Skip to main content
Erschienen in: Neurological Sciences 9/2022

31.05.2022 | Review Article

Reporting of “usual care” as the control group in randomized clinical trials of physiotherapy interventions for multiple sclerosis is poor: a systematic review

verfasst von: Matteo Paci, Federico Risaliti, Leonardo Pellicciari

Erschienen in: Neurological Sciences | Ausgabe 9/2022

Einloggen, um Zugang zu erhalten

Abstract

Objective

To compare the description of interventions defined as “usual care” in control groups with those provided in experimental groups in physiotherapy randomized clinical trials for multiple sclerosis.

Methods

Two independent reviewers conducted a literature search and study selection from five databases from their inception to February 2021. Randomized clinical trials aimed to physiotherapy multiple sclerosis treatment and providing “usual care” in the control group were included. Intervention reporting was assessed using the TIDieR checklist. Word and reference counts for each group were extracted. The methodological quality was assessed by the PEDro scale.

Results

Twenty-four articles were included. The TIDieR total scores, word, and reference count were statistically higher in the experimental group, when compared to the control group (p < 0.001). The TIDieR total score is not correlated with PEDro score, word, publication year, or reference counts.

Conclusion

Control treatments identified as “usual care” are underdescribed when compared to experimental treatments, affecting the validity, generalizability, and interpretability of results.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Alla S, Pearson JF, Taylor BV, Miller DH, Clarke G, Richardson A, Willoughby E, Abernethy DA, Sabel CE, Mason DF (2016) Disability profile of multiple sclerosis in New Zealand. J Clin Neurosci 28:97–101CrossRef Alla S, Pearson JF, Taylor BV, Miller DH, Clarke G, Richardson A, Willoughby E, Abernethy DA, Sabel CE, Mason DF (2016) Disability profile of multiple sclerosis in New Zealand. J Clin Neurosci 28:97–101CrossRef
2.
Zurück zum Zitat Ontaneda D, Thompson AJ, Fox RJ, Cohen JA (2017) Progressive multiple sclerosis: prospects for disease therapy, repair, and restoration of function. Lancet 389:1357–1366CrossRef Ontaneda D, Thompson AJ, Fox RJ, Cohen JA (2017) Progressive multiple sclerosis: prospects for disease therapy, repair, and restoration of function. Lancet 389:1357–1366CrossRef
3.
Zurück zum Zitat Campbell E, Coulter EH, Mattison PG, Miller L, McFadyen A, Paul L (2016) Physiotherapy rehabilitation for people with progressive multiple sclerosis: a systematic review. Arch Phys Med Rehabil 97:141-151.e143CrossRef Campbell E, Coulter EH, Mattison PG, Miller L, McFadyen A, Paul L (2016) Physiotherapy rehabilitation for people with progressive multiple sclerosis: a systematic review. Arch Phys Med Rehabil 97:141-151.e143CrossRef
4.
Zurück zum Zitat Amatya B, Khan F, Galea M (2019) Rehabilitation for people with multiple sclerosis: an overview of Cochrane Reviews. Cochrane Database Syst Rev 1:Cd012732PubMed Amatya B, Khan F, Galea M (2019) Rehabilitation for people with multiple sclerosis: an overview of Cochrane Reviews. Cochrane Database Syst Rev 1:Cd012732PubMed
5.
Zurück zum Zitat McGinley MP, Goldschmidt CH, Rae-Grant AD (2021) Diagnosis and treatment of multiple sclerosis: a review. JAMA 325:765–779CrossRef McGinley MP, Goldschmidt CH, Rae-Grant AD (2021) Diagnosis and treatment of multiple sclerosis: a review. JAMA 325:765–779CrossRef
6.
Zurück zum Zitat Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN (2009) Considering usual medical care in clinical trial design. PLoS Med 6:e1000111CrossRef Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN (2009) Considering usual medical care in clinical trial design. PLoS Med 6:e1000111CrossRef
7.
Zurück zum Zitat World Medical Association (2001) World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 79(4):373–374 World Medical Association (2001) World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 79(4):373–374
8.
Zurück zum Zitat Negrini S, Arienti C, Pollet J, Buraschi R, Gobbo M (2019) Opening the black box of ‘usual care’ and finding a black hole: a numerical systematic review on ‘usual care’ control groups in stroke rehabilitation RCTs. BMJ Evid Based Med 24:A27–28 Negrini S, Arienti C, Pollet J, Buraschi R, Gobbo M (2019) Opening the black box of ‘usual care’ and finding a black hole: a numerical systematic review on ‘usual care’ control groups in stroke rehabilitation RCTs. BMJ Evid Based Med 24:A27–28
9.
Zurück zum Zitat Negrini S, Arienti C, Pollet J, Engkasan JP, Francisco GE, Frontera WR, Galeri S, Gworys K, Kujawa J, Mazlan M, Rathore FA, Schillebeeckx F, Kiekens C (2019) Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. J Clin Epidemiol 114:108–117CrossRef Negrini S, Arienti C, Pollet J, Engkasan JP, Francisco GE, Frontera WR, Galeri S, Gworys K, Kujawa J, Mazlan M, Rathore FA, Schillebeeckx F, Kiekens C (2019) Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. J Clin Epidemiol 114:108–117CrossRef
10.
Zurück zum Zitat Lohse KR, Pathania A, Wegman R, Boyd LA, Lang CE (2018) On the reporting of experimental and control therapies in stroke rehabilitation trials: a systematic review. Arch Phys Med Rehabil 99:1424–1432CrossRef Lohse KR, Pathania A, Wegman R, Boyd LA, Lang CE (2018) On the reporting of experimental and control therapies in stroke rehabilitation trials: a systematic review. Arch Phys Med Rehabil 99:1424–1432CrossRef
11.
Zurück zum Zitat Thompson BT, Schoenfeld D (2007) Usual care as the control group in clinical trials of nonpharmacologic interventions. Proc Am Thorac Soc 4:577–582CrossRef Thompson BT, Schoenfeld D (2007) Usual care as the control group in clinical trials of nonpharmacologic interventions. Proc Am Thorac Soc 4:577–582CrossRef
12.
Zurück zum Zitat Freedland KE, Mohr DC, Davidson KW, Schwartz JE (2011) Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 73:323–335CrossRef Freedland KE, Mohr DC, Davidson KW, Schwartz JE (2011) Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 73:323–335CrossRef
13.
Zurück zum Zitat Levack WM, Martin RA, Graham FP, Hay-Smith EJ (2019) Compared to what? An analysis of the management of control groups in Cochrane reviews in neurorehabilitation. Eur J Phys Rehabil Med 55:353–363PubMed Levack WM, Martin RA, Graham FP, Hay-Smith EJ (2019) Compared to what? An analysis of the management of control groups in Cochrane reviews in neurorehabilitation. Eur J Phys Rehabil Med 55:353–363PubMed
14.
Zurück zum Zitat Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 151:W65-94CrossRef Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 151:W65-94CrossRef
15.
Zurück zum Zitat Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687CrossRef Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687CrossRef
16.
Zurück zum Zitat Yamato TP, Maher CG, Saragiotto BT, Catley MJ, Moseley AM (2018) Rasch analysis suggested that items from the template for intervention description and replication (TIDieR) checklist can be summed to create a score. J Clin Epidemiol 101:28–34CrossRef Yamato TP, Maher CG, Saragiotto BT, Catley MJ, Moseley AM (2018) Rasch analysis suggested that items from the template for intervention description and replication (TIDieR) checklist can be summed to create a score. J Clin Epidemiol 101:28–34CrossRef
17.
Zurück zum Zitat Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG (2013) Growth in the Physiotherapy Evidence Database (PEDro) and use of the PEDro scale. Br J Sports Med 47:188–189CrossRef Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG (2013) Growth in the Physiotherapy Evidence Database (PEDro) and use of the PEDro scale. Br J Sports Med 47:188–189CrossRef
18.
Zurück zum Zitat Kelly LE, Davies EH, Saint-Raymond A, Tomasi P, Offringa M (2016) Important issues in the justification of a control treatment in paediatric drug trials. Arch Dis Child 101:962–967CrossRef Kelly LE, Davies EH, Saint-Raymond A, Tomasi P, Offringa M (2016) Important issues in the justification of a control treatment in paediatric drug trials. Arch Dis Child 101:962–967CrossRef
19.
Zurück zum Zitat Yu AM, Balasubramanaiam B, Offringa M, Kelly LE (2018) Reporting of interventions and “standard of care” control arms in pediatric clinical trials: a quantitative analysis. Pediatr Res 84:393–398CrossRef Yu AM, Balasubramanaiam B, Offringa M, Kelly LE (2018) Reporting of interventions and “standard of care” control arms in pediatric clinical trials: a quantitative analysis. Pediatr Res 84:393–398CrossRef
20.
Zurück zum Zitat Berti A, Pini M, Ferrarello F (2020) Argentine tango in the care of Parkinson’s disease: a systematic review and analysis of the intervention. Complement Ther Med 52:102474CrossRef Berti A, Pini M, Ferrarello F (2020) Argentine tango in the care of Parkinson’s disease: a systematic review and analysis of the intervention. Complement Ther Med 52:102474CrossRef
21.
Zurück zum Zitat O’Neil J, McEwen D, Kang BK, Dorion M, Brosseau L, Imoto AM, Álvarez Gallardo IC, Westby MD (2021) Intervention reporting and dissemination of information for the management of hand osteoarthritis. J Hand Ther 34(3):362–368 O’Neil J, McEwen D, Kang BK, Dorion M, Brosseau L, Imoto AM, Álvarez Gallardo IC, Westby MD (2021) Intervention reporting and dissemination of information for the management of hand osteoarthritis. J Hand Ther 34(3):362–368
22.
Zurück zum Zitat Burgess LC, Wainwright TW, James KA, von Heideken J, Iversen MD (2021) The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review. Trials 22:388CrossRef Burgess LC, Wainwright TW, James KA, von Heideken J, Iversen MD (2021) The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review. Trials 22:388CrossRef
23.
Zurück zum Zitat Pieri E, Bonetti F, Pellicciari L, Scipioni F (2021) Well-described exercises for chronic low back pain in Life Science Literature: a systematic review. J Back Musculoskelet Rehabil (in press) Pieri E, Bonetti F, Pellicciari L, Scipioni F (2021) Well-described exercises for chronic low back pain in Life Science Literature: a systematic review. J Back Musculoskelet Rehabil (in press)
24.
Zurück zum Zitat McEwen D, O’Neil J, Miron-Celis M, Brosseau L (2019) Content reporting in post-stroke therapeutic circuit-class exercise programs in randomized control trials. Top Stroke Rehabil 26:281–287CrossRef McEwen D, O’Neil J, Miron-Celis M, Brosseau L (2019) Content reporting in post-stroke therapeutic circuit-class exercise programs in randomized control trials. Top Stroke Rehabil 26:281–287CrossRef
25.
Zurück zum Zitat Slade SC, Dionne CE, Underwood M, Buchbinder R, Beck B, Bennell K, Brosseau L, Costa L, Cramp F, Cup E, Feehan L, Ferreira M, Forbes S, Glasziou P, Habets B, Harris S, Hay-Smith J, Hillier S, Hinman R, Holland A, Hondras M, Kelly G, Kent P, Lauret GJ, Long A, Maher C, Morso L, Osteras N, Peterson T, Quinlivan R, Rees K, Regnaux JP, Rietberg M, Saunders D, Skoetz N, Sogaard K, Takken T, van Tulder M, Voet N, Ward L, White C (2016) Consensus on Exercise Reporting Template (CERT): modified Delphi study. Phys Ther 96:1514–1524CrossRef Slade SC, Dionne CE, Underwood M, Buchbinder R, Beck B, Bennell K, Brosseau L, Costa L, Cramp F, Cup E, Feehan L, Ferreira M, Forbes S, Glasziou P, Habets B, Harris S, Hay-Smith J, Hillier S, Hinman R, Holland A, Hondras M, Kelly G, Kent P, Lauret GJ, Long A, Maher C, Morso L, Osteras N, Peterson T, Quinlivan R, Rees K, Regnaux JP, Rietberg M, Saunders D, Skoetz N, Sogaard K, Takken T, van Tulder M, Voet N, Ward L, White C (2016) Consensus on Exercise Reporting Template (CERT): modified Delphi study. Phys Ther 96:1514–1524CrossRef
26.
Zurück zum Zitat Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, de Bie RA, van den Ende CH, van Meeteren NL (2012) Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS ONE 7:e38031CrossRef Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, de Bie RA, van den Ende CH, van Meeteren NL (2012) Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS ONE 7:e38031CrossRef
27.
Zurück zum Zitat Kattackal TR, Cavallo S, Brosseau L, Sivakumar A, Del Bel MJ, Dorion M, Ueffing E, Toupin-April K (2020) Assessing the reporting quality of physical activity programs in randomized controlled trials for the management of juvenile idiopathic arthritis using three standardized assessment tools. Pediatr Rheumatol Online J 18:41 Kattackal TR, Cavallo S, Brosseau L, Sivakumar A, Del Bel MJ, Dorion M, Ueffing E, Toupin-April K (2020) Assessing the reporting quality of physical activity programs in randomized controlled trials for the management of juvenile idiopathic arthritis using three standardized assessment tools. Pediatr Rheumatol Online J 18:41
Metadaten
Titel
Reporting of “usual care” as the control group in randomized clinical trials of physiotherapy interventions for multiple sclerosis is poor: a systematic review
verfasst von
Matteo Paci
Federico Risaliti
Leonardo Pellicciari
Publikationsdatum
31.05.2022
Verlag
Springer International Publishing
Erschienen in
Neurological Sciences / Ausgabe 9/2022
Print ISSN: 1590-1874
Elektronische ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-022-06167-9

Weitere Artikel der Ausgabe 9/2022

Neurological Sciences 9/2022 Zur Ausgabe

Leitlinien kompakt für die Neurologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Niedriger diastolischer Blutdruck erhöht Risiko für schwere kardiovaskuläre Komplikationen

25.04.2024 Hypotonie Nachrichten

Wenn unter einer medikamentösen Hochdrucktherapie der diastolische Blutdruck in den Keller geht, steigt das Risiko für schwere kardiovaskuläre Ereignisse: Darauf deutet eine Sekundäranalyse der SPRINT-Studie hin.

Frühe Alzheimertherapie lohnt sich

25.04.2024 AAN-Jahrestagung 2024 Nachrichten

Ist die Tau-Last noch gering, scheint der Vorteil von Lecanemab besonders groß zu sein. Und beginnen Erkrankte verzögert mit der Behandlung, erreichen sie nicht mehr die kognitive Leistung wie bei einem früheren Start. Darauf deuten neue Analysen der Phase-3-Studie Clarity AD.

Viel Bewegung in der Parkinsonforschung

25.04.2024 Parkinson-Krankheit Nachrichten

Neue arznei- und zellbasierte Ansätze, Frühdiagnose mit Bewegungssensoren, Rückenmarkstimulation gegen Gehblockaden – in der Parkinsonforschung tut sich einiges. Auf dem Deutschen Parkinsonkongress ging es auch viel um technische Innovationen.

Demenzkranke durch Antipsychotika vielfach gefährdet

23.04.2024 Demenz Nachrichten

Wenn Demenzkranke aufgrund von Symptomen wie Agitation oder Aggressivität mit Antipsychotika behandelt werden, sind damit offenbar noch mehr Risiken verbunden als bislang angenommen.

Update Neurologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.