Reflections on my application for an NIHR fellowship

Each year the National Institute for Health Research (NIHR) in the UK award a range of fellowships to support individuals (clinicians, academics etc from a range of backgrounds) on a trajectory to becoming future leaders in NIHR research. What the fellowship offers is dependent on the person applying and the stage of their career, among other things. Full details of the NIHR fellowship programmes are available here .

In August of 2018 I was awarded an NIHR post-doctoral fellowship which, for me, means that my salary is covered for the next four years to undertake a bespoke training programme while undertaking further research and engaging with leading clinical and academic mentors to facilitate my development as a future leader in NIHR research. So, you can see already that an award of an NIHR fellowship provides major opportunities.

I often get requests for advice from people thinking about embarking on this journey so in this blog I want to reflect on my application process, hoping it will be useful for others. But, to add a caveat; this blog is my reflection on my experience and is not official advice from the NIHR. For those wanting official advice then the NIHR academy are easy to contact via their website and are always happy to advise. Also, I have now applied for three fellowships;

·       - The first one was successful but I thought my application could have been better and was disappointed with my performance at the interview.

·       - The second one was unsuccessful but I was really pleased with both my application and my interview!

·       - The third one was successful; I was really pleased with my application but genuinely gutted after the interview, I thought I could have done so much better, so much so that I was already making alternative plans before hearing that the fellowship had been awarded.

This tells me that I am no expert in the decision making process that leads to the award of a NIHR fellowship and I do not have any magic solutions to offer. Please bear this in mind if you choose to read on…

The process starts with the application form

In short, no it does not! Fellowships are personal awards to support the development of individuals capable of making an impact through NIHR research. The fellowship application is judged in relation to the person, the place(s) where the fellowship would be hosted as well as the supervisors or mentors, the training programme and the research project. Recognising all these components, if your thought process begins at the time the application is live then I suspect you might submit an application that you will later reflect could have been better, or might never actually get to the point of submitting.

Planning to submit an application begins months in advance. I first approached my manager at Keele, Professor Nadine Foster, in May 2017 prior to a December 2017 submission date. We both recognised that the six months window was tight but worth a go. I had the advantage of my previous NIHR fellowship which had given me a significant boost and also I had recently received funding from the NIHR for another study so my CV was ready in terms of publications, invited presentations, awards and research grant capture etc (all important academic metrics). These factors all contribute to the assessment of the person in this context. Most often, at the outset of this fellowship pathway, these aspects of the CV need to be developed and it is important to recognise this right from the start so that you are ready to submit the best application you can. This might mean that planning begins two to three years before your fellowship application is submitted. Thankfully now the NIHR, for example, offer pre-doctoral fellowships to support in this way (more details on the NIHR website here ).

The person

Unlike research project grants where funds are awarded to a project team, these fellowships are awarded to individuals, as described. So, success can be very sweet for that individual but the opposite is also true. When my first application for a post-doctoral fellowship was not supported in 2015 it really knocked me back and made me question my future steps. Not long after this rejection, Nadine Foster reached out to me from Keele to ask whether I would like to spend some time with her and her team to contribute to their research but also develop my own research ideas. Despite the resulting five hour commute from my home in Yorkshire to Keele in Staffordshire, I did not hesitate to accept the offer. Looking back, I’m not sure where I would have been now without Nadine’s offer of support; I guess that is one of those pivotal moments that happens to many of us in our lives. Why am I reflecting on this? Well, ask anyone who has been through the process; it is an emotional journey. Being offered the award is immense, but rejection can have a huge impact too that really tests your resilience – just something to be aware of and to recognise if you do, or have felt like this then you are not alone.

The place

Eighteen months prior to the award of my fellowship, I had successfully applied for a permanent position at Keele. This was helpful because of Keele's track-record and research focus. It was also helpful to be around others that have trod this path before me. To be at Keele I have moved my family from our original home in Yorkshire to be closer to work because the five hour commute just wasn’t sustainable. With three children of and approaching high-school age, this is not a decision taken lightly and I have often reflected that there is a selfishness to this. But, without the move, I am not confident that I would have been successful with the fellowship or even currently have an academic position. Again, why am I saying this? Well, the place is important; to develop you need to be in the best place possible so this needs careful thought and, unfortunately, might not always be the most convenient place.

The supervisors/ mentors

Who do you want to be like? Who is an expert in your chosen area? Who has experience of these NIHR fellowship programmes? These are good starting questions when thinking about the team you want around you to support you on this journey. Aim high and also think international.

I feel very fortunate to have the mentor team I do; Professors Nadine Foster, Amar Rangan, David Beard and Dr Julia Wade who have all already contributed in their own way. It is helpful to identify these people and get them involved as early as possible.

But, as well, don’t forget a very important group of supervisors/ mentors – the patients who the research will affect! Establishing a working relationship with patients and engaging with them in this process is immensely helpful, just make sure this is on your initial plan and not just an after thought!

The project

Most often I am approached by physiotherapists interested in applying for a doctoral fellowship; this is to be expected given my background and fellowship experience. These conversations often begin along the lines of; ‘I’ve got a great idea for a research project, I want to see if this muscle contraction is better than that muscle contraction for this condition that I’m really interested in.’ Of course, it is fine to start thinking in this way but you need to think strategically with reference to your project. Is this research idea just important to me, or would a national funder see this as an important research question that has a clear pathway to patient benefit. Often this means, for now at least, that you might not be able to follow your initial path; be open to this and let your idea(s) evolve as you engage with all the relevant stakeholders, e.g. priority setting groups, patients, colleagues, mentors/ supervisors and the funder.

But, of course; a fellowship is not an award to undertake a research project in isolation. So, you need to be thinking about how the project offers the opportunity to facilitate your development. The research project in my fellowship is a pilot trial exploring the feasibility of undertaking a larger randomised controlled trial that would compare surgery with a programme of physiotherapist-led exercise for traumatic tears of the rotator cuff. Some of the feedback that I received questioned how this project would facilitate my development as a future leader of NIHR research given that I had already led randomised controlled trials. My argument was that this will be a bigger, more challenging and complex study than I have led before, and will be complemented by other important investigations to determine feasibility (The Quintet Recruitment Intervention – Google it, very interesting) which I don’t have prior experience of. Also, the research aligns with my bespoke training programme that includes development as a leader, design of efficient randomised trials and the Quintet Recruitment Intervention. The research also provides a vehicle for me to engage with my expert mentor team which I see as a key component of my fellowship.

The training programme

I realise I’ve written too much already for the purpose of a blog so I’ll keep this penultimate section brief. It is somewhat ironic that the training programme is the last section because in the context of a fellowship this absolutely should not be the case. Fellowships provide significant opportunity to access training, in various forms, that you would typically not have access to outside of a fellowship. Think carefully about your development needs and how these link to your proposed research. For me, the most helpful think I did was to reach out to other fellowship holders to ask about their training plans and this really helped to begin to develop my ideas.

The process

Depending upon the fellowship scheme, you will likely submit an initial application that will then be scrutinised and, if short-listed, then be invited to submit a full application followed by an interview. The application process is detailed on the NIHR website so I just want to dedicate these last few words to the emotion of the interview. I prepared by reading and re-reading my application, discussing my application widely with clinical and academic colleagues and then having two mock interviews; one at Keele and one in Bristol. But, nothing quite prepares you for the day; facing 16 to 20 very clever people means that you will never anticipate the questions they ask. Following the expected five minute presentation, my opening question from the interview panel was, ‘so how does physiotherapy actually work?’ Wow, big question – wasn’t expecting that! After 20 to 25 minutes of questions from a range of clinicians, methodologists and patients you are excused and enter no-mans land – six weeks of waiting until you hear the outcome. This is a difficult time because the award means so much and I also felt that I could have done better, so was disappointed in myself. I had no clue how to answer one of the questions but felt I should have known; I stuttered for a little bit and then just admitted ‘I’m sorry, I don’t have a credible answer for you.’ I googled it as soon as I got out of the interview which made me feel even worse!

When the e-mail informing me of the outcome dropped in to my inbox, and I read the first line I genuinely cannot describe the feeling. I was working at home and my eldest son was kicking a ball in the back garden. I had to tell someone and he was the closest. ‘I got the fellowship’ I stuttered, he looked at me blankly ‘does that mean you’ll get more money?’ ‘No, son’, I said, ‘but I’m still very happy’ as he started kicking his ball again. Life goes on…

As is often the case, I could write much more…but I’ve got a fellowship to complete, so hope that some aspects of my ramblings were useful to those of you who made it this far.

Chris Littlewood (October 2018)

The SELF managed exercise programme

A few years back I reported the design, development and evaluation of a SELF managed exercise programme for rotator cuff tendinopathy here, here and here. The programme was based on the work of others, including McKenzie & May, and evolved through learning from systematic reviews (here, here and here) and a whole bunch of other literature summarised in my PhD thesis here.

The SELF managed exercise programme involved prescribing just one exercise in relation to the most painful shoulder movement and progressed over a minimum of a 12-week period guided by the symptom response, i.e. exercise should be acceptable to the patient while doing the exercise, immediately after the exercise, and 24-hours later (no use of visual analogue scales and terms such as 3, 4 or 5/10 and no time frame, i.e. it's ok providing the symptoms settle within 24 to 48 hours etc).

The SELF managed exercise was prescribed in relation to what was described as a self-managed framework including helping the patient to understand their problem along the lines of; 'this is a problem with the muscles and tendons of your shoulder, they're lacking fitness, capacity, strength' (limitations of this explanation recognised but aiming to do no harm and provide an understanding that facilitates engagement with exercise). Time is spent in the clinic with the patient practising their exercise so they feel confident to do this independently (more on this later); exercise prescription is supported with an exercise diary and used as a basis to discuss exercise adherence in subsequent follow-up sessions; goals are set using the Patient Specific Functional Scale as a guide; questions are asked about when the patient will fit the single exercise in to their daily routine before a schedule for further follow-up appointments, if required, is agreed.

Recognising that many people with this type of shoulder pain complain of abduction related pain, abduction was used as an example to guide how the SELF managed exercise would be initially prescribed and progressed in previous reports. But, it seems this has been misinterpreted by some and the SELF managed exercise programme has been seen solely an abduction loading programme; it isn't.

The single exercise programme is initially directed towards the most painful or problematic shoulder movement which could be abduction but could also be reaching up to a shelf, bench pressing, serving at tennis, reaching behind etc etc. In the clinic, clues to the most painful or problematic shoulder movement will be gained while taking the history. In terms of the examination, this begins by asking the patient to demonstrate the shoulder movement that most provokes their problem - this is now termed the baseline functional test. Then, movements of the neck are examined to see if they have an effect on the shoulder pain or movement. If they do, and increase or decrease the pain, then it is probably sensible to spend some time exploring the neck a little more before undertaking further testing of the shoulder. If movements of the neck do not influence the shoulder, then the next step is to exclude shoulder pain with stiffness and a simple lateral rotation test is done for this purpose. To confirm the provisional diagnosis of 'rotator cuff tendinopathy' resistance is then applied to the baseline functional test in the pre-symptomatic range, e.g. inner-range flexion if reaching to a shelf is a problem, with the aim of reproducing the familiar shoulder pain. If this test is positive then the next stage of the examination is initiated which aims to identify the type and dose of exercise to be prescribed.

So, for example, if reaching forward to a shelf over 90 degrees is problematic then the movement is broken down and testing could begin with isometric flexion in a step-stance position (to mimic the functional movement as far as possible). The response to 3 sets of 10 isometric flexions is examined remembering that the symptom response should be acceptable during and after and this will vary between patients. If a pain response is not acceptable to the patient then quite simply you wouldn't provoke it. After 3 sets of 10 isometric flexions, if the symptom response is acceptable the next progression could be to isotonic inner-range flexion using theraband or a hand-weight. Again, the response to 3 sets of 10 repetitions is evaluated and if the response remains acceptable then the exercise is progressed further, for example to mid-range flexion with theraband. The aim is to commence an exercise programme that directly challenges the functional problem, so in this case the aim is to introduce loading at 90 degrees of flexion and beyond.

This process helps to identify the type of exercise; begin with the most painful or problematic movement and if loading of this is unacceptable then commence the training with a different movement and return to the most painful or problematic movement when the threat response has reduced sufficiently. This process also helps to identify the dose of exercise; 3 sets of 10 is used as a starting point for the assessment but does not need to be the exercise prescription in all cases. For some, 3 sets of 10 will result in an unacceptable response so a reduced number might be prescribed. For some their functional demand might require higher repetitions so the exercise prescription would reflect this. For some their functional demand might require sustained loading so the exercise prescription would reflect this. In the previous studies listed above, the exercise was prescribed twice per day. Interestingly we still don't know what the optimal frequency is but I think prescribing a programme of this nature and doing it on most days could be a useful starting point.

One clear advantage of going through this process in the clinic is that the patient develops confidence to exercise and has a clear understanding of how to do this but also they are learning how to progress and regress their exercise. So if they want to push on they can begin to understand the principles but equally if the symptom response becomes unacceptable then they know how to regress their exercise, so hopefully enhancing self-efficacy and reducing reliance on the physiotherapist.

The exercise would be progressed over a minimum of a 12-week period based on the symptom response, and using acceptability as the guide. Patients should not begin the 12-week programme with one exercise and end doing the same exercise; progress is expected.

Consider another example; the patient who complains of pain when serving at tennis. The tennis serve could be broken down and testing could begin with isometric medial rotation with the arm by the side. Then progressed to isotonic medial rotation but still with the arm by the side. Then isotonic medial rotation with the arm in 30 degrees of abduction etc etc. Progress is based on acceptable symptom response with the aim of retraining in the zone which is most problematic. This could commence on day one or might take a number of weeks to achieve through the various progressions.

I hope this adds some clarity; no detailed recipes just some guiding principles.

As I mentioned in a previous blog here, there were methodological limitations with the SELF study which means it is not safe to conclude that this approach is better or worse than other approaches at the moment. However, it is an approach that has been developed using existing evidence and is theoretically informed but further evaluation through high-quality, adequately powered randomised controlled trials comparing against other exercise programmes and/ or wait-and-see approaches might be worthwhile to help develop our understanding.

Thanks for making it this far...
Chris

Critical Appraisal of a RCT (June 2018) - Spanish version

¡Amigos! Volvemos con un nuevo artículo para evaluar con el fin de considerar la utilidad al tomar decisiones con nuestros pacientes.

Al examinar la evidencia de la investigación con respecto a la efectividad de los tratamientos, a menudo encontramos mensajes contradictorios y pruebas que apuntan en diferentes direcciones, esto puede ser un proceso confuso.

Esto es especialmente cierto cuando se consideran los problemas que afectan la región del hombro donde las inconsistencias en la terminología y los criterios de diagnóstico para afecciones como el síndrome de pinzamiento subacromial (SAIS) pueden dificultar aún más las comparaciones entre los estudios.  

Bueno, hoy presentamos un artículo de seguimiento con un seguimiento de 10 años que compara un abordaje quirúrgico versus un enfoque conservador en pacientes con SAIS diagnosticados:

La descompresión subacromial produce mejores resultados clínicos que la terapia por si sola: un estudio prospectivo aleatorizado de pacientes con un mínimo de seguimiento de 10 años. Am J Sports Med. Mayo de 2018; 46 (6): 1397-140

Este es un ECA prospectivo con un seguimiento de 10 años, cuyo objetivo fue comparar los resultados obtenidos en pacientes diagnosticados con pinzamiento subacromial tratados con un abordaje quirúrgico de descompresión subacromial (cirugía abierta o artroscópica) o con tratamiento de fisioterapia según el protocolo de Bohmer.

Se reclutaron pacientes con dolor subacromial que persistieron después de la terapia conservadora (fisioterapia no estructurada, antiinflamatorios no esteroideos e inyección local de corticosteroides) que fueron remitidos a un departamento de ortopedia de las unidades de atención primaria. Después de reclutar 95 pacientes consecutivos con SAIS, 87 pacientes cumplieron con los criterios de inclusión y dieron su consentimiento por escrito. Los criterios de inclusión fueron dolor subacromial durante al menos 6 meses. Los criterios de exclusión fueron diabetes mellitus, trastorno neurológico o espinal de cualquier naturaleza, OA radiográfica, la presencia de trastornos articulares crónicos (p. Ej., Artritis reumatoide), ruptura completa del manguito rotador de y SAIS de grado III. 

Los pacientes fueron aleatorizados en 3 grupos utilizando una forma estratificada y ciega (sobres sellados) haciendo ajustes para los factores de confusión identificados por los autores (sexo y edad). Los grupos fueron acromioplastia abierta (grupo de cirugía abierta [OSG]), acromioplastia artroscópica (grupo de cirugía artroscópica [ASG]) o tratamiento no quirúrgico (grupo de fisioterapia [PTG]), los detalles fueron los siguientes

•         Cirugía abierta: el procedimiento se realizó de acuerdo con Rockwood y Lyons

•         Cirugía artroscópica: la descompresión subacromial artroscópica se realizó de acuerdo con Ellman

•         Tratamiento no quirúrgico: el PTG recibió tratamiento de acuerdo con el método descrito por Bohmer

Las medidas de evaluación clínica fueron: puntaje constant, SF-36, puntaje de Watson y Sonnabend, rango de movimiento en términos de elevación activa y rotación interna, y la fuerza en la abducción.

Además, se evaluaron los exámenes ecográficos y radiográficos al comienzo del estudio y durante el seguimiento.

Los autores plantean la hipótesis de que después de 10 años de tratamiento inicial, los pacientes sometidos a acromioplastia tendrían un mejor resultado clínico y un menor riesgo de desarrollar rupturas del manguito de los rotadores y la osteoartritis (OA) en comparación con los tratados con fisioterapia.

Los resultados del estudio durante el seguimiento de 10 años se informan como diferencias estadísticamente significativas a favor de las intervenciones quirúrgicas en las mediciones de rango de movimiento activo, fuerza muscular y puntaje constante. No se encontraron diferencias estadísticamente significativas en los puntajes de Watson y Sonnabend, SF-36, y en las evaluaciones radiográficas y de ultrasonido

Al igual que con muchos estudios, hay limitaciones que deben tenerse en cuenta. Para el propósito de este blog nos enfocaremos en lo siguiente:

1.       Tamaño de la muestra - poder estadístico - desgaste

2.       Diferencia en las características de referencia entre los grupos comparados

Tamaño de la muestra - poder estadístico – desgaste:

Los autores describen en la sección MÉTODOS que "El diseño del estudio se planificó para incluir 40 pacientes en cada grupo de tratamiento" y que "El tamaño de muestra estimado fue de 36 pacientes por grupo", pero luego agregan que "el estudio se cerró después de reclutar a 87 pacientes". (OSG, n = 24, ASG, n = 29, PTG, n = 34) ". En otras palabras, el estudio requería de 108 pacientes para tener un poder adecuado para detectar una diferencia. Los tamaños de muestra pequeños generalmente se asocian con un aumento del riesgo de error de tipo II (no se encuentra una diferencia significativa cuando existe) debido a la falta de poder estadístico para detectar una diferencia. Dado que se encontró una diferencia significativa entre los grupos quirúrgicos y de fisioterapia, esto es menos preocupante en este estudio, aunque en la proyección de 10 años, hubo algunos resultados que no alcanzaron significación, lo que podría explicarse por el pequeño tamaño de muestra.  Como se discutió en un blog anterior (http://research4physiotherapists.blogspot.com/2018/01/critical-appraisal-of-rct-january-2018.html), un tamaño de muestra pequeño no es solo una preocupación desde la perspectiva de la generalización, sino también en relación a hallazgos falsos positivos. Sumado a esto, durante el seguimiento, observamos un desgaste del 38% en el grupo de tratamiento quirúrgico abierto, y un desgaste general del 24,2% de los sujetos del estudio. Esto puede esperarse en un estudio de seguimiento de 10 años, pero estos factores deben considerarse al construir el diseño de la investigación y no se mencionaron estrategias estadísticas para explicar esta tasa de abandono.   

Diferencia en las características basales entre los grupos comparados:

Como hemos visto anteriormente en otras publicaciones de blog (http://research4physiotherapists.blogspot.com/2016/12/the-randomised-controlled-trial.html) una de las formas más seguras de distribuir las características de los sujetos por igual entre los diferentes grupos de tratamientos en estudios de intervención, tanto en características conocidas como desconocidas, es la aleatorización de los sujetos en los grupos de tratamiento. Entonces, a través de las reglas del azar, podemos estar seguros de que los grupos son comparables entre sí y atribuir cualquier diferencia en los resultados a la intervención que se está estudiando. En primer lugar, los autores afirman que los grupos al inicio fueron comparables, sin embargo, en un análisis más cuidadoso, observamos lo siguiente: En la duración de los síntomas de los sujetos asignados a cada grupo de tratamiento, 17 individuos (55%) pertenecientes al grupo de tratamiento conservador mostraron una duración de sus síntomas mayor a 36 meses, más del doble que los 8 presentes en el grupo de cirugía artroscópica, y mucho más alto que el grupo de cirugía abierta (11 personas).   Esto significa que los grupos que se comparan son diferentes incluso antes de que estén expuestos a los grupos de tratamiento. Por lo tanto, no podemos estar seguros de que las diferencias encontradas entre los grupos de intervención quirúrgica y el grupo de tratamiento de fisioterapia a los 10 años no estén influenciadas por estos, y otras diferencias desconocidas.

Conclusiones

Las fortalezas del estudio incluyeron una comparación aleatorizada y un seguimiento a largo plazo. Sin embargo, los resultados deben interpretarse con precaución debido a las preocupaciones sobre el tamaño de la muestra y el riesgo de hallazgos casuales, así como las diferencias iniciales en los grupos de tratamiento en relación con factores pronósticos importantes.

Estos hallazgos también deben considerarse en el contexto del reciente ensayo controlado aleatorio CSAW (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32457-1/fulltext ) y una revisión sistemática comparando cirugía con programas que incorporan ejercicios dirigidos por fisioterapeutas (https://www.tandfonline.com/doi/abs/10.3109/09638288.2014.907364) y también otro ECA con seguimiento de 10 años que informó que no hubo diferencia entre la cirugía y un programa incorporando ejercicios dirigidos por fisioterapeutas (https://www.ncbi.nlm.nih.gov/pubmed/28566400). 

 Tomás Parraguez, Brian Cho, Paul Regan, Chris Littlewood, Sijmen Hacquebord

Critical Appraisal of a RCT (June 2018)

We return again with a new article to appraise in order to consider usefulness when making decisions with our patients.

When examining research evidence regarding treatment effectiveness we often find contradictory messages and evidence pointing in different directions, this can prove to be a confusing process. This is especially true when considering conditions affecting the shoulder region where inconsistencies in terminology and diagnostic criteria for conditions such as subacromial impingement syndrome (SAIS), can make comparisons between studies even more difficult.

Well, today we bring up a follow-up article with a 10 year follow-up comparing a surgical approach versus a conservative approach in patients diagnosed SAIS:

Subacromial Decompression Yields a Better Clinical Outcome Than Therapy Alone: ​​A Prospective Randomized Study of Patients With a Minimum 10-Year Follow-up. Am J Sports Med. May 2018; 46 (6): 1397-140

This is a prospective RCT with a 10-year follow-up; the objective was to compare the results obtained in patients diagnosed with SAIS treated with subacromial decompression (open or arthroscopic surgery) or with physiotherapy according to the Bohmer protocol.

Patients with subacromial pain that persisted after conservative therapy (unstructured physiotherapy, non-steroidal anti-inflammatory drugs, and local injection of corticosteroids) who were referred to an orthopeadic department from primary care units were recruited. After recruiting 95 consecutive patients with SAIS, 87 patients met the inclusion criteria and gave their written consent. The inclusion criteria were subacromial pain for at least 6 months. The exclusion criteria were diabetes mellitus, neurological or spinal disorder of any nature, radiographic OA, the presence of chronic joint disorders (e.g. rheumatoid arthritis), full thickness rupture of the  rotator cuff, and SAIS stage III.

The patients were randomized into three groups; open acromioplasty (open surgery group [OSG]), arthroscopic acromioplasty (arthroscopic surgery group [ASG]) or non-surgical treatment (physical therapy group [PTG]). The details of the treatments are as follows:

•         Open surgery: The procedure was performed according Rockwood and Lyons.

•         Arthroscopic Surgery: Arthroscopic subacromial decompression was performed according to Ellman.

•         Non-surgical treatment: The PTG received treatment according to the method described by Bohmer.

The clinical evaluation measures were: The Constant score, SF-36, Watson and Sonnabend score,  range of movement in terms of active elevation and internal rotation, and strength in abduction.

In addition,  ultrasound and radiographic examinations were evaluated at the beginning of the study and during follow-up.

The authors hypothesized that after 10 years, patients who had undergone acromioplasty would have a better clinical outcome and a lower risk of developing ruptures of the rotator cuff and osteoarthritis (OA) compared to those treated with the physiotherapy programme.

The results of the study through the 10-year follow-up are reported as statistically significant differences in favour of the surgical interventions in the active range of motion measurements, muscular strength and Constant score. No statistically significant differences were found in the Watson and Sonnabend scores, SF-36, and in the radiographic and ultrasound assessments.

As with many studies, there are limitations that need to be considered. For the purpose of this blog we will focus on the following:

1.       Sample size - statistical power - attrition

2.       Difference in the baseline characteristics between the compared groups

Sample size - statistical power - attrition:

The authors describe in the METHODS section that "The study design was planned to include 40 patients in each treatment group" and that "The estimated sample size was 36 patients per group" but then they add that "the study was closed after recruiting 87 patients (GSO, n = 24, ASG, n = 29, PTG, n = 34)". In other words, the study required 108 patients to to have adequate power to detect a difference. Small sample sizes are generally associated with an increase risk of type II error (not finding a significant different when one exists) due to a lack of statistical power to detect a difference.  Since a significant difference was found between the surgical and physiotherapy groups, this is less of a concern in this study although in the 10-year projection, there were some results that did not reach significance, which could be explained by the small sample size. As discussed in a previous blog (http://research4physiotherapists.blogspot.com/2018/01/critical-appraisal-of-rct-january-2018.html) a small sample size is not only a concern from the perspective of generalisability but also risks false positive findings. Given the size of the three randomised groups in this RCT this is a concern with  this study.   Added to this, during the follow-up, a 38% attrition was observed in the open surgical treatment group, and an overall attrition of 24.2% of the study subjects. This may be expected in a 10-year follow-up study, but these factors should be considered when constructing the research design and consideration given for strategies to account for missing data.

  

Difference in baseline characteristics between the groups compared:

As we have seen previously in other blog posts (http://research4physiotherapists.blogspot.com/2016/12/the-randomised-controlled-trial.html) one of the safest ways to distribute the characteristics of subjects equally between the different treatment groups in intervention studies, both in known and unknown characteristics is through randomization. So through the rules of chance, we can be sure that the groups are comparable to each other, and attribute any differences in the results, to the intervention that is being studied. In the first instance, the authors state that the groups in the baseline were comparable, however, in a more careful analysis, consider the following: when observing the duration of the symptoms of the subjects assigned to each treatment group, 17 individuals ( 55%) belonging to the physiotherapy treatment group showed a duration of their symptoms greater than 36 months, more than double that of the 8 present in the arthroscopic surgery group, and much higher than the open surgery group (11 people). ). This means that the groups that are compared are different even before they are exposed to the treatment groups. Thus we cannot be  sure that the differences found between the surgical intervention groups and the physiotherapy treatment group at 10 years are not influenced by these, and other unknown, differences.

Conclusions:

The strengths of the study included a randomised comparison and longer-term follow-up. However, the results should be interpreted with caution because of concerns about the sample size, and risk of chance findings, as well as baseline differences in the treatment groups in relation to important prognostic factors.

These findings should also be considered in the context of the recent CSAW randomised controlled trial (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32457-1/fulltext) and a systematic review comparing surgery with programmes incorporating physiotherapist-led exercise (https://www.tandfonline.com/doi/abs/10.3109/09638288.2014.907364) and also one other RCT with 10-year follow-up that reported no difference between surgery and a programme incorporating physiotherapist-led exercise (https://www.ncbi.nlm.nih.gov/pubmed/28566400).

Tomas Parraguez, Brian Cho, Paul Regan, Chris Littlewood,  Sijmen Hacquebord

Critical Appraisal of a RCT (April 2018) - Spanish Version

Evaluación crítica de un ensayo controlado aleatorio (ECA)

El blog de este mes se centrará en un ECA con el objetivo de evaluar el efecto de agregar punción secas a un programa de ejercicios para personas con síndrome de dolor subacromial; Arias-Buría et al. (2017). Una revisión sistemática reciente ha reconocido investigaciones evidenciada de baja calidad que se han realizado en relación con las afecciones musculoesqueléticas y la punción seca hasta la fecha, concluyendo que aunque la punción seca parece ser superior al compararla con pacientes “sin tratamiento” o tratamiento simulado, no hay diferencia en comparación con otros tratamientos de terapia física (1). Por lo tanto, dada la baja calidad de la evidencia y la incertidumbre resultante, parece haber un caso de un ECA de alta calidad con poder estadístico adecuado en esta área clínica.

Arias-Buria y otros (2017). Ejercicios y punción seca para el síndrome de dolor subacromial: un ensayo aleatorio en grupo paralelo. The Journal of Pain, 18 (1), 11-18

El objetivo del estudio fue examinar si la adición de punción seca para puntos gatillo (TrP-DN) a un programa de ejercicios era más efectiva que un programa de ejercicios en el tratamiento del síndrome de dolor subacromial (SAPS) durante 12 meses.

Los pacientes se incluyeron en este ECA de acuerdo con los siguientes criterios:

·       Dolor de hombro unilateral no traumático

·       Dolor por al menos 3 meses

·       Puntuación mínima de 4 puntos en una escala numérica de 11 puntos.

SAPS fue diagnosticado en base a la presencia de un arco doloroso y dos hallazgos positivos en cualquiera de las siguientes pruebas: Hawkins-kennedy, Neer, Empty can, Drop arm, and Lift-off tests.

Un total de 50 pacientes fueron aleatorizados; 25 para punción seca de puntos gatillos más ejercicio (TrP-DN + ejercicio) y 25 para el grupo de solo ejercicio. Ambos grupos recibieron el mismo programa de ejercicios que consta de tres ejercicios centrados en el supraespinoso, el infraespinoso y los estabilizadores escapulares. Los participantes fueron instruidos para realizar tres series de 12 repeticiones con una fase excéntrica lenta. El programa debía realizarse dos veces al día durante un período de cinco semanas. Un fisioterapeuta supervisor le enseñó el programa en la primera sesión y lo supervisó en las cuatro sesiones subsiguientes.

Durante la segunda y cuarta sesiones, el grupo de ejercicio TrP-DN + recibió punción seca para puntos gatillo además de realizar la intervención de ejercicio detallada anteriormente. La identificación de los puntos gatillos dolorosos se dejó a discreción del fisioterapeuta tratante. El fisioterapeuta tenía experiencia en la aplicación de punción seca en punto gatillo. 

El resultado clínico primario para el ECA fue el cuestionario de Discapacidades del hombro y la mano del brazo (DASH) y el resultado secundario fue una Escala de valoración del dolor numérico de 11 puntos (NPRS) en una escala de 0 a 10. Los datos de los resultados se evaluaron al inicio del estudio, una semana y, tres, seis y 12 meses después del período de intervención.

El ECA no encontró diferencias significativas en las puntuaciones de NPRS entre los grupos en ninguno de los momentos. Sin embargo, en cambio, el ECA informó diferencias clínicamente significativas entre los grupos con respecto a las puntuaciones DASH en todos los puntos temporales de seguimiento. Por lo tanto, los autores concluyeron que la adición de ejercicio TrP-DN + fue más efectiva que el ejercicio solo para pacientes con SAPS.

Las fortalezas de este ECA incluyen un protocolo prerregistrado, una pregunta clínica relevante y una decisión de investigación adecuada, incluyendo adecuados procesos de aleatorización y apropiadas medidas de resultado.

Para el propósito de este blog, hemos seleccionado dos puntos para mayor discusión:

1.       La discrepancia entre los puntajes DASH y NPRS

2.       El tamaño y configuración de la muestra

Discrepancia entre DASH y NPRS:

Un hallazgo interesante de este ECA es el hallazgo discrepante entre los resultados DASH y NPRS, es decir, no diferencias entre grupos en relación con el NPRS, pero diferencias clínicamente significativas entre los grupos en relación con el puntaje DASH. Esto es interesante porque el dolor y la discapacidad han demostrado fuertes correlaciones y, a menudo, muestran relaciones directas (2).

Estábamos interesados en ver si esta discrepancia existía en otros ensayos para comprender mejor si esta discrepancia entre los puntajes DASH y el dolor era exclusiva de este ensayo. Una breve búsqueda bibliográfica identificó otros ensayos que también usaron el DASH para medir el resultado funcional donde la medida de resultado primaria también fue el dolor (VAS o NPRS) en diferentes momentos. Una crítica para cada prueba está más allá del alcance de este blog, sin embargo, estábamos interesados en ver si esta discrepancia entre VAS y DASH era consistente entre la base de la literatura actual.

Un ECA de Lombardi et al (3) comparó el entrenamiento de resistencia progresivo contra un control en lista de espera para el tratamiento del dolor de hombro. Informaron disminuciones significativas en la EVA en reposo y movimiento en el seguimiento de 2 meses con una disminución asociada en las puntuaciones DASH 2 (función laboriosa) y DASH 3 (actividades de la vida diaria) a favor del grupo de intervención. En este ECA, los puntajes DASH se correlacionaron positivamente con las disminuciones del dolor en reposo y el movimiento en todos los puntos temporales.

Esta misma tendencia también se observó en los siguientes ECA:

Simsek et al (4) compararon la adición de kinesio-taping a un programa de ejercicios versus solo el programa de ejercicios sobre el dolor y la función del hombro. Las mejoras en el dolor nocturnos dolor con actividad favorecieron al grupo de intervención y también mostraron una correlación con puntuaciones mejoradas en el DASH en el seguimiento final, 2 semanas después del tratamiento.

 Bron et al (5) informaron sobre el tratamiento de los PG identificados usando compresión manual, estiramiento y aplicación en frío con estiramiento, además de asesoramiento ergonómico y un programa complementario de ejercicios en el hogar. Esto fue comparado con un grupo “en espera”. Los autores informaron mejoras en el dolor en el movimiento (VAS-P1), dolor promedio durante la semana pasada (VAS-P2) y el peor dolor en la última semana (VAS-P3) con disminuciones asociadas en el DASH en el punto de seguimiento final; tomado a las 12 semanas. No se encontraron diferencias significativas en el primer seguimiento (6 semanas) en DASH o VAS.

Zhang et al (6) compararon la adición de acupuntura manual contralateral versus solo ejercicio. Los puntajes del VAS siempre favorecieron al grupo experimental en todos los puntos de tiempo (2 semanas, 4 semanas, 8 semanas y 16 semanas) con mejoras asociadas en DASH 

Parece que esta discrepancia en la puntuación del dolor y el resultado funcional informada por Arias-Buría et al. (2017) no se informó anteriormente en otros ECAs. Por lo tanto, los hallazgos parecen únicos y, por lo tanto, justifican una investigación más exhaustiva para confirmar o rechazar lo que podría ser un hallazgo casual. 

Respuesta del autor:

Este es un buen punto para la discusión. Creemos que no hay realmente discrepancias entre NPRS y DASH ya que ambos resultados, el dolor y la discapacidad cubren diferentes aspectos del espectro del paciente. De hecho, mirando las variables al comienzo de la prueba, el dolor y la discapacidad tienen una fuerte correlación. Los resultados de nuestro estudio respaldan que ambos resultados mejoran de manera similar, pero la única diferencia es que los pacientes que reciben punción seca muestran mayores mejoras en la función informada por el paciente. Creemos que no se debe considerar como una discrepancia, ya que creemos que el dolor y la función no siempre evolucionan de manera similar. De hecho, esto se ve comúnmente en la práctica clínica, los pacientes con altos niveles de dolor informan niveles relacionados de discapacidad no correlacionados con los niveles de dolor y opuestos. Estamos totalmente de acuerdo en que estos hallazgos deben ser replicados y estudiados en futuros estudios.

Tamaño y configuración de la muestra

El tamaño de la muestra es un tema cubierto en blogs anteriores (aquí y aquí), por lo que no discutiremos más en relación con este ECA, pero esta limitación sigue siendo relevante.

Además, como reflejan los autores del ECA, así como el tamaño de muestra pequeño, un problema adicional es que todos los participantes fueron reclutados de un solo centro. Esto limita la posibilidad de generalización. Las características presentes en un grupo de pacientes que se presentan en un centro pueden no reflejar con precisión las de otras áreas. Las percepciones culturales y las experiencias individuales parecen influir mucho en el dolor y la discapacidad (7, 8, 9).

Conclusión

En general, este ECA tiene muchas fortalezas. Sin embargo, los hallazgos discrepantes entre los resultados DASH y NPRS y el tamaño de muestra pequeño extraído de un centro son motivo de precaución cuando se considera la relevancia de estos hallazgos para la práctica clínica. Este hallazgo necesitaría ser replicado en un ECA más grande y con múltiples sitios antes de que podamos recomendar la implementación de este enfoque en la práctica clínica con confianza.

Respuesta del autor:

Estamos de acuerdo en que necesitamos estudios multicéntricos que incluyan diferentes terapeutas en diferentes países para una mejor extrapolación de los resultados.

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Gracias por leer, espero que haya sido útil; pensamientos recibidos con gratitud

Brian Cho, Paul Regan, Chris Littlewood, Tomás Parraguez, Sijmen Hacquebord, Fedde van Hees

Critical Appraisal of a RCT (April 2018)

Critical appraisal of a randomised controlled trial (RCT)

This month’s blog will focus on a RCT aiming to evaluate the effect of adding dry needling to an exercise programme for people with subacromial pain syndrome; Arias-Buría et al. (2017). A recent systematic review has recognized the low quality research evidence that has been conducted in relation to musculoskeletal conditions and dry needling to date and concluded that although dry needling appears to be superior to no treatment or sham, there is no difference when compared to other physical therapy treatments (1). Hence, given the low-quality of the evidence base and the resultant uncertainty, there appears to be a case for a high-quality, adequately powered RCT in this clinical area.

Arias-Buria et al (2017). Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel Group Trial. The Journal of Pain, 18(1), 11-18
 

The purpose of the study was to examine whether the addition of trigger point dry needling (TrP-DN) to an exercise programme was more effective than exercises alone in the treatment of subacromial pain syndrome (SAPS) over 12 months.

Patients were included in this RCT according to the following criteria:

·      - Unilateral non-traumatic shoulder pain

·      - Pain for at least 3 months

·      - Scoring minimum of 4 points on an 11-point numeric scale.

SAPS was diagnosed based on the presence of a painful arc and two positive findings on any of the following tests: Hawkins-kennedy, Neer, Empty can, Drop arm, and Lift-off tests.

A total of 50 patients were randomized; 25 to the trigger point dry needling plus exercise (TrP-DN+exercise) and 25 to the exercise alone group. Both groups received the same exercise program consisting of three exercises focusing on the supraspinatus, infraspinatus, and scapular stabilizers. Participants were instructed to perform three sets of 12 repetitions with a slow eccentric phase. The program was to be done twice per day for a period of five weeks. A supervising physiotherapist taught the program in the first session and monitored in the subsequent four sessions. 

During the second and fourth sessions, the TrP-DN + exercise group received trigger point dry needling in addition to performing the exercise intervention detailed above. Identification of painful trigger points was left to the discretion of the treating physiotherapist.  The physiotherapist was experienced in the application of trigger point dry needling.

The primary clinical outcome for the RCT was the Disabilities of the Arm Shoulder and Hand questionnaire (DASH) and the secondary outcome was an 11-point Numeric Pain Rating Scale (NPRS) on a 0 to 10 scale. Outcome data were assessed at baseline, one-week and, three, six, and 12 months following the intervention period.

The RCT found no significant differences in NPRS scores between groups at any of the time points. However, in contrast, the RCT reported clinically significant differences between the groups with regards to DASH scores at all follow-up time points. Hence, the authors concluded that the addition of TrP-DN + exercise was more effective than exercise alone for patients with SAPS.

Strengths of this RCT include a pre-registered protocol, a relevant clinical question and appropriate research decision, including adequate randomization processes and appropriate outcome measures.

For the purpose of this blog, we have selected two points for further discussion:

1. The discrepancy between DASH and NPRS scores

2. The sample size and setting

Discrepancy between DASH and NPRS:

One interesting finding from this RCT is the discrepant finding between the DASH and NPRS outcomes, i.e. no between-group differences in relation to the NPRS but clinically significant differences between groups in relation to the DASH score. This is interesting because pain and disability have demonstrated strong correlations and often exhibit direct relationships (2).

We were interested to see if this discrepancy existed in other trials to better understand if this discrepancy between DASH scores and pain was unique to this trial. A brief literature search identified other trials that also used the DASH to measure functional outcome where the primary outcome measure was also pain (VAS or NPRS) at different time points. A critique for each trial is beyond the scope of this present blog, however, we were interested to see if this discrepancy between VAS and DASH was consistent among the current literature base.

A RCT by Lombardi et al (3) compared progressive resistance training against a waiting list control for the treatment of shoulder pain. They reported significant decreases in VAS at rest and movement at the 2-month follow up with an associated decrease in DASH 2 (laborious function) and DASH 3 (activities of daily living) scores in favour of the intervention group. In this RCT, DASH scores were positively correlated with decreases in pain at rest and movement at all time points.

This same trend was also observed in the following RCTS:

Simsek et al (4) compared the addition of kinesio-taping to an exercise program versus the exercise program alone on shoulder pain and function. Improvements in night pain and pain with activity favored the intervention group and also showed a correlation with improved scores on the DASH at the final follow-up, 2 weeks after treatment.

Bron et al (5) reported on the treatment of identified TrPs using manual compression, stretching, and cold application with stretching in addition to ergonomic advice and a supplementary home exercise program. This was compared with a wait-and-see group. The authors reported improvements in pain on movement (VAS-P1), average pain over the past week (VAS-P2), and worst pain over the last week (VAS-P3) with associated decreases in the DASH at the final follow-up point; taken at 12 weeks. No significant differences were found at the first follow-up (6 weeks) in either DASH or VAS.

Zhang et al (6) compared the addition of contralateral manual acupuncture versus exercise alone. VAS scores consistently favored the experimental group at all time points (2 weeks, 4 weeks, 8 weeks, and 16 weeks) with associated improvements in DASH.

It seems that this discrepancy in the pain score and functional outcome reported by Arias-Buría et al. (2017) has not been reported before across many RCTs. Hence, the findings appear unique and thus warrant further investigation to confirm or reject what might be a chance finding.

Author Response:

This is a good point for discussion. We believe that there are no really discrepancies between NPRS and DASH since both outcomes, pain and disability cover different aspects of the patient`s spectrum. In fact, looking the variables at the beginning of the trial, pain and disability have a strong correlation. The results of our study support that both outcomes improve in a similar manner, but the only difference is that patients receiving dry needling exhibit better improvements in self-reported function. We believe it should be not considered as discrepancy, since we believe that pain and function do not always evolve in a similar manner. In fact, this is commonly see this in clinical practice, patients with high levels of pain report levels of related-disability not correlated with the levels of pain, and opposite. We completely agree that these findings should be replicated and studies in future studies.

Sample size and setting

Sample size is an issue covered in previous blogs (here and here) so we will not discuss further in relation to this RCT but this limitation remains relevant.

Furthermore, as the authors of the RCT reflect, as well as the small sample size, a further issue is that all participants were recruited from a single centre. This does limit generalizability. Characteristics present in a group of patients that present in one centre may not accurately reflect those in other areas. Cultural perceptions and individual experiences seem to play heavily into pain and disability (7, 8, 9).

Conclusion

Overall this RCT has many strengths. However, the discrepant findings between DASH and NPRS outcomes and the small sample size drawn from one centre give cause for caution when considering the relevance of these findings for clinical practice. This finding would need replicating in a larger, multi-site RCT before we could recommend implementing this approach in clinical practice with confidence.

Author Response:

We agree that we need multicenter studies including different therapists in different countries for better extrapolation of the results.

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Thanks for reading, hope it was useful; thoughts gratefully received.

Brian Cho, Paul Regan, Chris Littlewood, Tomas Parraguez, Sijmen Hacquebord, Fedde van Hees

References:

[1] Gattie, E., Cleland, J. A., & Snodgrass, S. (2017). The effectiveness of trigger point dry needling for musculoskeletal conditions by physical therapists: A systematic review and meta-analysis. journal of orthopaedic & sports physical therapy, 47(3), 133-149.

[2] Kromer, T. O., Sieben, J. M., de Bie, R. A., & Bastiaenen, C. H. (2014). Influence of fear-avoidance beliefs on disability in patients with subacromial shoulder pain in primary care: a secondary analysis. Physical therapy, 94(12), 1775-1784.

[3] Lombardi, I., Magri, A. G., Fleury, A. M., Da Silva, A. C., & Natour, J. (2008). Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Care & Research, 59(5), 615-622.

[4] Şimşek, H. H., Balki, S., Keklik, S. S., Öztürk, H., & Elden, H. (2013). Does Kinesio taping in addition to exercise therapy improve the outcomes in subacromial impingement syndrome? A randomized, double-blind, controlled clinical trial. Acta orthopaedica et traumatologica turcica, 47(2), 104-110.

[5] Bron, C., De Gast, A., Dommerholt, J., Stegenga, B., Wensing, M., & Oostendorp, R. A. (2011). Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial. BMC medicine, 9(1), 8.

[6] Zhang, H., Sun, J., Wang, C., Yu, C., Wang, W., Zhang, M., ... & Wan, Y. (2016). Randomised controlled trial of contralateral manual acupuncture for the relief of chronic shoulder pain. Acupuncture in Medicine, 34(3), 164-170.

[7] Campbell, C. M., & Edwards, R. R. (2012). Ethnic differences in pain and pain management. Pain management, 2(3), 219-230.

[8] Pillay, T., van Zyl, H. A., & Blackbeard, D. (2014). Chronic pain perception and cultural experience. Procedia-Social and behavioral sciences, 113, 151-160.

[9] Peacock, S., & Patel, S. (2008). Cultural influences on pain. Reviews in pain, 1(2), 6-9.