Advertisement

On the Reporting of Experimental and Control Therapies in Stroke Rehabilitation Trials: A Systematic Review

Published:February 02, 2018DOI:https://doi.org/10.1016/j.apmr.2017.12.024

      Abstract

      Objective

      To use the Centralized Open-Access Rehabilitation database for Stroke to explore reporting of both experimental and control interventions in randomized controlled trials for stroke rehabilitation (including upper and lower extremity therapies).

      Data Sources

      The Centralized Open-Access Rehabilitation database for Stroke was created from a search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Cumulative Index of Nursing and Allied Health from the earliest available date to May 31, 2014.

      Study Selection

      A total of 2892 titles were reduced to 514 that were screened by full text. This screening left 215 randomized controlled trials in the database (489 independent groups representing 12,847 patients).

      Data Extraction

      Using a mixture of qualitative and quantitative methods, we performed a text-based analysis of how the procedures of experimental and control therapies were described. Experimental and control groups were rated by 2 independent coders according to the Template for Intervention Description and Replication criteria.

      Data Synthesis

      Linear mixed-effects regression with a random effect of study (groups nested within studies) showed that experimental groups had statistically more words in their procedures (mean, 271.8 words) than did control groups (mean, 154.8 words) (P<.001). Experimental groups had statistically more references in their procedures (mean, 1.60 references) than did control groups (mean, .82 references) (P<.001). Experimental groups also scored significantly higher on the total Template for Intervention Description and Replication checklist (mean score, 7.43 points) than did control groups (mean score, 5.23 points) (P<.001).

      Conclusions

      Control treatments in stroke motor rehabilitation trials are underdescribed relative to experimental treatments. These poor descriptions are especially problematic for “conventional” therapy control groups. Poor reporting is a threat to the internal validity and generalizability of clinical trial results. We recommend authors use preregistered protocols and established reporting criteria to improve transparency.

      Keywords

      List of abbreviations:

      PEDro (Physiotherapy Evidence Database), RCT (randomized controlled trial), SCOAR (Centralized Open-Access Rehabilitation database for Stroke), TIDieR (Template for Intervention Description and Replication)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Archives of Physical Medicine and Rehabilitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Duff J.M.
        • Leather H.
        • Walden E.O.
        • LaPlant K.D.
        • George T.J.
        Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application.
        J Natl Cancer Inst. 2010; 102: 702-705
        • Glasziou P.
        • Meats E.
        • Heneghan C.
        • Shepperd S.
        What is missing from descriptions of treatment in trials and reviews?.
        BMJ. 2008; 336: 1472-1474
        • Schroter S.
        • Glasziou P.
        • Heneghan C.
        Quality of descriptions of treatments: a review of published randomised controlled trials.
        BMJ Open. 2012; 2: e001978
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        • et al.
        CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.
        BMC Med. 2010; 8: 18
        • Hoffmann T.C.
        • Glasziou P.P.
        • Boutron I.
        • et al.
        Better reporting of interventions: Template for Intervention Description and Replication (TIDieR) checklist and guide.
        BMJ. 2014; 348: g1687
        • Moher D.
        • Liberati A.
        • Tetzlaff J.
        • Altman D.G.
        • PRISMA Group
        Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement.
        Ann Intern Med. 2009; 151: 264-269
        • Lang C.E.
        • Lohse K.R.
        • Birkenmeier R.L.
        Dose and timing in neurorehabilitation: prescribing motor therapy after stroke.
        Curr Opin Neurol. 2015; 28: 549-555
        • Lohse K.R.
        • Schaefer S.Y.
        • Raikes A.C.
        • Boyd L.A.
        • Lang C.E.
        Asking new questions with old data: the Centralized Open-Access Rehabilitation Database for Stroke.
        Front Neurol. 2016; 7: 153
        • DeJong G.
        • Horn S.D.
        • Gassaway J.A.
        • Slavin M.D.
        • Dijkers M.P.
        Toward a taxonomy of rehabilitation interventions: using an inductive approach to examine the “black box” of rehabilitation.
        Arch Phys Med Rehabil. 2004; 85: 678-686
        • DeJong G.
        • Horn S.D.
        • Conroy B.
        • Nichols D.
        • Healton E.B.
        Opening the black box of poststroke rehabilitation: stroke rehabilitation patients, processes, and outcomes.
        Arch Phys Med Rehabil. 2005; 86: 1-7
        • Mohabbati-Kalejahi N.
        • Yazdi M.A.A.
        • Megahed F.M.
        • et al.
        Streamlining science with structured data archives: insights from stroke rehabilitation.
        Scientometrics. 2017; 113: 969-983
        • Hoffmann T.C.
        • Walker M.F.
        “TIDieR-ing up” the reporting of interventions in stroke research: the importance of knowing what is in the “black box”.
        Int J Stroke. 2015; 10: 657-658
        • Yamato T.
        • Maher C.
        • Saragiotto B.
        • et al.
        The TIDieR checklist will benefit the physical therapy profession.
        Phys Ther. 2016; 96: 930-931
        • van Vliet P.
        • Hunter S.M.
        • Donaldson C.
        • Pomeroy V.
        Using the TIDieR checklist to standardize the description of a functional strength training intervention for the upper limb after stroke.
        J Neurol Phys Ther. 2016; 40: 203-208
        • Schardt C.
        • Adams M.B.
        • Owens T.
        • Keitz S.
        • Fontelo P.
        Utilization of the PICO framework to improve searching PubMed for clinical questions.
        BMC Med Inform Decis Mak. 2007; 7: 16
        • Duncan P.W.
        • Sullivan K.J.
        • Behrman A.L.
        • et al.
        Body-weight-supported treadmill rehabilitation after stroke.
        N Engl J Med. 2011; 364: 2026
        • Harris J.E.
        • Eng J.J.
        • Miller W.C.
        • Dawson A.S.
        A self-administered Graded Repetitive Arm Supplementary Program (GRASP) improves arm function during inpatient stroke rehabilitation: a multi-site randomized controlled trial.
        Stroke. 2009; 40: 2123-2128
        • Lo A.
        • Guarino P.
        • Richards L.
        • Haselkorn J.
        • Wittenberg G.
        Robot-assisted therapy for long-term upper-limb impairment after stroke.
        N Engl J Med. 2010; 362: 1772-1783
        • Parry R.
        • Lincoln N.
        • Vass C.
        Effect of severity of arm impairment on response to additional physiotherapy early after stroke.
        Clin Rehabil. 1999; 13: 187-198
        • Saposnik G.
        • Teasell R.
        • Mamdani M.
        • et al.
        Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.
        Stroke. 2010; 41: 1477-1484
        • Dean C.M.
        • Ada L.
        • Bampton J.
        • Morris M.E.
        • Katrak P.H.
        • Potts S.
        Treadmill walking with body weight support in subacute non-ambulatory stroke improves walking capacity more than overground walking: a randomised trial.
        J Physiother. 2010; 56: 97
        • Timmermans A.A.
        • Verbunt J.A.
        • van Woerden R.
        • Moennekens M.
        • Pernot D.H.
        • Seelen H.A.
        Effect of mental practice on the improvement of function and daily activity performance of the upper extremity in patients with subacute stroke: a randomized clinical trial.
        J Am Med Dir Assoc. 2013; 14: 204-212
        • van Delden A.L.
        • Peper C.L.
        • Nienhuys K.N.
        • Zijp N.I.
        • Beek P.J.
        • Kwakkel G.
        Unilateral versus bilateral upper limb training after stroke: the upper limb training after stroke clinical trial.
        Stroke. 2013; 44: 2613-2616
        • Snijders T.
        • Bosker R.
        Multilevel analysis.
        Sage, Thousand Oaks2012
        • Holmes Finch W.
        • Bolin J.
        • Kelley K.
        Multilevel modelling using R.
        CRC Pr, Boca Raton2014
        • R Core Team
        R: a language and environment for statistical computing.
        (Available at:)
        http://www.r-project.org/
        Date accessed: September 17, 2014
        • Wickham H.
        • Francois R.
        dplyr: a grammar of data manipulation. R Package version 0.3.0.2.
        (Available at:)
        http://user2014.stat.ucla.edu/abstracts/talks/45_Wickham.pdf
        Date: 2014
        Date accessed: August 17, 2015
        • Bates D.
        lme4: mixed-effects modeling with R.
        Springer, New York2010
        • Wickham H.
        ggplot2: elegant graphics for data analysis.
        Springer-Verlag, New York2009
        • Kuznetsov A.
        • Brockhoff P.B.
        • Christensen R.H.B.
        lmerTest: tests for random and fixed effects for linear mixed effect models (lmer objects of lme4 package), v. 2.0–25.
        (Available at:) (Accessed June 30, 2017)
        • Whyte J.
        • Hart T.
        It's more than a black box, it's a Russian doll: defining rehabilitation treatments.
        J Phys Med Rehabil. 2003; 82: 639-652
        • Reinkensmeyer D.J.
        • Burdet E.
        • Casadio M.
        • et al.
        Computational neurorehabilitation: modeling plasticity and learning to predict recovery.
        J Neuroeng Rehabil. 2016; 13: 42
        • Dijkers M.
        • Hart T.
        • Tsaousides T.
        • Whyte J.
        Treatment taxonomy for rehabilitation: past, present, and prospects.
        Arch Phys. 2014; 95: S6-S16
        • Whyte J.
        • Dijkers M.
        • Hart T.
        • Zanca J.
        • Packel A.
        Development of a theory-driven rehabilitation treatment taxonomy: conceptual issues.
        Arch Phys. 2014; 95: S24-S32
        • Moher D.
        • Schulz K.F.
        • Altman D.G.
        The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.
        Lancet. 2001; 357: 1191-1194
        • Hoffmann T.
        • Erueti C.
        • Glasziou P.
        Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials.
        BMJ. 2013; 347: f3755
        • Donaldson C.
        • Tallis R.
        • Pomeroy V.
        A treatment schedule of conventional physical therapy provided to enhance upper limb sensorimotor recovery after stroke: expert criterion validity and intra-rater reliability.
        Physiotherapy. 2009; 95: 110-119
        • Hunter S.
        • Crome P.
        • Sim J.
        • Donaldson C.
        Development of treatment schedules for research: a structured review to identify methodologies used and a worked example of ‘mobilisation and tactile stimulation’ for stroke patients.
        Physiotherapy. 2006; 92: 195-207
        • Kleim J.A.
        • Barbay S.
        • Nudo R.J.
        Functional reorganization of the rat motor cortex following motor skill learning.
        J Neurophysiol. 1998; 80: 3321-3325
        • Nudo R.J.
        • Wise B.M.
        • SiFuentes F.
        • Milliken G.W.
        Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct.
        Science. 1996; 272: 1791-1794
        • Lang C.E.
        • Macdonald J.R.
        • Reisman D.S.
        • et al.
        Observation of amounts of movement practice provided during stroke rehabilitation.
        Arch Phys Med Rehabil. 2009; 90: 1692-1698
        • Lang C.
        • Strube M.
        • Bland M.
        • et al.
        Dose-response of task-specific upper limb training in people at least 6 months post stroke: a phase II, single-blind, randomized, controlled trial.
        Ann Neurol. 2016; 80: 342-354
        • Stinear C.M.
        • Barber P.A.
        • Coxon J.P.
        • Fleming M.K.
        • Byblow W.D.
        Priming the motor system enhances the effects of upper limb therapy in chronic stroke.
        Brain. 2008; 131: 1381-1390

      Linked Article

      • Specifying What We Study and Implement in Rehabilitation: Comments on the Reporting of Clinical Research
        Archives of Physical Medicine and RehabilitationVol. 99Issue 7
        • Preview
          Several guidelines have been published with the goal of increasing the usefulness of reports of clinical research. Although such guidelines may clarify key features of study design, the way in which rehabilitation treatments themselves are described continues to be problematic and limits the ability to replicate research, synthesize evidence across studies, or apply these treatments in practice. Lohse et al report little improvement in the description of rehabilitation treatments in recent years, with particular limitations in the description of comparison or standard-of-care treatments.
        • Full-Text
        • PDF