Systematic Reviews and Clinical Trials in Rehabilitation: Comprehensive Analyses of Publication Trends

Systematic Reviews and Clinical Trials in Rehabilitation: Comprehensive Analyses of Publication Trends

Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2016;-:------...

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Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2016;-:-------

ORIGINAL RESEARCH

Systematic Reviews and Clinical Trials in Rehabilitation: Comprehensive Analyses of Publication Trends Tiago S. Jesus, PhD From the Portuguese Ministry of Education, Aggregation of Schools of Escariz, Escariz, Portugal.

Abstract Objective: To analyze publication trends of clinical trials (CTs) and systematic reviews (SRs) in rehabilitation. Design: PubMed searches were performed with appropriate combinations of Medical Subject Headings. All entries until December 2013, and their yearly distributions since 1981 (when the first rehabilitation SR was identified), were retrieved. After the initial data visualization, data analyses were narrowed to specific periods. Linear regression techniques analyzed the growth of publications and their relative percentages over time. Setting: Not applicable. Participants: Not applicable. Interventions: Not applicable. Main Outcome Measures: Not applicable. Results: Although not observed for SRs, CTs have grown at a much higher rate in rehabilitation than in the broader health/medical fielddmore than twice the difference for both periods analyzed (1989e2001, 2001e2013). Rehabilitation journals published about 20% or less of the rehabilitation SRs and CTs, and no significant increases were observed over time (P>.05; 2001e2013). Neurologic conditions, particularly cerebrovascular, were the most addressed by rehabilitation SRs and CTs, while differences between neurologic and other groups of conditions typically widened over time (eg, more than doubled between neurologic and musculoskeletal conditions in 15y). Conclusions: While publications of CTs are increasing at a much higher rate within rehabilitation than within broader health care, further research is warranted to explain why this trend is not being followed by SRs, particularly those with meta-analysis. Similarly, research might determine whether the (growing) differences in the publications of rehabilitation SRs and CTs across groups of conditions are justified by clinical or population need. Archives of Physical Medicine and Rehabilitation 2016;-:------ª 2016 by the American Congress of Rehabilitation Medicine

Clinical trials (CTs), particularly randomized controlled trials (RCTs), and systematic reviews (SRs), especially systematic review and meta-analysis (SR&MA), have been increasing in popularity as research designs in health care. Accordingly, the number of publications with such designs has been growing substantially over the years.1 Publications of CTs and SRs in rehabilitation have also been rising extensively in physical rehabilitation.2,3 One recent study2 found that publications with “high-quality” study designs (eg, RCTs, CTs, meta-analyses) have been steadily increasing

Disclosures: none.

over the years, even more than “low-quality” study designs (eg, reviews, case reports). This study, nonetheless, made no distinction between systematic and nonsystematic reviews. There is little doubt that publications of CTs and SRs are growing in the broader health care field1,4 and in rehabilitation in particular.2,3 However, important details of the rehabilitation publication trends for CTs and SRs remain unanswered. For instance, within the available data, it is hard to ascertain whether the publications of SRs and CTs in rehabilitation are increasing more than the publications of SRs and CTs in the broader health/ medical field, since both are increasing.1,4 Furthermore, even though publication trends have been analyzed within specific rehabilitation journals,5-13 little is known about the distribution of

0003-9993/16/$36 - see front matter ª 2016 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2016.06.017

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rehabilitation SRs and CTs published across rehabilitation journals. Finally, publication trends have been analyzed within the rehabilitation of specific conditions14-16; however, they do not reveal how rehabilitation CTs and SRs are distributed over the full range of conditions typically treated by rehabilitation. In filling these knowledge gaps, informing further research, its funding, and even journal editorial policies, this article aims to comprehensively analyze the publication trends of SRs and CTs in rehabilitation. Specifically, it aims to determine (1) how much publications of CTs and SRs in rehabilitation (and their subforms SR&MA and RCTs) have increased over time, inclusively when compared with the increase of the same research designs for the broader health/medical field; (2) the number and percentage of rehabilitation-related CTs and SRs published by (which) rehabilitation journals; and (3) the number and growth of CTs and SRs published across (groups of) conditions typically benefiting from rehabilitation.

Methods The PubMed database (http://www.ncbi.nlm.nih.gov/pubmed) was used for this analysis, as it was in previous analyses of rehabilitation publication trends.2,14,15 Although not fully comprehensive, PubMed indexes many journals within a field (eg, at any given time, PubMed indexed 113 journals within the field of physical and medicine rehabilitation). To any new article added to the PubMed database, trained indexers assign relevant key terms from a hierarchical tree of Medical Subject Headings (MeSH), which then can be used for any tailored searches. Based on these search facilities, targeted searches were conducted on PubMed, all filtered for “humans.” To further streamline these searches, a set of MeSH terms related to rehabilitation was assembled (using the operator “OR”),2 but excluding (using the operator “NOT”) any related MeSH terms deemed nonapplicable (eg, “substance abuse treatment centers”). The set of rehabilitation MeSH terms was then appropriately combined (using the operator “AND”) with relevant MeSH terms for research designs, rehabilitation journals, or both. With regard to research designs, SRs, CTs, SR&MA, and RCTs were first searched within the rehabilitation field, and then for the entire PubMed (ie, the broader health/medical sciences). A combination of research-based study designs (SRs, CTs, observational, validation, and comparative studies, etc, excluding case reports) was also searched together within the rehabilitation niche, to calculate the prevalence of SRs and CTs within rehabilitation research. With regards to searches across journals, those journals covering the field of rehabilitation were first searched altogether. Then, the search strategy was narrowed to a group of 6 rehabilitation journals (approximately 5% of all of those indexed in PubMed) that published the highest number of SRs and CTs, determined by counting the number of rehabilitation SRs and CTs published in each journal. Finally, a search analysis within each of those 6 journals was performed.

List of abbreviations: CT MeSH RCT SR SR&MA

clinical trial Medical Subject Headings randomized controlled trial systematic review systematic review and meta-analysis

Importantly, the set of rehabilitation MeSH terms was applied all through journal searches. This meant that articles not indexed for any rehabilitation-related MeSH terms were not considered, albeit published by “rehabilitation” journals. Lastly, (groups of) conditions typically benefiting from rehabilitation were selected from the MeSH tree and then exclusively searched as a major field, coupled with a rehabilitation subheading. This allowed for an exclusive focus on the main condition(s) addressed. Supplemental appendix S1 (available online only at http://www.archives-pmr.org/) details the search strategy used. Searches were conducted in February 2016, but only articles published until December 2013 were retrieved in order to account for the typical 2-year delay of PubMed indexation.15 All the entries from each search, and their yearly occurrences since 1981 (when the first SRs in rehabilitation were identified), were exported into Excela spreadsheets, computed into appropriate statistics (eg, percentages), and displayed into time-series plots. After primary data visualization, the plots and data analyses were narrowed to relevant periods emerging from the data. For example, SR&MA were found indexed only after 2001. Therefore, SR analyses were conducted only within the 2001 to 2013 period. CTs, on the other hand, became prevalent at an earlier date; hence, CT analyses were also conducted over the previous period, within the same extension of time (1989e2001). The same period is nonetheless used for any direct comparisons. Within the relevant periods, simple linear regression analyses were conducted using Excel. Specifically, linear regressions were used to analyze publication growths and their relative percentages over time. P values <.05 were considered statistically significant.

Results SRs and CTs in rehabilitation versus the broader health/medical sciences Rehabilitation SRs totaled about 4066 entries (24.3% of which were SR&MA), while there were approximately 8 times more rehabilitation CTs (32,577 entries, 67.7% of which were RCTs). Figure 1 shows that publications of all these designs have increased significantly over time (P<.01; minimum r2Z.86: 2001e2013). More importantly, table 1 shows that yearly publications of CTs have increased at a much higher rate in the rehabilitation field than in the broader health/medical field: more than twice the difference, for both periods analyzed (1989e2001; 2001e2013). Table 1 also shows that the percentage increase of rehabilitation SRs was nearly double that of rehabilitation CTs (20.2% vs 10,7% per year, 2001e2013), but was similar to that of SRs in the broader health/medical field (20.2% vs 18.9%). Finally, yearly publications of SR&MA had the highest percentage increases within the rehabilitation field, but such growth was, nonetheless, lower than that of SR&MA in the broader health/medical field (37.3% vs 53.6%).

Evolving preponderance of SRs and CTs within rehabilitation research Figure 2 shows that overall, publications of either SRs or CTs have been gaining preponderance within a set of rehabilitation research designs, but that increase was particularly evidenced

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3500

Rehab SRs

Amount of PublicaƟons

3000 slope= 175.1 r²= 0.96; p<0.01

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Rehab RCTs 2000 slope= 146.9 r²= 0.96; p<0.01

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slope= 48.7 r²= 0.93; p<0.01

500

slope= 14.7 r²= 0.86; p<0.01

0 2001

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Rehab SRs+MA

2013

Years

Fig 1 Amount of CTs, RCTs, SRs, and SR&MA in rehabilitation published for every year since 2001. Linear regression lines and analyses (slope, r2, and P values) are shown.

within the more recent period (P<.01: 2001e2013). When the analysis was extended for a longer period (1989e2013), which is only applicable to CTs, the observed increase was less statistically significant (PZ.04) and less linear (r2Z.18) over time. In 2013, CTs and SRs accounted for nearly half (51.4%) and nearly one tenth (10.6%) of the rehabilitation research publications, respectively.

SRs and CTs in rehabilitation journals Rehabilitation journals published a total of 806 SRs and 4885 CTs with rehabilitation-related MeSH terms. This translated to only 19.8% and 15% of all of those rehabilitation SRs and CTs, respectively. As such, most of the rehabilitation SRs (80.2%) and CTs (85%) were published outside of rehabilitation journals. Figure 3 shows no significant increases in the percentage of CTs and SRs published by all rehabilitation journals in recent years (P>.05: 2001e2013), even though this was observed for CTs in the earlier period (P<.01; 1989e2001).

Table 1 Average yearly percentage growths of the studied designs for 2 subsequent periods Publication Type SRs Rehab SRs Rehab SR&MA SRs (full PubMed) SR&MA (full PubMed) CTs Rehab CTs Rehab RCTs CTs (full PubMed) RCTs (full PubMed)

1989e2001

2001e2013 20.2 37.3 18.9 53.6

15.4 15.1 6.7 6.5

10.7 12.3 4.6 6.0

NOTE. Values are percentages. The table provides data for both rehabilitation and the broad health/medical field (full PubMed database). For SRs, values were computed only for the 2001 to 2013 period.

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Rehabilitation journals publishing more SRs and CTs The 6 rehabilitation journals that have published the highest number of rehabilitation-related CTs and SRs are indicated in figure 4. The Archives of Physical Medicine and Rehabilitation stands out with the highest number of publications for rehabilitation CTs (and for CTs and SRs combined), while Clinical Rehabilitation stands out with the highest number of publications for rehabilitation SRs (and second highest for CTs and SRs combined). Figure 5 shows that since 1997 (when Clinical Rehabilitation was first indexed), each of the 6 journals has had significant increases in the publications for rehabilitation CTs and SRs (combined value), even though the amount of such increase and its linearity varied substantially across those journals (r2 values ranging from .39 to .95). More importantly, figure 6 shows that publications of SRs and CTs have not become more preponderant within a set of research designs for any of those 6 rehabilitation journals (P>.05), although Clinical Rehabilitation comes close (PZ.06). Given that publications of SRs and CTs have increased significantly for all 6 journals (see fig 5), this suggests that important increases also occurred in a number of publications for other research designs.

SRs and CTs in the rehabilitation of varying conditions Figure 7 shows how many SRs and CTs have addressed (groups of) conditions typically benefiting from rehabilitation. Cerebrovascular diseases and nontraumatic musculoskeletal diseases stand out as the most addressed, while neoplasms, spinal cord injuries, and craniocerebral trauma stand out as the least addressed. Aggregating the conditions further, the set of neurologic diseases stands out as the most addressed by SR and CTs (nZ3394), followed by a set of disease manifestations such as pain, motor, and other disease implications (cognitive, sensorial, communication) (nZ2697). Musculoskeletal conditions (nZ2291) and a set

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%

slope= 0.86 r²= 0.85; p<0.01

slope= 0.27 r²=0.18; p=0.04

40

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% of SRs within RehabilitaƟon Research PublicaƟons ([2001-2013])

slope= 0.66 r²= 0.93; p<0.01

10

1994

1999

2004

% CTs within RehabilitaƟon Research PublicaƟons ([1989:2013] & [19892013])

2009

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Fig 2 How percentages of rehabilitation SRs and CTs evolved over time among a set of rehabilitation research publications (eg, original research þ SRs, excluding case reports). Regression lines and analyses (slope, r2, and P values) are shown.

of other diseases (respiratory, neoplasms, cardiac) (nZ2182) were the least addressed. Regarding the proportion of SRs per CTs, figure 8 shows substantial imbalances across conditions. With the use of the extreme poles, for musculoskeletal trauma, SRs accounted for 21.7% of the number of CTs, while for motor manifestations the percentage value was more than 3 times lower (6.6%). Lastly, figure 9 shows that publications of rehabilitation SRs and CTs have increased over the past 15 years for all groups of conditions (P<.01; minimum r2Z.86). More importantly, figure 9 also shows that the differences across the groups of conditions typically have widened over time. For example, in 2013 alone, the amount of rehabilitation SRs and CTs on neurologic conditions (nZ419) was 2.2 times higher than that focused on musculoskeletal conditions (nZ 190), while this difference was negligible 15 years earlier (nZ47 vs nZ46).

Discussion This article presents a comprehensive analysis of publication trends of CTs and SRs in rehabilitation. As expected,1,2,14,15 the number of CTs and SRs in rehabilitation has increased over time; however, less predictable findings have also been revealed. For instance, publications of CTs (and RCTs) were increasing at a much higher rate (more than double) in rehabilitation than in the broader health/medical science field. This may be framed within a movement toward opening the “rehabilitation black box”dthat is, narrowing the historical knowledge gap about the effects of specific rehabilitation interventions.17 Also, there is increasing evidence that chronic conditions and disability are increasing worldwide18-20; Hence, more of the overall health research resources may have been allocated to rehabilitation CTs, even though current health-funding mechanisms may not be

25 slope= 0.38 r²= 0.26; p=0.08

% of rehab-related SRs published by rehab journals

20

%

15 slope= 0.75 r²= 0.72; p<0.01

slope= 0.07 r²= 0.12; p=0.25 % of rehab-related CTs published by rehab journals

10

5

0 1989

1994

1999

2004

2009

Years

Fig 3 The evolution over time in the percentage of rehabilitation-related SRs and CTs published by rehabilitation journals. Regression lines and analyses (slope, r2, and P values) are shown for the periods under analyses.

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5

1200 73 1000

Amount of publicaƟons

800 95 600

SRs 987

CTs

400 36

52

18

291

262

290

Phys Ther

(Scand) J Rehabil Med

Am J Phys Med Rehabil

573

87

200

190

0 Arch Phys Med Rehabil

Clin Rehabil

Disabil Rehabil

Fig 4 The 6 rehabilitation journals with more publications of rehabilitation SRs and CTs combined, including how much of each design each journal has published. Abbreviations: Am J Phys Med Rehabil, American Journal of Physical Medicine and Rehabilitation; Arch Phys Med Rehabil, Archives of Physical Medicine and Rehabilitation; Clin Rehabil, Clinical Rehabilitation; Disabil Rehabil, Disability and Rehabilitation; Phys Ther, Physical Therapy; (Scand) J Rehabil Med, Scandinavian Journal of Rehabilitation Medicine.

more nominally, those of SRs have shown greater percentage increases. Finally, the preponderance of CTs within rehabilitation research has grown markedly since 2001 (P<.01: 2001e2013), but less so when analyzing an extended period (PZ.04: 1989e 2013). Those nuanced results emphasize the need for performing comprehensive analyses of rehabilitation publication trends (ie, with varying parameters, comparisons, and periods). Second, there is a need to understand why publications of SR&MA in rehabilitation are growing at a slower pace than the publications of SR&MA in the broader health/medical field. While the heterogeneity of rehabilitation research may pose additional challenges,22 meta-analytical approaches can increasingly accommodate data from either heterogeneous sources (eg, using random-effects meta-analyses)23-26 or from

optimal for pushing all the needed funding toward rehabilitation research.21 Whatever the causes, the rehabilitation field seems to be reducing the gap in the “quantity” of CTs to other health fields, even though the “quality” of those CTs has not been examined. Aligned with previous data,2 SR&MA were found to be the research design with the highest percentage increases in rehabilitation. The main novelty here is that such growth is notably inferior to that of the SR&MA in the broader health/medical field. Two major comments arise from this. First, different comparisons have provided different results, in turn leading to seemingly opposite conclusions (ie, on whether SR&MA were growing strongly or insufficiently in rehabilitation). This ambiguity is also apparent within other study results. For example, while publications of rehabilitation CTs have grown

90

Arch Phys Med Rehabil slope= 2.23 r²= 0.54; p<0.01

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Clin Rehabil slope= 3.48 r²= 0.95; p<0.01

Amount of publicaƟons

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Disabil Rehabil slope= 2.15 r²= 0.76; p<0.01

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(Scand) J Rehabil Med slope= 1.95 r²= 0.74; p<0.01

40 30

Am J Phys Med Rehabil slope= 0.78 r²= 0.4; p<0.01

20

Phys Ther slope= 1.44 r²= 0.63; p<0.01

10 0 1997

1999

2001

2003

2005

2007

2009

2011

2013

Years

Fig 5 How the amount of rehabilitation SRs and CTs (value combined) has evolved over the years for the rehabilitation journals publishing them with the greatest frequency. Linear regression analyses (slope, r2, and P values) are shown. Tendency lines are drawn only for the 2 journals that stand out with more yearly publications. Abbreviations: Am J Phys Med Rehabil, American Journal of Physical Medicine and Rehabilitation; Arch Phys Med Rehabil, Archives of Physical Medicine and Rehabilitation; Clin Rehabil, Clinical Rehabilitation; Disabil Rehabil, Disability and Rehabilitation; Phys Ther, Physical Therapy; (Scand) J Rehabil Med, Scandinavian Journal of Rehabilitation Medicine.

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T.S. Jesus 100

Clin Rehabil slope= 0.91 r² = 0.22; p=0.06

90

Arch Phys Med Rehabil slope = -0.21 r² = 0.005; p=0.8

80 70

%

Phys Ther slope= -0.3 r² = 0.006; p=0.78

60 50

(Scand) J Rehabil Med slope= -0.91 r²= 0.078; p=0.28

40 30

Am J Phys Med Rehabil slope= -0.6 r² = 0.036; p=0.47

20 10 0 1997

1999

2001

2003

2005

2007

2009

2011

2013

Disabil Rehabil slope= -0.73 r²= 0.0315; p=0.5

Years

Fig 6 How the percentage of SRs and CTs within all empirical research publications for each journal has evolved over time. Simple linear regression analyses (slope, r2, and P values) are shown. Abbreviations: Am J Phys Med Rehabil, American Journal of Physical Medicine and Rehabilitation; Arch Phys Med Rehabil, Archives of Physical Medicine and Rehabilitation; Clin Rehabil, Clinical Rehabilitation; Disabil Rehabil, Disability and Rehabilitation; Phys Ther, Physical Therapy; (Scand) J Rehabil Med, Scandinavian Journal of Rehabilitation Medicine.

rehabilitation research. Pragmatic clinical trials and practice-based research can be valid alternatives or complements for explaining which treatments, and mostly which combination, work better in “real” practice.32-39 Also, both the complexity and urgency of measuring disability and rehabilitation outcomes call for developing/publishing many psychometric studies.40,41 Therefore, an important part of rehabilitation research may still be devoted to research designs other than CTs or SRs, and that may not necessarily be a sign of any scientific weakness. Rehabilitation journals accounted for the publication of a relatively low (approximately 20% or less) percentage of all SRs and CTs in rehabilitation. While these findings seem relatively surprising, a number of questions can be raised. For example, are most rehabilitation CTs and SRs being published in generalist medical journals of higher impact factor? What factors have driven the

alternative interventions that have not been directly compared (eg, using network meta-analyses).27,28 Given the impetus to advance both the quantity and the quality of SRs in rehabilitation,3,22,29-31 these questions highlight possibilities for further investigation. Both SRs and CTs have become more preponderant study designs among rehabilitation research, but this overall trend was not been verified in all instances analyzed (eg, not for any of the 6 rehabilitation journals analyzed since 1997). In addition to SRs and CTs, the set of other research-based study designs, including observational, psychometric, and multicenter studies, among others, also showed an increase in the number of publications. This could be explained as follows. Traditional CTs and RCTs are not always possible and sometimes not the best method for answering some complex questions within contemporary 1800 1600

225

Groups of condiƟons:

225 1400

Specific disease manifestaƟons

1200

800

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136 139 1476

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1013 400

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786 626

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Musculoskeletal condiƟons diseases

83

1393

66

600

34

55

296

266

553

670

Neurologic Neurological condiƟons diseases

56

Other diseases (respiratory, neoplasms, cardiovascular)

283

0

Fig 7 How many SRs (displayed above) and CTs (displayed below) were published in the rehabilitation of different (groups of) conditions, including specific disease manifestations. Abbreviations: Cogn., cognitive; Commun., communication; Sensor., sensorial.

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25

Groups of condiƟons:

20

Specific disease manifestaƟons

15

Neurological condiƟons

% 21.7

20.7

10 17.7 15.2 10.5

5

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Musculoskeletal condiƟons

19.8

16.2 12.4

11.5

8.6

6.6

Other diseases (respiratory, neoplasms, cardiovascular)

0

Fig 8 Percentage of SRs per CTs across diverse conditions typically benefiting from rehabilitation. Abbreviations: Cogn., cognitive; Commun., communication; Sensor., sensorial.

authors’ choice for journals?42 This seems to be a relatively unchartered territory that may warrant further investigation. Apart from the causes, the consequences of such dispersed publication of rehabilitation CTs and SRs may be indicative of the need to (1) use and particularly increase the competency of using the search tools of databases such as PubMed43-45; (2) use online platforms that synthesize/aggregate/update scientific information (eg, http://www.strokengine.ca; www.otseeker.com; http://www. pedro.org.au; https://www.rehabinreview.com)4,46-48; and finally (3) benefit from the broader development of knowledge translation activities.47,49 All of these actions may help busy professionals keep up with the high volume of rehabilitation SRs and CTs and their dispersed publication (ie, most of which are published outside rehabilitation journals). As observed in the broader health/medical field,4 the set of neurologic conditions (eg, more cerebrovascular ones) was the

most addressed by rehabilitation SRs and CTs, followed by disease manifestations often resulting from neurologic conditions. More importantly, the differences in the number of SRs and CTs from these to other groups of conditions have widened over time. The complexity involved within the rehabilitation of neurologic conditions may explain this finding, even though musculoskeletal conditions, and particularly back pain, account for a higher disability burden and greater costs on population-wide metrics.18,50 Further investigation may determine whether the (growing) differences in the quantity of rehabilitation CTs and SRs across conditions are justified by either clinical or population need. Lastly, imbalances were observed in the percentage of SRs per CTs across many treated conditions (up to more than 3 times the difference). Hence, there is possibly a greater need for more SRs on the rehabilitation of certain conditions.

450

Neurologic Injuries/Diseases slope= 22.5 r² = 0.93; p<0.01

400

Amount of publicaƟons

350

Manifestations slope= 15.9 r²= 0.91; p<0.01

300 250

Musculoskeletal Injuries/Diseases slope= 10.1 r²= 0.91; p<0.01

200 150

Other (respiratory, cardiac, neoplasms) slope= 8.2 r²= 0.86; p<0.01

100 50 0 1998

2000

2002

2004

2006

2008

2010

2012

Years

Fig 9 How the amount of rehabilitation SRs and CTs (value combined) has evolved over the years by major groups of conditions. Linear regression lines and analyses (slope, r2, and P values) are shown.

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Study limitations

Keywords

Several limitations apply to this study. For instance, it only includes publications and journals indexed by PubMed. Additionally, since all entries were considered valid, any limitations of the PubMed indexing system (and of the searching strategy) are all reflected in this study. Notwithstanding these limitations, a previous study2 in rehabilitation, which used a similar search strategy, found that in >90% of the cases the authors agreed with PubMed indexers. After that study, a reorganization of the MeSH tree resulted in higher precision for the research designs classified within the CTs group.51 In contrast to current recommendations,52-54 the PubMed indexation system still lacks a specific MeSH term for classifying SRs. Accordingly, no single criterion standard approach exists for sifting out SRs in PubMed.1,29,52,53 Additionally, as part of current PubMed policies, fewer MeSH terms are typically assigned for “reviews” as compared with RCTs. Because of all these limitations, the results for SRs pertaining to rehabilitation might be both less precise and less sensitive than those for rehabilitation CTs. Other limitations apply to the validity of the data retrieved. For instance, although a comprehensive list of MeSH terms related to rehabilitation has been used, it is always difficult to determine whether an MeSH term, or an article itself, relates or does not relate to rehabilitation. This limitation stems from the basic difficulty in defining the limits of what content pertains or does not pertain to rehabilitation.55,56 Furthermore, this study only referred to the number of publications, and not how well or detailed the studies have been conducted and reported; these latter topics have been addressed by other studies29,57-59 in rehabilitation. Thus, each study is given equal weight, regardless of whether the study has been rigorously conducted and reported. Moreover, the delay of the PubMed indexation process may account for the slight difference in the results retrieved (particularly during the last few years analyzed), should the searches be reproduced at a later stage. Finally, although regression analyses were conducted on individual trends, no additional statistical tests were performed to identify significant differences across varying trends.

Clinical trials as topic; Publications; Rehabilitation; Review literature as topic

Conclusions Some important and at times unexpected findings have emerged from this study; some of them might trigger further investigation. While publications of CTs in rehabilitation have increased at a higher rate than in the broad health/medical field, further research is warranted to determine why the same trend has not been observed in SRs, particularly SR&MA. Having determined that the volume of rehabilitation CTs and SRs published has been rising steadily, and that about 80% of those are published outside rehabilitation journals, helping busy clinicians keep up to date with the latest research findings, or at least their resultant practice implications, is a major challenge for the field. Finally, there are increasing differences in the publications of SRs and CTs between neurologic and other groups of conditions. Further research may determine whether this is justified by clinical or population need.

Supplier a. Excel (Microsoft Office 2010); Microsoft Corp.

Corresponding author Tiago S. Jesus, PhD, Portuguese Ministry of Education, Aggregation of Schools of Escariz, 4540-320 Escariz, Portugal. E-mail address: [email protected].

Acknowledgments I thank Bernie Guan, MSc, for editorial assistance with the language in the preparation of the manuscript.

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9 36. Hart T, Bagiella E. Design and implementation of clinical trials in rehabilitation research. Arch Phys Med Rehabil 2012;93(8 Suppl): S117-26. 37. Gordon WA. Clinical trials in rehabilitation research: balancing rigor and relevance. Arch Phys Med Rehabil 2009;90(11 Suppl):S1-2. 38. Johnston M, Vanderheiden G, Farkas M, Rogers E, Summers J, Westbrook J. The challenge of evidence in disability and rehabilitation research and practice: a position paper. NCDDR Task Force on Standards of Evidence and Methods. Austin: SEDL; 2009. 39. Johnston MV, Dijkers MP. Toward improved evidence standards and methods for rehabilitation: recommendations and challenges. Arch Phys Med Rehabil 2012;93(8 Suppl):S185-99. 40. Heinemann AW. State-of-the-science on postacute rehabilitation: setting a research agenda and developing an evidence base for practice and public policy. An introduction. Arch Phys Med Rehabil 2007;88:1478-81. 41. Velozo CA, Seel RT, Magasi S, Heinemann AW, Romero S. Improving measurement methods in rehabilitation: core concepts and recommendations for scale development. Arch Phys Med Rehabil 2012;93(8 Suppl):S154-63. ¨ zc¸akar L, Franchignoni F, Kara M, Mun˜oz Lasa S. Choosing a 42. O scholarly journal during manuscript submission: the way how it rings true for physiatrists. Eur J Phys Rehabil Med 2012;48:643-7. 43. Buchanan H, Siegfried N, Jelsma J. Survey instruments for knowledge, skills, attitudes and behaviour related to evidence-based practice in occupational therapy: a systematic review. Occup Ther Int 2016;23:59-90. 44. Sadeghi-Bazargani H, Tabrizi JS, Azami-Aghdash S. Barriers to evidence-based medicine: a systematic review. J Eval Clin Pract 2014;20:793-802. 45. Michaleff ZA, Costa LO, Moseley AM, et al. CENTRAL, PEDro, PubMed, and EMBASE are the most comprehensive databases indexing randomized controlled trials of physical therapy interventions. Phys Ther 2011;91:90-7. 46. Moore JL, Raad J, Ehrlich-Jones L, Heinemann AW. Development and use of a knowledge translation tool: the Rehabilitation Measures Database. Arch Phys Med Rehabil 2014;95:197-202. 47. Levac D, Glegg SM, Camden C, Rivard LM, Missiuna C. Best practice recommendations for the development, implementation, and evaluation of online knowledge translation resources in rehabilitation. Phys Ther 2015;95:648-62. 48. McCluskey A, Bennett S, Hoffmann T, Tooth L. OTseeker helps library and allied health professionals to find quality evidence efficiently. Health Info Libr J 2010;27:106-13. 49. Jones CA, Roop SC, Pohar SL, Albrecht L, Scott SD. Translating knowledge in rehabilitation: systematic review. Phys Ther 2015;95: 663-77. 50. Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil 2014;95:986-95. 51. US National Library of Medicine. MEDLINE data changese2016. NLM technical bulletin. Available at: https://www.nlm.nih.gov/pubs/ techbull/nd15/nd15_medline_data_changes_2016.html#pub_types1. Accessed February 24, 2016. 52. Wilczynski NL, Haynes RB. Consistency and accuracy of indexing systematic review articles and meta-analyses in medline. Health Info Libr J 2009;26:203-10. 53. Boluyt N, Tjosvold L, Lefebvre C, Klassen TP, Offringa M. Usefulness of systematic review search strategies in finding child health systematic reviews in MEDLINE. Arch Pediatr Adolesc Med 2008;162:111-6. 54. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiology and reporting characteristics of systematic reviews. PLoS Med 2007;4:e78. 55. Wilczynski NL, Lokker C, McKibbon KA, Hobson N, Haynes RB. Limits of search filter development. J Med Libr Assoc 2016;104:42-6.

10 56. Jesus TS, Hoenig H. Postacute rehabilitation quality of care: toward a shared conceptual framework. Arch Phys Med Rehabil 2015;96: 960-9. 57. Snell K, Hassan A, Sutherland L, et al. Types and quality of physical therapy research publications: has there been a change in the past decade? Physiother Can 2014;66:382-91.

T.S. Jesus 58. Chevan J, Haskvitz EM. Reported characteristics of participants in physical therapy-related clinical trials. Phys Ther 2015;95: 884-90. 59. Kerry R, Madouasse A, Arthur A, Mumford SD. Analysis of scientific truth status in controlled rehabilitation trials. J Eval Clin Pract 2013;19:617-25.

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Reviews and trials: publication trends

Supplemental Appendix S1 Search Strategy This appendix details the search terms used in the searches as organized by sets of related content. Each set was appropriately combined (with the operator “AND”) with 1 or more of the other sets for each search conducted in PubMed, in combinations described in the main text (see Methods section for details).

Introductory notes  The organization of the MeSH tree and the detailed definitions and elements included within each MeSH term can be found and searched online at: http://www.ncbi.nlm.nih.gov/mesh/ 1000048. Lastly accessed: February 17, 2016.  The “rehabilitation set” was combined with the sets of “journals,” but it was not combined with the sets of “conditions”dalready coupled to a rehabilitation subheading (eg, “Neoplasms/rehabilitation”[majr]).  Finally, in each search, exclusion applies to all the entries that were indexed in PubMed in 2013, but which then have a final publication date only in 2014 or 2015. To facilitate this, references might be sorted in PubMed by “publication date.”

SETs of Terms, by category Common Set (humans and date limitsdused in all the searches, inclusively when searching the full PubMed database “humans”[MeSH Terms] AND (“1900/01/01”[PDAT] : “2013/ 12/31”)

Rehabilitation Set (“rehabilitation”[Subheading] OR “rehabilitation”[All Fields] OR “rehabilitation”[MeSH] OR “Physical and Rehabilitation Medicine”[Mesh] OR “Rehabilitation of Speech and Language Disorders”[Mesh] OR “rehabilitation centers”[MeSH] OR “Rehabilitation Nursing”[Mesh] OR “Rehabilitation, Vocational”[Mesh] OR “Activities of Daily Living”[Mesh] NOT “Correction of Hearing Impairment”[Mesh] NOT “Substance Abuse Treatment Centers”[Mesh] NOT “Mouth Rehabilitation”[Mesh])

Research Designs Systematic Reviews ((Review[ptyp] AND systematic[tw] AND systematic[sb]) OR “Cochrane Database Syst Rev”[Journal]) Systematic Reviews with meta-analyses (((Review[ptyp] AND systematic[tw] AND systematic[sb]) OR “Cochrane Database Syst Rev”[Journal]) AND meta-analysis[ptyp]) Clinical Trials (Clinical Trial[ptyp]) Randomized Controlled Trials (Randomized Controlled Trial[ptyp]) www.archives-pmr.org

10.e1 Empirical research designs (rehab research publications) set (Clinical Trial[ptyp] OR Evaluation Studies[ptyp] OR Comparative Study[ptyp] OR Meta-Analysis[ptyp] OR Observational Study[ptyp] OR Validation Studies[ptyp] OR Pragmatic Clinical Trial[ptyp] OR Clinical Study[ptyp] OR Multicenter Study[ptyp] OR ((Review[ptyp] AND systematic[tw] AND systematic[sb]) OR “Cochrane Database Syst Rev”[Journal])).

Rehabilitation Journals All Journals ever indexed in PubMed for Physical & Rehabilitation Medicinedincludes Occupational Therapy Available at: http://www.ncbi.nlm.nih.gov/nlmcatalog? termZPhysicalþandþRehabilitationþMedicine%5Bst%5D (“Acta Belg Med Phys”[Journal] OR “Adv Clin Rehabil”[Journal] OR “Am Correct Ther J”[Journal] OR “Am J Occup Ther”[Journal] OR “Am J Phys Med”[Journal] OR “Am J Phys Med Rehabil”[Journal] OR “Am Rehabil”[Journal] OR “Ann Readapt Med Phys”[Journal] OR “Ann Phys Rehabil Med”[Journal] OR “Ann Phys Med”[Journal] OR “Annu Rev Rehabil”[Journal] OR “Arch Phys Ther (Leipz)”[Journal] OR “Arch Phys Med Rehabil”[Journal] OR “ARN J”[Journal] OR “Artif Limbs”[Journal] OR “Assist Technol”[Journal] OR “Aust J Physiother”[Journal] OR “Aust Occup Ther J”[Journal] OR “Braz J Phys Ther”[Journal] OR “Bull Prosthet Res”[Journal] OR “Can J Occup Ther”[Journal] OR “Clin Rehabil”[Journal] OR “Dev Neurorehabil”[Journal] OR “Disabil Health J”[Journal] OR “Disabil Rehabil”[Journal] OR “Disabil Rehabil Assist Technol”[Journal] OR “Eura Medicophys”[Journal] OR “Eur J Phys Rehabil Med”[Journal] OR “Fysiatr Revmatol Vestn”[Journal] OR “IEEE Int Conf Rehabil Robot”[Journal] OR “IEEE Trans Neural Syst Rehabil Eng”[Journal] OR “IEEE Trans Rehabil Eng”[Journal] OR “Int Disabil Stud”[Journal] OR “Int J Rehabil Res”[Journal] OR “Int Rehabil Med”[Journal] OR “J Belge Med Phys”[Journal] OR “J Belge Med Phys Rehabil”[Journal] OR “J Belge Rhumatol Med Phys”[Journal] OR “J Back Musculoskelet Rehabil”[Journal] OR “J Bodyw Mov Ther”[Journal] OR “J Burn Care Rehabil”[Journal] OR “J Cardiopulm Rehabil”[Journal] OR “J Cardiopulm Rehabil Prev”[Journal] OR “J Dance Med Sci”[Journal] OR “J Geriatr Phys Ther”[Journal] OR “J Hand Ther”[Journal] OR “J Head Trauma Rehabil”[Journal] OR “J Neuroeng Rehabil”[Journal] OR “J Neurol Phys Ther”[Journal] OR “J Occup Rehabil”[Journal] OR “J Orthop Sports Phys Ther”[Journal] OR “J Outcome Meas”[Journal] OR “J Pediatr Rehabil Med”[Journal] OR “J Physiother”[Journal] OR “J Rehabil”[Journal] OR “J Rehabil Med”[Journal] OR “J Rehabil Med Suppl”[Journal] OR “J Rehabil R D”[Journal] OR “J Rehabil Res Dev”[Journal] OR “J Rehabil Res Dev Clin Suppl”[Journal] OR “J Soc Work Disabil Rehabil”[Journal] OR “J Spinal Cord Med”[Journal] OR “J Sport Rehabil”[Journal] OR “J Am Paraplegia Soc”[Journal] OR “J Assoc Phys Ment Rehabil”[Journal] OR “Man Ther”[Journal] OR “Neuropsychol Rehabil”[Journal] OR “NeuroRehabilitation”[Journal] OR “Neurorehabil Neural Repair”[Journal] OR “Occup Ther Health Care”[Journal] OR “Occup Ther Int”[Journal] OR “Orizz Ortop Odie Riabil”[Journal] OR “Ortop Traumatol Rehabil”[Journal] OR “OTJR (Thorofare N J)”[Journal] OR “Pediatr Phys Ther”[Journal] OR “Pediatr Rehabil”[Journal] OR “Phys Med Rehabil Clin N Am”[Journal] OR “Phys Occup Ther Pediatr”[Journal] OR “Phys Ther”[Journal] OR “Phys Ther Sport”[Journal] OR “Physiotherapy”[Journal] OR “Physiother Res Int”[Journal] OR “Physiother

10.e2 Theory Pract”[Journal] OR “PM R”[Journal] OR “Presse Therm Clim”[Journal] OR “Prog Phys Ther”[Journal] OR “Qual Life Res”[Journal] OR “Radiobiol Radioter Fis Med”[Journal] OR “Record (Washington)”[Journal] OR “Rehab Manag”[Journal] OR “Rehabil Fyz Lek”[Journal] OR “Rehabilitation (Stuttg)”[Journal] OR “Rehabil Lit”[Journal] OR “Rehabil Nurs”[Journal] OR “Rehabil Psychol”[Journal] OR “Rehabil Rec”[Journal] OR “Rehabilitation (Bonn)”[Journal] OR “Rev Bras Fisioter”[Journal] OR “Rheumatol Phys Med”[Journal] OR “Rheumatol Rehabil”[Journal] OR “Scand J Occup Ther”[Journal] OR “Scand J Rehabil Med”[Journal] OR “Scand J Rehabil Med Suppl”[Journal] OR “Soc Rehabil Rec”[Journal] OR “Spec Educ”[Journal] OR “Spec Educ Forward Trends”[Journal] OR “Top Spinal Cord Inj Rehabil”[Journal] OR “Top Stroke Rehabil”[Journal] OR “Torture”[Journal] OR “Train Sch Bull (Vinel)”[Journal] OR “Trans Am Clin Climatol Assoc”[Journal] OR “Vopr Kurortol Fizioter Lech Fiz Kult”[Journal] OR “Z Physiother”[Journal]) The 6 of the above journals publishing more SRs/CTs combineddafter determining the amount of publications for each of the journals above (“Am J Phys Med Rehabil”[Journal] OR “Arch Phys Med Rehabil”[Journal] OR “Clin Rehabil”[Journal] OR “Disabil Rehabil”[Journal] OR “Scand J Rehabil Med”[Journal] OR “J Rehabil Med”[Journal] OR “Phys Ther”[Journal]) Note: The “Scand J Rehabil Med” and the “J Rehabil Med” refer to the same journal in 2 subsequent periodsdie, the second replaced the first. Individually for each of the 6 above Each of the 6 journals above is used at each time.

Conditions typically benefiting from rehabilitation Manifestations Pain: “Pain/rehabilitation”[majr] Motor: (“Dyskinesias/rehabilitation”[majr] OR “Neuromuscular Manifestations/rehabilitation”[majr] OR “Paralysis/rehabilitation”[majr] OR “Paresis/rehabilitation”[majr] OR “Gait Disorders, Neurologic/rehabilitation”[majr] OR “Reflex, Abnormal/ rehabilitation”[majr]) Other Manifestations (cognitive/neurobehavioral, sensorial, communication) (“Neurobehavioral Manifestations/rehabilitation”[majr] OR “Somatosensory Disorders/rehabilitation”[majr] OR “Vertigo/ rehabilitation”[majr] OR “Voice Disorders/rehabilitation”[majr]) Neurologic Diseases: Cerebrovascular diseases: “Cerebrovascular Disorders/rehabilitation”[majr]

T.S. Jesus Spinal Cord Injury: “Spinal Cord Injuries/rehabilitation”[majr] Craniocerebral trauma: “Craniocerebral Trauma/rehabilitation”[majr] Nervous System Diseases (other) ((((((((((“Nervous System Diseases/rehabilitation”[majr]) NOT “Nervous System Neoplasms/rehabilitation”[majr]) NOT “Trauma, Nervous System/rehabilitation”[majr]) NOT “Cerebrovascular Disorders/rehabilitation”[majr]) NOT “Neurologic Manifestations/rehabilitation”[majr]) NOT “Auditory Diseases, Central/rehabilitation”[majr]) NOT “Epilepsy/rehabilitation”[majr]) NOT “Headache Disorders/rehabilitation”[majr]) NOT “Sleep wake Disorders/rehabilitation”[majr]) NOT “Neurotoxicity Syndromes/rehabilitation”[majr]) Notes:  Whether explicitly excluded or not, the term “Chronobiology Disorders/rehabilitation”[majr]) made no difference in the results, so it was not used in this search.  Some terms explicitly excluded (ie, “Headache Disorders/ rehabilitation”[majr] NOT “Sleep wake Disorders/rehabilitation”[majr]) had some entries that could potentially fit as physical rehabilitation interventions, while many others would not; therefore, the terms were excluded. Altogether, including or excluding those 2 terms accounts for <4% of all the entries found within this item. Musculoskeletal Conditions: Musculoskeletal Diseases: (“Musculoskeletal Diseases/rehabilitation”[majr]) Musculoskeletal Trauma/injuries (((((((((((((((((“Amputation, Traumatic/rehabilitation”[majr]) OR “Arm Injuries/rehabilitation”[majr] OR “Birth Injuries/rehabilitation”[majr]) OR “Athletic Injuries/rehabilitation”[majr]) OR “Back Injuries/rehabilitation”[majr]) OR “Burns/rehabilitation”[majr]) OR “Contusions/rehabilitation”[majr]) OR “Dislocations/rehabilitation”[majr]) OR “Fractures, Bone/rehabilitation”[majr]) OR “Fractures, Cartilage/rehabilitation”[majr]) OR “Hand Injuries/rehabilitation”[majr) OR “Hip Injuries/rehabilitation”[majr]) OR “Leg Injuries/rehabilitation”[majr) OR “Multiple Trauma/rehabilitation”[majr]) OR “Neck Injuries/rehabilitation”[majr]) OR “Occupational Injuries/rehabilitation”[majr]) OR “Soft Tissue Injuries/ rehabilitation”[majr]) OR “Tendon Injuries/rehabilitation”[majr]) Other Diseases Cardiac/cardiovascular: (“Cardiovascular Diseases/rehabilitation”[majr] NOT “Cerebrovascular Disorders/rehabilitation”[majr]) Neoplasms: (“Neoplasms/rehabilitation”[majr]) Respiratory Tract Diseases: “Respiratory Tract Diseases/rehabilitation”[majr]

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