Selection, Confounding, and Attrition Biases in Randomized Controlled Trials of Rehabilitation Interventions What Are They and How Can They Affect Randomized Controlled Trials Results? Basic Information for Junior Researchers and Clinicians

被引:9
作者
Armijo-Olivo, Susan [1 ,2 ,3 ,4 ]
De Oliveira-Souza, Ana Izabela Sobral [1 ,5 ]
Mohamad, Norazlin [4 ]
de Castro Carletti, Ester Moreira [6 ]
Fuentes, Jorge [7 ]
Ballenberger, Nikolaus [1 ]
机构
[1] Univ Appl Sci Osnabruck, Fac Econ & Social Sci, Caprivistr 30A, D-49076 Osnabruck, Germany
[2] Univ Alberta, Fac Rehabil Med, Edmonton, AB, Canada
[3] Univ Alberta, Fac Dent, Edmonton, AB, Canada
[4] Univ Alberta, Fac Rehabil Med, Dept Phys Therapy, Edmonton, AB T6G 2G4, Canada
[5] Univ Fed Pernambuco, Grad Program Neuropsychiat & Behav Sci, Recife, PE, Brazil
[6] Methodist Univ Piracicaba UNIMEP, Post Grad Program Human Movement Sci, Piracicaba, Brazil
[7] Catholic Univ Maule, Clin Res Lab, Dept Phys Therapy, Talca, Chile
关键词
Rehabilitation; Selection Biases; Confounding; Attrition Biases; Treatment Effects; Randomized Controlled Trials; PHYSICAL-THERAPY TRIALS; INTENTION-TO-TREAT; ALLOCATION CONCEALMENT; MISSING DATA; FOLLOW-UP; QUALITY; ASSOCIATION; OUTCOMES; IMPACT;
D O I
10.1097/PHM.0000000000001947
中图分类号
R49 [康复医学];
学科分类号
100215 ;
摘要
A thorough knowledge of biases in intervention studies and how they influence study results is essential for the practice of evidence-based medicine. The objective of this review was to provide a basic knowledge and understanding of the concept of biases and associated influence of these biases on treatment effects, focusing on the area of rehabilitation research. This article provides a description of selection biases, confounding, and attrition biases. In addition, useful recommendations are provided to identify, avoid, or control these biases when designing and conducting rehabilitation trials. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used. If not addressed appropriately, biases related to intervention research are a threat to internal validity and consequently to external validity. By addressing these biases, ensuring appropriate randomization, allocation concealment, appropriate retention techniques to avoid dropouts, appropriate study design and statistical analysis, among others, will generate more accurate treatment effects. Based on their impact on clinical results, a proper understanding of these concepts is central for researchers, rehabilitation clinicians, and other stakeholders working on this field.
引用
收藏
页码:1042 / 1055
页数:14
相关论文
共 84 条
[1]   Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study [J].
Abraha, Iosief ;
Cherubini, Antonio ;
Cozzolino, Francesco ;
De Florio, Rita ;
Luchetta, Maria Laura ;
Rimland, Joseph M. ;
Folletti, Ilenia ;
Marchesi, Mauro ;
Germani, Antonella ;
Orso, Massimiliano ;
Eusebi, Paolo ;
Montedori, Alessandro .
BMJ-BRITISH MEDICAL JOURNAL, 2015, 350
[2]   Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review [J].
Akl, Elie A. ;
Briel, Matthias ;
You, John J. ;
Sun, Xin ;
Johnston, Bradley C. ;
Busse, Jason W. ;
Mulla, Sohail ;
Lamontagne, Francois ;
Bassler, Dirk ;
Vera, Claudio ;
Alshurafa, Mohamad ;
Katsios, Christina M. ;
Zhou, Qi ;
Cukierman-Yaffe, Tali ;
Gangji, Azim ;
Mills, Edward J. ;
Walter, Stephen D. ;
Cook, Deborah J. ;
Schuenemann, Holger J. ;
Altman, Douglas G. ;
Guyatt, Gordon H. .
BMJ-BRITISH MEDICAL JOURNAL, 2012, 344 :e2809
[3]   Are Biases Related to Attrition, Missing Data, and the Use of Intention to Treat Related to the Magnitude of Treatment Effects in Physical Therapy Trials? A Meta-Epidemiological Study [J].
Armijo-Olivo, Susan ;
da Costa, Bruno R. ;
Ha, Christine ;
Saltaji, Humam ;
Cummings, Greta G. ;
Fuentes, Jorge .
AMERICAN JOURNAL OF PHYSICAL MEDICINE & REHABILITATION, 2022, 101 (06) :520-529
[4]   Attrition, missing data, compliance, and related biases in randomized controlled trials of rehabilitation interventions: towards improving reporting and conduct [J].
Armijo-Olivo, Susan ;
Machalicek, Wendy ;
De Oliveira-Souza, Ana, I ;
Dennett, Liz ;
Ballenberger, Nikolaus .
EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE, 2020, 56 (06) :817-828
[5]   Influence of attrition, missing data, compliance, and related biases and analyses strategies on treatment effects in randomized controlled trials in rehabilitation: a methodological review [J].
Armijo-Olivo, Susan ;
Machalicek, Wendy ;
Dennett, Liz ;
Ballenberger, Nikolaus .
EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE, 2020, 56 (06) :799-816
[6]   Blinding in Rehabilitation Research Empirical Evidence on the Association Between Blinding and Treatment Effect Estimates [J].
Armijo-Olivo, Susan ;
Dennett, Liz ;
Arienti, Chiara ;
Dahchi, Mustafa ;
Arokoski, Jari ;
Heinemann, Allen W. ;
Malmivaara, Antti .
AMERICAN JOURNAL OF PHYSICAL MEDICINE & REHABILITATION, 2020, 99 (03) :198-209
[7]   Blinding in Physical Therapy Trials and Its Association with Treatment Effects A Meta-epidemiological Study [J].
Armijo-Olivo, Susan ;
Fuentes, Jorge ;
da Costa, Bruno R. ;
Saltaji, Humam ;
Ha, Christine ;
Cummings, Greta G. .
AMERICAN JOURNAL OF PHYSICAL MEDICINE & REHABILITATION, 2017, 96 (01) :34-44
[8]   What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study [J].
Armijo-Olivo, Susan ;
Saltaji, Humam ;
da Costa, Bruno R. ;
Fuentes, Jorge ;
Ha, Christine ;
Cummings, Greta G. .
BMJ OPEN, 2015, 5 (09)
[9]   PEDro or Cochrane to Assess the Quality of Clinical Trials? A Meta-Epidemiological Study [J].
Armijo-Olivo, Susan ;
da Costa, Bruno R. ;
Cummings, Greta G. ;
Ha, Christine ;
Fuentes, Jorge ;
Saltaji, Humam ;
Egger, Matthias .
PLOS ONE, 2015, 10 (07)
[10]   Identifying Items to Assess Methodological Quality in Physical Therapy Trials: A Factor Analysis [J].
Armijo-Olivo, Susan ;
Cummings, Greta G. ;
Fuentes, Jorge ;
Saltaji, Humam ;
Ha, Christine ;
Chisholm, Annabritt ;
Pasichnyk, Dion ;
Rogers, Todd .
PHYSICAL THERAPY, 2014, 94 (09) :1272-1284