesign where we intervened, meaningwe gave all the treatment or all 151 kids between 10 and 14the exact same treatment.

  • 05:21

    MICHAEL SKOVDAL [continued]: And the reason why we went with a cohort studyfor this research project and notwith a randomized trial, which is higher up in the evidencehierarchy, is that sometimes in health sciencewe actually jump too quickly into the randomized trial,which was something we learned backwhen we did our original randomized trial

  • 05:44

    MICHAEL SKOVDAL [continued]: on supervised exercises.So we wanted to start out with a cohort studyto actually get an idea, is this effective?Do the kids actually, are they satisfied with the resultafter this treatment?Is there good adherence to the treatmentwe're actually delivering?

  • 06:04

    MICHAEL SKOVDAL [continued]: And in this study, we use both self report outcomesmeaning questionnaire-based outcomes and alsoobjective measures of knee function and knee strengthand hip strength to look at the changes across the 12 monthswhere we actually followed this group of adolescents.

  • 06:26

    MICHAEL SKOVDAL [continued]: And one of the important aspects whendoing interventional studies with kids, besides making surethat the intervention actually matches the adolescent needs,is to make sure that the adolescents understandthe questionnaires that you're giving to them.You want to make sure that they're actually respondingto the questions you ask them.

  • 06:48

    MICHAEL SKOVDAL [continued]: You can't just take questionnairesor prompts as we call them from adultsand then use it directly on adolescents.You have to make sure they actually understand it.And the same thing when you want to lookat measures of knee strength or hip strength or knee function,you have to make sure that the methods you use

  • 07:09

    MICHAEL SKOVDAL [continued]: are actually reliable and valid for an adolescent population.For example, in adults, we have a lot of reliability studieson how you should do measurement of knee strength.But you can't necessarily think well it'salso reliable on adolescents because maybe they are notmotivated, maybe they can't go through the same procedures

  • 07:32

    MICHAEL SKOVDAL [continued]: as adults.So an important learning thing here,at least for us is, whenever we do interventional studieson kids, children, adolescents wehave to make certain that all the procedures we go through,methods we use to capture data that they're actuallyvalid for this age group.

  • 07:53

    MICHAEL SKOVDAL [continued]: That's really, really important.So we collected data at baseline 3, 6, and 12 months.And when you have repeated measures of dataon the same individuals over a period of time,one of the way to analyze the datais by a repeated measures ANOVA which we used in this.

  • 08:15

    MICHAEL SKOVDAL [continued]: This is particularly useful when youhave the same group of individualsthat you follow over the course of timeto look at changes in outcomes.And the interesting thing for me in this study,was how the adolescents actually responded to the intervention.

  • 08:37

    MICHAEL SKOVDAL [continued]: So the intervention actually consisted of four visitswith the physiotherapist.That's actually less compared to the other trialwe did which had 16 supervised exercise sessionswith the physiotherapist.So here, they only saw a physiotherapist four times,so more minimal intervention.

  • 08:58

    MICHAEL SKOVDAL [continued]: But here we were more focused on actually teachingthe adolescent and the parents all the good things theycould do for the knee pain.So really, what would you say give them ownershipand give them knowledge to actually manage itthemselves instead of relying on health care practitioners.And that is a major shift compared

  • 09:18

    MICHAEL SKOVDAL [continued]: to what have been done before on this population.So this figure showing here is actually results from threeof our trials.So these are the success rates after three months.In the first one you can see thatour previous exercise-focused trials, the success rate

  • 09:40

    MICHAEL SKOVDAL [continued]: have been roughly 30% to 40% after three months.But in this new intervention thatfocused much more on education and self-management,you can see that it's more than 80%that actually have a successful outcome after three months.

  • 10:01

    MICHAEL SKOVDAL [continued]: After three months, more than 80% of the adolescentsactually had a successful outcome.And now you wonder 80% is that good or bad?In our other two studies involving the same age group,adolescents with patellofemoral pain, roughly between 30%and 40% had a successful outcome after three months.

  • 10:26

    MICHAEL SKOVDAL [continued]: So here we actually had twice as many adolescentswho had what we considered a successful outcome evenafter three months.And after 12 months, it was the same.And furthermore, more than 90% were actually satisfiedwith the result of the treatment, whichis much higher than previously and 95% would actually

  • 10:50

    MICHAEL SKOVDAL [continued]: recommend the same treatment if they had a friend sufferingfrom knee pain.And I think that's a strong proxythat the adolescent actually thought that the results weregood but that they also found the intervention meaningfulbecause more than 95% would recommend itto a friend suffering from the same type of knee pain.

  • 11:13

    MICHAEL SKOVDAL [continued]: But we also had challenges when we did that trial.And one of the big challenges we had was in the beginningwhere we had to recruit the adolescents into the study.We originally anticipated to go out into schoolsand get all kids in schools to complete a questionnaire.And if they reported knee pain, we

  • 11:34

    MICHAEL SKOVDAL [continued]: would invite them in for clinical examinationwith an orthopedic surgeon or a physiotherapistto verify the diagnosis.But during this period, in Denmark, the schoolswere undergoing massive changes, so none of the schoolsreally bought into the ideas that we had.So we went around thought, well, what can wedo instead and then this for the first study where we actually

  • 11:58

    MICHAEL SKOVDAL [continued]: used social media to recruit adolescents into our trial.And this was a massive success.Within only a few weeks, we reached the intended targetof more than 150 young adolescents sufferingfrom patellofemoral pain.So that was good.But one thing we always have to be wary about, or at least

  • 12:20

    MICHAEL SKOVDAL [continued]: consider is, if we out in schools, who is itthat we are recruiting.Well, they are most likely not careseeking because their symptoms are not severe enoughfor them to take content into the health care system.If we recruit through social media, nowthis is my impression from those we got from there,

  • 12:40

    MICHAEL SKOVDAL [continued]: is that many of them have alreadytried the typical treatments in the health care systemor they've been dissatisfied with the result or the advicethey got from their health care practitioner.And that is why they sign up to participate in such a trial.And that's important to consider when you press the button

  • 13:01

    MICHAEL SKOVDAL [continued]: and say we'll also add social media.Because sometimes, or at least we need to reflect,who is it that we are going to recruit from social mediacompared to schools, compared to going out into hospitalsor general practices to recruit care-seeking adolescentsand their parents into these trials?

  • 13:24

    MICHAEL SKOVDAL [continued]: And one of the challenges we anticipated in this trialwas ethics.Because when you do interventional studies,at least in Denmark, on adolescents younger than 15,then you need to have a signed informedconsent from both parents.And that can be logistically challenging to do.

  • 13:47

    MICHAEL SKOVDAL [continued]: And the way we went around this was that both in the researchteam but also making a small advisory boardof parents that we tried to discuss this with;how do we most easily obtain informed consent from bothof you?And back then, when it was 2016 or 2017

  • 14:09

    MICHAEL SKOVDAL [continued]: when we did the recruitment, we ended upwith a paper-based version and thensending photos of an signed informed consentto us as the researchers.But today, with all the advances thathas been made in for example REDCapand electronic signatures I thinkI would do it slightly differently.They I think, while the parents and kids

  • 14:32

    MICHAEL SKOVDAL [continued]: were in there and if we needed to get an informedconsent from the parent at home, Iwould do something about calling them and then sending thema link through a text or an email through REDCapwhere you can nowadays do an electronic signature.So you can easily get two signatureswhen the adolescents are in for the clinical examination,

  • 14:54

    MICHAEL SKOVDAL [continued]: because that would make it more easycompared to sending paper-based versions homewith the kid and one parent and thenhaving to send them or email them back to makesure you have both parents.Another interesting challenge we hadwas that when parents and kids then came in for an informationconversation about what would it entail

  • 15:16

    MICHAEL SKOVDAL [continued]: to be included in this trial, we actuallyhad a few parents that said, no my daughter or sonis not going to participate in this trial,despite the child wanted to.But due to the content of the intervention, whichalso included a period of four weeks, where they couldn't

  • 15:36

    MICHAEL SKOVDAL [continued]: participate in sport the parents said wellthat's going to hamper my son's participation in the finalsor and the Nationals in four months so he can't participatein this trial despite his knee pain.But then we later understood that if we as researchersand clinicians become even better at explaining

  • 15:59

    MICHAEL SKOVDAL [continued]: to the participants and the parentsthe rationale for why the intervention looka certain way, then people said wow, nowI understand why this is an essential componentof the intervention.Yes, now my daughter or son can actually participate.So that was a strong learning point for usto not underestimate the time required

  • 16:23

    MICHAEL SKOVDAL [continued]: to make a really good informationconversation about what does it entailto be included in this trial.And as I've set this trial was sortof a culmination of 10 years of workwhere we've done lots of fails but we alsolearned quite a few things.

  • 16:43

    MICHAEL SKOVDAL [continued]: So my ideas for continued reading,which is not just specific to adolescent patellofemoral pain,but can be used across the adolescent fieldor even in adults it's the different steps we went throughuntil we ended up at the adolescent specific managementstrategies.

  • 17:04

    MICHAEL SKOVDAL [continued]: So I think there's some good learning aims in that for youbecause at least I would have likedto read about that before we starteddoing interventional studies on adolescentswith patellofemoral pain.Another point for continued reading and reflectionis, how do we actually go about developing and also evaluating

  • 17:25

    MICHAEL SKOVDAL [continued]: these types of interventions?And there the UK Medical Research Councilhave done a really nice frameworkfor how to develop and also evaluatethese types of complex interventionsthat include more than one component as here,where we're both doing exercise we're engaging with parents,

  • 17:46

    MICHAEL SKOVDAL [continued]: sports clubs, and teaching the adolescents to self manage.And this framework is very, very usefulfor going through the different strategic stepsto make sure you don't end up doing the same mistakeas I did by jumping too quickly into the randomized trial.So I hope you've enjoyed this introduction or overview

  • 18:09

    MICHAEL SKOVDAL [continued]: of the case study we've done and Ihope you're now more prepared to also start your own first studyon maybe treating or following adolescentswith certain health complaints.Thank you.[FURTHER READING]

Abstract

Michael Skovdal Rathleff, PhD, Professor in the Department of Health Science and Technology at Aalborg University, uses a case study to illustrate a prospective intervention study with adolescents, including research design, data collection and analysis, challenges, and tips.

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Conducting a Prospective Intervention Study With Adolescents

Michael Skovdal Rathleff, PhD, Professor in the Department of Health Science and Technology at Aalborg University, uses a case study to illustrate a prospective intervention study with adolescents, including research design, data collection and analysis, challenges, and tips.

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