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  • 00:14

    BIRGITTA LANGHAMMER: Good morning, everyone.My name is Birgitta Langhammer.I'm a Professor at the Oslo Metropolitan University, whereI am a Teacher and Researcher.Before that, I was a Physiotherapiststarting clinical practice, working mainlywith neurological rehabilitation.And this is my favorite subject, of course, and especially

  • 00:37

    BIRGITTA LANGHAMMER [continued]: research within stroke, where I haveworked both in national institutionsand international institutions with patients.I'm also affiliated to Sunnaas Rehabilitation Hospital,which is the largest rehabilitationcenter in Norway.And there, I am part of the research team,

  • 00:57

    BIRGITTA LANGHAMMER [continued]: and I'm also involved in the Sunnaas International Network.Today's talk is going to be about complex methodsand complex interventions because the new norm in healthresearch is now evidence-based practiceand evidence-based medicine.

  • 01:18

    BIRGITTA LANGHAMMER [continued]: So we try to do our best to give the evidence to whatwe are doing, and of course, in my interest,it is to look at interventions.So complex may relate to the contextwhere you are going to do your research thatwill be if it's a single or multi-centered trial,

  • 01:41

    BIRGITTA LANGHAMMER [continued]: or whether it's a local, regional, national trial,or international trial.And of course, complex may also relateto the interventions you are doingbecause the interventions in health research such as minehave no specified ingredients that you

  • 02:02

    BIRGITTA LANGHAMMER [continued]: can say that this is working and this is not working.We do a complex method like, for example, includingboth strength, balance, endurance training,and task-oriented training.And we can't pick out one of themas the single ingredients working.Complex may also be related to the outcome measures we do.

  • 02:28

    BIRGITTA LANGHAMMER [continued]: The outcome measures can be quantitative or qualitative.And, of course, that takes interpretationwhen you're looking at the resultsand how you are doing the analysis.Time is also complexity in this respectbecause you're not just taking a pill.You are perhaps doing exercises three, four, or five

  • 02:50

    BIRGITTA LANGHAMMER [continued]: times a week, and perhaps of different intensityand of different time length.And that will, of course, influence the results.What else can be challenging whenyou're doing this research?Well, of course, the analysis that theycan be more or less complex.So today, I thought I'd tell you about four examples

  • 03:13

    BIRGITTA LANGHAMMER [continued]: that I have done in my research, and we started outwith a three RCTs that we say randomized controlled trials.And we end up with a cohort, the fourth timeon the different aspects that I encountered there.

  • 03:35

    BIRGITTA LANGHAMMER [continued]: So when we do our trials, we are in needof a design of the trials.And of course, I mentioned that wewere doing randomized controlled trials,and when we do these randomized controlled trials,it is good to use checklists, checklists like, for example,the concept that is used to check out

  • 03:56

    BIRGITTA LANGHAMMER [continued]: that you have all the aspects with you whenyou are doing the research.Otherwise, there are other checkliston the equator.com that you can usefor your quantitative or other types of science.And, of course, when you write the project,you outline how the study goes.

  • 04:19

    BIRGITTA LANGHAMMER [continued]: And when you get money for that study, you are very happy,and then you have to sit down and do a study protocol thatwill say, you operationalize how youare going to do the study so that you are sure that you havemet all the precautions that you can

  • 04:41

    BIRGITTA LANGHAMMER [continued]: do to avoid BS in your trial.And of course, one of these things in the protocolis to decide how you're going to doit, who is going to be involved, where is it going to be held,and time limits of the trial.

  • 05:03

    BIRGITTA LANGHAMMER [continued]: And you also have to be--get ethical recommendations.You have to declare to do your research in termsof the Helsinki Declaration, of course,and you have to get that acknowledged.And another thing that is very important

  • 05:25

    BIRGITTA LANGHAMMER [continued]: to do when you do a project is to registeryour project in some sort of officialregister in order to get your papers published.This is a prerequisite these days.And in there, you also say when you start upand when you think you will be ending your study.

  • 05:49

    BIRGITTA LANGHAMMER [continued]: And you will also publish your end results there.If we should start with the first examplewe did about our randomized controlled trial,then the focus of the trial was the intervention.We did the randomized controlled trials in accordance

  • 06:10

    BIRGITTA LANGHAMMER [continued]: with the concert regimes, with blindingof testers and the patients.We couldn't blind the therapist.We had the Helsinki Declarations in order.We had a place that was a single-center study.

  • 06:31

    BIRGITTA LANGHAMMER [continued]: And we were following these patientsin a standardized location.So all the other treatment was equal for all the patients whowere into the trial, both those whowere randomized to the intervention and thoseinto the control.The only thing that differed was the interventionthey got from the physiotherapists.

  • 06:52

    BIRGITTA LANGHAMMER [continued]: And this was an intervention basedon the different theoretical constructs.So the therapist had to work in accordancewith a hierarchical understanding of the CNS in onegroup, and the other group workedwith a systemic theoretical understanding of the CNS

  • 07:17

    BIRGITTA LANGHAMMER [continued]: in the other group.And that, of course, influenced how they work for the patients,but the patients think of treatment,so they didn't really know what was the difference themselves.But in order to keep this very separate,we had to work out protocols for the interventions thatwas very strict, so that we knew that all the therapists working

  • 07:39

    BIRGITTA LANGHAMMER [continued]: with these patients did the same thing in the intervention groupand in the other intervention grouplike we were comparing two interventions here.We also had to keep the patients apart so that theyweren't mixing and telling each other of the interventions.We had to keep the testers blinded so

  • 08:01

    BIRGITTA LANGHAMMER [continued]: that they were not influenced by one or the otherswhen they did it.And the trial continued as long as the patients werein the same unit and they didn't transfer overto another organizational level in this respect, and so forth.It was straightforward, and we could compare these two

  • 08:23

    BIRGITTA LANGHAMMER [continued]: and say that the randomization process in a waytook care of the other BS that we had,and we could conclude that one wasmore efficient than the others whenit came to multi-function when it came to length of stayin the hospital, et cetera.And then, we wanted to follow these patients up

  • 08:46

    BIRGITTA LANGHAMMER [continued]: when they came home, and we realizedthat the patients were getting worse again because theywere not using what they had learned in the acute unit.So we set up a new randomized controlled trial,and this time, we started the interventionsbased on our results from the first study,

  • 09:08

    BIRGITTA LANGHAMMER [continued]: but in a different organizational levelin the municipalities.And in the municipalities, you have three different waysof getting exercise.You can get them in your home by the community-based services,or you can go to private practice and do the exercises,or you are in an institution, and you get the exercise.

  • 09:32

    BIRGITTA LANGHAMMER [continued]: And, of course, the level of complexityarose here because now we have the longitudinal aspects.We were going to do this for a whole year.The intervention was the same in the intervention group,so we could do a program specified and standardizedto all the therapists, and the control group

  • 09:55

    BIRGITTA LANGHAMMER [continued]: got care as usual.But we were testing these patients very often.We tested them when they came into the acute stroke unitand as they discharged.When they were discharged, they wererandomized into these two groups and tested in the community

  • 10:17

    BIRGITTA LANGHAMMER [continued]: three weeks after, and three months, six months, and oneyear after.So this was the longitudinal design,and of course, the complexity here was in regard of time,will the patients adhere to the training for the period of timethat we set up.They had to do 80 hours of therapy for a year.

  • 10:39

    BIRGITTA LANGHAMMER [continued]: At least, that was a minimum.In the intervention group, it was therapist-driven,but in the control group, they could do whatever they liked,and they could do no treatment.But if they felt that they needed one,they could go to the doctor and say, please send me to someoneand help me with this.

  • 11:03

    BIRGITTA LANGHAMMER [continued]: The patients were tested regularly, as I said,and they were given their test results.And of course, when we looked at the results, in the end,there was no difference between the group,and then we had to go back to our papers,and we saw that adherence to the training in the intervention

  • 11:23

    BIRGITTA LANGHAMMER [continued]: group was just as we had set up.They were following the interventions as they should,and they were reporting improved and maintained motor function,but so was the control group.And when we looked at the adherentsand how much therapy those patients had,they were doing the same amount of therapy

  • 11:45

    BIRGITTA LANGHAMMER [continued]: because the testing in itself wasmotivating for these patients, so theyhad trained equally amounts.And one thing that surprised us wasthat when we looked at that controlgroup, the self-efficacy in these patients, that is,the belief in what they could do themselves,was higher than it was in our therapy-driven groups.

  • 12:09

    BIRGITTA LANGHAMMER [continued]: And then, we realized that the tests themselveswere enough to drive people forward and adherenceto therapy increases when you are aware of your results.This was very intriguing, so we decidedwe should do a new randomized controlled trial.Again, we adhere to the concert rules.

  • 12:34

    BIRGITTA LANGHAMMER [continued]: And this time, the intervention was also at focus,but this time the intervention was a motivator, a coach thatshould visit the patients in their home each monthand the patient should set up their goals as they preferredand the coach should say that yes, OK, you

  • 12:58

    BIRGITTA LANGHAMMER [continued]: can do this in that community-based health serviceor there is a group exercising therethat you can maintain that or you could contactthis and that therapist.So the patients themselves were active.They were just guided by the coach,

  • 13:18

    BIRGITTA LANGHAMMER [continued]: and every month this coach came to themfor one and a half year.And this time, we thought we'd do no testing underway,so we'll do a baseline testing.When they come to the control one monthafter at the hospital, they will randomize them, test themand randomize them, and then theydo the follow-up in their home communities.

  • 13:41

    BIRGITTA LANGHAMMER [continued]: This time it was also a multi-center trial.So the complexity went up.We had two large hospitals, we had through communitiesor municipalities that participated,and we had to teach therapists in these municipalities

  • 14:02

    BIRGITTA LANGHAMMER [continued]: the treatment, and they were doing thisfor a full-time job for one and a half year.And then, we tested our patients at the end of these 18 months.And of course, you can imagine that keeping adherenceto such a program for such a long time,

  • 14:23

    BIRGITTA LANGHAMMER [continued]: setting new goals for your life, and as the same timelife passes, things happen.This is quite an experience, and it was for our patientsas well.But in the end, there was no difference between the group.

  • 14:44

    BIRGITTA LANGHAMMER [continued]: Our patients both kept their levels high,but we had different difficulty with the control group gettingthe numbers in because they had forgotten that they were partof a test, and they went out into their livesand forgot all about it.

  • 15:04

    BIRGITTA LANGHAMMER [continued]: So when we called them up after one and a half year,many of them didn't even rememberthat they had signed up, and this is, of course,one of the things that makes it very complex with such a longadherence period.And another time and another thingis that the people who signed up for this were pretty motivated,

  • 15:27

    BIRGITTA LANGHAMMER [continued]: and they wanted someone to help them out.Of course, they expected perhaps some more hands-on treatment,more driving, the thing that you thinkwhen you have a physiotherapist in front of youthat they will lead the group, so to say theywould lead the intervention.

  • 15:48

    BIRGITTA LANGHAMMER [continued]: And so many were perhaps a bit disappointed in that.So we had drop-outs that perhaps made --perhaps were more the core of the group herethan the ones who finished it because theywere very motivated and they were not that disabled,unfortunately.

  • 16:10

    BIRGITTA LANGHAMMER [continued]: But the thing is that from doing a one-single trialin a hospital to doing a trial where you havethe intervention going on in a municipalitywith many other different biases coming into your research

  • 16:30

    BIRGITTA LANGHAMMER [continued]: is very, very complex, and it's a learning experience.But I think we improve the design now.So now we are doing a fourth study on this trial as well,and we hope that we get some results from that.The fourth study was a cohort studybecause we were doing this in an international arena.

  • 16:53

    BIRGITTA LANGHAMMER [continued]: We included seven countries, nine different clinics,so it was definitely a multi-center trial.And we were trying to do--we were looking at acute stroke patients who hadmoderate to severe disability.These patients are normally sent in all countries

  • 17:17

    BIRGITTA LANGHAMMER [continued]: to specialize rehabilitation because theyare in need of more complex interventions,and a variety of them in the multidisciplinary teamare involved in this research.So the aim was this was that did we really define specialized

  • 17:39

    BIRGITTA LANGHAMMER [continued]: rehabilitation in the same way?And did we use outcomes in the same way?And how did this influence patient's rehabilitationoutcomes?How long were they in the institutions, et cetera?

  • 18:00

    BIRGITTA LANGHAMMER [continued]: These were the main questions that wewere interested in looking at.And of course, doing such a complicated trial,then you tried to make it as simple as possible,so we wanted a short period of timewhere we recruited patients, and we did the intervention,and then we just wanted to do a case-control.

  • 18:21

    BIRGITTA LANGHAMMER [continued]: We started doing the test at the baseline when we started up,and we did it when they were discharged,and then we tried to follow them upto six months in these different countries.And of course, here we have different organizations,different political systems, and different economical systems

  • 18:44

    BIRGITTA LANGHAMMER [continued]: how health treatment is paid, and whogets treatment, et cetera.So this was a very interesting studyto do because we included countries like the USand Sweden and Norway and Palestine, Israel,

  • 19:05

    BIRGITTA LANGHAMMER [continued]: and China and Russia.So these were very different that we call ourselvesthe Little United Nations.And of course, we have to introduce the protocol as usualand agree on the protocol agree if itwas possible to do the study within the time limits

  • 19:27

    BIRGITTA LANGHAMMER [continued]: and if they had possibilities to do it, and everybody agreed.We also had to agree on ethical approval.We all had to adhere to the Helsinki Declaration,but of course, in some countries like the Gaza, we did the Gaza,

  • 19:49

    BIRGITTA LANGHAMMER [continued]: and we did the Bethlehem and Palestine, both of them,and they had quite different actually within themselves,and they have no regional ethical committeesin those countries, the same for China and for Russia,so we had local ethical committees there.

  • 20:09

    BIRGITTA LANGHAMMER [continued]: And of course, in the US, it was a privatized health sectorcompared to the example is Russia, where all ispaid by the state and in China.And so, we had quite the challenge there.So first, we had to decide about the definition of specialized

  • 20:29

    BIRGITTA LANGHAMMER [continued]: rehabilitation.And for that, we did the complete research.We looked at the papers.We had them describe what they had in their different healthdepartment, what sort of persons, medical doctors,

  • 20:52

    BIRGITTA LANGHAMMER [continued]: nurses, therapists, speech therapist, psychologists,et cetera.So we got everything done.And then, we looked at, are thereany definitions golden standards of whatspecialized rehabilitation is, and we found actually one.The British Society of Rehabilitation Medicine

  • 21:12

    BIRGITTA LANGHAMMER [continued]: has put up some guidelines for whatshould be included into these guidelines,so we made a 10-point list, and thenwe checked these clinics out, and we try to make this as fairas possible.So the leaders of the hospitals had to send their description.

  • 21:33

    BIRGITTA LANGHAMMER [continued]: The health workers had to send their description,and in addition, we visited every place,and we filmed so that we could go back and look at it.And then, we had workshops physical and workshopsdigitally.So we agreed upon, yes, this is the correct description,

  • 21:54

    BIRGITTA LANGHAMMER [continued]: so to check that out, specialized rehabilitation.And, of course, these clinics came out very differently.And then, we looked at the interventions.They had to describe what sort of interventionsthe patients got when they came to the clinic, how this wasdone in terms of how often frequency, how intensive, what

  • 22:19

    BIRGITTA LANGHAMMER [continued]: type of therapies, and how long the therapies were.And of course, then we have to check this out,and of course, we did that also with the visitsand also that they had to write downhow long the therapy lasted for the patients.And then, of course, we had to agree upon the outcomes.

  • 22:40

    BIRGITTA LANGHAMMER [continued]: How were we supposed to evaluate the outcomes?And then, we had to find an outcome thatwas used in many of these clinics,and of course, activities of daily livingis something that everybody wants to know, you know,can you do this when you come home?

  • 23:01

    BIRGITTA LANGHAMMER [continued]: So we had two different outcomes.It was the functional independence measure,and it was the bottle index that we use.And this was very good because we could thendo a combination of the clinics that knew the bottle index.We could do a calculation so that the film and the BI

  • 23:24

    BIRGITTA LANGHAMMER [continued]: was approximately the same when we came out.So they are built on the same level.And so, therefore, it was easy for us to use that.But then we introduced another scalebecause health-related quality of lifeis also interesting to see how are these persons satisfied

  • 23:46

    BIRGITTA LANGHAMMER [continued]: with their lives after stroke, et ceteraafter their therapy sits.And then, we introduce the life satisfaction scale,and this was new to everybody.And that was very good because then wecould see what did this person put into life satisfaction.What was the quality of life for the different person

  • 24:06

    BIRGITTA LANGHAMMER [continued]: in these different clinics?And of course, this also led to interesting discussionswhen we met because we realized wehad to transfer this outcome.Now, this has to do in back and forth so that they come outin the natural language, and they can

  • 24:28

    BIRGITTA LANGHAMMER [continued]: be transferred back to English.In this case, it is a Swedish outcome,but then many people don't know Swedish.So we had to do it in the English outcome.And of course, then you have to ask the questionin a certain order.And what we realized was that in some states,

  • 24:52

    BIRGITTA LANGHAMMER [continued]: some of these questions were socially veryintimate questions, so the interviewers--we had many discussions you can'task that in our companies.No, you can't say it, and you mustn'tsay in that order, et cetera.So we have to drive some sort of education throughout this

  • 25:14

    BIRGITTA LANGHAMMER [continued]: as well, so that the persons used the scales as they weresupposed to do and that they did this back translation,and we could check it as well.And that the we had even had to go in and sayyou mustn't ask this question in a full gym, for example,

  • 25:36

    BIRGITTA LANGHAMMER [continued]: you have to have this in a secluded roombecause these are sensitive things,so the person can feel safe that they staywith you in the secluded area.And I mean, you have to go through everythingfrom the bottom up this time to get the clear result.And we were very fortunate, so we had the developerof the scale with us all along.

  • 25:57

    BIRGITTA LANGHAMMER [continued]: So for her, it was interesting to follow these discussionsas well.So in research, in many ways, you have this--you learn a lot as a researcher as well as you go along.So that was the outcomes.And then, of course, the time we set.We agreed upon a time limit that we

  • 26:19

    BIRGITTA LANGHAMMER [continued]: could go in and do this within three months from the start.But as you know, things happen.So war broke out, natural disasters put a floodingin New York, so the hospital was set outof work for several months.So, of course, we had to do revisions of the protocol

  • 26:41

    BIRGITTA LANGHAMMER [continued]: and change the timelines.And so, we extended it for six months in all clinics,and then we had fruitful discussionsand followed it up of the six months,and then even did a one-year follow-up at this time.But this exemplifies how natural disasters influence it.

  • 27:03

    BIRGITTA LANGHAMMER [continued]: Man-made disasters influence it, and alsothat the outcomes can create quite the confusion.For example, in Russia, they change the whole thing,they were upside down the bottle index,and we had to go in and do differences, or to change it

  • 27:24

    BIRGITTA LANGHAMMER [continued]: and to have a talk with them.And we also came up with very exciting different waysof treating.The Americans were very efficientworking in 45 minutes with high intensity of trainingwhile the Russians chose 10 minutes of each,and some of them were very passive treatment.

  • 27:45

    BIRGITTA LANGHAMMER [continued]: So, of course, all these difficultiesthat arose with the times that were differentand the understanding of the outcomes, et cetera,made us realize that in order to analyze the dataand not to have too many free radicals or insecurities

  • 28:09

    BIRGITTA LANGHAMMER [continued]: where we did that, we had to revisethe protocol during the time.And, as I said, we prolong the inclusion timeand the recruitment.In the end, we recruited 210 patients, all of them,and we did several workshops.

  • 28:31

    BIRGITTA LANGHAMMER [continued]: The activities of daily living were not such a problem,but the problem was the life satisfactionwith the understanding of that satisfaction.So before we let them do the actual testingfor the patients, we had to do several workshops in orderto agree upon, you have to do it in the same order

  • 28:57

    BIRGITTA LANGHAMMER [continued]: that the questions are put in the test kit.You have to do it in a secluded area,and you have to let the patients talk a bitabout their experiences.So we actually added three columns

  • 29:18

    BIRGITTA LANGHAMMER [continued]: where the patients could say somethingabout their life satisfaction in generalso that it was more or less the qualitative test in the end.And we also added a structured questionnaire,where we try to fill out some questions that

  • 29:41

    BIRGITTA LANGHAMMER [continued]: would sort of support the life satisfaction scale.And this was very interesting because everybodywas very supportive, and they wanted to do thisand, for example, China was very gratefulbecause they had never asked these questionsin their facilities before, and they

  • 30:04

    BIRGITTA LANGHAMMER [continued]: thought it added so much to their general practice,so they wanted to include them further.And actually, as a result of this,a PhD student came to Norway to do a PhD did this,she followed up on the life satisfaction on quality of lifein China.

  • 30:24

    BIRGITTA LANGHAMMER [continued]: And we still work together on this project today.When you are doing your research nowin complex methods, which you allwant to do since you are health researchersand you will always be curious on something newand try it out in your own surroundings.And I wish you every luck with that.

  • 30:48

    BIRGITTA LANGHAMMER [continued]: Then just have some small rules.Do write a protocol in the beginning so that you have a,how, when, and what are we going to do.And then, you do study-specific files defining it moreinto detail, so it becomes sort of a recipe of how you

  • 31:09

    BIRGITTA LANGHAMMER [continued]: are going to do your research.So everybody knows what they are going to do in the research.Keep this simple.Keep outcome measures the generalwants that are used in many other studiesso that you can compare your results with others,and do invite your collaborators into this work

  • 31:34

    BIRGITTA LANGHAMMER [continued]: so that you discuss, and that you revise before you startthe study, preferably, so that everything is in order for youto start off with, preferably, a pilot before you startthe main study because then you have the study protocols,

  • 31:55

    BIRGITTA LANGHAMMER [continued]: you have the collaborators, and you do a trial,does this work or not?And then, you can revise once more before you start upthe main trial.And then you have enhanced the qualityof your study immensely.I think that these are the things

  • 32:16

    BIRGITTA LANGHAMMER [continued]: you need to do in practical.In addition, you need to have a cohesive spiritand friendly atmosphere in your research groupbecause you want the processes to be transparent.If somebody makes a mistake, you wantthem to tell you that instead of keeping it

  • 32:36

    BIRGITTA LANGHAMMER [continued]: the secret so that perhaps it ruins your results,you have something that it's in there that will disturbthe analysis or the interpretation of the samebecause somebody did something that wasn't in the protocol.These are the simple rules I leave you with.And I'm very happy to share them with you.

  • 32:57

    BIRGITTA LANGHAMMER [continued]: Good luck with your future work.Thank you.

Abstract

Professor Birgitta Langhammer, PhD, Department of Physiotherapy, Oslo Metropolitan University, discusses four progressively more complex randomized controlled trials to illustrate complex methods and complex interventions in physiotherapy research.

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Applying Complex Methods in Physiotherapy Research

Professor Birgitta Langhammer, PhD, Department of Physiotherapy, Oslo Metropolitan University, discusses four progressively more complex randomized controlled trials to illustrate complex methods and complex interventions in physiotherapy research.

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