- Email: [email protected]
50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS
Physiotherapy xxx (2017) xxx–xxx
Review
50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017 Gráinne Kelly a,∗ , Aoife Reilly a , Hannah Moloney a , Jonathan Moran a , Caitriona Cunningham b , Julie Broderick a a
Department of Medicine, Division of Physiotherapy, Trinity Centre for Health Sciences, Trinity College Dublin, James’ Campus, Dublin 8, Ireland b School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Belfield, Dublin 4, Ireland
Abstract Background Randomised controlled trials (RCTs) are described as the gold standard of investigative clinical research. Evidence based practice is critical to the physiotherapy profession, and it is therefore important to explore the research underpinning practice by examining published RCTs. Objectives The main aims of this review were to profile the quantity and quality of RCTs published in the journal Physiotherapy over the past 50 years. Data sources Physiotherapy journal, hand searched (1967 to 1987) and electronically (1988 to 2017). Study selection or eligibility criteria Studies identified as RCTs. Study appraisal and synthesis methods Quality assessed via PEDRO criteria. Results 120 RCTs were identified from January 1967 to January 2017. The frequency of RCTs published has increased steadily and the UK was the most common source of RCTs, but the prevalence of non-UK based trials is increasing. The quality of RCTs improved steadily over the decades, with a mean PEDro score of 6.9 in the most recent decade (2017 to 2008), indicative of ‘high quality’. The mean number of trial participants was 60 and the most commonly evaluated area was musculoskeletal physiotherapy. Limitations RCTs were not evaluated against CONSORT criteria. Conclusion and implications of key findings Frequency of publication of RCTs in the journal Physiotherapy has increased over this time, mirroring trends in the wider medical literature. This highlights the predominance of some areas of research such as musculoskeletal and exercise-based research while other prominent areas such as neurology appear to be less researched. © 2018 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. Keywords: Randomised controlled trials; Quality; Quantity
Introduction Evidence-based physiotherapy is informed by ‘relevant, high quality clinical research’ [1] which guides clinical behaviours and practice [2]. The best evidence about the effects of physiotherapy interventions is derived from randomised controlled trials (RCTs) and systematic reviews of RCTs [3,4].
∗
Corresponding author. E-mail address: [email protected] (G. Kelly).
RCTs are described as the gold standard of investigative clinical research [5] and are the most rigorous way of testing if a cause–effect relationship exists in an experiment [6]. We sometimes assume that conduct of RCTs is a new phenomenon in physiotherapy research, but in fact, a study by Colebrook [7] which investigated the effects of ultraviolet irradiation in school children appears to be the first human study which can be classified as an RCT [5] and notably evaluated a physiotherapy treatment. True random allocation was employed in this study as opposed to alternate allocation methods which were employed before this time. This study by Colebrook [7] predated the 1934 Medical Research
https://doi.org/10.1016/j.physio.2018.08.005 0031-9406/© 2018 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
2
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Council trial [8] that evaluated the treatment of pneumonia and which is commonly, although incorrectly, believed to be the first modern clinical trial. By 1960, there were 15 recorded physiotherapy RCTs with at least one published trial in each of the three core areas of physiotherapy; musculoskeletal, neurology and cardiothoracic [9]. Each of these was published in a medical journal. It was not until 1967 that the first RCT was published in a physiotherapy specific journal [10]. Since these early publications, the number of published RCTs has grown exponentially in physiotherapy research [9,11], mirroring the trends in the wider medical literature. The profession of physiotherapy covers a wide range of clinical sub-disciplines which have been defined by the Physiotherapy Evidence Database (PEDro) indexing system that classifies studies relevant to physiotherapists. Moseley et al. [12] identified 14,910 RCTs indexed on PEDro. These RCTs were most commonly published in the areas of musculoskeletal (29%) and cardiothoracics (21%) compared to less commonly investigated fields such as oncology (3%), ergonomics and occupational health (2%). A study by Kamper et al. [13] was performed in 2015 and also referred to PEDro, reporting 23,049 RCTs indexed as of October 2014. Results mirrored those from the Moseley et al. [12] study with the most commonly studied areas reported to be musculoskeletal, cardiothoracics and gerontology. Lower numbers of studies were noted in the sub-disciplines of sports and paediatrics. Physiotherapy is the longest established physiotherapy specific journal and 2017 marked half a century of RCTs publication in the journal. In the early years of this journal, this journal would have represented one or just one of a small number of journals widely read by physiotherapists. In more recent years the so-called ‘knowledge explosion’ has meant physiotherapists access and submit research to a broad range of speciality and non-speciality journals. Nonetheless, capturing trends in RCT, and wider clinical research within this prominent, cross-disciplinary physiotherapy journal provides an important snapshot of the output of physiotherapy research producers and its corollary the research available to the journal readership — the consumers of research. More broadly, in order to advance the profession of physiotherapy it is essential to understand how physiotherapy literature has evolved, which can track trends and highlight areas where there is a paucity of research [11]. The overall aim of this paper was to quantify and profile sources, content and quality of work of all RCTs in the journal of Physiotherapy from 1967 to 2017. Aims Primary aims • To quantify the number of RCTs published in Physiotherapy between 1967 and 2017.
• To report the quality of RCTs published using the PEDRO scale. Secondary aims • To examine the global origin of published RCTs, the subdisciplines of physiotherapy practice included in RCTs, the types of interventions used within physiotherapy RCTs and the trend in clinical outcomes that were published by the journal. • To quantify non-RCT research and systematic reviews published in Physiotherapy between 1967 and 2017. • To profile the research methodologies and global origin of non-RCT original research published in the journal.
Methods Study design This study took a quantitative retrospective descriptive design, following systematic review methodology where possible. No ethical approval was required in order to conduct this study as it was a retrospective review of previous studies, and no human participants were involved in the presented study. Inclusion criteria Randomised controlled trials In addressing the primary aims of this study all full RCTs published in the journal Physiotherapy between January 1967 and January 2017 were included. The search began from the year 1967 as this has been reported as the year the first RCT was published in any physiotherapy specific journal [9]. In addition, preparatory work for this review consisted of hand searching the journal back to 1950, which provided further confirmation of the absence of RCTs prior to 1967. An RCT was defined as “an experiment in which two or more interventions, possibly including a control intervention or no intervention, are compared by being randomly allocated to participants” [14]. This definition was consistent with that of other large studies investigating RCTs indexed on PubMed [15,16] and the Cochrane Collaboration criteria [17]. Given the lack of consensus in terminology of RCTs, particularly in relation to earlier studies, the following study types were included; RCT, randomised trial, randomised clinical trial, randomised controlled clinical trial and randomised controlled clinical trials. Clinical trials where it was explicitly stated that random allocation had been employed were also included. RCT protocols, secondary analysis and split body trials were excluded from this study, as were abstracts of RCTs. As Physiotherapy is a UK journal, every trial was published in the English language.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Original research and systematic reviews In addressing the secondary aims of this study all original research, and systematic reviews were included if published between January 1967 and January 2017. Only full research articles were included, no abstracts or published protocols were included. Research methodologies included both quantitative and qualitative methods. Case series, case studies and clinical audits were also included. A taxonomy on research methodologies from the Agency for Healthcare Research Quality [18] was referred to when the study design was not explicitly stated in the relevant paper.
Identification of studies and data extraction A process of double data extraction was employed for the collection and retrieval of all data to minimise errors. GK assessed all data and an independent assessor (data divided between the following study personnel; AR, MH or JB) also assessed all data which was then cross checked for accuracy. If consensus could not be reached, a third assessor (JM) was consulted.
Data collection In order to address the primary and secondary aims of this study, articles in each individual issue of Physiotherapy were searched in reverse chronological order, starting with January 2017 and working backwards to January 1967. The journal published 12 issues per year from 1967 to 2003 and four issues per year thereafter. Journal volumes were available electronically between 1988 and 2017, and prior to that in paper format. Initially the title and abstract of all electronically available articles were reviewed to ascertain if they were original research, systematic reviews or RCTs. If the trial design could not be ascertained from the title and abstract, then the full paper was retrieved and reviewed. Paper copies of the journal were obtained from the library of Trinity College Dublin (TCD) in order to hand-search the full text of all articles published from 1967 to 1987. Any volumes of the journal which were unavailable through TCD library were obtained from alternative Irish university libraries. A similar process of title and abstract review as described above for electronic articles was undertaken for the paper journals. As above, in the case where trial design could not be ascertained from the title and abstract, then the full paper was reviewed. Any RCTs identified that were available electronically were saved to the same file so that all RCTs published by the journal were easily accessible to the research team. RCTs found in the printed issues were scanned and saved to file so they could be collected in electronic format for review. Following this process, assessors reviewed the number of original articles, systematic reviews and RCTs identified and checked for any errors or omissions.
3
Data retrieval For original research and systematic reviews, with the exception of RCTs, data were extracted using an agreed proforma which was designed prior to data collection. Information extracted from this literature included the year of publication, type of research methodology, and the country or countries where the research was conducted. As with the data collection process above, information was extracted by two assessors who then met to discuss any disagreements. Where consensus was an issue a third assessor was consulted. Similarly, all RCTs found were independently reviewed by two assessors with data extracted using an agreed proforma. Data extracted included year of publication, country where the research was conducted, trial registration, subdiscipline of physiotherapy (from PEDro guidelines including: cardiothoracics, continence and women’s health, ergonomics and occupational health, gerontology, musculoskeletal, neurology, oncology, orthopaedics, paediatrics, sports, no appropriate value in this field), interventions employed, number of participants, outcome of the RCTs, and RCT quality. These data were inputted into a proforma on Microsoft Excel, two independent assessors met to review all data extracted, with merging of Microsoft Excel spreadsheets. Again, where consensus was an issue a third assessor was consulted. Prior to the study, all assessors reviewed a selected publication year for all original research, systematic reviews and RCTs and completed the research proforma for that year. Consistencies in data extraction were reviewed and issues addressed prior to conducting the full review. Data methodological quality Assessment of methodological quality of included RCTs was determined through the use of the PEDro (Physiotherapy Evidence Database) scale and overall score allocation [19]. The PEDro scale is an 11 item checklist developed through a modified Delphi survey. It includes items such as randomisation; blinding of participants, assessors and therapists; allocation concealment; reporting of findings and statistical analysis. All items on the checklist, with the exception of item one, were allocated a score of 0 (criterion not satisfied) or 1 (criterion satisfied), culminating in a total maximum score of 10 points (all items reported), and a score range of 0 to 10 points. RCTs awarded a higher score are deemed to be of superior methodological quality. Data analysis Data analysis was carried out using Microsoft Excel. Descriptive statistics were utilised firstly for all citations to address the secondary aims of the study (quantification of citations, countries of publication and study methodologies). Descriptive statistics for RCTs included the number of RCTs, and the decade split from 1967 onwards; the countries of publication; subdisciplines of physiotherapy practice; and
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
ARTICLE IN PRESS
No. of Pages 8
4
G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
356 316
350
286
300 250 173
200 150
99
100 50
5
15
29
31
40
1978-1987
1988-1997
1998-2007
2008-2017
0 1967-1977
Years
Fig. 1. RCT and non-RCT studies published across decades from 1967 to 2017 in Physiotherapy journal.
interventions used. The first analysis of data classified RCTs into one of the subdisciplines of physiotherapy, based on those defined by PEDro and the spread of subdisciplines was quantified. Secondly, the general trends in RCT publication since 1967 were reported. Thirdly, the variety of countries in which trials took place were categorized based on trial location rather than the author’s country of affiliation.
Results Randomised controlled trials In total 120 RCTs were published in Physiotherapy between January 1967 and January 2017. Quality of RCTs as evidenced by mean (SD) PEDro scores was noted to increase markedly over the decades, 1967 to 1977; 3.0 (1.4), 1978 to 1987; 5.5 (1.9), 1988 to 1997; 5.3 (2.8), 1998 to 2007; 5.8 (0.7) and 2008 to 2017; 6.9 (1.5). Examples of recently published highly scoring trials, scoring 9/10 on PEDro total scores were Pérez-Merino et al. and Wang et al. [20,21]. The majority of RCTs were UK-based studies (n = 75, 63%), followed by Australia (n = 6, 5%), Spain (n = 5, 4%), Norway (n = 5, 4%), Brazil (n = 3, 3%), Israel (n = 3, 3%), and Canada (n = 3, 3%). Fig. 2 shows the global distribution of all RCTs published in Physiotherapy between January 1967 and January 2017. In assessing the spread of RCT publication throughout the decades there has been a steady increase as the decades have evolved: 1967 to 1977 n = 5; 1978 to 1987 n = 15; 1988 to 1997 n = 29; 1998 to 2007 n = 31; 2008 to 2017 n = 40 (Fig. 1). The most significant increase in RCT publication appears to coincide with the advent of electronic publication of the journal in 1988. When examining the subdisciplines of physiotherapy which RCTs investigated, the majority report on areas of musculoskeletal physiotherapy (n = 62, 52%), followed by cardiothoracics (n = 20, 17%) and women’s health (n = 10, 8%), Fig. 3a. Within muscu-
loskeletal physiotherapy, low back pain and knee pain are the areas that received the most attention accounting for 18% each, followed by the shoulder (n = 8, 13%) and then the foot and ankle (n = 6, 10%), Fig. 3b. Within cardiothoracics, chronic obstructive pulmonary disease the most commonly investigated condition (n = 4, 20%). The most common interventions investigated were exercise therapy (n = 51, 43%), followed by electrotherapy (n = 43, 36%), and then manual therapy and massage (n = 9, 8%), as shown in Fig. 4. In total 7110 individuals participated in 120 RCTs with the mean participant number being n = 60 (SD = 53.3, range 8 to 330). Sixteen studies (19%) had participant numbers in excess of 100. Randomisation was well documented. The first RCT to cite a registration number in a public trials registry was in 2011. In total, 16 RCTs included a trial registration number, representing 53% (16/30) of RCTs published since 2011. Original research and systematic reviews In total 1350 original citations and systematic reviews were published in the journal Physiotherapy between January 1967 and January 2017. Excluding 120 RCTs this accounted for 1230 non-RCTs and systematic reviews. Systematic reviews accounted for 6% of these citations (n = 79), with the first systematic review published in 1993. Systematic review publication rates were noted to have increased substantially in the previous two decades. Of the 1230 non-RCTs 83% were of quantitative design (n = 1017), with surveys (n = 184, 15%) being the most commonly published, followed by observational studies (n = 124, 10%), cross sectional and cohort studies (n = 120, 10%), equipment and outcome measure evaluation including psychometric property evaluation (n = 98, 8%). Case studies, case series (n = 152, 12%) and audits (n = 80, 7%) were more prevalent in publication in the earlier years of the journal Physiotherapy. Other research methodologies included Delphi studies, cross-over studies, pre post and repeated measures studies. Qualitative research
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
5
Fig. 2. Global origin of all RCTs published in Physiotherapy.
Fig. 3. (a) Number of RCTs published in physiotherapy sub-disciplines in Physiotherapy journal. Key: Cardio = cardiothoracics; Geront = gerontology; Oncol = oncology; Paeds = paediatrics; Ortho = orthopaedics; MSK = musculoskeletal; examples of other include education and mental health. (b) Number of RCTs published in musculoskeletal sub-disciplines in Physiotherapy journal. Key: LBP = low back pain; STI = soft tissues injury; TMJ = temporomandibular joint; examples of other include rheumatoid arthritis and healthy volunteers.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043; 6
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Fig. 4. Number of RCTs published which evaluate different treatment types.
accounted for 8% (n = 101) of publications, with publication increasing considerably in the past two decades; 33 studies had mixed methodology of quantitative and qualitative design. Fig. 1 also illustrates the decade publication spread of RCTs and non-RCT original research and systematic reviews and supplementary File 1 shows all research articles published in Physiotherapy between January 1967 and January 2017. The majority of research was conducted in the UK (n = 841, 68%), followed by Australia (n = 94, 8%), Ireland (n = 35, 3%), USA (n = 32, 3%) and Canada (n = 32, 3%). Discussion This review tracked the evolution of research within the journal Physiotherapy over the past 50 years. This is timely considering the journal is the longest established physiotherapy specific journal and has reached a worthy milestone of half a century of RCT publication. Overall, an increase in research publications was observed across all decades, with a sharp rise noted in the late 1980s and early 1990s. Not surprisingly this coincided with the advent of the electronic publication of the journal in 1988. This allowed access of the journal to a wider audience with researchers outside of the United Kingdom submitting research for publication and extending the global reach of the journal and indeed physiotherapy research. The global spread of authors publishing in the journal particularly from the 1990s onwards demonstrates the impact of the journal. In the early years of publication, research methodologies used were on the lower levels of the hierarchical evidence pyramid with methodologies such as case studies, case series and clinical audits being to the fore, reflecting trends in the wider medical literature at the time. That was also when the profession was nascent and emerging from major world events such as the two World Wars. As the profession has evolved so too has the calibre of the research published and
the methodologies used to achieve this, with more RCTs and systematic reviews being published from the 1990s onwards, and the first systematic review in 1993. Clinical trial registration, a relatively recent phenomenon, which minimises publication bias and aids accessibility and transparency of clinical research, was recommended in 2011 and became a mandatory requirement in 2013 in Physiotherapy, adopted from a proposal from the International Committee of Medical Journal Editors (ICMJE). This is evidenced by the first reporting of clinical trial registration the same year in 2011, which was in fact earlier than other journals in the field. Over half (53%) of RCTs published since 2011 included clinical trial registration details, which compares favourably to physiotherapy journals in general which was reported to be 30% [22,23]. The fact that not all RCTs published in Physiotherapy have reported clinical trial registration numbers may be partly due to the lag time between trial conduction and eventual publication and an allowance in the intervening period (2011 to 2013) for higher quality papers which had not been registered. Reflective also of the evolution and sophistication of RCT methodologies over the decades, PEDro scores improved, with the mean PEDro score from the most recent decade 6.9 indicative of ‘high quality’ research (https://www.strokengine.ca/glossary/pedro-score/). This may in part be related to the requirement to present RCTs according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and at submission to include a complete CONSORT flow chart (http://www.consort-statement.org/). This trend of incrementally increasing PEDro scores over time was also shown by Maher et al. [9]. Worthy of note, a large number of RCTs received lower scores in some PEDro subsections due to lack of blinding of the participants, assessors and in particular therapists delivering the interventions, categories which were not possible to satisfy due to the nature of the interventions
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
which must be borne in mind when reviewing PEDro scores in this journal. Also a number of other limitations pertain to the PEDro assessment tool. These are mainly due to each item in the scale carrying the same weight with an aggregate score generated [24]. In a study comparing the PEDro scale to the Cochrane Risk of Bias criteria, Armijo-Olivo et al. [25] showed that almost 60% of physical therapy trials evaluated were considered to be adequate quality based on a PEDro cut-off of ≥5 points but many trials did not meet accepted quality standards such as random sequence generation, allocation concealment and blinding of study assessors defined by the Cochrane Risk of Bias tool, which can substantially effect estimates of treatment effect. Overall poor agreement was demonstrated between the Cochrane and PEDro risk of biases approaches. Whilst cognisant of these limitations, the PEDro tool was chosen due to its widespread use within the global physiotherapy community [26] and previous evidence of validity [27,28]. The metamorphosis of physiotherapy as a profession is also observed in the types of interventions investigated within the RCTs. In the early years more emphasis appeared to be on electrophysical agents such as Faradism and Shortwave Diathermy. This has declined in recent decades which mirrors the trend in clinical practice away from these modalities. Exercise therapy has always been a main stay of the physiotherapy profession, with our roots in remedial gymnastics. Exercise is regarded as the best supported intervention in the physiotherapy field [13] and similarly we found that exercise interventions accounted for the highest proportion of those investigated in published RCTs. While the breadth of physiotherapy practice was well represented in terms of scope of topics investigated, nonetheless, a number of prominent subdisciplines of physiotherapy appear to be under-represented such as neurology and gerontology, representing an opportunity to continue to develop the evidence base in these areas. The low number of studies in the area of sports is remarkable, perhaps related to the difficulty in attracting research funding [13] comparted to more clinically aligned areas. Other areas not well represented were paediatrics and oncology. Many findings from the present study mirror results reported from Maher et al. [9] who described evidence indexed in the PEDro database. Consistent findings were the progressive growth in the research base in physiotherapy sub-disciplines. Maher et al. [9] also noted that high profile areas such as ergonomics and sports physical therapy have little discipline specific evidence to guide practice which was also mirrored in the present study. Sub-disciplines not well represented may be due to a dearth of RCTs submitted to the journal for consideration, so the onus should be on researchers, clinicians and grant awarding bodies to prioritise other areas of physiotherapy research so all areas can evolve based on research findings to inform practice. It is also possible that RCTs from the sub-disciplines underrepresented in this journal may be published in specialty/medical journals rather than a professional journal such as Physiotherapy.
7
The mean number of trial participants was 60 and 16 studies, (19%) had participant numbers in excess of 100. It is not known if these studies in general were over or under powered. Notably language used to describe disability has evolved considerably over the years, with much of the language and imaging included in earlier publications no longer used or accepted e.g. ‘handicapped children’ ‘crippled survivors’. In keeping with this professional and progressive ethos the journal has been ‘ahead of its time’ with publications on cancer survivorship as early as March 1971, and introduction of the concept of ‘interdisciplinary’ collaborations in 1968. Strengths of this review are that it appears to be the first attempt to map the evolution of RCTs in this journal. In order to produce the most accurate results, the methodical and time consuming searches were conducted electronically and by hand of all journals since 1967, with double data extraction to minimise errors. Limitations were the lack of evaluation of RCTs against the CONSORT checklist which was beyond the scope of this study. It was also difficult to compare indices reported in this paper to equivalent literature as this type of analysis does not appear to have been conducted in other physiotherapy or other allied health journals. This review focuses on RCTs as they are regarded as high quality forms of evidence and follow firmly codified methodology [29]. We acknowledge that this review provides an insight of clinical research in one physiotherapy specific journal and other physiotherapy journals and broader medical and sports focussed journals also publish physiotherapy related clinical research. Nonetheless, as this is a highly ranked, long-standing and cross-disciplinary journal we felt a comprehensive evaluation of the evolution of RCTs within the journal to recent times would help assess the status quo and assist with future planning in terms of RCT and clinical research publication. A future broader review could be an interesting and revelatory follow-on to the present review. High quality clinical research such as RCTs are the foundation for evidence based practice. A single RCT does not direct practice, but is the building block for systematic reviews upon which practice is based. Clearly RCTs continue to evolve based on more robust, and more robustly reported methodologies as evidenced in this paper. This paper tracks the laudable increase in quality, quantity and diversity of RCTs in the journal Physiotherapy, but it also serves as a reminder to represent all areas of practice where possible and continually attempt to minimise sources of bias to truly inform practice in the most optimal manner. Acknowledgements We would also like to acknowledge the work of Claire Taylor in the development phase of this work. Ethical approval: No ethical approval was required for this study. Conflicts of interest: None declared.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/ j.physio.2018.08.005. References [1] Herbert R, Jamtvedt G, Mead J, Hagen KB. Evidence-based physiotherapy: what why and how? In: Practical evidence-based physiotherapy. London: Elsevier; 2005. p. 1–10. [2] Dannapfel P, Peolsson A, Nilsen P. What supports physiotherapists’ use of research in clinical practice? A qualitative study in Sweden. Implement Sci 2013;8:31. [3] Bury TJ. Evidence-based healthcare explained. In: Bury TJ, Mead JM, editors. Evidence-based healthcare: a practical guide for therapists. Oxford: Butterworth-Heinemann; 1998. p. 3–25. [4] Herbert R, Jamtvedt G, Mead J, Hagen KB. What constitutes evidence? In: Practical evidence-based physiotherapy. London: Elsevier; 2005. p. 19–50. [5] Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285:1992–5. [6] Sibbald B, Roland M. Understanding controlled trials: why are randomised controlled trials important? BMJ 1998;316:201. [7] Colebrook D. Irradiation and health: an ultra-violet irradiation of school children. Med Res Counc Spec Rep Ser 1929;131:1–47. [8] Chalmers. MRC Therapeutic Trials Committee’s report on serum treatment of lobar pneumonia. BMJ 1934. [9] Maher CG, Moseley AM, Sherrington C, Elkins MR, Herbert RD. A description of the trials, reviews, and practice guidelines indexed in the PEDro database. Phys Ther 2008;88:1068–77. [10] Landen BR. Heat or cold for the relief of low back pain? Phys Ther 1967;47:1126–8. [11] Moseley AM, Herbert RD, Sherrington C, Maher CG. Evidence for physiotherapy practice: a survey of the Physiotherapy Evidence Database (PEDro). Aust J Physiother 2002;48:43–9. [12] Moseley AM, Elkins MR, Janer-Duncan L, Hush JM. The quality of reports of randomized controlled trials varies between subdisciplines of physiotherapy. Physiother Can 2014;66:36–43. [13] Kamper SI, Moseley AM, Herbert RD, Maher CG, Elkins MR, Sherrington C. 15 years of tracking physiotherapy evidence on PEDro, where are we now? Br J Sports Med 2015;49:907–9. [14] Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004;183:1539–44. [15] Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159–62.
[16] Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2013;340:c723. [17] Higgins JPT, Green S. Cochrane Handbook for Systematic Review of Interventions Version 5.1.0. The Cochrane Collacoration. 2011; Available form www.cochrane-handbook.org. [Accessed 20 March 2016]. [18] Viswanathan M, Berkman ND, Dryden DM, Hartling L. Assessing risk of bias and confounding in observational studies of interventions or exposures: further development of the RTI item bank. Methods research report. (Prepared by RTI–UNC Evidence-based Practice Center under contract No. 290-2007-10056-I). AHRQ publication no. 13-EHC106EF. Rockville, MD; Canada: Agency for Healthcare Research and Quality; 2013. August. [19] Herbert R, Moseley A, Sherrington C. PEDro: a database of randomised controlled trials in physiotherapy. Health Inf Manag 1998;28(4):186–8. [20] Pérez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE, González R, et al. Evaluation of the effectiveness of three physiotherapeutic treatments for subacromial impingement syndrome: a randomised clinical trial. Physiotherapy 2016;102(1):57–63. [21] Wang P, Yang L, Li H, Lei Z, Yang X, Liu C, et al. Effects of whole-body vibration training with quadriceps strengthening exercise on functioning and gait parameters in patients with medial compartment knee osteoarthritis: a randomised controlled preliminary study. Physiotherapy 2016;102:86–92. [22] Pinto RZ, Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther 2013;93(3):299–309. [23] Babu AS, Veluswamy SK, Rao PT, Maiya AG. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther 2014;94(1):83–90. [24] da Costa BR, Hilfiker R, Egger M. PEDro’s bias: summary quality scores should not be used in meta-analysis. J Clin Epidemiol 2013;66:75–7. [25] Armijo-Olivo S, da Costa BR, Cummings GG, Ha C, Fuentes J, Saltaji H, et al. PEDro or Cochrane to assess the quality of clinical trials? A meta-epidemiological study. PLOS One 2015;10(7):e0132634. [26] Campos TF, Beckenkamp PR, Moseley AM. Usage evaluation of a resource to support evidence-based physiotherapy: the Physiotherapy Evidence Database (PEDro). Physiotherapy 2013;99(3):252–7. [27] de Morton NA. The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. Aust J Physiother 2009;55(2):129–33. [28] Macedo LG, Elkins MR, Maher CG, Moseley AM, Herbert RD, Sherrington C. There was evidence of convergent and construct validity of Physiotherapy Evidence Database quality scale for physiotherapy trials. J Clin Epidemiol 2010;63(8). [29] Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli I, Moher D, et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine. BMJ 2018;360:k400.
Available online at www.sciencedirect.com
ScienceDirect
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
No. of Pages 8
ARTICLE IN PRESS
Physiotherapy xxx (2017) xxx–xxx
Review
50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017 Gráinne Kelly a,∗ , Aoife Reilly a , Hannah Moloney a , Jonathan Moran a , Caitriona Cunningham b , Julie Broderick a a
Department of Medicine, Division of Physiotherapy, Trinity Centre for Health Sciences, Trinity College Dublin, James’ Campus, Dublin 8, Ireland b School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Belfield, Dublin 4, Ireland
Abstract Background Randomised controlled trials (RCTs) are described as the gold standard of investigative clinical research. Evidence based practice is critical to the physiotherapy profession, and it is therefore important to explore the research underpinning practice by examining published RCTs. Objectives The main aims of this review were to profile the quantity and quality of RCTs published in the journal Physiotherapy over the past 50 years. Data sources Physiotherapy journal, hand searched (1967 to 1987) and electronically (1988 to 2017). Study selection or eligibility criteria Studies identified as RCTs. Study appraisal and synthesis methods Quality assessed via PEDRO criteria. Results 120 RCTs were identified from January 1967 to January 2017. The frequency of RCTs published has increased steadily and the UK was the most common source of RCTs, but the prevalence of non-UK based trials is increasing. The quality of RCTs improved steadily over the decades, with a mean PEDro score of 6.9 in the most recent decade (2017 to 2008), indicative of ‘high quality’. The mean number of trial participants was 60 and the most commonly evaluated area was musculoskeletal physiotherapy. Limitations RCTs were not evaluated against CONSORT criteria. Conclusion and implications of key findings Frequency of publication of RCTs in the journal Physiotherapy has increased over this time, mirroring trends in the wider medical literature. This highlights the predominance of some areas of research such as musculoskeletal and exercise-based research while other prominent areas such as neurology appear to be less researched. © 2018 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. Keywords: Randomised controlled trials; Quality; Quantity
Introduction Evidence-based physiotherapy is informed by ‘relevant, high quality clinical research’ [1] which guides clinical behaviours and practice [2]. The best evidence about the effects of physiotherapy interventions is derived from randomised controlled trials (RCTs) and systematic reviews of RCTs [3,4].
∗
Corresponding author. E-mail address: [email protected] (G. Kelly).
RCTs are described as the gold standard of investigative clinical research [5] and are the most rigorous way of testing if a cause–effect relationship exists in an experiment [6]. We sometimes assume that conduct of RCTs is a new phenomenon in physiotherapy research, but in fact, a study by Colebrook [7] which investigated the effects of ultraviolet irradiation in school children appears to be the first human study which can be classified as an RCT [5] and notably evaluated a physiotherapy treatment. True random allocation was employed in this study as opposed to alternate allocation methods which were employed before this time. This study by Colebrook [7] predated the 1934 Medical Research
https://doi.org/10.1016/j.physio.2018.08.005 0031-9406/© 2018 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
2
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Council trial [8] that evaluated the treatment of pneumonia and which is commonly, although incorrectly, believed to be the first modern clinical trial. By 1960, there were 15 recorded physiotherapy RCTs with at least one published trial in each of the three core areas of physiotherapy; musculoskeletal, neurology and cardiothoracic [9]. Each of these was published in a medical journal. It was not until 1967 that the first RCT was published in a physiotherapy specific journal [10]. Since these early publications, the number of published RCTs has grown exponentially in physiotherapy research [9,11], mirroring the trends in the wider medical literature. The profession of physiotherapy covers a wide range of clinical sub-disciplines which have been defined by the Physiotherapy Evidence Database (PEDro) indexing system that classifies studies relevant to physiotherapists. Moseley et al. [12] identified 14,910 RCTs indexed on PEDro. These RCTs were most commonly published in the areas of musculoskeletal (29%) and cardiothoracics (21%) compared to less commonly investigated fields such as oncology (3%), ergonomics and occupational health (2%). A study by Kamper et al. [13] was performed in 2015 and also referred to PEDro, reporting 23,049 RCTs indexed as of October 2014. Results mirrored those from the Moseley et al. [12] study with the most commonly studied areas reported to be musculoskeletal, cardiothoracics and gerontology. Lower numbers of studies were noted in the sub-disciplines of sports and paediatrics. Physiotherapy is the longest established physiotherapy specific journal and 2017 marked half a century of RCTs publication in the journal. In the early years of this journal, this journal would have represented one or just one of a small number of journals widely read by physiotherapists. In more recent years the so-called ‘knowledge explosion’ has meant physiotherapists access and submit research to a broad range of speciality and non-speciality journals. Nonetheless, capturing trends in RCT, and wider clinical research within this prominent, cross-disciplinary physiotherapy journal provides an important snapshot of the output of physiotherapy research producers and its corollary the research available to the journal readership — the consumers of research. More broadly, in order to advance the profession of physiotherapy it is essential to understand how physiotherapy literature has evolved, which can track trends and highlight areas where there is a paucity of research [11]. The overall aim of this paper was to quantify and profile sources, content and quality of work of all RCTs in the journal of Physiotherapy from 1967 to 2017. Aims Primary aims • To quantify the number of RCTs published in Physiotherapy between 1967 and 2017.
• To report the quality of RCTs published using the PEDRO scale. Secondary aims • To examine the global origin of published RCTs, the subdisciplines of physiotherapy practice included in RCTs, the types of interventions used within physiotherapy RCTs and the trend in clinical outcomes that were published by the journal. • To quantify non-RCT research and systematic reviews published in Physiotherapy between 1967 and 2017. • To profile the research methodologies and global origin of non-RCT original research published in the journal.
Methods Study design This study took a quantitative retrospective descriptive design, following systematic review methodology where possible. No ethical approval was required in order to conduct this study as it was a retrospective review of previous studies, and no human participants were involved in the presented study. Inclusion criteria Randomised controlled trials In addressing the primary aims of this study all full RCTs published in the journal Physiotherapy between January 1967 and January 2017 were included. The search began from the year 1967 as this has been reported as the year the first RCT was published in any physiotherapy specific journal [9]. In addition, preparatory work for this review consisted of hand searching the journal back to 1950, which provided further confirmation of the absence of RCTs prior to 1967. An RCT was defined as “an experiment in which two or more interventions, possibly including a control intervention or no intervention, are compared by being randomly allocated to participants” [14]. This definition was consistent with that of other large studies investigating RCTs indexed on PubMed [15,16] and the Cochrane Collaboration criteria [17]. Given the lack of consensus in terminology of RCTs, particularly in relation to earlier studies, the following study types were included; RCT, randomised trial, randomised clinical trial, randomised controlled clinical trial and randomised controlled clinical trials. Clinical trials where it was explicitly stated that random allocation had been employed were also included. RCT protocols, secondary analysis and split body trials were excluded from this study, as were abstracts of RCTs. As Physiotherapy is a UK journal, every trial was published in the English language.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Original research and systematic reviews In addressing the secondary aims of this study all original research, and systematic reviews were included if published between January 1967 and January 2017. Only full research articles were included, no abstracts or published protocols were included. Research methodologies included both quantitative and qualitative methods. Case series, case studies and clinical audits were also included. A taxonomy on research methodologies from the Agency for Healthcare Research Quality [18] was referred to when the study design was not explicitly stated in the relevant paper.
Identification of studies and data extraction A process of double data extraction was employed for the collection and retrieval of all data to minimise errors. GK assessed all data and an independent assessor (data divided between the following study personnel; AR, MH or JB) also assessed all data which was then cross checked for accuracy. If consensus could not be reached, a third assessor (JM) was consulted.
Data collection In order to address the primary and secondary aims of this study, articles in each individual issue of Physiotherapy were searched in reverse chronological order, starting with January 2017 and working backwards to January 1967. The journal published 12 issues per year from 1967 to 2003 and four issues per year thereafter. Journal volumes were available electronically between 1988 and 2017, and prior to that in paper format. Initially the title and abstract of all electronically available articles were reviewed to ascertain if they were original research, systematic reviews or RCTs. If the trial design could not be ascertained from the title and abstract, then the full paper was retrieved and reviewed. Paper copies of the journal were obtained from the library of Trinity College Dublin (TCD) in order to hand-search the full text of all articles published from 1967 to 1987. Any volumes of the journal which were unavailable through TCD library were obtained from alternative Irish university libraries. A similar process of title and abstract review as described above for electronic articles was undertaken for the paper journals. As above, in the case where trial design could not be ascertained from the title and abstract, then the full paper was reviewed. Any RCTs identified that were available electronically were saved to the same file so that all RCTs published by the journal were easily accessible to the research team. RCTs found in the printed issues were scanned and saved to file so they could be collected in electronic format for review. Following this process, assessors reviewed the number of original articles, systematic reviews and RCTs identified and checked for any errors or omissions.
3
Data retrieval For original research and systematic reviews, with the exception of RCTs, data were extracted using an agreed proforma which was designed prior to data collection. Information extracted from this literature included the year of publication, type of research methodology, and the country or countries where the research was conducted. As with the data collection process above, information was extracted by two assessors who then met to discuss any disagreements. Where consensus was an issue a third assessor was consulted. Similarly, all RCTs found were independently reviewed by two assessors with data extracted using an agreed proforma. Data extracted included year of publication, country where the research was conducted, trial registration, subdiscipline of physiotherapy (from PEDro guidelines including: cardiothoracics, continence and women’s health, ergonomics and occupational health, gerontology, musculoskeletal, neurology, oncology, orthopaedics, paediatrics, sports, no appropriate value in this field), interventions employed, number of participants, outcome of the RCTs, and RCT quality. These data were inputted into a proforma on Microsoft Excel, two independent assessors met to review all data extracted, with merging of Microsoft Excel spreadsheets. Again, where consensus was an issue a third assessor was consulted. Prior to the study, all assessors reviewed a selected publication year for all original research, systematic reviews and RCTs and completed the research proforma for that year. Consistencies in data extraction were reviewed and issues addressed prior to conducting the full review. Data methodological quality Assessment of methodological quality of included RCTs was determined through the use of the PEDro (Physiotherapy Evidence Database) scale and overall score allocation [19]. The PEDro scale is an 11 item checklist developed through a modified Delphi survey. It includes items such as randomisation; blinding of participants, assessors and therapists; allocation concealment; reporting of findings and statistical analysis. All items on the checklist, with the exception of item one, were allocated a score of 0 (criterion not satisfied) or 1 (criterion satisfied), culminating in a total maximum score of 10 points (all items reported), and a score range of 0 to 10 points. RCTs awarded a higher score are deemed to be of superior methodological quality. Data analysis Data analysis was carried out using Microsoft Excel. Descriptive statistics were utilised firstly for all citations to address the secondary aims of the study (quantification of citations, countries of publication and study methodologies). Descriptive statistics for RCTs included the number of RCTs, and the decade split from 1967 onwards; the countries of publication; subdisciplines of physiotherapy practice; and
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
ARTICLE IN PRESS
No. of Pages 8
4
G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
356 316
350
286
300 250 173
200 150
99
100 50
5
15
29
31
40
1978-1987
1988-1997
1998-2007
2008-2017
0 1967-1977
Years
Fig. 1. RCT and non-RCT studies published across decades from 1967 to 2017 in Physiotherapy journal.
interventions used. The first analysis of data classified RCTs into one of the subdisciplines of physiotherapy, based on those defined by PEDro and the spread of subdisciplines was quantified. Secondly, the general trends in RCT publication since 1967 were reported. Thirdly, the variety of countries in which trials took place were categorized based on trial location rather than the author’s country of affiliation.
Results Randomised controlled trials In total 120 RCTs were published in Physiotherapy between January 1967 and January 2017. Quality of RCTs as evidenced by mean (SD) PEDro scores was noted to increase markedly over the decades, 1967 to 1977; 3.0 (1.4), 1978 to 1987; 5.5 (1.9), 1988 to 1997; 5.3 (2.8), 1998 to 2007; 5.8 (0.7) and 2008 to 2017; 6.9 (1.5). Examples of recently published highly scoring trials, scoring 9/10 on PEDro total scores were Pérez-Merino et al. and Wang et al. [20,21]. The majority of RCTs were UK-based studies (n = 75, 63%), followed by Australia (n = 6, 5%), Spain (n = 5, 4%), Norway (n = 5, 4%), Brazil (n = 3, 3%), Israel (n = 3, 3%), and Canada (n = 3, 3%). Fig. 2 shows the global distribution of all RCTs published in Physiotherapy between January 1967 and January 2017. In assessing the spread of RCT publication throughout the decades there has been a steady increase as the decades have evolved: 1967 to 1977 n = 5; 1978 to 1987 n = 15; 1988 to 1997 n = 29; 1998 to 2007 n = 31; 2008 to 2017 n = 40 (Fig. 1). The most significant increase in RCT publication appears to coincide with the advent of electronic publication of the journal in 1988. When examining the subdisciplines of physiotherapy which RCTs investigated, the majority report on areas of musculoskeletal physiotherapy (n = 62, 52%), followed by cardiothoracics (n = 20, 17%) and women’s health (n = 10, 8%), Fig. 3a. Within muscu-
loskeletal physiotherapy, low back pain and knee pain are the areas that received the most attention accounting for 18% each, followed by the shoulder (n = 8, 13%) and then the foot and ankle (n = 6, 10%), Fig. 3b. Within cardiothoracics, chronic obstructive pulmonary disease the most commonly investigated condition (n = 4, 20%). The most common interventions investigated were exercise therapy (n = 51, 43%), followed by electrotherapy (n = 43, 36%), and then manual therapy and massage (n = 9, 8%), as shown in Fig. 4. In total 7110 individuals participated in 120 RCTs with the mean participant number being n = 60 (SD = 53.3, range 8 to 330). Sixteen studies (19%) had participant numbers in excess of 100. Randomisation was well documented. The first RCT to cite a registration number in a public trials registry was in 2011. In total, 16 RCTs included a trial registration number, representing 53% (16/30) of RCTs published since 2011. Original research and systematic reviews In total 1350 original citations and systematic reviews were published in the journal Physiotherapy between January 1967 and January 2017. Excluding 120 RCTs this accounted for 1230 non-RCTs and systematic reviews. Systematic reviews accounted for 6% of these citations (n = 79), with the first systematic review published in 1993. Systematic review publication rates were noted to have increased substantially in the previous two decades. Of the 1230 non-RCTs 83% were of quantitative design (n = 1017), with surveys (n = 184, 15%) being the most commonly published, followed by observational studies (n = 124, 10%), cross sectional and cohort studies (n = 120, 10%), equipment and outcome measure evaluation including psychometric property evaluation (n = 98, 8%). Case studies, case series (n = 152, 12%) and audits (n = 80, 7%) were more prevalent in publication in the earlier years of the journal Physiotherapy. Other research methodologies included Delphi studies, cross-over studies, pre post and repeated measures studies. Qualitative research
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
5
Fig. 2. Global origin of all RCTs published in Physiotherapy.
Fig. 3. (a) Number of RCTs published in physiotherapy sub-disciplines in Physiotherapy journal. Key: Cardio = cardiothoracics; Geront = gerontology; Oncol = oncology; Paeds = paediatrics; Ortho = orthopaedics; MSK = musculoskeletal; examples of other include education and mental health. (b) Number of RCTs published in musculoskeletal sub-disciplines in Physiotherapy journal. Key: LBP = low back pain; STI = soft tissues injury; TMJ = temporomandibular joint; examples of other include rheumatoid arthritis and healthy volunteers.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043; 6
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Fig. 4. Number of RCTs published which evaluate different treatment types.
accounted for 8% (n = 101) of publications, with publication increasing considerably in the past two decades; 33 studies had mixed methodology of quantitative and qualitative design. Fig. 1 also illustrates the decade publication spread of RCTs and non-RCT original research and systematic reviews and supplementary File 1 shows all research articles published in Physiotherapy between January 1967 and January 2017. The majority of research was conducted in the UK (n = 841, 68%), followed by Australia (n = 94, 8%), Ireland (n = 35, 3%), USA (n = 32, 3%) and Canada (n = 32, 3%). Discussion This review tracked the evolution of research within the journal Physiotherapy over the past 50 years. This is timely considering the journal is the longest established physiotherapy specific journal and has reached a worthy milestone of half a century of RCT publication. Overall, an increase in research publications was observed across all decades, with a sharp rise noted in the late 1980s and early 1990s. Not surprisingly this coincided with the advent of the electronic publication of the journal in 1988. This allowed access of the journal to a wider audience with researchers outside of the United Kingdom submitting research for publication and extending the global reach of the journal and indeed physiotherapy research. The global spread of authors publishing in the journal particularly from the 1990s onwards demonstrates the impact of the journal. In the early years of publication, research methodologies used were on the lower levels of the hierarchical evidence pyramid with methodologies such as case studies, case series and clinical audits being to the fore, reflecting trends in the wider medical literature at the time. That was also when the profession was nascent and emerging from major world events such as the two World Wars. As the profession has evolved so too has the calibre of the research published and
the methodologies used to achieve this, with more RCTs and systematic reviews being published from the 1990s onwards, and the first systematic review in 1993. Clinical trial registration, a relatively recent phenomenon, which minimises publication bias and aids accessibility and transparency of clinical research, was recommended in 2011 and became a mandatory requirement in 2013 in Physiotherapy, adopted from a proposal from the International Committee of Medical Journal Editors (ICMJE). This is evidenced by the first reporting of clinical trial registration the same year in 2011, which was in fact earlier than other journals in the field. Over half (53%) of RCTs published since 2011 included clinical trial registration details, which compares favourably to physiotherapy journals in general which was reported to be 30% [22,23]. The fact that not all RCTs published in Physiotherapy have reported clinical trial registration numbers may be partly due to the lag time between trial conduction and eventual publication and an allowance in the intervening period (2011 to 2013) for higher quality papers which had not been registered. Reflective also of the evolution and sophistication of RCT methodologies over the decades, PEDro scores improved, with the mean PEDro score from the most recent decade 6.9 indicative of ‘high quality’ research (https://www.strokengine.ca/glossary/pedro-score/). This may in part be related to the requirement to present RCTs according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and at submission to include a complete CONSORT flow chart (http://www.consort-statement.org/). This trend of incrementally increasing PEDro scores over time was also shown by Maher et al. [9]. Worthy of note, a large number of RCTs received lower scores in some PEDro subsections due to lack of blinding of the participants, assessors and in particular therapists delivering the interventions, categories which were not possible to satisfy due to the nature of the interventions
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
which must be borne in mind when reviewing PEDro scores in this journal. Also a number of other limitations pertain to the PEDro assessment tool. These are mainly due to each item in the scale carrying the same weight with an aggregate score generated [24]. In a study comparing the PEDro scale to the Cochrane Risk of Bias criteria, Armijo-Olivo et al. [25] showed that almost 60% of physical therapy trials evaluated were considered to be adequate quality based on a PEDro cut-off of ≥5 points but many trials did not meet accepted quality standards such as random sequence generation, allocation concealment and blinding of study assessors defined by the Cochrane Risk of Bias tool, which can substantially effect estimates of treatment effect. Overall poor agreement was demonstrated between the Cochrane and PEDro risk of biases approaches. Whilst cognisant of these limitations, the PEDro tool was chosen due to its widespread use within the global physiotherapy community [26] and previous evidence of validity [27,28]. The metamorphosis of physiotherapy as a profession is also observed in the types of interventions investigated within the RCTs. In the early years more emphasis appeared to be on electrophysical agents such as Faradism and Shortwave Diathermy. This has declined in recent decades which mirrors the trend in clinical practice away from these modalities. Exercise therapy has always been a main stay of the physiotherapy profession, with our roots in remedial gymnastics. Exercise is regarded as the best supported intervention in the physiotherapy field [13] and similarly we found that exercise interventions accounted for the highest proportion of those investigated in published RCTs. While the breadth of physiotherapy practice was well represented in terms of scope of topics investigated, nonetheless, a number of prominent subdisciplines of physiotherapy appear to be under-represented such as neurology and gerontology, representing an opportunity to continue to develop the evidence base in these areas. The low number of studies in the area of sports is remarkable, perhaps related to the difficulty in attracting research funding [13] comparted to more clinically aligned areas. Other areas not well represented were paediatrics and oncology. Many findings from the present study mirror results reported from Maher et al. [9] who described evidence indexed in the PEDro database. Consistent findings were the progressive growth in the research base in physiotherapy sub-disciplines. Maher et al. [9] also noted that high profile areas such as ergonomics and sports physical therapy have little discipline specific evidence to guide practice which was also mirrored in the present study. Sub-disciplines not well represented may be due to a dearth of RCTs submitted to the journal for consideration, so the onus should be on researchers, clinicians and grant awarding bodies to prioritise other areas of physiotherapy research so all areas can evolve based on research findings to inform practice. It is also possible that RCTs from the sub-disciplines underrepresented in this journal may be published in specialty/medical journals rather than a professional journal such as Physiotherapy.
7
The mean number of trial participants was 60 and 16 studies, (19%) had participant numbers in excess of 100. It is not known if these studies in general were over or under powered. Notably language used to describe disability has evolved considerably over the years, with much of the language and imaging included in earlier publications no longer used or accepted e.g. ‘handicapped children’ ‘crippled survivors’. In keeping with this professional and progressive ethos the journal has been ‘ahead of its time’ with publications on cancer survivorship as early as March 1971, and introduction of the concept of ‘interdisciplinary’ collaborations in 1968. Strengths of this review are that it appears to be the first attempt to map the evolution of RCTs in this journal. In order to produce the most accurate results, the methodical and time consuming searches were conducted electronically and by hand of all journals since 1967, with double data extraction to minimise errors. Limitations were the lack of evaluation of RCTs against the CONSORT checklist which was beyond the scope of this study. It was also difficult to compare indices reported in this paper to equivalent literature as this type of analysis does not appear to have been conducted in other physiotherapy or other allied health journals. This review focuses on RCTs as they are regarded as high quality forms of evidence and follow firmly codified methodology [29]. We acknowledge that this review provides an insight of clinical research in one physiotherapy specific journal and other physiotherapy journals and broader medical and sports focussed journals also publish physiotherapy related clinical research. Nonetheless, as this is a highly ranked, long-standing and cross-disciplinary journal we felt a comprehensive evaluation of the evolution of RCTs within the journal to recent times would help assess the status quo and assist with future planning in terms of RCT and clinical research publication. A future broader review could be an interesting and revelatory follow-on to the present review. High quality clinical research such as RCTs are the foundation for evidence based practice. A single RCT does not direct practice, but is the building block for systematic reviews upon which practice is based. Clearly RCTs continue to evolve based on more robust, and more robustly reported methodologies as evidenced in this paper. This paper tracks the laudable increase in quality, quantity and diversity of RCTs in the journal Physiotherapy, but it also serves as a reminder to represent all areas of practice where possible and continually attempt to minimise sources of bias to truly inform practice in the most optimal manner. Acknowledgements We would also like to acknowledge the work of Claire Taylor in the development phase of this work. Ethical approval: No ethical approval was required for this study. Conflicts of interest: None declared.
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005
PHYST-1043;
No. of Pages 8
8
ARTICLE IN PRESS G. Kelly et al. / Physiotherapy xxx (2017) xxx–xxx
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/ j.physio.2018.08.005. References [1] Herbert R, Jamtvedt G, Mead J, Hagen KB. Evidence-based physiotherapy: what why and how? In: Practical evidence-based physiotherapy. London: Elsevier; 2005. p. 1–10. [2] Dannapfel P, Peolsson A, Nilsen P. What supports physiotherapists’ use of research in clinical practice? A qualitative study in Sweden. Implement Sci 2013;8:31. [3] Bury TJ. Evidence-based healthcare explained. In: Bury TJ, Mead JM, editors. Evidence-based healthcare: a practical guide for therapists. Oxford: Butterworth-Heinemann; 1998. p. 3–25. [4] Herbert R, Jamtvedt G, Mead J, Hagen KB. What constitutes evidence? In: Practical evidence-based physiotherapy. London: Elsevier; 2005. p. 19–50. [5] Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285:1992–5. [6] Sibbald B, Roland M. Understanding controlled trials: why are randomised controlled trials important? BMJ 1998;316:201. [7] Colebrook D. Irradiation and health: an ultra-violet irradiation of school children. Med Res Counc Spec Rep Ser 1929;131:1–47. [8] Chalmers. MRC Therapeutic Trials Committee’s report on serum treatment of lobar pneumonia. BMJ 1934. [9] Maher CG, Moseley AM, Sherrington C, Elkins MR, Herbert RD. A description of the trials, reviews, and practice guidelines indexed in the PEDro database. Phys Ther 2008;88:1068–77. [10] Landen BR. Heat or cold for the relief of low back pain? Phys Ther 1967;47:1126–8. [11] Moseley AM, Herbert RD, Sherrington C, Maher CG. Evidence for physiotherapy practice: a survey of the Physiotherapy Evidence Database (PEDro). Aust J Physiother 2002;48:43–9. [12] Moseley AM, Elkins MR, Janer-Duncan L, Hush JM. The quality of reports of randomized controlled trials varies between subdisciplines of physiotherapy. Physiother Can 2014;66:36–43. [13] Kamper SI, Moseley AM, Herbert RD, Maher CG, Elkins MR, Sherrington C. 15 years of tracking physiotherapy evidence on PEDro, where are we now? Br J Sports Med 2015;49:907–9. [14] Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004;183:1539–44. [15] Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159–62.
[16] Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2013;340:c723. [17] Higgins JPT, Green S. Cochrane Handbook for Systematic Review of Interventions Version 5.1.0. The Cochrane Collacoration. 2011; Available form www.cochrane-handbook.org. [Accessed 20 March 2016]. [18] Viswanathan M, Berkman ND, Dryden DM, Hartling L. Assessing risk of bias and confounding in observational studies of interventions or exposures: further development of the RTI item bank. Methods research report. (Prepared by RTI–UNC Evidence-based Practice Center under contract No. 290-2007-10056-I). AHRQ publication no. 13-EHC106EF. Rockville, MD; Canada: Agency for Healthcare Research and Quality; 2013. August. [19] Herbert R, Moseley A, Sherrington C. PEDro: a database of randomised controlled trials in physiotherapy. Health Inf Manag 1998;28(4):186–8. [20] Pérez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE, González R, et al. Evaluation of the effectiveness of three physiotherapeutic treatments for subacromial impingement syndrome: a randomised clinical trial. Physiotherapy 2016;102(1):57–63. [21] Wang P, Yang L, Li H, Lei Z, Yang X, Liu C, et al. Effects of whole-body vibration training with quadriceps strengthening exercise on functioning and gait parameters in patients with medial compartment knee osteoarthritis: a randomised controlled preliminary study. Physiotherapy 2016;102:86–92. [22] Pinto RZ, Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther 2013;93(3):299–309. [23] Babu AS, Veluswamy SK, Rao PT, Maiya AG. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther 2014;94(1):83–90. [24] da Costa BR, Hilfiker R, Egger M. PEDro’s bias: summary quality scores should not be used in meta-analysis. J Clin Epidemiol 2013;66:75–7. [25] Armijo-Olivo S, da Costa BR, Cummings GG, Ha C, Fuentes J, Saltaji H, et al. PEDro or Cochrane to assess the quality of clinical trials? A meta-epidemiological study. PLOS One 2015;10(7):e0132634. [26] Campos TF, Beckenkamp PR, Moseley AM. Usage evaluation of a resource to support evidence-based physiotherapy: the Physiotherapy Evidence Database (PEDro). Physiotherapy 2013;99(3):252–7. [27] de Morton NA. The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. Aust J Physiother 2009;55(2):129–33. [28] Macedo LG, Elkins MR, Maher CG, Moseley AM, Herbert RD, Sherrington C. There was evidence of convergent and construct validity of Physiotherapy Evidence Database quality scale for physiotherapy trials. J Clin Epidemiol 2010;63(8). [29] Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli I, Moher D, et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine. BMJ 2018;360:k400.
Available online at www.sciencedirect.com
ScienceDirect
Please cite this article in press as: Kelly G, et al. 50 years of randomised controlled trials published in the journal Physiotherapy: a review 1967 to 2017. Physiotherapy (2017), https://doi.org/10.1016/j.physio.2018.08.005